The Effect of Catgut Embedding at Acupoints Versus Nonacupoints in Abdominal Obesity: Protocol for a Multicenter, Double-Blind, 16-Week Randomized Controlled Trial.

BACKGROUND: Obesity is an increasing problem worldwide. The effective treatments for obesity mainly include diet, physical activity, behavioral intervention, pharmacotherapy, and bariatric surgery, which all have certain limitations. As a specific type of acupuncture therapy, acupoint catgut embedding (ACE) has gained substantial attention in the management of obesity in recent years. Previous studies suggested that ACE may be an effective obesity treatment. However, the evidence for the efficacy of ACE in abdominal obesity (AO) remains inadequate due to the paucity of high-quality studies. OBJECTIVE: This study aims to investigate the difference in the effectiveness of catgut embedding at acupoints and catgut embedding at nonacupoints in patients with AO and to further validate the efficacy and safety of ACE for AO. METHODS: This is a multicenter, double-blind, 16-week randomized controlled trial. A total of 92 eligible participants with AO will be randomly divided into 2 groups (1:1 allocation ratio). The ACE group will receive catgut embedding at acupoints and the control group will receive catgut embedding at nonacupoints. The intervention will be performed every 2 weeks for a total of 6 sessions. Follow-up will be performed every 2 weeks for a total of 2 visits. The primary outcome is waist circumference. Secondary outcomes include body weight, BMI, hip circumference, and the visual analog scale of appetite. Upon the completion of the trial, we will evaluate the effect of catgut embedding at acupoints or nonacupoints on obesity indicators in patients with AO. For treatment outcomes, an intention-to-treat analysis will be performed. RESULTS: The start of recruitment began in August 2019 and is expected to end in September 2023. CONCLUSIONS: Although studies have been conducted to demonstrate the effectiveness of ACE in the treatment of obesity, the evidence for the efficacy of ACE in AO remains insufficient due to the quality of the studies. This rigorous normative randomized controlled trial will verify the effect of catgut embedding at acupoints or nonacupoints in patients with AO. The findings will provide credible evidence as to whether ACE is an effective and safe treatment for AO. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800016947; https://tinyurl.com/2p82257p. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46863.

Brain-Imaging Mechanisms on Female Abdominal Obesity Treated by "Shu-Mu" Acupoint Catgut Embedding and Compatibility Relation: Study Protocol for a 12-Week Randomized Controlled Trial.

Background: Acupoint catgut embedding (ACE) has been proven to be effective and safe in the treatment of obesity, but few studies have been conducted involving its central mechanisms. Our previous study has demonstrated the effectiveness of Shu-Mu ACE in the treatment of abdominal obesity (AO). However, the neurological mechanism of Shu-Mu ACE for weight loss has not yet been elucidated. The mechanism of the combination of the Shu and Mu acupoints may be related to the central integrative effects of the brain. This paper aims to explore the potential neural mechanisms of Shu-Mu ACE in female patients with AO. Methods and Analysis: A total of 100 eligible female AO patients and 20 healthy female subjects will be recruited for this study. 100 AO patients will be randomly allocated to five groups: Shu-Mu ACE (Group A), Shu ACE (Group B), Mu ACE (Group C), sham ACE (Group D), and waiting-list (Group E). Treatment will be administrated once every two weeks for 12 weeks. The body mass index (BMI), waist circumference (WC), Visual Analog Scales (VAS) of appetite, Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) will be utilized to evaluate the clinical efficacy. Outcomes will be assessed at baseline and at each time point of treatment. Multimodal MRI will be performed at baseline and after 12-week treatment and the results will be used to investigate the neural mechanisms of ACE for obesity. Neurological changes and clinical data will be analysed for correlation. Discussions: This study hypothesized that Shu-Mu ACE therapy has a synergistic effect and may treat AO by modulating the neuropathological alterations in the brain. Our findings will demonstrate the neurological mechanism of AO treated by "Shu-Mu" Acupoint Catgut Embedding and compatibility relation. Trial Registration: This trial is registered at the Chinese Clinical Trial Registration Center (No. ChiCTR2100048920).

Effect of Acupoint Catgut Embedding for Abdominally Obese Female with Strong Appetite: Mixed Analysis of a Randomized Clinical Trial.

Background: Abdominal obesity (AO) is not only a health issue, but also a serious impact on women's work and life. The article of acupoint catgut embedding (ACE) on AO has already been accepted to be published and showed significant effect. However, whether ACE is effective for abdominally obese female with strong appetite is still unclear. Methods: This is a mixed analysis of a multicenter, double-blind, randomized controlled trial.Which was conducted in China between July 2018 and March 2020 (n = 101), while with the supplementary samples (n = 22) between April 2020 and June 2022. According to the appetite and intervention methods, 123 abdominally obese female were divided into ACE group with strong appetite (n = 27) and moderate appetite (n = 31), control (non-acupoint catgut embedding) group with strong appetite (n = 37) and moderate appetite (n = 28). Four subgroups were given a 12-week actual intervention period and a 4-week follow-up. Waist circumference (WC), appetite, body weight and BMI were applied and assessed at baseline and after 6, 12 and 16 weeks. Results: In this study, the mean onset age of abdominal obesity in females was 25.27 (8.19) years old. The longer duration of AO, the lower the appetite in females (p<0.05). At 12 and 16 weeks, ACE group with strong appetite showed significant decrease in WC and appetite than control group with strong appetite (p<0.01). However, ACE group with moderate appetite showed no significant decrease than control group with moderate appetite in WC, appetite, body weight and BMI (p>0.05). At 12 and 16 weeks, there was no significant difference in appetite between the ACE groups (strong and moderate appetite)(p>0.05), while there was still a difference between the control groups (p<0.05). Conclusion: Younger abdominally obese female had a stronger appetite. ACE own the remarkable therapeutic effects for younger abdominally obese female and showed the perfect effect on appetite-reduction.

Efficacy of contralateral acupuncture in women with migraine without aura: protocol for a randomised controlled trial.

INTRODUCTION: Migraine is a common neurological disorder with a higher prevalence occurring in women. Migraine without aura (MwoA) is the most common type of migraine. In recent years, the safety and effectiveness of acupuncture for migraines have been internationally recognised. Contralateral acupuncture (CAT) (Jùcì) is an ancient classic acupuncture technique from Huang Di Nei Jing that refers to the acupoints on the right side (healthy side) selected for diseases on the left (affected side) and vice versa. Some studies have shown that efficacy of CAT on the painful disorder is even better than ipsilateral acupuncture (IAT), but there remains a lack of high-quality evidence to support it. METHODS AND ANALYSIS: This is a single-centre, randomised and sham-controlled clinical trial in China with three parallel groups that aim to evaluate the efficacy of CAT in women with unilateral MwoA. 243 participants will be randomly divided into the experimental group (CAT group), control group 1 (IAT group) and control group 2 (sham acupuncture group) (1:1:1 allocation ratio). Each group will be given 30-minute treatment sessions, once every other day, approximately three times per week, for a total of 24 treatments and follow-up visits two times. The primary outcome is the changes in days of migraine attacks. The secondary outcomes are frequency of migraine attacks, intensity of migraine, migraine duration, the dose of intake of acute medication, the Migraine-Specific Quality of Life Questionnaire, the Migraine Disability Assessment Score, the Headache Impact Test-6 and the Pittsburgh Sleep Quality Index. The data will be collected at the baseline time (week 0), end of treatment (week 4-8) and the follow-up time (week 12-16). Adverse events will be collected and recorded during each treatment. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Sports Trauma Specialist Hospital of Yunnan Province (2021-01). All participants will provide written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registration Center (ChiCTR2100051479).

Acupuncture for perimenopausal depressive disorder: A systematic review and meta-analysis protocol.

BACKGROUND: Perimenopausal depressive disorder (PDD) is a disease that plagues many perimenopausal women. There is an urgent need for a safe way to treat the disease. With few side effects, acupuncture treatment for PDD has been gradually accepted. However, at present, the evidence is insufficient and relevant studies are not in-depth enough. The purpose of this study is to explore the efficacy and safety of acupuncture for PDD. METHODS: All randomized controlled trials articles on acupuncture treatment of PDD will be searched in databases such as MEDLINE, EBASE, Cochrane Library, Springer, World Health Organization International Clinical Trials Registry Platform, China National Knowledge Infrastructure, Wan Fang, Chinese Biomedical Literature Database, Chinese Scientific Journal Database and so on. Non-RCT articles will be screened and key information will be extracted. The primary outcome is the Hamilton depression scale. Second outcomes are the Hamilton anxiety scale, Quality of life scale, changes of symptoms in traditional Chinese medicine and hormone levels. RESULTS: This systematic review will provide the highest level of evidence and provide an evaluation of the efficacy and safety of acupuncture for PDD. CONCLUSION: This study provides evidence for evaluating the efficacy and safety of acupuncture in the treatment of PDD. PROSPERO REGISTRATION NUMBER: CRD42018115811.