Randomized Controlled Trials of Tianma Gouteng Decoction Combined with Nifedipine in the Treatment of Primary Hypertension: A Systematic Review and Meta-Analysis

Background. Hypertension is a primary risk factor for cardiovascular disease (CVD). Tianma Gouteng decoction (TGD), originating from Zabingzhengzhixinyi, has been used for thousands of years in China to treat hypertension, giddiness, and migraine. This updated meta-analysis aimed at assessing the efficacy and safety of TGD combined with nifedipine in the treatment of primary hypertension. Methods. Related research published prior to September 1, 2019, was found in electronic databases without language limitations. Fourteen studies were selected and analyzed for specified criteria, including the quality of the studies. All outcomes were recorded exhaustive. Data management and analysis were performed using RevMan 5.3 software. Results. A total of 1,537 (769 cases in the experimental group and 768 cases in the control group) patients were enrolled. The total efficacy rate was improved significantly for the combination of nifedipine with TGD compared to nifedipine treatment alone (I2 = 22%, RR = 1.17, and 95% CI: 1.12 to 1.22). Traditional Chinese medicine (TCM) symptoms of patients were obviously improved in the experimental group than in the control group (I2 = 44%, RR = 1.26, and 95% CI: 1.17 to 1.36). TGD combined with nifedipine shows a better effect than nifedipine in decreasing diastolic blood pressure (I2 = 95%, MD = −5.32, and 95% CI: −8.19 to −2.45) and systolic blood pressure (I2 = 98%, MD = −9.35, and 95% CI: −15.03 to −3.67) of patients. A sensitivity analysis was conducted for SBP and DBP by removing 2 studies and recalculated the combined estimate on remaining studies. The results of SBP showed a small heterogeneity (I2 = 17%, MD = −13.95, 95% CI: −14.86 to −13.05, and P<0.00001) when two studies (shicaihong 2017 and xiaoyugao 2017) were removed. And the results of DBP showed no heterogeneity (I2 = 0, MD = −8.36, 95% CI: −8.91 to −7.81, and P<0.00001) when two studies (panzhixiong 2019 and shicaihong 2017) were removed. Conclusion. The combination of TGD and nifedipine has a better effect in the treatment of hypertension, including blood pressure lowering and patients’ TCMs improving. However, our findings must be handled with care because of the small sample size and low quality of clinic trials cited. Other rigorous and large-scale RCTs are in need to confirm these results.

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Analysis of Clinical Efficacy of Traditional Chinese Medicine in Recovery Stage of Stroke: A Systematic Review and Meta-Analysis

Cardiovascular Therapeutics ◽

10.1155/2020/7172052 ◽

2020 ◽

Vol 2020 ◽

pp. 1-35

Author(s):

Xue Zhang ◽

Xiao-Fei Zhang ◽

Lin Wang ◽

Dong-Yan Guo ◽

Jia-Min Zhang ◽

...

Keyword(s):

Large Scale ◽

Clinical Symptoms ◽

Small Sample Size ◽

Meta Analysis ◽

Recovery Period ◽

Small Sample ◽

Comprehensive Treatment ◽

Neural Function ◽

Routine Treatment

Background. We provide an updated meta-analysis with detailed information on a combination of TCM and routine treatment. Methods. Retrieve appropriate articles with no language restrictions on keywords until 8 July 2019 in an electronic database. All trajectories are screened according to certain criteria. The quality of certified research was also evaluated. We made a detailed record of the results of the measurement. Meta-analysis was carried out by using the Revman 5.3 software. Results. Sixty-seven RCTs were included, and 6594 subjects were analyzed. Compared with routine treatment, the total effective rate (TER) of TCM combined with routine treatment was improved, and the recovery of stroke was also significantly accelerated. Regulation of blood lipids by notably shrinking the contents of TC, TG, and LDL and enhancing the levels of HDL. The levels of serum hs-CRP, WHV, and WLV decreased significantly, indicating that the expression of thrombomodulin was decreased after the comprehensive treatment of traditional Chinese medicines (TCMs). The combination of TCM treatment could enhance the protection of neural function by decreasing the NIHSS scoring while increasing the BI scoring. Paeoniae Radix Rubra, Angeticae Sinensis Radix, etc., can effectively improve the clinical symptoms of stroke convalescent patients and promote the recovery of neurological function. ACU of Baihui, Renzhong, etc., can improve the clinical rehabilitation effect of patients. However, our findings must be handled with care because of the small sample size and low quality of clinic trials cited. Other rigorous and large-scale RCTs are in need to confirm these results. Conclusion. A combination of TCM and routine treatment in the treatment of stroke could improve TER, and it is beneficial to the rehabilitation of patients in the recovery period of apoplexy. These effects can be mediated by a combination of several mechanisms. Nevertheless, due to the limitations of this study, these results should be handled with caution.

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Mesenchymal Stem Cell Therapy for Acetaminophen-Related Liver Injury: A Systematic Review and Meta-Analysis of Experimental Studies in Vivo

Current Stem Cell Research & Therapy ◽

10.2174/1574888x16666211007092055 ◽

2021 ◽

Vol 16 ◽

Author(s):

Li Wang ◽

Yiwen Zhang ◽

Jiajun Zhong ◽

Yuan Zhang ◽

Shuisheng Zhou ◽

...

Keyword(s):

Systematic Review ◽

Stem Cell ◽

Liver Injury ◽

Mesenchymal Stem Cell ◽

Small Sample Size ◽

Meta Analysis ◽

Experimental Studies ◽

Small Sample ◽

Control Group

Objective: The efficacy of mesenchymal stem cell (MSC) therapy in acetaminophen-induced liver injury has been investigated in animal experiments, but individual studies with a small sample size cannot be used to draw a clear conclusion. Therefore, we conducted a systematic review and meta-analysis of preclinical studies to explore the potential of using MSCs in acetaminophen-induced liver injury. Methods: Eight databases were searched for studies reporting the effects of MSCs on acetaminophen hepatoxicity. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were used. SYRCLE’s risk of bias tool for animal studies was applied to assess the methodological quality. A meta-analysis was performed by using RevMan 5.4 and STATA/SE 16.0 software. Results: Eleven studies involving 159 animals were included according to PRISMA statement guidelines. Significant associations were found for MSCs with the levels of alanine transaminase (ALT) (standardized mean difference (SMD) − 2.58, p < 0.0001), aspartate aminotransferase (AST) (SMD − 1.75, p = 0.001), glutathione (GSH) (SMD 3.7, p < 0.0001), superoxide dismutase (SOD) (SMD 1.86, p = 0.022), interleukin 10 (IL-10) (SMD 5.14, p = 0.0002) and tumor necrosis factor-α (TNF-α) (SMD − 4.48, p = 0.011) compared with those in the control group. The subgroup analysis showed that the tissue source of MSCs significantly affected the therapeutic efficacy (p < 0.05). Conclusion: Our meta-analysis results demonstrate that MSCs could be a potential treatment for acetaminophen-related liver injury.

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Acupuncture for Chronic Pain-Related Insomnia: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/5381028 ◽

2019 ◽

Vol 2019 ◽

pp. 1-10

Author(s):

Fushui Liu ◽

Jianyu You ◽

Qi Li ◽

Ting Fang ◽

Mei Chen ◽

...

Keyword(s):

Chronic Pain ◽

Sample Size ◽

Small Sample Size ◽

Meta Analysis ◽

Sham Acupuncture ◽

Small Sample ◽

Control Group ◽

Large Sample Size ◽

Cure Rate ◽

Significant Difference

Objectives. Acupuncture has been widely used to relieve chronic pain-related insomnia (CPRI). However, the efficacy of acupuncture for CPRI is uncertain. The purpose of this study was to evaluate the efficacy of acupuncture for CPRI. Methods. Seven electronic databases were searched from inception to December 2018. Randomized controlled trials (RCTs) were included if acupuncture was compared to sham acupuncture or conventional drug therapies for treating CPRI. Two reviewers screened each study and extracted data independently. Statistical analyses were conducted by RevMan 5.3 software. Results. A total of nine studies involving 944 patients were enrolled. The pooled analysis indicated that acupuncture treatment was significantly better than control group in improving effective rate (OR = 8.09, 95%CI = [4.75, 13.79], P < 0.00001) and cure rate (OR = 3.17, 95%CI = [2.35, 4.29], P < 0.00001), but subgroup analysis showed that there was no statistically significant difference between acupuncture and sham acupuncture in improving cure rate (OR =10.36, 95% CI [0.53, 201.45], P=0.12) based on one included study. In addition, meta-analysis demonstrated that acupuncture group was superior to control group in debasing PSQI score (MD = -2.65, 95%CI = [-4.00, -1.30], P = 0.0001) and VAS score (MD = -1.44, 95%CI = [-1.58, -1.29], P < 0.00001). And there was no significant difference in adverse events (OR =1.73, 95%CI = [0.92, 3.25], P =0.09) between the two groups. Conclusions. Acupuncture therapy is an effective and safe treatment for CPRI, and this treatment can be recommended for the management of patients with CPRI. Due to the low quality and small sample size of the included studies, more rigorously designed RCTs with high quality and large sample size are recommended in future.

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Experience of Using an App in HIV Patients Older Than 60 Years: Pilot Program (Preprint)

10.2196/preprints.9904 ◽

2018 ◽

Author(s):

Julián Olalla ◽

Jose María García de Lomas ◽

Efrén Márquez ◽

Francisco Jesús González ◽

Alfonso Del Arco ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Hiv Infection ◽

New Technologies ◽

Small Sample Size ◽

Mobile App ◽

Small Sample ◽

Control Group

BACKGROUND New technologies can promote knowledge of HIV infection among patients suffering from this disease. Older patients with HIV infection represent an increasingly large group that could benefit from the use of specific apps. OBJECTIVE The aim of the study was to observe the acceptability and use of a mobile app on HIV infection in patients at least 60 years old and offer them the possibility of anonymously establishing contact with their peers. METHODS A series of clinical and psychosocial parameters were studied in 30 HIV-infected patients of over 60 years. The patients must be at least 60 years old, with a follow-up in the outpatient clinic for at least 1 year and without pathologies that limit his or her life expectancy to less than a year. They must know how to read and write. To be part of the group assigned to the app, they had to have their own smartphone and confirm that they were connected to the internet from that device. Overall, 15 of them were randomized to use an app and 15 were in the control group. All tests were repeated after 6 months. RESULTS The median age of patients was 66.5 years. Among them, 29 patients had an undetectable viral load at baseline. The median number of comorbid diseases was 2. Overall, 11 of them lived with their partners and 19 lived alone. They spent an average of 5 hours a day sitting down, and 56% (17/30) of them referred high physical activity. They scored 4 out of 5 for general quality of life perception. Moreover, 80% (24/30) presented high adherence to their treatment, and the average number of concomitant medications was 5. In the 6-min walking test, they covered a distance of 400 meters, and 3 of them desaturated during the test. The 15 patients made frequent use of the app, with 2407 sessions and an average of 7 min and 56 seconds time of use with a total of 13,143 screen views. During the 6 months of the trial, 3 non-AIDS events took place. There were no significant modifications to body mass index, blood pressure measurements, lipid profile, or immuno-virology information data. There were no differences in the questionnaire scores for perception of quality of life, confessed physical activity, or antiretroviral treatment (ART) and non-ART treatment adherence. CONCLUSIONS Significant differences between studied parameters were not objectified in these patients, possibly because this trial has significant limitations, such as a small sample size and only a brief follow-up period. However, patients did use the app frequently, making this a possible intervention to be proposed in future subsequent studies.

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Effect of Patient-Centered Self-Management Program on Blood Pressure, Renal Function Control, and the Quality of Life of Patients With Hypertensive Nephropathy: A Longitudinal Randomized Controlled Trial

Biological Research For Nursing ◽

10.1177/10998004211061877 ◽

2021 ◽

pp. 109980042110618

Author(s):

Mei-Chen Lee ◽

Shu-Fang Vivienne Wu ◽

Kuo-Cheng Lu ◽

Wen-Hug Wang ◽

Yen-Yen Chen ◽

...

Keyword(s):

Quality Of Life ◽

Blood Pressure ◽

Controlled Trial ◽

Management Program ◽

Self Management ◽

Control Group ◽

Patient Centered ◽

Hypertensive Nephropathy ◽

Experimental Group

This longitudinal study with a randomized controlled trial evaluated the long-term effectiveness of the patient-centered self-management intervention program on the control of blood pressure and renal function, as well as the quality of life of patients with hypertensive nephropathy. The control group ( n = 38) received usual care while the experimental group ( n = 38) participated in a patient-centered self-management program. After the pre-test, the intervention was performed with the experimental group once a week for a total of 4 weeks. Then, the post-test was performed 1, 3, and 6 months later. A questionnaire was used to collect the demographic data and disease characteristics, laboratory data, and quality of life scale. This study tracked three time points (i.e., 1, 3, and 6 months) after the intervention and found that the experimental group achieved significant results in controlling systolic blood pressure ( p < 0.001), diastolic blood pressure ( p = 0.007), and eGFR ( p = 0.013). Significant results were achieved in the overall quality of life ( p < 0.001) and the quality of life in the physical (PHC; p < 0.001) and mental health components (MHC; p < 0.001). Furthermore, the effects in the experimental group lasted for as long as 6 months and were better than those in the control group. Moreover, this program can provide nursing staff with a reference different from traditional health education methods.

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Effect of vitamins C and E supplementation onHelicobacter pylorieradication: a meta-analysis

British Journal Of Nutrition ◽

10.1017/s0007114511003813 ◽

2011 ◽

Vol 106 (11) ◽

pp. 1632-1637 ◽

Cited By ~ 11

Author(s):

Guogang Li ◽

Lan Li ◽

Chaohui Yu ◽

Li Chen

Keyword(s):

Methodological Quality ◽

Eradication Rate ◽

Small Sample Size ◽

Meta Analysis ◽

Small Sample ◽

Cochrane Library ◽

Significant Difference ◽

H Pylori ◽

Randomised Controlled

Vitamins C and E can act as potent antioxidants to reduce the damage caused by reactive oxygen species in gastric mucosa. Whether vitamin supplements forHelicobacter pylorieradication regimen could improve the rate of eradication remains uncertain. Therefore, we performed a meta-analysis to evaluate the efficacy of vitamins C and E supplementation for the eradication ofH. pylori. Searches were conducted in the databases PubMed, EMBASE and Cochrane Library. Randomised controlled trials (RCT) that fulfilled the inclusion criteria and addressed the clinical questions of this analysis were further assessed. Of the six RCT included, five had a low methodological quality. Of the six RCT, three compared the efficacy of the eradication regimenv.eradication regimen plus vitamins C and E. The result of the meta-analysis showed a non-significant difference in the eradication rate ofH. pyloribetween the two groups (risk ratio (RR) 0·93,P = 0·76). Another three RCT compared the eradication regimenv.eradication regimen plus vitamin C only, and there too there was no significant difference in the eradication rate (RR 0·83,P = 0·32). In conclusion, vitamins C and/or E supplements to theH. pylorieradication regimen could not improve the eradication rate. However, currently available data do not draw a definitive conclusion about the effectiveness of antioxidant vitamins onH. pylorieradication, owing to the small sample size and low-to-moderate methodological quality.

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Long-Term Effects of Mind-Body Exercises on the Physical Fitness and Quality of Life of Individuals With Substance Use Disorder—A Randomized Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2020.528373 ◽

2020 ◽

Vol 11 ◽

Author(s):

Dong Zhu ◽

Mei Jiang ◽

Ding Xu ◽

Wolfgang I. Schöllhorn

Keyword(s):

Quality Of Life ◽

Blood Pressure ◽

Physical Fitness ◽

Vital Capacity ◽

Repeated Measure ◽

Control Group ◽

Healthy Population ◽

Intervention Protocol ◽

Experimental Group

Background: Mind-body exercises (MBE) are sequences of low to medium-intensity activities that benefit healthy performers physically and mentally. In contrast to the unmodified application of traditional tai chi, qi gong, or yoga in the healthy population, MBEs are typically tailored for individuals with substance abuse disorder (SUD). Despite numerous applications in practice, the detailed effects of tailor-made MBEs for SUD are unclear.Objectives: This study aimed to analyze and compare changes in the physical fitness and quality of life of individuals with SUD that underwent conventional or tailor-made MBEs.Methods: A total of 100 subjects obtained from the Shanghai Mandatory Detoxification and Rehabilitation Center with SUD were randomly assigned into two groups. The subjects in the experimental group (n = 50) practiced tailored MBE for 60 min a day, five times a week, for 3 months. The subjects (n = 50) in the control group were treated with conventional rehabilitation exercises with the same intervention protocol. The outcomes of fitness and quality of life for drug addiction were measured at the beginning and after 3 and 6 months by a questionnaire (QOL-DA). A two-way repeated measure analysis of variance was applied to compare the difference of treatments in the two groups.Results: Statistically significant differences for the experimental group were found in systolic (p < 0.01, η2 = 0.124) and diastolic blood pressure (p < 0.01, η2 = 0.097), pulse (p < 0.01, η2 = 0.086), vital capacity (p < 0.05, η2 = 0.036), flexibility (p < 0.01, η2 = 0.143), and aerobic endurance (p < 0.01, η2 = 0.165). Results of the QOL-DA showed statistically significant differences between the experimental and control groups in total score (p < 0.01, η2 = 0.158) with greater effects on the former.Conclusions: This study provided evidence that tailored MBE could lead to remarkable effects with regard to blood pressure, vital capacity, flexibility, and aerobic endurance in comparison with conventional rehabilitation methods.Clinical Trial Registration: ChiCTR-IPR-14005343.

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Use of GnRH Analogues in the Reduction of Submucous Fibroid for Surgical Hysteroscopy: A Systematic Review and Meta-Analysis

Revista Brasileira de Ginecologia e Obstetrícia / RBGO Gynecology and Obstetrics ◽

10.1055/s-0040-1712446 ◽

2020 ◽

Vol 42 (10) ◽

pp. 649-658

Author(s):

Thayane Delazari Corrêa ◽

Isabela Maciel Caetano ◽

Pedro Henrique Tannure Saraiva ◽

Maurício Bechara Noviello ◽

Admário Silva Santos Filho

Keyword(s):

Clinical Trials ◽

Small Sample Size ◽

Meta Analysis ◽

Original Data ◽

Small Sample ◽

Control Group ◽

Gnrh Analogue ◽

Gnrh Analogues ◽

Hysteroscopic Myomectomy ◽

Submucous Fibroid

Abstract Objective Gonadotropin-releasing hormone analogues (GnRH-a) have been used preoperatively before hysteroscopic myomectomy to decrease the size and vascularization of the myomas, but evidence to support this practice is weak. Our objective was to analyze the use of GnRH-a in the reduction of submucous fibroid as a facilitator for surgical hysteroscopy from published clinical trials. Data sources Studies from electronic databases (Pubmed, Scielo, EMBASE, Scopus, PROSPERO), published between 1980 and December 2018. The keywords used were fibroid, GnRH analogue, submucous, histeroscopy, histeroscopic resection and their correspondents in Portuguese. Study selection The inclusion criteria were controlled trials that evaluated the GnRH-a treatment before hysteroscopic resection of submucous myomas. Four clinical trials were included in the meta-analysis. Data collection Two review authors extracted the data without modification of the original data, using the agreed form. We resolved discrepancies through discussion or, if required, we consulted a third person. Data synthesis The present meta-analysis included a total of 213 women and showed no statistically significant differences in the use of GnRH-a compared with the control group for complete resection of submucous myoma (relative risk [RR]: 0.94; 95% confidence interval [CI]: 0.80–1.11); operative time (mean difference [MD]: - 3.81; 95%CI : - 3.81–2.13); fluid absorption (MD: - 65.90; 95%CI: - 9.75–2.13); or complications (RR 0.92; 95%CI: 0.18–4.82). Conclusion The present review did not support the routine preoperative use of GnRH-a prior to hysteroscopic myomectomy. However, it is not possible to determine its inferiority when compared with the other methods due to the heterogeneity of existing studies and the small sample size.

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Yoga for Treating Rheumatoid Arthritis: A Systematic Review and Meta-Analysis

Frontiers in Medicine ◽

10.3389/fmed.2020.586665 ◽

2020 ◽

Vol 7 ◽

Author(s):

Xiangling Ye ◽

Zehua Chen ◽

Zhen Shen ◽

Guocai Chen ◽

Xuemeng Xu

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Physical Function ◽

Grip Strength ◽

Inflammatory Cytokines ◽

Large Scale ◽

Small Sample Size ◽

Meta Analysis ◽

Small Sample ◽

Cochrane Library

Purpose: Rheumatoid arthritis (RA) is a pervasive inflammatory autoimmune disease that seriously impairs human health and requires more effective non-pharmacologic treatment approaches. This study aims to systematically review and evaluate the efficacy of yoga for patients with RA.Methods: Medline (through PubMed), Cochrane Library, EMBASE (through SCOPUS), and Web of Science database were screened through for articles published until 20 July 2020. Randomized controlled trials (RCTs) of yoga in patients with RA were included. Outcomes measures were pain, physical function, disease activity, inflammatory cytokines, and grip strength. For each outcome, standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated.Result: Ten trials including 840 patients with RA aged 30–70 years were identified, with 86% female participants. Meta-analysis revealed a statistically significant overall effect in favor of yoga for physical function (HAQ-DI) (5 RCTs; SMD = −0.32, 95% CI −0.58 to −0.05, I2 = 15%, P = 0.02), disease activity (DAS-28) (4 RCTs; SMD = −0.38, 95% CI −0.71 to −0.06, I2 = 41%, P = 0.02) and grip strength (2 RCTs; SMD = 1.30, 95% CI 0.47–2.13, I2 = 63%, P = 0.002). No effects were found for pain, tender joints, swollen joints count or inflammatory cytokines (i.e., CRP, ESR, IL-6, and TNF-α).Summary: The findings of this meta-analysis indicate that yoga may be beneficial for improving physical function, disease activity, and grip strength in patients with RA. However, the balance of evidence showed that yoga had no significant effect in improving pain, tender joints, swollen joints count, and inflammatory cytokines in patients suffering from RA. Considering methodological limitations, small sample size, and low-quality, we draw a very cautious conclusion in the results of the estimate of the effect. High-quality and large-scale RCTs are urgently needed in the future, and the real result may be substantially different.

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Acupuncture for the Treatment of Gastro-Oesophageal Reflux Disease: A Systematic Review and Meta-Analysis

Acupuncture in Medicine ◽

10.1136/acupmed-2016-011205 ◽

2017 ◽

Vol 35 (5) ◽

pp. 316-323 ◽

Cited By ~ 11

Author(s):

Jiajie Zhu ◽

Yu Guo ◽

Shan Liu ◽

Xiaolan Su ◽

Yijie Li ◽

...

Keyword(s):

Systematic Review ◽

Reflux Disease ◽

Small Sample Size ◽

Meta Analysis ◽

Small Sample ◽

Oesophageal Reflux ◽

Symptom Improvement ◽

Significant Heterogeneity ◽

Oesophageal Reflux Disease

Background Gastro-oesophageal reflux disease (GORD) is one of the most common diseases presenting to gastroenterology clinics. Acupuncture is widely used as a complementary and alternative treatment for patients with GORD. Objective To explore the effectiveness of acupuncture for the treatment of GORD. Methods Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected. Data extraction and quality evaluation were performed by two authors independently and RevMan 5.2.0 was used to analyse data. Results A total of 12 trials involving 1235 patients were included. Meta-analyses demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone (relative risk (RR) 1.17, 95% CI 1.09 to 1.26; p=0.03; six studies) with no significant heterogeneity (I2=0%, p=0.41). Recurrence rates of those receiving MA/EA alone were lower than those receiving WM (RR 0.42,95% CI 0.29 to 0.61; p<0.001; three studies) with low heterogeneity (I2=7%, p=0.34), while global symptom improvement (six studies) and symptom scores (three studies) were similar (both p>0.05). Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD. Conclusion This meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions. Trial registration number PROSPERO Systematic review registration no. CRD42016041916.

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