Influence of patient-clinician relationship style on acupuncture outcomes in functional dyspepsia: A multi-site randomized controlled trial in Korea.

INTRODUCTION: Research suggests that a warm and empathic "patient-centered" patient-clinician relationship produces better clinical outcomes when compared with a more neutral "disease-centered" relationship. Acupuncturists performed both styles of therapy for patients with functional dyspepsia in Korea. METHODS: The present randomized controlled trial assigned patients (n = 73) to identical acupuncture treatment with either patient-centered augmented care or disease-centered limited care. The Korean version of the Nepean Dyspepsia Index (NDI-K) was the primary outcome measure. Secondary outcome measures included Consultation And Relational Empathy (CARE) scale. RESULTS: Both groups showed improvement in NDI-K. Patient-centered augmented acupuncture produced less effective symptom improvement compared to disease-centered limited acupuncture (NDI-K sum score and frequency; P = 0.008 and P = 0.037 respectively). CARE scores were higher for the augmented versus limited group (P = 0.001), supporting the fidelity of the experimentally controlled patient/clinician relationship. There were no significant differences between the groups in any of other secondary outcomes. CONCLUSION: Patients demonstrated greater improvement following acupuncture conducted with a more neutral, "disease-centered" style of relationship. This result is counter to similar research conducted in Western countries and suggests that cultural factors can significantly shape optimum styles of acupuncture therapy. PRACTICE IMPLICATIONS: Clinicians should consider cultural differences when applying acupuncture therapy.

Herbal medicine, Banxia-xiexin tang, for functional dyspepsia: a systematic review and meta-analysis.

Background: The demand for complementary and alternative medicine for the management of functional dyspepsia (FD) is increasing due to the insufficient efficacy of conventional treatment options. In Asia, the Chinese herbal medicine formula Banxia-xiexin tang (BXT) has been used to treat FD. Methods: We searched 11 digital medical databases on 1 September 2021. Randomized controlled trials (RCTs) that investigated the efficacy of BXT or combination therapy (BXT plus Western medicines) for FD were selected. The outcome parameters were total clinical efficacy rate (TCE), motilin level, symptom checklist-90-revised (SCL-90-R), and visual analog scale (VAS) for dyspepsia and adverse events. Cochrane risk of bias tool 2.0 (RoB 2) was used for the quality assessment of included studies. Results: The meta-analysis comprised 57 RCTs with 5,525 participants. BXT was more efficacious, with a higher TCE than Western medicine. Combination therapy (BXT plus Western medicine) also resulted in a higher TCE than Western medicine. Combination therapy improved motilin levels and psychological symptoms to a greater extent than Western medicine, evidenced by a higher SCL-90-R score. However, no significant difference in VAS scores was observed between the BXT and placebo groups. BXT and combination therapy were associated with fewer adverse events than Western medicine or placebo. Conclusion: Our findings suggest that BXT and its combination therapy may be an effective and safe alternative treatment for FD. More RCTs with better methodologies are required to strengthen this evidence. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019123285], identifier [CRD42019123285].

An Overview of Systematic Reviews of Herbal Medicine for Irritable Bowel Syndrome.

Background: Irritable bowel syndrome (IBS) is a common disorder with abdominal pain and bowel habits changes. Herbal medicines (HMs) are frequently used in the treatment of IBS. Therefore, several systematic reviews (SRs) have been conducted to assess the efficacy and safety of HM in IBS patients. This study aimed to investigate the methodology and quality of evidence of SRs, and to describe the current state of research and evidence for the treatment of IBS with HM. Methods: SRs published up to January 2022 were searched using six electronic databases. SRs and/or meta-analyses on the use of HMs for IBS were included. The effects of placebo, conventional medicine (CM), and probiotics were compared with those of HMs. Two investigators independently extracted the data and assessed methodological quality using the Measure Tool to Assessment System Reviews 2 (AMSTAR 2). Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was used to evaluate the quality of evidence for each main finding. Results: Eighteen SRs were included in this overview. Among them, eight SRs reported only specific subtypes of IBS: six SRs reported patients with diarrhea-predominant IBS, and two SRs reported patients with constipation-predominant IBS. In terms of total efficacy, HM was more effective than placebo, CM, or probiotics. HM showed a more significant effect than CM in relieving independent IBS symptom score (abdominal pain score, diarrhea score, abdominal distension score, stool frequency score, etc.) and recurrence rate. The rate of adverse events was significantly lower with HM compared to CM, and no serious adverse events were reported with HM treatment. According to AMSTAR 2, the methodological quality of the included SRs was extremely low. Furthermore, the quality of evidence for total efficacy was considered low or very low according to the GRADE tool. Conclusion: HM can be considered as an effective and safe treatment for IBS. However, the methodological quality of the included SRs and the quality of evidence was generally low. Therefore, well-designed randomized controlled trials are needed in the future so that a high-quality SR can be used to better assess the safety and efficacy of HM in the treatment of IBS. Systematic Review Registration: https://osf.io/nt6wz, identifier 10.17605/OSF.IO/NT6WZ.

Gwakhyangjeonggi-san for irritable bowel syndrome: A protocol for systematic review and meta-analysis.

BACKGROUND: Irritable bowel syndrome (IBS) is a chronic functional bowel disorder characterized by abdominal pain or discomfort, stool irregularities, and bloating. Owing to its atypical symptoms and various mechanisms, there is no standard treatment for IBS. Gwakhyangjeonggi-san (GJS), a traditional Korean herbal medicine, has been used to treat lower intestinal abnormalities in Asia. We will systematically review randomized controlled trials (RCTs) to evaluate the efficacy and safety of GJS as a complementary treatment for IBS. METHODS AND ANALYSIS: Four English databases, namely, Medline (via PubMed), EMBASE, the Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database, will be searched for entries up to May, 2021. Additional databases will include 5 Korean databases, 1 Chinese database, and 1 Japanese database. RCTs and quasi-RCTs will be searched for to assess the effectiveness and safety of GJS. The primary outcome measure will be the overall efficacy rate, and the secondary outcome will include data such as global symptom scores, IBS Quality of Life measurements, and adverse events. Data analysis will be performed using Review Manager Version 5.3, and the risk of bias will be assessed using the Cochrane Collaboration's risk-of-bias tool. The quality of the results will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. CONCLUSION: This systematic review will provide evidence for the efficacy and safety of GJS for IBS. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/V93JN (https://osf.io/v93jn).

Herbal medicine for irritable bowel syndrome: An overview of systematic reviews protocol.

BACKGROUND: Irritable bowel syndrome (IBS) is a common disorder characterized by the recurrence of abdominal pain and changes in bowel habits. Owing to the limitations of conventional treatments, patients with IBS are often dissatisfied with the effect of treatment and have a poor quality of life. Herbal medicines (HMs) are frequently used for the treatment of IBS. This protocol was designed through an overview of systematic reviews (SRs), to investigate the safety and efficacy of HMs for treating IBS. METHODS: SRs published up to May 2021 will be searched from the following 6 electronic databases: Medline (via PubMed), EMBASE, Cochrane Database of Systematic Reviews, Allied and Complementary Medicine Database, Oriental Medicine Advanced Searching Integrated System, and China National Knowledge Infrastructure database. SRs and/or meta-analyses on the use of HMs for IBS will be included in this overview. The effects of a placebo, no treatment, usual care, or conventional treatment will be compared with those of HMs. Two investigators will independently extract the data and assess the methodological and evidence quality for each main finding. The total clinical effectiveness rate will be measured as the primary outcome. RESULTS: This overview is expected to provide data on the use of HMs for the treatment of IBS based on qualitative and quantitative syntheses of the included SR data. CONCLUSION: This overview will evaluate and propose the efficacy and safety of HMs for the treatment of IBS. REGISTRATION NUMBER: DOI 10.17605/OSF.IO/NT6WZ (https://osf.io/nt6wz).

The efficacy of the traditional Korean herbal medicine Tongsayobang for the treatment of irritable bowel syndrome: A protocol for a systematic review and meta-analysis.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional bowel disorder with symptoms of recurrent abdominal pain associated with a change in stool frequency or appearance that decreases patient quality of life. Conventional Western medicine has limited efficacy in treating IBS. Tongsayobang (TSYB) is a traditional Korean medicine that has been used to treat lower intestinal problems. This study provides a procedure for conducting a systematic review of the efficacy and safety of TSYB for IBS. METHODS AND ANALYSIS: The main electronic databases will be searched up to May 2021 for randomized controlled trials and quasi-randomized controlled trials evaluating the effect of TSYB or modified TSYB on patients with IBS. The primary outcome will be the overall efficacy rate. The secondary outcome will be data such as IBS-related quality of life, global symptom scores, and adverse events. This study will adopt the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and will involve a meta-analysis, if possible. The methodological quality of the included studies will be assessed using the Risk of Bias tool from the Cochrane Handbook, version 6.1.0. ETHICS AND DISSEMINATION: Ethical approval is not required because this study does not include any participants' personal information. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/M32BK (https://osf.io/m32bk).

Herbal medicine Banha-sasim-tang for the treatment of functional dyspepsia protocol for a systematic review of randomized controlled trials.

BACKGROUND: Functional dyspepsia (FD) has a high prevalence rate. The dyspeptic symptoms are not easily cured despite the availability of various conventional Western medical treatments. Banha-sasim-tang (BST) is a traditional herbal medicine that has long been used for treating FD. METHODS: The following databases will be searched from inception to January 2019: Medline via PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, Allied and Complementary Medicine Database, National Digital Science Library, Korean Medical Database (KoreaMed), Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, China National Knowledge Infrastructure Database, and Citation Information by Nii. Randomized controlled trials (RCTs) that used BST or herbs-added BST for treating FD will be included in the systematic review. Control groups in these RCTs will be the placebo, no-treatment, and conventional Western medicine groups. RCTs that compared BST and Western medicine combination therapy with the conventional Western medicine will also be included in the systematic review to investigate the synergistic effect of BST and Western medicine. Data extraction and evaluation of risk of bias will be performed by 2 independent investigators. The primary outcome will be the total clinical effective rate and secondary outcomes will include gastrointestinal symptom scale, visual analog scale, FD-related quality of life, electrogastrography, plasma motilin, dyspepsia-related symptom score, gastric emptying, and adverse events. RevMan version 5.3 will be used for data integration and analysis. RESULTS: This systematic review will provide a high-quality integration of current evidence of BST for treating FD from several aspects including total clinical effective rate, dyspepsia-related symptoms, quality of life, and adverse events. CONCLUSIONS: This systematic review will provide evidence of the effectiveness and safety of BST on FD. ETHICS AND DISSEMINATION: Identifying information of the participants will not be revealed; hence, this protocol does not need ethical approval. The systematic review will be published in a peer-reviewed journal and disseminated electronically. TRIAL REGISTRATION NUMBER: PROSPERO CRD42019123285.