Acupuncture on GB34 for immediate analgesia and regulating pain-related anxiety for patients with biliary colic: a protocol of randomized controlled trial.

BACKGROUND: Biliary colic (BC) is a frequent hepatobiliary disorder encountered in emergency departments. Acupuncture may be effective as an alternative and complementary medicine for BC. Nonetheless, rigorous trials investigating its efficacy are lacking. Therefore, the aim of this study protocol is to determine whether acupuncture provides immediate relief of pain and associated symptoms in BC patients. METHOD: Eighty-six participants who aged from 18 to 60 years with BC will be recruited in the First People's Hospital of Longquanyi District, Chengdu (West China Longquan Hospital Sichuan University). All participants will be allocated into two treatment groups including acupuncture group and sham acupuncture group using a 1:1 ratio. Each group will only receive a single 30-min needle treatment while waiting for their test results after completing the routine examination for BC. The primary outcome of the study is to assess the change in pain intensity after the 30-min acupuncture treatment. The secondary outcomes of the study include the change in pain intensity at various time points, the degree of gastrointestinal symptoms at different time points, the level of anxiety experienced during pain episodes at different time points, the score of Pain Anxiety Symptoms Scale-20 (PASS-20), the score of Fear of Pain Questionnaire-III (FPQ-III), and the score of Pain Catastrophizing Scale (PCS), among others. DISCUSSION: The results of this research will provide substantial evidence regarding the efficacy of acupuncture in alleviating symptoms associated with BC. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2300070661. Registered on 19 April 2023.

Efficacy and safety of acupuncture for postpartum hypogalactia: protocol for a systematic review and meta-analysis.

INTRODUCTION: Breast milk is recognised as the best natural food for neonates, but many women experience postpartum hypogalactia (PH). Randomised trials have found that acupuncture exert therapeutic effect on women with PH. However, systematic reviews on the efficacy and safety of acupuncture are still lacking; therefore, this systematic review aims to evaluate the efficacy and safety of acupuncture for PH. METHODS AND ANALYSIS: Six English databases (PubMed, Cochrane Library, EMBASE, EBSCO, Scopus, and Web of Science) and four Chinese databases (China National Knowledge Infrastructure, Wan-Fang, Chinese Biomedical Literature and Chinese Scientific Journal) will be systematically searched from their establishment to 1 September 2022. Randomised controlled trials of the efficacy of acupuncture for PH will be reviewed. The study selection, data extraction and research quality evaluation will be conducted independently by two reviewers. The primary outcome is the change in serum prolactin level from baseline to the end of treatment. Secondary results include milk secretion volume, total effectiveness rate, degree of mammary fullness, rate of exclusive breast feeding, and adverse events. A meta-analysis will be performed using RevMan V.5.4 statistical software. Otherwise, a descriptive analysis will be conducted. The risk of bias will be assessed using the revised Cochrane risk-of-bias tool. ETHICS AND DISSEMINATION: This systematic review protocol does not require ethical approval because it does not include private information/data of the participants. This article will be published in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42022351849.

Modulation effects of different treatments on periaqueductal gray resting state functional connectivity in knee osteoarthritis knee pain patients.

BACKGROUND: The analgesic effect of acupuncture is widely recognized, but the mechanical characteristics of acupuncture for pain relief, compared to non-steroidal anti-inflammatory (NSAIDs) and placebo medication, remain unknown. AIMS: To compare the modulation effects of acupuncture treatment with NSAIDs and placebo medication on descending pain modulation system (DPMS) in knee osteoarthritis (KOA) patients. METHODS: This study recruited 180 KOA patients with knee pain and 41 healthy controls (HCs). Individuals with KOA knee pain were divided randomly into groups of verum acupuncture (VA), sham acupuncture (SA), celecoxib (SC), placebo (PB), and waiting list (WT), with 36 patients in each group. VA and SA groups included ten sessions of puncturing acupoints or puncturing non-acupoints acupuncture treatment for two successive weeks. Celecoxib capsules were continuously given orally to patients in the SC group at a dosage of 200 mg daily for 2 weeks. In the PB group, patients received a placebo capsule once a day for 2 weeks at the same dosage as celecoxib capsules. In the WL group, patients did not receive any treatment. Patients underwent a resting-state BOLD-fMRI scan pre- and post-receiving the therapy, whereas HCs only underwent a baseline scan. Seed (ventrolateral periaqueductal gray, vlPAG, a key node in DPMS) based resting-state functional connectivity (rs-FC) was applied in the data analysis. RESULTS: All groups demonstrated improved knee pain scores relative to the initial state. There was no statistical difference between the VA and SA groups in all clinical outcomes, and vlPAG rs-FC alterations. KOA knee pain individuals reported higher vlPAG rs-FC in the bilateral thalamus than HCs. KOA knee pain patients in the acupuncture group (verum + sham, AG) exhibited increased vlPAG rs-FC with the right dorsolateral prefrontal cortex (DLPFC) and the right angular, which is associated with knee pain improvement. In contrast with the SC and PB group, the AG exhibited significantly increased vlPAG rs-FC with the right DLPFC and angular. Contrary to the WT group, the AG showed greater vlPAG rs-FC with the right DLPFC and precuneus. CONCLUSIONS: Acupuncture treatment, celecoxib, and placebo medication have different modulation effects on vlPAG DPMS in KOA knee pain patients. Acupuncture could modulate vlPAG rs-FC with brain regions associated with cognitive control, attention, and reappraisal for knee pain relief in KOA patients, compared with celecoxib and placebo medication.

Modulation of cerebral cortex activity by acupuncture in patients with prolonged disorder of consciousness: An fNIRS study.

Background and objective: Acupuncture is a promising non-pharmacological therapy for patients with prolonged disorder of consciousness (PDOC); however, its underlying mechanism remains uncertain. This study aimed to reveal the modulatory effects of acupuncture on the cerebral cortex activity among patients with PDOC. Materials and methods: Twenty-eight PDOC patients were randomly assigned to the treatment (n = 14) or control (n = 14) group. The treatment group received one session of acupuncture, while the control group received one session of sham acupuncture. All patients underwent evaluation of the functional connectivity and activation response of the dorsolateral prefrontal cortex (DLPFC), primary motor cortex (M1), and primary somatosensory cortex (S1) via functional near-infrared spectroscopy. We further explored the potential correlation of the consciousness level and activation response/functional connectivity with acupuncture. Results: Compared to the control group, a single session of acupuncture significantly tended to enhance resting-state functional connectivity (rsFC) in DLPFC-M1, DLPFC-M1, and S1-S1. And the activation level of the DLPFC (both sides) in the acupuncture group is significantly higher than those in sham acupuncture group. However, no significant correlation was found between the consciousness level and activation response/functional connectivity. Conclusion: One session of acupuncture has a significant modulation of rsFC and activation in the DLPFC, M1, and S1 with PDOC patients. Acupuncture-evoked effect may have some functional significance in PDOC patients. This is an important step toward exploring the acupuncture effects on PDOC patients.

Acupuncture for emotional disorders in patients with inflammatory bowel disease: a systematic review protocol.

INTRODUCTION: Emotional disorders are often observed in inflammatory bowel disease (IBD). IBD with emotional disorders leads to poor quality of life. This systematic review aims to assess the effectiveness of acupuncture in patients with IBD with emotional disorders. METHODS AND ANALYSIS: Nine electronic databases, including Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Allied and Complementary Medicine Database, Cumulative Index to Nursing & Allied Health Literature, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, VIP Database and Wanfang Database, will be searched from inception to October 2021 without language restriction. The grey literature containing conference proceedings, as well as systematic reviews listed in the reference of definite publications, will also be retrieved. Randomised controlled trials either in English or Chinese reporting acupuncture therapy for IBD with emotional disorders will be included. The primary outcome is changes of emotional functioning outcomes. The Colitis Activity Index, Crohn's Disease Activity Index, C reactive protein and adverse events will be assessed as the secondary outcomes. More than two assessors will conduct the study retrieval and selection, as well as the data extraction and evaluation of the risk of bias. Data synthesis will be performed using a random-effects model based on the results of heterogeneity. Data analysis will be performed using RevMan software (V.5.4). Moreover, the dichotomous data will be presented as risk ratios, and the continuous data will be calculated using weighted mean difference or standard mean difference. ETHICS AND DISSEMINATION: This systematic review contains no individual patient data; thus, ethical approval is not required. Moreover, this review will be disseminated in a peer-reviewed journal or relevant conference. PROSPERO REGISTRATION NUMBER: CRD42020176340.

Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial.

INTRODUCTION: As the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity. METHODS AND ANALYSIS: This is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients' BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral-cerebral functional changes. ETHICS AND DISSEMINATION: This trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People's Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters. TRIAL REGISTRATION NUMBER: CTR2000034432.

Acupuncture for Quality of Life of Patients with Defecation Dysfunction after Sphincter Preserving Surgery for Rectal Cancer: A Systematic Review.

PURPOSE: To evaluate the effectiveness and safety of acupuncture for quality of life of patients with defecation dysfunction (DD) after sphincter preserving surgery for rectal cancer. METHODS: We searched nine online databases from inception to July 1, 2021, and did not restrict the type of language. Then, studies were independently selected by two research team members with screening criteria and risk bias assessment, and the data were extracted. The primary outcome was Quality of Life Questionnaire-Core 29 (QLQ-CR29). The data were then synthesized using the RevMan V.5.2 by random-effects model. Also, we used the standardized mean differences with 95% credible interval (CI) to describe the outcome of the analysis. RESULTS: A total of 6 randomized controlled trials (RCTs) (with 439 patients) were included in the systematic review, and data from 2 RCTs (with 200 patients) were used in the meta-analysis. Five studies (83%) were judged to have a medium risk of bias, and one was at high risk of bias. For synthesis, data from two medium-risk studies found that acupuncture or electropuncture may improve the QLQ-CR29 with urination (mean difference, -0.39 points; 95%CI, -0.46 to -0.32; I 2 = 34%), abdominal pain (mean difference, -0.71 points; 95%CI, -0.89 to -0.54; I 2 = 9%), stool (mean difference, -0.49 points; 95%CI, -0.77 to -0.20; I 2 = 57%), defecation (mean difference, -0.59 points; 95% CI, -0.85 to -0.33; I 2 = 51%), sexual function (mean difference, 0.93 points; 95% CI, 0.48 to 1.38; I 2 = 90%), and self-feelings (mean difference, 1.04 points; 95% CI, 0.36 to 1.73; I 2 = 94%). CONCLUSION: Findings in this study indicate that acupuncture or electropuncture may be effective and safe for DD, but the quality of included studies was very low. So, more large-scale, multicenter, long-term, and high-quality original research is still expected in the future.

Effectiveness and safety of acupuncture therapy for inflammatory bowel disease: a protocol of systematic review and meta-analysis.

INTRODUCTION: Previous reviews have suggested that the effectiveness of acupuncture for inflammatory bowel disease (IBD) has not well been demonstrated due to the limited randomised controlled trials (RCTs). In recent years, the growing research on acupuncture for IBD make it possible to conduct a further systematic review and synthesise more sufficient clinical data to evaluate the effectiveness and safety of acupuncture for IBD. METHODS AND ANALYSIS: Nine electronic databases without language restriction will be retrieved from inception to March 2021, including the Cochrane Library, MEDLINE, EMBASE, Ovid, the Allied and Complementary Medicine Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, the Chongqing Chinese Science and Technology Periodical Database and Wanfang Database. The RCTs on acupuncture for IBD will be included. The data screening, data extraction and the assessment of risk bias will be performed respectively by two reviewers. The quality of evidence will be evaluated by using the Grading of recommendation Assessment, Development and Evaluation application. The meta-analysis will be performed if heterogeneity analysis conducted on the RevMan software (V.5.3) is insignificant. The primary outcome was symptoms alleviation after acupuncture treatment or even in the follow-up. ETHICS AND DISSEMINATION: Ethical approval will not be needed because data of this review are not involved in patient's information and privacy. The results will be published and diffused in a peer-reviewed journal or relative conferences. TRIAL REGISTRATION NUMBER: CRD42020157903.

The cerebral mechanism underlying the acupoints with specific effect for gallbladder stone disease: protocol for a randomized controlled task-fMRI trial.

BACKGROUND: As it has been recorded in ancient Chinese classics, Yanglingquan (GB34) and Dannangxue (EX-LE6) are two important acupoints that can regulate the function of the gallbladder. Acupuncture at these two acupoints is considered particularly effective for gallbladder disease treatment, especially for alleviating gallbladder stone disease (GSD) symptoms that can be aggravated after intaking high-fat food. However, the superior effect between the two acupoints still needs to be further explored, as well as the underlying central mechanism has never been investigated to date. METHODS AND DESIGN: Ninety participants diagnosed with GSD will be randomly divided into group A (acupuncture at GB34), group B (acupuncture at EX-LE6), and group C (acupuncture at non-acupoint) in a ratio of 1:1:1. All of them will receive a 30-min acupuncture treatment with fatty-food cues being presented before and after acupuncture. During the task, participants will be scanned by MRI and required to rate their desire for high-/low-fat food with an 11-point Likert scale. Additionally, the participants' pain/discomfort sensation will be evaluated using the Numeric Rating Scale (NRS) at four timepoints, including before the 1st task fMRI scan, before and after acupuncture, and after the 2nd task fMRI scan. For both behavior and fMRI data, the ANOVA analysis will be conducted among three groups to testify the immediate effect of GB34 and EX-LE6. The post hoc t-test will be employed to further explore the superiority between acupuncture with GB34 and EX-LE6. Furthermore, correlation analyses will be conducted to investigate a possible correlation between neural changes and clinical data. DISCUSSION: In comparison to the non-acupoint, the results will firstly explore the superior effect between acupuncture with GB34 and EX-LE6 on GSD patients by observing their behavioral and neural response change to fatty-food cue, and then to investigate the underlying central mechanism. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000034368 . Registered on 3 July 2020.

Acupuncture Treatment for Cough-Variant Asthma: A Meta-Analysis.

BACKGROUND: In recent years, there have been many clinical reports on acupuncture treatment of cough-variant asthma, but no researcher has objectively analysed and evaluated the efficacy and safety of acupuncture treatment of cough-variant asthma from the perspective of evidence-based medicine. OBJECTIVE: To systematically evaluate the clinical efficacy and safety of acupuncture in treating cough-variant asthma and to provide reference values for clinical decision-making. METHODS: The comprehensive computer retrieval Chinese journal full-text database (CNKI), Chinese science and technology periodical database (VIP), ten thousand data knowledge service platform (WanFang Data), PubMed, Embase, and the Cochrane Library were used to collect literature for relevant randomized controlled trials (RCT) of acupuncture treatment of cough-variant asthma, as well as to retrieve papers and add reference retrieval after literature review, in accordance with the standard of literature filtering, data extraction, and quality evaluation. The data were meta-analysed using ReviewManager5.3 software recommended by Cochrane. RESULTS: A total of 11 randomized controlled clinical studies were screened and included, comprising 929 patients. The results of the meta-analysis showed that, compared with the control group, acupuncture intervention on CVA could enhance the total clinical effectiveness rate, reduce the relapse rate of drug withdrawal, relieve symptoms of cough, phlegm, and diaphragmatic congestion, and improve lung function-related indicators and immune inflammation indicators. There were statistically significant differences in all efficacy evaluation criteria. CONCLUSION: The clinical curative effect of acupuncture treatment for cough-variant asthma is precise and has certain advantages in relieving symptoms and reducing the recurrence rate. However, the low quality of the evaluation in the RCT research literature is a problem, and more high-quality clinical randomized controlled trials are needed to further verify the comprehensive clinical efficacy and safety of this treatment. Registration number: PROSPERO (no. CRD42020155244) (https://www.crd.york.ac.uk/prospero/).

Acupuncture for biliary colic: a systematic review protocol.

INTRODUCTION: Biliary colic (BC) is a severe pain associated with nausea and vomiting, which is the most common symptom among the gallstone population. This protocol proposes a methodology for conducting a systematic review and meta-analysis that aims to assess the benefits and safety of acupuncture in patients with BC. METHODS AND ANALYSIS: Clinical trials will be identified through nine databases from inception to December 2020, using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Allied and Complementary Medicine Database (AMED), CINAHL, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), VIP Database and Wanfang Database. Search words will be used for the BC and acupuncture. The analysis would include randomised, controlled, clinical trials of adults with BC that were published in either Chinese or English. The primary outcome is to measure pain relief. Two or three reviewers should be in charge of study selection, data extraction and evaluating the risk of bias. RevMan software (V.5.4) will be used to perform the assessment of the risk of bias and data synthesis. ETHICS AND DISSEMINATION: Ethics approval will not be required for this review, as it will only involve the collection of literature previously published. The results of this meta-analysis will be disseminated in a peer-reviewed journal or relevant conference, through publication. TRIAL REGISTRATION NUMBER: CRD42020167510.

Acupuncture and moxibustion for pain relief and quality of life improvement in patients with knee osteoarthritis: A protocol for systematic review and meta-analysis.

OBJECTIVE: The aim of this systematic review and meta-analysis is to assess the efficacy of acupuncture and moxibustion in pain relief and quality of life improvement of knee osteoarthritis (KOA) patients. METHODS: The following databases will be searched: MEDLINE, EMBASE, the Cochrane Library, Web of Science, Chinese Biomedical Literature Database, Chinese Nation Knowledge Infrastructure, Wanfang Database, the Chongqing VIP from inception to May 1, 2020. All randomized controlled trials (RCTs) used acupuncture or moxibustion to relieve pain and improve quality of life (QoL) among KOA patients will be included. Study selection, data extraction, quality assessment and assessment of risk bias will be performed by 2 reviewers independently. Data synthesis will be performed using Review Manager V5.3 software. A meta-analysis will be performed when there is sufficient available data. PROSPERO REGISTRATION NUMBER: CRD42020169724.