Hewei Jiangni recipe (和胃降逆方) improved the quality of life in patients with cold-heat mixed nonerosive reflux disease: a randomized, double-blinded study

doi:10.19852/j.cnki.jtcm.20250107.001

Abstract

Abstract:

OBJECTIVE: To evaluate the safety and efficacy of Hewei Jiangni recipe (和胃降逆方, HWJNR) for treating nonerosive gastroesophageal reflux (NERD) with cold-heat complex syndrome and to clarify its mechanism based on correlation analyses of intestinal flora and metabolites.

METHODS: Seventy-two patients with NERD and the Traditional Chinese Medicine (TCM) syndrome of intermingled heat and cold were randomly assigned to either the TCM group or the Western Medicine group, each receiving 8 weeks of treatment. The primary outcome was the score of the gastroesophageal reflux disease questionnaire (GERD-Q). Additionally, 10 healthy individuals were recruited. Mechanistic outcomes included correlation analyses of intestinal flora and metabolites in healthy individuals and NERD participants before and after treatment.

RESULTS: After 8 weeks, the effectiveness rate was 90% in the TCM group and 86.67% in the Western Medicine group (P >0.05). Compared with omeprazole, the TCM group significantly improved quality of life and alleviated symptoms such as loss of appetite, fatigue, bowel sounds, and coldness in the hands and feet (P < 0.05). Dysregulation of intestinal flora and metabolic pathways in NERD patients was restored to balance after TCM treatment, which appeared related to the TCM regulation of "cold and heat disorders."

CONCLUSION: HWJNR was clinically as effective as omeprazole and demonstrated advantages in improving quality of life.

Key words: non-erosive gastroesophageal reflux disease, randomized controlled trial, Hewei Jiangni recipe, Chinese herbal medicine, gut microbiota

ZHANG Xiaosi, ZHANG Shuangyuan, CHEN Hanqing, LIN Zhengdao, XIE Chune, LI Junxiang, LI Xiaohong. Hewei Jiangni recipe (和胃降逆方) improved the quality of life in patients with cold-heat mixed nonerosive reflux disease: a randomized, double-blinded study[J]. Journal of Traditional Chinese Medicine, 2025, 45(5): 1106-1118.

Figures/Tables 11

Figure 1 Flow chart of the study design according to the recommendations of the CONSORT ICF: informed consent form; HWJNNR: Hewei Jiangni recipe; ITT: intention-to-treat; FAS: full analysis set; PPS: per protocol set; SS: safety set; CONSORT: Consolidated Standards of Reporting Trials.

Table 1 Patient demographics and baseline clinical characteristic

Characteristic		TCM group (n = 30)	Western Medicine group (n = 30)	P value
Gender [n (%)]	Male	7 (23.33)	23 (76.67)	0.390
	Female	10 (33.33)	20 (66.67)
Age (years)	18-44	10	10	0.700
	45-59	9	12
	60-65	11	8

Table 2 The total score of GERD-Q scale before and after treatment between the two groups

Group	n	Before treatment	After treatment	t value	P value
TCM	30	9.6±1.8	6.2±1.9	9.029	<0.001
Western Medicine	30	9.6±1.6	6.1±1.6	12.209	<0.001

Table 3 Second outcomes before and after treatment

Outcome	Group	n	Before treatment	After treatment	Z/t value	P value
SF-36	TCM	30	121.55 (108.4, 132.4)	124 (112.55, 135)	－3.271	0.001
SF-36	Western Medicine	30	122.3 (112.1, 130.25)	122.4 (112.4, 132.35)	－1.477	0.140
PRO	TCM	30	50±20	27±17	8.381	<0.001
PRO	Western Medicine	30	44±13	28±13	7.807	<0.001
TCM symptom points	TCM	30	13±5	4±3	9.298	<0.001
TCM symptom points	Western Medicine	30	14±5	6±4	9.888	<0.001

Table 4 TCM single-symptom scores between the two groups before and after drug treatment [M (P25, P75)]

Symptoms	Group	n	Before treatment	After treatment	Z value	P value
Heartburn	TCM Western Medicine	30 30	2 (2, 4.5) 4 (2, 6)	0 (0, 0) 0 (0, 0)	－4.218 －4.815	<0.001 <0.001
Reflux	TCM Western Medicine	30 30	2 (2, 6) 2 (2, 4)	0 (0, 0) 0 (0, 0.5)	－4.477 －4.303	<0.001 <0.001
Latent pain in the upper abdominal	TCM Western Medicine	30 30	2 (0, 4) 2 (0, 4)	0 (0, 2) 0 (0, 2)	－3.535 －3.213	<0.001 0.001
Pain relief after eating	TCM Western Medicine	30 30	0 (0, 2) 0 (0, 2)	0 (0, 0) 0 (0, 2)	－2.000 －2.333	0.046 0.020
Loss of appetite	TCM Western Medicine	30 30	1 (0, 1.25) 1 (0, 1)	0 (0, 0.25) 0 (0, 1)	－3.346 －0.577	0.001 0.564
Fatigue	TCM Western Medicine	30 30	1 (1, 2) 1 (1, 2)	1 (0, 1) 1 (1, 1.25)	－3.448 －1.342	0.001 0.180
Bowel sounds	TCM Western Medicine	30 30	1 (0, 2) 1 (0, 2)	0 (0, 1) 1 (0, 2)	－3.640 －1.081	<0.001 0.279
Coldness in the hands and feet	TCM group Western Medicine	30 30	1 (0.75, 2) 1 (1, 1.25)	1 (0, 1) 1 (1, 1)	－3.520 －1.000	<0.001 0.317

Figure 2 Changes in flora between patients with NERD and normal subjects, and changes before and after drug treatment A: OUT clustering machine species annotation; B: distribution of gut microbiota in each group at the phylum and genus levels. B1: phylum level; B2: genus level; C: β-diversity analysis of intergroup flora differences across multiple groups by PCA; D: LEfSe analysis for identifying differential bacteria between the diseased and treated groups. D1: LDA thresholds of nonerosive gastroesophageal reflux patients compared with healthy subjects; D2: LDA thresholds of nonerosive gastroesophageal reflux patients before and after treatment with Hewei Jiangni recipe. HG: healthy group; TG1: before treatment of Hewei Jiangni recipe; WG1: before treatment of omeprazole; TG2: after treatment of Hewei Jiangni recipe; WG2: after treatment of omeprazole; DG: diseased group of nonerosive gastroesophageal reflux (TG1 + WG1).

Table 5 AMOVA between-group analysis

Group	SS	df	Fs	P value
DG-HG	0.690482 (4.68263)	1 (38)	5.60333	< 0.001^a
TG1-WG1	0.236027 (4.29291)	1 (28)	1.53946	0.169^b

Figure 3 Differences in metabolites and metabolic pathways between patients and normal subjects, and before and after Hewei Jiangni recipe treatment A: OPLS-DA splot showing the clustering of samples between patients, normal subjects, and before and after the treatment of Hewei Jiangni recipe. A1: OPLS-DA splot under positive ion mode; A2: OPLS-DA under negative ion mode. B: differential metabolite volcano plots and z-score. B1: the volcano plot of differential metabolite between nonerosive gastroesophageal reflux patients before Hewei Jiangni recipe treatment and normal subjects; B2: the volcano plot of differential metabolite after and before treatment of Hewei Jiangni recipe. OPLS-DA: orthogonal partial least squares discriminant analysis; HG: healthy group; TG1: before treatment of Hewei Jiangni recipe; TG2: after treatment of Hewei Jiangni recipe.

Table 6 Differential metabolites identified after HWJNR treatment compared to pre-treatment

No.	Name	mz	Formula	VIP	TG2 vs TG1
1	L-2,4-diaminobutyric acid	119.0897	C4H10N2O2	3.343279	↓^a
2	Acetaminophen	151.0619	C8H9NO2	2.988399	↑^b
3	Tryptamine	161.1076	C10H12N2	2.117216	↑^c
4	L-Alanyl-D-glutamate	201.0871	C8H14N2O5	2.324239	↓^c
5	D-Lysopine	219.1344	C9H18N2O4	2.236051	↓^c
6	Felbamate	239.1031	C11H14N2O4	3.525943	↑^a
7	Orphenadrine	270.1861	C18H23NO	2.649173	↑^b
8	Propafenone	342.2057	C21H27NO3	2.805302	↑^a
9	Norsolorinic acid	371.1453	C20H18O7	1.769136	↑^a
10	24,25-Dihydrolanosterol	428.3764	C30H52O	1.340831	↓^a
11	Thioguanine	166.0185	C5H5N5S	1.70374	↑^a
12	Beta-Glycerophosphoric acid	171.007	C3H9O6P	2.367763	↑^a
13	L-Theanine	173.0938	C7H14N2O3	2.505759	↑^a
14	Carglumic acid	190.0553	C6H10N2O5	2.145167	↑^a
15	20-HETE	320.2314	C20H32O3	2.747996	↑^a

Table 7 Reversal of 3 differential metabolites in NERD patients after HWJNR

No.	Name	mz	Formula	VIP	TG1 vs HG	TG2 vs TG1
1	L-2,4-diaminobutyric acid	119.0897	C4H10N2O2	3.343279	↑^a	↓^b
2	Felbamate	239.1031	C11H14N2O4	2.988399	↓^a	↑^b
3	Orphenadrine	270.1861	C18H23NO	2.747996	↓^a	↑^c

Figure 4 Differential metabolic pathways between patients and normal subjects, and before and after HWJNR treatment A: histogram of metabolic pathway differences between nonerosive gastroesophageal reflux patients before HWJNR treatment and normal subjects; B: bubble chart of metabolic pathway differences between nonerosive gastroesophageal reflux patients before HWJNR treatment and normal subjects; C: histogram of metabolic pathway differences after and before treatment of HWJNR; D: bubble chart of metabolic pathway differences after and before treatment of HWJNR. HWJNR: Hewei Jiangni recipe.

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