-
Digestive Diseases (Basel, Switzerland) 2023This systematic review summarizes published data on Menthacarin, the proprietary combination of peppermint oil and caraway oil, in the treatment of functional... (Meta-Analysis)
Meta-Analysis
Menthacarin, a Proprietary Peppermint Oil and Caraway Oil Combination, Improves Multiple Complaints in Patients with Functional Gastrointestinal Disorders: A Systematic Review and Meta-Analysis.
INTRODUCTION
This systematic review summarizes published data on Menthacarin, the proprietary combination of peppermint oil and caraway oil, in the treatment of functional gastrointestinal disorders. Efficacy was assessed by meta-analysis of placebo-controlled trials.
METHODS
We searched PubMed, the Cochrane Library, and the manufacturer's information system for clinical studies investigating the safety and efficacy of Menthacarin. Efficacy analyses included change from baseline of epigastric pain and general improvement of the patients' condition.
RESULTS
Five randomized trials involving 580 patients were found, demonstrating significant effects of Menthacarin on symptoms of functional dyspepsia (FD) compared to placebo or similar effects compared to a reference drug. Seven other studies reported favorable results on therapeutic application in FD patients with concomitant Helicobacter pylori infection, in irritable bowel syndrome (IBS), and on tolerability in FD patients from 12 years of age. Three trials in FD with 249 patients were eligible for meta-analysis. Results demonstrate a significant reduction in pain intensity (standardized mean difference: 0.80; 95% confidence interval (CI): 0.39-1.21) and in item 2 of the Clinical Global Impression Scale (risk ratio: 2.65; 95% CI: 1.81-3.87) for Menthacarin.
CONCLUSIONS
Menthacarin was shown to be effective and safe for the treatment of FD and represents a promising option for symptoms of IBS.
Topics: Humans; Irritable Bowel Syndrome; Helicobacter Infections; Helicobacter pylori; Dyspepsia
PubMed: 36502789
DOI: 10.1159/000528553 -
PloS One 2022Trastuzumab is a valuable therapy option for women with ERBB2(HER2)+ breast cancer tumours, often used in combination with chemotherapy and alongside other therapies. It... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Trastuzumab is a valuable therapy option for women with ERBB2(HER2)+ breast cancer tumours, often used in combination with chemotherapy and alongside other therapies. It is known to have adverse effects, but these have proved difficult to separate from the effects of other concurrent therapies patients are usually taking. This study aims to assess the adverse effects specifically attributable to trastuzumab, and whether they vary by patient subgroup or concurrent therapies.
METHODS
As registered on PROSPERO (CRD42019146541), we used previous systematic reviews as well as the clinicaltrials.gov registry to identify randomised controlled trials in breast cancer which compared treatment regimes with and without trastuzumab. Neoadjuvant, adjuvant and metastatic settings were examined. Data was extracted from those which had, as of July 2022, reported adverse events. Risk of bias was assessed using ROB2. Primary outcomes were adverse events of any type or severity (excluding death). A standard random-effects meta-analysis was performed for each outcome independently. In order to ascertain whether adverse effects differed by individual factors such as age or tumour characteristics, or by use of trastuzumab concurrently with hormone therapy, we examined individual-level patient data for one large trial, HERA.
RESULTS
79 relevant trials were found, of which 20 contained comparable arms of trastuzumab-containing therapy and corresponding matched therapy without trastuzumab. This allowed a comparison of 8669 patients receiving trastuzumab versus 9556 receiving no trastuzumab, which gave a list of 25 statistically and clinically significant adverse effects related to trastuzumab alone: unspecified pain, asthenia, nasopharyngitis, skin disorders (mainly rash), dyspepsia, paraesthesia, infections (often respiratory), increased lacrimation, diarrhoea, myalgia, oedema (limb/peripheral), fever, nose bleeds, cardiac events, insomnia, cough, back pain, dyspnoea, chills, dizziness or vertigo, hypertension, congestive heart failure, increased levels of aspartate aminotransferase, gastrointestinal issues and dehydration. Analysis of individual patient-level data from 5102 patients suggested that nausea is slightly more likely for women taking trastuzumab who are ER+ /also taking hormone therapy than for those who are ER-/not taking hormone therapy; no other potential treatment-subgroup interactions were detected. We found no evidence for significantly increased rates of neutropenia, anaemia or lymphopenia in patients on trastuzumab-containing regimes compared to those on comparable regimes without trastuzumab.
CONCLUSIONS
This meta-analysis should allow clinicians and patients to better identify and quantify the potential adverse effects of adding trastuzumab to their treatment regime for breast cancer, and hence inform their decision-making. However, limitations include serious risk of bias due to heterogeneity in reporting of the outcomes and the open-label nature of the trials.
Topics: Humans; Female; Trastuzumab; Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions; Neutropenia; Hormones
PubMed: 36454979
DOI: 10.1371/journal.pone.0275321 -
Psychology, Health & Medicine Jun 2023This systematic review and meta-analysis examined the efficacy of psychotherapy on symptoms of functional dyspepsia, anxiety, depression and quality of life. We searched... (Meta-Analysis)
Meta-Analysis
This systematic review and meta-analysis examined the efficacy of psychotherapy on symptoms of functional dyspepsia, anxiety, depression and quality of life. We searched Medline, Embase, PsycINFO, Emcare, Ovid Nursing, CINAHL, Cochrane Library, Informit Health Collection and ClinicalTrials.gov on 2 July 2021. Randomised controlled trials that compared psychotherapy to non-psychotherapy interventions in adults with functional dyspepsia were included. Meta-analyses were conducted (using Hedges's g) under random effects models. Overall, 1,575 records were identified after duplicates were removed, with nine randomised controlled trials (n = 786) included. Preliminary meta-analyses showed that psychotherapy outperformed control conditions at post-test and follow-up on functional dyspepsia symptom severity and anxiety symptoms, but no differences emerged for depressive symptoms. The qualitative synthesis showed psychotherapy's promise in improving quality of life in functional dyspepsia. Psychotherapy might have a small to moderate effect on functional dyspepsia symptoms and anxiety at short- and long-term. However, conclusions are limited by the small number of trials with a high risk of bias.
Topics: Adult; Humans; Dyspepsia; Quality of Life; Psychotherapy; Anxiety Disorders; Anxiety; Depression
PubMed: 36325620
DOI: 10.1080/13548506.2022.2141278 -
Neurogastroenterology and Motility Feb 2023Pharmacological trials in functional dyspepsia (FD) are associated with high placebo response rates. We aimed to identify the magnitude and contributing factors to the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pharmacological trials in functional dyspepsia (FD) are associated with high placebo response rates. We aimed to identify the magnitude and contributing factors to the placebo response.
METHODS
We conducted a systematic review and meta-analysis including randomized controlled trials (RCTs) with a dichotomous outcome in adult patients with FD that compared an active pharmacotherapeutic treatment with placebo. Our main outcome was identification of the magnitude of the pooled placebo response rate for the following endpoints: symptom responder, symptom-free responder, adequate relief responder, and combined endpoint responder (i.e., the primary endpoint of each specific trial regarding treatment response). Several putative moderators (i.e., patient, disease, and trial characteristics) were examined.
KEY RESULTS
We included 26 RCTs in our analysis. The pooled placebo response rate was 39.6% (95% CI 30.1-50.0) using the symptom responder definition, 20.5% (12.8-31.0) using the symptom-free responder definition, 38.5% (33.8-43.6) using the adequate relief responder definition, and 35.5% (31.6-39.7) using the combined endpoint responder definition. A lower overall baseline symptom score was significantly associated with a higher placebo response rate. No other moderators were found to significantly impact the placebo response rate. Due to the lack of data, no analyses could be performed according to individual FD subtypes or symptoms.
CONCLUSIONS AND INFERENCES
The pooled placebo response rate in pharmacological trials in FD is about 39%, depending on which responder definitions is used. Future trials should consider applying an entry criterion based on minimal level of symptom severity to decrease the placebo response. We also suggest separate reporting of core FD symptoms pending more concrete harmonization efforts in FD trials.
Topics: Adult; Humans; Dyspepsia; Placebo Effect; Treatment Outcome
PubMed: 36168188
DOI: 10.1111/nmo.14474 -
Zhongguo Zhong Yao Za Zhi = Zhongguo... Sep 2022This study aims to investigate the efficacy, safety, and cost-effecctiveness of Qizhi Weitong Granules in the treatment of functional dyspepsia. Specifically, two... (Meta-Analysis)
Meta-Analysis
This study aims to investigate the efficacy, safety, and cost-effecctiveness of Qizhi Weitong Granules in the treatment of functional dyspepsia. Specifically, two commonly used clinical protocols for the treatment of functional dyspepsia were selected: Qizhi Weitong Granules+Mosapride vs Mosapride alone(control). Meta-analysis of previous clinical studies was performed to examine the efficacy and safety, and pharmacoeconomic evaluation was carried out according to the results of the Meta-analysis. The cost-effectiveness analysis was carried out to elucidated the incremental cost-effectiveness ratio(ICER), and the sensitivity was analyzed with tornado dia-gram and Monte Carlo simulation. The willingness-to-pay threshold of patients for functional dyspepsia was investigated and compared with the ICER to evaluate whether Qizhi Weitong Granules was cost-effective. The result showed that the effective rate of Qizhi Weitong Granules combined with Mosapride in the treatment of functional dyspepsia was 95.49%, which was higher than that of Mosapride alone(73.30%)(OR=8.52, 95%CI[4.36, 16.64])(P<0.000 1). The two groups showed no significant difference in safety. The price of Qizhi Weitong Granules+Mosapride was higher than that of Mosapride alone. The ICER was 640.29 CNY, 1 506.67 CNY lower than the willingness-to-pay threshold. The sensitivity analysis showed that the analysis results were relatively stable. Thus, Qizhi Weitong Granules+Mosapride is safe, effective, and economical in the treatment of functional dyspepsia, which should be further promoted in clinical settings.
Topics: Benzamides; Cost-Benefit Analysis; Dyspepsia; Economics, Pharmaceutical; Gastrointestinal Agents; Humans; Morpholines; Treatment Outcome
PubMed: 36164921
DOI: 10.19540/j.cnki.cjcmm.20220529.502 -
Zhongguo Zhong Yao Za Zhi = Zhongguo... Sep 2022This study evaluated and compared the efficacy, safety and economy of four Chinese patent medicines(CPMs) in the treatment of functional dyspepsia(FD) using the method... (Meta-Analysis)
Meta-Analysis
This study evaluated and compared the efficacy, safety and economy of four Chinese patent medicines(CPMs) in the treatment of functional dyspepsia(FD) using the method of rapid health technology assessment. It aims to provide decision-makers with rapid decision-making information. The eight Chinese and English databases were comprehensively and systematically searched for the relevant clinical research. Studies were screened and evaluated. A total of 110 studies were identified, including 95 randomized controlled trials(RCTs), 7 controlled clinical trials(CCTs), 7 systematic review/Meta-analysis and 1 economic evaluation, among which 28 were Dalitong Granules, 49 were Zhizhu Kuanzhong Capsules, 3 were Biling Weitong Granules and 30 were Qizhi Weitong Granules(Tablets/Capsules). The quality of the included literature was generally low. The efficacy of four CPMs alone or combined with western medicine in the treatment of FD is different. Dalitong Granules was used to treat motility disorder in FD. Zhizhu Kuanzhong Capsules and Qizhi Weitong Granules(Tablets/Capsules) can treat FD patients with anxiety and depression. Qizhi Weitong Granules(Tablets/Capsules) were mainly used in FD for perimenopausal patients. There were no serious adverse reactions in the clinical study of four CPMs in the treatment of FD. Dalitong Granules has better effects than mosapride in the treatment of FD, but the cost is slightly higher. The cost-effectiveness ratio of Zhizhu Kuanzhong Capsules in the treatment of FD patients with anxiety and depression was lower than that of Domperidone. In terms of average daily price, Qizhi Weitong Tablets has the highest price(27.00 yuan per day), Qizhi Weitong Granules has the lowest price(5.04 yuan per day), Biling Weitong Granules has a relatively high price(15.53 yuan per day), followed by Dalitong Granules(13.03 yuan per day). The evidence of Dalitong Granules covered the efficacy, safety and economy, which is relatively complete compared with the other three drugs. It has effective potential in the treatment of motility disorder in FD. Further research in this field in the future is needed.
Topics: Capsules; China; Chlorobenzenes; Domperidone; Drugs, Chinese Herbal; Dyspepsia; Humans; Nonprescription Drugs; Stomach; Sulfides; Tablets; Technology Assessment, Biomedical
PubMed: 36164885
DOI: 10.19540/j.cnki.cjcmm.20220520.501 -
Therapeutic Advances in Gastroenterology 2022Prolonged symptoms after COVID-19 are an important concern due to the large numbers affected by the pandemic.
BACKGROUND
Prolonged symptoms after COVID-19 are an important concern due to the large numbers affected by the pandemic.
OBJECTIVES
To ascertain the frequency of gastrointestinal (GI) manifestations as part of long GI COVID.
DESIGN
A systematic review and meta-analysis of studies reporting GI manifestations in long COVID was performed.
DATA SOURCES AND METHODS
Electronic databases (Medline, Scopus, Embase, Cochrane Central Register of Controlled Trials, and Web of Science) were searched till 21 December 2021 to identify studies reporting frequency of GI symptoms in long COVID. We included studies reporting overall GI manifestations or individual GI symptoms as part of long COVID. We excluded pediatric studies and those not providing relevant information. We calculated the pooled frequency of various symptoms in all patients with COVID-19 and also in those with long COVID using the inverse variance approach. All analysis was done using R version 4.1.1 using packages 'meta' and 'metafor'.
RESULTS
A total of 50 studies were included. The frequencies of GI symptoms were 0.12 [95% confidence interval (CI), 0.06-0.22, = 99%] and 0.22 (95% CI, 0.10-0.41, = 97%) in patients with COVID-19 and those with long COVID, respectively. The frequencies of abdominal pain, nausea/vomiting, loss of appetite, and loss of taste were 0.14 (95% CI, 0.04-0.38, = 96%), 0.06 (95% CI, 0.03-0.11, = 98%), 0.20 (95% CI, 0.08-0.43, = 98%), and 0.17 (95% CI, 0.10-0.27, = 95%), respectively, after COVID-19. The frequencies of diarrhea, dyspepsia, and irritable bowel syndrome were 0.10 (95% CI, 0.04-0.23, = 98%), 0.20 (95% CI, 0.06-0.50, = 97%), and 0.17 (95% CI, 0.06-0.37, = 96%), respectively.
CONCLUSION
GI symptoms in patients were seen in 12% after COVID-19 and 22% as part of long COVID. Loss of appetite, dyspepsia, irritable bowel syndrome, loss of taste, and abdominal pain were the five most common GI symptoms of long COVID. Significant heterogeneity and small number of studies for some of the analyses are limitations of the systematic review.
PubMed: 36004306
DOI: 10.1177/17562848221118403 -
Phytomedicine : International Journal... Nov 2022A supplementary chapter on the diagnostic patterns of Traditional Medicine, including Traditional Chinese Medicine (TCM), was introduced into the latest edition of the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
A supplementary chapter on the diagnostic patterns of Traditional Medicine, including Traditional Chinese Medicine (TCM), was introduced into the latest edition of the International Classification of Diseases (ICD-11). However, evidence-based rules are yet to be developed for pattern differentiation in patients with specific conventional medicine diagnoses. Without such standardised rules, the level of diagnostic agreement amongst practitioners is unsatisfactory. This may reduce the reliability of practice and the generalisability of clinical research.
PURPOSE
Using cross-sectional study data from patients with functional dyspepsia, we reviewed and illustrated a quantitative approach that combines TCM expertise and computer algorithmic capacity, namely latent tree analysis (LTA), to establish score-based pattern differentiation rules.
REVIEW OF METHODS
LTA consists of six major steps: (i) the development of a TCM clinical feature questionnaire; (ii) statistical pattern discovery; (iii) statistical pattern interpretation; (iv) TCM diagnostic pattern identification; (v) TCM diagnostic pattern quantification; and (vi) TCM diagnostic pattern differentiation. Step (i) involves the development of a comprehensive questionnaire covering all essential TCM clinical features of the disease of interest via a systematic review. Step (ii) to (iv) required input from TCM experts, with the algorithmic capacity provided by Lantern, a dedicated software for TCM LTA.
MOTIVATIONAL EXAMPLE TO ILLUSTRATE THE METHODS
LTA is used to quantify the diagnostic importance of various clinical features in each TCM diagnostic pattern in terms of mutual information and cumulative information coverage. LTA is also capable of deriving score-based differentiation rules for each TCM diagnostic pattern, with each clinical feature being provided with a numerical score for its presence. Subsequently, a summative threshold is generated to allow pattern differentiation. If the total score of a patient exceeded the threshold, the patient was diagnosed with that particular TCM diagnostic pattern.
CONCLUSIONS
LTA is a quantitative approach to improving the inter-rater reliability of TCM diagnosis and addressing the current lack of objectivity in the ICD-11. Future research should focus on how diagnostic information should be coupled with effectiveness evidence derived from network meta-analysis. This will enable the development of an implementable diagnostics-to-treatment scheme for further evaluation. If successful, this scheme will transform TCM practice in an evidence-based manner, while preserving the validity of the model.
Topics: Cross-Sectional Studies; Diagnosis, Differential; Evidence-Based Medicine; Humans; Medicine, Chinese Traditional; Reproducibility of Results
PubMed: 35994848
DOI: 10.1016/j.phymed.2022.154392 -
Quality of Life Research : An... Mar 2023A systematic review of randomized controlled trials (RCTs) was conducted to assess the potential effect of therapeutic massage/Tuina on functional dyspepsia (FD)... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
A systematic review of randomized controlled trials (RCTs) was conducted to assess the potential effect of therapeutic massage/Tuina on functional dyspepsia (FD) patients.
METHOD
Twelve databases and three clinical trial registries were searched until December 2021, for RCTs that compared Tuina combined with or without conventional therapy versus conventional therapy in FD. We assessed the methodological quality of included trials by the Cochrane Risk of Bias tool, and graded the quality of the evidence. The data were presented as risk ratio (RR) or mean difference (MD) respectively with their 95% confidence interval (CI).
RESULTS
In total, 14 RCTs with 1128 FD participants were included. Compared with conventional therapy, Tuina showed significant beneficial effects on improving overall symptom (RR = 1.12, 95% CI 1.06 to 1.19, low certainty evidence), and early satiation (MD -0.44 scores, 95% CI -0.72 to -0.16, very low certainty evidence). Compared with conventional therapy, Tuina plus conventional therapy also significantly improved overall symptom (RR = 1.14, 95% CI 1.06-1.23, low certainty evidence), quality of life (MD 10.44 scores, 95% CI 7.65-13.23, low certainty evidence), and epigastric pain (MD -0.76 scores, 95% CI -1.11 to -0.41, low certainty evidence). No adverse events related to Tuina and cost-effectiveness were reported.
CONCLUSION
Low certainty evidence showed that Tuina significantly improved overall symptom of FD participants compared with conventional therapy. Low certainty evidence showed that Tuina plus conventional therapy obviously improved overall symptom and quality of life of FD participants compared with conventional therapy.
Topics: Humans; Dyspepsia; Quality of Life; Randomized Controlled Trials as Topic; Abdominal Pain; Massage
PubMed: 35976600
DOI: 10.1007/s11136-022-03228-6 -
Frontiers in Neuroscience 2022Functional dyspepsia (FD) is closely associated with gut-brain interaction disorder (DGBI), characterized by the interaction of gastrointestinal symptoms and central...
BACKGROUND AND AIMS
Functional dyspepsia (FD) is closely associated with gut-brain interaction disorder (DGBI), characterized by the interaction of gastrointestinal symptoms and central nervous system dysregulation. Chinese herbal medicine (CHM) has a good concurrent effect in the treatment of FD, especially for patients with concurrent psychological disorders. A meta-analysis was designed to evaluate the efficacy and safety of CHMs in the treatment of FD.
METHODS
The PubMed, Embase, Cochrane Library, Web of Science, Chinese Biological Medical Database (CBM), Wanfang Data, China National Knowledge Infrastructure (CNKI), and China Science and Technology Journal Database (VIP) were searched to collect randomized controlled trials of FD treated with CHM. The retrieval time limit is from the establishment of the database till 11 April 2022. Two researchers independently searched databases, screened documents, extracted data, and evaluated the risk of bias of included studies. RevMan 5.4 software was used for meta-analysis.
RESULTS
A total of 11 studies including 951 patients were included. The study was divided into two parts. The first part included 5 clinical trials, including 471 patients. The experimental group was treated only with CHM and the control group was only treated with placebo. The results of first part showed that the total effective rate of CHM in the treatment of FD was higher than that in the placebo group (84.5 vs. 49.4%) [relative risk (RR) = 1.76; 95% confidence interval (CI) (1.13, 2.75); = 0.01]. In addition, CHM treatment could reduce the total symptom score [standardized mean difference (SMD) = -10.05; 95% CI (-13.50, -6.59); = 5.70; < 0.0001] and depression score [SMD = -7.68; 95% CI (-14.43, -0.94); = 2.23; = 0.03]. The second part included 6 clinical trials, including 480 patients. The experimental group was only treated with CHM and the control group was treated with prokinetic agents combined with flupentixol melitracen (deanxit). The results of second part showed that the total effective rate of CHM in the treatment of FD was higher than that of the control group (92.6 vs. 78.8%) [RR = 1.17; 95% CI (1.09, 1.26), < 0.0001]. In addition, CHM treatment could reduce HAMA score [mean difference (MD) = -3.19; 95% CI (-3.79, -2.59); = 10.40; < 0.00001], HAMD score [MD = -4.32; 95% CI (-6.04, -2.61); = 4.94; < 0.00001], and gastric emptying rate [MD = 12.62; 95% CI (5.84, 19.40); = 3.65; = 0.0003]. The results of the two parts of the meta-analysis showed no serious adverse reactions, and there was no significant difference in the adverse reactions between the experimental group and the control group [MD = 1.14; 95% CI (0.53, 2.42); = 0.33; = 0.74]; [MD = 0.14; 95% CI (0.01, 2.67); = 1.30; = 0.19].
CONCLUSION
The current evidence shows that CHM treatment has great potential and safety in alleviating the symptoms of FD and improving the psychological disorders of anxiety and depression in patients with FD. Limited by the quantity and quality of the included studies and other biases, the above conclusions need more high-quality studies to be verified.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/, identifier [CRD42022311129].
PubMed: 35911981
DOI: 10.3389/fnins.2022.933290