Fluphenazine decanoate (depot) and enanthate for schizophrenia.
Author(s): Maayan N(1), Quraishi SN, David A, Jayaswal A, Eisenbruch M, Rathbone J, Asher R,
Adams CE.
Affiliation(s): Author information:
(1)Enhance Reviews Ltd, Central Office, Cobweb Buildings, The Lane, Lyford,
Wantage, UK, OX12 0EE.
Publication date & source: 2015, Cochrane Database Syst Rev. , 2:CD000307
BACKGROUND: Intramuscular injections (depot preparations) offer an advantage over
oral medication for treating schizophrenia by reducing poor compliance. The
benefits gained by long-acting preparations, however, may be offset by a higher
incidence of adverse effects.
OBJECTIVES: To assess the effects of fluphenazine decanoate and enanthate versus
oral anti-psychotics and other depot neuroleptic preparations for individuals
with schizophrenia in terms of clinical, social and economic outcomes.
SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register
(February 2011 and October 16, 2013), which is based on regular searches of
CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of
clinical trials.
SELECTION CRITERIA: We considered all relevant randomised controlled trials
(RCTs) focusing on people with schizophrenia comparing fluphenazine decanoate or
enanthate with placebo or oral anti-psychotics or other depot preparations.
DATA COLLECTION AND ANALYSIS: We reliably selected, assessed the quality, and
extracted data of the included studies. For dichotomous data, we estimated risk
ratio (RR) with 95% confidence intervals (CI). Analysis was by
intention-to-treat. We used the mean difference (MD) for normal continuous data.
We excluded continuous data if loss to follow-up was greater than 50%. Tests of
heterogeneity and for publication bias were undertaken. We used a fixed-effect
model for all analyses unless there was high heterogeneity. For this update. we
assessed risk of bias of included studies and used the GRADE (Grading of
Recommendations Assessment, Development and Evaluation) approach to create a
'Summary of findings' table.
MAIN RESULTS: This review now includes 73 randomised studies, with 4870
participants. Overall, the quality of the evidence is low to very low.Compared
with placebo, use of fluphenazine decanoate does not result in any significant
differences in death, nor does it reduce relapse over six months to one year, but
one longer-term study found that relapse was significantly reduced in the
fluphenazine arm (n = 54, 1 RCT, RR 0.35, CI 0.19 to 0.64, very low quality
evidence). A very similar number of people left the medium-term studies (six
months to one year) early in the fluphenazine decanoate (24%) and placebo (19%)
groups, however, a two-year study significantly favoured fluphenazine decanoate
(n = 54, 1 RCT, RR 0.47, CI 0.23 to 0.96, very low quality evidence). No
significant differences were found in mental state measured on the Brief
Psychiatric Rating Scale (BPRS) or in extrapyramidal adverse effects, although
these outcomes were only reported in one small study each. No study comparing
fluphenazine decanoate with placebo reported clinically significant changes in
global state or hospital admissions.Fluphenazine decanoate does not reduce
relapse more than oral neuroleptics in the medium term (n = 419, 6 RCTs, RR 1.46
CI 0.75 to 2.83, very low quality evidence). A small study found no difference in
clinically significant changes in global state. No difference in the number of
participants leaving the study early was found between fluphenazine decanoate
(17%) and oral neuroleptics (18%), and no significant differences were found in
mental state measured on the BPRS. Extrapyramidal adverse effects were
significantly less for people receiving fluphenazine decanoate compared with oral
neuroleptics (n = 259, 3 RCTs, RR 0.47 CI 0.24 to 0.91, very low quality
evidence). No study comparing fluphenazine decanoate with oral neuroleptics
reported death or hospital admissions.No significant difference in relapse rates
in the medium term between fluphenazine decanoate and fluphenazine enanthate was
found (n = 49, 1 RCT, RR 2.43, CI 0.71 to 8.32, very low quality evidence),
immediate- and short-term studies were also equivocal. One small study reported
the number of participants leaving the study early (29% versus 12%) and mental
state measured on the BPRS and found no significant difference for either
outcome. No significant difference was found in extrapyramidal adverse effects
between fluphenazine decanoate and fluphenazine enanthate. No study comparing
fluphenazine decanoate with fluphenazine enanthate reported death, clinically
significant changes in global state or hospital admissions.
AUTHORS' CONCLUSIONS: There are more data for fluphenazine decanoate than for the
enanthate ester. Both are effective antipsychotic preparations. Fluphenazine
decanoate produced fewer movement disorder effects than other oral antipsychotics
but data were of low quality, and overall, adverse effect data were equivocal. In
the context of trials, there is little advantage of these depots over oral
medications in terms of compliance but this is unlikely to be applicable to
everyday clinical practice.
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