Clinical efficacy of moluodan in the treatment of chronic atrophic gastritis: A protocol for systematic review and meta-analysis

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Medicine (Baltimore). 2022 Dec 30; 101(52): e32303.
Published online 2022 Dec 30. doi: 10.1097/MD.0000000000032303
PMCID: PMC9803472
PMID: 36596058

Clinical efficacy of moluodan in the treatment of chronic atrophic gastritis: A protocol for systematic review and meta-analysis​

Yunfeng Yu, MM,a,b Xinyu Yang, MM,bGang Hu, MM,a Shuang Yin, BM,bFei Zhang, MM,b Yandong Wen, MM,cYing Zhu, MD,a and Zhenjie Liu, MM

a,*
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Background:​

Chronic atrophic gastritis (CAG) is an important stage of precancerous lesions of gastric cancer, and also a key period of drug intervention. However, there is still a lack of drugs to maintain the treatment of CAG until the advent of moluodan.

Objective:​

This study was conducted to assess the clinical efficacy of moluodan in the treatment of CAG by meta-analysis and trial sequential analysis.

Methods:​

China National Knowledge Infrastructure, China Biology Medicine, VIP, Wanfang, Embase, PubMed, the Cochrane Library, and Web of Science databases were searched, all with the time limit from database establishment to July 2022. The published randomized controlled trials of moluodan for CAG were conducted for meta-analysis and trial sequential analysis.

Results:​

7 studies with a total sample size of 1143 cases were included. Compared to folic acid/vitamins, moluodan alone significantly increased the effective rate of pathological detection (relative risk [RR] = 1.73, 95% confidence interval [95%CI] = [1.48,2.02], P < .00001), and moluodan in combination with folic acid/vitamins significantly increased the effective rates of pathological detection (RR = 1.37, 95%CI = [1.23,1.52], P < .00001), gastroscopy (RR = 1.37, 95%CI = [1.18,1.60], P < .0001) and symptoms (RR = 1.25, 95%CI = [1.13,1.38], P < .0001). Harbord regression showed no publication bias (P = .22). Quality of evidence evaluation demonstrated moderate quality of evidence for all indicators.

Conclusions:​

Moluodan can improve the effective rates of pathological examination, gastroscopy and symptoms in patients with CAG, and play a role in slowing down the disease progression and reducing clinical symptoms. It may be a potential drug for the treatment of CAG and has the value of further exploration.

 

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1. Introduction​

Chronic atrophic gastritis (CAG) is a chronic inflammatory disease of the gastric mucosal tissue characterized by atrophy of the gastric mucosal glands, which may be accompanied by intestinal metaplasia and dysplasia.[1] Available studies suggest that “chronic non-atrophic gastritis - chronic atrophic gastritis - intestinal epithelial hyperplasia - atypical hyperplasia” is the unique progression pattern of gastric cancer.[2] CAG is a precancerous lesion of gastric cancer,[3] and its development is associated with helicobacter pylori (HP) infection.[4] It has been shown that eradication of HP can slow down the progression of gastric precancerous lesions[5,6] and reduce the incidence of gastric cancer in infected populations.[7] However, some patients with CAG continue to experience persistent discomfort after eradication of HP, and these symptoms significantly affect the patient’s daily life.[8] Additionally, the incidence of gastric cancer in patients with severe CAG can still reach 116/1,00,000 people after eradication of HP,[9] seriously endangering patients’ lives and health. Therefore, patients with CAG still need maintenance therapy after eradication of HP to further reduce the risk of gastric cancer and improve clinical symptoms. The Chinese Integrated Guideline on Clinical Management of Gastric Precancerous Conditions and Lesions state that folic acid and antioxidant vitamins are effective in improving the prognosis of CAG,[10] but the Management of Epithelial Precancerous Conditions and Lesions in the Stomach (MAPS II) do not recognize their benefit,[2] and CAG still lacks effective drugs for maintenance therapy. Therefore, it is necessary to explore other treatment options that can improve the prognosis of CAG.[7]

 

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Moluodan is a compound prescription of Chinese herbal medicine which developed by Professor Li EF, consisting of baizhu (Atractylodes Macrocephala), fuling (Poria), jineijin (Endothelium Corneum Gigeriae Galli), jiujiechangpu (Anemone altaica Fisch), zexie (Alismatis Rhizoma), puhuang (Pollen Typhae), sanqi (Notoginseng Radix), chuanxiong (Chuanxiong Rhizoma), danggui (Angelicae Sinensis Radix), diyu (Sanguisorbae Radix), baihe (Lilii Bulbus), shihu (Dendrobii Caulis), maidong (Ophiopogon japonicus (Linn. f.) Ker-Gawl), xuanshen (Scrophulariae Radix), yanhusuo (Corydalis Rhizoma), wuyao (Linderae Radix), baishao (Paeoniae Radix Alba).[11] Moluodan has been included in the MAPS II[2] in 2019 and recommended as a treatment for gastric precancerous lesions, especially mild dysplasia, in the Guidelines for the Clinical Application of Traditional Chinese Medicine in the Treatment of Chronic Gastritis[12] in 2020. The present study suggests that moluodan may increase serum gastrin by repairing gastrin-secreting cells and somatostatin-secreting cells in the gastric mucosa to treat CAG.[13] In addition, moluodan also significantly reduced the expression of EGF and EGFR in the serum of patients with CAG, thereby inhibiting further transformation of precancerous lesions in gastric cancer.[14] In recent years, an increasing number of clinical trials have suggested that moluodan has good efficacy in the treatment of CAG, but there are no relevant systematic evaluations and meta-analysis. Thus, this study used meta-analysis and trial sequential analysis (TSA) to evaluate the clinical efficacy of moluodan in the treatment of CAG, aiming to provide an evidence-based justification for the clinical application of moluodan.

 

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