Few well-controlled studies of androgen therapy have been reported in other rheumatological disorders. This is not just due to paucity of cases in the female-preponderant autoimmune diseases as there are no controlled studies of androgen therapy even in ankylosing spondylitis or gout, the male preponderant rheumato-logical diseases.
In systemic lupus erythematosus (SLE), only two small uncontrolled studies (including together five men among 17 patients) using androgen therapy (nandrolone decanoate) have been reported (Hazelton et al. 1983; Lahita et al. 1992). This information is so limited that no conclusions can be drawn without larger and better-designed studies. Another double-blind study randomised 28 women with mild to moderate SLE to treatment with DHEA (200 mg daily) or placebo for three months. Treatment with this weak androgen precursor did not improve SLE disease activity index, number of flares, prednisone usage or physician overall assessment, although there was an improvement in the patients overall assessment of well-being (Van Vollenhoven etal. 1995).
One study has examined the effects of treatment with stanozolol (10 mg daily) or placebo for 24 weeks in primary Raynaud's phenomenon and systemic sclerosis (Jayson et al. 1991). Although 43 patients (19 Raynaud's, 24 systemic sclerosis; including only 4 men) entered, only 28 patients (11 Raynauds, 17 systemic sclerosis) completed the study. Compared with placebo, stanozolol significantly improved ultrasonic Doppler index as well as finger pulp and nail bed temperatures but there was no difference in reported frequency or severity of vasospastic attacks, scleroderma skin score or grip strength. The clinical significance of the changes in digital small vessel function recorded in the absence of vasospasm and without reduction in attack rates is unclear.
A double-blind study randomised 20 women with primary Sjogren's syndrome to treatment with androgen (nandrolone decanoate 100 mg fortnightly) or placebo for six months (Drosos etal. 1988). Androgen therapy did not produce any significant improvement over placebo in objective validated measures of xerostomia (stimulated parotid flow rate measurements, labial salivary gland histology), xerophthalmia (Schirmer's I test, slit lamp eye examination after rose Bengal staining) or systemic disease (ESR) although the subjective assessment ofxerostomia by patients and physicians as well as overall patient's well-being assessment were significantly better on nandrolone. Virilisation was reported in nearly all nandrolone-treated women with this relatively high androgen dose but none discontinued for this reason. Again these studies reinforce the observations that androgen therapy may significantly improve feelings of well-being regardless of the underlying disease activity.
A recent randomised double-blind study examined the role of stanzolol as an adjunct to standard antihistamine therapy for chronic urticaria. Patients (20 men, 30 women) were randomised to treatment with stanazolol 4 mg daily or placebo in addition to antihistamine (cetrizine 10 mg daily) for 12 weeks (Parsad etal. 2001). Over 70% improvement in physician and patient scored urticaria was observed in 17/26 patients who received stanazolol, but in only 7/24 patients who received cetrizine alone. This highly statistically significant benefit was observed four weeks after starting treatment and continued throughout the study. Whether the benefits of stanazolol are gender-specific, or whether other androgens are also effective, has not been established.
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