Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials

Traditional Chinese medicine (TCM) prescriptions lack standardization due to the complex composition of the prescribed herbs, the unclear mechanism of the formulas, and a lack of scientific data to support the dose-response relationship. Here, we proposed a new clinical strategy of dosage modificati...

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Autores principales:	Rongrong Zhou, Yujiao Zheng, Xuedong An, De Jin, Fengmei Lian, Xiaolin Tong
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	traditional Chinese medicine critical value indicator dosage modification indication Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/4ca0671a9ca54502a86bda5811f965de
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spelling	oai:doaj.org-article:4ca0671a9ca54502a86bda5811f965de2021-12-02T00:35:40ZDosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials1663-981210.3389/fphar.2021.732698https://doaj.org/article/4ca0671a9ca54502a86bda5811f965de2021-12-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fphar.2021.732698/fullhttps://doaj.org/toc/1663-9812Traditional Chinese medicine (TCM) prescriptions lack standardization due to the complex composition of the prescribed herbs, the unclear mechanism of the formulas, and a lack of scientific data to support the dose-response relationship. Here, we proposed a new clinical strategy of dosage modification for TCM prescriptions to evaluate the clinical efficacy and guide the clinical medication. This study used two TCM prescriptions for the treatment of newly diagnosed type 2 diabetes mellitus (T2DM) to explore the key indications and the most appropriate critical values of dosage modification by analyzing two randomized controlled trials (RCTs). In this study, the indications refer to a change in the indicators from baseline at a certain time point (week 4, week 8, week 12), which could predict the change in outcome indicators, and the critical values refer to the change ranges closely related to the decrease in HbA1c at week 12. In Study 1, the correlation analysis between the change range of indicators at three time points (weeks 4, 8, and 12) from baseline and the decrease in HbA1c at week 12 from baseline (HbA1c 012) was carried out to screen the related indications. Next, we evaluate the related indications and the respective critical values to determine the key indicators, indications, and the most appropriate critical value. We conducted a correlation between the change range of key indicators (obtained from the result of Study 1) at three time points from baseline and HbA1c 012 to screen the key indications in the drug group, high-dose group, and low-dose group in Study 2. Key indications with critical values were determined to investigate the most appropriate critical value in the three groups separately. In Study 1, the key indicator was FBG, the key indication was FBG 04, and the most appropriate critical value was 0.5 mmol/L. In Study 2, the key indication was FBG 04 and the most appropriate critical value was 0.6 mmol/L in the drug group. In the high-dose group, the key indication was FBG 04, and the most appropriate critical value was 0.3 mmol/L. In the low-dose group, the key indication was FBG08, and the most appropriate critical value was 0.1 mmol/L. In addition, we summarized a verification strategy for dosage modification.Rongrong ZhouYujiao ZhengXuedong AnDe JinFengmei LianXiaolin TongFrontiers Media S.A.articletraditional Chinese medicinecritical valueindicatordosage modificationindicationTherapeutics. PharmacologyRM1-950ENFrontiers in Pharmacology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	traditional Chinese medicine critical value indicator dosage modification indication Therapeutics. Pharmacology RM1-950
spellingShingle	traditional Chinese medicine critical value indicator dosage modification indication Therapeutics. Pharmacology RM1-950 Rongrong Zhou Yujiao Zheng Xuedong An De Jin Fengmei Lian Xiaolin Tong Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials
description	Traditional Chinese medicine (TCM) prescriptions lack standardization due to the complex composition of the prescribed herbs, the unclear mechanism of the formulas, and a lack of scientific data to support the dose-response relationship. Here, we proposed a new clinical strategy of dosage modification for TCM prescriptions to evaluate the clinical efficacy and guide the clinical medication. This study used two TCM prescriptions for the treatment of newly diagnosed type 2 diabetes mellitus (T2DM) to explore the key indications and the most appropriate critical values of dosage modification by analyzing two randomized controlled trials (RCTs). In this study, the indications refer to a change in the indicators from baseline at a certain time point (week 4, week 8, week 12), which could predict the change in outcome indicators, and the critical values refer to the change ranges closely related to the decrease in HbA1c at week 12. In Study 1, the correlation analysis between the change range of indicators at three time points (weeks 4, 8, and 12) from baseline and the decrease in HbA1c at week 12 from baseline (HbA1c 012) was carried out to screen the related indications. Next, we evaluate the related indications and the respective critical values to determine the key indicators, indications, and the most appropriate critical value. We conducted a correlation between the change range of key indicators (obtained from the result of Study 1) at three time points from baseline and HbA1c 012 to screen the key indications in the drug group, high-dose group, and low-dose group in Study 2. Key indications with critical values were determined to investigate the most appropriate critical value in the three groups separately. In Study 1, the key indicator was FBG, the key indication was FBG 04, and the most appropriate critical value was 0.5 mmol/L. In Study 2, the key indication was FBG 04 and the most appropriate critical value was 0.6 mmol/L in the drug group. In the high-dose group, the key indication was FBG 04, and the most appropriate critical value was 0.3 mmol/L. In the low-dose group, the key indication was FBG08, and the most appropriate critical value was 0.1 mmol/L. In addition, we summarized a verification strategy for dosage modification.
format	article
author	Rongrong Zhou Yujiao Zheng Xuedong An De Jin Fengmei Lian Xiaolin Tong
author_facet	Rongrong Zhou Yujiao Zheng Xuedong An De Jin Fengmei Lian Xiaolin Tong
author_sort	Rongrong Zhou
title	Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials
title_short	Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials
title_full	Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials
title_fullStr	Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials
title_full_unstemmed	Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials
title_sort	dosage modification of traditional chinese medicine prescriptions: an analysis of two randomized controlled trials
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/4ca0671a9ca54502a86bda5811f965de
work_keys_str_mv	AT rongrongzhou dosagemodificationoftraditionalchinesemedicineprescriptionsananalysisoftworandomizedcontrolledtrials AT yujiaozheng dosagemodificationoftraditionalchinesemedicineprescriptionsananalysisoftworandomizedcontrolledtrials AT xuedongan dosagemodificationoftraditionalchinesemedicineprescriptionsananalysisoftworandomizedcontrolledtrials AT dejin dosagemodificationoftraditionalchinesemedicineprescriptionsananalysisoftworandomizedcontrolledtrials AT fengmeilian dosagemodificationoftraditionalchinesemedicineprescriptionsananalysisoftworandomizedcontrolledtrials AT xiaolintong dosagemodificationoftraditionalchinesemedicineprescriptionsananalysisoftworandomizedcontrolledtrials
_version_	1718403614352867328

Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials

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