ABSTRACT
BACKGROUND: Obesity is a major public health issue in China and around the world. While acupuncture is often used in clinical practice, there is a lack of conclusive evidence for its weight-loss effect. Thus we will conduct a parallel, randomised, sham-controlled trial to evaluate the efficacy and safety of acupuncture for treating obesity. METHODS AND ANALYSIS: A total of 160 eligible participants with obesity will be randomly assigned to the verum acupuncture group or sham acupuncture group at a ratio of 1:1. All participants will be treated three times a week for a duration of 12 weeks, and followed up for another 16 weeks. The primary outcome is the percentage change in body weight from baseline to Week 12. The secondary outcomes include body mass index (BMI), waist circumference (WC), body fat percentage (BF%), blood pressure, fasting blood glucose, insulin, glycosylated haemoglobin A1c, blood lipids, and physical functioning score on the Short Form 36 Health Survey. Other secondary outcomes including psychological and social functions will also be evaluated using the body image scale, psychological function scale, and social function scale of the BODY-Q, Rosenberg Self-Esteem Scale, Patient Health Questionnaire-9, and Dutch Eating Behaviour Questionnaire. BMI, WC, BF% and blood pressure will be evaluated at Week 0, 4, 8, 12 and 28. Other secondary outcomes will be measured at Week 0, 12 and 28, respectively. Adverse events will be recorded in detail during the trial. ETHICS AND DISSEMINATION: Ethical approval of this trial was granted by the Ethics Committee of Chengdu Sport University (2023-102). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (ChiCTR2200062092).
Subject(s)
Acupuncture Therapy , Body Mass Index , Obesity , Randomized Controlled Trials as Topic , Humans , Obesity/therapy , Acupuncture Therapy/methods , Adult , Female , Male , Waist Circumference , Middle Aged , Weight Loss , Young Adult , China , Blood Glucose/metabolism , Blood Glucose/analysis , Blood Pressure , Treatment OutcomeABSTRACT
Background: Acute ischemic stroke (AIS) is a leading cause of death and disability worldwide. This study aimed to evaluate the efficacy and safety of anisodine hydrobromide (Ani) injection in the treatment of AIS. Methods: Randomized controlled trials (RCTs) based on Ani injection for the treatment of AIS were retrieved from both Chinese and English databases. The retrieval period was from the databases' inception to May 2023. The Cochrane Collaboration Risk of Bias Tool was used to assess the methodological quality. The outcome indicators were analyzed using RevMan 5.3 software. Results: We included the findings of 11 RCTs encompassing 1,337 patients with AIS. Our meta-analysis revealed that Ani injection supplementation significantly reduced the National Institutes of Health Stroke Scale [MD = -1.53, 95%CI = (-1.94, -1.12), p < 0.00001], modified Rankin Scale [MD = -0.89, 95%CI = (-0.97, -0.81), p < 0.00001], and the relative time to peak [SMD = -0.81, 95%CI = (-1.08, -0.55), p < 0.00001] significantly. Additionally, Ani injection significantly increased the Barthel Index [MD = 10.65, 95%CI = (4.30, 17.00), p = 0.001], relative cerebral blood volume [SMD = 0.28, 95%CI = (0.02, 0.53), p = 0.03], and clinical efficacy [RR = 1.2, 95%CI = (1.08, 1.34), p = 0.001]. No statistically significant difference in the rate of adverse events was observed between the Ani injection supplemental group and the control group. Conclusion: Based on currently published evidence, Ani injection was found to be effective and safe in improving AIS outcome. Nevertheless, limitations of the included RCTs still exist, and thus, more multi-center, large-sample, high-quality RCTs are required to further verify the efficacy and safety of Ani injection in patients with AIS. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023427591], identifier [PROSPERO 2023 CRD42023427591].