Multicenter Randomized Double-Blind Controlled Clinical Study of Huoxue Tongluo Recipe(活血通络方)External Washing in the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Objective: To objectively evaluate the efficacy of Huoxue Tongluo Recipe(活血通络方) in the treatment of chemotherapy-induced peripheral neuropathy(CIPN).Methods: A multicenter, randomized, double-blind, block, and parallel-controlled study was conducted in which 184 subjects who met the inclusion criteria were randomized into a trial group(92 cases), a control group(46 cases), a placebo group(46 cases) at a 2:1:1 ratio, respectively.Huoxue Tongluo Recipe(活血通络方) granules, Huangqi Guizhi Wuwu Decoction(黄芪桂枝五物汤) instant granules, placebo instant granules were given for hand and foot soaking, with water temperature 38 ℃-45 ℃, soaking for 20 minutes and the intervention time was 14 days.Results:(1) The total effective test drug was 41.30%, the control group was 32.61%, and the placebo group was 32.61%.There was no significant difference in the efficiency of the 3 groups by CMH chi-square test(P>0.05);(2) In the statistics of previous chemotherapy regimens including oxaliplatin or paclitaxel as stratification factors, the overall efficiency of the trial group was significantly different from the other 2 groups.Conclusion: Huoxue Tongluo Recipe(活血通络方) external washing can improve the peripheral nerve injury caused by chemotherapy to some extent, especially in patients with previous chemotherapy regimen including oxaliplatin and paclitaxel.