Abstract
The objective of this study was to evaluate the efficacy of low dose dehydroepiandrosterone (DHEA) on health-related quality of life (HRQOL) in glucocorticoid treated female patients with systemic lupus erythematosus (SLE). Forty one women ( ≥ 5 mg prednisolone/day) were included in a double-blind, randomized, placebo-controlled study for 6 months where DHEA was given at 30 mg/20 mg ( ≤ 45/ ≥ 46 years) daily, or placebo, followed by 6 months open DHEA treatment to all patients. HRQOL was assessed at baseline, 6 and 12 months, using four validated questionnaires and the patients' partners completed a questionnaire assessing mood and behaviour at 6 months. DHEA treatment increased serum levels of sulphated DHEA from subnormal to normal. The DHEA group improved in SF-36 “role emotional” and HSCL-56 total score (both p < 0.05). During open DHEA treatment, the former placebo group improved in SF-36 “mental health” (p < 0.05) with a tendency for improvement in HSCL-56 total score (p = 0.10). Both groups improved in McCoy's Sex Scale during active treatment (p < 0.05). DHEA replacement decreased high-density lipoprotein (HDL) cholesterol and increased insulin-like growth factor I (IGF-I) and haematocrit. There were no effects on bone density or disease activity and no serious adverse events. Side effects were mild. We conclude that low dose DHEA treatment improves HRQOL with regard to mental well-being and sexuality and can be offered to women with SLE where mental distress and/or impaired sexuality constitutes a problem.
Acknowledgements
We thank research nurse Lotta Sjöberg, Uppsala, for monitoring the study, research nurse Marita Lindgren, Lund, for monitoring the study and compilation of SF-36, Dr Hans Mallmin, for expert help with the DXA analysis, Pia Fredriksson for assisting with questionnaires, Margareta Ericson for excellent technical assistance, Karolina Lundsten, BMsc, Uppsala, for compilation of DXA data and Lars Berglund, Uppsala Clinical Research Centre for valuable statistical advice. Financial support was provided by grants from the Swedish Research Council, the King Gustaf V 80-year Foundation, The Swedish County Council, The Swedish Rheumatism Foundation, Nanna Svartz Foundation, Magnus Bergvall Foundation, Österlen Foundation and Uppsala University Hospital Development Foundation.