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Meta-Analysis
. 2013 Nov 15;2013(11):CD003082.
doi: 10.1002/14651858.CD003082.pub3.

Haloperidol versus placebo for schizophrenia

Clive E Adams  1 , Hanna Bergman, Claire B Irving, Stephen Lawrie
Affiliations
Meta-Analysis

Haloperidol versus placebo for schizophrenia

Clive E Adams et al. Cochrane Database Syst Rev. .

Abstract

Background: Haloperidol was developed in the late 1950s for use in the field of anaesthesia. Research subsequently demonstrated effects on hallucinations, delusions, aggressiveness, impulsiveness and states of excitement and led to the introduction of haloperidol as an antipsychotic.

Objectives: To evaluate the clinical effects of haloperidol for the management of schizophrenia and other similar serious mental illnesses compared with placebo.

Search methods: Initially, we electronically searched the databases of Biological Abstracts (1985-1998), CINAHL (1982-1998), The Cochrane Library (1998, Issue 4), The Cochrane Schizophrenia Group's Register (December 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1998), and SCISEARCH. We also checked references of all identified studies for further trial citations and contacted the authors of trials and pharmaceutical companies for further information and archive material.For the 2012 update, on 15 May 2012, we searched the Cochrane Schizophrenia Group's Trials Register.

Selection criteria: We included all relevant randomised controlled trials comparing the use of haloperidol (any oral dose) with placebo for those with schizophrenia or other similar serious, non-affective psychotic illnesses (however diagnosed). Our main outcomes of interest were death, loss to follow-up, clinical and social response, relapse and severity of adverse effects.

Data collection and analysis: We evaluated data independently and extracted, re-inspected and quality assessed the data. We analysed dichotomous data using risk ratio (RR) and calculated their 95% confidence intervals (CI). For continuous data, we calculated mean differences (MD). We excluded continuous data if loss to follow-up was greater than 50% and inspected data for heterogeneity. We used a fixed-effect model for all analyses. For the 2012 update, we assessed risk of bias of included studies and used the GRADE approach to create a 'Summary of findings' table.

Main results: Twenty-five trials randomising 4651 people are now included in this review. We chose seven main outcomes of interest for the 'Summary of findings' table. More people allocated haloperidol improved in the first six weeks of treatment than those given placebo (4 RCTs n = 472, RR 0.67 CI 0.56 to 0.80, moderate quality evidence). A further eight trials also found a difference favouring haloperidol across the six weeks to six months period (8 RCTs n = 307 RR 0.67 CI 0.58 to 0.78, moderate quality evidence). Relapse data from two trials favoured haloperidol at < 52 weeks but the evidence was very low quality (2 RCTs n = 70, RR 0.69 CI 0.55 to 0.86). Moderate quality evidence showed about half of those entering studies failed to complete the short trials (six weeks to six months), although, at up to six weeks, 16 studies found a difference that marginally favoured haloperidol (n = 1812, RR 0.87 CI 0.80 to 0.95). Adverse effect data does, nevertheless, support clinical impression that haloperidol is a potent cause of movement disorders, at least in the short term. Moderate quality evidence indicates that haloperidol caused parkinsonism (5 RCTs n = 485, RR 5.48 CI 2.68 to 11.22), akathisia (6 RCTs n = 695, RR 3.66 CI 2.24 to 5.97, and acute dystonia (5 RCTs n = 471, RR 11.49 CI 3.23 to 10.85). Discharge from hospital was equivocal between groups (1 RCT n = 33, RR 0.85 CI 0.47 to 1.52, very low quality evidence). Data were not reported for death and patient satisfaction.

Authors' conclusions: Haloperidol is a potent antipsychotic drug but has a high propensity to cause adverse effects. Where there is no treatment option, use of haloperidol to counter the damaging and potentially dangerous consequences of untreated schizophrenia is justified. However, where a choice of drug is available, people with schizophrenia and clinicians may wish to prescribe an alternative antipsychotic with less likelihood of adverse effects such as parkinsonism, akathisia and acute dystonias. Haloperidol should be less favoured as a control drug for randomised trials of new antipsychotics.

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Conflict of interest statement

Claire Irving (nee Joy) ‐ None.

Clive Adams (CEA) ‐ has attended and presented at functions sponsored by Janssen‐Cilag and Eli Lilly. These companies have provided travel, accommodation and speaker expenses but no funds have been paid directly to CEA. Payments related to participation in meetings have been paid to an account to support schizophrenia research. The Cochrane Schizophrenia Group has multiple, and hopefully, balancing, competing interests. Potential conflicts of interest of the Group and individuals are described on http://cebmh.warne.ox.ac.uk/csg/ and sources and quantities of all funding, listed.

Steve Lawrie ‐ has been paid for speaking about critical appraisal by employees of the manufacturers of olanzapine, quetiapine, risperidone, and ziprasidone, and has been paid to speak about the management of schizophrenia by employees of the manufacturers of amisulpiride, olanzapine, risperidone, and clozapine. AM and ZN declare that they have no competing interests.

Hanna Bergman ‐ works for Enhance Reviews. Enhance Reviews Ltd is a private company that performs systematic reviews of the literature.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 1 Global state: 1a. Overall improvement: No marked global improvement.
1.2
1.2. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 2 Global state: 1b. Overall improvement: Average change in CGI‐S score (up to 6 weeks; high = poor).
1.3
1.3. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 3 Global state: 2. Hospital discharge: Not discharged from hospital (> 6‐24 weeks).
1.4
1.4. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 4 Global state: 3. Relapse (< 52 weeks).
1.5
1.5. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 5 Global state: 4. Leaving the study early.
1.6
1.6. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 6 Mental state: 1. No clinical improvement (< 20% reduction in BPRS score; up to 6 weeks).
1.7
1.7. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 7 Mental state: 2a. General symptoms: Average BPRS total score (up to 6 weeks; high = poor).
1.8
1.8. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 8 Mental state: 2b. General symptoms: Average change in PANSS total score (up to 6 weeks; high = poor).
1.9
1.9. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 9 Mental state: 3. Positive symptoms: Average change in PANSS positive score (up to 6 weeks; high = poor).
1.10
1.10. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 10 Mental state: 4. Negative symptoms: Average change in PANSS negative score (up to 6 weeks; high = poor).
1.11
1.11. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 11 Mental state: 5. Mood: Average change in CDS score (up to 6 weeks; high = poor).
1.12
1.12. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 12 Adverse effects: 1a. Movement disorders: Extrapyramidal symptoms.
1.13
1.13. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 13 Adverse effects: 1b. Movement disorders: Tardive dyskinesia.
1.14
1.14. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 14 Adverse effects: 1c. Movement disorders: Average changes scores (various scales; up to 6 weeks).
1.15
1.15. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 15 Adverse effects: 2. Other CNS.
1.16
1.16. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 16 Adverse effects: 3. Cardiovascular effects.
1.17
1.17. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 17 Adverse effects: 4. Other adverse effects.
1.18
1.18. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 18 SUBGROUP ANALYSIS: 1. MEN vs WOMEN: Global state: Overall improvement: No marked global improvement, > 6‐24 weeks (clinician rated).
1.19
1.19. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 19 SUBGROUP ANALYSIS: 2. 18‐65 YEARS vs < 18 YEARS: Global state: Overall improvement: No marked global improvement, > 6‐24 weeks (clinician rated).
1.20
1.20. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 20 SUBGROUP ANALYSIS: 3. ACUTE vs CHRONIC: Global state: Overall improvement: No marked global improvement, > 6‐24 weeks (clinician rated).
1.21
1.21. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 21 SUBGROUP ANALYSIS: 4. LOW DOSE vs MEDIUM TO HIGH DOSE.
1.22
1.22. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 22 SUBGROUP ANALYSIS: 5. DIAGNOSTIC CRITERIA vs NO DIAGNOSTIC CRITERIA.
1.23
1.23. Analysis
Comparison 1 HALOPERIDOL versus PLACEBO, Outcome 23 SENSITIVITY ANALYSIS: 1. ASSUMPTIONS FOR MISSING DATA vs NO ASSUMPTIONS FOR MISSING DATA: Global state: Overall improvement: No marked global improvement, up to 6 weeks (clinician rated).
See this image and copyright information in PMC

Update of

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NCT00156104 {published data only}
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NCT00189995 {published data only}
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NCT01161277 {published data only}
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References to other published versions of this review

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