Мелатонин для улучшения сна у взрослых в отделении интенсивной терапии
Appendices
Appendix 1. CENTRAL search strategy
| #1 | MeSH descriptor: [Critical Care] explode all trees |
| #2 | MeSH descriptor: [Critical Illness] explode all trees |
| #3 | MeSH descriptor: [Intensive Care Units] explode all trees |
| #4 | MeSH descriptor: [Respiration, Artificial] explode all trees |
| #5 | ((intensive or critical) near/3 (care or unit*)) or (critical* near/3 ill*) |
| #6 | (mechanical* near/3 ventilat*) or (artificial* near/3 respiration*) |
| #7 | #1 or #2 or #3 or #4 or #5 or #6 |
| #8 | melatonin or sleep* |
| #9 | MeSH descriptor: [Melatonin] explode all trees |
| #10 | MeSH descriptor: [Sleep] explode all trees |
| #11 | #8 or #9 or #10 |
| #12 | #7 and #11 |
| #13 | #12 in Trials |
Appendix 2. MEDLINE Ovid search strategy
| 1 | Critical Illness/ or Critical Care/ or exp Intensive Care Units/ or (ICU or ((intensive or critical) adj3 (care or unit*)) or (critical* adj3 ill*)).mp. or Respiration, Artificial/ or (mechanical* adj3 ventilat*).mp. or (artificial* adj3 respiration*).mp. |
| 2 | exp "Hypnotics and Sedatives"/ or Melatonin/ or sleep/ or (sleep* or hypnotic* or sedat* or melatonin).mp. |
| 3 | ((randomized controlled trial or controlled clinical trial).pt. or randomi*.ab. or placebo.ab. or clinical trials as topic.sh. or randomly.ab. or trial.ti.) not (animals not (humans and animals)).sh. |
| 4 | 1 and 2 and 3 |
Appendix 3. Embase Ovid search strategy
| 1 | critical illness/ or exp intensive care unit/ or exp intensive care/ or (ICU or ((intensive or critical) adj3 (care or unit*)) or (critical* adj3 ill*)).mp. or artificial ventilation/ or (mechanical* adj3 ventil*).mp. or (artificial* adj3 respiration*).mp. |
| 2 | hypnotic sedative agent/ or melatonin/ or sleep/ or (sleep* or hypnot* or sedat* or melatonin).mp. |
| 3 | ((crossover procedure or double blind procedure or single blind procedure).sh. or (crossover* or cross over*).ti,ab. or placebo*.ti,ab,sh. or (doubl* adj blind*).ti,ab. or (controlled adj3 (study or design or trial)).ti,ab. or allocat*.ti,ab. or trial*.ti,ab. or randomized controlled trial.sh. or random*.ti,ab.) not ((exp animal/ or animal.hw. or nonhuman/) not (exp human/ or human cell/ or (human or humans).ti.)) |
| 4 | 1 and 2 and 3 |
Appendix 4. CINAHL EBSCO search strategy
| S1 | (MM "Critical Illness") |
| S2 | (MM "Critically Ill Patients") |
| S3 | (MH "Critical Care+") |
| S4 | (MH "Intensive Care Units+") |
| S5 | (intensive or critical) N3 (care or unit*) OR critical* N3 ill* |
| S6 | (MH "Respiration, Artificial+") |
| S7 | mechanical* N3 ventilat* OR artificial* N3 respiration* |
| S8 | (S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7) |
| S9 | (MH "Hypnotics and Sedatives+") |
| S10 | (MM "Melatonin") |
| S11 | (MH "Sleep+") |
| S12 | sleep* OR hynotic* OR sedat* OR melatonin* |
| S13 | (S9 OR S10 OR S11 OR S12) |
| S14 | TX allocat* random* |
| S15 | (MH "Quantitative Studies") |
| S16 | (MH "Placebos") |
| S17 | TX placebo* |
| S18 | TX random* allocat* |
| S19 | (MH "Random Assignment") |
| S20 | TX randomi* control* trial* |
| S21 | TX ((singl* n1 blind*) or (singl* n1 mask*)) or TX ((doubl* n1 blind*) or (doubl* n1 mask*)) or TX ((tripl* n1 blind*) or (tripl* n1 mask*)) or TX ((trebl* n1 blind*) or (trebl* n1 mask*)) |
| S22 | TX clinic* n1 trial* |
| S23 | PT Clinical trial |
| S24 | (MH "Clinical Trials+") |
| S25 | S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 OR S23 OR S24 |
| S26 | S8 AND S13 AND S25 |
Appendix 5. PsycINFO EBSCO search strategy
| S1 | MM "Intensive Care" |
| S2 | MM "Artificial Respiration" |
| S3 | (intensive or critical) N3 (care or unit*) OR critical* N3 ill* |
| S4 | mechanical* N3 ventilat* OR artificial* N3 respiration* |
| S5 | (S1 OR S2 OR S3 OR S4) |
| S6 | MM "Melatonin" |
| S7 | MM "Sedatives" OR MM "Hypnotic Drugs" |
| S8 | DE "Sleep" OR DE "Napping" OR DE "NREM Sleep" OR DE "REM Sleep" |
| S9 | sleep* OR hynotic* OR sedat* OR melatonin* |
| S10 | (S6 OR S7 OR S8 OR S9) |
| S11 | DE ("Treatment Effectiveness Evaluation") |
| S12 | DE ("Treatment Outcomes") |
| S13 | DE ("Placebo") |
| S14 | DE ("Followup Studies") |
| S15 | placebo* OR random* OR "comparative stud*" OR clinical N3 trial* OR research N3 design OR evaluat* N3 stud* OR prospectiv* N3 stud* OR (singl* OR doubl* OR trebl* OR tripl*) N3 (blind* OR mask*) |
| S16 | S11 OR S12 OR S13 OR S14 OR S15 |
| S17 | S5 AND S10 AND S16 |
Study flow diagram
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study. Blank spaces in figure indicate that outcomes were not reported by study authors, and therefore risk of bias was not completed for these domains.
| Melatonin compared with no agent for the promotion of sleep in adult patients in the ICU | ||||
| Patient or population: adult patients in the ICU Settings: ICUs, in Australia, Italy, UK, and US Intervention: melatonin Comparison: no agent | ||||
| Outcomes | Impacts | No of participants | Quality of the evidence | Comments |
| Quantity and quality of sleep as measured through reports of participants or of family members or by personnel assessments Data collected at end of follow‐up | In 1 study, participants completed the RCSQ and study authors reported no difference in SEI scores between groups. This was consistent with nurse assessment for which study authors also reported no difference in SEI scores between groups 2 studies reported no difference in duration of sleep observed by nurses | 139 (3 studies) | ⊕⊝⊝⊝ | We did not conduct meta‐analysis because studies used different methods to report data |
| Quantity and quality of sleep as measured by PSG, actigraphy, BIS, or EEG Data collected at end of follow‐up | In 1 study, investigators used BIS and actigraphy to record sleep. Study authors reported no difference in SEI scores with both tools. Study authors also reported longer sleep in participants given melatonin which was not statistically significantly different, and also reported evidence of improved sleep in participants given melatonin from analysis of AUC using BIS data 1 study used PSG, with a large loss of participant data at follow‐up, which prevented analysis of sleep data | 37 (2 studies) | ⊕⊝⊝⊝ | We did not conduct meta‐analysis because studies differed in types of measurement tools |
| Anxiety or depression, or both Data collected at end of follow‐up | 1 study (using VNR ≥ 3) reported no evidence of a difference in anxiety scores between groups | 82 (1 study) | ⊕⊝⊝⊝ | We identified only one study and could not conduct meta‐analysis |
| Mortality Study authors did not report final timepoint for data collection. | 1 study reported one‐third of participants had died; number of deaths per group was not reported 1 study reported no evidence of a difference between groups in hospital mortality | 94 (2 studies) | ⊕⊝⊝⊝ | We did not conduct meta‐analysis because studies different in methods of reporting data |
| Length of stay in the ICU | One study reported no evidence of a difference in length of ICU stay between groups | 82 (1 study) | ⊕⊝⊝⊝ | We identified only 1 study and could not conduct meta‐analysis |
| Adverse events (such as nausea, dizziness and headache) Data collected at end of follow‐up | 1 study reported headache in one participant who was given melatonin 1 study reported a cutaneous rash in one participant in the control group, and 2 participants (1 participant in both groups) with excessive sleepiness | 107 (2 studies) | ⊕⊝⊝⊝ | We could not conduct meta‐analysis because studies different in reported types of adverse events |
| Acronyms and abbreviations AUC: area under the curve; BIS: bispectral index; EEG: electroencephalogram; ICU: intensive care unit; PSG: polysomnography; RCSQ: Richards‐Campbell Sleep Questionnaire; SEI: sleep efficiency index; VNR: verbal numeric range | ||||
| GRADE Working Group Grades of Evidence | ||||
| aWe downgraded by 2 levels for imprecision; there were few studies with few participants, and outcome measures included both personnel and participant reports. We downgraded by 1 level for study limitations; we noted differences in baseline characteristics in two studies which may have influenced results. We downgraded by 1 level for inconsistency; we noted differences in doses of melatonin given in each study. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in one study were generalizable to most ICUs bWe downgraded by 2 levels for imprecision; there were few studies very few participants, and outcome measures used different assessment tools which may not effectively measure sleep in the ICU patient. We downgraded by 1 level for study limitations; we noted differences in baselines characteristics in one study which may have influenced results. We downgraded 1 level for inconsistency; we noted differences in doses of melatonin given in each study. We downgraded by 1 level for study limitations; we noted high risk of performance bias and high attrition which prevented adequate outcome reporting cWe downgraded by 2 levels for imprecision; data was from one study with few participants, and we could not be certain whether this outcome was measured with an appropriate tool for patients in the ICU. We downgraded by 1 level for study limitations; pre‐treatment use of opiates differed between study groups. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs dWe downgraded by 2 levels for imprecision; there were few studies with few participants. We downgraded by 1 level for study limitations; we noted a high risk of performance bias and attrition bias in one study and we noted differences between groups in pre‐treatment use of opiates. We downgraded 1 level for inconsistency; doses of melatonin varied between studies. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs eWe downgraded by 2 levels for imprecision; data was from one study. We downgraded by 1 level for study limitations; pre‐treatment use of opiates differed between study groups. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs fWe downgraded by 2 levels for imprecision; there were few studies with few participants. We downgraded by 1 level for study limitations; we noted differences in baseline characteristics in two studies which may have influenced results. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs | ||||
| Outcome: quantity and quality of sleep as measured through reports of participants or family members or by personnel assessments | |||||
| Study | Measurement (tool) | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| SEI, patient assessment (RCSQ) | mean (95% CI): 0.41 (0.24 to 0.59); n: 12 | mean (95% CI): 0.50 (0.43 to 0.58); n: 12 | −0.09 (−0.28 to 0.09) | 0.32 | |
| SEI, nurse assessment (observations) | mean (95% CI): 0.45 (0.26 to 0.64); n: 12 | mean (95% CI): 0.51 (0.35 to 0.68); n: 12 | −0.06 (CI −0.29 to 0.17) | 0.58 | |
| Duration of sleep, nurse assessment (observations) | median (range): 240 minutes (75 to 331.3); n: 14 | median (range): 243.4 minutes (0 to 344.1); n: 18 | not reported | 0.98 | |
| Duration of sleep, nurse assessment (observations) | 9 p.m. to midnight, mean (SD): 1.5 (± 1.6) hours; n: 41 midnight to 7 a.m., mean (SD): 4.5 (± 1.9) hours; n: 41 | 9 p.m. to midnight, mean (SD): 1.4 (± 1.3) hours; n: 41 midnight to 7 a.m., mean (SD): 4.3 (± 1.8) hours; n: 41 | not reported | 0.92 0.83 | |
| Outcome: quantity and quality of sleep as measured by PSG, actigraphy, BIS, or EEG | |||||
| Study | Measurement (tool) | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| SEI (BIS) | Mean (95% CI): 0.39 (0.27 to 0.51); n: 12 | Mean (95% CI): 0.26 (0.17 to 0.36); n: 12 | 0.12 (CI −0.02 to 0.27) | 0.09 | |
| SEI (actigraphy) | Mean (95% CI): 0.73 (0.53 to 0.93); n: 12 | Mean (95% CI): 0.75 (0.67 to 0.83); n: 12 | −0.02 (CI −0.24 to 0.20) | 0.84 | |
| Quantity of nocturnal sleep (BIS) | Mean: 3.5 hours; n: 12 | Mean: 2.5 hours; n: 12 | Not reported | ‐ | |
| Outcome: anxiety or depression, or both | |||||
| Study | Measurement (tool) | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| Anxiety (using VNR) | Participants with score ≥ 3: 12; n: 41 | Participants with score ≥ 3: 14; n: 41 | Not reported | 0.10 | |
| Outcome: mortality at 30 days | |||||
| Study | Measurement | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| Mortality in hospital | 14; n: 41 | 15; n: 41 | Not reported | 0.82 | |
| Outcome: length of stay in the ICU | |||||
| Study | Measurement | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| ´Number of days | Median (IQR): 14 (8 to 20); n: 41 | median (IQR): 12 (9 to 29); n: 41 | Not reported | 0.75 | |
| * as reported by study authors BIS: bispectral index | |||||
