Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial

De Jin, Wen-Jing Huang, Xiang Meng, Fan Yang, Yu-Jiao Zheng, Qi Bao, Mei-Zhen Zhang, Ya-Nan Yang, Qing Ni, Feng-Mei Lian, Xiao-Lin Tong, De Jin, Wen-Jing Huang, Xiang Meng, Fan Yang, Yu-Jiao Zheng, Qi Bao, Mei-Zhen Zhang, Ya-Nan Yang, Qing Ni, Feng-Mei Lian, Xiao-Lin Tong

Abstract

Background: 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. 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/design: We 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.

Discussion: We 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 registration: ClinicalTrials.gov, NCT03010241 . Registered on 2 January 2017.

Keywords: Clinical trials; Diabetic distal symmetric polyneuropathy; Traditional Chinese medicine; Treatment.

Conflict of interest statement

Authors’ information

XLT, MD, is a professor and supervisor; vice president of Guang’anmen Hospital of the China Academy of Chinese Medical Sciences; and chief physician of the Department of Endocrinology.

Ethics approval and consent to participate

The central independent ethics committee of Guang An Men Hospital of the China Academy of Traditional Chinese Medicine has approved our study for the various centers (reference number 2016-092-KY-02), and patient consent was obtained before randomization.

Consent for publication

Each participant has provided consent to publish individual-patient data.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Entire design of this trial. DSPN Distal symmetric polyneuropathy
Fig. 2
Fig. 2
Treatment schedule. MDNS Michigan Diabetic Neuropathy Score
Fig. 3
Fig. 3
Content for the schedule of enrollment, interventions, and assessments

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