Background Anogenital warts (AGWs, condylomata acuminata) are among the most common STIs and may severely impact quality of life (QoL). Available treatment options are characterised by a high proportion of non-responders and recurrences.
Objective To systematically review and meta-analyse the available evidence from randomised controlled trials (RCTs) on topical treatments for AGWs considering short-term and long-term efficacy, effects on QoL and adverse events (AE).
Methods A comprehensive literature search was performed in Cochrane Central Register of Controlled Trials, Embase and MEDLINE. Included studies were evaluated with the Cochrane Collaboration's risk of bias tool. The confidence in the pooled effect estimates was evaluated according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and categorised as ‘very low’, ‘low’, ‘moderate’ or ‘high’.
Results Eighteen RCTs met the inclusion criteria. Regarding complete clearance (CC), imiquimod 3.75% and 5% cream, podophyllotoxin 0.5% solution and gel and polyphenon E 10% and 15% ointment were superior to placebo. Although more local AE and pain occurred in the actively treated groups, differences regarding dropouts due to AE were not statistically significant. For podophyllotoxin 0.15% cream, no placebo-controlled trials were available; however, in an active-controlled trial, it was inferior to podophyllotoxin 0.5% solution with respect to CC. No significant differences were detected between imiquimod 5% cream and podophyllotoxin 0.5% solution and between polyphenon E 10% and 15% ointment. No data on the influence on health-related QoL were available.
Conclusion Our confidence in the pooled estimates (GRADE quality of the evidence) ranged from very low to high. Apart from the given results, other aspects such as availability, costs or patient preference have to be considered when making a treatment choice. Due to the limited number of direct comparisons, conclusions on the relative efficacy of the different treatment options are restricted.
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RNW and LW contributed equally to this work
Handling editor Jackie A Cassell
Contributors RNW, LW, CD and AN developed the research question and methods section. RNW and LW selected eligible studies during the title/abstract screening and full-text evaluation, extracted data from the included studies, appraised the quality of the evidence, entered and double-checked data for RevMan and analysed/interpreted the data. RNW and LW developed the draft of the review. AN and CD were involved in cases of dissent with respect to extracted data/evaluations. AN and CD participated in analysing and interpreting the data and in the final editing of the draft. RNW coordinated contributions of the coauthors and compiled the final draft of the manuscript.
Funding This systematic review and meta-analysis has been supported with an unrestricted research grant by Meda Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg, Germany. The funding was institutional, not personal. The source of funding did not influence the conduct of the systematic review. Assessment and synthesis of the evidence were done independently from industrial interest. The sponsor had no influence on the content.
Competing interests The Division of Evidence based Medicine (dEBM) received research grants from various entities. The conduct of the current review was funded with an institutional research grant by Meda Pharma GmbH & Co. KG as stated above. The dEBM received research grants not associated with the current work by the Paul-Ehrlich-Gesellschaft für Chemotherapie e.V., European Academy of Dermatology and Venereology, Medigene, European Dermatology Forum, Pfizer, Merz, Deutsche Dermatologische Gesellschaft, Deutsche Gesellschaft für Allergologie und klinische Immunologie, Deutsche Dermatologische Akademie and GSK. The dEBM is currently involved in the development of a German clinical practice guideline on the management of human papillomavirus-associated anogenital lesions. AN is responsible for the grants given to dEBM. RNW, LW and CD declare to have no further conflicts of interests. AN has received personal honoraria for educational activity with direct or indirect sponsoring from Novartis, Pfizer, Boehringer Ingelheim, Bayer Healthcare, Jansen, MEDA.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement This was a systematic review with meta-analysis. All data items extracted from the original studies by the authors are presented within the article or its online supplement.
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