scholarly journals Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yaping Wang ◽  
Bin Liu ◽  
Xiuqiong Fu ◽  
Tiejun Tong ◽  
Zhiling Yu

Abstract Background The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis. Methods Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias. Results A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported. Conclusion SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management. Trial registration Systematic review registration: [PROSPERO registration: CRD42019139136].

2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Yuhong Zhou ◽  
Shutang Han ◽  
Yamin He

Background. Tongxieyaofang (TXYF), a prescription originated from traditional Chinese medicine (TCM), has been widely used on treating Diarrhea Predominant Irritable Bowel Syndrome (IBS-D). The purpose of this meta-analysis was to investigate whether TXYF was effective and safe for IBS-D. Methods. We searched seven electronic databases including CENTRAL, MEDLINE, PubMed, CNKI, VIP, CBM, and Wanfang Data up to 26 July 2017. Randomized controlled trails (RCTs) were eligible, regardless of blinding. Risk of bias of included trials was evaluated according to the Cochrane Handbook. Results. The total number of participants analyzed in the meta-analysis was 3062, of which 1556 received TXYF, while 1506 received ordinary treatment. The primary outcome was clinical effective rate. Compared with conventional medication which included probiotics, pinaverium bromide, trimebutine, and Oryzanol, TXYF significantly improved the clinical effective rate (n=37, OR: 4.61; 95% CI: 3.67–5.78; P < 0.00001) and decreased the adverse events (n=10, OR: 0.26; 95% CI: 0.08–0.86; P = 0.03). There was not significant association with the score of abdominal pain, defecating frequency, fecal property, and total symptom. Conclusions. We suggested a moderate recommendation for TXYF on IBS-D, due to the fact that the risk of bias of the finally included trails was not high. Considering that all identified studies were not of high qualities and large samples, further rigorously designed and large scale RCTs were necessary to improve the applicability of our study results.


2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.


2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Xi-qian Yang ◽  
Ling Liu ◽  
Wen-yu Yang ◽  
Huan-huan Dong ◽  
Yi-ran Yang ◽  
...  

Background. The Traditional Chinese Medicine (TCM) Qi-supplementing therapy has been used widely for treating myasthenia gravis (MG) in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of Qi-supplementing therapy as an adjunctive therapy in MG patients. Methods. Seven electronic databases were searched through June 2016. Randomized controlled trials (RCTs) evaluating the add-on effect of Qi-supplementing therapy in MG patients were included. The outcome measures were the total effective rate, relapse rate, and adverse events. Results. Twenty-three RCTs involving 1,691 MG patients were included. The included studies were of low-to-moderate quality. Meta-analysis showed that Qi-supplementing therapy combined with Western medicine (WM) significantly improved the total response rate and reduced the relapse risk during 6–24 months of follow-up. Subgroup analysis showed that Qi-supplementing therapy only affected the total response rate within the first 6 months of treatment. Moreover, the rate of adverse events was lower with the addition of Qi-supplementing therapy to WM than with WM only. Conclusions. Short-term Qi-supplementing therapy combined with WM appears to be superior to WM for improving the total response rate and reducing the relapse rate. However, more high-quality RCTs are warranted owing to methodological flaws of previous trials.


2020 ◽  
Author(s):  
ZHIQIANG WANG ◽  
Ambrish Singh ◽  
Salman Hussain ◽  
Pablo Molina Garcia ◽  
Benny Samuel Eathakkattu Antony

Osteoarthritis (OA) is a common chronic joint disease with limited pharmacological management options. Boswellia extracts (BE) or formulations containing BE are generally considered as safe and offers a modest efficacy for the treatment of OA. Although previous systematic reviews have assessed the efficacy of BE in OA, these reviews had excluded trials assessing various formulations containing BE and excluded various combinations of BE. Hence, this study aims to systematically review the evidence from RCTs assessing the efficacy and safety of both BE and formulations containing BE for the treatment of OA. Biomedical databases such as PubMed, Embase, and Google Scholar will be searched to identify the RCTs of BE or formulations containing BE in patients with OA (hand, knee, hip, or any other OA). Cochrane risk of bias tool will be used to assess the quality of included studies. Review Manager 5 (Rev Man) and STATA Version 16 will be used to conduct the statistical analysis.


2020 ◽  
Author(s):  
Zhiqiang Wang ◽  
Ambrish Singh ◽  
Benny Antony

AbstractTurmeric extracts have been used as a remedy for treating arthritis in traditional medicine. Recent years have witnessed the rise of different extracts from turmeric and randomised clinical trials (RCTs) evaluating the efficacy and safety of these extracts for the treatment of knee osteoarthritis (OA). This planned systematic review and meta-analysis aims to assess the efficacy and safety of turmeric extracts for the treatment of knee OA. Biomedical databases such as PubMed, Scopus, and Embase will be searched for RCTs reporting safety and efficacy of turmeric extracts for the treatment of knee OA. Cochrane risk of bias tool will be used to assess the methodological quality of the included studies, and a meta-analysis will be performed to pool the effect estimates.


2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Zahra Anjoman Azari ◽  
Mojgan Mirghafourvand ◽  
Ciara Hughes ◽  
Shiva Havizari

Context: Constipation is a prevalent symptom of gastrointestinal disorders, which has an annoying impact on health and quality of life. On the other hand, reflexology is a popular type of complementary and alternative medicine in medical practices. Objectives: The present study aimed to assess the effect of foot reflexology on constipation symptoms. Methods: Nine databases were systematically searched to detect relevant Randomized Clinical Trials. The current used the Cochrane Risk of Bias tool to evaluate the methodological quality of the included articles. The primary outcome was the improvement of constipation symptoms. The Standardized Mean Difference (SMD) was measured, and random effects were reported instead of the fixed effects due to the high heterogeneity. Results: Out of the 693 articles retrieved from the databases and eight additional records identified through other sources, 496 titles, 48 abstracts, and 16 full-texts were reviewed, and 11 articles were included in this study, out of which nine articles entered the meta-analysis. The findings of the meta-analysis indicated that foot reflexology had a significant effect on the constipation score (SMD: -0.82; 95% CI: -1.47 to -0.17; P value = 0.0001; I2 = 93%) Conclusions: Foot reflexology can effectively improve constipation symptoms; however, clinical trials with better designs are recommended.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Chan-Young Kwon ◽  
Boram Lee ◽  
Sun-Yong Chung ◽  
Jong Woo Kim ◽  
Aesook Shin ◽  
...  

Abstract This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were comprehensively searched from their inception dates until July 2019. Only randomized controlled trials (RCTs) using SGYMT as a monotherapy or adjunctive therapy for PSD patients were included. Where appropriate data were available, meta-analysis was performed and presented as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). We assessed the quality of RCTs using the Cochrane risk of bias tool and the Jadad scale. The quality of evidence for each main outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Twenty-one RCTs with 1,644 participants were included. In the comparison between the SGYMT and antidepressants groups, the SGYMT group scored significantly lower on both the Hamilton Depression Scale (HAMD) (8 studies; MD −2.08, 95% CI −2.62 to −1.53, I2 = 34%) and the National Institutes of Health Stroke Scale (NIHSS) (2 studies; MD −0.84, 95% CI −1.40 to −0.29, I2 = 19%), and significantly higher on the Barthel index (3 studies; MD 4.30, 95% CI 2.04 to 6.57, I2 = 66%). Moreover, the SGYMT group was associated with significantly fewer adverse events (6 studies; RR 0.13, 95% CI 0.05 to 0.37, I2 = 0%) than the antidepressants group. In the subgroup analysis, SGYMT treatment consistently reduced HAMD scores within the first 8 weeks of treatment, but thereafter this difference between groups disappeared. Comparisons between SGYMT combined with antidepressants, and antidepressants alone, showed significantly lower scores in the combination group for both HAMD (7 studies; MD = −6.72, 95% CI = −11.42 to −2.01, I2 = 98%) and NIHSS scores (4 studies; MD −3.03, 95% CI −3.60 to −2.45, I2 = 87%). In the subgroup analysis, the reductions of HAMD scores in the SGYMT combined with antidepressants group were consistent within 4 weeks of treatment, but disappeared thereafter. The quality of RCTs was generally low and the quality of evidence evaluated by the GRADE approach was rated mostly “Very low” to “Moderate.” The main causes of low quality ratings were the high risk of bias and imprecision of results. Current evidence suggests that SGYMT, used either as a monotherapy or an adjuvant therapy to antidepressants, might have potential benefits for the treatment of PSD, including short-term reduction of depressive symptoms, improvement of neurological symptoms, and few adverse events. However, since the methodological quality of the included studies was generally low and there were no large placebo trials to ensure reliability, it remains difficult to draw definitive conclusions on this topic. Further well-designed RCTs addressing these shortcomings are needed to confirm our results.


2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Jing Shan ◽  
Wen Cheng ◽  
Dong-xia Zhai ◽  
Dan-ying Zhang ◽  
Rui-pin Yao ◽  
...  

Objectives. To evaluate the efficacy and safety of Bushen Huoxue prescription (BSHXP) for endometriosis. Methods. A meta-analysis was performed, and studies were searched from the seven databases from the date of database establishment to April 30, 2017. Randomized controlled trials (RCTs) that explored the efficacy and safety of BSHXP for patients with endometriosis were included. Two assessors independently reviewed each trial. The Cochrane Risk of Bias assessment tool was used for quality assessment. Results. In the 13 included studies, the total effectiveness rates of BSHXP were higher than those of Western medicine (RR, 1.55; 95% CI, 1.03–2.32; P=0.04), but the dysmenorrhea alleviation rates of the two treatments did not significantly differ (RR, 1.28; 95% CI, 0.70–2.34; P=0.42). The pregnancy rates of BSHXP were also higher than those of hormone therapy (RR, 1.99; 95% CI, 1.17–3.39; P=0.01). However, whether BSHXP is more effective than Western medicine in diminishing endometriotic cyst remains unknown. Conclusions. Our study provides evidence that BSHXP is effective and safe for endometriosis, but this evidence is inconclusive because of the low methodological quality of the included RCTs. Our findings suggest that BSHXP is an alternative drug for endometriosis, but it should be further examined in future clinical research.


BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024752
Author(s):  
Lingxiao Chen ◽  
Paulo H Ferreira ◽  
Paula R Beckenkamp ◽  
Manuela L Ferreira

IntroductionSurgical and invasive procedures are widely used in adults with degenerative lumbar spinal stenosis when conservative treatments fail. However, little is known about the comparative efficacy and safety of these interventions. To address this, we will perform a network meta-analysis (NMA) and systematic review to compare the efficacy and safety of surgical and invasive procedures for adults with degenerative lumbar spinal stenosis.Methods and analysisWe will include randomised controlled trials assessing surgical and invasive treatments for adults with degenerative lumbar spinal stenosis. We will search AMED, CINAHL, EMBASE, the Cochrane Library and MEDLINE. Only English studies will be included and no restriction will be set for publication status. For efficacy, our primary outcome will be physical function. Secondary outcomes will include pain intensity, health-related quality of life, global impression of recovery, work absenteeism and mobility. For safety, our primary outcome will be all-cause mortality. Secondary outcomes will include adverse events (number of events or number of people with an event) and treatment withdrawal due to adverse effect. Two reviewers will independently select studies, extract data and assess the risk of bias (Revised Cochrane risk-of-bias tool for randomized trials) of included studies. The quality of the evidence will be evaluated through the Grading of Recommendations Assessment, Development and Evaluation framework. Random-effects NMA will be performed to combine all the evidence under the frequentist framework and the ranking results will be presented through the surface under the cumulative ranking curve and mean rank. All analyses will be performed in Stata and R.Ethics and disseminationNo ethical approval is required. The research will be published in a peer-reviewed journal.PROSPERO registration numberCRD42018094180.


2021 ◽  
Author(s):  
Sihan Peng ◽  
Ziyan Xie ◽  
Xiyu Zhang ◽  
Chunguang Xie ◽  
Jian Kang ◽  
...  

Abstract Background: The COVID-19 pandemic caused by the SARS-CoV-2 virus is a major health crisis that is affecting countries across the world. Patients infected with COVID-19 are often associated with mental health disorders, such as anxiety, depression, and sleep disorders. As a non-drug therapy applied in clinics for many years, music intervention is safe, effective, inexpensive, and devoid of side effects. Yet, there is a distinct lack of evidence to support the use of this technique. In this study, we aim to collect and evaluate the clinical evidence, in order to provide a basis for the efficacy and safety of music intervention in the treatment of COVID-19 patients with mental disorders.Methods: We plan to search a range of electronic databases from inception to the May 2021, including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Literature Database, and Chinese Science and Technology Periodical Database (VIP). All randomized controlled trials featuring music intervention to treat mental disorders such as anxiety, depression, or sleep disorders, for patients with COVID-19, will be included. The primary outcomes will be quantitative scores for anxiety, depression, and sleep disorder. The secondary outcomes will be quality of life and the safety profile of music intervention, including adverse events. Two reviewers will carry out the selection of studies, data extraction independently. The Cochrane risk of bias tool will be used to evaluate the risk of bias for the studies. We will use Review Manager V.5.3 software for data analysis. Subgroup analyses and sensitivity analyses are planned to assess the heterogeneity and reliability.Discussion: This is an up-to-date systematic review and meta-analysis of the efficacy and safety of music intervention on mental disorders (anxiety, depression, or sleep disorder) in COVID-19 patients, in order to provide clinicians, researchers, and policy makers, with powerful reference guidelines to facilitate treatment and improve the quality of life in COVID-19 patients with mental disorders.Systematic review registration: OSF 10.17605/OSF.IO/9RCX5


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