Comparative evaluation of the clinical efficacy of triple therapy and the addition use of TCM in treating Helicobacter pylori-associated gastritis

Chronic gastritis, defined as persistent inflammation of the gastric mucosa with multifactorial etiology (Yang et al., 2020), represents the most prevalent endoscopic diagnosis in China, constituting approximately 90% of gastroscopic examinations (Jiang et al., 2016, Yang et al., 2020). The etiology of gastritis is mainly related to Helicobacter pylori (H. pylori) (Jiang et al., 2016). Studies have shown that 70–90% of patients with chronic gastritis have an H. pylori infection (Jiang et al., 2016). CagA, an H. pylori–specific virulence factor, led to the downregulation of the proapoptotic factor, SIVA1, leading to chronic accumulation of DNA damage and an increased potential for neoplastic transformation (Saenz and Mills, 2020). Persistent H. pylori infection demonstrates limited spontaneous resolution. And the H. pylori infection increases the risk of peptic ulcers by 10–15%, mucosal atrophy by 5%, and gastric cancer by 1% (de Vries et al., 2008, Piazuelo et al., 2010, Sugano, 2016, Ye et al., 2018, National Clinical Research Center for Digestive Diseases (Shanghai), 2019). Chronic gastritis with H. pylori infection is considered the most significant risk factor for gastric cancer (Sugano et al., 2015). The incidence of gastric cancer after H. pylori eradication decreased to 0.53 (95% Confidence Interval [CI] 0.44–0.64) (Lee et al., 2016). Therefore, it is necessary to treat patients with chronic gastritis infected with H. pylori.

Currently, triple therapy, comprising a proton-pump inhibitor (PPI) with amoxicillin and clarithromycin, is still the most commonly used first-line therapy present, triple therapy (PPI, amoxicillin, clarithromycin) and quadruple therapy (PPI, bismuth, tetracycline, and metronidazole) are the main treatment options for clinical eradication of H. pylori, and the treatment cycle is 10 or 14 days (World Gastroenterology Organisation, 2021). However, the biofilm-forming capacity of H. pylori serves as a protective barrier against antimicrobial agents, inducing multidrug tolerance and substantially complicating eradication efforts. Hence, clarithromycin resistance has emerged as the principal determinant of therapeutic efficacy. The clarithromycin resistance rate is increasing rapidly in many countries, reaching 30% in Japan, 40% in Italy, and approximately 30% in Turkey (Thung et al., 2016). According to a study in China, the clarithromycin resistance rate increased from 37.41% to 52.55% (He et al., 2018). Long-term use or excessive use of antibiotics will produce more adverse reactions, and patients are prone to drug resistance, easily caused by patients with intestinal flora disorders (Li et al., 2015, Katelaris et al., 2023).

Chinese herbal medicines, as natural drugs, are increasingly prominent in treating H. pylori infections. Huanglian, betel nut, and dandelion have all been found to be effective in the treatment of H. Pylori (Cai and Jin, 2017). Chinese medicine treats chronic gastritis with syndrome differentiation, as it is categorised as "stomach pain" and "gastric abnormalities". Contemporary clinical investigations confirm that syndrome differentiation-based therapeutic strategies not only alleviate clinical symptoms and enhance patients' quality of life, but also exhibit synergistic anti-H. pylori effects (He and Zhu, 2021). Previous studies have shown that the eradication rate of H. pylori in triple therapy combined with herbal medicine is comparable to that of bismuth quadruple therapy, and the triple therapy combined with herbal medicine improves symptoms and reduces the incidence of adverse effects (Hu et al., 2012, Liu et al., 2017). So the combination of TCM is a new way of treating diseases associated with H. pylori infections under the current situation of H. pylori drug resistance (Hu et al., 2024). A multicenter study from China showed that bismuth triple therapy (10 days) combined with traditional Chinese medicine (14 days) achieved better efficacy in eradicating H. pylori and reduced antibiotic dosage (Chen et al., 2016). Based on our previous clinical experience, we believe that using triple therapy for 10 days and taking herbal medicine for an additional 14 days has significant results in terms of H. pylori treatment and improvement in quality of life. Therefore, in this study, we evaluated the efficacy and safety of the combination of TCM and triple therapy on the eradication rate of H. pylori, using triple therapy as a control.

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