OBJECTIVE:In the treatment of the symptoms of benign prostatic hyperplasia (BPH), a French guideline opposes the use of drugs in conjunction, in the absence of proven utility. The OCOS trial therefore compared one of the possible drug combinations (tamsulosin and Serenoa repens) with tamsulosin alone, to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients with symptoms of BPH.MATERIAL AND METHODS:In this double-blind, randomised trial, patients had to have an IPSS (International Prostate Symptom Score) > or = 13 and a Qmax between 7 and 15 mL/s. Tamsulosin (0.4 mg) was to be administered once a day for 52 weeks, with, twice daily, a placebo (TAM) or Serenoa repens 160 mg (TAM + SR).RESULTS:352 patients were recruited by 47 centres; 329 (average age 65) were randomised: 161 into the TAM group and 168 into the TAM + SR group. No statistically significant difference was found between the two groups, neither for the major end-point [change in total IPSS between the baseline value and the final evaluation (TAM: -5.2; TAM + SR: -6.0; p = 0.286)], nor for the secondary end-points [changes in the voiding scores (p = 0.239) and in filling scores (p = 0.475) of the IPSS, Qmax (p = 0.564), percentage of respondents according to the IPSS (p = 0.361), improvement in quality of life (IPSS-QoL: p = 0.091; UROLIFE BPH QoL: p = 0.442), safety].CONCLUSION:The addition of Serenoa repens to tamsulosin did not provide any significant benefit to the patients: the OCOS trial does not cast doubt on the guideline applicable to the treatment of BPH.

The aim of this study was to determine the pharmacokinetic profile of a 0.5% solution podophyllotoxin in children after applications on molluscum contagiosum. Eight children (age range 34 months to 14 years) received 15 to 40 applications of 5.4 mu l once daily and had to be treated for 7 to 30 days. Seven serum samples for podophyllotoxin assay were scheduled at day 1 and one at day 7. Podophyllotoxin in the serum was assayed using high performance liquid chromatography. Blood liver enzymes were also tested before the first administration and again at day 7. Podophyllotoxin concentrations remained below the quantification limit (0.50 ng/ml) at day 1 and day 7 for all but one patient, in whom a small peak at 0.70 ng/ml was measured 105 min after the first application (day 1) of 216 mu l on 40 lesions. In addition to this negligible systemic absorption of the drug after topical administration, no significant variation was observed for liver enzymes and no serious adverse effects were reported. Five patients were considered evaluable cases for efficacy of which 3 had good (disappearance of more than 50% of treated lesions) responses. These results are interesting and provide support for a placebo-controlled study to confirm the efficacy and safety of a 0.5% podophyllotoxin solution in the treatment of molluscum contagiosum in children.