Randomized Clinical Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Dec 15, 2023; 14(12): 1813-1823
Published online Dec 15, 2023. doi: 10.4239/wjd.v14.i12.1813
Acupuncture in diabetic peripheral neuropathy-neurological outcomes of the randomized acupuncture in diabetic peripheral neuropathy trial
Sebastian Hoerder, Isabel Valentina Habermann, Katrin Hahn, Gesa Meyer-Hamme, Miriam Ortiz, Weronika Grabowska, Stephanie Roll, Stefan N. Willich, Sven Schroeder, Benno Brinkhaus, Joanna Dietzel
Sebastian Hoerder, Isabel Valentina Habermann, Miriam Ortiz, Weronika Grabowska, Stephanie Roll, Stefan N. Willich, Benno Brinkhaus, Joanna Dietzel, Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin, Berlin 10117, Germany
Katrin Hahn, Department of Neurology, Charité Universitätsmedizin, Charitéplatz 1, Berlin 10117, Germany
Gesa Meyer-Hamme, Sven Schroeder, HanseMerkur Center of Traditional Chinese Medicine at University Hospital Eppendorff, Martinistr 52, Hamburg 20246, Germany
Author contributions: The study was conceptualized and coordinated by Dietzel J, Brinkhaus B, Hahn K, Willich SN and Ortiz M; Dietzel J, Habermann IV, Hoerder S, Ortiz M, Meyer-Hamme G, and Schroeder S acquired the patient data and performed the treatments; Dietzel J, Roll S and Grabowska W conducted the main data analysis; Brinkhaus B had the overall medical responsibility, and Brinkhaus B and Schroeder S were equally supervising the trial; Hoerder S and Dietzel J prepared the manuscript.
Institutional review board statement: The study protocol was approved by the ethics committee Berlin (EA1/183/18), Germany in October 2018. ACUDPN was performed in compliance with the Declaration of Helsinki and standards of Good Clinical Practice.
Clinical trial registration statement: The trial was registered on ClinicalTrials.gov NCT03755960.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare no conflict of interest.
Data sharing statement: Data can be obtained from the corresponding author under reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Joanna Dietzel, MD, Consultant Physician-Scientist, Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin, Luisenstr 57, Berlin 10117, Germany. joanna.dietzel@charite.de
Received: July 14, 2023
Peer-review started: July 14, 2023
First decision: August 16, 2023
Revised: October 2, 2023
Accepted: November 14, 2023
Article in press: November 14, 2023
Published online: December 15, 2023
Abstract
BACKGROUND

Diabetic 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.

AIM

To investigate the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.

METHODS

The 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.

RESULTS

Sixty-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.

CONCLUSION

Study 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.

Keywords: Diabetic peripheral neuropathy, Numbness, Nerve conduction study, Acupuncture

Core Tip: Diabetic peripheral neuropathy affects a high number of diabetic patients. It can lead to painful sensations of the lower extremities and loss of sensory function. The latter can lead to gait instability, falls and injury of the feet. Pharmacological treatments can only reduce painful symptoms but do not improve numbness; furthermore, they add to pharmacological burden of multimorbid patients. Acupuncture is a safe option to treat chronic pain; the potential to improve sensory loss is evaluated in this trial.