BJP-2000-BECH-421-8

Of the 21 usa trials five including 400 patients were

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Unformatted text preview: als). Of the 21 USA trials, five including 400 patients were excluded for the following reasons: three because of the diagnostic system used (Research Diagnostic Criteria; RDC; Spitzer et al, 1978); one because the double-blind follow-up was only for five follow-up weeks; and one because the TCA dose was too low. In addition 96 patients 4 21 B E CH E T AL randomised to receive a fixed dose of 5 mg/ day were excluded, as per our protocol. Of the 48 non-USA trials, 34 trials including 2047 patients were excluded for the following reasons: 23 because the DSM±III was not used (RDC; Feighner diagnostic criteria; ICD±9; World Health Organization, 1978); five because the control treatment was not a TCA (maprotiline, a monoamine reuptake inhibitor, was considered to be similar to TCAs although it is not tetracyclic, but mianserin was not); two because they were open-label uncontrolled trials; two because only one and two patients, respectively, had been recruited, one because a fixed dose of a TCA was used (clomipramine 75 mg); and one because there were only sparse data available for the 11 patients included. In total, 30 trials (16 USA and 14 non-USA) and 4120 patients (3447 USA and 673 non-USA) were included (62% of the total database) in accordance with the criteria defined in our protocol. ANALYSIS GROUPS AND METHODS The analyses of continuous data were performed by M.B. and confirmed by M.H. using the Cochrane Collaboration software (Review Manager, 1997). The analyses of the binary outcomes were performed by P.C. and M.H. using a specific software package (EasyMA; Cucherat et al, 1997). The trials were analysed in groups defined by where they were performed (USA and non-USA trials) and type of control treatment (placebo or TCA). Three types of analyses were performed for each outcome: (a) all randomised patients, classifying prematurely discontinued patients (before Day 42 in USA trials and Day 35 in non-USA trials) as failures (intentionto-treat); (b) all randomised patients who completed at least four weeks of therapy using ``a last-observation-carried-forward'' technique (efficacy analysis); and (c) all randomised patients with at least one post-baseline visit (end-point analysis) using ``a last-observation-carried-forward'' techn...
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