Efficacy of Shugan Hewei formula combined with rabeprazole in refractory gastroesophageal reflux disease: randomized, double-blind, placebo-controlled trial.

2024-09-19
European journal of medical research 29(1)
- Xiulian Zhang
- Zhongfu Wang
- Tingting Xu
- Lei Wei
- Fangying Liu
- Chunfang Liu
- Li Li
- Wei Zhang
- Shengliang Zhu

PubMed: 39300586
DOI: 10.1186/s40001-024-02030-z

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 264
Population: 264 participants with refractory gastroesophageal reflux disease (rGERD)
Methods: Randomly assigned to treatment group (SHF granules 20 mg combined with rabeprazole 10 mg) or control group (placebo SHF granules 20 mg combined with rabeprazole 20 mg); both groups undergo 8 weeks of treatment and 2 weeks of follow-up
Blinding: Double-blind
Duration: 8 weeks
Funding: Unclear

Large Human Trial

Objectives

To assess the efficacy of the Chinese herbal medication Shugan Hewei formula (SHF) combined with rabeprazole in patients with refractory gastroesophageal reflux disease (rGERD).

Method

A total of 264 participants were randomly assigned to the treatment group (n = 132) receiving SHF granules (20 mg) combined with rabeprazole (10 mg) and the control group (n = 132) receiving placebo SHF granules (20 mg) combined with rabeprazole (20 mg). Both groups undergo 8 weeks of treatment and 2 weeks of follow-up.

Results

The treatment group showed higher total clinical symptom efficacy and lower total symptom scores compared to the control group. The treatment group was superior to the control group in reducing rGERD major symptom scores, including heartburn, retrosternal pain, regurgitation and belching, and acid regurgitation. Additionally, treatment group (Z = 8.169, P < 0.001) and control group (Z = 9.800, P < 0.001) treatments were all significantly attenuated esophageal inflammation, demonstrating comparable efficacy. Patients with esophagitis grade A decreased from 40.34% to 17.23%, and those with grade B decreased from 11.76% to 3.78% in the treatment group. The results of the SF-36 scale showed that combination therapy was more effective in improving role limitations due to physical health, vitality, general health, total somato-physical health, and psychiatric mental health.

Conclusion

Our study reveals that the combined treatment of SHF with rabeprazole is more efficacious in managing patients with rGERD when contrasted with sole rabeprazole treatment.