(英文原文)Clinical efficacy and safety of benzoyl peroxide for acne vulgaris: Comparison between Japanese and Western patients
Abstract Benzoyl peroxide (BPO) has been well established as a common medication for acne vulgaris in many countries (e.g. in Europe and the USA), where clinical data have been accumulated over a long time. In Japan, the use of BPO for acne treatment was approved in 2014, and the results of clinical trials in Japanese patients have recently been reported. This review compares clinical study results between Japanese and Western patients. Clinical studies that had been performed in Western countries were searched on the basis of the criteria, double-blind studies of BPO monotherapy and comparison with a vehicle group. Two reports of Japanese studies were also selected by using the same criteria. Efficacy was assessed by comparing the mean difference between the BPO and the vehicle groups for reduction rate in the number of lesions from baseline, and there were no differences between Japanese and Western patients. Safety assessment also showed that the incidence of adverse events was higher in Japanese patients than in Western patients, but the characteristics of the adverse events were not different.Therefore, we conclude that there are no significant differences in the efficacy and safety of BPO between these patient populations. The efficacy and safety of long-term use in Japanese patients are also expected to be applicable to those in Western patients.
Key words acne vulgaris; benzoyl peroxide; clinical efficacy; ethnicity; safety
摘要：过氧化苯甲酰治疗痤疮的功效可能受到研究设计，实施和载体效应的影响。我们计划在随机对照试验中研究活性治疗和载体治疗的反应率，通过这种研究来确定准确的治疗效果，以评估局部使用过氧化苯甲酰治疗痤疮的疗效。我们对随机对照试验进行了系统评价，评估了过氧化苯甲酰治疗痤疮的功效。并比较了对照治疗组的反应率与过氧化苯甲酰组的反应率。有12项试验符合纳入标准，其中2818名患者接受了过氧化苯甲酰单药治疗，2004名接受载体治疗。痤疮病灶总数的平均减少率分别为44.3(SD = 9.2)和27.8(SD = 21.0)。活性治疗组中非炎性病灶平均减少41.5%(SD = 9.4)，载体组平均减少27.0%(SD = 20.9)。过氧化苯甲酰组炎症损害平均减少率为52.1(SD = 10.4)，载体组为34.7(SD = 22.7）。研究中，参加者的平均试验成功率分别为28.6(SD = 17.3)和15.2(SD = 9.5)。随机对照试验中，在评估局部痤疮治疗的患者反应时，可能会受到临床试验设计、实施、载体效应和自然疾病进展的影响。因此，加入“没有治疗”组可能更有助于确定准确的治疗效果。
(英文原文)Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne
Abstract Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehiclecontrolled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 %(SD = 9.4) in the active treatment group and 27.0 %(SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2(SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. ‘‘No treatment’’ groups may facilitate determination of accurate treatment efficacies.
Keywords Randomized controlled trial; Study design; Placebo effect; Placebo response; Acne; Topical administration; Vehicle delivery; Benzoyl peroxide