A controlled study of stanozolol in primary Raynaud's phenomenon and systemic sclerosis

Article Abstract:

In Raynaud's phenomenon, a blue color, sometimes followed by pallor, develops in the fingers during exposure to cold or other stimuli. Primary Raynaud's phenomenon has no known cause, while secondary Raynaud's phenomenon is associated with connective tissue or autoimmune diseases, in which the body makes antibodies against its own tissues. Progressive systemic sclerosis (scleroderma) is particularly associated with Raynaud's phenomenon and also includes progressive obstruction of blood vessels, proliferation of connective tissue, and tissue atrophy resulting from poor blood flow. A problem which contributes to blood vessel obstruction and poor blood flow is an increase in blood levels of fibrinogen, which is a precursor of fibrin, an important constituent of blood clots. Excessive fibrinogen levels may be due to a deficit in fibrinolysis, the biological degradation of fibrin. The effects of stanozolol, a steroid which can improve fibrinolysis, on 19 patients (17 female) with primary Raynaud's phenomenon and 24 patients (22 female) with progressive systemic sclerosis were compared with the effect of placebo (inert) treatment. Eleven patients in the first group and 17 patients in the second group completed the study. Side effects of stanozolol included weight gain and muscle cramps. One patient who had severe systemic sclerosis died, and the contribution of steroid-related liver dysfunction was unclear. Patients with primary Raynaud's phenomenon tended to have fewer and shorter attacks during 24 weeks of treatment with stanozolol, but this was not significant. Finger temperature tended to increase, but again not significantly, during stanozolol treatment. Clot lysis (break-up) improved significantly, as did levels of plasminogen (a component of the fibrinolysis system), and while fibrinogen levels decreased to a small extent. In patients with systemic sclerosis, artery patency (openness) was significantly increased, as was finger temperature. Blood clot dissolution tended to improve slightly with stanozolol, and plasminogen levels increased significantly. Skin involvement and grip strength tended to improve, but not to any great extent. The results suggest that stanozolol may be beneficial in treating Raynaud's phenomenon. (Consumer Summary produced by Reliance Medical Information, Inc.)

Systemic scleroderma, Raynaud's disease, Stanozolol

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5-Fluorouracil in the treatment of scleroderma: a randomised, double blind, placebo controlled international collaborative study

Article Abstract:

Scleroderma is one of the rheumatic diseases with an autoimmune basis (in which the body makes antibodies against its own tissues), and is characterized by stiffening of the skin, with possible systemic involvement as well. Treatment aimed at preventing or reversing tissue stiffening, or fibrosis, has been mostly unsuccessful, but cytotoxic (cell-destructive) agents, many of which are used to treat cancer, have resulted in some medical improvement, probably due to their effects on immune system cells. The effectiveness of six months of 5-fluorouracil treatment was evaluated in 26 patients with scleroderma and compared with placebo treatment in 20 patients. Patients treated with 5-fluorouracil significantly improved in their total skin score, ability to straighten joints, reactivity to cold; their own assessments of their status indicated improvement, as well. However, other functional measures and internal organ function did not improve. Almost all patients treated with 5-fluorouracil reported adverse effects, many of which responded to dose reduction, while only half of patients given placebo did so. Two patients given 5-fluorouracil died, one due to rapidly progressing scleroderma. The study suggests that treatment with 5-fluorouracil is associated with modest gains in function and mild toxicity in patients with scleroderma. Further research may reveal whether longer treatment or different dosing may lead to improved outcome. (Consumer Summary produced by Reliance Medical Information, Inc.)

Fluorouracil

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Can non-fundable trials be conducted anyway? The case for open, randomised, actively controlled trials in rheumatology

Article Abstract:

Nonblinded clinical trials without placebo comparison groups may be useful in rheumatology research. Open, randomized, actively controlled trials (ORACTs) are often the only option for research in some rare conditions. Such trials compare two or more approved treatment protocols without blinding the researchers or patients to the treatment assignment. Although this study design is not as rigorous as placebo-controlled, double-blind clinical trials, they may still produce useful information. When research funding is not available, the ORACT may be an effective test design.

Research, Methods, Clinical trials, Rheumatology

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