title: The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.
abstract: BACKGROUND
  Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone.
  
  
  METHODS
  A total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2 h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA-β) were also evaluated.
  
  
  RESULTS
  At week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69-1.14 for the Jinlida group vs. 0.34-0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2 h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported.
  
  
  CONCLUSIONS
  Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy.
  
  
  BACKGROUND
  Chinese Clinical Trial Register ChiCTR-TRC-13003159.
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Fengmei
authors.initials: F
authors.lastname: Lian
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Jiaxing
authors.initials: J
authors.lastname: Tian
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Xinyan
authors.initials: X
authors.lastname: Chen
authors.affiliation: Shijiazhuang Hospital of Traditional Chinese Medicine, Shijiazhuang, China.
authors.forename: Zhibin
authors.initials: Z
authors.lastname: Li
authors.affiliation: The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
authors.forename: Chunli
authors.initials: C
authors.lastname: Piao
authors.affiliation: Shanxi Province Hospital of Traditional Chinese Medicine, Taiyuan, China.
authors.forename: Junjie
authors.initials: J
authors.lastname: Guo
authors.affiliation: Bethune International Peace Hospital, Shijiazhuang, China.
authors.forename: Licheng
authors.initials: L
authors.lastname: Ma
authors.affiliation: The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine, Taiyuan, China.
authors.forename: Lijuan
authors.initials: L
authors.lastname: Zhao
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Chengdong
authors.initials: C
authors.lastname: Xia
authors.affiliation: Tang Center for Herbal Medicine Research, University of Chicago, Chicago, IL, United States of America.
authors.forename: Chong-Zhi
authors.initials: CZ
authors.lastname: Wang
authors.affiliation: Tang Center for Herbal Medicine Research, University of Chicago, Chicago, IL, United States of America.
authors.forename: Chun-Su
authors.initials: CS
authors.lastname: Yuan
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Tong
mesh_terms: D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007333:Insulin Resistance / Q000502:physiology; D050417:Insulin-Secreting Cells / Q000187:drug effects / Q000378:metabolism; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged
chemical_list: D004365:Drugs, Chinese Herbal; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C517652:hemoglobin A1c protein, human; C000601818:jinlida