scholarly journals A clinical study protocol for COVID-19 rehabilitation with herbal medicine and cardiorespiratory exercise (Preprint)

2020 ◽  
Author(s):  
Julien S. Baker ◽  
Zhaoxiang Bian ◽  
Wei Jia ◽  
Yike Guo ◽  
Yang Gao ◽  
...  
Keyword(s):  
Lung Function ◽  
Pulmonary Function ◽  
Immune Function ◽  
Herbal Medicines ◽  
Exercise Program ◽  
Controlled Clinical Trial ◽  
Primary Analysis ◽  
Chinese Herbal Medicines ◽  
Chinese Herbal ◽  
Group 2

BACKGROUND Recent studies revealed that most discharged patients with COVID-19 suffered ongoing symptoms months later. Rehabilitation interventions can help address the consequences of COVID-19. These include medically, physically, cognitively and psychologically related problems. To our knowledge, no studies have investigated the effects of rehabilitation following discharge from hospital. OBJECTIVE The specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in recovering COVID-19 patients. A further aim will be to examine how Chinese herbal medicines, gut microbiome and its metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process. METHODS In this triple-blinded, randomized, parallel groups, controlled clinical trial, we will recruit adult patients with COVID-19 who have been discharged from the hospital in Hong Kong and are suffering from impaired lung function and pulmonary function. A total of 172 eligible patients will be randomized into four equal groups: 1) cardiorespiratory exercise plus Chinese herbal medicines group, 2) cardiorespiratory exercise only group, 3) Chinese herbal medicines only group and 4) waiting list group (in which participants will receive Chinese herbal medicines after 24 weeks). These treatments will be administered for 12 weeks with a 12-week follow-up period. Primary outcomes include dyspnea, fatigue, lung function, pulmonary function, blood oxygen levels, immune function, blood coagulation, and related blood biochemistry. Measurements will be recorded prior to initiating the above treatments and repeated at the 13th and 25th weeks of the study. The primary analysis is aimed at comparing the outcomes between groups throughout the study period with alpha level of 0.05 (two-tailed). RESULTS The trial has not been recruiting patients. The proposed study will be completed in 24 months from 01 Jan 2021 to 31 Dec 2022. CONCLUSIONS NA CLINICALTRIAL ClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360

scholarly journals Reporting quality of Cochrane systematic reviews with Chinese herbal medicines

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Xuan Zhang ◽  
Qi-Ying Aixinjueluo ◽  
Si-Yao Li ◽  
Lisa-L Song ◽  
Chung-Tai Lau ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Meta Analysis ◽  
Herbal Medicines ◽  
Reporting Quality ◽  
Primary Analysis ◽  
Chinese Herbal Medicines ◽  
Chinese Herbal ◽  
Related Information ◽  
Meta Analyses

Abstract Background Chinese herbal medicines (CHMs) are the major interventions of traditional Chinese medicine (TCM), which are typically administered as either single herbs or formulas. The Cochrane systematic reviews (SRs) of CHMs are essential references for evaluating the efficacy and safety of CHMs interventions; they are expected to be accurate and reliable. This study aimed to assess the reporting quality of these SRs, particularly whether necessary information related to CHM was adequately reported. Methods The Cochrane Database was systematically searched for all SRs of CHM that were published up to 31 December 2017. The primary analysis was to assess their reporting quality based on 27-item of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and 9-item of CHM-related information designed according to TCM theory. Descriptive statistics were additionally used to analyze their baseline characteristics. Results A total of 109 Cochrane SRs of CHM were identified from 1999 to 2017. For 27-item of PRISMA, 26 had the reporting compliances higher than 50%, of which 11 were fully reporting (100%). However, for CHM-related information, 65 (59.6%) SRs did not report the specific name of the CHM in the title, 42 (38.5%) lacked TCM-related rationales in the introduction, 62 (56.9%) did not include CHM-related characteristics in the additional analyses, and 77 (70.6%) did not analyze CHM results in terms of TCM-related theories in the discussion. Of 97 SRs that included clinical trials, 38 (39.2%) did not provide the details of composition and dosage of CHMs, 85 (87.6%) did not report the CHM sources, 13 (13.4%) did not provide the dosage form, 95 (97.9%) lacked CHM quality control information, and 57 (58.8%) did not describe details of the controls. For 62 (72.9%) of 85 SRs that included meta-analysis, it was impossible to assess whether meta-analysis had been properly conducted due to inadequate reporting of CHM interventions. Conclusion Although the Cochrane SRs of CHM showed reporting compliance with PRISMA checklist, their reporting quality needs improvement, especially about full reporting of CHM interventions and of TCM-related rationales. Reporting guideline of “PRISMA extension for CHM interventions” should be developed thus to improve their quality.

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