Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

Lv, Lin; Wang, Fengyun; Ma, Xiang‐Xue; Li, Zhenhua; Huang, Suiping; Shi, Zhaohong; Ji, Hai-Jie; Bian, Li-Qun; Zhang, Bei-Hua; Chen, Ting; Yin, Xiaolan; Tang, Xudong

doi:10.3748/wjg.v23.i30.5589

Cited by 41 publications

(33 citation statements)

References 48 publications

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“…Functional dyspepsia (FD) is a common upper gastrointestinal disorder that occurs in 11–29% of the population globally. [ 1 ] Patients with FD usually complain of chronic or recurrent epigastric pain, epigastric burning, postprandial fullness, and early satiety, which severely impair patients' quality of life. [ 2 ] In general, FD is divided into two subtypes according to the main complaints: epigastric pain syndrome, in which the patients mainly complain of epigastric pain and/or burning, and postprandial distress syndrome (PDS), in which the patients mainly complain of postprandial fullness and/or early satiety.…”

Section: Introductionmentioning

confidence: 99%

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia

Chen

Wang

et al. 2018

Chinese Medical Journal

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Background:Functional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.Methods:The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared.Results:(1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo.Conclusion:Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.Trial Registration:https://clinicaltrials.gov/, NCT02460601.

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Section: Introductionmentioning

confidence: 99%

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia

Chen

Wang

et al. 2018

Chinese Medical Journal

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“…The studies published between 1991 and 2019 were included. Patients had FD, [15][16][17][18][19][20][21][22]13,14,[23][24][25][26][27][28][29][30][31][32] and constipation [56][57][58][59][60][61][62] in 19, 23 and 7 trials respectively. More than 33 different kinds of herbal formulae were tested in the included trials.…”

Section: Resultsmentioning

confidence: 99%

“…Literature searches identified 3782 potentially relevant titles after elimination of duplicates. After review of the abstracts, 121 full‐text publications were assessed, of which 50 studies were included in this review, involving a total of 7396 participants. As two of the studies shared the same group of patients with two aspects of results reported, so their data was abstracted as one, resulting in totally 49 trials for analysis.…”

Section: Resultsmentioning

confidence: 99%

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Herbal medicine in the treatment of functional gastrointestinal disorders: A systematic review with meta‐analysis

Tan

Gwee

Tack

et al. 2019

J of Gastro and Hepatol

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Background and Aims The efficacy of herbal medicines (HMs) for functional gastrointestinal disorders (FGIDs) including irritable bowel syndrome (IBS), functional dyspepsia (FD) and functional constipation (FC) is controversial. A systematic review with meta‐analysis was conducted to determine their effectiveness for FGIDs. Methods We searched the following electronic databases till July 2019 with English language restriction: The Cochrane Library, EMBASE and PUBMED. Randomized double‐blind controlled trials of HMs compared with placebo or conventional pharmacological drugs for adult FGIDs patients were included. Results In total, 49 trials involving 7396 participants with FGIDs were included. The risk of bias was low in 9, unclear in 36, and high in 4 trials. More than 33 different herbal formulae were tested. HMs demonstrated statistically significant benefits for symptom improvement compared with placebo in 46 trials (RR = 1.67, 95% CI 1.48–1.88). When compared with conventional pharmacological therapy in 5 trials, HMs were found to be non‐inferior (RR = 1.10, 95% CI 1.03–1.18). The number of trials with regards to FD, IBS and FC were 19, 23 and 7 respectively. Subgroup analysis found that HMs were better than placebo in alleviating symptoms for FD (RR = 1.50, 95% CI 1.32–1.69), IBS (RR = 1.62, 95% CI 1.32–1.97) and FC (RR = 3.83, 95% CI 2.26–6.50). HMs tended to have more patients with adverse events than placebo, but similar to conventional pharmacological drugs. Conclusions Our findings provide a positive signal for HMs as a potentially well‐tolerated and effective treatment for FGIDs, deserving further examination in high‐quality trials.

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“…us function of gathering Qi is closely related to the whole body condition and more closely to circulation and respiratory function, as Zhang Xichun said "gathering Qi actually controls general health while remains in cheat." Like Qi deficiency, when there is insufficient of Zong Qi, we often show symptoms such as fatigue and shortness of breath, which leads to decreased activity tolerance [2,43]. With the development of modern medicine, we found that the function of Zong Qi is related to the respiratory system, circulatory system, nervous system, and even reproductive system.…”

Section: Evidence-based Complementary and Alternative Medicinementioning

confidence: 99%

A Systematic Review and Meta‐Analysis on a Disease in TCM: Astragalus Injection for Gathering Qi Depression

Huang

Yan

et al. 2020

Evidence-Based Complementary and Alternative Medicine

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Zong Qi depression is a disease recorded in the literature of Chinese traditional medicine for a long time. In recent years, the theory of Zong Qi depression has been more and more applied to the diagnosis and treatment of a variety of diseases. Astragalus is the most important drug used to treat the depression of Zong Qi. Meanwhile, Astragalus injection is also widely used in a variety of diseases in accordance with the manifestations of Zong Qi subsidence. However, there is a lack of systematic review or meta-analysis of the clinical effect of Astragalus injection in the treatment of Zong Qi subsidence. Therefore, we searched for diseases characterized by symptoms of Zong Qi subsidence (including heart failure, respiratory failure, acute respiratory distress syndrome, and acute lung injury) and evaluated the effect of Astragalus injection in these diseases with mortality and distance of a 6-minute walking test. The results showed that the mortality of patients with subsidence of Zong Qi decreased in 1 month (OR, 0.26 [0.12, 0.61], 95% CI, P=0.002) and 1 year (OR, 0.38 [0.20, 0.69], 95% CI, P=0.002) after using Astragalus injection. The distance of 6-minute walking test after 7 (MD, 91.60 [6.89, 176.31], 95% CI, P=0.03), 14 (MD, 22.62 [13.80, 31.43], 95% CI, P<0.00001), and 28 days (MD, 108.31 [30.02, 186.59], 95% CI, P=0.007) of using Astragalus injection also increased. Therefore, we believe that Astragalus injection has a certain therapeutic effect on the depression of Zong Qi.

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Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

Cited by 41 publications

References 48 publications

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia

Herbal medicine in the treatment of functional gastrointestinal disorders: A systematic review with meta‐analysis

A Systematic Review and Meta‐Analysis on a Disease in TCM: Astragalus Injection for Gathering Qi Depression

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