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. 2013 Aug 29;2013(8):CD004844. doi: 10.1002/14651858.CD004844.pub3

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
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