Introduction and Objective: Diabetic polyneuropathy (DPN) is one of the main complications of T2D, with increased axonal degeneration due to poor glycaemic control. However, it is still undiagnosed, and treatment is limited to pain relief, but with potential side effects. Thus, other therapies, aselectroacupuncture (EA) have been proposed but with inconclusive results. Therefore, the interest of developing a randomized controlled trial (RCT) to evaluate the effect of EA on neuropathic symptoms by MNSI, MDNS, DN-4 and NRS, and electrophysiological parameters in patients with axonal DPN and T2D, compared to a sham EA control group.
Methods: This is a RCT, double-blinded, conducted in 18 patients with T2D, clinical and electrophysiological diagnosis of axonal DPN; treated with sham EA or EA, in a total of 16 sessions during two months. Statistical analysis was performed using the SPSS program, version 25. Given the sample size, non parametric statistics were used. Mann-Whitney U test and Wilcoxon statistic were applied to evaluate differences between and within each group, respectively. The protocol is still under development. It has been registered in ClinicalTrials (NCT05521737), and ICTRP (ISRCTN97391213).
Results: At baseline, patients had a median age of 56 years, with T2D progression of 15 years; at least a 72.2%reported DPN symptoms. However, just the 38.9% had previous clinical diagnosis. After intervention, EA group showed a significant reduction on neuropathic symptoms by MNSI (from 7.11 ± 1.90 to 3.89 ± 1.36), MDNS (10.89 ± 5.53 to 6.89 ± 4.08), DN-4 (5.56 ± 3 to 2.78 ± 1.92) and NRS scores (6.28 ± 1.42 to 2.33 ± 1.60); while Sham EA group had no statistical differences. On the other hand, right peroneal motor nerve conduction velocity decreased in Sham EA group (from 46.57 ± 9.69 m/s to 37.73 ± 4.68 m/s, p < 0.05), while in EA group did not change.
Conclusion: EA may delay DPN damage progression. However, further analyses are required.
M.F. Pérez Hernández: Research Support; Fundación IMSS, Secretaría de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México, Consejo Nacional de Humanidades, Ciencias y Tecnologías. A. Calderón Vallejo: None. D.C. Gómez Jiménez: None. E. Rodríguez Guerrero: None. J. Ordóñez Rodríguez: None. M.L. Gómez Esquivel: None. F. Aguilar Morales: None. M.G. Moreno Tovar: None. M.A. Zurita Muñoz: None. M.E. Ocharan Hernández: None. C.C. Calzada Mendoza: None. M. Cruz López: None. J. Peralta Romero: Research Support; Consejo Nacional de humanidades, Ciencia y Tecnologías (CONAHCYT), Instituto Mexicano del Seguro Social (IMSS), Secretaria de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México (SECTEI).
Instituto Mexicano del Seguro Social (R-2020-785-070); Secretarfa de Educaci=n, Ciencia, Tecnologfa e Innovaci=n (SECTEI) de la Ciudad de MTxico (SECTEI 132/2023); Consejo Nacional de Humanidades, Ciencias y Tecnologfas