Hartkamp A, Geenen R, Godaert G L R, Bootsma H, Kruize A A, Bijlsma J W J, Derksen R H W M
Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Ann Rheum Dis. 2008 Jan;67(1):91-7. doi: 10.1136/ard.2007.071563. Epub 2007 Jun 1.
Dehydroepiandrosterone (DHEA) administration has been reported to improve fatigue, psychological distress, and physical disability. These are common features of primary Sjögren syndrome (pSS). We investigated the effects of DHEA administration on fatigue, well-being, and functioning in women with pSS.
In a double-blind, randomised placebo-controlled clinical trial, 60 female patients with pSS received 200 mg oral DHEA or placebo. Primary outcome measures were general fatigue, depressive mood, mental well-being, and physical functioning. In addition, pain, sicca complaints and disease activity parameters were measured. Patients were assessed before treatment, after 3, 6, and 12 months on study medication, and 6 months after cessation of treatment.
Patients from both the DHEA- and placebo-treated group improved on general fatigue (p<0.001), mental well-being (p = 0.04), and depressive mood (p = 0.008). Physical functioning did not change (p = 0.44). Of the secondary outcome variables, complaints of a dry mouth diminished during treatment in both groups (p = 0.006), the erythrocyte sedimentation rate showed a decrease for the DHEA group (p = 0.02), and complaints of dry eyes improved in the placebo group (p = 0.01). The belief to have used DHEA was a stronger predictor for improvement of fatigue and well-being than the actual use of DHEA.
Our study does not support a superior effect of DHEA over placebo in female patients with pSS. Both DHEA and placebo induce improvement of fatigue and well-being. This may suggest possibilities for cognitive behavioural interventions.
据报道，服用脱氢表雄酮（DHEA）可改善疲劳、心理困扰和身体残疾。这些是原发性干燥综合征（pSS）的常见特征。我们研究了服用DHEA对pSS女性患者的疲劳、幸福感和功能的影响。
在一项双盲、随机、安慰剂对照临床试验中，60名pSS女性患者口服200mg DHEA或安慰剂。主要结局指标为一般疲劳、抑郁情绪、心理健康和身体功能。此外，还测量了疼痛、干燥症状和疾病活动参数。在治疗前、服用研究药物3、6和12个月后以及治疗停止6个月后对患者进行评估。
DHEA治疗组和安慰剂治疗组的患者在一般疲劳（p<0.001）、心理健康（p = 0.04）和抑郁情绪（p = 0.008）方面均有改善。身体功能没有变化（p = 0.44）。在次要结局变量中，两组患者在治疗期间口干症状均有所减轻（p = 0.006），DHEA组红细胞沉降率下降（p = 0.02），安慰剂组干眼症状有所改善（p = 0.01）。认为自己使用了DHEA比实际使用DHEA更能预测疲劳和幸福感的改善。
我们的研究不支持DHEA对pSS女性患者的疗效优于安慰剂。DHEA和安慰剂均可改善疲劳和幸福感。这可能提示认知行为干预的可能性。
