Hanlon 1965.
Methods | Allocation: randomised. Blindness: double. Duration: 30 days. Setting: multi‐centre, inpatient, Baltimore, Maryland (US). | |
Participants | Diagnosis: n = 270 schizophrenia; n = 52 neurotic or manifesting personality disorders*.
N = 421 (n = 322 remained on the project for at least five days).
Age: range 18 to 60 years, mean ˜ 36 years.
Sex: 162 F, 160 M.
History: acutely disturbed, newly‐admitted state psychiatric hospital inpatients. Included: newly admitted; between 18 to 60 years of age; "considered candidates for tranquilizing drug therapy"**. Excluded: admission under court order; presence of a complicating physical disease or disability; alcoholism; drug addiction; brain syndrome; senility. Consent: not stated. |
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Interventions | 1. Perphenazine: oral capsules of 8 mg and 16 mg, at least 24 mg/day, average dosage 38.61 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, n = 53.
2. Chlorpromazine: oral capsules of 100 mg and 200 mg, at least 300 mg/day, average dosage 395.56 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, N = 52.
3. Thioridazine: oral capsules of 50 mg and 100 mg, at least 150 mg/day, average dosage 193.46 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, N = 53.
4. Triflupromazine: oral capsules of 25 mg and 50 mg, at least 75 mg/day, average dosage 95.93 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, N = 53.
5. Prochlorperazine: oral capsules of 12.5 mg and 25 mg, at least 37.5 mg/day, average dosage 51.22 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, N = 52.
6.Thiopropazate: oral capsules of 5 mg and 10 mg, at least 15 mg/day, average dosage 20.83 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, N = 53.
7. Trifluoperazine: oral capsules of 2.5 mg and 5 mg, at least 7.5 mg/day, average dosage 11.49 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, N = 52.
8. Fluphenazine: oral capsules of 1.25 mg and 2.5 mg, at least 3.75 mg/day, average dosage 5.92 mg/day, at least 65 mg phenobarbital t.i.d. for the first 48 hours, N = 53. All above dosages depended on the clinical judgment of the treating physician. Additional medication: biperiden for parkinsonism, phenobarbital etc. for mild sedation. |
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Outcomes | Leaving the study early: any reason; due to adverse events.
Adverse events: skin rash; hypotensive reaction; akathisia; dyskinesia; edema; EPS; Parkinsonism; akinesia. Unable to use ‐ Mental state: MSRPP (no SD), IMPS, MMPI (no data). Behaviour: MACC, PRP (no data). |
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Notes | *Those that were in final evaluation. **Quote: "to insure the inclusion of the more disturbed patients, all referrals were administered a minimum parenteral dosage of 65 mg phenobarbital t.i.d for the first 28 hours" (p90). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised: no further details. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double‐blind: identical pink unmarked capsules. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Follow‐up: 76% in first evaluation at five days; of the n = 421 randomised, n = 322 remained on the project for at least five days. The n = 99 were not included in any of the post‐treatment analyses; the majority of these participants were considered ‘unacceptable on the basis of selection criteria’; n = 5 early side‐effect cases; others refused oral medication or were dropped for administrative treatment ‘unrelated to drug treatment’. Remaining post‐treatment evaluations: 68% in second evaluation at 15th day (n = 287) and 59% in third evaluation at 30th day (n = 248). |
Selective reporting (reporting bias) | Unclear risk | No SD or P values reported for scale data. |
Other bias | Unclear risk | Funding: Research Project Grant No. MY‐2152 of the National Advisory Mental Health Council, National Institutes of Health, US Public Health Service, administered by Friends of Psychiatric Research, Inc., Spring Grove State Hospital, Baltimore, Maryland (US). Pharmaceutical companies provided drugs for study (Sandoz; Schering Corp; GD Searle; Smith Kline and French Laboratories; Squibb; Knoll). Raters: not stated to be independent of treatment. |