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Efficacy of verum and sham acupoint catgut embedding for treatment of obesity: Study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Obesity has become a major public health hazard with epidemic proportions, affecting adults, adolescents, and children of both genders. Previous studies have suggested that acupoint catgut embedding (ACE) might be a potential therapeutic approach for obesity. The purpose of this study is to conduct a rigorous and normative trial to determine the efficacy of ACE for obesity. METHODS/DESIGN:A total of 99 eligible patients diagnosed with obesity will be recruited in this study. They will be randomly allocated to either the verum ACE group, sham ACE group, or waiting list (WL) group, with 33 patients in each group. Each patient in the two ACE-based groups will receive eight sessions of treatment, lasting over 8?weeks. The primary outcome is the reduction of body mass index (BMI) after treatment. Secondary outcomes will include waist circumference (WC), hip circumference (HC), waist:hip ratio, body fat percentage, blood lipid level, subcutaneous fat area, visceral fat area, and World Health Organization Quality of Life (WHOQOL). All the outcomes will be evaluated at baseline, at the end of the 8?weeks of treatments, and at 3?months of follow-up. The evaluators and data analyzers will be blinded to group allocation. DISCUSSION:The findings of this randomized, sham-, and WL-controlled trial will help to investigate the influence of ACE on clinical variables as well as visceral fat area of obesity, which will provide high-quality evidence on the efficacy of ACE for obesity. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR1800020248. Registered on December 21, 2018.

SUBMITTER: Zhou YM

PROVIDER: S-EPMC6880430 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Efficacy of verum and sham acupoint catgut embedding for treatment of obesity: Study protocol for a randomized controlled trial.

Zhou Yu-Mei YM Yan Bing B Yuan Wei-Qu WQ Yu Hai-Bo HB Yang Zhuo-Xin ZX

Trials 20191127 1

<h4>Background</h4>Obesity has become a major public health hazard with epidemic proportions, affecting adults, adolescents, and children of both genders. Previous studies have suggested that acupoint catgut embedding (ACE) might be a potential therapeutic approach for obesity. The purpose of this study is to conduct a rigorous and normative trial to determine the efficacy of ACE for obesity.<h4>Methods/design</h4>A total of 99 eligible patients diagnosed with obesity will be recruited in this s ...[more]

PMID: 31775839

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Project description:BackgroundObesity is a widespread chronic metabolic disease that significantly impairs quality of life. Studies have demonstrated the efficacy of both acupuncture and acupoint catgut embedding (ACE) in the management of obesity. However, the superiority of acupuncture combined with ACE over acupuncture alone remains a subject of controversy. This study aims to elucidate this controversy and provide robust clinical evidence.MethodsA comprehensive search of relevant literature from the initiation to July 2022 was carried out in 8 databases (PubMed, EMBASE, Cochrane database, Web of Science, CBM Database, CNKI, Wan-fang Database, and VIP Database). We included randomized controlled trials (RCTs) that investigated the treatment of simple obesity using acupuncture paired with ACE, with acupuncture alone as the control group. The pooled outcomes included body mass index (BMI), body weight (BW), %BF, waist circumference (WC), hip circumferences (HC), waist-to-hip ratio (WHR), therapeutic effective rate (TER), and adverse events. Two independent reviewers performed screening (using EndNote X9) and quality assessment (using the Cochrane Risk of Bias tool) for the included studies. with the software RevMan 5.3 was used to perform pooling of effect sizes. The certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE).ResultsA total of 20 trials involving 15 datasets (1616 participants) were included. The findings demonstrated significant improvements in outcome measures when acupuncture was combined with ACE, compared with acupuncture alone (BMI: MD = -1.49 kg/m2, 95% confidence interval [CI] = -1.93 to -1.04, P < .01; BW: MD = -2.38, 95% CI = -3.86 to -0.89, P < .01; %BF: MD = -2.19, 95% CI = -3.23 to -1.15, P < .01; WC: MD = -2.01, 95% CI = -3.66 to -0.35, P < .05; HC: MD = -0.83, 95% CI = -1.64 to -0.02, P < .05; WHR: MD = -0.02, 95% CI = -0.03 to -0.01, P < .01; TER: OR = 2.68, 95% CI = 1.93-3.74, P < .01). Adverse effects were reported in 4 studies.Conclusion subsectionsThe results of this meta-analysis indicate that acupuncture combined with ACE is superior to acupuncture alone in the treatment of obesity, which is supported by the subgroup analysis. The assessment of efficacy may have been influenced by variations in study quality, potentially amplifying the observed effects. RCTs with larger sample sizes and improved methodological quality are needed to enhance the validity of the findings.

Project description:purpose:The goals of this study is to investigate rat quadriceps muscle responses treated with different catgut embedding acupoint in various molecular pahtways by RNA-seq and real-time quantitative PCR methods and evaluaate protocols for optimal high-throughput data analysis. Methods:mRNA profiles of rat quadriceps muscle responses treated with catgut embedding acupoint 1 and 2 group,treadmill group and control were generated by sequencing, in sextuplicate, utilizing Illumina HiSeq 4000 platform. The raw RNA-seq data was filtered to remove adaptor contamination, low quality bases, and undetermined beses utilizing Cutadapt software. The filtered reads were aligned and mapped to the reference genome using Hisat 2.0. RT-qPCR validation was performed using SYBR green assays. Results:The transcription profiling results showed that there were 346 differentially expressed genes (DEGs) between the A and B groups. These included 221 up-regulated DEGs and 125 down-regulated DEGs. There were 363 DEGs between the B group and the C, which included 144 up-regulated DEGs and 219 down-regulated DEGs. There were 458 DEGs between the B group and D which included 248 up-regulated DEGs and 210 down-regulated DEGs. Through GO functional annotation, the DEGs were divided into three categories: cellular components, biological processes, and molecular functions. The above three functions were further divided into positive regulation of transcription by RNA polymerase II, and RNA polymerase II on transcription. Negative regulation, participation in nuclear synthesis, synthesis with cytoplasm, participation in extracellular exosome synthesis, participation in protein binding, and participation in metal ion binding, etc. After enrichment analysis, 16 metabolic pathways were found to be significantly enriched (p<0.05), which included chemical carcinogenesis, metabolism of cytochrome P450 to exogenous substances, circadian entrainment, circadian rhythm, protein digestion and absorption, PPAR Signaling pathways, drug metabolism - cytochrome P450, parathyroid hormone synthesis, secretion and action, steroid hormone biosynthesis, leishmaniasis, arachidonic acid metabolism, bile secretion, measles, linoleic acid metabolism, fat digestion and absorption, and fluid shear stress and atherosclerosis. By inspecting the bubble enrichment plot, we decided that the following would be important targets of our future studies: protein digestion and absorption; PPAR signaling pathway; synthesis, secretion and action of parathyroid hormone and other metabolic pathways.DEGs that enriche into pathways were verified by RT-qPCR. Conclusions: Our study provides new insights on the interaction between catgut embedding acupoint and rat quadriceps muscle responses.

Project description:In this study, we aim to evaluate the efficacy and safety of acupoint catgut embedding for the treatment of diarrhea-predominant irritable bowel syndrome and constipation-predominant irritable bowel syndrome. We searched seven online databases to collect studies published up to Feb 29th, 2020. Study quality of each included article was evaluated by the Cochrane Collaboration Risk of Bias Tool. Systematic reviews and meta-analyses were conducted based on the Cochrane systematic review method by using RevMan 5.3 software. Among the included trials, acupoint catgut embedding alone or plus oral western medicine or plus other acupoint-based therapies, or plus oral traditional Chinese medicine were the main therapies in the experimental groups. Interventions in control groups mainly include oral western medicine alone, other acupoint-based therapies alone, or other acupoint-based therapies alone. Primary outcomes in this study include recovery rate, accumulative marked effective rate, accumulative effective rate, and recurrence rate. Finally, 30 trials involving 1889 participants were included. The results of systematic reviews and meta-analyses show that acupoint catgut embedding alone or plus oral western medicine or plus other acupoint-based therapy or plus oral traditional Chinese medicine was significantly better compared with using oral western medicine alone in terms of efficacy for IBS-C and IBS-D. In addition, acupoint catgut embedding alone or plus oral western medicine or plus other acupoint-based therapy or plus oral traditional Chinese medicine could improve the effective rate and decrease the recurrence rate for IBS-D compared with using oral western medicine, other acupoint-based therapies, or oral traditional Chinese medicine alone. Adverse events of acupoint catgut embedding include local induration, redness, swelling, and itchiness, but they were all mild and disappeared swiftly with ordinary local interventions. There is an urgent need for RCTs of high quality and large sample size and with longer treatment duration and follow-up periods of acupoint catgut embedding for IBS.

Dataset Information

Efficacy of verum and sham acupoint catgut embedding for treatment of obesity: Study protocol for a randomized controlled trial.

Publications

Efficacy of verum and sham acupoint catgut embedding for treatment of obesity: Study protocol for a randomized controlled trial.

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