Oral N-acetylcysteine in the treatment of Raynaud's phenomenon secondary to systemic sclerosis: a randomized, double-blind, placebo-controlled clinical trial
Correa MJ, Mariz HA, Andrade LE, Kayser C
Published in Revista Brasileira de Reumatologia
Methodology
Randomised, double-blind, placebo-controlled trial; oral N-acetylcysteine 600 mg three times daily or placebo for four weeks; primary endpoint change in cutaneous microcirculation blood flow before and after cold stimulation by laser Doppler imaging at weeks 0 and 4, with attack frequency, severity and digital ulcer counts as secondary outcomes.
Key Findings
42 patients with Raynaud phenomenon secondary to systemic sclerosis were randomised to oral N-acetylcysteine 600 mg three times daily (1800 mg/day, n = 21) or placebo (n = 21) for four weeks. There was no significant change in digital microcirculation blood flow measured by laser Doppler imaging before or after cold stimulus in either group. Both groups improved significantly in attack frequency and severity with no difference between them; at study end the placebo group had three digital ulcers and the N-acetylcysteine group none. Treatment was well tolerated and no patient discontinued.
Conclusions
NAC orally at a dose of 1800mg/day showed no vasodilator effect on hands microcirculation after four weeks of treatment in patients with RP secondary to SSc.
Limitations
Small trial of 42 patients over only four weeks, too short and too small to detect effects on digital ulcers; the improvement seen in both arms suggests a strong placebo or seasonal effect.
Supplements Studied
NAC orally at a dose of 1800mg/day showed no vasodilator effect on hands microcirculation after four weeks of treatment in patients with RP secondary to SSc.
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