Efficacy of Chinese Herbal Formula Sini Zuojin Decoction in Treating Gastroesophageal Reflux Disease: Clinical Evidence and Potential Mechanisms

Abstract

Background: Based on 122 cases reported in China, data mining indicated that Sini Powder (SNP) and the Zuojin Pill (ZJP) are both widely used as the basic recipe for treating Gastroesophageal Reflux Disease (GERD). Objectives: To evaluate the intervention effects of Sini Zuojin Decoction (SNZJD) in patients with GERD. Methods: A comprehensive collection of randomized controlled trials (RCTs) using SNZJD in patients with GERD that were published in domestic and foreign journals was made by computer retrieval. RevMan 5.3 software was used for meta-analysis and bias risk assessment, Stata 14.0 software was used for sensitivity analysis, GRADE profiler 3.6 was used to evaluate the level of evidence, and trial sequential analysis (TSA), employed to control for random errors, was performed to assess the main outcomes. Network pharmacology analysis was applied to preliminarily study the mechanisms of action of SNZJD on GERD. Results: Thirteen articles were eventually included, covering a total of 966 patients. Metaanalysis indicated that: ① the SNZJD plus traditional stomach medicines (SPTSM) group was more effective than the traditional stomach medicines (TSM) group (RR = 1.16, 95% CI [1.04, 1.29], P = 0.009); ② the experimental group with SNZJD was significantly better than TSM controls in improving heartburn, substernal chest pain, acid regurgitation, and food regurgitation symptoms (P < 0.0001); ③ SPTSM could significantly decrease total symptom scores with substantial effectiveness (P < 0.00001). The recurrence rate and adverse effects of SNZJD treatment were significantly reduced (P < 0.05). TSA showed that the effective rate of meta-analysis might be reliable, but the recurrence and safety results were still uncertain. According to the evaluation by the GRADE method, the quality

A Methodological and Reporting Quality Assessment of Systematic Reviews/Meta-Analyses about Chinese Medical Treatment for Gastroesophageal Reflux Disease

“…After screening titles and abstracts, 72 studies were eligible for full-text review, and 39 studies were excluded according to the exclusion criteria. Finally, 33 reports [ 15 – 46 ], including 22 network meta-analyses (NMA)/MAs, 6 SRs, and 5 NMAs/MAs and SRs, underwent quality assessment. Information on the search protocol is shown in Figure 1 .…”

“…There were 28 reports [ 15 – 24 , 26 – 32 , 34 , 35 , 38 – 45 ] in Chinese and 5 reports [ 25 , 33 , 36 , 37 , 46 ] in English. 18 studies reported the sources of funding; but none of them were Cochrane reviews.…”

“…The average score for the 33 studies was 19.5 out of 27 points, suggesting that the quality of the included studies was low. A single study was used as the object for analysis; the highest score was 25 points [ 46 ], the lowest score was 15 points [ 45 ], and there was a large gap in quality between studies. The no reporting rate for PRISMA results was 19.9%, and the partial reporting rate was 15.2%.…”

Efficacy and safety of traditional Chinese herbal formula combined with western medicine for gastroesophageal reflux disease

“…In China, Traditional Chinese herbal formula has history-proven benefits for GERD, [ 13 ] and clinical studies have proved the efficacy and safety of Chinese herbal formula in treating GERD. [ 9 , 10 ] Mechanism research found that Chinese herbal formula could relieve dilated intercellular spaces and desmosome disruption in esophageal epithelium, protected mitochondria from fragmentation to significantly resist esophageal morphology changes in ovalbumin-induced and acid exposure rat model. [ 14 ] Also, they could improve the pH value of gastric contents, decrease the gastrointestinal hormones, and improve the inflammatory damage in rats.…”

“…[ 8 ] Clinical studies have proved the efficacy and safety of Chinese herbal formula in treating GERD, and they appeared to be maintained for a longer period of time. [ 9 , 10 ]…”