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
ARTICLE HIGHLIGHTS
Research background

Peripheral neuropathy in patients with diabetes type 2 is common. It can lead to loss of sensory function which increases the risk of gait disturbances and falls, or injuries of the feet that go unnoticed. Painful sensations occur frequently in diabetic peripheral neuropathy (DPN) which have an impact on quality of life.

Research motivation

Non-pharmacological therapeutic options are warranted for a patient group who is already confronted with polypharmacy. Pain control as well as restoration of sensory function are the motivation to evaluate the effects of acupuncture treatments on outcomes of neuropathy of the lower extremities.

Research objectives

What are the effects of 12 acupuncture treatments administered over the course of 8 wk on the subdimension of neuropathy, such as pain, tingling and numbness? Are the treatments safe and well-tolerated? How long do the effects last over the course of 24 wk?

Research methods

Open, multicenter, randomized controlled trial with patients suffering from diabetes type 2 and moderate to severe peripheral neuropathy.

Research results

Sixty-two participants were included and randomized in the two trial arms. A numeric rating scale for numbness, neuropathy symptom scores and clinical examinations showed significant and relevant improvements of neuropathy at week 8. Improvements remained significant up to 16 wk after the end of the intervention. No changes could be recorded in the nerve conduction studies. Only minor adverse events were recorded.

Research conclusions

Body acupuncture seems to have a positive effect on DPN-related neurological impairment. Improvement in numbness and clinical examination scores persist until 2 mo after end of treatment in a clinically significant way in comparison to the control group.

Research perspectives

Sham-controlled clinical trials with adequate patient numbers are needed to confirm these results and to identify specific effects.