A Cochrane review included 10 studies with a total of 686 subjects. Participants in 9 studies were described as having chronic schizophrenia without any diagnostic criteria described, and 9 studies were conducted in a hospital setting. The duration of the studies ranged from 4 weeks to 7 months. Overall, there was significant clinical improvement in clinical global state at medium term (mean 19 weeks) amongst people receiving trifluoperazine (RR 4.61, CI 1.54 to 13.84; 3 RCTs, n=417). Significantly fewer people receiving trifluoperazine left the studies early due to relapse or worsening at medium term (RR 0.34, CI 0.23 to 0.49; 2 RCTs, n=381). However, results were equivocal for leaving the study early at medium term for any reason (RR 0.80, CI 0.17 to 3.81; 2 RCTs, n=391) and due to severe adverse effects (RR 1.54, CI 0.56 to 4.24; 2 RCTs, n=391). Equivocal data were also found for intensified symptoms at medium term (RR 1.05, CI 0.54 to 2.05; 2 RCTs, n=80) and rates of agitation or distress again at medium term (RR 2.00, CI 0.19 to 20.72; 1 RCT, n=52). Comparison between low and high-dose trifluoperazine with placebo from a single study provided equivocal evidence of effects.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment), indirectness (short follow-up time, most of the studies conducted in hospital setting) and imprecise results (few studies for each comparison).
A Cochrane review included 7 RCTs with a total of 422 participants. The trials compared trifluoperazine with low-potency antipsychotic drugs. The follow-up time was between 4 and 52 weeks. The comparators were chlorpromazine, thioridazine and trifluoperazine. Trifluoperazine was not significantly different from low-potency antipsychotic drugs in terms of response to treatment (trifluoperazine 26%, low-potency drug 27%, RR 0.96 CI 0.59 to 1.56; 3 RCTs, n = 120). There was also no significant difference in acceptability of treatment with equivocal number of participants leaving the studies early due to any reason (trifluoperazine 20%, low-potency antipsychotics 16%, 3 RCTs, n = 239, RR 1.25, CI 0.72 to 2.17). There was no significant difference in numbers with at least one adverse effect (trifluoperazine 60%, low-potency antipsychotics 38%, RR 1.60, CI 0.94 to 2.74; 1 RCT, n = 60). However, at least one movement disorder was significantly more frequent in the trifluoperazine group (trifluoperazine 23%, low-potency antipsychotics 13%, RR 2.08 CI 0.78 to 5.55; 2 RCTs, n = 123) as well as incoordination (trifluoperazine 20%, low-potency antipsychotics 5%, RR 7.00, CI 1.60 to 30.66; 1 RCT, n = 60) and rigor (trifluoperazine 45%, low-potency antipsychotics 10%, RR 4.50, CI 1.58 to 12.84; 1 RCT, n = 60). No data were available for other outcomes of interest death, sedation and quality of life.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment), indirectness (short follow-up time, most of the studies conducted in hospital setting, all studies conducted in the 60's or 70's) and imprecise results (few studies for each comparison).