The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial.
<h4>Background</h4>In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly cont...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2019-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0221199 |
| _version_ | 1818729673239035904 |
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| author | Yueh-Hsiang Huang Szu-Tah Chen Feng-Hsuan Liu Sheng-Hwu Hsieh Chia-Hung Lin Miaw-Jene Liou Chih-Ching Wang Chung-Huei Huang Geng-Hao Liu Jr-Rung Lin Lan-Yan Yang Tzu-Yang Hsu Ming-Chung Lee Chun-Teng Huang Yi-Hong Wu |
| author_facet | Yueh-Hsiang Huang Szu-Tah Chen Feng-Hsuan Liu Sheng-Hwu Hsieh Chia-Hung Lin Miaw-Jene Liou Chih-Ching Wang Chung-Huei Huang Geng-Hao Liu Jr-Rung Lin Lan-Yan Yang Tzu-Yang Hsu Ming-Chung Lee Chun-Teng Huang Yi-Hong Wu |
| author_sort | Yueh-Hsiang Huang |
| collection | DOAJ |
| description | <h4>Background</h4>In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly controlled type 2 diabetes. YH1 is a concentrated Chinese herbal extract formula that combines Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San. This randomized, double-blind, placebo-controlled pilot study evaluated YH1 as an add-on medication for poorly controlled type 2 diabetes.<h4>Methods</h4>Forty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation.<h4>Results</h4>At week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of β cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial.<h4>Conclusions</h4>This pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and β-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification. |
| first_indexed | 2024-12-17T22:49:37Z |
| format | Article |
| id | doaj.art-56a7e06c118e4cd68dfc061d7027b1b2 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-17T22:49:37Z |
| publishDate | 2019-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-56a7e06c118e4cd68dfc061d7027b1b22022-12-21T21:29:42ZengPublic Library of Science (PLoS)PLoS ONE1932-62032019-01-01148e022119910.1371/journal.pone.0221199The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial.Yueh-Hsiang HuangSzu-Tah ChenFeng-Hsuan LiuSheng-Hwu HsiehChia-Hung LinMiaw-Jene LiouChih-Ching WangChung-Huei HuangGeng-Hao LiuJr-Rung LinLan-Yan YangTzu-Yang HsuMing-Chung LeeChun-Teng HuangYi-Hong Wu<h4>Background</h4>In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly controlled type 2 diabetes. YH1 is a concentrated Chinese herbal extract formula that combines Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San. This randomized, double-blind, placebo-controlled pilot study evaluated YH1 as an add-on medication for poorly controlled type 2 diabetes.<h4>Methods</h4>Forty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation.<h4>Results</h4>At week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of β cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial.<h4>Conclusions</h4>This pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and β-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification.https://doi.org/10.1371/journal.pone.0221199 |
| spellingShingle | Yueh-Hsiang Huang Szu-Tah Chen Feng-Hsuan Liu Sheng-Hwu Hsieh Chia-Hung Lin Miaw-Jene Liou Chih-Ching Wang Chung-Huei Huang Geng-Hao Liu Jr-Rung Lin Lan-Yan Yang Tzu-Yang Hsu Ming-Chung Lee Chun-Teng Huang Yi-Hong Wu The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. PLoS ONE |
| title | The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. |
| title_full | The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. |
| title_fullStr | The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. |
| title_full_unstemmed | The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. |
| title_short | The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. |
| title_sort | efficacy and safety of concentrated herbal extract granules yh1 as an add on medication in poorly controlled type 2 diabetes a randomized double blind placebo controlled pilot trial |
| url | https://doi.org/10.1371/journal.pone.0221199 |
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