Clinical Efficacy and Safety Evaluation of Supplementary Sijunzi Decoction in Treatment of ALS Patients with Sple-nasthenic Syndrome

ZHU Xu-ying; ZHANG Hong-zhi; LI Hua-qiang; ZHANG Shu-yu; CHEN Jing; WANG Jun; TANG Hai-yan; CAI Gan

doi:10.3969/j.issn.1002-3429.2017.01.028

Abstract：Objective To investigate the value of supplementary Sijunzi Decoction in improvement of the life func-tions and delay the disease progression of amyotrophic lateral sclerosis( ALS)patients with splenasthenic syndrome. Methods This study was designed as a randomized,double-blind and placebo-controlled clinical trial,and 50 ALS patients with sple-nasthenic syndrome during January 2013 and December 2015 were randomly divided into supplementary Sijunzi Decoction and placebo groups( n﹦25 for each group). Supplementary Sijunzi Decoction group was treated with supplementary with Sijunzi Decoction on the basis of western medicine treatment,while the placebo group was treated with placebo on the basis of western medicine. The course of treatment was 9 months in the two groups. In two groups,ALS function rating score( ALSFRS-r)and ALS symptom score of TCM splenasthenic syndrome were observed and compared before treatment,3 months,6 months and 9 months of treatment,and 3 months after stopping medication,and incidence rates of adverse reactions during the treatment were also observed and recorded. Results The differences in ALSFRS-r and ALS symptom scores of TCM splenasthenic syn-drome were statistically significant after treatment between the two groups by generalized estimating equations analysis (Wald χ2 ﹦594. 155,P﹤0. 05;Wald χ2 ﹦452. 196,P ﹤0. 05),and especially in the TCM splenasthenic syndrome,the supplementary Sijunzi Decoction effectively delayed the deterioration of related symptoms. In the two groups,the analysis of time levels of gross and fine motors in ALSFRS-r showed statistically significant differences( Wald χ2 ﹦166. 976,P ﹤0. 05;Wald χ2 ﹦97. 015,P﹤0. 05);however,the differences in bulbar and respiratory symptom scores were not statistically signif-icant(Wald χ2 ﹦0. 007,P﹥0. 05;Wald χ2 ﹦1. 918,P﹥0. 05). There were no serious adverse events during the treatment in the two groups. Conclusion Supplementary Sijunzi Decoction can delay the deterioration of neurological function in ALS patients with splenasthenic syndrome,and has good clinical efficacy in gross and fine motors.