Efficacy and safety of Piwei Peiyuan Prescription in the treatment of chronic atrophic gastritis: A multicenter, double-blind, double-simulated, randomized, controlled clinical trial

Author:

Zhang Yi1,Yang Qi2,Song Biao2,Tang Wei3,Yu Feng4,Chen Hua5,Ge Ping6,Fang Xusheng7,Pei Bei1,Sun Qin2,Li Xuejun2ORCID

Affiliation:

1. The Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China

2. Department of Spleen and Stomach, The Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China

3. Department of Spleen and Stomach, The Lu’an Hospital of Traditional Chinese Medicine, Lu’an, China

4. Department of Hepatobiliary, Spleen and Stomach, The Jieshou Hospital of Traditional Chinese Medicine, Jieshou, China

5. Department of Spleen and Stomach, The Chuzhou Hospital of Integrated Traditional Chinese and Western Medicine, Chuzhou, China

6. Department of Spleen and Stomach, The Ningguo Hospital of Traditional Chinese Medicine, Ningguo, China

7. Department of Spleen and Stomach, The Taihu County Hospital of Traditional Chinese Medicine, Anqing, China.

Abstract

The incidence of chronic atrophic gastritis (CAG) is on the rise due to the growing pressure in modern social life, increasing bad living habits and emotional disorders (such as anxiety and depression), and the aging of the population. Of note, digestive system diseases are the dominant diseases in the field of traditional Chinese medicine (TCM). Therefore, this study evaluated the efficacy and safety of Piwei Peiyuan Prescription, a TCM prescription, in the treatment of CAG through a multicenter, double-blind, randomized, controlled design. This research was organized by the Second Affiliated Hospital of Anhui University of TCM and simultaneously performed in 6 centers. A total of 120 CAG patients were included and randomized into 2 groups: group A (treatment with Piwei Peiyuan granules plus Weifuchun Simulant) and Group B (treatment with Weifuchun Tablets plus Piwei Peiyuan Simulant). These 2 groups were compared in terms of gastroscopy scores, TCM syndrome scores, and serological indicators at baseline and within 12 weeks after treatment. According to endoscopic biopsy for pathological observation, atrophy (2.56 ± 1.08 vs 3.00 ± 1.00, P = .028) and intestinal epithelial hyperplasia (1.00 ± 1.43 vs 1.69 ± 1.80, P = .043) scores were lower in group A than in group B. For the more, group A had higher effective rates for inflammation, atrophy, and intestinal metaplasia (IM) in various regions of the stomach, especially for atrophy/IM of the gastric angle (64%, P = .034) and atrophy/IM of the lesser curvature of gastric antrum (63%, P = .042) than group B. According to TCM syndrome scores, Piwei Peiyuan Prescription improved the scores of gastric distension (2.30 ± 1.13 vs 2.80 ± 0.99, P = .022), preference for warmth and pressure (1.44 ± 1.06 vs 1.36 ± 1.10, P = .041), and poor appetite and indigestion (0.78 ± 0.66 vs 1.32 ± 0.72, P = .018). GAS, MTL, and PGE2 expression was significantly elevated after treatment with Piwei Peiyuan Prescription (P < .001). Piwei Peiyuan Prescription is effective for CAG treatment with high safety.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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