Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease

Summary

Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.

Timeline

Start

2020-07-15

Primary completion

2021-12-01

Completion

2021-12-31

Outcome

Mixed primary results

paper Primary endpoints were the improvement rates of reflux and heartburn symptoms and VAS score changes. PMID 39839278 ↗

paper After 4 weeks, the improvement rate for reflux or heartburn symptoms was 79.49% in the JQ group vs. 58.97% in the placebo group (P < 0.05). PMID 39839278 ↗

paper VAS scores showed significant reductions in both groups but without notable inter-group differences. PMID 39839278 ↗

Publications

• Zhang T, Bai G, Wang W, Liu L, Zhou Z, Ji H, Zhang B, Tang X. Efficacy and safety of Jianpi Qinghua granules for non-erosive reflux disease with spleen deficiency and damp-heat syndrome: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Front Nutr. 2025 Jan 7;11:1509931. doi: 10.3389/fnut.2024.1509931. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Jianpi Qinghua granules	Traditional medicine (herbal / TCM)	—	—

Indications