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Association of Traditional Chinese Medicine Therapy and the Risk of Vascular Complications in Patients With Type II Diabetes Mellitus

View Article: PubMed Central - PubMed

ABSTRACT

With an increasing use of traditional Chinese medicine (TCM) in type 2 diabetes mellitus (T2DM), evidence of long-term benefit with adjunctive TCM treatment is limited. This study investigated whether the concurrent TCM treatment reduces the risk of vascular complications in T2DM patients by using a large population from National Health Insurance Research Database (NHIRD).

We identified 33,457 adult patients with newly diagnosed T2DM using anti-diabetic agents from a random sample of one million beneficiaries in the NHIRD between January 1, 2000 and December 31, 2011. We recruited 1049 TCM users (received TCM over 30 days with a diagnosis of T2DM) and randomly selected 4092 controls as the non-TCM cohort at a ratio of 1:4 frequency-matched by age, sex, hypertension, hyperlipidemia, and index year. We investigated the prescription pattern of TCM and conducted a Cox proportional hazards regression to calculate the hazard ratios (HRs) of stroke, chronic kidney diseases (CKD), and diabetic foot between the 2 cohorts.

In the TCM cohort, the prescription pattern of TCM was different between insulin and noninsulin patients. The most common herbs were Dan-Shen (Radix Salviae Miltiorrhizae) in noninsulin group and Da-Huang (Radix et Rhizoma Rhei) in insulin group. The most common formulae were Liu-Wei-Di-Huang-Wan in noninsulin group and Yu-Quan-Wan in insulin group. Although no significant reduction in the hazard ratio of CKD and diabetic foot, the incidence rate of stroke was 7.19 per 1000 person-years in the TCM cohort and 10.66 per 1000 person-years in the control cohort, respectively. After adjustment of age, sex, hypertension, hyperlipidemia, and antidiabetes agent use (including sulfonylureas, α-glucosidase, metformin, meglitinide, thiazolidinediones, and insulin), TCM cohorts were found to have a 33% decreased risk of stroke (95% CI = 0.46–0.97; P < 0.05).

This population-based retrospective study showed that the complementary TCM therapy might associate with the decreased risk of stroke in T2DM, suggesting TCM as an adjunctive therapy for T2DM to prevent subsequent stroke.

No MeSH data available.


Related in: MedlinePlus

Flow recruitment chart of newly diagnosed type 2 diabetes mellitus patients from a random sample of 1 million individuals from the National Health Insurance Research Database in Taiwan. NHIRD = National Health Insurance Research Database; T2DM = type 2 diabetes mellitus; TCM = traditional Chinese medicine.
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Figure 1: Flow recruitment chart of newly diagnosed type 2 diabetes mellitus patients from a random sample of 1 million individuals from the National Health Insurance Research Database in Taiwan. NHIRD = National Health Insurance Research Database; T2DM = type 2 diabetes mellitus; TCM = traditional Chinese medicine.

Mentions: The subjects were selected from the random 1 million individuals as follows (Figure 1). We considered patients to be T2DM sufferers if antidiabetic medication had been prescribed. First, we included patients who were newly diagnosed T2DM (ICD-9-CM 250.00, 250.000, and 250.02) and treated with antidiabetic agents between January 1, 2000 and December 31, 2011 (n = 33,457). Patients using TCM over 30 days with a diagnosis of T2DM were defined as TCM users, whereas those treated for less than 30 days were considered as non-TCM users. Their use of antidiabetes agent, including sulfonylureas, α-glucosidase, metformin, meglitinide, thiazolidinediones, and insulin, was also analyzed. The index date in TCM users was defined the 30th day under TCM treatment. We excluded patients with a history of stroke (ICD-9-CM 430–438), chronic kidney diseases (CKD) (ICD-9-CM 585, 250.40 or 250.42), diabetic foot (ICD-9-CM 682.7, 682.9, 444.22, 728.86, 707.0–707.7 or operation for amputation, debridement, or ostectomy), trauma, or fracture within 180 days before the date of index date, leaving 1049 diabetic patients. To assemble a comparison cohort, we randomly selected controls who were matched with the study cohort at a ratio of 1:4 on frequency of age, sex, hypertension, hyperlipidemia, and index year as the comparison cohort, using the same exclusion criteria during the same period. Finally, we selected 1049 patients as the TCM-combined cohort (mean age = 53.4 years, SD = 11.1 years). The 4092 controls (mean age = 53.7 years, SD = 10.7 years) comprised patients who received TCM <30 days following their T2DM diagnosis and their index dates were randomly assigned as TCM users. The Institutional Review Board of the China Medical University and Hospital approved this study (CMU-REC-101–102).


Association of Traditional Chinese Medicine Therapy and the Risk of Vascular Complications in Patients With Type II Diabetes Mellitus
Flow recruitment chart of newly diagnosed type 2 diabetes mellitus patients from a random sample of 1 million individuals from the National Health Insurance Research Database in Taiwan. NHIRD = National Health Insurance Research Database; T2DM = type 2 diabetes mellitus; TCM = traditional Chinese medicine.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4998271&req=5

Figure 1: Flow recruitment chart of newly diagnosed type 2 diabetes mellitus patients from a random sample of 1 million individuals from the National Health Insurance Research Database in Taiwan. NHIRD = National Health Insurance Research Database; T2DM = type 2 diabetes mellitus; TCM = traditional Chinese medicine.
Mentions: The subjects were selected from the random 1 million individuals as follows (Figure 1). We considered patients to be T2DM sufferers if antidiabetic medication had been prescribed. First, we included patients who were newly diagnosed T2DM (ICD-9-CM 250.00, 250.000, and 250.02) and treated with antidiabetic agents between January 1, 2000 and December 31, 2011 (n = 33,457). Patients using TCM over 30 days with a diagnosis of T2DM were defined as TCM users, whereas those treated for less than 30 days were considered as non-TCM users. Their use of antidiabetes agent, including sulfonylureas, α-glucosidase, metformin, meglitinide, thiazolidinediones, and insulin, was also analyzed. The index date in TCM users was defined the 30th day under TCM treatment. We excluded patients with a history of stroke (ICD-9-CM 430–438), chronic kidney diseases (CKD) (ICD-9-CM 585, 250.40 or 250.42), diabetic foot (ICD-9-CM 682.7, 682.9, 444.22, 728.86, 707.0–707.7 or operation for amputation, debridement, or ostectomy), trauma, or fracture within 180 days before the date of index date, leaving 1049 diabetic patients. To assemble a comparison cohort, we randomly selected controls who were matched with the study cohort at a ratio of 1:4 on frequency of age, sex, hypertension, hyperlipidemia, and index year as the comparison cohort, using the same exclusion criteria during the same period. Finally, we selected 1049 patients as the TCM-combined cohort (mean age = 53.4 years, SD = 11.1 years). The 4092 controls (mean age = 53.7 years, SD = 10.7 years) comprised patients who received TCM <30 days following their T2DM diagnosis and their index dates were randomly assigned as TCM users. The Institutional Review Board of the China Medical University and Hospital approved this study (CMU-REC-101–102).

View Article: PubMed Central - PubMed

ABSTRACT

With an increasing use of traditional Chinese medicine (TCM) in type 2 diabetes mellitus (T2DM), evidence of long-term benefit with adjunctive TCM treatment is limited. This study investigated whether the concurrent TCM treatment reduces the risk of vascular complications in T2DM patients by using a large population from National Health Insurance Research Database (NHIRD).

We identified 33,457 adult patients with newly diagnosed T2DM using anti-diabetic agents from a random sample of one million beneficiaries in the NHIRD between January 1, 2000 and December 31, 2011. We recruited 1049 TCM users (received TCM over 30 days with a diagnosis of T2DM) and randomly selected 4092 controls as the non-TCM cohort at a ratio of 1:4 frequency-matched by age, sex, hypertension, hyperlipidemia, and index year. We investigated the prescription pattern of TCM and conducted a Cox proportional hazards regression to calculate the hazard ratios (HRs) of stroke, chronic kidney diseases (CKD), and diabetic foot between the 2 cohorts.

In the TCM cohort, the prescription pattern of TCM was different between insulin and noninsulin patients. The most common herbs were Dan-Shen (Radix Salviae Miltiorrhizae) in noninsulin group and Da-Huang (Radix et Rhizoma Rhei) in insulin group. The most common formulae were Liu-Wei-Di-Huang-Wan in noninsulin group and Yu-Quan-Wan in insulin group. Although no significant reduction in the hazard ratio of CKD and diabetic foot, the incidence rate of stroke was 7.19 per 1000 person-years in the TCM cohort and 10.66 per 1000 person-years in the control cohort, respectively. After adjustment of age, sex, hypertension, hyperlipidemia, and antidiabetes agent use (including sulfonylureas, &alpha;-glucosidase, metformin, meglitinide, thiazolidinediones, and insulin), TCM cohorts were found to have a 33% decreased risk of stroke (95% CI&#8202;=&#8202;0.46&ndash;0.97; P&#8202;&lt;&#8202;0.05).

This population-based retrospective study showed that the complementary TCM therapy might associate with the decreased risk of stroke in T2DM, suggesting TCM as an adjunctive therapy for T2DM to prevent subsequent stroke.

No MeSH data available.


Related in: MedlinePlus