Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol
Journal Title: Traditional Medicine Research - Year 2018, Vol 3, Issue 4
Abstract
Background:The rapid growth of type 2 diabetes mellitus (T2DM) remains a big challenge for clinicians worldwide. Traditional Chinese medicine may bring a new approach for solving this problem. The Tianqi Capsule Diabetes Prevention Study (REDUCES Study) reported that 1 years of therapy with Tianqi capsule reduced the risk of diabetes by 32.1% compared with the placebo. Here we aimed to assess the long-term effect of Tianqi capsule on prevention of T2DM in people with impaired glucose tolerance after discontinuation of active intervention. Methods/design: 420 subjects will be followed-up for 8 years to assess the long-term effect of Tianqi capsule intervention. The causes of death and the status of living subjects will be investigated. Follow-up data for living subjects will be collected by personal interview and clinical examination and medical record review to determine diabetes status. Questionnaires will be given to all the subjects to investigate the factors that probably affect the diabetes status during the 8-year of discontinuation of intervention. The primary outcome is the incidence of T2DM, and the secondary outcomes are body mass index, blood glucose, blood lipids and blood pressure. The Cox proportional hazards model will be used to estimate the hazard ratio for diabetes incidence. Analyses will be done with SAS 8.2 software package. Discussion: Results from this study may provide evidence for the long-term efficacy of Tianqi capsule in patients with prediabetes. The findings will provide a basis for further confirmatory studies. Ethics: The protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital of China Academy of Chinese Medical Sciences (approval number 2016-046-KY-01). Study registration number: ClinicalTrials.gov; NCT02848053.
Authors and Affiliations
Bing Pang, Chun-Yong Han, Qing-Hu He, Jing Liu, Qing-Wei Li, Yu-Jiao Zheng, Feng-Mei Lian, Xiao-Lin Tong
Keywords
Related Articles
- EP ID EP45224
- DOI 10.12032/TMR201812075
- Views 265
- Downloads 0
Astragalus injection as an adjuvant treatment for colorectal cancer: a meta-analysis
Background: The combination of Chinese patent medicine Astragalus injection and Western medicine has achieved a certain clinical effect in colorectal cancer patients. However, due to the uneven basic conditions and resea...
Pharmacological research progress of ursolic acid for the treatment of liver diseases
Ursolic acid is a natural pentacyclic triterpenoid with various pharmacological activities such as anti-inflammatory, hepatoprotective, antitumor, and hypoglycemic activity. This natural product is widely present in many...
A prospective, randomized controlled trial of sanguisorba oil in the treatment of tamoxifen-related vaginitis in breast cancer patients
This study provides further insights into the clinical efficacy of sanguisorba oil in the treatment of tamoxifen-related (TAM) vaginitis in breast cancer patients. Sanguisorba oil for external use was effective in the tr...
Evaluating the clinical efficacy of Thunder-Fire moxibustion combined with ovulation monitoring in the treatment of adenomyosis combined with infertility
This study evaluated the clinical efficacy of Thunder-Fire moxibustion combined with ovulation monitoring for the treatment of adenomyosis-associated infertility. A series of 120 patients diagnosed with uterine adenomyos...
Effects of acupuncture treatment for irritable bowel syndrome: a systematic review and meta-analysis
his article has selected a variety of major medical retrieval system. Based on the Meta-Analysis of the 17 documents, the effect of different types of acupuncture on irritable bowel syndrome in 4 evaluation criteria was...