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The safety and efficacy of Houtou Jianweiling tablet in patients with chronic non-atrophic gastritis: a double-blind, non-inferiority, randomized controlled trial

Summary

This study tested a traditional Chinese herbal medicine called Houtou Jianweiling Tablet against omeprazole, a common stomach medication, for treating chronic stomach inflammation. The herbal tablet worked just as well as the conventional drug at relieving stomach pain, bloating, and reducing harmful bacteria, while being very safe with almost no side effects. This suggests that people with mild to moderate stomach inflammation could use this natural herbal alternative instead of, or alongside, conventional medications.

Background

Chronic non-atrophic gastritis (CNAG) is a common digestive system disease with high prevalence affecting quality of life. Houtou Jianweiling Tablet (HTJWT) is a Chinese patent medicine used clinically for over 20 years with proven efficacy in treating CNAG. This study aimed to establish the clinical efficacy and safety of HTJWT in Pakistani patients with mild to moderate CNAG symptoms.

Objective

To evaluate the non-inferiority of Houtou Jianweiling Tablet compared to Omeprazole in treating chronic non-atrophic gastritis and to assess its clinical effectiveness and safety profile in patients with mild to moderate symptoms.

Results

Clinical improvement rates were 91.1% for HTJWT and 91.0% for Omeprazole (p=0.9824), demonstrating non-inferiority with 95% CI lower limit (-0.0781) exceeding the -0.15 margin. H. pylori negative conversion rates were 70.1% and 71.8% respectively (p=0.8125). Only one adverse event was reported in the control group with no serious adverse events in either group, and no significant differences in vital signs or laboratory parameters.

Conclusion

Houtou Jianweiling Tablet is non-inferior to Omeprazole for treating chronic non-atrophic gastritis with similar efficacy and excellent safety profile. The traditional Chinese medicine formulation represents a safe and effective alternative therapy for CNAG patients with mild to moderate symptoms without significant adverse effects.
  • Published in:Frontiers in Pharmacology,
  • Study Type:Clinical Trial,
  • Source: PMID: 38440179
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