Efficacy and safety of Chinese herbal medicine Qirui Weishu capsule in treating chronic non-atrophic gastritis: A multicentre, double-blind, randomized controlled clinical trial

Chen, Hua-Fang; Yang, Gong; Huang, Zhijun; Zhao, Gang; Chen, Zhimin; Zen, Yao-Ming; Li, Huizhen; Hu, Yunlian

doi:10.1016/j.jep.2022.115341

Cited by 9 publications

(10 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…TCM treatment evaluation is often based on a 28-day treatment cycle or a 56-day treatment cycle. 19 , 20 Therefore, in this study, a 28-day treatment cycle was applied for CNAG with GHSC treatment, according to the clinical experience in our hospital. The quantitative rating scale (TEI) was utilized for the efficacy evaluation, which was commonly accepted in clinical studies.…”

Section: Discussionmentioning

confidence: 99%

The Efficacy of Chaihu-Guizhi-Ganjiang Decoction on Chronic Non-Atrophic Gastritis with Gallbladder Heat and Spleen Cold Syndrome and Its Metabolomic Analysis: An Observational Controlled Before-After Clinical Trial

Wen,

Liu,

Pang

et al. 2024

DDDT

View full text Add to dashboard Cite

Purpose The aim of this study was to verify the effectiveness and explore the mechanism of Chaihu-Guizhi-Ganjiang decoction (CGGD) in the treatment of chronic non-atrophic gastritis (CNAG) with gallbladder heat and spleen cold syndrome (GHSC) by metabolomics based on UHPLC-Q-TOF/MS. Patients and Methods An observational controlled before-after study was conducted to verify the effectiveness of CGGD in the treatment of CNAG with GHSC from January to June 2023, enrolling 27 patients, who took CGGD for 28 days. 30 healthy volunteers were enrolled as the controls. The efficacy was evaluated by comparing the traditional Chinese medicine (TCM) syndrome and CNAG scores, and clinical parameters before and after treatment. The plasma levels of hormones related to gastrointestinal function were collected by ELISA. The mechanisms of CGGD in the treatment of CNAG with GHSC were explored using a metabolomic approach based on UHPLC-Q-TOF/MS. Results Patients treated with CGGD experienced a statistically significant improvement in TCM syndrome and CNAG scores (p < 0.01). CGGD treatment evoked the concentration alteration of 15 biomarkers, which were enriched in the glycerophospholipid metabolism, and branched-chain amino acids biosynthesis pathways. Moreover, CGGD treatment attenuated the abnormalities of the gastrointestinal hormone levels and significantly increased the pepsinogen level. Conclusion It was the first time that this clinical trial presented detailed data on the clinical parameters that demonstrated the effectiveness of CGGD in the treatment of CNAG with GHSC patients. This study also provided supportive evidence that CNAG with GHSC patients were associated with disturbed branched-chain amino acid metabolism and glycerophospholipid levels, suggesting that CNAG treatment based on TCM syndrome scores was reasonable and also provided a potential pharmacological mechanism of action of CGGD.

show abstract

Section: Discussionmentioning

confidence: 99%

The Efficacy of Chaihu-Guizhi-Ganjiang Decoction on Chronic Non-Atrophic Gastritis with Gallbladder Heat and Spleen Cold Syndrome and Its Metabolomic Analysis: An Observational Controlled Before-After Clinical Trial

Wen,

Liu,

Pang

et al. 2024

DDDT

View full text Add to dashboard Cite

show abstract

“… Medicines Ingredients TCM Effects Type of study Banxia Xiexin decoction [ 16 , 17 ] Rhizoma Pinelliae , Radix Scutellariae , Rhizome Coptidis , Rhizoma Zingibers , Radix Glycyrrhizae , Fructus Ziziphi Jujubae , Radix Ginseng . Clear heat and remove dampness Meta-analysis Huangqi Jianzhong Tang [ 18 ] Radix Astragali , Radix Paeoniae Alba , Ramulus Cinnamomi , Fructus Jujubae , Glycyrrhizae Radix Et Rhizoma Praeparata Cum Melle , Rhizoma Zingiberis Recens , Saccharum Granorum Invigorate the spleen-stomach and replenish qi Meta-analysis QiruiWeishu capsule [ 19 ] Panax notoginsen g, Rheumofficinale, Alum, Ophicalcitum Remove stasis and dehumidification, guide hysteresis and cleare heat RCT Shenling Baizhu Powder [ 20 ] Atractylodes macrocephala Koidz, Panax ginseng C.A.Mey, Smilax glabra Roxb, Coix lacryma-jobi var. ma-yuen (Rom.Caill.)…”

Section: Clinical Evidence Of Tcms On Cgmentioning

confidence: 99%

“…A multicenter, double-blind, randomized controlled clinical trial was conducted to evaluate the effectiveness of QiruiWeishu capsule in the treatment of CNAG. The results showed that the capsule was effective in relieving stomach pain, reducing the inflammation of gastric mucosa, and improving the scores of TCM symptoms [ 19 ].…”

Section: Clinical Evidence Of Tcms On Cgmentioning

confidence: 99%

Progress in traditional Chinese medicine against chronic gastritis: From chronic non-atrophic gastritis to gastric precancerous lesions

Liu

Zhu

Zhang

et al. 2023

Heliyon

View full text Add to dashboard Cite

“…Herbal-based therapies are considered as an alternative option, especially by people who prefer natural remedies or worried about the possible adverse effects of conventional drugs ( Tilburt and Kaptchuk, 2008 ; Chen et al, 2022 ). Additionally, when used properly, herbal medicines are generally regarded as safe and well-tolerated and have fewer adverse effects than the allopathic drugs ( Fang et al, 2017 ; El-Dahiyat et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

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

Shah,

Fatima,

Khan

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

Background: Common symptoms of Chronic Non-atrophic Gastritis (CNAG) include nausea, stomach distension, and abdominal pain. The Houtou Jianweiling Tablet (HTJWT) is a chinese patent medicine (CN1368229A) and it has been used clinically for more than 20 years with proven clinical efficacy in treating CNAG, prompted us to establish the clinical efficacy and safety of HTJWT on patients with mild to moderate CNAG symptoms in Pakistani population.Methods: This phase II, double-blind, randomized, parallel-controlled trial was conducted in a single center between November 2022 and February 2023 in Pakistan. In a ratio of 1:1, total 240 CNAG patients with erosion identified by pathological biopsy and gastroscopy were randomly assigned to control (Omeprazole) group (n = 120) and the treatment (HTJWT) group (n = 120). Patients in the treatment group received orally four HTJWT (0.38g/tablet), three times a day and one placebo of Omeprazole enteric-coated tablet prior to breakfast, daily. On the other hand, patients in the control group received one Omeprazole enteric-coated tablet (20 mg/tablet) prior to breakfast and four placebo of HTJWT, thrice a day. The patients consumed the investigated drugs (i.e., treatment and control) treatment regimen was followed for a duration of 28 days. The safety of the patients were evaluated through adverse events, serious adverse events and laboratory tests such as blood biochemistry, urine analysis, liver and renal function tests. Vital signs like; blood pressure, pulse rate, body temperature, respiratory rate for all the patients were recorded. The cardiac status of the patients were assessed through electrocardiogram (ECG). The primary efficacy indicators were the improvement rate of gastric distention and gastralgia as the main clinical symptoms. Secondary indicators were visual analogue score (VAS); improvement rate of secondary clinical symptoms and signs; improvement rate of total clinical signs and symptoms; the disappearance/remission rate of Gastric pain and, remission/disappearance time of gastric distension; and the negative conversion rate of Helicobacter pylori (H. pylori). The outcomes among each group were compared using the chi-square test.Results: Patients in both groups had good drug compliance (80%–120%), and there was no statistically significant difference in the patients’ baseline characteristics. The clinical improvement rate was found to be 91.1% in the treatment group and 91.0% in the control group with negligible variation among the two groups (p = 0.9824; 95% confidence interval: -0.0781–0.0798). Similarly, hardly no difference was found in the negative conversion rate of H. pylori between the treatment group and the control group (i.e., 70.1% and 71.8% respectively, p = 0.8125). There were no significant differences in respiratory rate, vital signs, blood pressure, laboratory results for blood biochemistry, urine analysis, liver and renal function tests between the two groups. The ECG assessment carried out for the treatment and control group revealed no considerable difference. Margin variation in the disappearance time of gastric pain (p = 0.1860) and remission rate (p = 0.5784) between the two groups were observed. The control group exhibited a faster remission period for gastrointestinal discomfort indications as compared to treatment group (p = 0.0430). Only one patient in the control group experienced mild to moderate adverse events, namely,; epigastric pain and dyspepsia. The results were consistent with the intention-to-treat and per-protocol analysis that included patients who were 100% compliant to the assigned therapy.Conclusion: The lower limit of confidence interval (CI, 95%) for the differences in the effective rate between the treatment and the control groups was found to be −0.0781 which is greater than −0.15, hence the treatment group is non-inferior to the control group. The therapeutic dosage used in the trial and treatment period did not cause any significant adverse event, and there were no obvious changes in the ECG profile, vital signs and biochemistry of the patients. Based on the clinical efficacy evaluation and reported adverse events, it can be concluded that the HTJWT is a safe and effective traditional chinese medicine for the treatment of patients suffering from chronic non-atrophic gastritis with mild to moderate symptoms.Clinical Trial Registration: [www.clinicaltrials.gov], identifier [NCT04672018].

show abstract

Efficacy and safety of Chinese herbal medicine Qirui Weishu capsule in treating chronic non-atrophic gastritis: A multicentre, double-blind, randomized controlled clinical trial

Cited by 9 publications

References 23 publications

The Efficacy of Chaihu-Guizhi-Ganjiang Decoction on Chronic Non-Atrophic Gastritis with Gallbladder Heat and Spleen Cold Syndrome and Its Metabolomic Analysis: An Observational Controlled Before-After Clinical Trial

The Efficacy of Chaihu-Guizhi-Ganjiang Decoction on Chronic Non-Atrophic Gastritis with Gallbladder Heat and Spleen Cold Syndrome and Its Metabolomic Analysis: An Observational Controlled Before-After Clinical Trial

Progress in traditional Chinese medicine against chronic gastritis: From chronic non-atrophic gastritis to gastric precancerous lesions

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

Contact Info

Product

Resources

About