Chronic gastritis (CG), which is induced by various causes, is a very common disease of the digestive tract and is an inflammatory condition of the gastric mucosa . Among the possible etiological factors, Helicobacter pylori (HP) infection is the most common cause of chronic gastritis worldwide, with the remaining cases arising due to smoking, drinking, duodenal juice reflux, food allergies, heredity, drug-induced injuries, immunity, Crohn’s disease, other infectious pathogens or radiation [2–4]. Chronic gastritis can be categorized into non-atrophic gastritis, atrophic gastritis and special types of gastritis, according to the Consensus on Chronic Gastritis in China (Shanghai 2012) . Chronic non-atrophic gastritis (CNG) is characterized by the infiltration of chronic inflammatory cells and the absence of atrophy in the mucosal layer. Although the prevalence rate in the general population remains unclear, a national multicenter cross-sectional study led by the Digestive Endoscopy Branch of Chinese Medical Association showed that 49.3% of the investigated patients (4,389/8,892) with upper gastrointestinal symptoms who underwent diagnostic upper endoscopy for the evaluation of gastrointestinal symptoms from 33 centers had CNG, which was the most common . Symptomatic patients with CNG may manifest nonspecific dyspeptic symptoms, such as epigastric discomfort, distention, belching, acid regurgitation, nausea, vomiting, loss of appetite and anergy, while some patients have no symptoms. The pathogenesis of chronic gastritis is complex and difficult to cure. The focused Western medical treatment of chronic gastritis involves the eradication of HP, antacids, prokinetics and mucosal-protective agents to ameliorate the symptoms [5, 6]. However, even if treated with the above standard therapies, some patients will not be freed from this disease. Traditional Chinese medicine (TCM), which has recently become a research focus in particular contexts, can broaden the therapeutic approaches to CNG [7–11].
Traditional Chinese medicine, which has been established for over 5,000 years, has been widely used to treat diseases, including CNG. Based on its clinical manifestations, CNG can be categorized as Weiwantong (stomach ache), Piman (abdominal distention) or Caoza (gastritis discomfort) in the field of Chinese medicine (CM); TCM divides CNG into five common single syndrome patterns: (1) spleen (Pi) and stomach (Wei) deficiency syndrome (including spleen and stomach qi deficiency syndrome and spleen and stomach deficiency-cold syndrome); (2) incoordination between liver (Gan) and stomach syndrome (including liver qi invading stomach syndrome and stagnant heat in liver and stomach syndrome); (3) stomach yin deficiency syndrome; (4) spleen and stomach dampness-heat syndrome; and (5) blood stasis in stomach collaterals syndrome . The concurrence of two or more individual patterns can be considered a complicated pattern and is common in clinical practice . The TCM treatment relies on correct syndrome differentiation (SD), by which accumulating symptoms and signs are identified through inspection, auscultation and olfaction, inquiring, and palpation to uncover the ongoing abnormal condition. Therefore, TCM agents operate through other pathways that may be helpful for patients who are nonresponsive to standard therapies.
A new TCM drug, the Jian-Wei-Qu-Tong Pills (JWQTP), is currently being manufactured by Anbang Pharmaceutical Limited by Share Ltd, Hunan, China. The prescription for this pill is based on both TCM theory and the clinical experience and herbal studies of prominent TCM doctors on the treatment of CNG. Components of the pill include: Radix Pseudostellariae, Rhizoma Coptidis, Rhizoma Atractylodis Macrocephalae, Semen Coicis, Rhizoma Pinelliae Preparata, Radix Notoginseng, Pollen Typhae, Herba Taraxaci Mongolici, Rhizoma Corydalis Yanhusuo, Cortex Magnoliae Officinalis and Radix Glycyrrhizae preparata. All of these herbs have been approved by the China Food and Drug Administration (CFDA). This pill can strengthen the spleen, supplement qi, clear heat, remove dampness and promote blood circulation to remove blood stasis and relieve pain. Thus, it can be used for spleen and stomach qi deficiency with damp-heat stasis syndrome (SSQDDSS) in CNG patients. Preclinical pharmacologic experiments, which have not been published, show that JWQTP can neutralize gastric acid; reduce gastric acidity, pepsin activity, free mucus, gastrin, TNF-α and IL-2; elevate the level of IL-4; create balance between the Th1 and Th2 cells; and then reduce inflammation in rats’ gastric mucosa to protect against CG. Furthermore, this treatment was able to eradicate HP in the gastric mucosa of mice to some degree, provide an analgesic effect and play a regulatory role on gastric emptying. Additionally, there was no evidence to show an adverse or toxic effect in toxicological studies.
The specific objectives of this trial included evaluating the efficacy and safety of JWQTP in treating CNG patients with SSQDDSS, including any dose-effect relationship, and providing evidence for a Phase III clinical program.