Efficacy and relapse-suppression of severe plaque psoriasis by oxymatrine: Results from a single blinded randomized controlled clinical trial

Abstract

Background

Current drugs in psoriasis treatment are associated with drawbacks such as rapid recrudescence, high costs and unwanted side effects. Oxymatrine has a long clinical use in the treatment of hepatitis and cancer in China.

Objective

To explore the efficacy and safety of oxymatrine injection in patients with severe plaque psoriasis.

Methods

Sixty-seven patients were randomly allocated to receive oxymatrine injections (0.6 g/d, 8weeks) or acitretin capsules (0.75mg/kg·d from week 0~2 and 20-30 mg/d from week 3~8), and followed up for another 24 weeks. The primary end point was the percentage of patients with ≥50% reduction of psoriasis area and severity index (PASI 50) at week 32. The secondary end points included the skin classification grade and the dermatology life quality index (DLQI). Side effects during the whole study were recorded to assess the safety profile.

Results

Treatment with oxymatrine or acitretin for 8 weeks significantly decreased PASI score, skin classification grade and DLQI score (P<0.001), with no significant differences between oxymatrine and acitretin groups in terms of PASI 50. However, at week 32, the relapse rate in oxymatrine group were significantly lower than that of acitretin group (P<0.001). Moreover, while the number of patients with metabolic abnormalities was increased in the acitretin group, a significant reduction was observed in the oxymatrine group. In addition, rates of adverse reactions were significantly decreased in the oxymatrine group as compared to that of acitretin group (P<0.001).

Conclusion

Treatment with oxymatrine effectively ameliorated the severe plaque psoriasis, and was accompanied by only minor adverse effects.

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