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Meta-Analysis
. 2014 Jan 11;2014(1):CD010226.
doi: 10.1002/14651858.CD010226.pub2.

Trifluoperazine versus placebo for schizophrenia

Kai Koch  1 , Kamel Mansi, Euan Haynes, Clive E Adams, Stephanie Sampson, Vivek A Furtado
Affiliations
Meta-Analysis

Trifluoperazine versus placebo for schizophrenia

Kai Koch et al. Cochrane Database Syst Rev. .

Abstract

Background: Trifluoperazine is a long-established high potency typical antipsychotic drug used in the treatment of schizophrenia and schizophrenia-like illnesses.

Objectives: To determine absolute effects of trifluoperazine for schizophrenia and schizophrenia-like illnesses compared with placebo.To critically appraise and summarise current evidence on the resource use, cost and economic evaluation of trifluoperazine compared with placebo for schizophrenia.

Search methods: Searches of the Cochrane Schizophrenia Group's register of trials (July 2012), supplemented with handsearching, reference searching, personal communication and contact with industry. Two review authors undertook a search for economic studies using the Cochrane Schizophrenia Group's Health Economic Database (CSzGHED) on the 9th April 2013.

Selection criteria: All available clinical randomised trials involving people with schizophrenia and schizophrenia-like illnesses that compare trifluoperazine with placebo.

Data collection and analysis: Studies for the effects of interventions were reliably selected by a review team and data were doubly independently extracted to reduce bias. We only used dichotomous data, using intention-to-treat analysis when possible. Data were estimated using risk ratio (RR) with 95% confidence intervals (CI). A 'Summary of findings' table was produced, where possible, for each primary outcome using GRADE. Economic studies were searched and reliably selected by review authors (VF and SS) to provide an economic summary of available data. Where no relevant economic studies were eligible for inclusion, the economic review team valued the already-included effectiveness outcome data to provide a rudimentary economic summary.

Main results: This review included 10 studies with a total number of 686 participants featuring in 20 different outcomes of interest. Overall, there was significant clinical improvement in clinical global state at medium term amongst people receiving trifluoperazine (3 RCTs, n = 417, RR 4.61, CI 1.54 to 13.84, low quality evidence) and significantly fewer people receiving trifluoperazine left the studies early due to relapse or worsening at medium term (2 RCTs, n = 381, RR 0.34, CI 0.23 to 0.49, low quality evidence). However, results were equivocal for leaving the study early at medium term for any reason (2 RCTs, n = 391, RR 0.80, CI 0.17 to 3.81, very low quality evidence) and due to severe adverse effects (2 RCTs, n = 391, RR 1.54, CI 0.56 to 4.24, very low quality evidence). Equivocal data were also found for intensified symptoms at medium term (2 RCTs, n = 80, RR 1.05, CI 0.54 to 2.05, very low quality evidence) and rates of agitation or distress again at medium term (1 RCT, n = 52, RR 2.00, CI 0.19 to 20.72, very low quality evidence). Comparison between low and high-dose trifluoperazine with placebo from a single study provided equivocal evidence of effects. For economic outcomes, we valued outcomes in GBP terms and presented them in additional tables; there was an estimated saving of £3488.3 in favour of trifluoperazine. However, numerous assumptions were made and these savings need to be interpreted in light of those assumptions.

Authors' conclusions: Our results agree with existing evidence that compared to placebo, trifluoperazine is an effective antipsychotic for people with schizophrenia. Furthermore, our review provides supportive evidence that trifluoperazine increases the risk of extrapyramidal adverse effects. Although the effect sizes against placebo are similar to those observed with other agents, they are based on data from many small, pre-CONSORT trials with generally either a low or very low GRADE evidence that has limited implication for clinical practice. Large, independent trials are needed that adhere to the CONSORT statement to compare trifluoperazine with placebo used in the treatment of schizophrenia and schizophrenia-like illnesses.

PubMed Disclaimer

Conflict of interest statement

Kai Koch ‐ none. Kamel Mansi ‐ none. Euan Haynes ‐ none. Clive E Adams ‐ none. Stephanie Sampson ‐ none. Vivek Furtado ‐ none.

Figures

1
1
Study flow diagram.
2
2
Study flow diagram: economic summary (2013)
3
3
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 1 Global state: 1. clinical improvement (as defined by each study).
1.2
1.2. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 2 Behaviour: 1. any clinically significant agitation or distress (as defined by each study).
1.3
1.3. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 3 Behaviour: 2. use of adjunctive medication for sedation.
1.4
1.4. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 4 Behaviour: 3. clinical improvement (as defined by each study).
1.5
1.5. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 5 Mental state: 1. any clinically significant response in psychotic symptoms (as defined by each study).
1.6
1.6. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 6 Mental state: 2. any clinically significant response in positive symptoms.
1.7
1.7. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 7 Leaving the study early: 1. any reason.
1.8
1.8. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 8 Leaving the study early: 2. severe adverse effects.
1.9
1.9. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 9 Leaving the study early: 3. due to relapse or worsening.
1.10
1.10. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 10 Extrapyramidal adverse effects: 1. general.
1.11
1.11. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 11 Extrapyramidal adverse effects: 2. use of anti‐Parkinson drugs.
1.12
1.12. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 12 Extrapyramidal adverse effects: 3. dyskinesia.
1.13
1.13. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 13 Extrapyramidal adverse effects: 4. akathisia.
1.14
1.14. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 14 Extrapyramidal adverse effects: 5. Parkinsonism.
1.15
1.15. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 15 Extrapyramidal adverse effects: 6. dystonia.
1.16
1.16. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 16 Other adverse effects: 1. general.
1.17
1.17. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 17 Other adverse effects: 2. specific.
1.18
1.18. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 18 Other adverse effects: 3. laboratory data.
1.19
1.19. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 19 Hospital and service utilisation outcomes: 1. hospital transfer/ home leave.
1.20
1.20. Analysis
Comparison 1 TRIFLUOPERAZINE versus PLACEBO, Outcome 20 Hospital and service utilisation outcomes: 2. hospital discharge.
2.1
2.1. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 1 Global state: 1. clinical improvement (as defined by each study).
2.2
2.2. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 2 Leaving the study early: 1. any reason.
2.3
2.3. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 3 Leaving the study early: 2. severe adverse effects.
2.4
2.4. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 4 Leaving the study early: 3. due to relapse or worsening.
2.5
2.5. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 5 Extrapyramidal adverse effects: 2. akathisia.
2.6
2.6. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 6 Extrapyramidal adverse effects: 3. Parkinsonism.
2.7
2.7. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 7 Extrapyramidal adverse effects: 4. dystonia.
2.8
2.8. Analysis
Comparison 2 TRIFLUOPERAZINE (LOW DOSE) versus PLACEBO, Outcome 8 Other adverse effects: 2. specific.
3.1
3.1. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 1 Global state: 1. clinical improvement (as defined by each study).
3.2
3.2. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 2 Leaving the study early: 1. any reason.
3.3
3.3. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 3 Leaving the study early: 2. severe adverse effects.
3.4
3.4. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 4 Leaving the study early: 3. due to relapse or worsening.
3.5
3.5. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 5 Extrapyramidal adverse effects: 1. akathisia.
3.6
3.6. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 6 Extrapyramidal adverse effects: 2. Parkinsonism.
3.7
3.7. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 7 Extrapyramidal adverse effects: 3. dystonia.
3.8
3.8. Analysis
Comparison 3 TRIFLUOPERAZINE (HIGH DOSE) versus PLACEBO, Outcome 8 Other adverse effects: 1. specific.
See this image and copyright information in PMC

Update of

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