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An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules

OBJECTIVE: To summarize the characteristics and the outcomes of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Granules manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd. METHODS: Databases including China National Knowledge Infrastructure, VIP, Wanfang, PubMed, Coc...

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Autores principales: Han, Mei, Lai, Lily, Li, Xin-xue, Zhao, Nan-qi, Li, Jing, Xia, Yun, Liu, Jian-Ping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487121/
https://www.ncbi.nlm.nih.gov/pubmed/31110552
http://dx.doi.org/10.1155/2019/6486293
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author Han, Mei
Lai, Lily
Li, Xin-xue
Zhao, Nan-qi
Li, Jing
Xia, Yun
Liu, Jian-Ping
author_facet Han, Mei
Lai, Lily
Li, Xin-xue
Zhao, Nan-qi
Li, Jing
Xia, Yun
Liu, Jian-Ping
author_sort Han, Mei
collection PubMed
description OBJECTIVE: To summarize the characteristics and the outcomes of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Granules manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd. METHODS: Databases including China National Knowledge Infrastructure, VIP, Wanfang, PubMed, Cochrane Library, and clinicaltrials.gov were searched in March 2018 for relevant randomized controlled trials (RCTs). Two reviewers independently screened for and selected studies, extracted data, and checked data extraction. Methodological quality was evaluated using the Cochrane Risk of Bias tool. For the outcome, the characteristics of the study, the cure rate, the effectiveness rate, and advert events were described with a method of bibliometrics. Also, we performed meta-analysis only if there were ≥2 studies treated by the same intervention and evaluated by the same outcome. RESULTS: A total of 40 placebo-controlled RCTs treated for 17 diseases were included in our analysis involving 4,632 patients. 16 of 19 studies treated by CHM granules only showed positive result in patients with HBV, HCV, fever, depression, nonalcoholic fatty liver disease, AIDS, and asthma while negative result was shown in patients with migraine. 17 of 21 studies treated by combination therapy against conventional therapy showed positive result in patients with HBV, herpes simplex keratitis, COPD, liver cirrhotic ascites, Parkinson's disease, and diabetic peripheral neuropathy while negative result was shown in patients with myasthenia gravis, angina pectoris, and depression. The pooled result cannot demonstrate that the notifying kidney formula granules had the superior effect with placebo on the clearance of serum HBV DNA and HBeAg in HBV carriers with a RR (and the 95% CI) of 2.97 [0.74,11.91] and 1.99 [0.93,4.29], respectively. But, the CHM granules can reduce within-group HBV DNA levels by more than 2 lgIU/ml; the RR (and 95% CI) was 4.64 [2.89,7.45]. Qizhu granules had a significant effect on clearance of HCV RNA with a RR (and 95% CI) of 6.26 [2.16,18.16]. And, the heat-clearing and detoxifying formula granules were superior to placebo in resolution of cold symptom among patients with fever with a RR and 95% CI of 2.58 [1.40,4.74]. Based on the conventional therapy, the pooled result demonstrated that the Regulating liver formula granules were superior to placebo on the clearance of serum HBeAg in chronic hepatitis B patients with a RR (and the 95% CI) of 1.73 [1.30,2.31]. The EeChen decoction granules were superior to placebo in COPD patients with a RR (and the 95% CI) of 1.13 [1.06,1.22]. 28 of the 40 studies reported adverse events. There were 51 adverse events in CHM formula granules group or combination group (n=2,483) and 26 in control group (n=2,122) totally. Most of the adverse symptoms spontaneously resolved after completing the courses of treatment and the other adverse symptoms improved after symptomatic treatment. CONCLUSION: 16 of 19 studies treated by CHM granules only showed positive result in 7 diseases and negative result in 1 disease. 17 of 21 studies treated by combination therapy against conventional therapy showed positive result in 6 diseases and negative result in 3 diseases. However, both the absolute and relative effectiveness of CHM formula granules compared with placebo need to be considered clinically.
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spelling pubmed-64871212019-05-20 An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules Han, Mei Lai, Lily Li, Xin-xue Zhao, Nan-qi Li, Jing Xia, Yun Liu, Jian-Ping Evid Based Complement Alternat Med Review Article OBJECTIVE: To summarize the characteristics and the outcomes of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Granules manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd. METHODS: Databases including China National Knowledge Infrastructure, VIP, Wanfang, PubMed, Cochrane Library, and clinicaltrials.gov were searched in March 2018 for relevant randomized controlled trials (RCTs). Two reviewers independently screened for and selected studies, extracted data, and checked data extraction. Methodological quality was evaluated using the Cochrane Risk of Bias tool. For the outcome, the characteristics of the study, the cure rate, the effectiveness rate, and advert events were described with a method of bibliometrics. Also, we performed meta-analysis only if there were ≥2 studies treated by the same intervention and evaluated by the same outcome. RESULTS: A total of 40 placebo-controlled RCTs treated for 17 diseases were included in our analysis involving 4,632 patients. 16 of 19 studies treated by CHM granules only showed positive result in patients with HBV, HCV, fever, depression, nonalcoholic fatty liver disease, AIDS, and asthma while negative result was shown in patients with migraine. 17 of 21 studies treated by combination therapy against conventional therapy showed positive result in patients with HBV, herpes simplex keratitis, COPD, liver cirrhotic ascites, Parkinson's disease, and diabetic peripheral neuropathy while negative result was shown in patients with myasthenia gravis, angina pectoris, and depression. The pooled result cannot demonstrate that the notifying kidney formula granules had the superior effect with placebo on the clearance of serum HBV DNA and HBeAg in HBV carriers with a RR (and the 95% CI) of 2.97 [0.74,11.91] and 1.99 [0.93,4.29], respectively. But, the CHM granules can reduce within-group HBV DNA levels by more than 2 lgIU/ml; the RR (and 95% CI) was 4.64 [2.89,7.45]. Qizhu granules had a significant effect on clearance of HCV RNA with a RR (and 95% CI) of 6.26 [2.16,18.16]. And, the heat-clearing and detoxifying formula granules were superior to placebo in resolution of cold symptom among patients with fever with a RR and 95% CI of 2.58 [1.40,4.74]. Based on the conventional therapy, the pooled result demonstrated that the Regulating liver formula granules were superior to placebo on the clearance of serum HBeAg in chronic hepatitis B patients with a RR (and the 95% CI) of 1.73 [1.30,2.31]. The EeChen decoction granules were superior to placebo in COPD patients with a RR (and the 95% CI) of 1.13 [1.06,1.22]. 28 of the 40 studies reported adverse events. There were 51 adverse events in CHM formula granules group or combination group (n=2,483) and 26 in control group (n=2,122) totally. Most of the adverse symptoms spontaneously resolved after completing the courses of treatment and the other adverse symptoms improved after symptomatic treatment. CONCLUSION: 16 of 19 studies treated by CHM granules only showed positive result in 7 diseases and negative result in 1 disease. 17 of 21 studies treated by combination therapy against conventional therapy showed positive result in 6 diseases and negative result in 3 diseases. However, both the absolute and relative effectiveness of CHM formula granules compared with placebo need to be considered clinically. Hindawi 2019-04-11 /pmc/articles/PMC6487121/ /pubmed/31110552 http://dx.doi.org/10.1155/2019/6486293 Text en Copyright © 2019 Mei Han et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review Article
Han, Mei
Lai, Lily
Li, Xin-xue
Zhao, Nan-qi
Li, Jing
Xia, Yun
Liu, Jian-Ping
An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules
title An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules
title_full An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules
title_fullStr An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules
title_full_unstemmed An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules
title_short An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules
title_sort overview of the randomized placebo-controlled trials of chinese herbal medicine formula granules
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487121/
https://www.ncbi.nlm.nih.gov/pubmed/31110552
http://dx.doi.org/10.1155/2019/6486293
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