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Dehydroepiandrosterone Reduces Flares in Mild-to-Moderate Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) flares in adult women can be significantly reduced with oral dehydroepiandrosterone (DHEA), say Taiwanese researchers.

DHEA treatment was found to be well tolerated at a dosage of 200 mg a day and to improve the overall assessment of disease activity by patients.

This multi-centre randomized, double-blind study of 120 adult women with active SLE was conducted by investigators at the National Defense Medical Center, Taipei, Veteran's General Hospital, Taichung, Veteran's General Hospital, Taipei and Chang-Gung Memorial Hospital, Taipei, Taiwan, Republic of China.

Sixty-one patients were given 200 mg of oral DHEA a day and 61 received placebo for 24 weeks.

The Systemic Lupus Activity Measure (SLAM) was used to score the mean change from baseline to primary end point after 24 weeks of treatment. Secondary end points included change in SLE Disease Activity Index (SLEDAI) score, time to first flare as well as the physician's and subject's global assessment scores at week 24.

Baseline characteristics were well balanced between the two groups.

There was no statistically significant difference between the groups in mean reductions in SLAM scores from baseline, DHEA -2.6 ± 3.4 versus placebo -2.0 ± 3.8, mean ± SD.

In the DHEA group the number of subjects with flares was decreased by 16 percent. Based on time to first flare, the findings showed 18.3 percent of DHEA-treated patients versus 33.9 percent of placebo-treated patients (P = 0.044).

Statistical significance was seen between the two groups in the mean change in the patient's global assessment, DHEA -5.5 versus placebo 5.4 (P = 0.005).

Compared with the placebo group, the number of patients with serious adverse effects mainly related to SLE flare was significantly lower in the DHEA group (P = 0.010).

The researchers found expected hormonal effects which included increased testosterone levels and increased incidence of acne.

There were no serious safety issues or life-threatening reactions.
Arthritis & Rheumatism 2002;46:11:2924-2927. "Dehydroepiandrosterone treatment of women with mild-to-moderate systemic lupus erythematosus: A multicenter randomized, double-blind, placebo-controlled trial"

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