Treatment of External Genital Warts in Men Using 5% Imiquimod Cream Applied Three Times a Week, Once Daily, Twice Daily, or Three Times a Day

Kh, Fife; Ferenczy, Alex; Jm, Douglas; Dr, Brown; Smith, M. Hamblin; Ml, Owens

doi:10.1097/00007435-200104000-00007

Cited by 64 publications

(52 citation statements)

References 16 publications

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“…Meta-analysis of the studies by Fife et al 129 and Trofatter et al 134 found no statistically significant differences between imiquimod 5% cream applied three times weekly, once daily or twice daily (all possible comparisons) (forest plot presented in Appendix 7).…”

Section: Complete Clearance At Another Time Pointmentioning

confidence: 99%

“…58 Studies were identified evaluating application of imiquimod 5% for 4, 8, 12 and 16 weeks 130,133 and at application schedules of once daily, twice daily and three times daily. 129,134 After consultation with clinical experts on the potential influence of treatment duration, dose and formulation (relates to ease of application) on clinical effectiveness, the following assumptions were made for the purposes of carrying out meta-analysis, both direct and indirect:…”

Section: Interventions and Comparatorsmentioning

confidence: 99%

“…Of the 60 studies included in the review, seven studies (based on the clinical assumptions outlined in Quantity and quality of research available) presented results on complete clearance at ≥ 1 month. 114,129,133,134,150,159,160 Three studies were not suitable for the MTC as they evaluated various dosing schedules of the same treatment. 129,134,150 Only two 114,159 of the four remaining studies were judged to be of unclear or low risk of bias, with the remaining studies deemed to be at high risk of bias because they were reported only as a conference abstract or enrolled people with HIV infection.…”

Section: Complete Clearance At Another Time Pointmentioning

confidence: 99%

“…Of the three studies not included in the MTC, Fife et al 129 and Trofatter et al 134 compared various dosing schedules of imiquimod 5% cream and Simmons 150 assessed different doses of clinician-applied podophyllin. Meta-analysis of the studies by Fife et al 129 and Trofatter et al 134 found no statistically significant differences between imiquimod 5% cream applied three times weekly, once daily or twice daily (all possible comparisons) (forest plot presented in Appendix 7).…”

Section: Complete Clearance At Another Time Pointmentioning

confidence: 99%

“…61,62,112,[116][117][118][119]121,129,138 Of the 10 studies, three were deemed to be at an unclear or low risk of bias, provided data in a format that could be incorporated into a meta-analysis and evaluated interventions meeting the assumptions outlined earlier. 61,116,118 As per the protocol, sensitivity analysis for this outcome was not planned.…”

Section: Appearance Of New Anogenital Warts During Treatmentmentioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of interventions for the treatment of anogenital warts: systematic review and economic evaluation

Thurgar¹,

Barton²,

Karner³

et al. 2016

Health Technol Assess

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BackgroundTypically occurring on the external genitalia, anogenital warts (AGWs) are benign epithelial skin lesions caused by human papillomavirus infection. AGWs are usually painless but can be unsightly and physically uncomfortable, and affected people might experience psychological distress. The evidence base on the clinical effectiveness and cost-effectiveness of treatments for AGWs is limited.ObjectivesTo systematically review the evidence on the clinical effectiveness of medical and surgical treatments for AGWs and to develop an economic model to estimate the cost-effectiveness of the treatments.Data sourcesElectronic databases (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library databases and Web of Science) were searched from inception (or January 2000 for Web of Science) to September 2014. Bibliographies of relevant systematic reviews were hand-searched to identify potentially relevant studies. The World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov were searched for ongoing and planned studies.Review methodsA systematic review of the clinical effectiveness literature was carried out according to standard methods and a mixed-treatment comparison (MTC) undertaken. The model implemented for each outcome was that with the lowest deviance information criterion. A de novo economic model was developed to assess cost-effectiveness from the perspective of the UK NHS. The model structure was informed through a systematic review of the economic literature and in consultation with clinical experts. Effectiveness data were obtained from the MTC. Costs were obtained from the literature and standard UK sources.ResultsOf 4232 titles and abstracts screened for inclusion in the review of clinical effectiveness, 60 randomised controlled trials (RCTs) evaluating 19 interventions were included. Analysis by MTC indicated that ablative techniques were typically more effective than topical interventions at completely clearing AGWs at the end of treatment. Podophyllotoxin 0.5% solution (Condyline®, Takeda Pharmaceutical Company Ltd; Warticon®solution, Stiefel Laboratories Ltd) was found to be the most effective topical treatment evaluated. Networks for other outcomes included fewer treatments, which restrict conclusions on the comparative effectiveness of interventions. In total, 84 treatment strategies were assessed using the economic model. Podophyllotoxin 0.5% solution first line followed by carbon dioxide (CO2) laser therapy second line if AGWs did not clear was most likely to be considered a cost-effective use of resources at a willingness to pay of £20,000–30,000 per additional quality-adjusted life-year gained. The result was robust to most sensitivity analyses conducted.LimitationsLimited reporting in identified studies of baseline characteristics for the enrolled population generates uncertainty around the comparability of the study populations and therefore the generalisability of the results to clinical practice. Subgroup analyses were planned based on type, number and size of AGWs, all of which are factors thought to influence treatment effect. Lack of data on clinical effectiveness based on these characteristics precluded analysis of the differential effects of treatments in the subgroups of interest. Despite identification of 60 studies, most comparisons in the MTC are informed by only one RCT. Additionally, lack of head-to-head RCTs comparing key treatments, together with minimal reporting of results in some studies, precluded comprehensive analysis of all treatments for AGWs.ConclusionsThe results generated by the MTC are in agreement with consensus opinion that ablative techniques are clinically more effective at completely clearing AGWs after treatment. However, the evidence base informing the MTC is limited. A head-to-head RCT that evaluates the comparative effectiveness of interventions used in clinical practice would help to discern the potential advantages and disadvantages of the individual treatments. The results of the economic analysis suggest that podophyllotoxin 0.5% solution is likely to represent a cost-effective first-line treatment option. More expensive effective treatments, such as CO2laser therapy or surgery, may represent cost-effective second-line treatment options. No treatment and podophyllin are unlikely to be considered cost-effective treatment options. There is uncertainty around the cost-effectiveness of treatment with imiquimod, trichloroacetic acid and cryotherapy.Study registrationThis study is registered as PROSPERO CRD42013005457.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Complete Clearance At Another Time Pointmentioning

confidence: 99%