[Clinical efficacy of mecobalamin in the treatment of oligozoospermia--results of double-blind comparative clinical study].

The clinical efficacy of mecobalamin in the treatment of male infertility was investigated by means of a multicenter collaborative study with 25 participating institutions. The study was carried out as a double-blind, comparative trial using three administration groups: 6,000 micrograms of mecobalamin per day, 1,500 micrograms of mecobalamin per day and a placebo group for 12 wk. The following results were obtained. 1. The total number of evaluated subjects was 375, consisting of 125 in the 6,000 micrograms/day mecobalamin group, 124 in the 1,500 micrograms/day mecobalamin group and 126 in the placebo group. There were no significant differences among the three administration groups in terms of the patient's background factors. 2. When all of the patients were analyzed, there were no statistically significant differences among the three administration groups in terms of the efficacy in relation to the sperm count or the motility rate. 3. However, it was decided to perform a more detailed analysis of the therapeutic efficacy in patients whose pretreatment sperm counts were 20 x 10(6)/ml or less. The reasons for this decision were two-fold: 1) There was a large degree of fluctuation in patients whose pretreatment sperm counts showed a mean value of more than 20 x 10(6)/ml for two or more determinations, and it was surmised that this fluctuation might have masked any therapeutic effect in those cases. 2) The WHO definition of oligozoospermia was recently decided as a sperm count of 20 x 10(6)/ml or less.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes