Intervenciones para el prurito en personas con nefropatía crónica avanzada
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "...allocated to two groups test and control using block randomization." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | High risk | No placebo group |
| Blinding of outcome assessment (detection bias) | Unclear risk | No placebo group, not reported |
| Incomplete outcome data (attrition bias) | Low risk | Less than %10 attrition per study protocol |
| Selective reporting (reporting bias) | Low risk | Specified results clearly reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Balanced blocked randomization with a block size of four was used." |
| Allocation concealment (selection bias) | Low risk | QUOTE: "Each set of eight bottles were packed into one container, each of which was numbered for each patient." "Code‐breaking was carried out after data analysis." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "All the participants and the investigator were blinded to group assignment." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "All the participants and the investigator were blinded to group assignment." |
| Incomplete outcome data (attrition bias) | Unclear risk | Dropouts: treatment group (9); control group (7) |
| Selective reporting (reporting bias) | Low risk | Results clearly and fully reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "They were divided into two groups of experimental and control as random allocation block" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Single blind" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "The interviewer did not know the patients grouping into intervention and control" |
| Incomplete outcome data (attrition bias) | Unclear risk | 10 dropouts post‐randomisation |
| Selective reporting (reporting bias) | Unclear risk | Not specified what metrics of severity are being tested |
| Other bias | Unclear risk | During the study 72% and 52% of patients in the experimental and control group consumed medications such as antihistamines, Renagel, hydroxyzine, erythropoietin, and gabapentin No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "double‐blind randomised, Patients were randomly assigned to two groups " |
| Allocation concealment (selection bias) | Unclear risk | QUOTE: "double‐blind randomised" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double‐blind randomised, patients and drug distributors were not aware of the prescribed medications " |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "double‐blind randomised, patients and drug distributors were not aware of the prescribed medications" |
| Incomplete outcome data (attrition bias) | Low risk | All patients randomised completed the study |
| Selective reporting (reporting bias) | High risk | Baseline scores not reported, raw scores not reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "The physician investigator enrolled the subjects into this study, and using a computer‐generated block of four, another investigator generated the random allocation sequence that divided the patients into two groups. The identities of the patients in each group were concealed from both the investigators and the patients." |
| Allocation concealment (selection bias) | Low risk | QUOTE: "The physician investigator enrolled the subjects into this study, and using a computer‐generated block of four, another investigator generated the random allocation sequence that divided the patients into two groups. The identities of the patients in each group were concealed from both the investigators and the patients." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "The identities of the patients in each group were concealed from both the investigators and the patients" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "The identities of the patients in each group were concealed from both the investigators and the patients" |
| Incomplete outcome data (attrition bias) | Low risk | 3 dropouts (6%) "due to relocation". Unlikely to influence patients' body part/sides served as controls |
| Selective reporting (reporting bias) | Unclear risk | Split body trial with only aggregate intervention level data without patient level comparisons provided |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Participants were randomised to receive active drug and placebo in a double‐blind crossover study." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Participants were randomised to receive active drug and placebo in a double‐blind crossover study." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Patients recorded the intensity of pruritus each day on a 0‐to‐10 visual analogue scale" Patient assessed VAS |
| Incomplete outcome data (attrition bias) | Unclear risk | 3/19 dropouts. Dropouts were balanced. Not ITT |
| Selective reporting (reporting bias) | Low risk | Cross‐over study, protocol in advance, both periods combined reported |
| Other bias | Unclear risk | Supported by grant from Glaxo Group Research and Yorkshire Kidney Research Fund |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "...included in a double blind randomised study that evaluated the effects of classic antihistaminic (group AH) before the effects of a placebo (P) during 4 weeks." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "...included in a double blind randomised study that evaluated the effects of classic antihistaminic (group AH) before the effects of a placebo (P) during 4 weeks." |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts post randomisation |
| Selective reporting (reporting bias) | High risk | Only P‐values and t‐scores reported; unable to meta‐analyse |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE "determined by randomization" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE "double blind" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE "double blind" |
| Incomplete outcome data (attrition bias) | Unclear risk | 11 dropouts |
| Selective reporting (reporting bias) | High risk | Only percentage change and P‐values reported |
| Other bias | Unclear risk | Abstract‐only publication |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised" |
| Allocation concealment (selection bias) | Unclear risk | QUOTE: "randomised" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "packaged in similar soft gel capsules containing 1 g ethyl ester each" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "packaged in similar soft gel capsules containing 1 g ethyl ester each" |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts and complete reporting |
| Selective reporting (reporting bias) | Low risk | No dropouts and complete reporting |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE "randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Unclear risk | Insufficient information to permit judgement |
| Selective reporting (reporting bias) | Unclear risk | Baseline, percent change and CI reported |
| Other bias | Unclear risk | Abstract‐only publication |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "17 pruritic hemodialysis patients were randomised to one of two treatment groups: UVA (placebo) or UVB phototherapy." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "In a single blinded fashion" |
| Blinding of outcome assessment (detection bias) | Low risk | Patient reported VAS scores |
| Incomplete outcome data (attrition bias) | Unclear risk | No post randomisation dropouts |
| Selective reporting (reporting bias) | Unclear risk | No placebo results explicitly reported. Reported in bar graph |
| Other bias | Low risk | QUOTE: "Supported by the United States Veterans Administration." No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group (DS)
Control group 1 (P1)
Control group 2 (P2)
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomization was conducted using an online randomiser (http://www.randomization.com) following stratification for gender and age (in 5‐year categories)" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "All were packaged in containers void of labelling except for the treatment code number and were identical in terms of shape, size and colour so that identification of treatment assignment was unknowable to the participant, study investigators and medical personnel. The code for treatment identification was held by a company representative and revealed only after data were analysed." ‐Treatments were unlabeled. coded, and held by a third party |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "DS, P1 and P2 were identical in colour, texture and scent. All were packaged in containers void of labelling except for the treatment code number and were identical in terms of shape, size and colour so that identification of treatment assignment was unknowable to the participant, study investigators and medical personnel. The code for treatment identification was held by a company representative and revealed only after data were analysed." ‐Treatments were virtually identical unlabeled. coded, and held by a third party |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "DS, P1 and P2 were identical in colour, texture and scent. All were packaged in containers void of labelling except for the treatment code number and were identical in terms of shape, size and colour so that identification of treatment assignment was unknowable to the participant, study investigators and medical personnel. The code for treatment identification was held by a company representative and revealed only after data were analysed." ‐Treatments were virtually identical unlabeled. coded, and held by a third party |
| Incomplete outcome data (attrition bias) | Unclear risk | 4,5,4 dropouts from DS, P1, P2 |
| Selective reporting (reporting bias) | Low risk | Baseline and post interventions results fully reported |
| Other bias | High risk | Ahava Dead Sea Laboratories, Ein Bokek, Israel, provided a research grant to the research fund of the Institute of Nephrology and the Epidemiology and Research Unit at E. Wolfson Medical Center, Holon, Israel. Two of the co‐authors, Miriam Oron and Zeevi Maor, are employees at Ahava Dead Sea Laboratories |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | Double blind |
| Blinding of outcome assessment (detection bias) | Low risk | Double blind |
| Incomplete outcome data (attrition bias) | High risk | Multiple patient dropouts |
| Selective reporting (reporting bias) | High risk | No statistics reported |
| Other bias | Low risk | No evidence for publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: '"randomly allocated" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "double blinded" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "double blinded" |
| Incomplete outcome data (attrition bias) | High risk | 15% dropout rate, unclear allocation |
| Selective reporting (reporting bias) | High risk | Only "p > 0.1" reported |
| Other bias | Unclear risk | No washout period. No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "...were randomised for a six‐week UVB(N=10) double‐blind non‐crossover study against placebo (UVA, N=9)" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double‐blind non‐crossover..." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Assessment was made by a single investigator who was blind‐folded for the type of UV therapy to avoid observer variation." |
| Incomplete outcome data (attrition bias) | Low risk | One post‐randomisation patient in the UVB group died of a stroke |
| Selective reporting (reporting bias) | High risk | Distribution of VAS reported as bimodal and nonlinear. No means were reported. Only P‐values (Fisher exact test) and graphs |
| Other bias | Unclear risk | Abstract‐only publication; insufficient information to permit judgement |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "At the end of the baseline day, patients were randomly assigned to group A or group B." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "patients applied topical GLA‐rich cream or placebo cream in a double‐blind fashion to their entire body" |
| Blinding of outcome assessment (detection bias) | Low risk | Patient recorded pruritus score, double blinded |
| Incomplete outcome data (attrition bias) | Low risk | 1 dropout (allergic reaction to GLA cream) |
| Selective reporting (reporting bias) | Unclear risk | Median and IQR clearly reported for each treatment phase. Group level data without individual patient level comparisons provided |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "An independent technician allocated the patients into one of two groups, either HPHD or CHD, according to a random‐number table" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double blind" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "double blind" |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts after randomisation |
| Selective reporting (reporting bias) | Low risk | All results clearly and fully reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Treatment order was arranged from computer generated numbers" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "by a coauthor who did not participate in observations" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blinded" and "were unknown by the observers and patients" |
| Blinding of outcome assessment (detection bias) | Low risk | Double blind, patients made self‐evaluations, base creams ""were unknown by the observers and patients" |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients completed the trial and were analysed. |
| Selective reporting (reporting bias) | Low risk | Baseline and post interventions results fully reported Intervention level data report with patient level graphical comparison comparisons provided. Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods. |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "patients were randomly assigned" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "All placebo and intervention labelling hidden by treatment code." "Code broken only after completion" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "All treatment was hidden by treatment code. Both placebo and intervention delivered in the same way." |
| Blinding of outcome assessment (detection bias) | Low risk | Assessment performed by a "single investigator who was unaware of treatment assignments" "treatment code was only broken after the trial had ended" |
| Incomplete outcome data (attrition bias) | Low risk | One withdrawal in second crossover period (recorded as non‐responding for at least the first week). Unclear if ITT, but unlikely to significantly influence results |
| Selective reporting (reporting bias) | High risk | All entered patients completed the trial and were analysed VAS documented directly from patient diaries Intervention level data without patient level comparisons provided No washout period specified |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "randomised, double‐blind, vehicle controlled study" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "randomised, double‐blind, vehicle controlled study" |
| Blinding of outcome assessment (detection bias) | Low risk | Patient recorded VAS |
| Incomplete outcome data (attrition bias) | Unclear risk | 2 dropout in vehicle (kidney transplantation and lack of improvement) Unclear if ITT |
| Selective reporting (reporting bias) | High risk | No SDs reported |
| Other bias | High risk | Supported by Fujisawa Health Care Inc, Deerfield, Ill. |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Unclear of specific method in translation, but a randomisation technique is likely used |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | Double blinded |
| Blinding of outcome assessment (detection bias) | Low risk | Double blinded |
| Incomplete outcome data (attrition bias) | Low risk | All 24 patients reported on for each 2‐week period |
| Selective reporting (reporting bias) | Low risk | Main outcomes fully reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Study described as "randomised double‐blind placebo‐controlled"; method of randomisation not reported |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "double‐blind"; insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "double‐blind"; insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Unclear risk | Insufficient information to permit judgement |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
| Other bias | Unclear risk | Abstract‐only publication; insufficient information to permit judgement |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomization was performed by using a simple random table," |
| Allocation concealment (selection bias) | Low risk | QUOTE: "The placebo was formulated by a pharmacist to have a similar base with the drug but not containing the active ingredient and stored in a tube without any labelling. A similar tube was used to store CS 4% to make both creams to look physically identical." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "The placebo was formulated by a pharmacist to have a similar base with the drug but not containing the active ingredient and stored in a tube without any labelling. A similar tube was used to store CS 4% to make both creams to look physically identical." |
| Blinding of outcome assessment (detection bias) | Low risk | The medications used were not revealed to their physicians |
| Incomplete outcome data (attrition bias) | Low risk | All entered patients completed the trial and were analysed |
| Selective reporting (reporting bias) | Low risk | Baseline and results clearly reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "randomly assigned to pregabalin or doxepin based on block randomization" |
| Allocation concealment (selection bias) | Unclear risk | QUOTE: "Patients were not blind to their treatment, but who evaluated the participants and who statistically analyzed the results did not know the allocated medication of each patient" |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "Patients were not blind to their treatment, but who evaluated the participants and who statistically analyzed the results did not know the allocated medication of each patient" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Patients were not blind to their treatment, but who evaluated the participants and who statistically analyzed the results did not know the allocated medication of each patient" |
| Incomplete outcome data (attrition bias) | Unclear risk | Not ITT, 9 dropouts in each arm all with justifications |
| Selective reporting (reporting bias) | Low risk | Clear reporting of scores at all time points |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | QUOTE: "Patients were divided into two groups randomly by alternation method" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blinded", "Fish oil and placebo capsules with the same shape and volume" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes came from "observation and interview", "double blinded" No other specific information |
| Incomplete outcome data (attrition bias) | Low risk | All entered patients completed the trial and were analysed |
| Selective reporting (reporting bias) | Unclear risk | Results reported as percent reduction of a customised itch score Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods. |
| Other bias | Low risk | No evidence for publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomization was performed by using a simple random table." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double Blind", Patients given unlabelled medication as start of trial" |
| Blinding of outcome assessment (detection bias) | Low risk | Patient recorded VAS |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients completed the trial and were analysed |
| Selective reporting (reporting bias) | Low risk | Baseline and results clearly reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "Blinded" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "Blinded" |
| Incomplete outcome data (attrition bias) | Unclear risk | Unclear if any patient dropped out |
| Selective reporting (reporting bias) | Low risk | Full results clearly reported |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "were randomly assigned to one of two treatment schedules" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not reported, similar control treatment |
| Blinding of outcome assessment (detection bias) | High risk | Not reported, likely known to assessors |
| Incomplete outcome data (attrition bias) | High risk | 6 dropouts due to unspecified concurrent illness. Unknown which arm they were randomised to. Not Intention to treat |
| Selective reporting (reporting bias) | High risk | Unclear grading of pruritis and not classified by patient; unable to meta‐analyse |
| Other bias | Unclear risk | Poor/minimal exclusion criteria; no evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "were randomly assigned to one of two treatment schedules" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Not reported, similar control treatment |
| Blinding of outcome assessment (detection bias) | High risk | Not reported, likely known to assessors |
| Incomplete outcome data (attrition bias) | High risk | 6 dropouts due to unspecified concurrent illness. Unknown which arm they were randomised to. Not Intention to treat |
| Selective reporting (reporting bias) | Unclear risk | Unclear grading of pruritis and not classified by patient |
| Other bias | Unclear risk | Poor/minimal exclusion criteria; no evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomisation was performed by an individual unrelated to the clinical follow‐up using specific software" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "Randomisation was performed by an individual unrelated to the clinical follow‐up using specific software, and the information was held in a sealed opaque envelope containing the name of the therapeutic agent proposed for each group. The randomisation list was under the care of the researchers and patients were labelled as “Group 1” or “Group 2” |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Both groups were instructed to take one tablet every 12 hours and received two bottles identified as “Home” and “Dialysis”. The “Home” bottle was taken at home by the patient who was directed to take medication twice a day on non‐HD days and once daily on HD days. To maintain blinding of the study, for the GABA group, the “Home” bottle contained a placebo identical to the gabapentin capsule, and the medication was stored in the “Dialysis” bottle. The “Dialysis” bottle remained in the Dialysis Unit, and the medication was administered to patients at the end of the session by the responsible technician. Participants and assessors were blinded to the treatment groups" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Participants and assessors were blinded to the treatment groups" |
| Incomplete outcome data (attrition bias) | Low risk | Statistical analysis was conducted by intention to treat (ITT). The missing data (dropouts) were replaced by the last recorded values (LOCF) 1 dropout in each arm post randomisation |
| Selective reporting (reporting bias) | Low risk | Results clearly reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "On a random and blinded basis, patients were assigned to" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "On a random and blinded basis, patients were assigned", "We conducted a double‐blind," |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "double‐blinded", "The daily pruritus scores of patients were collected VAS from patient diaries.", "On a random and blinded basis, patients were assigned" |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients completed the trial and were analysed. Multiple 1 week washout periods preceding intervention and control periods. |
| Selective reporting (reporting bias) | Unclear risk | All entered patients completed the trial and were analysed Both periods combined reported with mean change and standard deviations reported in full Intervention level data without patient level comparisons provided. Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods |
| Other bias | Low risk | No intervention first group (however 1 week washout). No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "A staff team not involved in the trial organized and held the randomisation list and serially numbered envelopes." |
| Allocation concealment (selection bias) | Low risk | QUOTE: "A staff team not involved in the trial organized and held the randomisation list and serially numbered envelopes. They passed envelopes to the principal investigator after demonstrating that the patient has consented to the trial." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "The non‐thermal therapy group received a plain adhesive patch placed on the same acupoint and routine care. The principal investigator stayed with these patients for the same duration as the thermal therapy group." QUOTE: "The staff team was did not know to which treatment group a patient would be allocated. The principal investigator opened envelopes to reveal the study treatment allocation and then administered the intervention." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "The staff team was did not know to which treatment group a patient would be allocated. The principal investigator opened envelopes to reveal the study treatment allocation and then administered the intervention." |
| Incomplete outcome data (attrition bias) | Unclear risk | Eight participants (thermal group = 3, non‐thermal group = 5) declined or were unable to participate in the study for various reasons (e.g. dermatological disorders and other medical conditions). Not ITT. |
| Selective reporting (reporting bias) | Low risk | Baseline and results reported for both arms |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly assigned by random serial number generated from a random number table |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | High risk | No change to dialysis for control group |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Unclear risk | Insufficient information to permit judgement |
| Selective reporting (reporting bias) | Low risk | Baseline and final scores fully reported |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "randomly allocated to two groups with the aid of ClinStat software" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Low risk | < 10% dropout in both groups and balanced |
| Selective reporting (reporting bias) | Unclear risk | All results clearly reported |
| Other bias | Low risk | No evidence for publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "The enrolled patients were randomly assigned to the treatment and control groups, with an allocation ratio of 1: 1, according to a sequence of computer‐generated randomised codes" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "The control group received time‐matched exposures to long‐ wave UVA. The doses of UVA were approximately 1– 6 J cm‐2, which was an appropriate control in this study." "Single blinded" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "Single blinded" |
| Incomplete outcome data (attrition bias) | Low risk | An allocation ratio of 1:1 of is reported |
| Selective reporting (reporting bias) | Low risk | Baseline and results reported for both arms |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "receive 5 µg, 2.5 µg nalfurafine or a placebo using a variable size permuted block design stratified by centre" |
| Allocation concealment (selection bias) | Unclear risk | QUOTE: "variable size permuted block design" this implies the assignments are coded |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "The patients took the soft capsules containing the drug or placebo once daily" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "double blinded". Patient's directly recorded their VAS scores. |
| Incomplete outcome data (attrition bias) | Low risk | QUOTE: "Each arm had 2‐3 patients discontinue due to adverse effects. 1 patient in each arm who did not received any treatment were not analysed." |
| Selective reporting (reporting bias) | Low risk | Baseline and post interventions results fully reported |
| Other bias | Low risk | No evidence for publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Low risk | All patients completed the trial and are reported on |
| Selective reporting (reporting bias) | High risk | Pre and post intervention scores not reported |
| Other bias | Unclear risk | No female participants; no evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "This was a randomised study (drawing of lots)" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | High risk | Not reported. Likely not blinded. No discussion for treatment concealment |
| Blinding of outcome assessment (detection bias) | High risk | Not blinded |
| Incomplete outcome data (attrition bias) | Unclear risk | Unclear number of dropouts, at least 10 |
| Selective reporting (reporting bias) | High risk | Missing raw data (No standard deviations for either group or baseline scores score for the natrexone group reported) |
| Other bias | High risk | Conflicting results and arbitrary definitions of improvement; no evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patient randomly selected letters |
| Allocation concealment (selection bias) | Low risk | QUOTE: "Sealed letters" |
| Blinding of participants and personnel (performance bias) | High risk | Participants aware of their intervention |
| Blinding of outcome assessment (detection bias) | High risk | Participants aware of their intervention |
| Incomplete outcome data (attrition bias) | Unclear risk | Specified pre and post intervention scores not reported, but some surrogate statistics are |
| Selective reporting (reporting bias) | Low risk | < 10% dropouts post randomisation |
| Other bias | Unclear risk | Patients recruited mid study to replace all dropout as specified in their protocol |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | QUOTE: "All qualified participants were recruited. Those currently receiving haemodialysis treatment every Monday, Wednesday and Friday were enrolled in experimental group 1; those currently receiving haemodialysis treatment on Tuesday, Thursday and Saturday, were enrolled in experimental group 2. The control group consisted of patients randomly selected from the above two groups." Quasi‐RCT |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | High risk | Doctor administered questionnaire with no blinding reported |
| Incomplete outcome data (attrition bias) | Low risk | 3 skin rash, privacy concerns and hospitalisation. Unclear which treatment arms they were in |
| Selective reporting (reporting bias) | Low risk | Change in pruritus and baseline pruritus reported |
| Other bias | Unclear risk | Poor exclusion criteria. Blinding likely not possible as intended for intervention type. No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "...enrolled in the study and based on block randomization method, were randomised into 2 groups of 40 participants" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "All medication and placebo tablets were similar in size, shape, weight, color, and package. Clinical investigators, laboratory personnel, and patients were all masked to the treatment assignment and code breaking was done at the end of study" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "All medication and placebo tablets were similar in size, shape, weight, color, and package. Clinical investigators, laboratory personnel, and patients were all masked to the treatment assignment and code breaking was done at the end of study" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "All medication and placebo tablets were similar in size, shape, weight, color, and package. Clinical investigators, laboratory personnel, and patients were all masked to the treatment assignment and code breaking was done at the end of study" |
| Incomplete outcome data (attrition bias) | Low risk | < 10% dropout in each arm, roughly equal, with explanation |
| Selective reporting (reporting bias) | Low risk | Outcomes clearly reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomly assigned by lottery into 2 groups" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blind" QUOTE: "The placebo was prepared in a same size and colour packages as Capsian 0.03% ointment tubes." |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "Double blind" QUOTE: "The placebo was prepared in a same size and colour packages as Capsian 0.03% ointment tubes." |
| Incomplete outcome data (attrition bias) | Low risk | All entered patients completed the trial and were analysed |
| Selective reporting (reporting bias) | Low risk | Baseline and results reported for both arms |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised, triple‐blind study" |
| Allocation concealment (selection bias) | Unclear risk | QUOTE: "randomised, triple‐blind study" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "randomised, triple‐blind study" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "randomised, triple‐blind study" |
| Incomplete outcome data (attrition bias) | Low risk | < 10% dropouts per arm with explanation |
| Selective reporting (reporting bias) | Low risk | Clear results |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A simple randomization will be carried out by computer using the medcalc software" |
| Allocation concealment (selection bias) | High risk | "open, comparative clinical trial" |
| Blinding of participants and personnel (performance bias) | High risk | "open, comparative clinical trial" |
| Blinding of outcome assessment (detection bias) | High risk | "open, comparative clinical trial" |
| Incomplete outcome data (attrition bias) | Low risk | 5% attrition rate (2 drop out in the gabapentin group and none in the Loratidine group) |
| Selective reporting (reporting bias) | Low risk | All results fully and clearly reported |
| Other bias | Low risk | "The study is financed by the Hospital de Concentración ISSEMyM Satélite" No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "A Double‐Blind randomised Trial" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "Double‐Blind" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "Double‐Blind" and patient recorded diary |
| Incomplete outcome data (attrition bias) | Unclear risk | Unclear, but with implication of no dropouts |
| Selective reporting (reporting bias) | Low risk | Baseline and postintervention results reported |
| Other bias | Unclear risk | QUOTE: "Supported in part by research grants from Fresenius AG, Oberursel; the Khalil Foundation; the Robert‐Bosch Foundation, Stuttgart; and Fa Medice, Iserlohn, Germany" |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE "randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE "Double Blinded" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE "Double Blinded" |
| Incomplete outcome data (attrition bias) | Unclear risk | Insufficient information to permit judgement |
| Selective reporting (reporting bias) | Unclear risk | Change in pruritus and baseline pruritus reported |
| Other bias | Unclear risk | Abstract only |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Randomly assigned" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | High risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Unclear risk | Insufficient information to permit judgement |
| Selective reporting (reporting bias) | High risk | No numeric results |
| Other bias | Unclear risk | Abstract‐only publication; poorly explained inclusion/exclusion criteria |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised" |
| Allocation concealment (selection bias) | Unclear risk | QUOTE: "Double blind" |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "Double blind" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "Double blind" |
| Incomplete outcome data (attrition bias) | Unclear risk | Unclear dropout rate |
| Selective reporting (reporting bias) | High risk | Only group means and a nonspecific P value reported |
| Other bias | Unclear risk | Abstract‐only publication; insufficient information to permit judgement |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "On a random basis, 24 patients were blindly allocated..." |
| Allocation concealment (selection bias) | Low risk | QUOTE: "On a random basis, 24 patients were blindly allocated..." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "... were blindly allocated to the ondansetron‐placebo sequence and 10 to the placebo‐ondansetron sequence" |
| Blinding of outcome assessment (detection bias) | Low risk | QUUOTE: "Double blind", VAS directly recorded by patients. Investigator independent from implementation |
| Incomplete outcome data (attrition bias) | High risk | Not ITT. ~25% attrition. Non‐compliance and complications partially addressed. Cross‐over design likely limits the severity of the bias |
| Selective reporting (reporting bias) | Low risk | VAS from patient diaries. All baselines and results reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "On a random and blinded basis" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "On a random and blinded basis" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "On a random and blinded basis" |
| Incomplete outcome data (attrition bias) | Low risk | QUOTE: "All of the patients completed the study" |
| Selective reporting (reporting bias) | Low risk | The mean difference of pruritus score (VAS) before and after treatment was fully reported. One week washout in between all interventions and controls. Carry‐over effects unlikely |
| Other bias | Unclear risk | Abstract‐only publication; group level data without patient level comparisons provided; correlation may inflate SE |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "The patients were randomly allocated to receive either gabapentin 400 mg or placebo" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "to prepare the placebo, we emptied gabapentin capsules and refilled them with flour, thus making them indistinguishable" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "double blind" VAS from patient diaries. Investigator independent |
| Incomplete outcome data (attrition bias) | Low risk | All entered patients completed the trial and were analysed |
| Selective reporting (reporting bias) | Low risk | Baseline and mean decreases reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "The patients were then randomly assigned into treatment and placebo groups." |
| Allocation concealment (selection bias) | Low risk | QUOTE: "At the end of the study the drug and placebo groups were determined by decoding." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blind", "while the other group received a similar shaped and coloured capsule which was a placebo" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Neither the patients nor the physicians had any knowledge of the group to which patients were assigned. The patients were assigned codes, and at the end of the study the drug and placebo groups were determined by decoding." |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patient completed the trial and were analysed |
| Selective reporting (reporting bias) | Low risk | Baseline and postintervention results clearly recorded |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Treatment group 3
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: Assigned by random numbers to 3 groups (two with 8 patients and one with 9). The CONSORT flowchart that describes the progress of the patients through the trial" |
| Allocation concealment (selection bias) | Unclear risk | QUOTE: "Assigned by random numbers to 3 groups (two with 8 patients and one with 9). The CONSORT flowchart that describes the progress of the patients through the trial" |
| Blinding of participants and personnel (performance bias) | High risk | Topical and scented intervention versus oral |
| Blinding of outcome assessment (detection bias) | High risk | Topical and scented intervention versus oral |
| Incomplete outcome data (attrition bias) | Low risk | 2 dropouts post randomisation due to kidney transplantation |
| Selective reporting (reporting bias) | High risk | Only 3‐day washout. Intervention level data without patient level comparisons provided |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "The patients were randomly divided into groups 1 and 2" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "single‐blind" |
| Blinding of outcome assessment (detection bias) | High risk | QUOTE: "single‐blind" |
| Incomplete outcome data (attrition bias) | Low risk | Anaemia from myelodysplasic syndrome in montelukast arm (1); death but to myocardial infarction in placebo (1) Not ITT, but followed the Good Clinical Practices guidelines in RCTs which recommended including the MI patient and excluding the myelodysplasic patient |
| Selective reporting (reporting bias) | Unclear risk | Only percent changes recorded with no baseline Intervention level data without patient level comparisons provided Carry‐over effects unlikely due to washout periods |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomization was done by random number list" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "single‐blinded trial" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "single‐blinded trial" |
| Incomplete outcome data (attrition bias) | Low risk | All randomised patient analysed |
| Selective reporting (reporting bias) | Low risk | All results clearly reported |
| Other bias | Low risk | No evidence for publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "...randomised in two groups..." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double‐blind", "Patients and investigators were not aware of the medications prescribed." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Double‐blind", "Patients and investigators were not aware of the medications prescribed." |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients randomised and analysed at trial completion. No dropouts |
| Selective reporting (reporting bias) | Low risk | Mean and SE of VAS at baseline and after the intervention reported in full for both placebo and Gabapentin groups |
| Other bias | Unclear risk | Abstract‐only publication; insufficient information to permit judgement |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomization was performed by using a simple random table" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "The used medications were not revealed to the treating physicians." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "The patients were oriented as to how to interpret their pruritus based on Visual Analogue Scale (VAS)" |
| Incomplete outcome data (attrition bias) | Low risk | 1 dropout from Nicotinamide group |
| Selective reporting (reporting bias) | Low risk | All baseline and weekly results reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "open, randomised and comparative study" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts in either group |
| Selective reporting (reporting bias) | Unclear risk | Baseline and weekly results all reported Group level data without individual patient level comparisons provided |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Factorial block randomisation was used for allocation sequence" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "The allocation sequence was concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed envelopes." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Clinical investigators, laboratory personnel, and patients were all masked to the treatment assignment." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Clinical investigators, laboratory personnel, and patients were all masked to the treatment assignment." |
| Incomplete outcome data (attrition bias) | Low risk | One dropout (1% attrition rate), unlikely to change study results |
| Selective reporting (reporting bias) | Low risk | All baseline and final results reported |
| Other bias | Low risk | No evidence for publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "...randomly we divided patients into two groups" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "This double blinded clinical trial" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "This double blinded clinical trial" |
| Incomplete outcome data (attrition bias) | Unclear risk | During the course of study one patient from control group died due to an accident and three patients of this group quit the study as a result of feeling no relief in their symptom. Twenty‐one patients remained in control group |
| Selective reporting (reporting bias) | Low risk | Clearly reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised, double‐blind, placebo‐controlled crossover study" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blind" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Double blind". Patient recorded their own scores "on a daily basis by marking a visual analogue scale (VAS)" |
| Incomplete outcome data (attrition bias) | Low risk | 5 dropouts. Mostly from developing an indication for opiates. ITT protocol followed |
| Selective reporting (reporting bias) | Unclear risk | Means and CIs from each week reported for each of naltrexone and placebo Group level data without patient level comparisons provided. Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Treatment group 3
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Patients were randomly assigned into three groups" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blinded" |
| Blinding of outcome assessment (detection bias) | Low risk | Double blinded, patient reported Duo score |
| Incomplete outcome data (attrition bias) | High risk | 16 dropouts out of 41 enrolled |
| Selective reporting (reporting bias) | Low risk | Detail table of results (mean, standard error) at baseline, postintervention, and net change for all groups |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Patients were randomly assigned..." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Double blinded, "treatments "administered orally in identical opaque capsules", "iron pills masked the charcoal stained stools" |
| Blinding of outcome assessment (detection bias) | Unclear risk | "Double blind", unclear is assessors blinded |
| Incomplete outcome data (attrition bias) | High risk | Likely 9 dropouts/20, patients dropped for low compliance |
| Selective reporting (reporting bias) | High risk | Incomplete results with arbitrary markers for improvement |
| Other bias | Unclear risk | No washout indicated, unlike other naltrexone studies; no evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "entered a randomised double‐blind placebo controlled crossover study (figure 1)" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blind" |
| Blinding of outcome assessment (detection bias) | Low risk | Double blind. Patient recorded their own scores |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patients completed the trial and were analysed |
| Selective reporting (reporting bias) | Unclear risk | Unclear reporting of placebo itch score SDs Group level data without patient level comparisons provided. Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods. |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "They were randomly assigned..." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "...placed in another capsule in order to provide placebo capsules similar in shape, size, and colour." "The patients and the physicians involving in their management were blind to the randomization." |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "The patients and the physicians involving in their management were blind to the randomization. Assessments based on clinician subjective reports." |
| Incomplete outcome data (attrition bias) | Low risk | One patient dropout from doxepin group; did not complete placebo portion |
| Selective reporting (reporting bias) | Unclear risk | Aggregate results reported, arbitrary and subjective reporting of outcomes Group level data without patient level comparisons provided. Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods. |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "The random permuted block method was used" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "the [researcher] was unaware of whether they were assigned to the intervention or control", "triple blinded" |
| Blinding of participants and personnel (performance bias) | Unclear risk | QUOTE: "triple blinded"; unclear how one can blind patients to temperature |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "triple blinded" |
| Incomplete outcome data (attrition bias) | Low risk | No post randomisation dropouts |
| Selective reporting (reporting bias) | High risk | Only baseline VAS reported. Quantitative results of the regression not reported |
| Other bias | Unclear risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE " in a random order" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE "in double blind manner" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE "in double blind manner" |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts reported |
| Selective reporting (reporting bias) | High risk | Only nonspecific, interpreted results reported |
| Other bias | Unclear risk | Abstract only publication |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation table |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Blinded" while discussing participants |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "Blinded" |
| Incomplete outcome data (attrition bias) | Low risk | < 10% dropouts |
| Selective reporting (reporting bias) | Low risk | Full results reported with paired testing |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | QUOTE: "By alternation" |
| Allocation concealment (selection bias) | High risk | QUOTE: "By alternation" |
| Blinding of participants and personnel (performance bias) | High risk | QUOTE: "Unblinded" |
| Blinding of outcome assessment (detection bias) | High risk | QUOTE: "Unblinded" |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts |
| Selective reporting (reporting bias) | Low risk | Results reported in full |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Computer‐generated random numbers" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "A research pharmacist prepackaged ergocalciferol and placebo tablets into opaque bottles. A research nurse, who did not participate in con sent, pruritus surveys, or study analysis assigned patients to the appropriate pill bottle. The research nurse also dispensed the medication to the patient (within 1 week of the prerandomization visit and randomisation assignment)." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Patients and investigators were blinded to the allocation of the study drug." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Patients and investigators were blinded to the allocation of the study drug." |
| Incomplete outcome data (attrition bias) | Low risk | ITT protocol, 6 dropout (4 in Ergocalciferol group) |
| Selective reporting (reporting bias) | Low risk | Baseline and result fully reported at www.clinicaltrial.gov |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "were randomly assigned" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double blind" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | High risk | 18/29 completed the study after randomisation, no ITT |
| Selective reporting (reporting bias) | High risk | Only subjective responder rates recorded with arbitrary cut offs. Group level data without patient level comparisons provided. Carry‐over effects unlikely due to washout periods. |
| Other bias | Low risk | No evidence for publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "patients were randomly assigned to two treatments" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blinded" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled patient completed the trial and were analysed |
| Selective reporting (reporting bias) | Low risk | All patient outcomes reported |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "randomised double blind study design" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blind" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Unclear risk | 5 dropout (2 placebo, 1 rHuEPO) reasons not reported |
| Selective reporting (reporting bias) | Unclear risk | Baseline VAS scores not reported |
| Other bias | Unclear risk | Insufficient information to permit judgement |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Patients were randomised into either gabapentin (25 patients) or pregabalin (25 patients) treatment arms using computer generated random numbers." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study |
| Incomplete outcome data (attrition bias) | Unclear risk | 5 dropouts from each group. ITT unclear |
| Selective reporting (reporting bias) | Unclear risk | Change (mean and SD) in VAS clearly reported for each treatment type and period Group level data without patient level comparisons provided. Carry‐over effects unlikely due to washout periods. |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Multi‐center (21 US sites), randomised (1:1), double‐blind, placebo‐controlled, parallel‐group Phase 2 study" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double‐blind, placebo‐controlled, parallel‐group Phase 2 study" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "double‐blind, placebo‐controlled, parallel‐group Phase 2 study" |
| Incomplete outcome data (attrition bias) | Unclear risk | One dropout in the placebo group, unlikely to affect outcomes |
| Selective reporting (reporting bias) | Low risk | Mean and SD of changes and baseline VAS score reported for both CR845 and placebo |
| Other bias | High risk | The present study was fully supported by Cara Therapeutics, Inc. The authors received medical writing assistance from Edward Weselcouch, PhD, of PharmaWrite (Princeton, NJ), which was funded by Cara Therapeutics, Inc. RHS, JWS, and FM are employees of Cara Therapeutics, Inc |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Treatment group 3
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Patients were randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Unclear risk | Dropouts not reported |
| Selective reporting (reporting bias) | High risk | 1.0 µg/kg and placebo results not fully reported |
| Other bias | High risk | Abstract‐only publications; funded by Cara Therapeutics |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions |
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "in a randomised..." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double blind" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "double‐blind" |
| Incomplete outcome data (attrition bias) | Unclear risk | Dropouts not reported |
| Selective reporting (reporting bias) | Unclear risk | Unclear reporting. Assumed to be results from 120 min, but not clear. No results of the ANOVA reported |
| Other bias | Unclear risk | Abstract only; no declaration relating to conflicts of interest |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Route not specified but implied oral | |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Patients were randomised assigned" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double‐blinded" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "double‐blinded" |
| Incomplete outcome data (attrition bias) | Unclear risk | Partial reporting on 5 dropout |
| Selective reporting (reporting bias) | Low risk | Within and between group changes clearly reported |
| Other bias | Low risk | Abstract only; no declaration relating conflicts of interest |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not reported |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | High risk | 17/33 patients failed to complete study |
| Selective reporting (reporting bias) | High risk | No data available to meta‐analyse |
| Other bias | Unclear risk | Insufficient information to permit judgement |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "The order of study medicaments used was randomly assigned for consecutive patients according to a computer‐generated randomization code." |
| Allocation concealment (selection bias) | Low risk | QUOTE: "Both observer and patient were blinded to the identity of the medications, which were contained in identical opaque plastic bottles." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Both observer and patient were blinded to the identity of the medications, which were contained in identical opaque plastic bottles." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Both observer and patient were blinded to the identity of the medications, which were contained in identical opaque plastic bottles." |
| Incomplete outcome data (attrition bias) | Low risk | One dropout, unlikely to change results |
| Selective reporting (reporting bias) | Unclear risk | Baseline and final scores recorded in full Group level data without patient level comparisons provided. Carry‐over effects unlikely due to washout periods |
| Other bias | Low risk | Interventions used "as required". No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Table of random numbers" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "Vial arranged in order and patient enters study area with unlabelled vials" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double Blind", "Identical vials" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "investigator unaware of vial order" |
| Incomplete outcome data (attrition bias) | High risk | Four placebo patients unaccounted for in analysis |
| Selective reporting (reporting bias) | High risk | Simple binary response fully reported, only 6 placebo patients reported on with no explanation |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Treatment order is block‐randomized with the use of computer‐generated random numbers" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blinded" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Double blind, doctor evaluated, complex assignments |
| Incomplete outcome data (attrition bias) | Unclear risk | 2 dropouts, not ITT |
| Selective reporting (reporting bias) | High risk | Placebo results not reported Group level data without patient level comparisons provided |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised into control and treatment groups" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Unclear risk | Unblinded (used a radiation barrier) |
| Blinding of outcome assessment (detection bias) | High risk | Unblinded (used a radiation barrier) |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts |
| Selective reporting (reporting bias) | High risk | Qualitative results only |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "On a random basis..." |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Blinded" |
| Blinding of outcome assessment (detection bias) | Low risk | Patient recorded VAS independent of assessors |
| Incomplete outcome data (attrition bias) | Low risk | All patient enrolled completed the trial |
| Selective reporting (reporting bias) | High risk | Placebo results not reported Intervention level data without patient level comparisons provided. Carry‐over effects unlikely due to washout periods |
| Other bias | Low risk | No evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 3
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Randomization was performed by site personnel, using a centralized interactive web‐based randomization system, which assigned unique blister card numbers reflecting the blinded treatment assignment" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "Randomization was performed by site personnel, using a centralized interactive web‐based randomization system, which assigned unique blister card numbers reflecting the blinded treatment assignment" |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "The sponsor, study site personnel, and all contract research organization personnel involved in the conduct of the trial were blinded to treatment assignment. Matching placebo was used" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "The sponsor, study site personnel, and all contract research organization personnel involved in the conduct of the trial were blinded to treatment assignment. Matching placebo was used" |
| Incomplete outcome data (attrition bias) | High risk | Not ITT, high number of post‐randomisation dropout with explanation |
| Selective reporting (reporting bias) | Low risk | Numerical rate scale clearly reported |
| Other bias | High risk | For‐profit pharmaceutical development |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomly assigned" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "double‐blind" |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "double‐blind" |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts |
| Selective reporting (reporting bias) | Low risk | Results clearly reported |
| Other bias | Unclear risk | Washout period unclear; no evidence of publication or funding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | QUOTE: "Stratified randomization method where the prognostic factor was the gender variable" |
| Allocation concealment (selection bias) | Low risk | QUOTE: "Drug packages were prepared by the principal investigator (G.V.). Both the participants and the investigator that administered the interventions and assessed the outcomes were blinded to group assignment. Code breaking was performed at the end of data analysis." |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Drug packages were prepared by the principal investigator (G.V.). Both the participants and the investigator that administered the interventions and assessed the outcomes were blinded to group assignment. Code breaking was performed at the end of data analysis." |
| Blinding of outcome assessment (detection bias) | Low risk | QUOTE: "Drug packages were prepared by the principal investigator (G.V.). Both the participants and the investigator that administered the interventions and assessed the outcomes were blinded to group assignment. Code breaking was performed at the end of data analysis." |
| Incomplete outcome data (attrition bias) | High risk | 11 dropouts from each arm. Not analysed on ITT
|
| Selective reporting (reporting bias) | Low risk | Clearly reported full results |
| Other bias | Low risk | No evidence of publication or funding bias. |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Study 1 treatment group
Study 1 control group
Study 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "patients were randomly assigned in this study" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double blinded" |
| Blinding of outcome assessment (detection bias) | Low risk | Double blinded, Patient recorded VAS independent of assessor |
| Incomplete outcome data (attrition bias) | Low risk | < 10% attrition and balanced, analysed with ITT |
| Selective reporting (reporting bias) | Low risk | Cross‐over period 2 ignored, but mentioned in protocol |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "The patients were randomly assigned into two study groups:" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "in a double‐blind manner." |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) | Low risk | All patient enrolled completed the trial |
| Selective reporting (reporting bias) | Unclear risk | No actual itch scores reported. Only bar graph and P‐values |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "a randomised, double‐blind, controlled comparative trial" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "a randomised, double‐blind, controlled comparative trial" |
| Blinding of outcome assessment (detection bias) | Unclear risk | Clinical evaluation, double blinded |
| Incomplete outcome data (attrition bias) | Low risk | One dropout (~3%), unlikely to changes study results |
| Selective reporting (reporting bias) | High risk | Only a regression slope result reported |
| Other bias | High risk | Financial conflicts of interest ‐ Funding obtained from Stiefel Laboratories (GSK), a manufacturer of skin care products |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
Control group
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "Patients were randomly assigned to 12 weeks of treatment" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | Low risk | QUOTE: "Double‐blind" |
| Blinding of outcome assessment (detection bias) | Unclear risk | QUOTE: "prescription of pregabalin for UP was not mentioned in the dispensatory." |
| Incomplete outcome data (attrition bias) | Low risk | ~5% dropout rate. Unclear in following ITT |
| Selective reporting (reporting bias) | Low risk | Baseline and final itch results reported in full for all interventions and placebo (mean and standard error) |
| Other bias | Low risk | No evidence of publication, funding, or other confounding bias |
| Study characteristics | ||
| Methods |
| |
| Participants |
| |
| Interventions | Treatment group 1
Treatment group 2
| |
| Outcomes |
| |
| Notes |
| |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | QUOTE: "randomised" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts post randomisation |
| Selective reporting (reporting bias) | Low risk | VAS clearly reported for both groups |
| Other bias | Low risk | No evidence of publication or funding bias |
APD ‐ automated peritoneal dialysis; BP ‐ blood pressure; CKD ‐ chronic kidney disease; DM ‐ diabetes mellitus; (rHu)EPO ‐ (recombinant human) erythropoietin; ESKD ‐ end‐stage kidney disease; Hb ‐ haemoglobin; HCT ‐ haematocrit; HD ‐ haemodialysis; HDF ‐ haemodiafiltration; ITT ‐ intention‐to‐treat; IV ‐ intravenous; Kt/V ‐ dialysis adequacy; M/F ‐ male/female; PD ‐ peritoneal dialysis; (i)PTH ‐ (intact) parathyroid hormone; RCT ‐ randomised controlled trial; SBP ‐ systolic blood pressure; SC ‐ subcutaneous; SD ‐ standard deviation; SE ‐ standard error; SLE ‐ systemic lupus erythematosus; UV ‐ ultraviolet; VAS ‐ visual analogue scale; WBC ‐ white blood cell/s
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| QUOTE: "All patients with pruritus entered in a crossover, double‐blind trial with nicergoline. In a first period of six dialyses, they received either nicergoline (daily oral dose, 30 mg, and intravenous dose during dialyses, 5 mg) or placebo. In the second period of six dialyses, patients received the crossover treatment" COMMENT: Randomisation unclear; unable to confirm | |
| Wrong intervention: not applicable pruritus intervention for this review (music) | |
| Wrong intervention: not applicable pruritus intervention for this review (homeopathy) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupuncture) | |
| Wrong intervention: not applicable pruritus intervention for this review (self care) | |
| Wrong intervention: not applicable pruritus intervention for this review (exercise for cardiovascular health) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupuncture) | |
| Wrong study design: no control | |
| Wrong intervention: not applicable pruritus intervention for this review (massage) | |
| Wrong intervention: not applicable pruritus intervention for this review (massage) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupuncture) | |
| Other: study terminated due to lack of enrolment | |
| Wrong intervention: not pruritus intervention (acupuncture) | |
| Wrong population: includes all pruritus, not just uraemic pruritus | |
| QUOTE: " At entry patients were selected to receive loratidine or placebo for two weeks after which crossover occurred" COMMENT: Randomisation unclear and no mention of dose | |
| Protocol only. No update in > 30 years | |
| We did not consider allocation based on dialysis schedule as quasi‐randomisation. More than alternation or other forms of quasi‐RCT this introduces additional bias | |
| Recruitment status unknown (not yet recruiting as of 7 July 2007) | |
| Recruitment status unknown (not yet recruiting as of 4 February 2010) | |
| Recruitment status unknown (not yet recruiting as of 23 February 2010) | |
| Recruitment status unknown (not yet recruiting as of 4 February 2010) | |
| Recruitment status: terminated due to insufficient patient recruitment (17 March 2016) | |
| Recruitment status unknown (not yet recruiting as of 15 April 2014) | |
| Recruitment status unknown (not yet recruiting as of 10 January 2014) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupuncture) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupressure) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupressure) | |
| Wrong intervention: not applicable pruritus intervention for this review (aromatherapy) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupuncture) | |
| Wrong control: UVA versus PUVA are indistinguishable interventions | |
| We did not consider allocation based on dialysis schedule as quasi‐randomisation. More than alternation or other forms of quasi‐RCT this introduces additional bias | |
| Areas on each patient are randomised to treatment rather than patients | |
| Wrong intervention: not applicable pruritus intervention for this review (acupressure) | |
| We did not consider allocation based on dialysis schedule as quasi‐randomisation. More than alternation or other forms of quasi‐RCT this introduces additional bias | |
| Wrong intervention: not applicable pruritus intervention for this review (massage) | |
| Wrong intervention: not applicable pruritus intervention for this review (acupuncture) |
Characteristics of studies awaiting classification [ordered by study ID]
| Methods |
|
| Participants |
|
| Interventions | Treatment group
Control group
|
| Outcomes |
|
| Notes |
|
| Methods |
|
| Participants |
Inclusion criteria
Exclusion criteria
|
| Interventions | Treatment group 1
Treatment group 2
Control group
|
| Outcomes |
|
| Notes |
|
| Methods |
|
| Participants |
Inclusion criteria
Exclusion criteria
|
| Interventions | Treatment group
Control group
|
| Outcomes |
|
| Notes |
|
| Methods | Parallel, open‐label, RCT |
| Participants | Inclusion criteria:
Exclusion criteria:
|
| Interventions |
|
| Outcomes |
|
| Notes |
|
ADAMA ‐ asymmetric dimethylarginine; BMI ‐ body mass index; BMP2 ‐ bone morphogenetic protein 2; CABG ‐ coronary artery bypass grafting; CKD ‐ chronic kidney disease; CRP ‐ C‐reactive protein; ESKD ‐ end‐stage kidney disease; HD ‐ haemodialysis; MOS ‐ medical outcomes study; NRS ‐ numerical rating scale; NYHA ‐ New York Heart Association; PCI ‐ percutaneous coronary intervention; PGIC ‐ Patient Global Impression of Change; (i)PTH ‐ (intact) parathyroid hormone; QoL ‐ quality of life; RCT ‐ randomised control trial; URR ‐ urea reduction ratio; VAS ‐ visual analogue scale
Characteristics of ongoing studies [ordered by study ID]
| Study name | In patients with end stage renal failure on dialysis, does evening primrose oil, compared to omega‐3 fish oil and placebo improve pruritis? |
| Methods | Double blinded, placebo controlled RCT |
| Participants | Patients with ESKD undergoing dialysis (in hospital or at home) |
| Interventions |
|
| Outcomes | VAS, rule of nines and questions involving QoL |
| Starting date | Not yet recruiting |
| Contact information | Dr Jane Holt Department of Renal Medicine Wollongong Hospital Dudley Street Wollongong NSW 2500 + 61 02 4222 5443 |
| Notes |
| Study name | A phase IV, randomised, double‐blind, controlled, parallel group trial to evaluate the effectiveness and safety of balneum plus vs emollient in the treatment of uraemic pruritus in haemodialysis patients |
| Methods | Double‐blind, controlled, parallel RCT |
| Participants | Receiving HD for the treatment of ESKD for at least 3 months; aged > 18 years |
| Interventions |
|
| Outcomes | The primary outcome measure will be reduction in itch intensity as measured by VAS |
| Starting date | 13 November 2015 |
| Contact information | Jacqueline Nevols Queen Alexandra Hospital Portsmouth PO6 3LY UK 02392286000 |
| Notes |
| Study name | Effect of omega‐3 on pruritus scale in hemodialysis patients |
| Methods | Double‐blinded, parallel RCT |
| Participants | HD for at least 3 months; pruritus duration > 8 weeks; without any dermatologic problems; no hypersensitivity to omega‐3; no malabsorption or other gastrointestinal problems (chronic diarrhoea > 2 weeks); not using anticoagulant and antiplatelet drugs Exclusion criteria: non‐compliance; kidney transplantation; antihistamine or gabapentin using; anaemia (Hb < 7 g/dL); PTH > 300 µg/L; phosphorus >7 mg/dL; INR rising; aged > 16 years |
| Interventions | Omega‐3 fatty acid supplementation |
| Outcomes | Questionnaire (VAS) |
| Starting date | 22 November 2013 |
| Contact information | Firouzeh Moeinzadeh University of Medical Sciences Iran, Islamic Republic of +98 31 1625 5555 |
| Notes |
| Study name | The effect of aloe vera gel on pruritus severity of hemodialysis patients |
| Methods | Double‐blind, controlled, parallel RCT |
| Participants | Receiving HD for the treatment of ESKD for at least 3 months; aged > 18 years |
| Interventions | Aloe vera gel will be used 2 times in a day for 1 month |
| Outcomes | 5‐D pruritus scale |
| Starting date | 23 July 2015 |
| Contact information | Azam Malek Hoseini Arak University of Medical Sciences, Alamolhoda St, Arak Arak 3817834467 Iran +98 86 3226 7892 |
| Notes |
| Study name | A multicenter, double‐blind, randomised, placebo‐controlled study to evaluate the safety and efficacy of intravenous CR845 in hemodialysis patients with moderate‐to‐severe pruritus, with a 52‐week open label extension |
| Methods | Double‐blind, parallel RCT |
| Participants | Receiving HD for the treatment of ESKD for at least 3 months; aged > 18 years |
| Interventions | IV CR845 0.5 µg/kg administered after each dialysis session (3 times/week) versus IV placebo |
| Outcomes | Reduction in itch intensity Improvement in itch‐related QoL |
| Starting date | 20 February 2018 |
| Contact information | Frédérique Menzaghi, PhD, Cara Therapeutics |
| Notes |
| Study name | A multicenter, double‐blind, randomised, placebo‐controlled study to evaluate the safety and efficacy of intravenous CR845 in hemodialysis patients with moderate‐to‐severe pruritus, with a 52‐week open label extension |
| Methods | Parallel, double blind, RCT |
| Participants | 350 |
| Interventions | CR845 0.5 µg/kg versus placebo |
| Outcomes | 24‐hour worst itching intensity (NRS) |
| Starting date | 17 July 17 2018 |
| Contact information | Georgine Ragsdale, PharmD 203‐406‐3700 [email protected] |
| Notes |
| Study name | Safety and efficacy of PG102P for the coNtrol of prUritus in patients underGoing hemodialysis (SNUG Trial): study protocol for a randomised control trial |
| Methods | Parallel, double blind, RCT |
| Participants | 80 |
| Interventions | PG102P 1.5 g/day |
| Outcomes | VAS |
| Starting date | May 1, 2018 |
| Contact information | Yong Chul Kim, MD +82‐2‐2072‐1724 Seoul National University Boramae Medical Center |
| Notes |
ESKD ‐ end‐stage kidney disease; Hb ‐ haemoglobin; HD ‐ haemodialysis; INR ‐ international normalised ratio; NRS ‐ numerical rating scale; PTH ‐ parathyroid hormone; QoL ‐ quality of life; RCT ‐ randomised controlled trial; VAS ‐ visual analogue scale
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Itch Show forest plot | 30 | Std. Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 1.1  Comparison 1: Pharmacological interventions (oral or IV), Outcome 1: Itch | ||||
| 1.1.1 GABA analogues | 5 | 297 | Std. Mean Difference (IV, Random, 95% CI) | ‐2.14 [‐2.43, ‐1.85] |
| 1.1.2 GABA analogues versus antihistamine | 5 | 220 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.44 [‐0.75, ‐0.14] |
| 1.1.3 Ondansetron | 3 | 183 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.17 [‐0.49, 0.15] |
| 1.1.4 Kappa‐opioid agonist | 4 | 661 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.43 [‐0.60, ‐0.27] |
| 1.1.5 Mu‐opioid antagonist | 2 | 62 | Std. Mean Difference (IV, Random, 95% CI) | ‐4.10 [‐11.05, 2.85] |
| 1.1.6 Nalbuphine | 1 | 179 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.22 [‐0.54, 0.10] |
| 1.1.7 Cromolyn | 1 | 40 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.31 [‐2.00, ‐0.62] |
| 1.1.8 Nicotinamide | 1 | 50 | Std. Mean Difference (IV, Random, 95% CI) | 0.32 [‐0.23, 0.88] |
| 1.1.9 EPO | 1 | 20 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.50 [‐1.39, 0.39] |
| 1.1.10 Cholestyramine | 2 | 20 | Std. Mean Difference (IV, Random, 95% CI) | 0.00 [‐0.89, 0.89] |
| 1.1.11 Montelukast | 2 | 87 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.40 [‐1.87, ‐0.92] |
| 1.1.12 Sertraline | 1 | 46 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.56 [‐1.15, 0.03] |
| 1.1.13 Lidocaine | 1 | 16 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.81 [‐1.87, 0.25] |
| 1.1.14 Gabapentin versus pregabalin | 1 | 40 | Std. Mean Difference (IV, Random, 95% CI) | 0.01 [‐0.61, 0.63] |
| 1.1.15 GABA analogues versus doxepin | 1 | 72 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.84 [‐1.33, ‐0.36] |
| 1.2 Itch (dichotomous) Show forest plot | 3 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| Analysis 1.2  Comparison 1: Pharmacological interventions (oral or IV), Outcome 2: Itch (dichotomous) | ||||
| 1.2.1 Lidocaine | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.2.2 Thalidomide | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.2.3 Doxepin | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Itch Show forest plot | 10 | Std. Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 2.1  Comparison 2: Topical interventions, Outcome 1: Itch | ||||
| 2.1.1 Capsaicin cream | 2 | 112 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.84 [‐1.22, ‐0.45] |
| 2.1.2 Pramoxine cream | 1 | 27 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.35 [‐1.11, 0.41] |
| 2.1.3 Calcineurin Inhibitor cream | 1 | 60 | Std. Mean Difference (IV, Random, 95% CI) | 0.39 [‐0.13, 0.90] |
| 2.1.4 Dead Sea lotion | 1 | 41 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.52 [‐1.14, 0.10] |
| 2.1.5 Cromolyn cream | 1 | 60 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.34 [‐0.85, 0.17] |
| 2.1.6 Baby oil | 1 | 93 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.87 [‐1.32, ‐0.43] |
| 2.1.7 L‐arginine salve | 1 | 48 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.25 [‐0.82, 0.32] |
| 2.1.8 Polyunsaturated fatty acids | 2 | 78 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.91 [‐1.99, 0.17] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Itch Show forest plot | 7 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 3.1  Comparison 3: Oral or IV supplements, Outcome 1: Itch | ||||
| 3.1.1 Polyunsaturated fatty acids | 1 | 22 | Mean Difference (IV, Random, 95% CI) | ‐11.30 [‐19.01, ‐3.59] |
| 3.1.2 L‐carnitine (IV) | 1 | 12 | Mean Difference (IV, Random, 95% CI) | ‐0.26 [‐2.85, 2.33] |
| 3.1.3 Zinc sulfate | 2 | 76 | Mean Difference (IV, Random, 95% CI) | ‐1.77 [‐2.88, ‐0.66] |
| 3.1.4 Ergocalciferol | 1 | 50 | Mean Difference (IV, Random, 95% CI) | 0.40 [‐2.48, 3.28] |
| 3.1.5 Turmeric | 1 | 100 | Mean Difference (IV, Random, 95% CI) | ‐6.40 [‐7.42, ‐5.38] |
| 3.1.6 Fumaria parviflora | 1 | 63 | Mean Difference (IV, Random, 95% CI) | ‐3.90 [‐5.04, ‐2.76] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Itch Show forest plot | 4 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 4.1  Comparison 4: Haemodialysis modality, Outcome 1: Itch | ||||
| 4.1.1 High flux or permeability HD | 3 | 202 | Mean Difference (IV, Random, 95% CI) | ‐2.62 [‐3.72, ‐1.52] |
| 4.1.2 NMR haemoperfusion | 1 | 90 | Mean Difference (IV, Random, 95% CI) | ‐2.37 [‐2.89, ‐1.85] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Itch Show forest plot | 5 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 5.1  Comparison 5: Other interventions, Outcome 1: Itch | ||||
| 5.1.1 UV‐B | 4 | 86 | Mean Difference (IV, Random, 95% CI) | ‐4.06 [‐8.40, 0.28] |
| 5.1.2 Thermal therapy | 1 | 49 | Mean Difference (IV, Random, 95% CI) | ‐2.06 [‐6.54, 2.42] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 6.1 Cholestyramine Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | ‐0.24 [‐0.86, 0.38] | |
| Analysis 6.1  Comparison 6: Cross‐over studies with paired data, Outcome 1: Cholestyramine | ||||
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Comparison 1: Pharmacological interventions (oral or IV), Outcome 1: Itch
Comparison 1: Pharmacological interventions (oral or IV), Outcome 2: Itch (dichotomous)
Comparison 2: Topical interventions, Outcome 1: Itch
Comparison 3: Oral or IV supplements, Outcome 1: Itch
Comparison 4: Haemodialysis modality, Outcome 1: Itch
Comparison 5: Other interventions, Outcome 1: Itch
Comparison 6: Cross‐over studies with paired data, Outcome 1: Cholestyramine
| Pharmacological interventions versus placebo for the relief of itch in people with advanced chronic kidney disease | |||||
| Patient or population: uraemic pruritus Settings: outpatient and multi‐centre Intervention: pharmacological treatments Comparison: placebo | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative Effect | No. of participants | Quality of the evidence | |
|---|---|---|---|---|---|
| Reduction of risk of placebo | Reduction of risk with pharmacological interventions | ||||
| GABA analogue VAS(0 to 10 cm) | The mean VAS score of the placebo group ranged from 0.8 to 2 cm lower than pretreatment scores | The mean reduction in VAS score of the GABA analogue group was 4.95 cm lower (5.46 to 4.44 lower) than placebo | ‐ | 297 (5) | ⊕⊕⊕⊕ HIGH |
| Ondansetron VAS(0 to 10 cm) | The mean VAS score of the placebo group ranged from 0.1 to 2 cm lower than pretreatment scores | The mean reduction in VAS score of the ondansetron agonist group was 0.38 cm lower (1.04 lower to 0.27 higher) than placebo | ‐ | 183 (3) | ⊕⊕⊕⊕ HIGH |
| Kappa‐opioid agonist VAS(0 to 10 cm) | The mean VAS score of the placebo group ranged from 1.3 to 1.9 cm lower than pretreatment scores | The mean reduction in VAS score of the kappa‐opioid agonist group was 1.05 cm lower (1.40 to 0.70 lower) than placebo | ‐ | 661 (5) | ⊕⊕⊕⊕ HIGH |
| Mu‐opioid antagonist VAS(0 to 10 cm) | The mean VAS score of the placebo group ranged from 0.5 to 1 cm lower than pretreatment scores | The mean reduction in VAS score of the mu‐opioid antagonist group was 4.29 cm lower (10.24 lower to 1.66 higher) than placebo | ‐ | 62 (2) | ⊕⊕⊝⊝ LOW1,2 |
| Nalbuphine VAS(0 to 10 cm) | The mean VAS score of the placebo group was 3.2 cm lower than pretreatment scores | The mean reduction in VAS score of the nalbuphine group was 0.75 cm lower (1.70 lower to 0.20 higher) than placebo | ‐ | 179 (1) | ⊕⊕⊝⊝ LOW2,3 |
| Cromolyn VAS(0 to 10 cm) | The mean VAS score of the placebo group was 3 cm lower than pretreatment scores | The mean reduction in VAS score of the cromolyn group was 4.8 cm lower (7.03 to 2.57 lower) than placebo | ‐ | 40 (1) | ⊕⊕⊝⊝ LOW1,2 |
| Nicotinamide VAS(0 to 5 cm) | The mean VAS score of the placebo group was 1.7 cm lower than pretreatment scores | The mean reduction in VAS score of the nicotinamide group was 0.47 cm higher (0.32 lower to 1.26 higher) than placebo | ‐ | 50 (1) | ⊕⊕⊝⊝ LOW1,2 |
| EPO Duo score(0 to 40) | The mean Duo score of the placebo group was 1.5 lower than pretreatment scores | The mean reduction in Duo score of the EPO group was 14.5 lower (38.78 lower to 9.78 higher) than placebo | ‐ | 20 (1) | ⊕⊝⊝⊝ |
| Cholestyramine 0 to 3 severity scale | The mean itch score of the placebo group ranged from 1.3 to 0.7 lower than pretreatment scores | The mean reduction in VAS score of the cholestyramine group was 0.24 higher (0.38 lower to 0.86 higher) than placebo | ‐ | 15 (2) | ⊕⊕⊝⊝ LOW1,4 |
| Montelukast Duo score (0 to 81) and VAS (0 to 10 cm) | The mean Duo score and VAS of the placebo group was 7 points and 0.5 cm lower (respectively) than pretreatment scores. | TheSMD reduction of the montelukast group was 1.4 lower (1.87 to 0.92 lower) than placebo | ‐ | 87 (2) | ⊕⊕⊕⊝ MODERATE5 |
| Sertraline VAS(0 to 10 cm) | The mean VAS score of the placebo group was 3.7 lower than pretreatment scores | The mean reduction in VAS score of the sertraline group was 1.8 cm lower (3.65 lower to 0.05 higher) than placebo | ‐ | 46 (1) | ⊕⊕⊝⊝ LOW1,2 |
| Lidocaine Itch relief | 167 per 1000 | 800 per 1000 | 4.80 | 16 (1) | ⊕⊝⊝⊝ |
| Sodium thalidomide Itch relief | 133 per 1000 | 556 per 1000 | 4.17 | 33 (1) | ⊕⊝⊝⊝ |
| Doxepin Itch relief | 208 per 1000 | 875 per 1000 (396 to 1000) | 4.20 (1.90 to 9.30) | 48 (1) | ⊕⊕⊝⊝ |
| The reduction of risk of pharmacological versus placebo (column 3) is the additional risk reduction in addition to the benefit provided by the placebo. "Lower" indicates a reduction or negative numerical change versus baseline. CI: Confidence interval; SMD: standardised mean difference; RR: Risk Ratio; VAS: visual analogues scale | |||||
| GRADE Working Group grades of evidence | |||||
| 1Evidence of certainty was downgraded one level because of the reliance of the estimated effect on a small number of participants 2Evidence of certainty was downgraded one level because of the imprecise treatment estimate 3Evidence of certainty was downgraded one level because of study risks of bias 4Evidence of certainty was downgraded one level because heterogeneous results utilizing nonvalidated itch scoring methods 5Evidence of certainty was downgraded one level as homogeneity was difficult to assess (due to well validated but different itch scoring methods) and that the analysis would benefit from a greater number of participants | |||||
| Topical treatments versus placebo for the relief of itch in people with advanced chronic kidney disease | ||||
| Patient or population: uraemic pruritus Settings: outpatient and multi‐centre Intervention: topical treatments Comparison: placebo | ||||
| Outcomes | Anticipated absolute effects* (95% CI) | No. of participants | Quality of the evidence | |
|---|---|---|---|---|
| Reduction of risk of placebo | Reduction of risk with topical treatments | |||
| Capsaicin cream VAS and Duo’s score | The mean VAS and Duo score of this vehicle group was 1.7 cm and 13.4 lower (respectively) than pretreatment scores. | The SMD of the capsaicin group was 0.84 lower (1.22 to 0.45 lower) than vehicle | 112 (2) | ⊕⊕⊕⊝ MODERATE1 |
| Pramoxine lotion VAS(0 to 10 cm) | The mean VAS score of this vehicle group was 1.4 cm lower than pretreatment scores. | The mean reduction in VAS score of the pramoxine lotion group was 1.97 lower (6.06 lower to 2.12 higher) than vehicle | 27 (1) | ⊕⊝⊝⊝ VERY LOW2,3,4 |
| Calcineurin inhibitor VAS(0 to 10 cm) | The mean VAS score of this vehicle group was 7.1 cm lower than pretreatment scores. | The mean reduction in VAS score of the calcineurin inhibitor group was 1.2 higher (0.36 lower to 2.76 higher) than vehicle | 80 (2) | ⊕⊝⊝⊝ VERY LOW2,3,4 |
| Dead Sea lotion 1 to 5 severity score | The mean severity score of this vehicle group was 3 lower than pretreatment scores. | The mean reduction in severity score of the Dead Sea Lotion group was 2 lower (4.31 lower to 0.31 higher) than vehicle | 41 (1) | ⊕⊝⊝⊝ VERY LOW2,3,4 |
| Cromolyn cream VAS (0 to 5 cm) | The mean VAS score of this vehicle group was 1.4 cm lower than pretreatment scores. | The mean reduction in VAS score of the cromolyn cream group was 0.8 cm lower (1.98 lower to 0.38 higher) than vehicle | 60 (1) | ⊕⊕⊝⊝ |
| Baby oil Itch Severity Scale(0 to 21) | The mean Itch Severity Scale of this vehicle group was 1 lower than pretreatment scores. | The mean reduction in Itch Severity Scale of the baby oil group was 2.36 lower (3.29 to 1.44 lower) than vehicle | 125 (2) | ⊕⊕⊝⊝ |
| L‐arginine salve 0 to 3 severity score | The mean severity score of this vehicle group was 3.4 lower than pretreatment scores. | The mean reduction in severity score of the L‐arginine salve group was 0.58 lower (1.86 lower to 0.7 higher) than vehicle | 48 (1) | ⊕⊕⊝⊝ |
| Polyunsaturated fatty acids VAS (0 to 10 cm) Duo score | The mean VAS and Duo score of this vehicle group was 1 cm lower and 5 points higher (respectively) than pretreatment scores. | The SMD of the polyunsaturated fatty acids group was 0.91 lower (1.99 lower to 0.17 higher) than vehicle | 78 (2) | ⊕⊕⊝⊝ |
| The reduction of risk of pharmacological versus placebo (column 3) is the additional risk reduction in addition to the benefit provided by the placebo. "Lower" indicates a reduction or negative numerical change versus baseline. CI: Confidence interval; SMD: standardised mean difference; VAS: visual analogue scale | ||||
| GRADE Working Group grades of evidence | ||||
| 1Evidence of certainty was downgraded one level as homogeneity was difficult to assess (due to well validated but different itch scoring methods) and that the analysis would benefit from a greater number of participants 2Evidence of certainty was downgraded one level because of the reliance of the estimated effect on a small number of participants 3Evidence of certainty was downgraded one level because of the imprecise treatment estimate 4Evidence of certainty was downgraded one level because of study risks of bias 5Evidence of certainty was downgraded two levels because of study risks of bias and use of a non‐validated itch scoring method. 6Evidence of certainty was downgraded one level because of the imprecise and small treatment estimate | ||||
| Supplements, HD modalities, and other treatments for the relief of itch in people with advanced chronic kidney disease | ||||
| Patient or population: uraemic pruritus Settings: outpatient and multi‐centre Intervention: supplements, HD modalities, and other treatments Comparison: placebo; other HD comparators | ||||
| Outcomes | Anticipated absolute effects* (95% CI) | No. of participants | Quality of the evidence | |
|---|---|---|---|---|
| Reduction of risk of comparator | Reduction of risk with supplements, HD modalities, and other treatments | |||
| Polyunsaturated fatty acids 0 to 5severity score | The mean severity score of this placebo group was 1.6% lower than pretreatment scores. | The mean reduction in 0 to 5 severity score of the polyunsaturated fatty acids group was 11.3% lower (9.0 to 3.6 lower) than placebo | 22 (1) | ⊕⊕⊝⊝ LOW1,2 |
| L‐carnitine VAS (0 to 6 cm) | The mean VAS score of this placebo group was 0.2 higher than pretreatment scores. | The mean reduction in VAS score of the L‐carnitine group was 0.26 lower (2.85 lower to 2.43 higher) than placebo | 12 (1) | ⊕⊕⊝⊝ |
| Zinc sulfate VAS (0 to 10 cm) | The mean VAS and Duo score of this vehicle group was 4.3cm and 6.1 lower (respectively) than pretreatment scores. | The mean reduction of the zinc sulfate group was 1.77 lower (2.88 to 0.66 lower) than placebo | 76 (2) | ⊕⊕⊕⊝ MODERATE1 |
| Ergocalciferol 21 point scale | The mean score of this vehicle group was 6.1 lower than pretreatment scores. | The mean reduction in VAS score of the ergocalciferol group was 0.4 higher (2.52 lower to 3.32 higher) than placebo | 50 (1) | ⊕⊕⊝⊝ |
| Turmeric Duo score (5 to 40) | The mean Duo’s score of this vehicle group was 2 lower than pretreatment scores. | The mean reduction in VAS score of the turmeric group was 6.4 lower* (7.42 to 5.38 lower) than placebo | 100 (1) | ⊕⊕⊕⊝ MODERATE1 |
| Fumaria parviflora VAS (0 to 10 cm) | The mean VAS score of this vehicle group was 2.2lower than pretreatment scores. | The mean reduction in VAS score of the Fumaria parviflora group was 3.90lower (5.04 to 2.76 lower) than placebo | 63 (1) | ⊕⊕⊝⊝ |
| High flux/permeability dialysis VAS (0 to 10 cm) | The mean VAS score of this control group ranged from 0.6 cm to 5.6 cm lower than pretreatment scores. | The mean reduction in VAS score of the high flow/permeability group was 2.60 cm lower (3.22 to 1.97 lower) than placebo | 202 (3) | ⊕⊕⊝⊝ |
| HD with haemoperfusion VAS (0 to 10 cm) | The mean VAS score of this control group was 0.6 cm lower than pretreatment scores. | The mean reduction in VAS score of the HD with haemoperfusion group was 2.37 cm lower (2.89 to 1.85 lower) than placebo | 90 (1) | ⊕⊕⊝⊝ |
| UV‐B Duo score, VAS, and %improvement | The mean Duo score and VAS of this control group was 2.2 points and 0.3 cm lower (respectively) than pretreatment scores. | The SMD of the UV‐B group was 2.49 lower (4.62 to 0.36 lower) than placebo | 86 (4) | ⊕⊕⊝⊝ |
| Thermal therapy VAS (0 to 10 cm) | The mean VAS score of this control group was 5.8 lower than pretreatment scores. | The mean reduction in VAS score of the thermal therapy group was 2.06 lower (6.98 lower to 2.84 higher) than placebo | 41 (1) | ⊕⊕⊝⊝ |
| The reduction of risk of pharmacological versus placebo (column 3) is the additional risk reduction in addition to the benefit provided by the placebo. "Lower" indicates a reduction or negative numerical change versus baseline. CI: Confidence interval; RR: Risk Ratio; SMD: standardised mean difference; VAS: visual analogue scale | ||||
| GRADE Working Group grades of evidence | ||||
| 1Evidence of certainty was downgraded one level because of the reliance of the estimated effect on a small number of participants 2Evidence of certainty was downgraded one level because of the imprecise treatment estimate 3Evidence of certainty was downgraded one level because of study risks of bias 4Evidence of certainty was downgraded one level because heterogeneity between studies | ||||
| Intervention | Participants | Route/dose | Intervention adverse effects | Control adverse effects |
|---|---|---|---|---|
| GABA analogue (pregabalin or gabapentin) versus placebo | 271 (6) | Pregabalin (a) Oral: 75 mg, twice/week Gabapentin (b) Oral: 400 mg, twice/week (c) Oral: 300 mg, 3 times/week (d) Oral: 300 mg/day (e) Oral: dose not reported | Gunal 2004 (c): somnolence, dizziness, fatigue Naghibi 2007 (e): somnolence Naini 2007 (b): somnolence, dizziness, nausea Nofal 2016 (d): somnolence (9/27), dizziness (5/27) Tol 2010 (c): not reported Yue 2015 (a): somnolence (3/67), loss of balance (2/67) | Gunal 2004: not reported Naghibi 2007: not reported Naini 2007: not reported Nofal 2016: not reported Tol 2010: not reported Yue 2015: not reported |
| Ondansetron versus placebo | 161 (3) | (a) Oral: 8 mg, 3 times/day (b) Oral: 8 mg, once/day (c) Oral: 8 mg, twice/day | Ashmore 2000 (a): not reported Murphy 2003 (b): constipation (1/14), ischaemic stroke (1/18), line sepsis (1/17) Yue 2015 (c): nausea and vomiting (2/64) | Ashmore 2000: not reported Murphy 2003: not reported Yue 2015: none |
| Kappa opioid agonists versus placebo | 626 (4) | Nalfurafine (a) Oral: 2.5 µg once/day (b) Oral: 5 µg once/day (c) IV: 5 µg, 3 times/week (d) IV: 2.5, 5 µg with dialysis CR845 (e) IV: 0.5 to 1.5 µg/kg with dialysis | Kumagai 2010 (a, b) 2.5 µg (oral): somnolence (4.5%); insomnia (7.1%), diarrhoea (4.5%), nasopharyngitis (8.0%) 5 µg (oral): constipation (7.9%), somnolence (3.5%), insomnia (14.9%), nasopharyngitis (12.3%) Spencer 2015 (e): not reported Spencer 2017 (e) (0.5 to 1.5 µg/kg): somnolence (9/129), dizziness (12/129), headache (5/129), diarrhoea (16/129), nausea (11/129) Bhaduri 2006 (d): not reported Wikstrom 2005 (c): headache (3/26), nausea (3/26), vomiting (2/26), insomnia (2/26), vertigo (2/26) | Kumagai 2010: nasopharyngitis (17.1%), headache (3.6%), vomiting (3.6%) Spencer 2015: not reported Spencer 2017: somnolence (1/45), dizziness (2/45), headache (1/45), diarrhoea (0/45) Wikstrom 2005: 13/25 (type not reported) |
| Mu opioid antagonists versus placebo | 31 (2) | Oral: 50 mg once/day | Pauli‐Magnus 2000: loss of appetite and nausea (9) Peer 1996: heartburn (2), abdominal discomfort (3) | Pauli‐Magnus 2000: nausea (1) Peer 1996: not reported |
| Nalbuphine versus placebo | 373 (1) | Oral: 60 or 120 mg, twice/day | 60 mg: serious adverse events (12.7%), adverse events leading to discontinuation (33/128) 120 mg: serious adverse events (6.7%), adverse events leading to discontinuation (27/120) | TREVITR02 2017: serious adverse events (15.4%), adverse events leading to discontinuation (7/123) |
| EPO versus placebo | 39 (2) | (a) IV: 36 U/kg/dialysis (b) SC: 2000 IU twice/day | De Marchi 1992 (a): not reported Sja'bani 1997 (b): not reported | De Marchi 1992: not reported Sja'bani 1997: not reported |
| Nicotinamide versus placebo | 50 (1) | Oral: 500 mg twice/day | Omidian 2013: not reported | Omidian 2013: not reported |
| Lidocaine versus placebo | 20 (1) | IV: 200 mg | Tapia 1977: not reported | Tapia 1977: not reported |
| Cholestyramine | 20 (2) | Oral: 5 mg, twice/day | Silverberg 1977: constipation (1/5), nausea (1/5) van Leusen 1978: not reported | Silverberg 1977: not reported van Leusen 1978: not reported |
| Montelukast versus placebo | 89 (2) | Oral: 10 mg/day | Mahmudpour 2017: not reported Nasrollahi 2007: myelodysplastic syndrome (1/8) | Mahmudpour 2017: Not reported Nasrollahi 2007: myocardial infarction (1/8) |
| Sertraline versus placebo | 50 (1) | Oral: 50 mg twice/day | Pakfetrat 2018: not reported | Pakfetrat 2018: not reported |
| Sodium thiosulfate versus placebo | 45 (1) | IV: 12.5 mg/dialysis session | Mohamed 2012: not reported | Mohamed 2012: not reported |
| Doxepin versus placebo | 24 (1) | Oral: 10 mg, twice/day | Pour‐Reza‐Gholi 2007: drowsiness (12/24) | Pour‐Reza‐Gholi 2007: not reported |
| Thalidomide versus placebo | 29 (1) | Oral: 100 mg/day | Silva 1994: not reported | Silva 1994: not reported |
| Cimetidine versus placebo | 13 (1) | Oral: 600 mg/day | Aubia 1980: not reported | Aubia 1980: not reported |
| Cromolyn versus placebo | 62 (1) | Oral: 135 mg, 3 times/day | Vessal 2010: flatulence (1/32) | Vessal 2010: nausea (5/30), diarrhoea (4/30) |
| Gabapentin versus pregabalin | 50 (1) | Oral gabapentin (300 mg, once/day) versus oral pregabalin (75 mg, once/day) | Gabapentin: not reported Pregabalin: not reported | ‐‐ |
| GADA versus ondansetron | 131 (1) | Oral pregabalin (75 mg twice/week) versus oral ondansetron (8 mg/day) | Pregabalin: somnolence (3/67), loss of balance (2/67) Ondansetron: not reported | ‐‐ |
| GABA analogue versus doxepin | 90 (1) | Oral pregabalin (50 mg every other night) versus oral doxepin (10 mg/night) | Pregabalin: intolerable adverse events (3/46), somnolence (6/37), oedema (3/37), drowsiness (3/27), imbalance (1/37), numbness (1/37) Doxepin: intolerable adverse events (1/44), nervousness (1/35) | ‐‐ |
| GABA analogue versus antihistamine | 212 (4) | (a) Oral gabapentin (100 mg/day) versus oral ketotifen (1 mg, twice/day) (b) Oral gabapentin (300 mg, 3 times/week) versus oral dexchlorpheniramine (6 mg, 3 times/week) (c) Oral gabapentin (300 mg/day) versus oral loratadine (10 mg/day) (d) Oral gabapentin (100 to 200 mg/day) versus oral hydroxyzine (10 mg/day) (e) Oral gabapentin (100 mg/day) versus oral hydroxyzine (10 mg/day) | Amirkhanlou 2016 (a) Gabapentin: drowsiness (4/26), dizziness (1/26) Ketotifen: drowsiness (4/26), dizziness (1/26) Gabapentin: total (11/30), drowsiness (17%) Dexchlorpheniramine: total (8/30), drowsiness (1/30) Marin 2013 (c) Gabapentin: somnolence (8/30) Loratadine: none reported Noshad 2011 (d) Gabapentin: complications (7/20) Hydroxyzine: complications (10/20) Gabapentin: (9/18) Loratadine: (4/16) | ‐‐ |
| Mu opioid antagonists versus antihistamine | 52 (1) | Oral naltrexone (50 mg/day) versus oral loratadine (10 mg/day) | Naltrexone (26): vomiting (2), nausea (9), anorexia (1), abdominal distention (1), malaise (1), cramps (2), sleep disturbances (5), vertigo (5), headache (2), somnolence (1), paraesthesia (1), withdrawn (10) Loratadine (26): vomiting (2), malaise (1), withdrawn from study (2) | ‐‐ |
| Ondansetron versus antihistamine | 20 (1) | (a) Ondansetron tablet (8 mg/day) versus cyproheptadine syrup (8 mg/day) (b) "3 doses ondansetron 8mg" versus "diphenhydramine 25mg" (c) Oral ondansetron (8 mg, 3 times/day) versus oral loratadine (10 mg twice/day) | Ozaykan 2001 (a): not reported Subach 2001 (b): not reported Mirnezami 2013 (c): not reported | ‐‐ |
| *when reported GABA ‐ gamma‐aminobutyric acid | ||||
| Intervention | Participants | Route/dose | Intervention adverse effects | Control adverse effects |
|---|---|---|---|---|
| Cromolyn cream versus placebo | 60 (1) | 4% cream | Feily 2012: burning sensation (6/30) | Feily 2012: none |
| Capsaicin cream versus placebo | 91 (4) | (a) 0.025%, 4 times/day (b) 0.03%, 4 times/day | Breneman 1992 (a): burning and stinging sensation (5), decrease in xerosis (3), dryness (2) Cho 1997 (a): not reported Makhlough 2010 (b): skin burning Tarng 1996 (a): local burning and/or stinging sensations | Breneman 1992: not reported Cho 1997: not reported Makhlough 2010: none Tarng 1996: local burning and/or stinging sensations |
| Pramoxine lotion versus placebo | 28 (1) | 1.0% twice/day | Young 2009: none | Young 2009: none |
| Baby oil versus placebo | 92 (1) | Chilled and unchilled 15 min application at least once/day | Lin 2012: not reported | Lin 2012: not reported |
| Dead Sea lotion versus placebo | 50 (1) | Entire body, twice/day | Boaz 2009: total adverse events (2/25) | Boaz 2009: total adverse events (3/25) |
| Sericin cream versus placebo | 50 (1) | 1 g, twice/day | Aramwit 2012a: not reported | Aramwit 2012a: not reported |
| L‐arginine salve versus placebo | 24 (1) | 25 µg/2.5 cm2 twice/day | Durant‐Finn 2008: not reported | Durant‐Finn 2008: not reported |
| Calcineurin inhibitors versus placebo | 80 (2) | TAC: 0.1% twice/day Pimecrolimus: 1.0% twice/day | Duque 2005: warmth sensation (6/12) Ghorbani 2012a: burning sensation which disappeared by the end of 8 weeks | Duque 2005: warmth sensation (3/8) Ghorbani 2012a: none |
| Sweet almond oil versus no intervention | 44 (1) | 100 mg/day | Afrasiabifar 2017: not reported | Afrasiabifar 2017: not reported |
| Gamma‐linoleic acid versus placebo | 17 (1) | 2.2%, 30 mL/day | Chen 2006e: allergic reaction (1/8) | Chen 2006e: none |
| Calcineurin inhibitors versus cromolyn | 60 (1) | Pimecrolimus: 2% twice/day Cromolyn: 4%, twice/day | Ghorbani Birgani 2011: unknown | Ghorbani Birgani 2011: unknown |
| Avena sativa versus diluted vinegar versus hydroxyzine | 23 (1) | Avena sativa: variable dose, twice/day Dilute vinegar: 30 mL twice/day Oral hydroxyzine: 10 mg/day | Nakhaee 2015: not reported | ‐‐ |
| Sarna versus eurax | 30 (1) | Sarna: 0.5% each of camphor, menthol, and phenol "as required" for 7 days Eurax: 10% crotamiton "as required" for 7 days | Sarna: none Eurax: rash (1) | ‐‐ |
| *when reported | ||||
| Intervention | Participants | Dose/route | Intervention adverse effects | Placebo adverse effects |
|---|---|---|---|---|
| Polyunsaturated fatty acids versus placebo | 89 (4) | Fish oil (a) Oral: 6 g/day (b) Oral: 3 g/day Omega‐3 fatty acids (c) Oral: 3 g/day | Begum 2004 (a): not reported Ghanei 2012 (c): not reported Mojgan 2017 (b): not reported Peck 1996 (a): not reported | Begum 2004: not reported Ghanei 2012: not reported Mojgan 2017: not reported Peck 1996: not reported |
| L‐carnitine versus placebo | 17 (1) | IV: 10 mg/kg, once/day | Mettang 1997: not reported | Mettang 1997: not reported |
| Zinc sulfate versus placebo | 80 (2) | (a) Oral: 220 mg/day (b) Oral: 200 mg twice/day | Mapar 2015 (a): none Najafabadi 2012 (b): none “attributable to zinc sulfate” | Mapar 2015: vomiting (1/20) Najafabadi 2012: not reported |
| Ergocalciferol versus placebo | 50 (1) | Oral: 50,000 IU/week | Shirazian 2013: none | Shirazian 2013: not reported |
| Turmeric (curcumin) versus placebo | 100 (1) | Oral: 500 mg (22.1 mg), 3 times/day | Pakfetrat 2014: none | Pakfetrat 2014: not reported |
| Fumaria parviflora versus placebo | 79 (1) | Oral: 1000 mg, 3 times/day | Akrami 2017: Gastric pain (4/39), rash (1/39) | Akrami 2017: abdominal pain (1/40), constipation (1/40) |
| Senna versus placebo | 60 (1) | Oral: dose and frequency not reported | Fallahzadeh 2015: not reported | Fallahzadeh 2015: not reported |
| Evening primrose oil | 16 (1) | Oral: 2 capsules/day (containing 360 mg of linoleic acid, 50 mg oleic acid and 45 mg of gamma‐linoleic acid) | Yoshimoto‐Furuie 1999: none | Yoshimoto‐Furuie 1999: none |
| Activated charcoal versus placebo | 20 (1) | Oral: 6 g/day | Pederson 1980: not reported | Pederson 1980: not reported |
| Charcoal versus aluminium hydroxide | 30 (1) | Charcoal: 6 g, 3 times/day Aluminium hydroxide: 30 mL, 3 times/day | Shariati 2010: not reported | ‐‐ |
| *when reported | ||||
| Intervention | Participants | Dose/route | Intervention adverse effects | Control adverse effects |
|---|---|---|---|---|
| High flux/ high permeability/high flow HD | 252 (4) | (a) High‐flow HD (b) High‐permeability HD (c) High‐flux HD | Aliasgharpour 2018 (a): not reported Chen 2009 (b): not reported Hui 2011 (c): not reported Jiang 2016 (c): not reported | Aliasgharpour 2018: not reported Chen 2009: not reported Hui 2011: not reported Jiang 2016: not reported |
| HD with haemoperfusion | 90 (1) | Haemoperfusion HA130‐RHA HA330‐RHA | Li 2017a: not reported | Li 2017a: not reported |
| Haemoperfusion plus HD versus haemoperfusion plus HDF | 40 (1) | Haemoperfusion plus HD Haemoperfusion plus HDF | Haemoperfusion plus HD: not reported Haemoperfusion plus HDF: not reported | ‐‐ |
| Magnesium‐free HD versus standard HD | 17 (1) | Standard HD: 0.85 mmol/L magnesium solution for 2 weeks | Carmichael 1988: not reported | Carmichael 1988: not reported |
| Calcium dialysate HD | 4 (1) | Calcium concentration 1.0 mmol/L 1.25 mmol/L 1.75 mmol/L | Kyriazis 2000: not reported | Kyriazis 2000: not reported |
| Cool versus normal dialysate | 60 (1) | Cool dialysate: 35.5oC, 3 times/week Normal dialysate: 37oC, 3 time/week | Rad 2017: not reported | Rad 2017: not reported |
| *when reported | ||||
| Intervention | Participants | Dose/route | Intervention adverse effects | Control adverse effects |
|---|---|---|---|---|
| UV‐B exposure | 75 (4) | (a) 0.19 nJ/cm2/sec, 3 times/week (b) Minimal erythema dose, twice/week (c) 4.4 watts/m2, twice/week (d) 200 mJ/cm2, 3 times/week | Blachley 1985 (a): not reported Chan 1995 (b): not reported Gilchrest 1977 (c): sunburn (3/10), tanning (5/10) Gilchrest 1979 (c): mild sunburn and tanning Ko 2011 (d): erythema (2/11) | Blachley 1985: not reported Chan 1995: not reported Gilchrest 1977: not reported Gilchrest 1979: not reported Ko 2011: not reported |
| UV‐A exposure | 11 (1) | UV‐A (exposure): 40 min exposure (10, 180 cm 85W UV‐A lamps) 3 times/week | Taylor 1983: not reported | Taylor 1983: not reported |
| Thermal therapy | 41 (1) | 40oC thermal therapy, twice/week | Hsu 2009: not reported | Hsu 2009: not reported |
| UV‐B exposure versus cetirizine | 30 (1) | UV‐B Whole body: 200 to 1038 mJ/cm2 every 3rd day for 15 sessions Cetirizine Oral: 10 mg/day for the same duration | Sherjeena 2017: not reported | ‐‐ |
| *when reported | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Itch Show forest plot | 30 | Std. Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.1.1 GABA analogues | 5 | 297 | Std. Mean Difference (IV, Random, 95% CI) | ‐2.14 [‐2.43, ‐1.85] |
| 1.1.2 GABA analogues versus antihistamine | 5 | 220 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.44 [‐0.75, ‐0.14] |
| 1.1.3 Ondansetron | 3 | 183 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.17 [‐0.49, 0.15] |
| 1.1.4 Kappa‐opioid agonist | 4 | 661 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.43 [‐0.60, ‐0.27] |
| 1.1.5 Mu‐opioid antagonist | 2 | 62 | Std. Mean Difference (IV, Random, 95% CI) | ‐4.10 [‐11.05, 2.85] |
| 1.1.6 Nalbuphine | 1 | 179 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.22 [‐0.54, 0.10] |
| 1.1.7 Cromolyn | 1 | 40 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.31 [‐2.00, ‐0.62] |
| 1.1.8 Nicotinamide | 1 | 50 | Std. Mean Difference (IV, Random, 95% CI) | 0.32 [‐0.23, 0.88] |
| 1.1.9 EPO | 1 | 20 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.50 [‐1.39, 0.39] |
| 1.1.10 Cholestyramine | 2 | 20 | Std. Mean Difference (IV, Random, 95% CI) | 0.00 [‐0.89, 0.89] |
| 1.1.11 Montelukast | 2 | 87 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.40 [‐1.87, ‐0.92] |
| 1.1.12 Sertraline | 1 | 46 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.56 [‐1.15, 0.03] |
| 1.1.13 Lidocaine | 1 | 16 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.81 [‐1.87, 0.25] |
| 1.1.14 Gabapentin versus pregabalin | 1 | 40 | Std. Mean Difference (IV, Random, 95% CI) | 0.01 [‐0.61, 0.63] |
| 1.1.15 GABA analogues versus doxepin | 1 | 72 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.84 [‐1.33, ‐0.36] |
| 1.2 Itch (dichotomous) Show forest plot | 3 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.2.1 Lidocaine | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.2.2 Thalidomide | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 1.2.3 Doxepin | 1 | Risk Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Itch Show forest plot | 10 | Std. Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.1.1 Capsaicin cream | 2 | 112 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.84 [‐1.22, ‐0.45] |
| 2.1.2 Pramoxine cream | 1 | 27 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.35 [‐1.11, 0.41] |
| 2.1.3 Calcineurin Inhibitor cream | 1 | 60 | Std. Mean Difference (IV, Random, 95% CI) | 0.39 [‐0.13, 0.90] |
| 2.1.4 Dead Sea lotion | 1 | 41 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.52 [‐1.14, 0.10] |
| 2.1.5 Cromolyn cream | 1 | 60 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.34 [‐0.85, 0.17] |
| 2.1.6 Baby oil | 1 | 93 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.87 [‐1.32, ‐0.43] |
| 2.1.7 L‐arginine salve | 1 | 48 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.25 [‐0.82, 0.32] |
| 2.1.8 Polyunsaturated fatty acids | 2 | 78 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.91 [‐1.99, 0.17] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Itch Show forest plot | 7 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.1.1 Polyunsaturated fatty acids | 1 | 22 | Mean Difference (IV, Random, 95% CI) | ‐11.30 [‐19.01, ‐3.59] |
| 3.1.2 L‐carnitine (IV) | 1 | 12 | Mean Difference (IV, Random, 95% CI) | ‐0.26 [‐2.85, 2.33] |
| 3.1.3 Zinc sulfate | 2 | 76 | Mean Difference (IV, Random, 95% CI) | ‐1.77 [‐2.88, ‐0.66] |
| 3.1.4 Ergocalciferol | 1 | 50 | Mean Difference (IV, Random, 95% CI) | 0.40 [‐2.48, 3.28] |
| 3.1.5 Turmeric | 1 | 100 | Mean Difference (IV, Random, 95% CI) | ‐6.40 [‐7.42, ‐5.38] |
| 3.1.6 Fumaria parviflora | 1 | 63 | Mean Difference (IV, Random, 95% CI) | ‐3.90 [‐5.04, ‐2.76] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Itch Show forest plot | 4 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 4.1.1 High flux or permeability HD | 3 | 202 | Mean Difference (IV, Random, 95% CI) | ‐2.62 [‐3.72, ‐1.52] |
| 4.1.2 NMR haemoperfusion | 1 | 90 | Mean Difference (IV, Random, 95% CI) | ‐2.37 [‐2.89, ‐1.85] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Itch Show forest plot | 5 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 5.1.1 UV‐B | 4 | 86 | Mean Difference (IV, Random, 95% CI) | ‐4.06 [‐8.40, 0.28] |
| 5.1.2 Thermal therapy | 1 | 49 | Mean Difference (IV, Random, 95% CI) | ‐2.06 [‐6.54, 2.42] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 6.1 Cholestyramine Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | ‐0.24 [‐0.86, 0.38] | |
