Sulpiride in the treatment of somatoform disorders: results of a European observational study to characterize the responder profile.

An open, observational study was conducted in five European countries to obtain information concerning the profile of patients responding to sulpiride. A total of 1,356 patients were evaluable for analysis. The majority of patients (81.1%) had at least three principal somatic complaints; asthenia being the most common, followed by dizziness and headache. Most patients (76.0%) were rated as moderately to extremely ill according to the Clinical Global Impression (CGI) severity score. All patients received oral sulpiride for 3-6 weeks (mean dose, 175 mg/day). Sulpiride demonstrated good efficacy as shown by a reduction in the incidence and severity of somatic complaints, and an improvement in CGI severity score and the Hopkins Symptom Checklist--58 items. Based on a CGI rating of very much or much improved, 58.2% of patients were rated as responders. Sulpiride was well tolerated. There were no serious adverse events and only 16 patients (1.2%) were withdrawn prematurely from the study due to adverse events. There were no differences between the countries regarding the patients' profile or their response to sulpiride. Thus, the prescription profile of sulpiride appears not to be culturally dependent.