Neurotic depression accompanied by somatic symptoms: a double-blind comparison of flupenthixol and diazepam in general practice.

Abstract

A total of 192 patients suffering from mild to moderate depression, with or without anxiety, accompanied by one or more specific somatic symptoms, was entered into a double-blind, multi-centre trial to compare flupenthixol and diazepam as treatments for psychosomatic syndromes in general practice. Each patient was treated for 4 weeks and assessed after 1, 2 and 4 weeks on the Hamilton Depression Scale, with visual analogue scales of depression and somatic symptoms, by global assessments (psychological and somatic symptoms) and on a side-effects scale. The principal somatic symptoms were tension headache (69 patients), epigastric discomfort (59 patients), chest pain (39 patients) and backache (25 patients). There were 9 drop-outs (2 on flupenthixol and 7 on diazepam), of whom 5 (2 on flupenthixol and 3 on diazepam) who were treated for at least 2 weeks were included in the analysis of results. All patients received 1 tablet a day (0.5 mg flupenthixol or 2.5 mg diazepam) for the first week. Thereafter, all except 5 patients (3 on flupenthixol and 2 on diazepam) had their dose doubled for the remaining 3 weeks of study. Both drugs were effective in producing consistent improvement in all four somatic symptom groups in terms of both depression and somatic symptoms over the 4 weeks of study. There was a trend throughout in favour of flupenthixol as the more therapeutically effective. Flupenthixol was significantly more effective in relieving depressive symptoms and somatic symptoms in all four somatic symptom groups considered together. It was also superior to diazepam as measured by its effect on the depression sub-scales, anxiety, agitated depression, retarded depression and melancholia. Both drugs were well tolerated, although diazepam-treated patients showed a moderate increase in side-effects scores initially, while the scores in patients treated with flupenthixol decreased consistently over all 4 weeks of the trial. It is concluded from this study that flupenthixol has an important place in the management of patients with psychosomatic illness.