Opipramol for the treatment of somatoform disorders results from a placebo-controlled trial.

ABSTRACT

Although somatoform disorders are highly prevalent, so far there is no established pharmacological treatment. Opipramol is a psychopharmacon widely prescribed in Germany. Early trials with opipramol showed the drug's effectiveness in anxiety states coupled with somatic complaints. Therefore, the efficacy of opipramol in somatoform disorders was evaluated using adequate clinical trial methods. A multicentre, randomized, 6-week, placebo-controlled clinical trial was performed in a total of 200 patients suffering from somatoform disorders according to ICD-10. In the main outcome criterion, the somatic subscore of the Hamilton Anxiety Scale, and in nearly all other outcome criteria opipramol (200 mg/day) was statistically more effective than placebo. A similar number of adverse events was noted in both groups. The results of this first-placebo-controlled study in somatoform disorders suggest efficacy of opipramol in this indication but need replication.