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Problems in the reporting of acne clinical trials: a spot check from the 2009 Annual Evidence Update on Acne Vulgaris.

ABSTRACT: In the course of producing the 2009 NHS Evidence--skin disorders Annual Evidence Update on Acne Vulgaris, 25 randomised controlled trials were examined. From these, at least 12 potentially serious problems of trial reporting were identified. Several trials concluded no effect of a treatment yet they were insufficiently powered to exclude potentially useful benefits. There were examples of duplicate publication and "salami publication", as well as two trials being combined and reported as one. In some cases, an incorrect "within-groups" statistical comparison was made and one trial report omitted original efficacy data and included only P values. Both of the non-inferiority studies examined failed to pre-specify a non-inferiority margin. Trials reported as "double-blind" compared treatments that were dissimilar in appearance or had differing adverse effect profiles. In one case an intention-to-treat analysis was not performed and there was a failure to account for all of the randomized participants. Trial results were made to sound more impressive by selective outcome reporting, emphasizing the statistical significance of treatment effects that were clinically insignificant, and by the use of larger-sounding odds ratios rather than rate ratios for common events. Most of the reporting problems could have been avoided by use of the CONSORT guidelines and prospective trial registration on a public clinical trials database.

SUBMITTER: Ingram JR

PROVIDER: S-EPMC2911424 | biostudies-other | 2010 Jul

REPOSITORIES: biostudies-other

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Problems in the reporting of acne clinical trials: a spot check from the 2009 Annual Evidence Update on Acne Vulgaris.

Ingram John R JR Grindlay Douglas J C DJ Williams Hywel C HC

Trials 20100712

In the course of producing the 2009 NHS Evidence--skin disorders Annual Evidence Update on Acne Vulgaris, 25 randomised controlled trials were examined. From these, at least 12 potentially serious problems of trial reporting were identified. Several trials concluded no effect of a treatment yet they were insufficiently powered to exclude potentially useful benefits. There were examples of duplicate publication and "salami publication", as well as two trials being combined and reported as one. In ...[more]

PMID: 20624287

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Project description:OBJECTIVE:We evaluated current evidence from randomised controlled trials (RCTs) regarding the effectiveness of chemical peeling for treating acne vulgaris. METHODS:Standard Cochrane methodological procedures were used. We searched MEDLINE, Cochrane Central Register of Controlled Trials and EMBASE via OvidSP through April 2017. Reviewers independently assessed eligibility, risk of bias and extracted data. RESULTS:Twelve RCTs (387 participants) were included. Effectiveness was not significantly different: trichloroacetic acid versus salicylic acid (SA) (percentage of total improvement: risk ratio (RR) 0.89; 95% CI 0.73 to 1.10), glycolic acid (GA) versus amino fruit acid (the reduction of inflammatory lesions: mean difference (MD), 0.20; 95%?CI -3.03 to 3.43), SA versus pyruvic acid (excellent or good improvement: RR 1.11; 95%?CI 0.73 to 1.69), GA versus SA (good or fair improvement: RR 1.00; 95%?CI 0.85 to 1.18), GA versus Jessner's solution (JS) (self-reported improvements: RR 1.00; 95%?CI 0.44 to 2.26), and lipohydroxy acid versus SA (reduction of non-inflammatory lesions: 55.6%vs48.5%, p=0.878). Combined SA and mandelic acid peeling was superior to GA peeling (percentage of improvement in total acne score: 85.3%vs68.5%, p<0.001). GA peeling was superior to placebo (excellent or good improvement: RR 2.30; 95%?CI 1.40 to 3.77). SA peeling may be superior to JS peeling for comedones (reduction of comedones: 53.4%vs26.3%, p=0.001) but less effective than phototherapy for pustules (number of pustules: MD -7.00; 95%?CI -10.84 to -3.16). LIMITATIONS:The methodological quality of the included RCTs was very low to moderate. Meta-analysis was not possible due to the significant clinical heterogeneity across studies. CONCLUSION:Commonly used chemical peels appear to be similarly effective for mild-to-moderate acne vulgaris and well tolerated. However, based on current limited evidence, a robust conclusion cannot be drawn regarding any definitive superiority or equality among the currently used chemical peels. Well-designed RCTs are needed to identify optimal regimens.

Dataset Information

Problems in the reporting of acne clinical trials: a spot check from the 2009 Annual Evidence Update on Acne Vulgaris.

Publications

Problems in the reporting of acne clinical trials: a spot check from the 2009 Annual Evidence Update on Acne Vulgaris.

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