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. 2023 Feb 14:103:adv00867.
doi: 10.2340/actadv.v103.3364.

Specific-class Skin Side-effects of Drugs Might Compromise Blinding in Randomized Controlled Trials

Affiliations

Specific-class Skin Side-effects of Drugs Might Compromise Blinding in Randomized Controlled Trials

Giao Do-Pham et al. Acta Derm Venereol. .
No abstract available

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Forest plots describing the occurrence of specific class side-effects (SCSE) in experimental and control groups of randomized controlled trials of acitretin, isotretinoin and imiquimod. (References are available in Appendix S1) “Events” are the number of patients with specific class side-effects, and “Total” represents the number of patients included in the trial. Control includes placebo (for 25/40 trials, 62.5%) or active comparator (for 14/40 trials, 35%) and in one trial (1/40, 2.5%), experimental treatment was compared with both placebo and active comparator. 95% CI: 95% confidence interval.

References

    1. Bello S, Moustgaard H, Hróbjartsson A. Unreported formal assessment of unblinding occurred in 4 of 10 randomized clinical trials, unreported loss of blinding in 1 of 10 trials. J Clin Epidemiol 2017; 81: 42–50. - PubMed
    1. Savović J, Jones HE, Altman DG, Harris RJ, Juni P, Pildal J, et al. . Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012; 157: 429–438. - PubMed
    1. Boutron I, Estellat C, Guittet L, Dechartres A, Sackett DL, Hróbjartsson A, et al. . Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review. PloS Med 2006; 3: e425. - PMC - PubMed
    1. Hróbjartsson A, Emanuelsson F, Skou Thomsen AS, Hilden J, Brorson S. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol 2014; 43: 1272–1283. - PMC - PubMed
    1. Lacouture ME, Sibaud V, Anadkat MJ, Kaffenberger B, Leventhal J, Guindon K, et al. . Dermatologic adverse events associated with selective fibroblast growth factor receptor inhibitors: overview, prevention, and management guidelines. Oncologist 2021; 26: e316–e326. - PMC - PubMed