A Cochrane review [Abstract] 1 included 25 studies with a total of 4651 subjects with schizophrenia. The majority of participants were hospitalised and chronically ill. Eight studies specifically stated that participants were currently acutely ill. A wide range of doses of haloperidol was used in the trials. Eight studies lasted for less than 6 weeks and 15 studies presented data for 6 weeks to 6 months period. More people allocated haloperidol improved in the first 6 weeks of treatment than those given placebo (RR 0.67, CI 0.56 to 0.80; 4 RCTs, n=472). There was also a difference favouring haloperidol across the 6 weeks to 6 months period (RR 0.67 CI 0.58 to 0.78; 8 RCTs, n=307). Relapse data from two trials (n=70) favoured haloperidol at<52 weeks (RR 0.69, CI 0.55 to 0.86). About half of those entering studies failed to complete the short trials (6 weeks to 6 months), although, at up to 6 weeks, 16 studies (n=1812) found a difference that marginally favoured haloperidol (RR 0.87, CI 0.80 to 0.95). Adverse effect data support clinical impression that haloperidol is a potent cause of movement disorders, at least in the short term. Haloperidol caused parkinsonism (RR 5.48, CI 2.68 to 11.22; 5 RCTs, n = 485), akathisia (RR 3.66, CI 2.24 to 5.97; 6 RCTs, n=695) and acute dystonia (RR 11.49, CI 3.23 to 10.85; 5 RCTs n=471). Discharge from hospital was equivocal between groups (RR 0.85, CI 0.47 to 1.52; 1 RCT, n=33). Data were not reported for death and patient satisfaction.
Comment: The quality of evidence is downgraded by study quality (inadequate allocation concealment, high drop-out rate) and indirectness (short follow-up time, few patient-important outcomes).
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