Diabetic peripheral neuropathy (DPN) is a common complication of type 1 and type 2 diabetes mellitus. Duration of diabetes and hyperglycemia are major risk factors; however, rigorous glycemic control has shown to be insufficient to prevent DPN in type 2 diabetes. Metabolic sequelae directly affect neuronal tissues and the vasa nervorum, causing changes in nerve microvasculature with reduced nerve perfusion and endoneurial hypoxia. Several pathomechanisms contribute to peripheral nerve injury in DPN, including oxidative stress, mitochondrial dysfunction, inflammation, and altered gene regulation. Recent research focuses on endoplasmic reticulum stress (ERS) and mediated cell apoptosis in the pathophysiology of DPN.
DPN typically presents as a chronic, symmetrically distributed stocking glove, length-dependent sensorimotor polyneuropathy. Sensory clinical manifestations include neuropathic pain, paresthesia, hyperesthesia, or hypoesthesia.7 Motor symptoms occur less frequently. DPN is associated with increased risks of foot ulcers, Charcot arthropathy, and lower extremity amputation8 and a greater risk of falling due to gait insecurity. Overall, DPN causes elevated healthcare costs. Pharmacologic treatment is limited to palliating neuropathic pain and paresthesia, whereas neuronal degeneration remains unaffected.
During the last decades, acupuncture was empirically applied for treatment of DPN, yielding positive reports.
The aim of the ACUDIN (ACUpuncture and laser acupuncture for treatment of DIabetic peripheral Neuropathy) trial was to quantify the effect of acupuncture on DPN in NCS and on patient-reported outcome measures (PROMs) and clinical variables compared with placebo.
INTERVENTIONS
The ACUDIN treatment concept was developed by acupuncture experts based on Traditional Chinese Medicine meridian theory and previously tested in a study for neuropathy of unknown cause. The bilateral acupuncture point selection consisted of two multiple local points, Ex-LE-10 (Bafeng) and Ex-LE-12 (Qiduan), and ST-34 (Lianqiu)with a total of 20 needles. According to Chinese medicine theory, Bafeng enhances the peripheral blood flow, Qiduan promotes local activation of Qi, and Lianqiu improves the Qi flow through meridians and Luo channels.This concept was standardized for all patients owing to a relatively even effect on local meridians caused by DPN.
All participants received 10 identical treatment sessions weekly for 10 consecutive weeks. Needle acupuncture was performed with sterile disposable stainless-steel needles 0.2 × 15 mm for Ex-LE-10 and Ex-LE-12, and 0.3 × 30 mm for ST-34, both manufactured by Wujiang City Cloud & Dragon Medical Devise Co. Ltd, China. After skin disinfection, needles were inserted perpendicularly to a depth of 0.2-0.3 cm at Qiduan, 0.8-1.2 cm at Bafeng, and 1.5-2.0 cm at Lianqiu. Depth varied with the thickness of the skin and subcutaneous tissues at the site of the acupuncture points. Needles remained in place for 20 minutes. They were then removed by a staff member not involved in further study procedures and disposed in puncture-resistant containers. Verum laser acupuncture was performed with two Laserneedle devices (European patent PCT/DE 102006008774.7) using multichannel semiconductor laser diodes for simultaneous acupoint stimulation. Activated diodes emitted a wavelength of 685 nm in continuous mode. Each channel provided an optical power of 35 mW. Power density was 2.3 kJ/cm2 per channel with a spot diameter of 500 μm.18 After local disinfection, laser needles were placed at an angle of 90° directly on the skin. With activation, laser radiation was emitted for 20 minutes, then deactivated automatically; laser needles were removed by a staff member not involved in further procedures. Placebo laser acupuncture was performed under identical conditions, but manipulating an invalid point on the laser device touch screen meant no laser light was emitted.
Acupuncturists are members of one registered German physicians society for acupuncture. They have completed a standardized training course, undertaken formal accreditation by examination, a period of supervised medical experience for administering interventions, and have been trained for the implementation of laser acupuncture.
PRIMARY OUTCOME
Of 180 participants, 172 completed the study. Sural SNAP and sural and tibial nerve conduction velocities improved significantly after 10 treatments when comparing needle acupuncture to placebo. Needle acupuncture showed earlier onset of action than laser acupuncture. PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture and for heat sensation following laser acupuncture.
Figure 1. Results Obtained by Nerve Conduction Studies. Data are presented as mean [SEM], CI 95%, *P < 0.05, **P < 0.001. (A) Group comparison of delta sural SNAP at week 15; (B) mean changes of sural SNAP from baseline to weeks 6 and 15; (C) group comparison of delta sural SNCV at week 15; (D) mean changes of sural SNCV from baseline to weeks 6 and 15; (E) group comparison of delta tibial MNCV at week 15; (F) mean changes of tibial MNCV from baseline to weeks 6 and 15; (G) group comparison of delta tibial MNAP at week 15; (H) mean changes of tibial MNAP from baseline to weeks 6 and 15. Subfigure A shows a significant improvement in the primary outcome variable sural SNAP induced by needle acupuncture but not by laser acupuncture compared with placebo. Subfigure B shows a faster onset of action for needle acupuncture compared with laser acupuncture and more pronounced effects after 15 weeks compared with 6 weeks for needle and laser acupuncture. Subfigure C shows a significant improvement of sural SNCV induced by needle acupuncture but not by laser acupuncture as compared with placebo. Subfigure D shows a faster onset of action for needle acupuncture compared with laser acupuncture and more pronounced effects after 15 weeks compared with 6 weeks for both needle and laser acupuncture. Subfigures E and F show a significant improvement of tibial MNCV induced by needle acupuncture but not by laser acupuncture as compared with placebo. Subfigures G and H show that no significant change of MNAP was achieved in any treatment group. SNAP, sensory nerve action potential; SNCV, sensory nerve conduction velocity; MNCV, motor nerve conduction velocity; MNAP, motor nerve action potential; CNA, classical needle acupuncture, VLA, verum laser acupuncture, PLA, placebo laser acupuncture.
CONCLUSONS
Classical needle acupuncture had significant effects on DPN. Improvement in NCS values presumably indicates structural neuroregeneration following acupuncture.
MY COMMENTS
Diabetic neuropathy needs to use Chinese herbs to control the whole disease progression, and combine with acupuncture to control symptoms.
Reference:
Gesa Meyer-Hamme , Thomas Friedemann , Johannes Greten , Christian Gerloff , Sven Schroeder. Electrophysiologically verified effects of acupuncture on diabetic peripheral neuropathy in type 2 diabetes: The randomized, partially double-blinded, controlled ACUDIN trial. J Diabetes. 2021 Jun;13(6):469-481. doi: 10.1111/1753-0407.13130.
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