BJP-2000-BECH-421-8

8 242 136 207 169253 efficacy 560 346 214 244 197304

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Unformatted text preview: -point 46.2 52.9 76.7 0.73 (0.53^1.02) Non-USA trials v. TCA All studies v. TCA Intention to treat 39.5 38.3 1.2 1.05 (0.87^1.26) Efficacy 57.5 62.5 75.0 0.82 (0.65^1.02) End-point 45.7 46.3 70.6 0.97 (0.81^ 1.16) *P40.01; TCA, tricyclic antidepressant. statistically significant differences were observed. In the non-USA trials no statistically significant differences were observed. CGI Table 3 shows the results for the CGI outcome, both the remission rates (percentage of `very much improved' and `much improved') and the odds ratio analyses. The analyses for the fluoxetine v. placebo trials gave results that were similar to those obtained for HDRS±17 outcome, that is, all differences were statistically significant. Table 3 Meta-analysis of quantitative data (effect size) When the results for all seven trials assessing fluoxetine v. placebo are pooled an effect size of 70.30 in favour of fluoxetine was obtained, with a 95% CI of 70.39 to 70.21 (see Fig. 1). For the HDRS±6 outcome an effect size of 70.37 was observed (95% CI: 70.46 to 70.28). Figure 2 shows the results for the trials v. TCAs. The pooled effect size for the HDRS±17 outcome in the USA trials was 0.00 with a 95% CI of 70.18 to 0.10. The pooled Meta-analysis of patients classified as `very much' or `much' improved on the Clinical Global Impression Scale (CGI) Meta-analysis of binary data for treatment effects Trials HDRS ^17 Table 2 shows the results obtained with HDRS±17, using both the percentage of responders and odds ratio analysis. The efficacy analysis had the highest response rates in the comparisons. The overall difference for fluoxetine v. placebo was 21.4% in the efficacy analysis but only 13.6% in the intention-to-treat analysis. In all the analyses fluoxetine showed a statistically significant benefit compared with placebo. In the USA trials of fluoxetine v. TCA no Percentage of responders on CGI Difference Log odds ratio analysis Fluoxetine Placebo Odds ratio 95% CI Intention to treat 43.9 29.6 14.3 1.89* (1.57^2.29) Efficacy 65.6 41.3 24.3 2.40* (1.94^2.98)...
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