Abstract
BackgroundDiabetic distal symmetric polyneuropathy (DSPN) is one of the most common microvascular complications of diabetes mellitus, and it has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and disability rate. The current medications for DSPN are not entirely satisfactory. Preliminary studies indicated that the Chinese herbal TangBi Formula may alleviate signs and symptoms and improve the velocity of nerve conduction in patients with DSPN. This study was designed to determine if Chinese herbal medicine used in combination with conventional treatment is more effective than conventional treatment alone.Methods/designWe are conducting a multicenter, placebo-controlled, double-blind, randomized, controlled clinical trial as a means of assessing the therapeutic effects of traditional Chinese medicine (TCM) treatment. A total of 188 patients will be randomized in a 1:1 ratio to a treatment group (TangBi Formula plus mecobalamin) and a control group (placebo plus mecobalamin). The test period lasts 6 months, during which all of the patients will be given standard medical care as recommended by established guidelines. The primary outcome will be development of differences in changes in clinical symptoms and signs in patients and changes in Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. The secondary outcome will be changes in nerve conduction velocity and in single clinical signs and symptoms. Safety assessments and adverse events will also be evaluated.DiscussionWe postulate that patients with DSPN will benefit from therapy that includes TCM. If successful, this work will provide an evidence-based complementary therapeutic approach for treatment of DSPN.Trial registrationClinicalTrials.gov, NCT03010241. Registered on 2 January 2017
Highlights
Diabetic distal symmetric polyneuropathy (DSPN) is one of the most common microvascular complications of diabetes mellitus, and it has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and disability rate
We postulate that patients with DSPN will benefit from therapy that includes traditional Chinese medicine (TCM)
A superiority trial is planned to test the hypothesis that TangBi Formula used in combination with conventional treatment is more effective than conventional treatment alone in alleviating the clinical symptoms of DSPN and improving NCV of patients with DSPN
Summary
The aim of DSPN treatment is to decrease symptoms and reduce the risk of hospital admission, raise quality-of-life standards, and reduce the incidence of disability. Some types of TCM therapy, such as Tang-tong-fang, have been shown to be beneficial in patients with DPN, a common complication secondary to diabetic microvascular injury [22]. Reports have shown that TCM has had some success in the treatment of DPN. Some studies concentrate on nerve repair and regeneration, signaling pathways, neurotrophic factor, free radicals, and so forth [23,24,25,26,27], but there is less clinical research on the interaction of DSPN with TCM. At the time of manuscript submission, 73 patients had been recruited, and no subject had yet completed the treatment
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