Dataset Information

Clinical efficacy and safety of traditional Chinese patent medicine for hyperthyroid heart disease: study protocol for a systematic review and meta-analysis.

ABSTRACT:

Background

Hyperthyroid heart disease (HHD), one of the most common complications of hyperthyroidism, is a serious public health problem due to the direct toxic or indirect effects of excessive thyroid hormone on the heart, resulting in high mortality and increasing health care costs. Traditional Chinese patent medicines (TCPMs), developed by combining modernized pharmaceutical technologies with ancient TCM theories, have been widely used in the treatment of HHD. However, the safety and efficacy of TCPMs used in patients with HHD has been uncertain and there has been no standard clinical trial published to confirm this. Thus, we conduct a study to evaluate the safety and efficacy of TCPMs for HHD.

Methods

The reference lists of randomized controlled trials and 8 electronic databases will be independently and systematically searched by 2 review authors in August 2018. Four English databases [EMBASE, PubMed, National Guideline Clearinghouse (NGC), and Cochrane Central Register of Controlled Trials (CENTRAL)] and 4 Chinese databases [Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure [CNKI], Wanfang Database, and VIP Database] will be included. The primary outcomes will be assessed according to the effective rate of treatment, electrocardiogram, and thyroid hormone levels. Data synthesis will be precisely computed using the RevManV5.3 software when a data-analysis is allowed. Methodological quality will be assessed according to Cochrane Handbook.

Results

This study will provide a high-quality synthesis of current evidence of TCPMs for HHD from different aspects, including the clinical symptoms, thyroid hormone levels, and ECG changes.

Conclusion

The conclusion of this systematic review will provide evidence to prove whether TCPMs are effective therapeutic intervention for patient with HHD.

SUBMITTER: Wang Q

PROVIDER: S-EPMC6250447 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical efficacy and safety of traditional Chinese patent medicine for hyperthyroid heart disease: study protocol for a systematic review and meta-analysis.

Wang Qing Q Li Chun C Di Sha S Han Lin L Zhao Linhua L Tong Xiaolin X

Medicine 20181101 45

<h4>Background</h4>Hyperthyroid heart disease (HHD), one of the most common complications of hyperthyroidism, is a serious public health problem due to the direct toxic or indirect effects of excessive thyroid hormone on the heart, resulting in high mortality and increasing health care costs. Traditional Chinese patent medicines (TCPMs), developed by combining modernized pharmaceutical technologies with ancient TCM theories, have been widely used in the treatment of HHD. However, the safety and ...[more]

PMID: 30407305

Similar Datasets

Project description:Background:Traditional Chinese Patent Medicine (TCPM) is now being used more and more extensively for primary hypertension in China. However, the comparative efficacy and safety of it need more clarified evidence. Thus, we conducted a Bayesian network meta-analysis to compare TCPMs with other interventions. Methods:We searched China National Knowledge Infrastructure (CNKI), WanFang Data, PubMed, Embase, and Cochrane Library from inception to April 2019 for randomized controlled trials (RCTs) with diagnosis of primary hypertension that compared the efficacy of TCPMs with antihypertension drugs (ADs). Two researchers screened literature, extracted data, and evaluated risk of bias independently. The primary outcomes were systolic blood pressure (SBP) and diastolic blood pressure (DBP). The secondary outcomes were adverse effects (AEs), total cholesterol (TC), and triglyceride (TG). We used the Bayesian network meta-analysis to compare interventions and described the categorical variable and the continuous variable as odds ratio (OR) and mean difference (MD), respectively. Besides, we ranked all interventions via the Surface Under the Cumulative Ranking (SUCRA) values and conducted metaregression with nine covariates as additional analysis. Results:We included 192 studies with 23366 patients diagnosed as primary hypertension in total. For SBP reduction, eighteen interventions were significantly better than AD. Among them, Yinxingye (YXY) + AD (MD = -12, 95% CrI [-16, -8.5]) was superior to others in the rank plot with SUCRA 0.91. For DBP reduction, sixteen interventions were significantly better than AD. Among them, Qinggan Jiangya (QGJY) + AD (MD = -8.7, 95% CrI [-12, -5.5]) and Qiju Dihuang (QJDH) + AD (MD = -8.8, 95% CrI [-12, -5.2]) were superior to others in the rank plot with SUCRA 0.89. To summarize the SUCRA values, we found that QGJY + AD and YXY + AD had the most significant reductions for both SBP and DBP. YXY + AD was the best one for both TC (MD = -1.3, 95% CrI [-1.9, -0.64]) and TG (MD = -0.52, 95% CrI [-0.92, -0.11]) reductions. Considering adverse effects, we found two interventions had significant differences comparing with AD. Among them, YXY + AD was the best one with SUCRA of 0.01. Conclusion:In all TCPMs, QGJY + AD and YXY + AD may be the best options for hypertension. Meanwhile, YXY + AD can improve blood lipids in patients with hypertension. However, due to the vague reports of adverse effects and other limitations, more evidence, especially that provided by high-quality studies, is needed to prove the advantages of TCMPs.

Project description:BackgroundChronic heart failure (CHF) is a global public health problem. Therefore, novel and effective drugs that show few side-effects are needed. Early literature studies indicated that Huangqi injection is one of the most commonly used traditional Chinese patent medicines for CHF in China. As a large number of clinical studies has been carried out and published, it is essential to evaluate the effectiveness and safety of Huangqi injection. Therefore, we carried out this systematic review under the support of the framework of the Joint Sino-Italian Laboratory (JoSIL).ObjectivesTo evaluate the efficacy and safety of Huangqi injection for CHF according to the available scientific knowledge.MethodsAn extensive search including PubMed, EMBASE, CBM, the Cochrane Library and Chinese literature databases was performed up to July 2008. Clinical trials regarding Huangqi injection for the treatment of CHF were searched for, irrespective of languages. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration and STATA 9.2 were used for data analysis.ResultsAfter selection of 1,205 articles, 62 RCTs and quasi-RCTs conducted in China and published in Chinese journals were included in the review. The methodological quality of the trials was low. In most trials inclusion and exclusion criteria were not specified. Furthermore, only one study evaluated the outcomes for drug efficacy after an adequate period of time. For these reasons and because of the different baseline characteristics we did not conduct a meta-analysis.ConclusionsAlthough available studies are not adequate to draw a conclusion on the efficacy and safety of Huangqi injection (a traditional Chinese patent medicine), we hope that our work could provide useful experience on further studies on Huangqi injections. The overall level of TCM clinical research needs to be improved so that the efficacy of TCM can be evaluated by the international community and possibly some TCM can enter into the international market.

Project description:ObjectivesBy performing an overview of systematic reviews and meta-analyses of the efficacy and safety of oral Chinese patent medicine combined with conventional therapy in the treatment of heart failure, to evaluate the reliability and applicability of the conclusions of the current studies and provide evidence for clinical decision-making.MethodsSystematic reviews and meta-analyses of oral Chinese patent medicine combined with conventional therapy treating heart failure were searched based on standardized search strategy in six electronic databases including PubMed, Embase, Cochrane Library (No. 2 of 2020), China National Knowledge Infrastructure (CNKI), Wanfang Database (Wanfang), and Chinese Scientific Journal Database (VIP) from inception to February 2020. The literature was independently screened and extracted by two researchers. The methodological quality of the included literature was evaluated using the AMSTAR-2 (A Measurement Tool to Assess Systematic Review 2). If necessary, we would summarize the original research data and further perform data synthesis using RevMan software (version 5.3), and the evidence quality of the included literature was graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.ResultsA total of 38 systematic reviews and meta-analyses were included, involving 11 kinds of oral Chinese patent medicines, including Qili Qiangxin Capsules (11/38), Qishen Yiqi Dropping Pills (9/38), Shexiang Baoxin Pills (4/38), Wenxin Keli (2/38), Tongxinluo Capsules (2/38), Compound Danshen Dripping Pills (2/38), Zhenyuan Capsules (3/38), Buyi Qiangxin Tablets (2/38), Yangxinshi Tablets (1/38), Xuezhikang (1/38), and Yixinshu Capsules (1/38). The methodological quality of all literature was rated as critically low. The grading of the quality of evidence was 43 moderate, 101 low, and 40 very low. The main reason for the degradation of evidence quality was the risk of bias. In the evaluation of efficacy, there was no statistically significant difference between the two groups in terms of mortality, which is a piece of low-quality evidence. Qili Qiangxin Capsules or Qishen Yiqi Dripping Pills combined with conventional therapy can significantly reduce the hospitalization rate of patients with chronic heart failure, and the quality of the evidence is moderate. The overall efficacy of oral Chinese patent medicine combined with conventional therapy in improving the clinical symptoms, quality of life, exercise endurance, laboratory tests, physical examination, and other indicators of patients with heart failure is confirmed. In the evaluation of safety, there was no significant difference between the two groups.ConclusionsOral Chinese patent medicine combined with conventional therapy has good clinical efficacy and safety in the treatment of heart failure. However, due to its low level of methodological quality and evidence quality, the current evidence-based conclusions need to be further verified.

Project description:ObjectiveIntegrated therapy of traditional Chinese medicine (TCM) and Western medicine (WM) has gradually been applied to the treatment of rheumatoid arthritis (RA). Recently published studies have provided a wealth of data and information about the effectiveness of combination treatments, but high-quality evidence-based meta-analysis on this issue is not available yet. This study was conducted to compare and evaluate the efficacy and safety of the integrated therapy for RA.MethodsPubMed, EMBASE, and the Cochrane Library were searched up to January 2020. Randomized controlled trials (RCTs) that compared the efficacy and safety of integrative TCM-WM with WM alone for RA were included. The outcome measures contained therapeutic effects (TEs), tender joint count (TJC), swollen joint count (SJC), duration of morning stiffness (DMS), grip strength (GS), disease activity score in 28 joints (DAS28), rheumatoid factor (RF), anti-cyclic peptide containing citrulline (anti-CCP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and adverse events (AEs) to assess the efficacy and safety of different treatments.ResultsA total of 20 RCTs with 2269 patients met the inclusion criteria. TCM used in these studies included Chinese herbal decoctions and tablets or capsules made from herbs and their extracts, while WM included disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids (GC). Compared with patients receiving WM treatment alone, patients with integrative TCM-WM treatment showed better TEs (OR = 3.03, 95% CI [2.36, 3.88]). The integrative treatment group showed reductions in TJC (MD = -1.17, 95% CI [-2.12, -0.21]), SJC (MD = -0.87, 95% CI [-1.85, 0.10]), DMS (SMD = -0.69, 95% CI [-0.98, -0.41]), DAS28 (MD = -0.43, 95% CI [-0.57, -0.29]), RF (SMD = -0.59, 95% CI [-0.91, -0.27]), anti-CCP (SMD = -0.21, 95% CI [-0.36, -0.06]), ESR (MD = -8.36, 95% CI [-12.60, -4.12]), and CRP (MD = -6.73, 95% CI [-9.38, -4.08]), and increment in GS (SMD = 0.12, 95% CI [-0.63, 0.87]). AEs, especially gastrointestinal disorders, abnormal liver function, leukopenia, skin allergies and rashes, headaches and dizziness, and alopecia, significantly decreased (OR = 0.37, 95% CI [0.29, 0.47]) in the integrative treatment group.ConclusionsThe findings of this meta-analysis indicate that integrative TCM-WM could obtain effective and safe results in the treatment of RA. Using TCM as an adjunctive therapy in RA has great prospects for further development.

Dataset Information

Clinical efficacy and safety of traditional Chinese patent medicine for hyperthyroid heart disease: study protocol for a systematic review and meta-analysis.

Background

Methods

Results

Conclusion

Publications

Clinical efficacy and safety of traditional Chinese patent medicine for hyperthyroid heart disease: study protocol for a systematic review and meta-analysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets