Flupenthixol versus diazepam in the treatment of psychosomatic disorders: a double-blind, multi-centre trial in general practice.
In a Finnish general practice 120 patients with psychosomatic disorders, manifest as syndromes of tension headache, cardiac neurosis, dizziness or muscular tension, were randomly allocated to treatment over a 4-week period with either flupenthixol (1 to 2 mg per day) or diazepam (5 to 10 mg mg per day). The 4 syndromes and 12 associated symptoms (anxiety, fatigue, depression, pain, asthenia, muscle fatiguability, tension, dyspnoea, restlessness, palpitations, sleep disorders, and vertigo) were rated on a 4-point scale on entry, at 2 weeks and at 4 weeks. Both drugs reduced significantly the average total scores for syndromes and single symptoms after 2-weeks' treatment. Flupenthixol was the more effective in relieving fatigue and vertigo; diazepam in relieving headache, anxiety, tension, restlessness and sleep disturbance. Cardiac neurosis, palpitations and general muscular tension responded poorly to both drugs. After 4 weeks, relief of vertigo, pain and fatigue was more evident in the flupenthixol group, and of anxiety, tension and restlessness in the diazepam group. Side-effects were complained of at some stage by 17 patients in the flupenthixol group (9 of fatigue, 5 of sleep disturbance, 1 of constipation, 1 of extrapyramidal symptoms, and 1 of weight gain) and by 16 patients in the diazepam group (10 of fatigue, 4 of sleep problems and 2 of diarrhoea).
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003975:Diazepam / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005475:Flupenthixol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011602:Psychophysiologic Disorders / Q000188:drug therapy*; D011897:Random Allocation; D013892:Thioxanthenes / Q000627:therapeutic use*
D013892:Thioxanthenes; D005475:Flupenthixol; D003975:Diazepam