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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.

Lian F, Tian J, Chen X, Li Z, Piao C, Guo J, Ma L, Zhao L, Xia C, Wang CZ, Yuan CS, Tong X - PLoS ONE (2015)

Bottom Line: There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01).No serious adverse events were reported.Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone.

View Article: PubMed Central - PubMed

Affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

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.

Conclusion: 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.

Trial registration: Chinese Clinical Trial Register ChiCTR-TRC-13003159.

No MeSH data available.


Related in: MedlinePlus

Flow diagram of participant screening, randomization, and treatment.Four subjects in the Jinlida group and 2 subjects in the placebo group were excluded from the study due to various reasons listed.
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pone.0130550.g001: Flow diagram of participant screening, randomization, and treatment.Four subjects in the Jinlida group and 2 subjects in the placebo group were excluded from the study due to various reasons listed.

Mentions: Based on our previous clinical practice using Jinlida in the treatment in this study patient population, i.e., type 2 diabetes patients ineffectively controlled with metformin monotherapy, we noticed that the HbA1c level generally reduced 0.5% or more, and this observation was supported by a pilot study in five patients. Thus, with HbA1c 0.5% reduction with Jinlida, we need to enroll 77 subjects per group to ensure an 80% power to detect that the Jinlida group has a significantly better effect on HbA1c than that of placebo group. Considering factors such as dropouts, 96 subjects were recruited per group (Fig 1, S1 File).


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.

Lian F, Tian J, Chen X, Li Z, Piao C, Guo J, Ma L, Zhao L, Xia C, Wang CZ, Yuan CS, Tong X - PLoS ONE (2015)

Flow diagram of participant screening, randomization, and treatment.Four subjects in the Jinlida group and 2 subjects in the placebo group were excluded from the study due to various reasons listed.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4476735&req=5

pone.0130550.g001: Flow diagram of participant screening, randomization, and treatment.Four subjects in the Jinlida group and 2 subjects in the placebo group were excluded from the study due to various reasons listed.
Mentions: Based on our previous clinical practice using Jinlida in the treatment in this study patient population, i.e., type 2 diabetes patients ineffectively controlled with metformin monotherapy, we noticed that the HbA1c level generally reduced 0.5% or more, and this observation was supported by a pilot study in five patients. Thus, with HbA1c 0.5% reduction with Jinlida, we need to enroll 77 subjects per group to ensure an 80% power to detect that the Jinlida group has a significantly better effect on HbA1c than that of placebo group. Considering factors such as dropouts, 96 subjects were recruited per group (Fig 1, S1 File).

Bottom Line: There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01).No serious adverse events were reported.Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone.

View Article: PubMed Central - PubMed

Affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

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.

Conclusion: 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.

Trial registration: Chinese Clinical Trial Register ChiCTR-TRC-13003159.

No MeSH data available.


Related in: MedlinePlus