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To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women. The study included 458 women aged 27–79 years enrolled in a double-blind, placebo-controlled trial. The patients with predominantly SUI were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or duloxetine 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the incontinence episode frequency (IEF) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF <14 and ≥14). Analysis of covariance was used to analyse I-QOL scores. The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of ≥ 14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine ( P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial. These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America. [ABSTRACT FROM AUTHOR]

Background: Different versions of the General Health Questionnaire (GHQ), including the GHQ-12 and GHQ-28 have been subjected to factor analysis in a variety of countries. The World Health Organization study of psychological disorders in general health care offered the opportunity to investigate the factor structure of both GHQ versions in 15 different centres., Methods: The factor structures of the GHQ-12 and GHQ-28 extracted by principal component analysis were compared in participating centres. The GHQ-12 was completed by 26,120 patients and 5,273 patients completed the GHQ-28. The factor structure of the GHQ-28 found in Manchester in this study was compared with that found in the earlier study in 1979., Results: For the GHQ-12, substantial factor variation between centres was found. After rotation, two factors expressing depression and social dysfunction could be identified. For the GHQ-28, factor variance was less. In general, the original C (social dysfunction) and D (depression) scales of the GHQ-28 were more stable than the A (somatic symptoms) and B (anxiety) scales. Multiple cross-loadings occurred in both versions of the GHQ suggesting correlation of the extracted factors. In Manchester, the factor structure of the GHQ had changed since its development. Validity as a case detector was not affected by factor variance., Conclusions: These findings confirm that despite factor variation for the GHQ-12, two domains, depression and social dysfunction, appear across the 15 centres. In the scaled GHQ-28, two of the scales were remarkably robust between the centres. The cross-correlation between the other two subscales, probably reflects the strength of the relationship between anxiety and somatic symptoms existing in different locations.