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.
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).
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).
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).
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).