Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial: a critical appraisal.

摘要: Summary Aim Arits et al. aimed to assess whether the effectiveness of imiquimod and fluorouracil is not inferior methyl aminolaevulinic acid (MAL) photodynamic therapy (PDT) in patients with superficial basal cell carcinoma. Setting design This single-blind, noninferiority, randomized controlled trial was conducted at one coordinating academic hospital six peripheral dermatological departments Netherlands between March 2008 August 2010. Study exposure Patients a carcinoma were randomly assigned be treated PDT (two treatments); or 5% cream, once daily five times week for 6 weeks; cream twice 4 weeks. Follow-up visits planned after 3 months 1 year. Outcomes The primary outcome defined as probability that patient free tumour reoccurrence both 3 12 months' follow-up. Secondary outcomes aesthetic area, compliance adverse reactions. Results In total 911 assessed eligibility, whom 601 randomized: 202 receive MAL-PDT, 198 201 cream. The proportions (95% confidence intervals) 12 months 72·8% (66·8–79·4) 83·4% (78·2–88·9) 80·1% (74·7–85·9) For moderate-to-severe pain burning sensation reported most often during treatment itself. creams, local swelling, erosion, crust formation itching skin mentioned often. Conclusions Arits conclude topical noninferior superior MAL-PDT carcinoma. Imiquimod suggested preferred treatment.