Treatment of functional dyspepsia with serotonin agonists: a meta-analysis of randomized controlled trials

BACKGROUND: Functional dyspepsia (FD) is often treated with serotonin agonists; however, the efficacy of such agents has recently been questioned. The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) comparing serotonin agonists with other types of prokinetics in patients with FD. METHODS: Included studies were RCTs that compared serotonin agonists, including cisapride and mosapride, with dopamine antagonists, including metoclopramide and domperidone, and an opiate agonist, trimebutine, in patients with FD. Studies were identified by searching the Medline database (January 1951 - January 2005) and Cochrane Library (Issue 4, 2004), and by manual searches. The difference in the probability of patients' responses between the serotonin agonists and control agents was used as a summary statistic for the treatment effect. Meta-regression analysis was used to detect sources of heterogeneity. RESULTS: Five studies were identified. In total, 467 subjects were assigned to a serotonin agonist arm, and 322 subjects were assigned to a control arm. In the overall analysis, the summary statistic was 0.019 (95% confidence interval [CI]: -0.055 to 0.093; P = 0.612), indicating that the patients' responses to serotonin agonists were similar to those to control agents. However, in the stratified meta-analysis of cisapride and mosapride, mosapride had a 6.7% greater probability of producing a response compared with control agents (summary statistic: 0.067; 95% CI: 0.010-0.124; P = 0.021), whereas no significant effect was observed with cisapride. CONCLUSION: The data suggest that mosapride may be more effective than cisapride for the treatment of FD. Although FD is a chronic condition, efficacy was assessed over short periods in the studies used for the present meta-analysis. Long-term RCTs are needed to confirm the effect.     

Meta-analysis of the effects of prokinetic agents in patients with functional dyspepsia

BACKGROUND: Functional dyspepsia (FD) is often treated with prokinetic agents; however, the efficacy of prokinetic agents in patients with FD has been questioned recently. The aim of this study was to perform a meta-analysis of the effects of prokinetic agents in patients with FD. METHODS: Prokinetic agents, including metoclopramide, domperidone, trimebutine, cisapride, itopride and mosapride, used for treatment of FD between 1951 and 2005 were identified. Twenty-seven studies were selected. Difference in the probability of response between the interventional drug and placebo was used as a summary statistic for the treatment effect. Meta-regression analysis was used to detect sources of heterogeneity. RESULTS: In total, 1844 subjects were assigned to an experimental arm, and 1591 subjects were assigned to a placebo arm. Publication bias was ruled out by funnel plot and statistical testing (P = 0.975). In the overall analysis, the summary statistic was 0.295 (95% confidence interval: 0.208-0.382, P < 0.001), indicating that the interventional drug has 30% excess probability of producing a response compared with placebo. The most significant source of heterogeneity was the year of publication (P < 0.001). CONCLUSION: The data clearly indicate that prokinetic agents are significantly more effective than placebo in the treatment of FD. Although FD is a chronic condition, efficacy was assessed over short periods. Long-term randomized controlled trials are needed to confirm the effect.     

Chinese patent medicine for functional dyspepsia effects: A protocol for systematic review and Bayesian network meta-analysis

Background:In recent years, many clinical studies have suggested that various Chinese patent medicines have the potential to treat functional dyspepsia (FD). This study aims to conduct a systematic review and Bayesian network meta-analysis to evaluate the effectiveness of different Chinese patent medicines for FD.Methods:A comprehensive retrieval method will be executed in the following databases: PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBM), VIP Database, and Wanfang Database. Clinical randomized controlled trials (RCTs) of 9 Chinese patent medicines for FD are searched, and the retrieval time is from inception to October 2021. Three reviewers will screen the RCTs that meet the inclusion criteria and extract the data independently. The outcomes include total clinical efficiency, cure rate, recurrence rate, symptom score, and adverse events. Cochrane risk-of-bias tool will be carried to assess RCTs quality. The “gemtc” package and “rjags” package in R software will be used to manage data within the Bayesian framework.Results:The results can provide relatively objective evidence to evaluate the effectiveness of these 9 Chinese patent medicines in treating FD, which may help clinicians to develop a more effective and safer treatment plan.Conclusion:This study aims to provide new options for Chinese patent medicine treatment of FD in terms of its efficacy and safety.     

A meta-analysis of randomized controlled trials of a traditional Chinese medicine prescription,modified RunChang-Tang,in treating functional constipation

Background:Modified Runchang-Tang (MRCT), a Chinese herbal medicine, is widely used to treat functional constipation (FC), which is a common digestive system disease. However, its efficacy has not been evaluated systematically and objectively. Thus, a meta-analysis was conducted to assess the efficacy and safety of MRCT for treating functional constipation.Methods:We searched for relevant publications from Embase, Medline, The Cochrane Library, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chinese Scientific Journals Database, and Wanfang Data for relevant literature. The timeframe of retrieval was set from the founding date of each database to July 15, 2020.Result:A total of 26 randomized controlled trials with 2103 individuals were included in this meta-analysis. All trials were conducted in mainland China and were written in Chinese. The results showed that MRCT monotherapy provided better symptom relief in FC patients compared to prokinetic agent monotherapy (odds ratio, [OR] = 4.06), osmotic laxatives (OR = 4.39) and stimulant laxatives (OR = 2.99). Additionally, there were no obvious adverse effects in MRCT group compared with control group.Conclusion:MRCT treatment is an efficient and safe treatment for FC. However, considering the limitations of this study, further well-designed randomized controlled trials are required to validate this conclusion.     

Reversal of gastric electrical dysrhythmias by cisapride in children with functional dyspepsia report of three cases

Summary Three children (ages 5, 7.6, and 8 years), with recurrent unexplained upper abdominal symptoms such as vomiting, epigastric pain, anorexia, early satiety and without structural or mucosal abnormalities of gastrointestinal tract, underwent electrogastrography (EGG)—recording of gastric electrical activity using cutaneous electrodes positioned on the epigastric region and connected to a recording polygraph. Frequency of EGG signals was analyzed by fast Fourier transform. Significant changes of fasting and fed gastric myoelectrical activity (tachygastria, bradygastria, flatline pattern) were recorded in the three patients; furthermore, gastric emptying (GE) of a solid-liquid mixed meal, measured by ultrasonography, was significantly prolonged in them. A follow-up study was carried out after an eight-week course with oral cisapride: in all patients symptoms improved, GE time normalized, and EGG analysis showed normal electrical rhythm. It is suggested that gastric dysrhythmias can play a pathogenetic role in patients with functional gastrointestinal symptoms and that symptomatic improvement is accompanied by normalization of gastric electrical rhythm.     

Sulpiride improves functional dyspepsia: A double-blind controlled study

A 4-week placebo-controlled trial was performed to study the efficacy of sulpiride, a hypothalamic non-sedative neuroleptic and dopamine antagonist, in the treatment of 100 patients with functional dyspepsia, defined as dyspeptic symptoms despite normal endoscopy and cholecystography. Two patients on sulpiride were withdrawn because of sleepiness; no other undue side effects were recorded. At the end of 4 weeks, significantly (P < 0.02) more patients on sulpiride had improvement of nausea and belching (78%, 54% respectively) than patients on placebo (45%, 17% respectively). Pain and vomiting disappeared in approximately 50% and 70% of patients, respectively. In the overall assessment, 72% and 39% of the patients on sulpiride and placebo respectively had satisfactory improvement or became symptom-free (P < 0.001). Response to treatment was not related to personal and environmental factors. It was concluded that sulpiride was effective in improving symptoms of dyspepsia, particularly nausea and belching.     

Yu ping feng san for pediatric allergic rhinitis: A systematic review and meta-analysis of randomized controlled trials

Background:The potential treatment effects and safety of Yu ping feng san (YPFS) for pediatric allergic rhinitis (PAR) patients have yet to be studied systematically.Objectives:To assess the effects and safety of YPFS for treat pediatric patients, allergic rhinitis.Methods:We systematically searched PubMed, EMBASE (Excerpta Medical Database), Cochrane library, Chinese Cochrane Centre''s Controlled Trials Register platform, Wanfang Chinese Digital Periodical and Conference Database, China National Knowledge Infrastructure Database, and VIP Chinese Science, from inception dates to November 1, 2019. Randomized controlled trials (RCTs) were included. The risk of bias in the trials was assessed in accordance with the Cochrane Handbook, version 5.1.0. RevMan 5.3 software was used to perform a meta-analysis. Grading of Recommendations Assessment, Development and Evaluation methodology was applied to evaluate the evidence quality for each outcome. The quality of evidence for each outcome measurement was low for 4 outcomes and very low for 5 outcomes.Results:A total of 10 RCTs involving 1069 participants (3–15 years old) fulfilled the inclusion criteria. After exclusion, 8 RCTs were pooled for efficacy assessment. The overall efficacy evaluation result did not show benefit for the experimental group (relative risk 0.32, CI 95% 0.24–0.45; P = .98;) Investigation of variation of serum IgA, immunoglobulin E, IgG in three studies in 2 groups returned no statistical significance. YPFS gave relatively better safety (relative risk 0.29, CI 95% 0.14–0.58; P = .0005; Fig. S8 and lower recurrence rates than did Western medical therapy.Conclusions:Current evidence cannot support the routine use of YPFS for treatment of PAR. This may be due to poor-quality study-design limitations of the included YPFS studies. Our data showed that the use of YPFS for PAR is relatively safe compared to Western medical therapy, but a conclusion could not be drawn because only 5 studies were analyzed. Every study suffered from some methodological limitation. Therefore, further large, rigorously-designed studies are necessary to determine conclusively the utility of YPFS in PAR.     

Efficacy of Helicobacter pylori eradication therapy for treatment of functional dyspepsia: A protocol for systematic review and meta-analysis

Objective:The effect of Helicobacter pylori (H pylori) eradication therapy in functional dyspepsia (FD) patients was inconsistent in previously published randomized controlled trials. Therefore, we performed a comprehensive protocol for systematic review and meta-analysis in order to assess whether H pylori eradication therapy benefits patients with FD.Methods:In this systematic review and meta-analysis, we will search Web of Science, Embase, PubMed, Wanfang Data, Medline, Science Direct, Cochrane Library through April, 2021. The protocol was written following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Data extraction was performed independently and only randomized clinical trials were included in this study. The risk of bias assessment was performed using the tool recommended in the Cochrane Handbook for Systematic Reviews of Interventions. All calculations were carried out with Stata 11.0 (The Cochrane Collaboration, Oxford, United Kingdom).Results:We hypothesized that H pylori eradication therapy compared to no eradication therapy has a statistically significant benefit for symptom relief and can also reduce the development of peptic ulcer disease.Conclusion:This study expects to provide credible and scientific evidence for the efficacy of H pylori eradication therapy for patients with FD.OSF registration number:10.17605/OSF.IO/4EHRB     

Therapeutic effect of Chinese herbal medicines for post-stroke depression: A meta-analysis of randomized controlled trials

Background:Whether the addition of Chinese herbal medicine (CHM) in routine western medicines for post-stroke depression yields additional therapeutic effects still remains to be controversial. This study aimed to assess the efficacy and safety of combination of CHM with routine western medicines versus routine western medicines alone in patients with post-stroke depression (PSD).Methods:Electronic databases such as PubMed, EmBase, Cochrane library, and China National Knowledge Infrastructure were systematically searched from inception till October 2019. Studies designed as randomized controlled trials (RCTs) and that investigated the therapeutic effects of CHM plus routine western medicines (CHM group) versus routine western medicines alone (control group) in PSD patients were eligible. The relative risk (RR) and weighted mean difference (WMD) with 95% confidence interval (CI) were used to assess the categories and continuous data using random-effects model. Software STATA was applied to perform statistical analysis (Version 10.0; StataCorp, TX,).Results:A total of 18 RCTs involving a total of 1,367 PSD patients were selected for final analysis. The effective rate in CHM group was significantly higher than that in control group (RR: 1.18; 95%CI: 1.12–1.24; P < .001). Moreover, patients in CHM group showed association with lower Hamilton Depression Rating Scale (WMD: -3.17; 95%CI: -4.12 to -2.22; P < .001) and Scandinavian Stroke Scale (WMD: -3.84; 95%CI: -5.73 to -1.96; P < .001) than those in control group. Furthermore, patients in CHM were associated with high level of Barthel Index than those in control group (WMD: 11.06; 95%CI: 4.01 to 18.10; P = .002). Finally, patients in CHM group had lower risk of gastrointestinal (RR: 0.49; 95%CI: 0.31–0.77; P = .002) and neurological (RR: 0.50; 95%CI: 0.33–0.75; P = .001) adverse events than those in control group.Conclusions:The study findings revealed that addition of CHM to routine therapies could improve the therapeutic effects and reduce gastrointestinal or neurological adverse events.     

Comparative efficacy and acceptability of psychotropic drugs for functional dyspepsia in adults: A systematic review and network meta-analysis

Psychotropic drugs are frequently used for functional dyspepsia (FD); however, the efficacy of these drugs for treating FD remains controversial. We aimed to comprehensively compare the relative efficacies of different psychotropic drugs for FD in adults.To conduct this study, we searched the PubMed, Embase, and Cochrane Library databases on March 10, 2019, and conducted a frequentist network meta-analysis on the search results. The primary outcome was treatment efficacy estimated by the proportion of patients who achieved a certain percentage decrease in symptoms or who dropped below the threshold of the global FD symptom scores. The secondary outcome was acceptability, defined as all-cause discontinuation. Odds ratios (ORs) were reported with 95% confidence intervals (CIs).We deemed 10 trials to be eligible for analysis, and these trials included 970 participants and 10 psychotropic drugs. Flupentixol + melitracen (F + M) (OR, 10.00; 95% CI, 1.59 to 62.73), tandospirone (3.24, 1.38 to 7.60), imipramine (2.21, 1.02 to 4.79), and amitriptyline (1.71, 1.06 to 3.09) were significantly superior to placebo. According to the surface under the cumulative ranking curve, the most effective treatment was F + M (89.0%), whereas the least effective was R137696 (13.6%). In terms of acceptability, escitalopram (0.32, 0.11 to 0.92) was ranked as the worst drug (12.6%), followed by imipramine and sertraline.The present network meta-analysis suggests that F + M, tandospirone, imipramine, and amitriptyline are more effective than placebo as treatment for FD. Our results indicate that among the ten psychotropic drugs included, F + M is likely to be the most effective drug for alleviating dyspepsia symptoms.     

The effectiveness of acupoint herbal patching for functional dyspepsia: A protocol for systematic review and meta-analysis

Background:Functional dyspepsia (FD) has gradually developed into a multiple disease of the digestive system that most patients may be accompanied by mental and emotional disorders, such as insomnia, anxiety, and depression. Acupoint herbal patching (AHP) is usually used as an alternative therapy for patients with FD. This study aimed to design a systematic review and meta-analysis to explore the effects of AHP on FD.Methods:We will search the Cochrane Central Register of Controlled Trials, the Web of Science, PubMed, Embase, the Chinese Biomedical Literature Database, the Chinese Scientific Journal Database, the Wan-Fang Database, and the China National Knowledge Infrastructure for randomized controlled trials of FD treated by AHP from inception to June 30, 2021. The primary outcome measures contain clinical effective rate, the symptom score of FD, and secondary outcome measures consist of quality of life, incidence of adverse events, and recurrence rate. We will use RevMan V.5.3 software to analyze data. Two reviewers will evaluate the risk of bias and the quality of the studies by the Cochrane Collaboration risk of bias tool and the Grading of Recommendations Assessment, Development, and Evaluation approach, separately.Results:This systematic review protocol will analyze the effectiveness, quality of life, improvement of the symptom, and safety of AHP therapy for FD.Conclusion:The findings of this systematic review will provide evidence to evaluate the effectiveness and safety of AHP for FD.     

柴胡疏肝散加味联合黛力新治疗功能性消化不良疗效观察

[目的] 评价柴胡疏肝散加味联合黛力新治疗肝郁气滞型功能性消化不良(FD)的疗效,为中医的疏肝解郁剂与西医的抗抑郁药联合治疗FD提供临床依据。[方法] 114 例经确诊的肝郁气滞型 FD患者随机分为 3 组,治疗组45例服用柴胡疏肝散加味煎剂200 ml,2次/d,加黛力新1片,1次/d; 对照Ⅰ组39例服用柴胡疏肝散加味煎剂200 ml,2次/d;对照Ⅱ组30例服法莫替丁20 mg,2次/d,联合多潘立酮10 mg,3次/d。疗程均为4周。观察症状改善以及疗效情况,并做对比分析。[结果] 4 周后的治疗有效率:治疗组93.3%,对照Ⅰ组71.8%,对照Ⅱ组73.3%。三组比较,治疗组与对照组差异有统计学意义(P<0.01);对照Ⅰ组与对照Ⅱ组之间差异无统计学意义(P>0.05)。[结论] 柴胡疏肝散加味联合黛力新治疗肝郁气滞型FD的疗效优于单用柴胡疏肝散及法莫替丁、多潘立酮。     

功能性消化不良中医证型与胃电图的关系探讨

临床上笔者根据功能性消化不良所具有的证候特征,分为三型:即脾胃虚弱型、肝气犯胃型及肝郁胃热型。其中脾胃虚弱型与肝气犯胃型类似于运动障碍型,而肝郁胃热型类似于溃疡样型。本文对120例功能性消化不良中医证型与胃电图之间的关系进行分析,发现脾胃虚弱型组胃电幅值比正常组及肝郁胃热型组低,肝气犯胃型组胃电幅值则呈不规则变化,肝郁胃热型组胃电幅值比正常人组高(P<0.05)。胃电波幅在一定程度上反映了中医脾、胃、肝的病理生理变化。胃电图对功能性消化不良的中医证型提供了一定的诊断依据。     

功能性消化不良的中医治疗概况

功能性消化不良(functional dyspepsia,FD)是常见的功能性胃肠病之一,临床表现包括上腹疼痛、早饱、餐后不适、上腹烧灼感等。目前FD的诊断主要以功能性胃肠病罗马Ⅳ标准为依据,分为餐后不适综合征(postprandial discomfort syndrome,PDS),上腹痛综合征(epigastric pain syndrome,EPS)以及二者的重叠3个亚型[1]。有研究显示,全球FD的发病率为10%~30%[2]。     

The efficacy of cognitive behavior stress management on functional dyspepsia: A protocol for systematic review and meta-analysis

Background:Functional dyspepsia and digestive disorders are common, debilitating and costly. Little information is available about the role of stress management in terms of cognitive-behavioral treatment of dyspepsia. We performed a protocol for systematic review and meta-analysis to evaluate the effectiveness of cognitive behavior stress management for the treatment of functional dyspepsia.Methods:A comprehensive search of several databases from 1966 to March 2022 will be conducted. The databases include Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. The primary outcome for this study was the rate of successful treatment (presence of no more than mild pain or discomfort after treatment). The secondary outcomes were improvement of dyspepsia at short-term (<1 year) and long-term (≥1 year) follow up, improvement in quality of life, and development of treatment-related adverse events. The risk of bias in each included study will be assessed utilizing the Cochrane Collaboration''s risk of bias tool. The Review Manager 5.3 (Cochrane Collaboration, Oxford, UK) will be used to analyze the data.Results:We will synthesize the current studies to evaluate the effectiveness and safety of cognitive behavior stress management on functional dyspepsia.Conclusion:The result of this review will provide more reliable references to help clinicians make decisions when dealing with functional dyspepsia.     

中药治疗功能性消化不良的概况

功能性消化不良(functional dyspepsia,FD)是一种常见的功能性胃肠疾病,临床症状有上腹痛、上腹胀、早饱、嗳气、食欲不振、恶心、呕吐等,但其临床表现不能用器质性、系统性或代谢性疾病等来解释,罗马Ⅳ标准[1]按其临床表现分为餐后不适综合征和上腹痛综合征2大类。西方国家流行病学调查发现,有20%~40%的普通人有FD症状,国内也同样有20%~45%的人出现FD症状,消化科门诊中FD患者占总量的20%~40%[2]。