Probiotics for treating eczema

Areti Makrgeorgou; Jo Leonardi‐Bee; Fiona J Bath‐Hextall; Dedee F Murrell; Mimi LK Tang; Amanda Roberts; Robert J Boyle

doi:10.1002/14651858.CD006135.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Trial sequential analysis for a minimum difference of ‐2 points difference in eczema symptoms (SCORAD part C; range 0 to 20) between probiotic and no probiotics at 90% power. The blue z‐curve of the meta‐analysis shows that the optimal heterogeneity‐adjusted information size of 258 has been reached. This suggests that future trials of similar interventions are unlikely to change the findings of no significant difference between probiotic and control for detection of at least a 2‐point difference.

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Figure 5

Trial sequential analysis for a minimum difference of ‐1.5 points difference in eczema symptoms (SCORAD part C; range 0 to 20) between probiotics and no probiotics at 90% power. The blue z‐curve of the meta‐analysis has crossed the red v‐shaped line of futility and has reached the optimal heterogeneity‐adjusted information size of 456. This suggests that future trials of similar interventions are unlikely to change the findings of no significant difference between probiotic and control for detection of at least a 1.5‐point difference.

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Figure 6

Trial sequential analysis for a minimum difference of ‐1 point difference in eczema symptoms (SCORAD part C; range 0 to 20) between probiotics and no probiotics at 90% power. The blue z‐curve of the meta‐analysis has not crossed the red v‐shaped line of futility and has not yet reached the optimal heterogeneity‐adjusted information size of 1026. This suggests that future trials of similar interventions may change the findings of no significant difference between probiotic and control for detection of at least a 1‐point difference.

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Figure 7

Egger's plot for Analysis 1.1: probiotic vs placebo for participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment.

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Figure 8

Egger's plot for Analysis 1.8: probiotic vs placebo for global eczema severity score (total SCORAD) at the end of treatment.

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Figure 9

Egger's plot for Analysis 1.9: probiotic vs placebo for global eczema severity score (total SCORAD) at the end of treatment ‐ sensitivity analysis ‐ change score.

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Analysis 1.1

Comparison 1 Probiotic vs placebo, Outcome 1 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment.

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Analysis 1.2

Comparison 1 Probiotic vs placebo, Outcome 2 Participant‐ or parent‐rated global change in eczema symptoms at the end of treatment (binary outcome).

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Analysis 1.3

Comparison 1 Probiotic vs placebo, Outcome 3 Change in participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end treatment (continuous outcome).

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Analysis 1.4

Comparison 1 Probiotic vs placebo, Outcome 4 Participant‐ or patient‐related quality of life score at the end of treatment.

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Analysis 1.5

Comparison 1 Probiotic vs placebo, Outcome 5 Participant‐ or patient‐related quality of life score at the end of treatment.

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Analysis 1.6

Comparison 1 Probiotic vs placebo, Outcome 6 Parent‐ or participant‐rated eczema severity (SCORAD part C) within 6 months after treatment has ceased.

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Analysis 1.7

Comparison 1 Probiotic vs placebo, Outcome 7 Participant‐ or parent‐related quality of life within 6 months after treatment has ceased.

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Analysis 1.8

Comparison 1 Probiotic vs placebo, Outcome 8 Global eczema severity score (total SCORAD) at the end of treatment.

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Analysis 1.9

Comparison 1 Probiotic vs placebo, Outcome 9 Global eczema severity score (total SCORAD) at the end of treatment ‐ sensitivity analysis ‐ change score.

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Analysis 1.10

Comparison 1 Probiotic vs placebo, Outcome 10 Global eczema severity score (total SCORAD) at the end of treatment ‐ low risk of bias studies only.

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Analysis 1.11

Comparison 1 Probiotic vs placebo, Outcome 11 Investigator‐rated eczema severity (SCORAD parts A/B) at the end of treatment ‐ continuous outcome.

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Analysis 1.12

Comparison 1 Probiotic vs placebo, Outcome 12 Global eczema severity score (total SCORAD) within 6 months after treatment has ceased.

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Analysis 1.13

Comparison 1 Probiotic vs placebo, Outcome 13 Investigator‐rated eczema severity (SCORAD parts A/B) within 6 months after treatment has ceased.

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Analysis 1.14

Comparison 1 Probiotic vs placebo, Outcome 14 Adverse events (short term).

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Analysis 1.15

Comparison 1 Probiotic vs placebo, Outcome 15 Participant/parent‐rated global change in symptoms of eczema at the end of treatment ‐ stratified by age groups.

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Analysis 1.16

Comparison 1 Probiotic vs placebo, Outcome 16 Participant/parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ stratified by age groups.

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Analysis 1.17

Comparison 1 Probiotic vs placebo, Outcome 17 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by age groups.

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Analysis 1.18

Comparison 1 Probiotic vs placebo, Outcome 18 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by presence of atopy.

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Analysis 1.19

Comparison 1 Probiotic vs placebo, Outcome 19 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by challenge‐proven food allergy.

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Analysis 1.20

Comparison 1 Probiotic vs placebo, Outcome 20 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by eczema severity.

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Analysis 1.21

Comparison 1 Probiotic vs placebo, Outcome 21 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ stratified by probiotic ‐ Lactobacillus species.

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Analysis 1.22

Comparison 1 Probiotic vs placebo, Outcome 22 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ stratified by probiotic ‐ Bifidobacterium species.

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Analysis 1.23

Comparison 1 Probiotic vs placebo, Outcome 23 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ number of probiotics.

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Analysis 1.24

Comparison 1 Probiotic vs placebo, Outcome 24 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ probiotics with no prebiotics.

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Analysis 1.25

Comparison 1 Probiotic vs placebo, Outcome 25 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ Lactobacillus species.

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Analysis 1.26

Comparison 1 Probiotic vs placebo, Outcome 26 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ Bifidobacterium species.

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Analysis 1.27

Comparison 1 Probiotic vs placebo, Outcome 27 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ number of probiotics.

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Analysis 1.28

Comparison 1 Probiotic vs placebo, Outcome 28 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ probiotics with no prebiotics.

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Comparison: probiotics vs no probiotics for treating eczema
Patient or population: male and female patients 0 to 55 years of age with physician‐diagnosed eczema Settings: primary or secondary care. Europe: 22 studies with 1390 participants. Asia: 8 studies with 500 participants. Australasia: 2 studies with 116 participants Intervention: probiotics ± prebiotics Comparison: no probiotics
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	No probiotics	Probiotics
Primary outcome 1: participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of active treatment Visual analogue scale for itch and sleep disturbance ranging from 0 to 10 for each symptom and combined ranging from 0 to 20. The higher the score, the more severe the symptoms Duration of follow‐up from baseline until end of active treatment from 6 weeks to 3 months	Mean SCORAD part C score ranged across control groups from 2 to 7.9	Mean SCORAD part C score in the intervention groups was 0.44 points lower (1.22 lower to 0.33 higher)	‐	754 (13)	⊕⊕⊕⊝ moderate^a	Two cross‐over studies included. Significant heterogeneity between studies Post hoc trial sequential analysis showed no effects of probiotics over control and suggests that further studies of currently available probiotic strains for this outcome may be futile
Primary outcome 1: participant‐ or parent‐rated global change in eczema symptoms at the end of active treatment (binary outcome) Change in risk for worsened/unchanged eczema Duration of follow‐up from baseline until end of active treatment from 6 weeks to 3 months	Low‐risk population		OR 0.40 (0.14 to 1.15)	135 (3)	⊕⊕⊝⊝ low^b	One cross‐over study included. Number of studies for this outcome was small. Moderate heterogeneity between studies
	300 per 1000	146 per 1000 (57 to 330)
	Medium‐risk population
	400 per 1000	210 per 1000 (85 to 434)
	High‐risk population
	500 per 1000	286 per 1000 (123 to 535)
*Primary outcome 2: participant‐ or parent‐rated participant* quality of life score at the end of active treatment** Scales used: DLQI, IDQoL, Skindex‐29, CDLQI. On those scales, the higher the score, the more severely the quality of life is affected Duration of follow‐up from baseline until end of active treatment from 8 weeks to 3 months	Mean DLQI score ranged across control groups from 5.3 to 8.5	Mean participant quality of life score in the intervention groups was 0.03 standard deviations higher (0.36 lower to 0.42 higher)	‐	552 (6)	⊕⊕⊝⊝ low^c	Small number of studies for this outcome. Significant heterogeneity
*Primary outcome 2: participant‐ or parent‐rated family* quality of life score at the end of active treatment** Scale used: DFI, FDLQI. On those scales, the higher the score, the more severely the quality of life is affected Duration of follow‐up from baseline until end of active treatment from 8 weeks to 3 months	Mean change in DFI score during treatment ranged across control groups from ‐2 points to ‐3 points	Mean family quality of life score in the intervention groups was 0.19 standard deviations lower (0.56 lower to 0.18 higher)	‐	358 (3)	⊕⊝⊝⊝ very low^d	Very small number of studies for this outcome. Significant heterogeneity
Secondary outcome 4: global eczema severity score (total SCORAD) at the end of active treatment (Investigator‐rated eczema severity) Scale used: total SCORAD ranging from 0 to 103. The higher the score, the more severe the disease Duration of follow‐up from baseline until end of active treatment from 8 weeks to 16 weeks	Mean total SCORAD ranged across control groups from 8.5 to 40.21 points	Mean total SCORAD score in the intervention groups was 3.91 points lower (5.86 to 1.96 points lower)	‐	1596 (24)	⊕⊕⊝⊝ low^e	Two cross‐over studies included. Extreme levels of heterogeneity for this outcome. Evidence of reporting bias
Secondary outcome 6: adverse events (gastrointestinal symptoms) during active treatment Duration of follow‐up from baseline until end of active treatment from 8 weeks to 3 months	Low‐risk population		RR 1.54 (0.90 to 2.63)	402 (7)	⊕⊕⊝⊝ low^f	Small number of studies reported adverse events. Small number of events were included in this analysis
	0 per 1000	0 per 1000 (0 to 0)
	Medium‐risk population
	100 per 1000	154 per 1000 (90 to 263)
	High‐risk population
	200 per 1000	308 per 1000 (180 to 526)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CDLQI: Children's Dermatology Life Quality Index; CI: confidence interval; DFI: Dermatitis Family Impact; DLQI: Dermatology Life Quality Index; FDLQI: Family Dermatology Life Quality Index; IDQoL: Infant Dermatitis Quality of Life; OR: odds ratio; RR: risk ratio; SCORAD: Severity Scoring of Atopic Dermatitis.
GRADE Working Group grades of evidence. High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate.
^aDowngraded by one level due to inconsistency as there was significant heterogeneity among studies (I² = 57%). ^bDowngraded by two levels due to small number of studies for this outcome (imprecision) and because of moderate levels of heterogeneity among studies (I² = 48%). ^cDowngraded by two levels due to small number of studies for this outcome (imprecision) and because of significant levels of heterogeneity among studies (I² = 68%). ^dDowngraded by three levels due to inconsistency (one level) as there was significant heterogeneity among studies (I² = 57%) and because of very small number of studies (imprecision) for this outcome (two levels). ^eDowngraded by two levels because of extreme levels of heterogeneity among studies (I² = 79%) and because of evidence of reporting bias. ^fDowngraded by two levels because of small number of studies reporting adverse events and small number of events in the meta‐analysis for this outcome (imprecision).

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Table 1. Terms used to categorise trial participants with eczema

Forms of eczema included	Forms of eczema excluded
Atopic eczema	Seborrhoeic eczema
Atopic dermatitis	Contact eczema
Besnier's prurigo	Allergic contact eczema
Neurodermatitis atopica (German)	Irritant contact eczema
Flexural eczema/dermatitis	Discoid/nummular eczema
Periorbital eczema	Asteatotic eczema
Childhood eczema	Varicose/stasis eczema
Infantile eczema	Photo‐/light‐sensitive eczema
'Eczema' unspecified	Chronic actinic dermatitis
Constitutional eczema	Dyshidrotic eczema
Endogenous eczema	Pompholyx eczema
Chronic eczema	Hand eczema
Neurodermatitis	Frictional lichenoid dermatitis
Neurodermatitis (German)	Lichen simplex
	Occupational dermatitis
	Prurigo

Table 1. Terms used to categorise trial participants with eczema

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Table 2. Non‐parametric analyses of SCORAD scores

	Isolauri 2mo LGG	Isolauri 2mo Bb12	Isolauri 2mo placebo
N	9	9	9
Median	1	0	13.4
IQR	0.1 to 8.7	0 to 3.8	4.5 to 18.2
IQR: interquartile range. SCORAD: Severity Scoring of Atopic Dermatitis.

Table 2. Non‐parametric analyses of SCORAD scores

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Table 3. Other parameters for quality assessment of included studies

Study	Clarity of methods	Compliance	Dietary management
Brouwer 2006	Clear	No compliance measures described	Adequate exclusion of other probiotics during the study
Cukrowska 2008	Total daily dose of intervention clear, but individual dose, frequency, and mode of administration not given	No compliance measures reported	Not stated
Drago 2012	Clear	Dose count (returned sachet packets counted by clinical investigator). Compliance measured for the 2 groups: 84.5% and 84.7%. No significant difference	Clear instructions given: no change in usual diet but avoid any type of fermented food containing live micro‐organisms
Drago 2014	Clear	No information provided	No information provided
Farid 2011	Aims and Interventions clear. Outcomes not clear and baseline severity (SCORAD) not given	No information given	Inadequate information
Flinterman 2007	Aims, interventions clear	Inadequate information	Inadequate information
Folster‐Holst 2006	Clear	No compliance measures reported	Not stated
Gerasimov 2010	Total daily dose of probiotics not clear. Remaining methods clear	Compliance checked from the parental report and the weight of remaining powder. Reported that there were no differences in compliance between the 2 groups	No information on adequate exclusion of other probiotics from the diet. Participants with challenge proved milk or egg allergy followed milk or egg elimination diet, respectively
Goebel 2010	Clear	Compliance based on count of remaining capsules: average 94% for all groups and 93.6%, 95%, and 93.3% for Bifidobacterium, Lactobacillus, and placebo groups, respectively. No significant difference in compliance between the 3 groups (P = 0.6). No participating child had compliance lower than 72%	No information given
Gore 2011	All methods clear Reporting of adverse events suggests that these were the result of the change in formula but the numbers are totals from intervention and control groups, and it is not certain whether the AEs are associated with the formula or the probiotics	No compliance measures reported	Instructions given that other fermented or probiotic‐containing products were to be avoided
Gromert 2009	Inadequate information available	No information	No information
Gruber 2007	Unclear what the placebo was; otherwise clear	92.5% of doses taken by probiotic group; 94.4% by placebo group	Not stated, other than encouragement to avoid allergens
Guo 2015	Dose and exact consistency of probiotics unclear	No information	No information
Han 2012	Preparation of the intervention not clear. Otherwise clear	No compliance measure described	Clear instructions not to consume fermented food and products containing live micro‐organisms
Hol 2008	Trial designed to study effects of probiotics in participants with cow's milk allergy. Effects of probiotics on eczema ‐ secondary outcome. Aims, interventions, and outcome measures clear	Compliance measure not presented. "To optimise compliance, participants were supplied with study formula through the study team and batches were delivered at home"	No information provided
Iemoli 2012	Clear	Method: count of return sachets. Reported that compliance was similar in the 2 groups but no measures reported	Instructions given so that participants do not change their diet during trial but should avoid fermented food products containing live micro‐organisms
Isolauri 2000	Unclear ‐ dose and duration of probiotic treatment received not clearly described. Severity of participant eczema at baseline not described	No compliance measures reported	Not stated
Ivankhnenko 2013	Placebo not described. Otherwise methods clear	No compliance measures reported	Not stated
Kirjavainen 2003	Unclear ‐ intended duration of study treatment not stated	No compliance measures reported	Not stated
Lin 2015	Exact dose of probiotics not given	No information provided	No information provided
Majamaa 1997	Unclear ‐ precise dose of probiotic received by participants not stated	No compliance measures described	Not stated
Matsumoto 2014	Clear	No information provided	Clearly stated: "All patients were asked to avoid probiotic supplements, fermented milk, lactic acid bacterial drinks and fermented soybean (natto) during the experimental period…"
Nermes 2010	Clear	No compliance measures reported	Not stated
Passeron 2006	Clear	No compliance measures described	Not stated
Roessler 2007	Clear	No compliance measures described	Adequate exclusion of prebiotics and probiotics 3 weeks before the start and during the 20 weeks of the intervention
Rosenfeldt 2003	Clear	No compliance measures described	Adequate exclusion of other probiotics during study
Shafiei 2011	Intervention type not clear: synbiotic mixture of 7 strains of probiotics and fructo‐oligosaccharide. Dose, frequency of intake, and preparation clear Baseline characteristics given only for participants who completed the trial	No compliance measures reported	Unclear. Stated that participants did not change diet before or during the trial
Sistek 2006	Clear	Assessed by 2 telephone calls	One participant noted to have taken non‐study probiotic
Taniuchi 2005	Clear	No compliance measures described	Not stated
Van der Aa 2010	Clear	No compliance measures reported. Participants' parents were keeping diary for formula intake and adverse events. Formula with intervention was given on demand and at the end of intervention. No significant differences in formula intake were noted between the 2 groups	Unclear
Viljanen 2005	Method for diagnosing eczema not described	No compliance measures described	Not stated
Wang 2015	All clear. In the publication, not clear what the placebo was, but this was clarified by the study author	Yes: capsule count performed	Yes Stated: "During the study…and other probiotics were not permitted"
Weston 2005	Clear	Sachet counts and parent‐completed sachet administration chart. Good compliance (94%) ‐ no differences between the 2 groups	Adequate exclusion of other probiotics during study
Woo 2010	Clear	No measure of compliance was reported, but it was stated that the 2 groups had no difference in compliance	No information provided
Wu 2012	Aims, interventions, and outcome measures clear. Exclusion criteria not given	Patients and parents were to return to investigators all unused intervention. No measure was reported	Instruction given to parents not to feed their children other probiotic preparations during the intervention
Wu 2015	Aims, interventions, and outcome measures clear. Dose of probiotic not given in colony‐forming units, or similar measure of bacterial numbers	Compliance recorded: assessed based on a count of returned medication	No information provided
Yang 2014	All clear	No information given	Instructions given to avoid any commercial probiotic‐containing products 2 weeks before study initiation. No comment about diet during the trial
Yesilova 2012	All clear	No information provided	No information provided
Yoshida 2010	Placebo not described. Otherwise clear	No compliance measures reported	No information given
SCORAD: Severity Scoring of Atopic Dermatitis.

Table 3. Other parameters for quality assessment of included studies

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Table 4. Changes in the need for other eczema treatment during active treatment

	Rosenfeldt 2003	Gruber 2007	Weston 2005	Folster‐Holst 2006	Gerasimov 2010	Han 2012	Wu 2012	Woo 2010	Van der Aa 2010	Gore 2011	Wu 2015
Median grams hydrocortisone butyrate applied (range)	Probiotic: 7.8 (0 to 67) Placebo: 6.0 (0 to 59)	‐	‐	‐	‐	‐	‐	‐	‐	‐	‐
Mean grams 1% hydrocortisone applied (SD)	‐	Probiotic: 0.8 (45.0) Placebo: 3.5 (29.8)	‐	‐	‐	‐	‐	‐	‐	‐	‐
Median change in topical corticosteroid use score (IQR)	‐	‐	Probiotic: 0.25 (‐6.7 to 7.0) Placebo: ‐1.0 (‐8.0 to 0.7)	‐	‐	‐	‐	‐	‐	‐	‐
Mean applications per week (SD)	‐	‐	‐	Probiotic: 3.0 (0.6) Placebo: 3.2 (0.9)	Probiotic: 0.8 (0.9) Placebo: 1.2 (1.4)	‐	‐	‐	‐	‐	‐
Number of participants using topical CS during study (%)	‐	‐	‐	‐	‐	Baseline Probiotics: 13/58 (22.4%) Placebo: 14/60 (23.3%) At end of treatment Probiotics: 13/44 (29.5%) Placebo: 14/39 (36%)	‐	Probiotic: 22/45 (49%) Placebo: 20/43 (46%)	Baseline Synbiotic: 25/45 (55.6%) Placebo: 22/44 (50%) At end of treatment Synbiotic: 22/41 (53.7%) Placebo: 24/42 (57.1%)	‐	‐
Mean grams 0.25% prednicarbate applied during study (SD)	‐	‐	‐	‐	‐	Probiotic: 1.6 g (6.5) Placebo: 1.5 g (4.0)	‐	‐	‐	‐	‐
Mean applications of CS or calcineurin inhibitor per month (SD)	‐	‐	‐	‐	‐	‐	Probiotic: 23.5 (19.1) Placebo: 19.1 (19)	‐	‐	‐	‐
Median grams of 0.1% prednicarbate during Intervention (range)	‐	‐	‐	‐	‐	‐	‐	Probiotic: 11 (0 to 63) Placebo: 13 (0 to 83)	‐	‐	‐
Median change in grams of 0.1% prednicarbate use during intervention (range)	‐	‐	‐	‐	‐	‐	‐	Probiotic: ‐0.5 (‐2.7 to 1.3) Placebo: ‐0.3 (‐1.9 to 2.5)	‐	‐	‐
Number of participants using standard skin care at end of intervention	‐	‐	‐	‐	‐	‐	‐	‐	‐	Probiotic: 29/88 (33%) Placebo: 21/47 (45%)	‐
Number of participants using different potencies of TCS at end of intervention	‐	‐	‐	‐	‐	‐	‐	‐	‐	Emollients only Probiotic: 31/88 (35%) Placebo: 18/47 (38%) Mild Probiotic: 54/88 (61%) Placebo: 29/47 (62%) ≥ moderate/potent Probiotic: 3/88 (3%) Placebo: 0	‐
Mean grams of TCS (hydrocortisone 1% or mometasone 0.1%) used during study (SD)	‐	‐	‐	‐	Probiotic: 25.6 (14.5) Placebo: 33.3 (11.4)	‐	‐	‐	‐	‐	‐
Median grams of TCS (hydrocortisone 1% or mometasone 0.1%) used during study (range)	‐	‐	‐	‐	Probiotic: 25.0 (0.0 to 45.0) Placebo: 35.0 (15.0 to 50.0)	‐	‐	‐	‐	‐	‐
Mean total amount (gr) of corticosteroid used during treatment period ± SD	‐	‐	‐	‐	‐	‐	‐	‐	‐	‐	Probiotic: 5.87 ± 7.48 Placebo: 4.73 ± 5.48
CS: corticosteroids. IQR: interquartile range. SD: standard deviation. TCS: topical corticosteroids.

Table 4. Changes in the need for other eczema treatment during active treatment

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Comparison 1. Probiotic vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment Show forest plot	13		Mean difference (Random, 95% CI)	‐0.44 [‐1.22, 0.33]

1.1 Parallel‐group trials	11		Mean difference (Random, 95% CI)	‐0.42 [‐1.27, 0.43]
1.2 Cross‐over trials	2		Mean difference (Random, 95% CI)	‐0.52 [‐3.16, 2.12]
2 Participant‐ or parent‐rated global change in eczema symptoms at the end of treatment (binary outcome) Show forest plot	3		Odds ratio (Random, 95% CI)	0.40 [0.14, 1.15]

2.1 Parallel‐group trials	2		Odds ratio (Random, 95% CI)	0.70 [0.27, 1.77]
2.2 Cross‐over trials	1		Odds ratio (Random, 95% CI)	0.18 [0.05, 0.60]
3 Change in participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end treatment (continuous outcome) Show forest plot	9		Mean Difference (Random, 95% CI)	‐0.70 [‐1.47, 0.06]

3.1 Parallel‐group trials	8		Mean Difference (Random, 95% CI)	‐0.82 [‐1.62, ‐0.02]
3.2 Cross‐over studies	1		Mean Difference (Random, 95% CI)	0.66 [‐1.79, 3.11]
4 Participant‐ or patient‐related quality of life score at the end of treatment Show forest plot	6		Std. Mean Difference (Random, 95% CI)	0.03 [‐0.36, 0.42]

4.1 Infant's Dermatitis Quality of Life Index (IDQoL)	2		Std. Mean Difference (Random, 95% CI)	0.35 [0.08, 0.62]
4.2 Dermatology Life Quality Index	1		Std. Mean Difference (Random, 95% CI)	‐0.33 [‐0.95, 0.29]
4.3 Skindex‐29 Questionnaire	2		Std. Mean Difference (Random, 95% CI)	‐0.66 [‐4.24, 2.92]
4.4 Children's Dermatology Quality of Life Index	1		Std. Mean Difference (Random, 95% CI)	‐0.39 [‐0.70, ‐0.08]
5 Participant‐ or patient‐related quality of life score at the end of treatment Show forest plot	3		Std. Mean Difference (Random, 95% CI)	‐0.19 [‐0.56, 0.18]

5.1 Dermatitis Family Impact Questionnaire (DFI)	2		Std. Mean Difference (Random, 95% CI)	‐0.31 [‐0.86, 0.24]
5.2 Family Dermatology Dermatology Life Quality Index	1		Std. Mean Difference (Random, 95% CI)	‐0.01 [‐0.32, 0.30]
6 Parent‐ or participant‐rated eczema severity (SCORAD part C) within 6 months after treatment has ceased Show forest plot	3	185	Mean Difference (IV, Random, 95% CI)	‐1.81 [‐3.13, ‐0.49]

7 Participant‐ or parent‐related quality of life within 6 months after treatment has ceased Show forest plot	2	261	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.35, 0.20]

7.1 Dermatology Life Quality Index	1	46	Std. Mean Difference (IV, Random, 95% CI)	‐0.14 [‐0.75, 0.48]
7.2 Child Dermatology Life Quality Index	1	215	Std. Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.37, 0.25]
8 Global eczema severity score (total SCORAD) at the end of treatment Show forest plot	24		Mean difference (Random, 95% CI)	‐3.91 [‐5.86, ‐1.96]

8.1 Parallel‐group studies	22		Mean difference (Random, 95% CI)	‐3.84 [‐5.95, ‐1.72]
8.2 Cross‐over studies	2		Mean difference (Random, 95% CI)	‐4.14 [‐7.68, ‐0.59]
9 Global eczema severity score (total SCORAD) at the end of treatment ‐ sensitivity analysis ‐ change score Show forest plot	14		Mean difference (Random, 95% CI)	‐4.46 [‐6.49, ‐2.43]

9.1 Parallel‐group trial	13		Mean difference (Random, 95% CI)	‐4.53 [‐6.72, ‐2.33]
9.2 Cross‐over trial	1		Mean difference (Random, 95% CI)	‐3.93 [‐9.25, 1.40]
10 Global eczema severity score (total SCORAD) at the end of treatment ‐ low risk of bias studies only Show forest plot	8		Mean difference (Random, 95% CI)	Totals not selected

10.1 Parallel‐group studies	8		Mean difference (Random, 95% CI)	0.0 [0.0, 0.0]
11 Investigator‐rated eczema severity (SCORAD parts A/B) at the end of treatment ‐ continuous outcome Show forest plot	10	529	Mean Difference (IV, Random, 95% CI)	‐2.24 [‐4.69, 0.20]

12 Global eczema severity score (total SCORAD) within 6 months after treatment has ceased Show forest plot	7		Mean difference (Random, 95% CI)	‐7.72 [‐11.85, ‐3.59]

12.1 Parallel‐group studies	6		Mean difference (Random, 95% CI)	‐9.27 [‐13.88, ‐4.65]
12.2 Cross‐over studies	1		Mean difference (Random, 95% CI)	0.2 [‐3.86, 4.26]
13 Investigator‐rated eczema severity (SCORAD parts A/B) within 6 months after treatment has ceased Show forest plot	2	102	Mean Difference (IV, Random, 95% CI)	‐8.11 [‐13.14, ‐3.09]

14 Adverse events (short term) Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

14.1 Gastrointestinal symptoms	7	402	Risk Ratio (M‐H, Random, 95% CI)	1.54 [0.90, 2.63]
15 Participant/parent‐rated global change in symptoms of eczema at the end of treatment ‐ stratified by age groups Show forest plot	3		Odds ratio (Random, 95% CI)	Totals not selected

15.1 Age under 2 years	1		Odds ratio (Random, 95% CI)	0.0 [0.0, 0.0]
15.2 Age 2 to 12 years	1		Odds ratio (Random, 95% CI)	0.0 [0.0, 0.0]
15.3 Age not categorised	1		Odds ratio (Random, 95% CI)	0.0 [0.0, 0.0]
16 Participant/parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ stratified by age groups Show forest plot	12		Mean difference (Random, 95% CI)	Subtotals only

16.1 Age under 2 years	5		Mean difference (Random, 95% CI)	‐0.39 [‐2.20, 1.42]
16.2 Age 2 to 12 years	4		Mean difference (Random, 95% CI)	‐0.63 [‐2.04, 0.78]
16.3 Age not categorised	2		Mean difference (Random, 95% CI)	‐2.23 [‐3.71, ‐0.74]
16.4 Adults only	2		Mean difference (Random, 95% CI)	1.01 [‐0.82, 2.84]
17 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by age groups Show forest plot	24		Mean difference (Random, 95% CI)	Subtotals only

17.1 Age under 2 years	10		Mean difference (Random, 95% CI)	‐0.99 [‐3.97, 1.99]
17.2 Age 2 to 12 years	3		Mean difference (Random, 95% CI)	‐6.08 [‐9.68, ‐2.48]
17.3 Age not categorised	7		Mean difference (Random, 95% CI)	‐5.25 [‐10.43, ‐0.07]
17.4 Adults only	5		Mean difference (Random, 95% CI)	‐6.51 [‐10.09, ‐2.93]
18 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by presence of atopy Show forest plot	23		Mean difference (Random, 95% CI)	Subtotals only

18.1 Participants with atopy	4		Mean difference (Random, 95% CI)	‐3.90 [‐15.52, 7.73]
18.2 Participants with unknown atopic status	19		Mean difference (Random, 95% CI)	‐4.15 [‐6.02, ‐2.27]
19 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by challenge‐proven food allergy Show forest plot	21		Mean difference (Random, 95% CI)	Subtotals only

19.1 Food allergy present	3		Mean difference (Random, 95% CI)	‐1.84 [‐6.22, 2.54]
19.2 Unknown food allergic status	18		Mean difference (Random, 95% CI)	‐3.21 [‐5.63, ‐0.79]
20 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by eczema severity Show forest plot	6		Mean Difference (IV, Random, 95% CI)	Subtotals only

20.1 Severe eczema (SCORAD over 40)	5	95	Mean Difference (IV, Random, 95% CI)	‐3.71 [‐10.05, 2.64]
20.2 Moderate eczema (SCORAD 15 to 40)	6	279	Mean Difference (IV, Random, 95% CI)	‐2.95 [‐7.65, 1.74]
20.3 Mild eczema (SCORAD under 15)	1	8	Mean Difference (IV, Random, 95% CI)	‐5.53 [‐15.29, 4.23]
21 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ stratified by probiotic ‐ Lactobacillus species Show forest plot	12		Mean difference (Random, 95% CI)	Subtotals only

21.1 Lactobacillus GG alone or in combination with or without prebiotic	1		Mean difference (Random, 95% CI)	1.79 [0.29, 3.29]
21.2 Lactobacillus rhamnosus alone or in combination with or without prebiotic	5		Mean difference (Random, 95% CI)	‐0.82 [‐2.24, 0.60]
21.3 Lactobacillus salivarius alone or in combination with or without prebiotic	1		Mean difference (Random, 95% CI)	0.0 [‐0.88, 0.88]
21.4 Lactobacillus casei/paracasei alone or in combination with or without prebiotics	2		Mean difference (Random, 95% CI)	0.56 [‐0.29, 1.41]
21.5 Any Lactobacillus species alone or in combination with or without prebiotics	12		Mean difference (Random, 95% CI)	‐0.50 [‐1.31, 0.31]
22 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ stratified by probiotic ‐ Bifidobacterium species Show forest plot	5		Mean difference (Random, 95% CI)	Subtotals only

22.1 Bifidobacterium lactis alone or in combination with or without prebiotics	4		Mean difference (Random, 95% CI)	‐0.34 [‐1.92, 1.24]
22.2 Bifidobacterium breve alone or in combination with or without prebiotics	1		Mean difference (Random, 95% CI)	1.3 [‐2.15, 4.75]
22.3 Any Bifidobacteria species alone or in combination with or without prebiotic	5		Mean difference (Random, 95% CI)	‐0.11 [‐1.47, 1.25]
23 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ number of probiotics Show forest plot	13		Mean difference (Random, 95% CI)	Subtotals only

23.1 Studies using single probiotic with or without prebiotics	8		Mean difference (Random, 95% CI)	‐0.40 [‐1.45, 0.66]
23.2 Studies using multiple probiotics with or without prebiotics	5		Mean difference (Random, 95% CI)	‐0.58 [‐1.98, 0.81]
24 Participant‐ or parent‐rated symptoms of eczema (SCORAD part C) at the end of treatment ‐ probiotics with no prebiotics Show forest plot	13		Mean difference (Random, 95% CI)	‐0.44 [‐1.22, 0.33]

25 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ Lactobacillus species Show forest plot	21		Mean difference (Random, 95% CI)	Subtotals only

25.1 Lactobacillus GG alone or in combination with or without prebiotic	3		Mean difference (Random, 95% CI)	3.37 [0.55, 6.20]
25.2 Lactobacillus rhamnosus alone or in combination with or without prebiotic	5		Mean difference (Random, 95% CI)	‐3.49 [‐9.81, 2.83]
25.3 Lactobacillus salivarius alone or in combination with or without prebiotic	6		Mean difference (Random, 95% CI)	‐6.86 [‐10.08, ‐3.63]
25.4 Lactobacillus casei/paracasei alone or in combination with or without prebiotics	6		Mean difference (Random, 95% CI)	‐2.58 [‐7.21, 2.05]
25.5 Any Lactobacillus species alone or in combination with or without prebiotics	21		Mean difference (Random, 95% CI)	‐3.80 [‐6.06, ‐1.54]
26 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ Bifidobacterium species Show forest plot	12		Mean difference (Random, 95% CI)	Subtotals only

26.1 Bifidobacterium lactis alone or in combination with or without prebiotics	7		Mean difference (Random, 95% CI)	‐1.90 [‐5.42, 1.63]
26.2 Bifidobacterium breve alone or in combination with or without prebiotics	3		Mean difference (Random, 95% CI)	‐0.36 [‐11.39, 10.67]
26.3 Any Bifidobacteria species alone or in combination with or without prebiotic	12		Mean difference (Random, 95% CI)	‐2.26 [‐5.14, 0.63]
27 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ number of probiotics Show forest plot	24		Mean difference (Random, 95% CI)	Subtotals only

27.1 Studies using single probiotic with or without prebiotics	13		Mean difference (Random, 95% CI)	‐4.90 [‐7.66, ‐2.15]
27.2 Studies using multiple probiotics with or without prebiotics	12		Mean difference (Random, 95% CI)	‐3.54 [‐6.50, ‐0.58]
28 Global eczema severity score (total SCORAD) at the end of treatment ‐ stratified by probiotic ‐ probiotics with no prebiotics Show forest plot	24		Mean difference (Random, 95% CI)	‐3.83 [‐5.81, ‐1.86]

Comparison 1. Probiotic vs placebo

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