RESUMO
Objective: To observe the clinical efficacy and safety of Yaotongning Capsule in acute lumbar muscle fiber inflammation (cold damp stagnation syndrome). Methods: A randomized, double-blind, placebo controlled multicenter and clinical trial was performed. The 144 patients were randomly divided into two groups, 72 cases in the treatment group treated with Yaotongning Capsule and 72 cases in the control group treated with placebo, 14 d as a course of treatment. Results: After one course of treatment, there was significant difference in the curative rate between treatment group and control group. According to FAS analysis, the ratio of control/effective cases and total cases (effective rate) in the treatment group was higher than that in the control group (P < 0.001). According to PPS analysis, the effective rate of the treatment group was obviously higher than that of the control group (P < 0.001). The pain relief of FAS and PPS in the treatment group also surpasses that in the control group (P < 0.001). And the differences both had statistical significance. Among 144 patients, the adverse events were found in three cases with the incidence of 2.10%. All of the adverse events were found in the control group and there were no remarkable adverse event and side effect in the treatment group. The incidence rate of adverse event in the treatment group was similar to that in the control group (P = 0.245). Conclusion: Yaotongning Capsule for lumbar muscle fiber inflammation has reliable efficacy, safety, and less incident of adverse effects.