A randomized controlled trial of Kangfuxin Liquid for diabetic peripheral neuropathy

Kangfuxin Liquid, a traditional Chinese medicine preparation, has been widely used in the clinical practice. However, its effects on improving neuropathic symptoms and nerve conduction function in patients with diabetic peripheral neuropathy (DPN) have not been fully elucidated.

To evaluate the efficacy and safety of Kangfuxin Liquid when applied topically to the lower legs in patients with DPN.

A single-center, randomized, controlled design was employed. DPN patients were enrolled and randomly assigned in a 1:1 ratio to either the Kangfuxin Liquid group or the placebo group. All participants underwent a daily 20-min topical application for two weeks, using gauze saturated with 50 mL of the assigned solution on both lower limbs, covered with cling film. Assessments were performed at baseline and post-treatment, including the Toronto Clinical Neuropathy Score (TCSS), nerve conduction velocity (NCV), inflammatory markers (CRP, TNF-α, IL-6), and glycemic-related parameters.

The study enrolled 73 patients (42 males [57.5%] and 31 females [42.5%]) with a mean age of 66.85 ± 8.70 years. After 2 weeks of treatment, the Kangfuxin Liquid group demonstrated significant improvements from baseline in the total TCSS score, symptom score, and sensory test score, with both the total score and symptom score being significantly lower than those in the placebo group (P < 0.05). Regarding nerve conduction, the sensory conduction velocity of the common peroneal nerve and tibial nerve increased significantly from baseline in the Kangfuxin Liquid group, and the post-treatment tibial nerve conduction velocity was superior to that of the placebo group. There were no statistically significant differences in inflammatory markers or the incidence of adverse events between the two groups. Only two cases of skin allergy were reported in the Kangfuxin Liquid group.

Short-term use of Kangfuxin Liquid can improve symptoms and partial nerve conduction function (sensory nerve conduction velocity in the tibial nerve), in DPN patients, with a favorable safety profile.