Comment: The quality of the evidence is downgraded by study quality (inadequate allocation concealment, more than 20% loss to follow-up), inconsistency (heterogeneity in patients), imprecise results (limited study size for comparisons) and indirectness of evidence (differences in studied patients, short follow-up time, very old studies).
A Cochrane review [Abstract] 1 included 7 studies with a total of 1567 subjects. They had schizophrenia or schizophrenia-like psychosis according to clinical criteria. The low-potency comparators were chlorpromazine, chlorprothixene and thioridazine. In a few studies various low-potency antipsychotics (LPAPs) could be administered. Four studies were conducted in hospitals. Three studies had one month follow-up and two studies up to 2 months follow-up, 2 studies had 3 to 6 months follow-up. Fluphenazine was not significantly different from LPAPs in terms of response to treatment (fluphenazine 55%, LPAPs 55%, RR 1.06, CI 0.75 to 1.50; 2 RCTs, n = 105). There was also no significant difference in acceptability of treatment with equivocal numbers of participants leaving the studies early due to any reason (fluphenazine 36%, LPAPs 36%, RR 1.00, CI 0.88 to 1.14, 6 RCTs, n = 1532). There was no significant difference between fluphenazine and LPAPs for numbers experiencing at least one adverse effect (70% vs. 88%, respectively, RR 0.79, CI 0.58 to 1.07; 1 RCT, n = 65). However, at least one movement disorder occurred significantly more frequently in the fluphenazine group (15% vs. 10%, respectively, RR 2.11, CI 1.41 to 3.15; 3 RCTs, n = 971). In contrast, LPAPs produced significantly more sedation (20% vs. 64%, respectively, RR 0.31, CI 0.13 to 0.77; 1 RCT, n = 65). No data were available for the outcomes of death and quality of life. Adverse effects occurred significantly more frequently in the fluphenazine group: akathisia 15% vs. 6%, respectively (RR 2.28, CI 1.58 to 3.28; 5 RCTs, n = 1209); dystonia 5% vs. 2%, respectively (RR 2.66, CI 1.25 to 5.64; 4 RCTs, n = 1309); loss of associated movement 20% vs. 2%, respectively (RR 11.15, CI 3.95 to 31.47; 1 RCT, n = 338); rigor 27% vs. 12%, respectively (RR 2.18, CI 1.20 to 3.97; 2 RCTs, n = 403) and tremor 15% vs. 6%, respectively (RR 2.53, CI 1.37 to 4.68; 2 RCTs, n = 403). For other adverse effects, significantly less events occurred for for fluphenazine than for LPAPs: dizziness 8% vs. 17%, respectively (RR 0.49, CI 0.32 to 0.73; 4 RCTs, n = 1051); drowsiness 18% vs. 25%, respectively (RR 0.67, CI 0.53 to 0.86; 3 RCTs, n = 986); dry mouth 11% vs. 18%, respectively (RR 0.63, CI 0.45 to 0.89; 4 RCTs, n = 1051); nausea 4% vs. 15%, respectively (RR 0.25, CI 0.14 to 0.45; 3 RCTs, n = 986) and vomiting 3% vs. 8%, respectively (RR 0.36, CI 0.18 to 0.72; 3 RCTs, n = 986).
A Cochrane review [Abstract] 2 included 4 studies with a total of 202 subjects.
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