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

2019 ◽  
Vol 2019 ◽  
pp. 1-12
Author(s):  
Mei Han ◽  
Lily Lai ◽  
Xin-xue Li ◽  
Nan-qi Zhao ◽  
Jing Li ◽  
...  

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.

2021 ◽  
Vol 12 ◽  
Author(s):  
Xu-Qin Du ◽  
Li-Peng Shi ◽  
Wen-Fu Cao ◽  
Zhi-Wei Chen ◽  
Biao Zuo ◽  
...  

Background: The outbreak of coronavirus disease 2019 (COVID-19) has rapidly spread to become a global emergency since December 2019. Chinese herbal medicine plays an important role in the treatment of COVID-19. Chinese herbal medicine honeysuckle is an extremely used traditional edible and medicinal herb. Many trials suggest that honeysuckle has obtained a good curative effect for COVID-19; however, no systematic evaluation on the clinical efficacy of honeysuckle in the treatment of COVID-19 is reported. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine honeysuckle in the treatment of COVID-19.Methods: Seven electronic databases (PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Database, and China Biology Medicine) were searched to identify randomized controlled trials (RCTs) of honeysuckle for adult patients (aged ≥ 18 years) with COVID-19. The Cochrane Risk of Bias Tool was applied to assess the methodological quality of trials. Review Manager 5.3 software was used for data analysis.Results: Overall, nine RCTs involving 1,286 patients were enrolled. Our meta-analyses found that combination therapy of honeysuckle and conventional therapy was more effective than conventional therapy alone in lung computed tomography (CT) [relative risk (RR) = 1.24, 95% confidence interval (95%CI) (1.12, 1.37), P < 0.0001], clinical cure rate [RR = 1.21, 95%CI (1.12, 1.31), P < 0.00001], and rate of conversion to severe cases [RR = 0.50, 95%CI (0.33, 0.76), P = 0.001]. Besides, combination therapy can improve the symptom score of fever, cough reduction rate, symptom score of cough, and inflammatory biomarkers (white blood cell (WBC) count; C-reactive protein (CRP)) (P < 0.05).Conclusion: Honeysuckle combined with conventional therapy may be beneficial for the treatment of COVID-19 in improving lung CT, clinical cure rate, clinical symptoms, and laboratory indicators and reducing the rate of conversion to severe cases. Besides, combination therapy did not increase adverse drug events. More high-quality RCTs are needed in the future.


2020 ◽  
Author(s):  
Bai-lin Chen ◽  
Ming-zhu Zhang ◽  
Zi-wei Huang ◽  
Hong-rui Zhang ◽  
Chang Xu ◽  
...  

Abstract Background: Diarrhea is a common symptom of acquired immune deficiency syndrome (AIDS) occurring either at the early stage of human immunodeficiency virus (HIV) infection or advanced stage, generally not fetal but seriously affect the quality of life.The treatment of HIV/AIDS-associated diarrhea based on traditional Chinese medicine (TCM) syndrome differentiation or combined with conventional therapy has showed better effect, and improve the immune status of patients to a certain extent, which may have a good application prospect. This is a protocol for a systematicreview on health care intervention. The objective is toassess the beneficial effect and safety of Chinese herbal medicine for people with HIV/AIDS-associated diarrhea.Methods: We will search and include randomized controlled trials comparing Chinese herbal medicine with placebo or other active interventions, regardless of language and publication status. The primary outcome will be diarrhea frequency (per day or per week) and fecal character. Databases to be searched include The Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; PubMed;China National Knowledge Infrastructure (CNKI); Wanfang Data; Chinese Biomedical Literature Database (SinoMed) and China Science and Technology Journal database (VIP). For each step, two reviewers will independently perform the selection of studies, data extractionand assess their methodological quality by the Cochrane risk of bias tool. We will analyze data, and performmeta-analyses if data available.Discussion: By providing current evidence of the beneficial effect and safety of Chinese herbal medicine for people with HIV/AIDS-associated diarrhea,we intend toidentify potentialtherapeutic modality that may be of benefits so to inform practice.


SLEEP ◽  
2021 ◽  
Author(s):  
Yoann Birling ◽  
Xiaoshu Zhu ◽  
Nicole Avard ◽  
Caterina Tannous ◽  
Paul P Fahey ◽  
...  

Abstract Study Objectives The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. Methods We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for four weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events. Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. Results A non-significant (p > 0.05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with adverse events was not significantly different (p > 0.05) between the two groups. Except for subjective sleep onset latency, which had a non-significant (p > 0.05) medium effect (Cohen’s d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen’s d < 0.4) and non-significant (p > 0.05). The acceptability and tolerability were high in the active group. Conclusions ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.


2019 ◽  
Vol 2019 ◽  
pp. 1-16 ◽  
Author(s):  
Jing Yan ◽  
Zhi-wei Miao ◽  
Jun Lu ◽  
Fei Ge ◽  
Li-hua Yu ◽  
...  

Purpose. To comprehensively evaluate the efficacy and safety of acupuncture combined with Chinese herbal medicine (CHM) in treating irritable bowel syndrome with diarrhea (IBS-D). Methods. Relevant randomized controlled trials (RCTs) were systemically retrieved from electronic databases from inception to March 2018, including the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biological Medical Database (CBM, SinoMed), China Science and Technology Journal Database (VIP), and Wan Fang Data. Meanwhile, pooled estimates, including the 95% confidence interval (CI), were calculated for primary and secondary outcomes of IBS-D patients. Besides, quality of relevant articles was evaluated using the Cochrane Collaboration’s risk of bias tool, and the Review Manager 5.3 and Stata12.0 softwares were employed for analyses. Results. A total of 21 RCTs related to IBS-D were included into this meta-analysis. Specifically, the pooled results indicated that (1) acupuncture combined with CHM might result in more favorable improvements compared with the control group (relative risk [RR] 1.29; 95% CI 1.24–1.35; P =0.03); (2) the combined method could markedly enhance the clinical efficacy in the meantime of remarkably reducing the scores of abdominal pain (standardized mean difference [SMD] –0.45; 95% CI –0.72, –0.17; P = 0.002), abdominal distention/discomfort (SMD –0.36; 95% CI –0.71, –0.01; P = 0.04), diarrhea (SMD –0.97; 95% CI –1.18, –0.75; P < 0.00001), diet condition (SMD –0.73; 95% CI –0.93, –0.52; P<0.00001), physical strength (SMD –1.25; 95% CI –2.32, –0.19; P = 0.02), and sleep quality (SMD –1.02; 95% CI –1.26, –0.77; P < 0.00001) compared with those in the matched groups treated with western medicine, or western medicine combined with CHM. Additionally, a metaregression analysis was constructed according to the name of prescription, acupuncture type, treatment course and publication year, and subgroup analyses stratified based on the names of prescriptions and acupoints location were also carried out, so as to explore the potential heterogeneities; and (3) IBS-D patients treated with the combined method only developed inconspicuous adverse events; more importantly, the combined treatment had displayed promising long-term efficacy. Conclusions. Findings in this study indicate that acupuncture combined with CHM is suggestive of an effective and safe treatment approach for IBS-D patients, which may serve as a promising method to treat IBS-D in practical application. However, more large-scale, multicenter, long-term, and high-quality RCTs are required in the future, given the small size, low quality, and high risk of the studies identified in this meta-analysis.


2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Jie Wang ◽  
Xingjiang Xiong ◽  
Guoyan Yang ◽  
Yuqing Zhang ◽  
Yongmei Liu ◽  
...  

Background. Chinese herbs are potentially effective for hypertension. Qi Ju Di Huang Wan (QJDHW) is a commonly used Chinese herbal medicine as a monotherapy or in combination with other antihypertensive agents for the treatment of essential hypertension (EH). However, there is no critically appraised evidence such as systematic reviews or meta-analyses on the effectiveness and safety of QJDHW for EH.Methods and Findings. CENTRAL, PubMed, CBM, CNKI, VIP, and online clinical trial registry websites were searched for published and unpublished randomized controlled trials (RCTs) of QJDHW for essential hypertension up to January 2013 with no language restrictions. A total of 10 randomized trials involving 1024 patients were included. Meta-analysis showed that QJDHW combined with antihypertensive drugs was more effective in lowering blood pressure and improving TCM syndrome for the treatment of essential hypertension than antihypertensive drugs used alone. No trials reported severe adverse events related to QJDHW.Conclusions. Our review suggests that QJDHW combined with antihypertensive drugs might be an effective treatment for lowering blood pressure and improving symptoms in patients with essential hypertension. However, the finding should be interpreted with caution because of the poor methodological quality of included trials. There is an urgent need for well-designed, long-term studies to assess the effectiveness of QJDHW in the treatment of essential hypertension.


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