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Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional chinese medicine: a systematic review.
Abstract
BACKGROUND:
After the publication of the CONSORT 2010 statement, few studies have been conducted to assess the reporting quality of randomized clinical trials (RCTs) on treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) published in Chinese journals.
OBJECTIVE:
To investigate the current situation of the reporting quality of RCTs in leading medical journals in China with the CONSORT 2010 statement as criteria.
METHODS:
The China National Knowledge Infrastructure (CNKI) electronic database was searched for RCTs on the treatment of diabetes mellitus with TCM published in the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica from January to December 2011. We excluded trials reported as “animal studies”, “in vitro studies”, “case studies”, or “systematic reviews”. The CONSORT checklist was applied by two independent raters to evaluate the reporting quality of all eligible trials after discussing and comprehending the items thoroughly. Each item in the checklist was graded as either “yes” or “no” depending on whether it had been reported by the authors.
RESULTS:
We identified 27 RCTs. According to the 37 items in the CONSORT checklist, the average reporting percentage was 45.0{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, in which the average reporting percentage for the “title and abstract”, the “introduction”, the “methods”, the “results”, the “discussion” and the “other information” was 33.3{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, 88.9{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, 36.4{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, 54.4{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, 71.6{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f} and 14.8{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, respectively. In the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica the average reporting percentage was 42.2{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, 56.8{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, and 46.0{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f}, respectively.
CONCLUSIONS:
The reporting quality of RCTs in these three journals was insufficient to allow readers to assess the validity of the trials. We recommend that editors require authors to use the CONSORT statement when reporting their trial results as a condition of publication.
Association of Traditional Chinese Medicine Therapy and the Risk of Vascular Complications in Patients With Type II Diabetes Mellitus: A Nationwide, Retrospective, Taiwanese-Registry, Cohort Study.
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{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f} decreased risk of stroke (95{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f} 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.
Integrative traditional Chinese medicine therapy reduces the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE:
Life-long insulin is the standard treatment for type 1 diabetes mellitus (T1DM). The role of traditional Chinese medicine (TCM) in T1DM is still not clear. The aim of this study is to explore the prescription pattern of TCM and its impact on the risk of diabetic ketoacidosis (DKA) in patients with T1DM.
MATERIALS AND METHODS:
We retrieved samples from the registry for catastrophic illness patients from the National Health Insurance Research Database (NHIRD). Based on a frequency (1:4) matched case-control design, patients with T1DM in 2000-2011 were designated as cases (TCM users) and controls (non-TCM users). TCM treatment for patients with T1DM was analyzed. The incidence of DKA and the annual costs of emergency visits and hospitalizations were evaluated for all causes.
RESULTS:
Overall, 416 subjects were TCM users, whereas a total of 1608 matched subjects were classified as non-TCM users. The most common Chinese herbal formula and single herb is Liu-wei-di-huang-wan (Six-ingredient pill of Rehmannia) and Huang-qi (Radix Astragali; Astragalus membranaceus (Fisch.) Bunge, Astragalus membranaceus var. mongholicus (Bunge) P.K.Hsiao), respectively. Compared with non-TCM users, we found a 33{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f} reduction in DKA incidence for all TCM users (aHR 0.67, 95{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f} CI 0.56-0.81, p <0.000) and a 40{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f} reduction for users receiving TCM treatment for more than 180 days (aHR 0.58, 95{d382666222b3cff0b1122f689bebcc8d35b41f83934c69a0d9586603ddee8f2f} CI 0.41-0.82, p <0.01). There were no significant differences between TCM users and non-users in the frequency and medical costs of emergency visits and hospitalizations.
CONCLUSIONS:
Integrative TCM use may reduce the risk of DKA in patients with T1DM. Our results suggest that TCM may have a substantial positive impact on the management of TIDM.
