Objective: To assess the safety and efficacy of lecithinized superoxide dismutase (PC-SOD) in patients with ulcerative colitis (UC).
Method: PC-SOD was injected once daily at doses of 40 mg (n = 22) and 80 mg (n = 20) for a total treatment period of 4 weeks. Efficacy was assessed by UC-Disease Activity Index (DAI) total score. All side effects were recorded and investigated.
Results: At 4 weeks, the UC-DAI total score was significantly decreased vs baseline in both the 40 mg and 80 mg groups. It was confirmed that PC-SOD 80 mg was, at least, not significantly superior to PC-SOD 40 mg. Twenty incidences of side effects were noted in 12 (54.55%) of 22 patients in the 40 mg group, while there were three incidences of side effects in two (10.00%) of 20 patients in the 80 mg group. None of these side effects was severe. Thus it was concluded that the test drug is safe when given at daily dosages of 40 mg and 80 mg.
Conclusion: In this pilot study PC-SOD improved UC more rapidly than previously existing drugs. A double blind, placebo-controlled clinical trial of PC-SOD 40 mg/day is required to confirm the efficacy of this agent against UC.