Menon 1972.
Methods | Allocation: random. Blinding: unclear. Duration: 16 weeks (6‐week observation period; 10 weeks treatment period). Design: parallel (3 groups), single centre. Setting: inpatient, Government Mental Hospital, Madras, India. |
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Participants | Diagnosis: chronic schizophrenia (clinical diagnosis, when evidence of thought disorder; poverty of ideas; fixility of attitudes; narrowing of interest; apathy; lack of initiative; catatonic mannerisms; delusions and hallucinations). N = 60 *(n = 40 included in the analysis ‐ see interventions). Age: range 20‐52 years old (trifluoperazine group mean 37.50 years; placebo group 34.60 years). Sex: 30M, 30F *(20M, 20F included in analysis ‐ x3 groups, with 10M and 10F in each). Ethnicity: not stated. Consent: not stated. History: length of hospitalisation range 1.5‐9 years (trifluoperazine group mean 3.75 years; placebo group 4.13 years). Included: continuous hospitalisation for minimum of 1 year; ‘normal intelligence’. Excluded: presence of physical complications (e.g. pulmonary tuberculosis, liver disorders, diabetes, hypertension and other organic involvement). |
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Interventions | 1. Trifluoperazine: fixed dose 5.0 mg tablet tds, = 15 mg daily, n = 20. 2. Placebo: fixed dose 1 tds, n = 20. *(3. Trifluperidol: fixed dose 0.5 mg tablet tds, = 1.5 mg daily, n = 20 ‐ this group was not included in the analysis). |
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Outcomes | Global state: clinical improvement (QPSS rating) (defined as ‘marked’ or ‘moderate’ improvement). Behaviour: clinical improvement (Wings rating) (defined as ‘marked’ or ‘moderate’ improvement). Extrapyramidal adverse effects ‐ general. 1Adverse effects: EPS. Unable to use ‐ Anti‐Parkinsonism drugs: administered as needed (no data). Laboratory data: blood count, urine analysis, liver profiles (no data reported). |
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Notes | 1Adverse effects were calculated from a percentage. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised ‐ quote, "random allocation of patients to the three trial groups" (p20) ‐ no further details. |
Allocation concealment (selection bias) | Unclear risk | Quote ‐ "random allocation of patients to the three trial groups ensured against any bias entering in the allocation of patients to the particular treatment" (p20) ‐ no further details. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Single (assessor) – "bias in the evaluation of treatment was avoided by keeping the research workers blind" (p20). No details of participant blinding. Quote: "the research workers evaluating the effects of the drugs were kept "blind" as to the medication each patient received" (p18). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details. |
Selective reporting (reporting bias) | High risk | No data reported for laboratory investigations. No statistical data reported for rating scales QPSS and Wings. |
Other bias | Unclear risk | Funding: Ethnor Limited (India) supplied drugs and ‘financial assistance’. Raters: psychiatric assessment made independently by two psychiatrists (QPSS and Wings). |