Effectiveness of Xiangsha Liujun pills (香砂六君丸) on decreased digestive function in convalescent patients of coronavirus disease 2019: a randomized, double blind, placebo controlled clinical trial

doi:10.19852/j.cnki.jtcm.2023.03.005

Abstract

Abstract:

OBJECTIVE: To evaluate the effectiveness and safety of Xiangsha Liujun pills (香砂六君丸) on the decreased digestive function in patients in the recovery phase of the Coronavirus disease 2019 (COVID-19).

METHODS: A randomized, double blind, placebo controlled clinical trial was conducted. A total of 200 COVID-19 patients in the recovery phase were included in our study in Ezhou Hospital of Traditional Chinese Medicine. Totally 200 subjects were randomly divided into a treatment group (Xiangsha Liujun pills) and a control group (placebo), with 100 in each group. Subjects took Xiangsha Liujun pills or placebo orally three times a day for two weeks. Three visits were scheduled at week 0 (baseline), week 1 (the middle of the intervention) and week 2 (the end of the intervention) for each eligible patient. The total efficacy rates for improving the Traditional Chinese Medicine (TCM) symptoms (fatigue, poor appetite, abdominal distension and loose stools) and the disappearance rates of symptoms were observed and compared in the treatment and control groups. Adverse events were recorded during the study period. SAS 9.4 was used to analyze the data.

RESULTS: A total of 200 patients were included in this study, among which 4 participants withdrew because the drugs did not work. Three patients were excluded for age. Before the treatment, there was no significant difference between the TCM symptoms scores of subjects. After 1 week of treatment, the full analysis set (FAS) showed that the efficacy rates for abdominal distension and loose stools in the treatment group were significantly higher than the control group (P < 0.05). There were no significant differences in the efficacy rates for fatigue and poor appetite between the two groups (P >0.05). In addition, the disappearance rate of fatigue in the treatment group was significantly higher than the control group (P <0.05); there were no significant differences between the two groups after treatment in the rates of poor appetite, abdominal distension, and loose stools (P>0.05). After 2 weeks of treatment, the efficacy rates for fatigue, poor appetite, abdominal distension, and loose stools in the treatment group were significantly higher than the control group (P <0.05). The disappearance rate of loose stools in the treatment group was significantly higher than the control group (P < 0.05). However, there were no significant differences in the disappearance rates of fatigue, poor appetite, and abdominal distension between the two groups (P > 0.05). No severe adverse events were reported by subjects during the study.

CONCLUSIONS: This clinical study confirmed that Xiangsha Liujun pills can effectively improve the symptoms related to the decreased digestive function in COVID-19 convalescent patients.

Key words: COVID-19, digestion, symptom complex, treatment outcome, safety, recovery phase, Xiangsha Liujun pills

ZHANG Yuehong, SHAO Xianzhi, ZHAO Qianlong, ZHAN Hualong, ZHANG Jianhua, DU Sisi, CHEN Jing, LIU Yingfang, ZHOU Haiwang, CHEN Xinsheng, HONG Ying, LIAN Fengmei, TONG Xiaolin, BA Yuanming. Effectiveness of Xiangsha Liujun pills (香砂六君丸) on decreased digestive function in convalescent patients of coronavirus disease 2019: a randomized, double blind, placebo controlled clinical trial[J]. Journal of Traditional Chinese Medicine, 2023, 43(3): 552-558.

Figures/Tables 6

References 28

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TCM Symptom	Group	Mean	Min-Max	Median	Mean±SD	F value	P value
Fatigue	Treatment	3	0-10	2	2.7±2.2	0.000	1.000
Fatigue	Control	3	0-7	3	2.7±1.9	0.000	1.000
Poor appetite	Treatment	3	0-9	3.5	2.8±2.2	﹣0.745	0.457
Poor appetite	Control	3	0-7	4	3.0±2.0	﹣0.745	0.457
Abdominal distension	Treatment	4	0-8	4	3.8±2.0	﹣0.754	0.451
Abdominal distension	Control	4	0-7	3	3.6±2.0	﹣0.754	0.451
Loose stools	Treatment	2	0-9	0	1.6±2.3	﹣1.518	0.131
Loose stools	Control	2	0-7	0	2.1±2.5	﹣1.518	0.131

TCM Symptom	Group	Mean	Min-Max	Median	Mean±SD	F value	P value
Fatigue	Treatment	3	0-10	2	2.7±2.2	0.000	1.000
Fatigue	Control	3	0-7	3	2.7±1.9	0.000	1.000
Poor appetite	Treatment	3	0-9	3.5	2.8±2.2	﹣0.745	0.457
Poor appetite	Control	3	0-7	4	3.0±2.0	﹣0.745	0.457
Abdominal distension	Treatment	4	0-8	4	3.8±2.0	﹣0.754	0.451
Abdominal distension	Control	4	0-7	3	3.6±2.0	﹣0.754	0.451
Loose stools	Treatment	2	0-9	0	1.6±2.3	﹣1.518	0.131
Loose stools	Control	2	0-7	0	2.1±2.5	﹣1.518	0.131

TCM Symptom	Group	Treatment time	Total number	Effective number	Ineffective number	Effective rate (%)	Ineffective rate (%)	P value
Fatigue	Treatment	1 week	80	48	32	60.00	40.00	0.174
	Control	1 week	83	41	42	49.40	50.60	0.174
	Treatment	2 weeks	80	70	10	87.50	12.50	0.006^a
	Control	2 weeks	83	58	25	69.88	30.12	0.006^a
Poor appetite	Treatment	1 week	75	48	27	64.00	36.00	0.408
	Control	1 week	80	46	34	57.50	42.50	0.408
	Treatment	2 weeks	75	72	3	96.00	4.00	<0.001^a
	Control	2 weeks	80	62	18	77.50	22.50	<0.001^a
Abdominal distension	Treatment	1 week	90	61	29	67.78	32.22	0.016^a
	Control	1 week	88	44	44	50.00	50.00	0.016^a
	Treatment	2 weeks	90	81	9	90.00	10.00	<0.001^a
	Control	2 weeks	88	52	36	59.09	40.91	<0.001^a
Loose stools	Treatment	1 week	40	29	11	72.50	27.50	0.001^a
	Control	1 week	52	20	32	38.46	61.54	0.001^a
	Treatment	2 weeks	40	37	3	92.50	7.50	<0.001^a
	Control	2 weeks	52	25	27	48.08	51.92	<0.001^a

TCM Symptom	Group	Treatment time	Total number	Effective number	Ineffective number	Effective rate (%)	Ineffective rate (%)	P value
Fatigue	Treatment	1 week	80	48	32	60.00	40.00	0.174
	Control	1 week	83	41	42	49.40	50.60	0.174
	Treatment	2 weeks	80	70	10	87.50	12.50	0.006^a
	Control	2 weeks	83	58	25	69.88	30.12	0.006^a
Poor appetite	Treatment	1 week	75	48	27	64.00	36.00	0.408
	Control	1 week	80	46	34	57.50	42.50	0.408
	Treatment	2 weeks	75	72	3	96.00	4.00	<0.001^a
	Control	2 weeks	80	62	18	77.50	22.50	<0.001^a
Abdominal distension	Treatment	1 week	90	61	29	67.78	32.22	0.016^a
	Control	1 week	88	44	44	50.00	50.00	0.016^a
	Treatment	2 weeks	90	81	9	90.00	10.00	<0.001^a
	Control	2 weeks	88	52	36	59.09	40.91	<0.001^a
Loose stools	Treatment	1 week	40	29	11	72.50	27.50	0.001^a
	Control	1 week	52	20	32	38.46	61.54	0.001^a
	Treatment	2 weeks	40	37	3	92.50	7.50	<0.001^a
	Control	2 weeks	52	25	27	48.08	51.92	<0.001^a

TCM Symptom	Group	Treatment time	Total number	Symptom disappear number	Symptom exist number	Symptom disappear rate (%)	Symptom exist rate (%)	P value
Fatigue	Treatment	1 week	80	6	74	7.50	92.50	0.047^a
	Control	1 week	83	1	82	1.20	98.80	0.047^a
	Treatment	2 weeks	80	26	54	32.50	67.50	0.867
	Control	2 weeks	83	28	55	33.73	66.27	0.867
Poor appetite	Treatment	1 week	75	4	71	5.33	94.67	0.150
	Control	1 week	80	1	79	1.25	98.75	0.150
	Treatment	2 weeks	75	32	43	42.67	57.33	0.736
	Control	2 weeks	80	32	48	40.00	60.00	0.736
Abdominal distension	Treatment	1 week	90	8	82	8.89	91.11	0.761
	Control	1 week	88	9	79	10.23	89.77	0.761
	Treatment	2 weeks	90	34	56	37.78	62.22	0.608
	Control	2 weeks	88	30	58	34.09	65.91	0.608
Loose stools	Treatment	1 week	40	10	30	25.00	75.00	0.835
	Control	1 week	52	14	38	26.92	73.08	0.835
	Treatment	2 weeks	40	25	15	62.50	37.50	0.022^a
	Control	2 weeks	52	20	32	38.46	61.54	0.022^a

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