Compound Ciwujia Granules for chronic fatigue syndrome with syndrome of deficiency of both heart and spleen: a multicenter, randomized, double-blind, double-dummy, positive drug-controlled trial
Jun Ren, Xiao-Tian Zhang, Chao-Qun Xie, Shou-Jian Wang, Ling-Jun Kong, Jing-Hu Li, Liang-Ji Liu, Ping Cui, Zhi-Geng Hu, Wen-Xia Zhao, Rong Zou, Yong-Chang Diwu, Hong Fang, Xiao-Jun Yang, Rong Li, Guang Ji, Min Fang, Wei-An Yuan
Abstract
This study aimed to evaluate the clinical efficacy and safety of Compound Ciwujia Granules in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen. It adopted a multicenter, double-blind, double-dummy, randomized controlled trial design and represented a pre-specified subgroup analysis regarding syndrome of deficiency of both heart and spleen from a registered clinical trial.
A total of 224 patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen were randomized, among whom 222 were included in the full analysis set(FAS). Patients were assigned in a 1∶1 ratio to the treatment group(Compound Ciwujia Granules + Guipi Granules placebo, 111 cases) and the control group(Guipi Granules + Compound Ciwujia Granules placebo, 111 cases), and the course of treatment lasted for 6 weeks.
The primary outcome was the improvement rate measured in the Chalder Fatigue Questionnaire-11(CFQ-11) after 6 weeks of treatment. The secondary outcomes included the improvement rate after 3 weeks of treatment, changes in CFQ-11 scores from baseline, changes in CFQ-11 physical and mental fatigue scores from baseline, and changes in TCM syndrome(deficiency of both heart and spleen) scores from baseline after 3 and 6 weeks of treatment. Safety was assessed by recording adverse events.
The results showed that 222 patients were included in the FAS, 203 in the per-protocol set(PPS), and 224 in the safety set(SS). In terms of primary outcome, FAS analysis showed that after 6 weeks of treatment, the improvement rate in CFQ-11 scores in experimental group was 73.99%(95%CI[69.10%, 78.87%]), compared to 52.87%(95%CI[47.99%, 57.76%]) in control group, with a between-group difference of 21.11%(95%CI[14.19%, 28.04%], P<0.000 1). PPS analysis was consistent with FAS(difference of 20.54%, P<0.000 1).
After treatment for 6 weeks, the decrease in CFQ-11 scores was-13.81 in treatment group, significantly greater than-9.87 in control group(difference of-3.95, 95%CI[-5.23,-2.66], P<0.000 1). Both physical fatigue and mental fatigue domain scores also favored the treatment group after 6 weeks of treatment(P<0.000 1). The reduction in TCM syndrome scores after treatment for 6 weeks was also significantly greater in the treatment group than in the control group(FAS difference of-1.30, P=0.001 4; PPS difference of-1.14, P=0.005 3). No serious adverse events occurred in either group.
In conclusion, Compound Ciwujia Granules significantly improved clinical symptoms in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen, demonstrating definite efficacy and good safety.
PubMed | DOI | Zhongguo Zhong Yao Za Zhi | Article in Chinese
Jun Ren, Xiao-Tian Zhang, Chao-Qun Xie, Shou-Jian Wang, Ling-Jun Kong, Jing-Hu Li, Liang-Ji Liu, Ping Cui, Zhi-Geng Hu, Wen-Xia Zhao, Rong Zou, Yong-Chang Diwu, Hong Fang, Xiao-Jun Yang, Rong Li, Guang Ji, Min Fang, Wei-An Yuan
Abstract
This study aimed to evaluate the clinical efficacy and safety of Compound Ciwujia Granules in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen. It adopted a multicenter, double-blind, double-dummy, randomized controlled trial design and represented a pre-specified subgroup analysis regarding syndrome of deficiency of both heart and spleen from a registered clinical trial.
A total of 224 patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen were randomized, among whom 222 were included in the full analysis set(FAS). Patients were assigned in a 1∶1 ratio to the treatment group(Compound Ciwujia Granules + Guipi Granules placebo, 111 cases) and the control group(Guipi Granules + Compound Ciwujia Granules placebo, 111 cases), and the course of treatment lasted for 6 weeks.
The primary outcome was the improvement rate measured in the Chalder Fatigue Questionnaire-11(CFQ-11) after 6 weeks of treatment. The secondary outcomes included the improvement rate after 3 weeks of treatment, changes in CFQ-11 scores from baseline, changes in CFQ-11 physical and mental fatigue scores from baseline, and changes in TCM syndrome(deficiency of both heart and spleen) scores from baseline after 3 and 6 weeks of treatment. Safety was assessed by recording adverse events.
The results showed that 222 patients were included in the FAS, 203 in the per-protocol set(PPS), and 224 in the safety set(SS). In terms of primary outcome, FAS analysis showed that after 6 weeks of treatment, the improvement rate in CFQ-11 scores in experimental group was 73.99%(95%CI[69.10%, 78.87%]), compared to 52.87%(95%CI[47.99%, 57.76%]) in control group, with a between-group difference of 21.11%(95%CI[14.19%, 28.04%], P<0.000 1). PPS analysis was consistent with FAS(difference of 20.54%, P<0.000 1).
After treatment for 6 weeks, the decrease in CFQ-11 scores was-13.81 in treatment group, significantly greater than-9.87 in control group(difference of-3.95, 95%CI[-5.23,-2.66], P<0.000 1). Both physical fatigue and mental fatigue domain scores also favored the treatment group after 6 weeks of treatment(P<0.000 1). The reduction in TCM syndrome scores after treatment for 6 weeks was also significantly greater in the treatment group than in the control group(FAS difference of-1.30, P=0.001 4; PPS difference of-1.14, P=0.005 3). No serious adverse events occurred in either group.
In conclusion, Compound Ciwujia Granules significantly improved clinical symptoms in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen, demonstrating definite efficacy and good safety.
PubMed | DOI | Zhongguo Zhong Yao Za Zhi | Article in Chinese