Abstract
Introduction: Painful diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes mellitus and a major cause of disability and poor quality of life in patients with diabetes. In addition, health care costs associated with DPN are increasing. Given the challenges and limitations of current pharmacological treatments, traditional herbal remedies present a viable option. As a result, we formulated a new topical treatment, “NeuroHelp”. This study aims to evaluate the effectiveness of the herbal medicine “NeuroHelp” in combination with oral gabapentin, and B vitamins on DPN symptoms.
Methods: We conducted a double-blinded, placebo-controlled, randomized clinical trial with parallel design on 84 type 2 diabetes patients with painful diabetic neuropathy. The 84 eligible patients were randomly allocated to one of two groups, either the intervention group (herbal medicine in combination with oral gabapentin, and B vitamins) or the placebo group (placebo in combination with oral gabapentin, and B vitamins). Topical herbal medicine ingredients were made of Citrullus colocynthis, Matricaria chamomilla, Althaea officinalis, Rheum officinale, Capparis spinosa, and Trigouella foenum graecum. A topical placebo ointment, with a similar appearance, texture and smell to the herbal medicine was made by a medicine manufacturer. Patients were evaluated for tingling feet, feet numbness, pinprick sensation, cold feet, monofilament test results, tuning fork test results, and pain using visual analogue scale (VAS) at baseline and three weeks after intervention as primary outcomes.
Results: The mean age of patients was 54.45 ± 8.72 years, 23.81% were male and 76.19% were female. Other baseline characteristics and diabetes relevant parameters revealed no significant differences between the intervention and placebo groups. NeuroHelp herbal medicine in combination with oral gabapentin, and B vitamins significantly reduced VAS for pain (mm) compared to placebo group after three weeks 24.0 ± 22.9 VS. 44.3 ± 33.1 (p<0.002). It also reduced diabetic neuropathy symptoms after three weeks compared to the placebo group including tingling feet 0 vs. 20 (47.60%) (p<0.001), foot numbness 2 (4.80%) vs. 13 (31%) (p<0.001), pinprick sensation 2 (4.8%) vs. 13 (31%) (p<0.001), and cold feet 0 vs. 5 (11.90%) (p=0.049).
Conclusions: Our study showed that three weeks topical application of NeuroHelp in combination with oral gabapentin, and B vitamins could improve diabetic neuropathy symptoms.
Keywords
Diabetic neuropathy, Type 2 diabetes, Neuropathic pain, Clinical trial, Herbal medicine, Topical ointment, Uncontrolled blood glucose