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

Although somatoform disorders are highly prevalent, so far there is no esta blished pharmacological treatment. Opipramol is a psychopharmacon widely pr escribed in Germany. Early trials with opipramol showed the drug's effectiv eness in anxiety states coupled with somatic complaints. Therefore, the eff icacy of opipramol in somatoform disorders was evaluated using adequate cli nical trial methods. A multicentre, randomized, 6-week, placebo-controlled clinical trial was performed in a total of 200 patients suffering from soma toform disorders according to ICD-10. In the main outcome criterion, the so matic subscore of the Hamilton Anxiety Scale, and in nearly all other outco me criteria opipramol (200 mg/day) was statistically more effective than pl acebo. A similar number of adverse events was noted in both groups. The res ults of this first-placebo-controlled study in somatoform disorders suggest efficacy of opipramol in this indication but need replication. (C) 2000 Pu blished by Elsevier Science B.V. All rights reserved.