Background Pimecrolimus was developed as an alternative to topical corticosteroids for treating eczema ( atopic dermatitis) but its efficacy and safety compared with existing treatments remains unclear. Objectives To assess the effects of topical pimecrolimus for treating eczema. Search strategy We searched the Cochrane Skin Group Specialised Register ( to October 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2006), MEDLINE ( from 2003 to October 2006), and EMBASE ( from 2005 to October 2006). We also contacted researchers and manufacturers in the field. Selection criteria Randomised controlled trials of 1.0% topical pimecrolimus used twice daily compared against other topical comparators for treating eczema. Data collection and analysis Two authors independently examined each retrieved study for eligibility and extracted data for efficacy, tolerability and safety. A random effects model was used to estimate the pooled risk ratios ( RRs) and 95% confidence intervals ( 95% CIs). Main results We included 31 trials ( 8019 participants) in the analysis. In short-term (<= 6 weeks) trials, pimecrolimus cream was significantly more effective and well-tolerated than vehicle (creambase, but not containing pimecrolimus). In long-term trials (>= 6 months), pimecrolimus was significantly better than vehicle in preventing flares ( 9 trials, 3091 participants, RR 1.47, 95% CI 1.32 to 1.64 at six months) and in improving quality of life. Pimecrolimus was significantly less effective than two topical corticosteroids, i.e. 0.1% triamcinolone acetonide for investigators' global assessment ( 1 trial, 658 participants, RR0.75, 95% CI 0.67 to 0.83) and 0.1% betamethasone valerate for participants' global assessment ( 1 trial, 87 participants, RR 0.61, 95% CI 0.45 to 0.81) at three weeks. Pimecrolimus was also associated with significantly more overall withdrawals and skin burning. None of the trials reported on key adverse effects such as thinning of skin. Pimecrolimus was significantly less effective than 0.1% tacrolimus for investigators' global assessment at six weeks (RR 0.58, 95% CI 0.46 to 0.74) and led to more withdrawals due to lack of efficacy ( RR 2.37, 95% CI 1.10 to 5.08) based on two trials involving 639 participants, but there was no significant difference in proportions of participants experiencing any adverse events. Authors' conclusions Topical pimecrolimus is less effective than moderate and potent corticosteroids and 0.1% tacrolimus. The therapeutic role of topical pimecrolimus is uncertain due to the absence of key comparisons with mild corticosteroids.
