Dataset Information

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial.

ABSTRACT:

Introduction

Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes.

Methods and analysis

This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population.

Ethics and dissemination

The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal.

Trial registration number

ChiCTR2200061408.

SUBMITTER: Zhuang R

PROVIDER: S-EPMC10989182 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial.

Zhuang Rong R Xiong Zhiyi Z Yan Shiyan S Zhang Haoran H Dong Qi Q Liu Weiai W Miao Jinling J Zhuo Yuanyuan Y Fan Xiaohong X Zhang Weiliang W Wang Xiaomei X Liu Lian L Cao Jianan J Zhang Tiansheng T Hao Chongyao C Huang Xingxian X Jiang Lijiao L

BMJ open 20240402 4

<h4>Introduction</h4>Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes.<h4>Methods and analysis</h4>This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1 ...[more]

PMID: 38569706

Similar Datasets

Project description:BackgroundDiabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness.AimTo investigate the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.MethodsThe acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care. Outcome parameters were evaluated after 8, 16 and 24 wk and included neurological scores, such as an 11-point numeric rating scale (NRS) 11 for hypesthesia, neuropathic pain symptom inventory (NPSI), neuropathy deficit score (NDS), neuropathy symptom score (NSS); nerve conduction studies (NCS) were assessed with a handheld point-of-care device.ResultsSixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.ConclusionStudy results suggest that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.

Project description:BackgroundPainful Diabetic Peripheral Neuropathy (PDPN) is a common complication of diabetes, it severely affects the quality of life of patients. Acupuncture has been shown to be effective in the treatment of PDPN. To evaluate the efficacy and safety of acupuncture for pain relief in patients diagnosed with diabetic peripheral neuropathy, we conducted a systematic review and meta-analysis.MethodWe thoroughly searched specific databases, which included PUBMED, EMBASE, Web of Science, the Cochrane Library, the Chinese Biomedical Literature Database, the Chinese National Knowledge Infrastructure, China Science and Technology Journal Database and the Wanfang Data. All randomized controlled trials of acupuncture therapy for PDPN with pain change scales were included. Included studies were assessed for methodological quality according to the risk of bias from the Cochrane handbook. Meta-analyses were carried out to analyze the outcomes, subgroup analyses, sensitivity analyses, and funnel plot analyses were undertaken.ResultsThis systematic review evaluated a total of 25 trials of acupuncture therapy in combination with conventional treatment, involving a total of 1,561 patients with PDPN. According to the results, among 16 trials using VAS scores with a total of 1,552 patients, 2 acupoint injection trials (MD -2.38, 95% CI: -2.76 to -2.01, p < 0.00001), 12 acupuncture trials (MD -1. 31, 95% CI: -1.60 to -1.02, p < 0.00001) and 2 moxibustion trials showed that acupuncture therapy combined with conventional treatment improved pain better than conventional treatment (MD -2.50, 95% CI: -2.76 to -2.24, p < 0.00001). In the subgroup analysis of the acupuncture group, the results of the 5 trials in which the location of acupuncture was only in the limbs (MD -1.27, 95% CI: -1.54 to -1.01, p < 0.00001) and the 7 trials both in limbs and torso (MD -1.38, 95% CI: -1.81 to -0.95, p < 0.00001) also demonstrated that acupuncture was effective in pain improvement.ConclusionThis meta-analysis analyzed the possible efficacy of acupuncture in combination with conventional treatment for pain in diabetic peripheral neuropathy, particularly when acupoints are located in the limbs. However, there are limitations to this meta-analysis and future clinical studies are needed to confirm these findings.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023449447, identifier (CRD42023449447).

Dataset Information

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets