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. 2015 Jan 16;2015(1):CD009831. doi: 10.1002/14651858.CD009831.pub2

Pöldinger 1977.

Methods Randomisation: “assigned at random”.
Blinding: double‐blind.
Duration: 28 days.
Design: parallel.
Location: not indicated.
Setting: not indicated.
Participants Diagnosis: schizophrenic syndromes (N = 33), excitable personality (N = 4), paranoid syndrome (N = 1), reactive excitement (N = 1), hypochondrial neurosis (N = 1).
N = 40.
Gender: not indicated.
Age: mean 49.7 years.
History: duration stable: not indicated, duration of illness: mean 14.35 years, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated.
Interventions 1. Haloperidol: flexible dose, dose range: 5 mg to 9 mg/day, mean final dose: 6.6 mg/day. N = 20.
2. Bromperidol: flexible dose, dose range: 5 mg to 12 mg/day, mean final dose: 6.6 mg/day. N = 20.
 
Flexible dose: “a uniform initial dose of 5 mg/day was chosen; this dose level could be increased or reduced in the further course of the treatment according to the patients´ individual needs.”
Rescue medication: administration of biperiden HCI (Akineton) was allowed.
“Administration of other psychotropic drugs was permitted in very urgent cases only.”
Outcomes Examined:
Clinically important response to treatment: Global evaluation of the effectiveness of both drugs.
Leaving the study early due to any reason.
Leaving the study early due to inefficacy of treatment.
Leaving the study early due to adverse effects.
Adverse effects: at least one movement disorder, use of antiparkinson medication, hypotension.
Unable to use:
Mental state general: “standard case report forms” (“among others – a 29‐item scale for the evaluation of the patients´ psychic conditions”) (scales not published).
Notes “All but 3 patients had been on other neuroleptics before the study; the effect of the previous treatment was scored moderate in 19 cases, insufficient in 17 cases, and poor in 1 case.”
5 participants with first episode.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “Assigned at random”. No further details.
Allocation concealment (selection bias) Unclear risk No further details.
Blinding (performance bias and detection bias) 
 (performance bias) Low risk “Double‐blind”. “identical‐looking tablets”. Tablets “were supplied in coded packages for patients´use”.
Blinding (performance bias and detection bias) 
 (detection bias) Unclear risk “Double‐blind”. No further details.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk “The treatment scheduled for 28 days was completed by all patients.”
Selective reporting (reporting bias) High risk No explicit description of the outcomes in the methods section of the publication. The outcome data were not fully addressed (no SDs available).
Other bias High risk “All but 3 patients had been on other neuroleptics before the study; the effect of the previous treatment was scored moderate in 19 cases, insufficient in 17 cases, and poor in 1 case.” Comment: The review authors assumed that many of the participants included in this trial were non‐responders to previous medications.