Emollients and moisturisers for eczema Edited (no change to conclusions)

Abstract

Background

Eczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and has a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.

Objectives

To assess the effects of moisturisers for eczema.

Search methods

We searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and GREAT. We searched five trials registers and checked references of included and excluded studies for further relevant trials.

Selection criteria

Randomised controlled trials in people with eczema.

Data collection and analysis

We used standard Cochrane methodological procedures.

Main results

We included 77 studies (mean duration: 6.7 weeks; 6603 participants, mean age: 18.6 years). Thirty‐six studies were at high risk of bias, 34 at unclear risk, and seven at low risk. Twenty‐four studies assessed our primary outcome of participant‐assessed disease severity, 13 assessed satisfaction, and 41 assessed adverse events. Secondary outcomes included investigator‐assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).

Six studies evaluated moisturiser versus no moisturiser. Participant‐assessed disease severity and satisfaction were not assessed. Moisturiser use yielded lower SCORing Atopic Dermatitis (SCORAD) scores than no moisturiser (3 studies, 276 participants; mean difference (MD) ‐2.42, 95% confidence interval (CI) ‐4.55 to ‐0.28), but the minimal important difference (MID) was unmet. Moisturiser use resulted in fewer flares (2 studies, 87 participants; RR 0.40, 95% CI 0.23 to 0.70), prolonged time to flare (median: 180 versus 30 days), and reduced use of topical corticosteroids (2 studies, 222 participants; MD ‐9.30 g, 95% CI ‐15.3 to ‐3.27). There was no clear difference in adverse events (1 study, 173 participants; risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.

With Atopiclair, 174/232 participants reported improvement in disease severity versus 27/158 using vehicle (3 studies; RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (4 studies, 396 participants; MD ‐2.65, 95% CI ‐4.21 to ‐1.09) and achieved more frequent satisfaction (2 studies, 248 participants; RR 2.14, 95% CI 1.58 to 2.89), fewer flares (3 studies, 397 participants; RR 0.18, 95% CI 0.11 to 0.31), and lower Eczema Area and Severity Index (EASI) scores (4 studies, 426 participants; MD ‐4.0, 95% CI ‐5.42 to ‐2.57), but the MID was unmet. The number of participants reporting adverse events was not statistically different (4 studies, 430 participants; RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.

Participants reported skin improvement more frequently with urea‐containing cream than placebo (1 study, 129 participants; RR 1.28, 95% CI 1.06 to 1.53; low‐quality evidence), with equal satisfaction between the two groups (1 study, 38 participants; low‐quality evidence). Urea‐containing cream improved dryness (investigator‐assessed) (1 study, 128 participants; RR 1.40, 95% CI 1.14 to 1.71; moderate‐quality evidence), and produced fewer flares (1 study, 44 participants; RR 0.47, 95% CI 0.24 to 0.92; low‐quality evidence), but caused more adverse events (1 study, 129 participants; RR 1.65, 95% CI 1.16 to 2.34; moderate‐quality evidence).

Three studies assessed glycerol‐containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (1 study, 134 participants; RR 1.22, 95% CI 1.01 to 1.48; moderate‐quality evidence), which also included improved investigator‐assessed SCORAD scores (1 study, 249 participants; MD ‐2.20, 95% CI ‐3.44 to ‐0.96; high‐quality evidence), but the MID was unmet. Participant satisfaction was not addressed. The number of adverse events reported was not statistically significant (2 studies, 385 participants; RR 0.90, 95% CI 0.68 to 1.19; moderate‐quality evidence).

Four studies investigated oat‐containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant‐assessed disease severity (1 study, 50 participants; RR 1.11, 95% CI 0.84 to 1.46; low‐quality evidence), satisfaction (1 study, 50 participants; RR 1.06, 95% CI 0.74 to 1.52; very low‐quality evidence), or investigator‐assessed disease severity (3 studies, 272 participants; standardised mean difference (SMD) ‐0.23, 95% CI ‐0.66 to 0.21; low‐quality evidence). In the oat group, there were fewer flares (1 study, 43 participants; RR 0.31, 95% CI 0.12 to 0.7; low‐quality evidence) and reduced use of topical corticosteroids (2 studies, 222 participants; MD ‐9.30g, 95% CI 15.3 to ‐3.27; low‐quality evidence), but more adverse events (1 study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low‐quality evidence).

We compared all moisturisers to placebo, vehicle, or no moisturiser. Participants considered moisturisers to be more effective for reducing eczema (5 studies, 572 participants; RR 2.46, 95% CI 1.16 to 5.23; low‐quality evidence) and itch (7 studies, 749 participants; SMD ‐1.10, 95% CI ‐1.83 to ‐0.38) than control. Participants in both treatment arms reported comparable satisfaction (3 studies, 296 participants; RR 1.35, 95% CI 0.77 to 2.26; low‐quality evidence). Moisturisers led to lower investigator‐assessed disease severity scores (12 studies, 1281 participants; SMD ‐1.04, 95% CI ‐1.57 to ‐0.51; high‐quality evidence) and fewer flares (6 studies, 607 participants; RR 0.33, 95% CI 0.17 to 0.62; moderate‐quality evidence), without a difference in adverse events (10 studies, 1275 participants; RR 1.03, 95% CI 0.82 to 1.30; moderate‐quality evidence).

Topical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator‐assessed disease severity scores (3 studies, 192 participants; SMD ‐0.87, 95% CI ‐1.17 to ‐0.57; moderate‐quality evidence) and flares (1 study, 105 participants; RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low‐quality evidence). There was no clear difference in number of adverse events (1 study, 125 participants; RR 0.39, 95% CI 0.13 to 1.19; very low‐quality evidence). Participant‐assessed disease severity was not addressed.

Authors' conclusions

Most moisturisers showed some beneficial effects; prolonging time to flare, reducing the number of flares and the amount of topical corticosteroids needed to achieve similar reductions in eczema severity. Moisturisers combined with active treatment gave better results than active treatment alone. We did not find reliable evidence that one moisturiser is better than another.

Author(s)

Esther J vanZuuren, Zbys Fedorowicz, Robin Christensen, Adriana PM Lavrijsen, Bernd WM Arents

Abstract

Plain language summary

Emollients and moisturisers for eczema 

Review question 

Do emollients and moisturisers help control eczema?

Background 

Eczema is a chronic (long‐lasting) skin disorder. Its main symptoms are dry skin and intense itching. Affected areas appear red, with crusts and scratches, and may ooze fluid. Moisturisers are considered important in eczema treatment, but there is uncertainty about how well they work, and whether any one moisturiser works better ‐ and is preferable ‐ to another.

Study characteristics 

We searched the medical literature up to December 2015, and identified 77 relevant studies with 6603 participants, with mainly mild to moderate eczema. Participant age ranged from four months to 84 years (mean: 18.6 years). Most studies lasted between two and six weeks; a few lasted six months.

Forty‐six studies received funding from pharmaceutical companies.

Key results 

Most moisturisers appeared to be effective. Twenty‐four studies reported participant‐assessed eczema severity. Only 13 studies assessed participant satisfaction with the moisturiser. Side effects (adverse events) were reported in 41 studies, although this information was often limited (mainly smarting, stinging, itch, redness). Most studies evaluated physician‐assessed severity of eczema (65 studies). Other outcomes addressed were skin barrier function (29 studies), flare prevention (16), quality of life (10), and corticosteroid use (8).

According to physicians, moisturisers reduced eczema severity compared with no moisturiser (3 studies), but the reduction was too small to be considered meaningful for patients. Moisturiser use resulted in fewer flares (2 studies), and reduced the need for topical corticosteroids (2 studies). Participant‐assessed eczema severity and satisfaction were not evaluated. There was no difference in the number of adverse events reported.

Participants thought Atopiclair (containing glycyrrhetinic acid) was more than four times more effective at improving eczema‐severity than the control (i.e. identical looking, but without glycyrrhetinic acid) (3 studies). However, physicians did not identify a meaningful difference for patients. Atopiclair led to greater reduction of itch (4 studies), more frequent participant satisfaction (2 studies), and fewer flares (3 studies). The number of reported adverse events was similar in each group.

Four studies evaluated urea‐containing cream. Participants using urea cream reported improvement more often than those using control (1 study). Satisfaction ratings in both groups were comparably positive (1 study). Urea‐containing cream improved dryness more often (physician assessment) (1 study) and led to fewer flares (1 study), but with more adverse events reported.

Three studies assessed glycerol‐containing moisturiser versus control. More participants in the glycerol group considered their skin to be improved (1 study), as did physicians, but these differences were not meaningful for patients. Participant satisfaction was not addressed. There was no difference in the number of adverse events reported.

Four studies investigated oat‐containing moisturisers versus no treatment or control. No differences between groups were observed for participant‐assessed improvement (1 study), participant satisfaction (1 study), or physician‐assessed improvement (3 studies). However, the oat group had fewer flares (1 study), and a reduced need for topical corticosteroids (2 studies). Oat creams caused more adverse events.

When we compared all moisturisers against no moisturiser or control, overall, participants considered moisturisers to be more than twice as effective in improving eczema than no moisturiser or control (5 studies), and more effective for itch (7 studies). Participants in both treatment arms reported comparable satisfaction (3 studies). According to physicians, moisturisers decreased eczema severity more than the control (12 studies), and led to fewer flares (6 studies). There were no differences between groups for the number of adverse events reported.

According to physicians, topical corticosteroids were more effective at improving eczema when used with a moisturiser, rather than used alone (3 studies), and also reduced the number of flares (1 study). This combination was also favoured by participants, though participant‐assessed disease severity was not addressed. There was no difference in the number of adverse events reported.

Quality of the evidence 

There was high certainty evidence for physician‐assessed disease severity for glycerol‐containing creams versus control and all moisturisers versus control. For most other outcomes across comparisons, there was low to moderate certainty evidence. The most important reasons for lowering the certainty of evidence were risk of bias in studies (e.g. no blinding, or missing data), or too few participants, which leads to less precise results.

Author(s)

Esther J vanZuuren, Zbys Fedorowicz, Robin Christensen, Adriana PM Lavrijsen, Bernd WM Arents

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Treatment for eczema encompasses active treatments to address active inflammatory lesions, management strategies to minimise triggers, life style measures and education about eczema, but also adjunctive therapies to optimise skin barrier function and to prevent flare‐ups. The use of moisturisers has always been an integral part of eczema treatment and there was an unmet need for summarising the overall evidence about their effects. This review included 77 studies from which, although we assessed most as being at unclear to high risk of bias, we have been able to draw the following conclusions:

  • There is low quality evidence that applying moisturisers is effective in reducing disease severity compared to not using moisturisers (investigator‐assessed outcome), although not to a clinically important extent, as the minimal important difference (MID) was not met. However, use of moisturisers reduced the number of participants who experienced a flare, prolonged the time to flare, reduced the rate of flare by a factor of almost four and reduced the total amount of topical corticosteroids that would have been needed to achieve similar reductions in the SCORing Atopic Dermatitis Index (SCORAD), all of which are clinically important.
  • There is moderate quality evidence that Atopiclair is more effective than vehicle (investigator and participant assessments), but the MID was not met. It had an important effect on itch and on reduction of flares.
  • There is low to moderate quality evidence that urea‐containing creams are more effective than no moisturiser, placebo or vehicle (based on both investigator and participant assessments), and reduced rate of flare by a third, but with more adverse events. Efficacy was confirmed by one study, at low risk of bias, conducted over 180 days, that showed that barrier‐strengthening moisturiser with 5% urea reduced the number of participants who experienced a flare, and increased time to flare in comparison to the reference cream.
  • There is moderate to high quality evidence that glycerol‐containing moisturisers are more effective than 'vehicle' or placebo (investigator and participant assessments), but the MID was not met.
  • There is low to very low quality evidence that there is no difference in efficacy between oat‐containing cream and vehicle or no moisturiser (investigator and participant assessments), and more adverse events were seen. However, the use of oat‐containing creams reduced flares by a third, rate of flare to a fifth, and reduced the need to apply topical corticosteroids.
  • There is high quality evidence that the use of moisturisers is more effective (investigator assessments) than the use of no moisturiser, vehicle or placebo (controls). Use of moisturisers had a large beneficial effect on itch compared to controls. However, due to considerable heterogeneity in the results, the use of different assessment scales and because the clinical relevance of this outcome is difficult to estimate, caution must be exercised in interpreting these data. Use of moisturiser reduced flares by a third, and rate of flare to almost a quarter. Reduced amounts of topical corticosteroids were needed when moisturisers were used.
  • There is low quality evidence that licochalcone‐containing cream is as effective as hydrocortisone acetate 1% cream (investigator assessments).
  • There is high quality evidence that twice weekly fluticasone propionate plus a moisturiser provides more effective eczema control than a moisturiser alone (participant assessments), and moderate quality evidence that it reduces the number of flares by a factor of two, and reduces the rate of flare to almost a quarter.
  • There is moderate quality evidence that combining topical active treatment with a moisturiser is more effective than treatment with active treatment alone (investigator assessments). There is also low quality evidence that participants were more satisfied with the combined treatment.
  • There were no differences between treatments for the number of participants experiencing an adverse event (except for urea‐ and oat‐containing creams), or in self‐assessed quality of life.
  • Reductions in itch were generally small, except with Atopiclair, where the effect seemed larger and clinically important.
  • Improvements in skin barrier function varied from small to more substantial improvements, but these were inconsistent across studies.
  • Overall, considering the various included studies and comparisons in this review we can conclude that the efficacy of moisturisers varied from minimal to substantial.

Moisturisers appeared to have a beneficial effect, but the extent of the effect varied widely, and in only a few studies did moisturisers produce a reduction in disease severity that met the MID. There is no convincing evidence that moisturisers improve eczema when used alone. However, the overall conclusion is that moisturisers are safe, prevent flares, prolong time to flare, reduce the amount of topical corticosteroids needed, and that topical active treatment is more effective when used in combination with moisturisers.

This review does not inform us about the importance of education in how to apply moisturisers, in particular how often they need to be applied and how much to use. However, since moisturisers reduce flares, prolong the time to flare, decrease the necessity for topical corticosteroids and increase the efficacy of active treatment, it makes clinical sense to encourage adherence to moisturiser therapy. This is especially important as moisturiser therapy is time consuming and often required throughout life, as eczema is a chronic condition.

This review provides no information about which moisturisers might be preferred for different parts of the body, or preferred during different seasons or personal circumstances, or which moisturisers best fit the actual disease status (acute or chronic) or severity (mild, moderate or severe). There is no evidence to support a 'one size fits all' approach. Therefore, clinical decisions about choices of moisturiser should be based on the available evidence, and take into account the experiences and preferences of the person with eczema.

Implications for research 

There was substantial variation in the way the included studies were conducted, and in their quality of reporting. Standardisation of outcome reporting, as suggested by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative, would improve the assessment and comparison of relevant outcomes significantly (www.comet-initiative.org). The Harmonising Outcome Measures in Eczema (HOME) initiative has defined and agreed a core set of domains, i.e. symptoms, signs, quality of life and long term control (www.nottingham.ac.uk/homeforeczema/index.aspx), while the Eczema Area and Severity Index (EASI) and the Patient Oriented Eczema Measure (POEM) have been agreed on as the best outcome measures for signs and symptoms, respectively. EASI, the objective SCORAD and POEM are scales recommended for studies (Schmitt 2007; Schmitt 2014). Of the 77 studies in this Cochrane Review, 14 used EASI, 25 used SCORAD (with objective SCORAD used in just four), and two used POEM, so there are clear opportunities for improved uniformity in future studies. The MIDs of SCORAD, objective SCORAD, EASI and POEM that were used in this review were based on the Schram 2012 study. Only the MID of POEM has been investigated in another study (Gaunt 2016), which determined a value of around 3, while we used 3.4 (Schram 2012). The MIDs of (objective) SCORAD and EASI have not been confirmed in other studies yet. As MIDs may vary by population and context (Schram 2012), further research is needed to confirm or adjust MIDs for relevant outcome measures.

In this review we were unable to conclude specifically that some of the moisturisers, or some ingredients in moisturisers, are better than others, as most head to head comparisons had been evaluated in single studies, which generally had small sample sizes. Since moisturisers can contain many different ingredients, more research is needed about their effects, and also about their safety on lesional and non‐lesional skin of people with eczema, including their potential for sensitisation and absorption (Halling‐Overgaard 2016). We were not able to conclude that the use of moisturisers is sufficient to treat (very) mild eczema, which therefore needs future research. In addition, more research is needed on the benefit of moisturisers in the different phases of the disease (i.e. acute, chronic and between flares), including the amounts and frequency of application that give the best results. This should yield information about adequate use of moisturisers and active treatment, and enable prevention of under‐ and over‐treatment with moisturisers or topical active treatments (such as corticosteroids), or both. The paediatric population is of especial importance, since the prevalence of eczema in this group is much higher than in adults, as are the negative consequences of under‐ and over‐treatment. Another area of consideration for further research is the possibility of increasing the efficacy of moisturisers by ensuring adherence through proper and timely information and education, and increasing self‐management skills.

Reporting of adverse events in future research needs to be more complete, with clear explanations of what is considered to be an adverse or unwanted event. Since in (acute) eczema almost everything applied to lesional skin causes transient stinging and erythema (Ring 2012a), thought needs to be given to whether this should be judged as an adverse event, or whether it should be classed as an adverse event only when the stinging and erythema persist over a longer period of time. The reporting of unwanted effects such as smell and stickiness, and difficulty in smearing and spreading, as adverse events hampers proper data collection about adverse events, although this information can be very useful for evaluating the suitability of a moisturiser. Almost half of the studies in this Cochrane Review did not report on adverse events, most probably because moisturisers are not always seen by investigators as treatment, but as more basic 'innocent' maintenance. Clinicians may fail to consider that this 'maintenance' is life long. The acceptability of a substance that smells, is sticky, ruins clothes, leaves traces on furniture and bed linen, and is expensive for people with eczema to purchase in the large quantities required, is an important area to consider. The distinction between these unwanted effects and treatment‐related adverse events is frequently blurred in the published research. Therefore reporting on such unwanted effects in addition to 'real' adverse events is to be recommended. Ideally, both patient satisfaction with the moisturisers and the acceptability of them in daily use should be included in patient‐assessed outcomes of studies.

Future randomised controlled trials should be rigorously designed and conducted, with adequate reporting on methodological aspects as well as complete and transparent reporting according to the Consolidated Standards of Reporting Trials (CONSORT) statement. This will improve critical appraisal and interpretation as well as assessment of the validity of the results.

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