Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review

ObjectivesTo examine variation in outcomes, outcome measurement instruments (OMIs) and measurement times in clinical trials of non-valvular atrial fibrillation (NVAF) and to identify outcomes for prioritisation in developing a core outcome set (COS) in this field.DesignThis study was a systematic review.Data sourcesClinical trials published between January 2015 and March 2019 were obtained from PubMed, the Cochrane Library, Web of Science, Wanfang Database, the China National Knowledge Infrastructure and SinoMed.Eligibility criteriaRandomised controlled trials (RCTs) and observational studies were considered. Interventions included traditional Chinese medicine and Western medicine. The required treatment duration or follow-up time was ≥4 weeks. The required sample size was ≥30 and≥50 in each group in RCTs and observational studies, respectively. We excluded trials that aimed to investigate the outcome of complications of NVAF, to assess the mechanisms or pharmacokinetics, or for which full text could not be acquired.Data extraction and synthesisThe general information and outcomes, OMIs and measurement times were extracted. The methodological and outcome reporting quality were assessed. The results were analysed by descriptive analysis.ResultsA total of 218 articles were included from 25 255 articles. For clinical trials of antiarrhythmic therapy, 69 outcomes from 16 outcome domains were reported, and 28 (31.82%, 28/88) outcomes were reported only once; the most frequently reported outcome was ultrasonic cardiogram. Thirty-one outcomes (44.93%, 31/69) were provided definitions or OMIs; the outcome measurement times ranged from 1 to 20 with a median of 3. For clinical trials of anticoagulation therapy, 82 outcomes from 18 outcome domains were reported; 38 (29.23%, 38/130) outcomes were reported only once. The most frequently reported outcome was ischaemic stroke. Forty (48.78%, 40/82) outcomes were provided OMIs or definitions; and the outcome measurement times ranged from 1 to 27 with a median of 8.ConclusionOutcome reporting in NVAF is inconsistent. Thus, developing a COS that can be used in clinical trials is necessary.

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Systematic Review of the Registered Clinical Trials of Coronavirus Disease 2019 (COVID-19)

10.1101/2020.03.01.20029611 ◽

2020 ◽

Cited By ~ 9

Author(s):

Rui-fang Zhu ◽

Yu-lu Gao ◽

Sue-Ho Robert ◽

Jin-ping Gao ◽

Shi-gui Yang ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Sample Size ◽

Western Medicine ◽

Observational Studies ◽

Small Sample Size ◽

Small Sample

AbstractBackgroundSince the outbreak of coronavirus disease 2019 (COVID-19), many researchers in China have immediately carried out clinical research scheme of the COVID-19. But, there is still a lack of systematic review of registered clinical trials. Therefore, we conducted a systematic review of the clinical trials of COVID-19 to summarize the characteristics of the COVID-19 registered clinical trials.MethodsThis study is based on the recommendations of the PRISMA in the Cochrane handbook. The databases from the Chinese Clinical Registration Center and the ClinicalTrials.gov were searched to collect the registered clinical trials of COVID-19. The retrieval inception date is February 9, 2020. Two researchers independently selected the literature based on inclusion and exclusion criteria, extracted data and evaluated the risk of bias.ResultsA total of 75 registered clinical trials (63 interventional studies and 12 observational studies) of COVID-19 were obtained. A majority of clinical trials were sponsored by Chinese hospitals. Only 11 trials have begun to recruit patients, and none of the registered clinical trials had been completed; 34 trials were early clinical exploratory trials or in a pre-experiment stage, 15 trials belonged to phrase III and 4 trials were phrase IV. The methods of intervention included traditional Chinese medicine involving 26 trials, Western medicine involving 30 trials, and integrated traditional Chinese medicine and Western medicine involving 19 trials. The subjects were mainly non-critical adult patients (≥ 18 years old). The median sample size of the trials was 100 (IQR: 60 - 200), and the median execute time of the trials was 179 d (IQR: 94 - 366 d). The main outcomes were clinical observation and examinations. Overall, both the methodology quality of interventional trials and observational studies were low.ConclusionsDisorderly and intensive clinical trials of COVID-19 using traditional Chinese medicine and western medicine are ongoing or will being carried out in China. However, based on the low methodology quality and small sample size and long studies execute time, we will not be able to obtain reliable, high-quality clinical evidence about COVID-19 treatment in the near future. Improving the quality of study design, prioritizing promising drugs, and using different designs and statistical methods are worth advocating and recommending for the clinical trials of COVID-19 in China.

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Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032256 ◽

2019 ◽

Vol 9 (12) ◽

pp. e032256 ◽

Cited By ~ 3

Author(s):

Ruijin Qiu ◽

Changming Zhong ◽

Songjie Han ◽

Tianmai He ◽

Ya Huang ◽

...

Keyword(s):

Myocardial Infarction ◽

Systematic Review ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set ◽

Semistructured Interviews

IntroductionMyocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.Methods and analysisWe will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.Ethics and disseminationThis project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at:http://www.comet-initiative.org/studies/details/1243).

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Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol

Trials ◽

10.1186/s13063-018-2904-0 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 7

Author(s):

Ruijin Qiu ◽

Min Li ◽

Xiaoyu Zhang ◽

Shiqi Chen ◽

Chengyu Li ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Study Protocol ◽

Outcome Measurement ◽

Core Outcome Set ◽

Core Outcome ◽

Measurement Instruments ◽

Outcome Set

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The association of fracture risk in atrial fibrillation patients and long-term anticoagulant therapy category: a systematic review and meta-analysis

PeerJ ◽

10.7717/peerj.10683 ◽

2021 ◽

Vol 9 ◽

pp. e10683

Author(s):

Jun Chen ◽

Lingchun Lyu ◽

Jiayi Shen ◽

Chunlai Zeng ◽

Cheng Chen ◽

...

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Hip Fracture ◽

Fracture Risk ◽

Hip Fractures ◽

Observational Studies ◽

Meta Analysis ◽

Cochrane Library ◽

Hip Fracture Risk ◽

Significant Difference

Objective Our study aimed to assess the risk of all fractures and hip fractures in patients with atrial fibrillation (AF) who took non-vitamin K antagonist oral anticoagulants (NOACs) compared to warfarin. Methods We searched PubMed, Embase, and Cochrane Library and Clinical Trials.gov Website. Reviewed related researches up to January 31, 2020, to identify studies with more than 12 months of follow-up data. The protocol for this systematic review and meta-analysis has been registered in the International Prospective Register of Systematic Reviews (PROSPERO Number: CRD42020156893). Results We included five RCT studies, and five observational studies that contained a total of 326,846 patients in our meta-analysis. Our meta-analysis showed that patients taken NOACs had no significant all fracture risk (RR = 0.91, 95% CI [0.81–1.01]) and hip fracture risk (RR = 0.92, 95% CI [0.82–1.03]) compared with those taken warfarin. Subanalysis showed that the risk of all fractures and hip fractures treated by NOACs were significant lower compared with warfarin in observational studies compared with RCT studies. Also, a subanalysis across the duration of anticoagulation showed the NOACs users have lower all fracture risk than warfarin users when the duration of anticoagulation ≤2 years (RR = 0.89, 95% CI [0.80–0.99]). Further analysis, significant lower all fracture risk in the rivaroxaban therapy (RR = 0.81; 95% CI [0.76–0.86]) compared with warfarin but no statistical significance in hip fracture. There were no significant difference of all fracture risk and hip fracture risk in dabigatran, apixaban, and edoxaban therapy compared with warfarin. Conclusion The meta-analysis demonstrated that NOACs associated with a significantly lower all fracture risk compared with warfarin when the duration of anticoagulation more than 2 years. Rivaroxaban users had lower risk of all fracture than warfarin users in AF patients. But there was no evidence to verify apixaban, edoxaban, and dabigatranin could decrease all fracture and hip fracture risk compared with warfarin.

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Traditional Chinese Medicine Injection Combined with Conventional Western Medicine in Treating Coronary Heart Disease after PCI:A Protocol systematic review and meta analysis of overview

10.37766/inplasy2020.7.0087 ◽

2020 ◽

Author(s):

Xiangmei Xu ◽

Wenna Yang ◽

Xuan Chen ◽

Yixuan Kong ◽

Jie Wang ◽

...

Keyword(s):

Systematic Review ◽

Coronary Heart Disease ◽

Heart Disease ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Western Medicine ◽

Meta Analysis

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Efficacy and Safety of Acupoint Catgut Embedding for Diarrhea-Predominant Irritable Bowel Syndrome and Constipation-Predominant Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/5812320 ◽

2020 ◽

Vol 2020 ◽

pp. 1-10

Author(s):

Jing Wu ◽

Qinwei Fu ◽

Shasha Yang ◽

Hui Wang ◽

Yaofeng Li

Keyword(s):

Systematic Review ◽

Irritable Bowel Syndrome ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Recurrence Rate ◽

Western Medicine ◽

Effective Rate ◽

Efficacy And Safety ◽

Irritable Bowel ◽

Meta Analyses

In this study, we aim to evaluate the efficacy and safety of acupoint catgut embedding for the treatment of diarrhea-predominant irritable bowel syndrome and constipation-predominant irritable bowel syndrome. We searched seven online databases to collect studies published up to Feb 29th, 2020. Study quality of each included article was evaluated by the Cochrane Collaboration Risk of Bias Tool. Systematic reviews and meta-analyses were conducted based on the Cochrane systematic review method by using RevMan 5.3 software. Among the included trials, acupoint catgut embedding alone or plus oral western medicine or plus other acupoint-based therapies, or plus oral traditional Chinese medicine were the main therapies in the experimental groups. Interventions in control groups mainly include oral western medicine alone, other acupoint-based therapies alone, or other acupoint-based therapies alone. Primary outcomes in this study include recovery rate, accumulative marked effective rate, accumulative effective rate, and recurrence rate. Finally, 30 trials involving 1889 participants were included. The results of systematic reviews and meta-analyses show that acupoint catgut embedding alone or plus oral western medicine or plus other acupoint-based therapy or plus oral traditional Chinese medicine was significantly better compared with using oral western medicine alone in terms of efficacy for IBS-C and IBS-D. In addition, acupoint catgut embedding alone or plus oral western medicine or plus other acupoint-based therapy or plus oral traditional Chinese medicine could improve the effective rate and decrease the recurrence rate for IBS-D compared with using oral western medicine, other acupoint-based therapies, or oral traditional Chinese medicine alone. Adverse events of acupoint catgut embedding include local induration, redness, swelling, and itchiness, but they were all mild and disappeared swiftly with ordinary local interventions. There is an urgent need for RCTs of high quality and large sample size and with longer treatment duration and follow-up periods of acupoint catgut embedding for IBS.

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Efficacy and Safety of Integrated Traditional Chinese Medicine and Western Medicine on the Treatment of Rheumatoid Arthritis: A Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/4348709 ◽

2020 ◽

Vol 2020 ◽

pp. 1-15 ◽

Cited By ~ 3

Author(s):

Qi Xing ◽

Ling Fu ◽

Zhichao Yu ◽

Xueping Zhou

Keyword(s):

Rheumatoid Arthritis ◽

Chinese Medicine ◽

Treatment Group ◽

Traditional Chinese Medicine ◽

Western Medicine ◽

Meta Analysis ◽

Cochrane Library ◽

Integrative Treatment ◽

Efficacy And Safety ◽

Integrated Therapy

Objective. Integrated 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. Methods. PubMed, 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. Results. A 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. Conclusions. The 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.

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Efficacy of Traditional Chinese Medicine Tonifying Kidney (Bushen) and Activating Blood (Huoxue) Prescription for Premature Ovarian Insufficiency: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/1789304 ◽

2020 ◽

Vol 2020 ◽

pp. 1-13

Author(s):

Hui-Fang Li ◽

Qi-Hong Shen ◽

Wen-Jun Chen ◽

Wei-Min Chen ◽

Zhang-Feng Feng ◽

...

Keyword(s):

Systematic Review ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Meta Analysis ◽

Scientific Journal ◽

Peak Systolic Velocity ◽

Premature Ovarian Insufficiency ◽

Cochrane Library ◽

Ovarian Insufficiency

Context. Premature ovarian insufficiency (POI) is one of the difficult gynecological diseases with complex etiologies. Tonifying kidney (bushen) and activating blood (huoxue) prescription (TKABP) is a popular traditional Chinese medicine (TCM) therapy which is commonly applied for POI. However, its efficacy and safety are still controversial. Objective. We carried out this systematic review and meta-analysis to evaluate the effectiveness of TKABP on POI. Methods. The following eight databases were searched from the establishment to September 30, 2019, for randomized controlled trials (RCTs): PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), the Chinese BioMedical database (CBM), Chinese Scientific Journal Database (VIP), and the Wanfang database. The quality of evidence was estimated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results. Twenty-three RCTs involving 1712 patients with POI were included. Compared to hormone therapy (HT) groups, TKABP groups showed a significantly higher total effective rate (RR: 1.10; 95% CI: 1.04–1.17; P<0.01, I2 = 32%). In addition, TKABP groups revealed a better improvement in terms of serum follicle-stimulating hormone (FSH) levels, serum estradiol (E2) levels, peak systolic velocity (PSV) of ovarian stromal blood, and Kupperman index (KI) score. However, serum luteinizing hormone (LH) levels and ovarian volume (OV) showed no significant statistical difference. Subgroup analyses showed that herbal paste and 3 months of treatment duration had a greater effect on the improvement of hormone levels. Besides, the occurrence of related adverse events in TKABP groups was lower than that in HT groups. Conclusions. Our review suggests that TKABP appears to be an effective and safe measure for patients with POI, and the herbal paste may be superior. However, the methodological quality of included RCTs was unsatisfactory, and it is necessary to verify its effectiveness with furthermore standardized researches of rigorous design.

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