Effect of electroacupuncture treatment on functional constipation in adults: A protocol for systematic review.

BACKGROUND: Electroacupuncture has been widely used to treat functional constipation. But its efficiency has not been scientifically and methodically evaluated. The objective of this study is to evaluate the efficiency and safety of the electroacupuncture treatment for functional constipation in adults. METHODS: This protocol of systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P). We will conduct the literature searching in the following electronic databases: the Cochrane Library, MEDLINE, EMBASE, Web of Science, Springer, the Chinese Science Citation Database (CSCD), China National Knowledge Infrastructure (CNKI), the Chinese Biomedical Literature Database (CBM), Wanfang, and the Chinese Scientific Journal Database (VIP). The time limit for retrieving studies is from establishment to July 2020 for each database. All published randomized controlled trials (RTCs) related to this review will be included. Review Manager (V.5.3.5) will be implemented for the assessment of bias risk and data analyses. The selection of the studies, data abstraction, and validations will be performed independently by 2 researchers. RESULTS: This review will assess the clinical efficacy and safety, as well as the acupoints characteristics of electroacupuncture on functional constipation (FC) in adults. CONCLUSION: This review will summarize the current evidence of electroacupuncture on FC outcomes and provide guidance for clinicians and patients to select electroacupuncture for FC in adults. TRAIL REGISTRATION NUMBER: This protocol of systematic review has been registered on PROSPERO website (No. CRD42019146715).

Evaluation of an effectiveness and safety of the electroacupuncture in the management of intractable neuropathic pain: A prospective, open-labeled, randomized, cross-over clinical trial.

BACKGROUND: There is no sufficient evidence on the effectiveness of acupuncture for neuropathic pain. This protocol describes a study that aims to evaluate the effectiveness and safety of electroacupuncture combined with conventional medicine for patients with intractable neuropathic pain, when compared with conventional medicine alone. METHODS/DESIGN: This study is a prospective, open-labeled, randomized, cross-over clinical trial. A total of 40 patients with neuropathic pain who had a numeric rating scale (NRS) score of over 4 despite receiving conventional treatment for more than 3 months will be enrolled. Participants will receive conventional treatment for neuropathic pain (treatment C) or treatment C combined with 12 additional sessions of electroacupuncture treatment (treatment A) for 6 weeks. Participants will be randomly assigned to 1 of the 2 sequence groups (AC and CA group) with a 1:1 allocation. The differences of responder in the composite efficacy outcomes, which consist of the NRS, Brief Pain Inventory-Short Form (BPI-SF) pain subscale, and global assessment at 6 weeks after randomization will be examined as the primary outcome. Secondary outcomes include differences in the NRS, the Short-Form McGill Pain Questionnaire, BPI-SF, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Medical Outcomes Study Sleep Scale, global assessment, EQ-5D, and incremental cost-effective ratio at 6 and 15 weeks after randomization. Adverse events, vital signs, and physical examinations will be recorded to evaluate safety. DISCUSSION: The study protocol for this trial will provide up-to-date evidence on the effectiveness and safety of electroacupuncture for patients with intractable neuropathic pain. The results will be disseminated through a peer-reviewed journal and conference presentations. TRIAL REGISTRATION: Clinical Research Information Service, ID: KCT0003615. Registered on March 12, 2019. https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=13410& ltype=&rtype=.

Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

BACKGROUND: Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using TEAS in elderly patients subjected to gastrointestinal surgery, and comparing dual-acupoint and single-acupoint stimulation. METHODS/DESIGN: A multicenter, randomized, controlled, three-arm design, large-scale trial is currently undergoing in four hospitals in China. Three hundred and forty-five participants are randomly assigned to three groups in a 1:1:1 ratio, receiving dual-acupoint TEAS, single-acupoint TEAS, and no stimulation, respectively. The primary outcome is incidence of pulmonary complications at 30 days after surgery. The secondary outcomes include the incidence of pulmonary complications at 3 days after surgery; the all-cause mortality within 30 days and 1 year after surgery; admission to the intensive care unit (ICU) and length of ICU stay within 30 days after surgery; the length of postoperative hospital stay; and medical costs during hospitalization after surgery. DISCUSSION: The result of this trial (which will be available in September 2019) will confirm whether TEAS before and during anesthesia could alleviate the postoperative pulmonary complications after gastrointestinal surgery in elderly patients, and whether dual-acupoint stimulation is more effective than single-acupoint stimulation. TRIALS REGISTRATIONS: ClinicalTrials.gov, ID: NCT03230045 . Registered on 10 July 2017.

Electroacupuncture plus standard of care for managing refractory functional dyspepsia: protocol of a pragmatic trial with economic evaluation.

INTRODUCTION: This trial proposes to compare the effectiveness and cost-effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality-of-life improvement among patients with functional dyspepsia (FD). METHODS AND ANALYSIS: This is a single-centre, pragmatic, randomised parallel-group, superiority trial comparing the outcomes of (1) EA plus on-demand gastrocaine group and (2) waiting list to EA plus on-demand gastrocaine group. 132 (66/arm) endoscopically confirmed, Helicobacter pylori-negative patients with FD will be recruited. Enrolled patients will respectively be receiving (1) 20 sessions of EA over 10 weeks plus on-demand gastrocaine; or (2) on-demand gastrocaine and being nominated on to a waiting list for EA, which entitles them 20 sessions of EA over 10 weeks after 12 weeks of waiting. The primary outcome will be the between-group difference in proportion of patients achieving adequate relief of symptoms over 12 weeks. The secondary outcomes will include patient-reported change in global symptoms and individual symptoms, Nepean Dyspepsia Index, Nutrient Drink Test, 9-item Patient Health Questionnaire (PHQ9), and 7-item Generalised Anxiety Disorder Scale (GAD7). Adverse events will be assessed formally. Results on direct medical costs and on the EuroQol (EQ-5D) questionnaire will also be used to assess cost-effectiveness. Analysis will follow the intention-to-treat principle using appropriate univariate and multivariate methods. A mixed model analysis taking into account missing data of these outcomes will be performed. Cost-effectiveness analysis will be performed using established approach. ETHICS AND DISSEMINATION: The study is supported by the Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China. It has been approved by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee. Results will be published in peer-reviewed journals and be disseminated in international conference. TRIAL REGISTRATION NUMBER: ChiCTR-IPC-15007109; Pre-result.

Comparison of the Cost-utility Analysis of Electroacupuncture and Nonsteroidal Antiinflammatory Drugs in the Treatment of Chronic Low Back Pain.

INTRODUCTION AND OBJECTIVE: Chronic low back pain (CLBP) is among the most common and important reasons for visiting a spine surgeon by patients; it is the second cause of visiting a doctor. Low back pain can cause considerable suffering and is a major financial burden in the society. There are many different methods available for the treatment of CLBP. This study aimed to compare the cost-utility of electroacupuncture (EA) and nonsteroidal antiinflammatory drugs (NSAIDs), as two common treatment methods for patients with CLBP. METHODS: This study was conducted on 100 patients suffering from CLBP. Cases were randomly selected from patients referring to two hospitals and four acupuncture clinics in Tehran. Forty-one patients received EA, and 59 patients were prescribed NSAIDs. The EuroQol five dimensions questionnaire was used to calculate quality-adjusted life-year. For calculating the total cost of the two treatment methods, face to face interview with patients was conducted by the researchers (using specific basic literature questionnaire), neurologists, and spine surgeons. The study perspective was social (direct and indirect costs calculated). RESULTS: The mean age for EA group was 41 ± 2.3 years, and for NSAIDs group, it was 38.0 ± 4.4 years. The average of the utility of patients under treatment by EA and NSAIDs was estimated as 0.70 and 0.627, respectively. The difference in utility between the two groups was significant (p ≤ 0.05). The total cost of EA and NSAIDs was estimated as 461.48 ± 57.8$ and 497.77 ± 85.2$ for one year (2016), respectively, which was also significant (p ≤ 0.05). CONCLUSION: The results indicate a significant difference between EA and NSAIDs in cases of both utility and total cost. The findings demonstrate that EA is more cost-effective than NSAIDs, as therefore can be considered as an alternative treatment for CLBP, with reasonable cost-utility.

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

BACKGROUND: Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery. METHODS/DESIGN: This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score ≥ 50 mm will be randomly assigned to either the EA with UC group (n = 54) or the UC group (n = 54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization. DISCUSSION: The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939 . Registered on 8 June 2016.

Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

BACKGROUND: Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. METHODS/DESIGN: This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. DISCUSSION: The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. TRIAL REGISTRATION: The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486 ) on 14 May 2015.

[Comparation of effect and cost-benefit analysis between acupoint catgut-embedding and electroacupuncture on simple obesity].

OBJECTIVE: To compare the clinical effect of acupoint catgut-embedding and electroacupuncture on simple obesity and evaluate the economics benefit by cost-benefit analysis. METHODS: Sixty cases were randomly devided into an acupoint catgut-embedding group and an electroacupuncture group, 30 cases in each group. Zhongwan (CV 12), Tianshu (ST 25), Daheng (SP 15), Shuifen (CV 9), Qihai (CV 6), Guanyuan (CV 4), Zusanli (ST 36) and Ashi acupoints were selected as the main acupoints in both groups. The acupoint catgut-embedding group was treated with acupoint catgut-embedding, once each week, four weeks as a course for two courses. The electroacupuncture group was treated with electroacupuncture, three times each week for eight weeks. RESULTS: 1) The total effective rate in the acupoint catgut-embedding group was 90.0% (27/30) and in the electroacupuncture group was 86.7% (26/30), with the similar therapeutic effect between the two groups (P > 0.05). 2) The body mass, body mass index (BMI), waistline, hip circumference and waist-to-hip ratio in the two groups were all decreased significantly (all P < 0.05). 3) The total medical treatment cost in the acupoint catgut-embedding group was 61 500 yuan and the cost per patient was 2050 yuan, and in the electroacupuncture group, the total cost was 117 210 yuan and the cost per patient was 3907 yuan. The cost effect analysis showed that there were 1857 yuan of the cost per patient in the acupoint catgut-embedding group less than that in the electroacupuncture group. CONCLUSION: Acupoint catgut-embedding has significant effect in treating simple obesity with low cost and fine economics benefit.

Pain relief during oocyte retrieval with a new short duration electro-acupuncture technique--an alternative to conventional analgesic methods.

BACKGROUND: Acupuncture previously has proved its pain-relieving effect for ovum pick-up (OPU). The analgesic effect of electro-acupuncture (EA) was evaluated when EA was applied for only a few minutes prior to OPU in an attempt to make EA more attractive for clinical use. METHODS: Two hundred patients undergoing OPU were randomized prospectively using sealed, unlabelled envelopes, to receive pain relief with either EA in combination with a paracervical block (PCB) (n = 100) or conventional medical analgesia (CMA) in combination with a PCB (n = 100). A visual analogue scale (VAS) was used to evaluate pain and anxiety before, during and after OPU. The primary outcome measure was pain relief; secondary end-points were costs, time to discharge and clinical outcome parameters. RESULTS: There were no differences in any VAS ratings before the procedure. Directly after OPU, the EA group reported significantly higher mean and maximum pain, and 'pain now' than the CMA group. At 30 min after OPU and thereafter, no significant differences were found between the groups regarding abdominal pain. Time to discharge and costs were significantly lower in the EA group compared with the CMA group. No differences in clinical outcome parameters were seen. CONCLUSION: A significant difference was found between the EA and the CMA groups regarding pain during the OPU, probably due to the fact that the CMA group was pre-medicated as part of the study design. Despite a per-operative difference in pain rating, EA, given a few minutes prior to OPU, is a good alternative to CMA. The procedure is well tolerated by the patients, with a shorter hospitalization time and lower costs.