Zitman 1991.
Methods | Double‐blind, placebo‐controlled cross‐over trial study | |
Participants | 34 patients, mean age 34 years Inclusion criteria: pain duration at least 6 months, age between 30 and 60 years Exclusion criteria: severe psychiatric disease, renal, hepatic or cardiac disorders, epilepsy, glaucoma, hypertension, prostate dysfunction | |
Interventions | Baseline (2 weeks) 75 mg amitriptyline and 3 mg flupentixol; first treatment (5 weeks) 75 mg amitriptyline and 3 mg flupentixol (scheme A) or 75 mg amitriptyline alone (scheme B); washout period (2 weeks) both groups placebo; 2nd treatment (5 weeks) crossing‐over from scheme A to B and vice versa | |
Outcomes | Zung depression scale, Hamilton depression scale, clinical screening for extrapyramidal side effects, Abnormal Involuntary Movement Scale (AIMS), pain intensities (numeric scale 0 = no pain, 10 = unbearable pain) No differences between the amitriptyline group and the amitriptyline + flupentixol group concerning the pain |
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Notes | Type of pain: somatoform pain disorder; 2 refused to participate, 9 dropped out during treatment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as "identical placebo tablets" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Described as "identical placebo tablets" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Imputation method not described |
Size | High risk | Fewer than 50 patients/treatment arm |
i.v. ‐ intravenous