Arowojolu Ayodele O, Gallo Maria F, Lopez Laureen M, Grimes David A
Department of Obstetrics and Gynaecology, College of Medicine, University College Hospital, Ibadan, Nigeria.
Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD004425. doi: 10.1002/14651858.CD004425.pub6.
Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women.
To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies.
In January 2012, we searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) (Aug 2011). For the initial review, we wrote to researchers to seek any unpublished or published trials that we might have missed.
We considered randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women.
We extracted data on facial lesion counts, both total and specific (i.e., open or closed comedones, papules, pustules and nodules); acne severity grades; global assessments by the clinician or the participant, and discontinuation due to adverse events. Data were entered and analyzed in RevMan. For continuous data, we calculated the mean difference (MD) and 95% confidence interval (CI). For dichotomous data, we calculated the Peto odds ratio (OR) and 95% CI.
The review includes 31 trials with 12,579 participants. Of 24 comparisons made, 6 compared a COC to placebo, 17 different COCs, and 1 compared a COC to an antibiotic. Of nine placebo-controlled trials with data for analysis, all showed COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. A levonorgestrel-COC group had fewer total lesion counts (MD -9.98; 95% CI -16.51 to -3.45), inflammatory and non-inflammatory lesion counts, and were more likely to have a clinician assessment of clear or almost clear lesions and participant self-assessment of improved acne lesions. A norethindrone acetate COC had better results for clinician global assessment of no acne to mild acne (OR 1.86; 95% CI 1.32 to 2.62). In two combined trials, a norgestimate COC showed reduced total lesion counts (MD-9.32; 95% CI -14.19 to -4.45), reduced inflammatory lesion and comedones counts, and more with clinician assessment of improved acne. For two combined trials of a drospirenone COC, the investigators' assessment of clear or almost clear skin favored the drospirenone group (OR 3.02; 95% CI 1.99 to 4.59). In one trial, the drospirenone-COC group showed greater (more positive) percent changes for total lesion count (MD 29.08; 95% CI 3.13 to 55.03), inflammatory and non-inflammatory lesion counts, and papule and closed comedone counts. A dienogest-COC group had greater percentage decreases in total lesion count (MD -15.30; 95% CI -19.98 to -10.62) and inflammatory lesion count, and more women assessed with overall improvement of facial acne. A CMA-COC group had more 'responders,' those with 50% or greater decrease in facial papules and pustules (OR 2.31; 95% CI 1.50 to 3.55)Differences in the comparative effectiveness of COCs containing varying progestin types and dosages were less clear, and data were limited for any particular comparison. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel. A COC with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes, but results were not consistent. A drospirenone COC appeared to be more effective than norgestimate or nomegestrol acetate plus 17β-estradiol but less effective than cyproterone acetate.
AUTHORS' CONCLUSIONS: This update yielded six new trials but no change in conclusions. The six COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since only one trial addressed this issue. The use of standardized methods for assessing acne severity would help in synthesizing results across trials as well as aid in interpretation.
痤疮是女性常见的皮肤疾病。尽管目前尚无统一的痤疮治疗方法,但含有雌激素和孕激素的复方口服避孕药(COCs)常用于女性痤疮患者。
比较复方口服避孕药(COCs)与安慰剂或其他活性治疗方法治疗面部痤疮的有效性。
2012年1月,我们在Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、POPLINE和LILACS的计算机数据库中检索了COCs与痤疮的随机对照试验。我们还在ClinicalTrials.gov和国际临床试验注册平台(ICTRP)(2011年8月)中检索了临床试验。在初步综述时,我们写信给研究人员,以寻找任何可能遗漏的未发表或已发表的试验。
我们纳入了以任何语言报道且比较了含雌激素和孕激素的COC与安慰剂或其他活性治疗方法治疗女性痤疮有效性的随机对照试验。
我们提取了面部皮损计数的数据,包括总数和特定类型(即开放性或闭合性粉刺、丘疹、脓疱和结节);痤疮严重程度分级;临床医生或受试者的整体评估,以及因不良事件而停药的数据。数据录入RevMan进行分析。对于连续性数据,我们计算了平均差(MD)和95%置信区间(CI)。对于二分性数据,我们计算了Peto比值比(OR)和95%CI。
本综述纳入了31项试验,共12579名受试者。在24项比较中,6项将一种COC与安慰剂进行比较,17项比较了不同的COC,1项将一种COC与一种抗生素进行比较。在9项有分析数据的安慰剂对照试验中,所有试验均显示与安慰剂相比,COCs可减少痤疮皮损计数、严重程度分级和自我评估的痤疮情况。左炔诺孕酮COC组的皮损总数较少(MD -9.98;95%CI -16.51至-3.45),炎症性和非炎症性皮损计数也较少,临床医生评估为皮损清除或几乎清除以及受试者自我评估痤疮皮损改善的可能性更大。醋酸炔诺酮COC在临床医生对无痤疮至轻度痤疮的整体评估方面效果更好(OR 1.86;95%CI 1.32至2.62)。在两项联合试验中,去氧孕烯COC显示皮损总数减少(MD -9.32;95%CI -14.19至-4.45),炎症性皮损和粉刺计数减少,更多患者经临床医生评估痤疮有所改善。在两项屈螺酮COC的联合试验中,研究者对皮肤清除或几乎清除的评估倾向于屈螺酮组(OR 3.02;95%CI 1.99至4.59)。在一项试验中,屈螺酮COC组在皮损总数(MD 29.08;95%CI 3.13至55.03)、炎症性和非炎症性皮损计数以及丘疹和闭合性粉刺计数方面的百分比变化更大(更积极)。地诺孕素COC组的皮损总数和炎症性皮损计数的百分比下降更大(MD -15.30;95%CI -19.98至-10.62),更多女性经评估面部痤疮整体改善。醋酸氯地孕酮COC组有更多“反应者”,即面部丘疹和脓疱减少50%或更多的患者(OR 2.31;95%CI 1.50至3.55)。含不同孕激素类型和剂量的COCs在比较有效性方面的差异不太明显,且任何特定比较的数据都有限。含醋酸氯地孕酮或醋酸环丙孕酮的COCs治疗痤疮的效果优于左炔诺孕酮。含醋酸环丙孕酮的COC治疗痤疮的效果优于含去氧孕烯的COC,但研究结果相互矛盾。同样,左炔诺孕酮在痤疮治疗效果上比去氧孕烯略有改善,但结果不一致。屈螺酮COC似乎比去氧孕烯或醋酸诺美孕酮加17β-雌二醇更有效,但比醋酸环丙孕酮效果差。
本次更新纳入了6项新试验,但结论未变。在安慰剂对照试验中评估的6种COCs可有效减少面部炎症性和非炎症性痤疮皮损。在治疗痤疮的有效性方面,不同类型的COCs之间未发现重要且一致的差异。由于仅有一项试验涉及此问题,因此COCs与其他痤疮治疗方法的比较尚不清楚。采用标准化方法评估痤疮严重程度将有助于综合各试验结果并辅助解释。