Press needle combined with plum blossom needle improves diabetic peripheral neuropathy by inhibiting pro-inflammatory cytokines: a randomized controlled trial.

OBJECTIVE: To evaluate the clinical efficacy and safety of combined press needle and plum-blossom needle therapy in patients with diabetic peripheral neuropathy (DPN), and to explore its therapeutic mechanism related to neuroinflammation. METHODS: A total of 225 DPN patients were enrolled and randomly divided into a treatment group, a control group and a sham needle group at a 1:1:1 ratio. All participants received basic treatment with oral epalrestat and mecobalamin for 6 months. The treatment group was administered press needle embedding combined with plum-blossom needle tapping; the sham needle group received identical simulated operations using blunt sham needles without effective stimulation; the control group received no additional cutaneous acupuncture interventions. Serum levels of interleukin-1β (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) were detected as primary outcomes. Secondary outcomes included motor and sensory nerve conduction velocity (NCV), nerve action potential amplitudes, modified Toronto Clinical Neuropathy Score (mTCNS) and Total Neuropathy Score (TNS). RESULTS: After 6 months of treatment, the levels of TNF-α, IL-6 and IL-1β in the treatment group were significantly lower than those in the control group and the sham needle group (P < 0.001). The Cohen's d values of TNF-α, IL-6 and IL-1β in the treatment group at the 2nd, 4th and 6th month were 0.753-1.364, 0.517-1.456 and 0.756-1.681 respectively, which were 1.5 to 2 times those of the other two groups. Compared with baseline, the treatment group yielded statistically greater improvements in all measured sensory conduction velocity (SCV) and motor conduction velocity (MCV) (all P < 0.05). Compared with the treatment group after intervention, the control and sham needle groups had significantly lower median, ulnar and sural SCV, median and ulnar MCV, ulnar sensory amplitude, ulnar, peroneal and tibial motor amplitude (all P < 0.05).The improvements of mTCNS and TNS in the treatment group at the 2nd, 4th and 6th month were markedly superior to those in the control and sham needle groups (P < 0.001). CONCLUSION: Combined therapy of press needles and plum blossom needles lowers pro-inflammatory cytokine levels, elevates NCV, improves DPN-associated scale scores, and ameliorates the function of both small and large nerve fibers, with favorable safety and tolerability profiles. Its therapeutic mechanism may involve inhibition of persistent neuroinflammatory cascades. CLINICAL TRIAL REGISTRATION: http://itmctr.ccebtcm.org.cn, identifier ITMCTR2025000607.