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Chinese herbal medicine for oesophageal cancer.
Chen, X, Deng, L, Jiang, X, Wu, T
The Cochrane database of systematic reviews. 2016;(1):CD004520
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Abstract
BACKGROUND Oesophageal cancer is the seventh leading cause of cancer death worldwide. Traditional Chinese herbal medicine is sometimes used as an adjunct to radiotherapy or chemotherapy for this type of cancer. This review was first published in 2007 and updated in 2009; this 2016 update is the latest version of the review. OBJECTIVES To assess the efficacy and possible adverse effects of the addition of Chinese herbal medicine to treatment with radiotherapy or chemotherapy for oesophageal cancer. SEARCH METHODS We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register, the Cochrane Library, MEDLINE, EMBASE, Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database and the Chinese Cochrane Centre Controlled Trials Register up to 1 October, 2015. We also searched databases of ongoing trials, the Internet and reference lists. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing the use of radiotherapy or chemotherapy with and without the addition of Chinese herbal medicine. DATA COLLECTION AND ANALYSIS At least two review authors independently extracted data and assessed trial quality. MAIN RESULTS We tried to contact the 142 study authors by telephone, and finally included nine studies with 490 participants. All included studies were conducted in China, and allocated advanced oesophageal cancer patients to radiotherapy or chemotherapy groups, with and without additional Chinese herbal medicine. Quality of life, short-term therapeutic effects, TCM symptoms and adverse events caused by radiotherapy or chemotherapy were reported in these studies. Overall, we considered the trials to be at unclear or high risk of bias.The quality of life measure was conducted before and after the intervention; our analysis showed a beneficial effect, both in number of participants experiencing an improvement (risk ratio (RR) 2.20, 95% confidence interval (CI) 1.42 to 3.39; 5 RCTs, 233 participants, change of performance status score ≥ 10) and number of participants experiencing a deterioration (RR 0.41, 95% CI 0.27 to 0.62; 6 RCTs, 287 participants, change of performance status score ≤ 10). We judged this to have low quality evidence, downgrading quality of evidence for risk of bias and imprecision, and upgrading quality of evidence for the large effect.For short-term therapeutic effects, the results suggest that traditional Chinese medicine (TCM) has a positive impact on improvement (complete response + partial response) (RR 1.17, 95% CI 1.02 to 1.35; 8 RCTs, 450 participants), moderate quality evidence and downgrading for risk of bias. There was no significant difference for progressive disease (RR 0.73, 95% CI 0.52 to 1.01; 8 RCTs, 450 participants), low quality evidence and downgrading for risk of bias and imprecision. Three studies assessed this outcome after four weeks or three months' follow-up, the remaining studies gave no detailed information for this outcome. TCM symptoms, which was similar to short-term therapeutic effects evaluated with TCM clinical criteria, was diagnosed in two studies of 88 people at the end of the intervention. The results suggest that TCM has a positive impact on both total effectiveness (RR 1.84, 95% CI 1.20 to 2.81) and ineffectiveness (RR 0.22, 95% CI 0.05 to 0.93); we judged the studies to have very low quality evidence, downgrading for risk of bias and imprecision.Nine studies reported a series of adverse events caused by radiotherapy or chemotherapy at the end of the intervention, including mucositis, radiation oesophagitis, arrest of bone marrow, gastrointestinal reactions, renal and hepatic impairment, white blood cell descent, neurotoxicity, cardiac toxicity and anaemia. For those containing multiple studies, we conducted a pooled analysis. As a result, TCM showed a significant effect on radiation oesophagitis (RR 0.66, 95% CI 0.47 to 0.94; 2 RCTs, 90 participants), gastrointestinal reactions (RR 0.54, 95% CI 0.36 to 0.81; 4 RCTs, 268 participants) and white blood cell descent (RR 0.60, 95% CI 0.44 to 0.83; 4 RCTs, 224 participants). The quality of evidence was low or very low, downgrading for risk of bias and imprecision. AUTHORS' CONCLUSIONS We currently find no evidence to determine whether TCM is an effective treatment for oesophageal cancer. The effect of TCM on short-term therapeutic effects is uncertain. TCM probably has positive effects on quality of life and on some adverse events caused by radiotherapy or chemotherapy in advanced oesophageal cancer patients undergoing radiotherapy or chemotherapy. The results of the review need to be interpreted cautiously owing to overall low quality evidence. Future trials should be large and correctly designed to detect important clinical effects and minimise risk of bias.
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Effects and tolerance of silymarin (milk thistle) in chronic hepatitis C virus infection patients: a meta-analysis of randomized controlled trials.
Yang, Z, Zhuang, L, Lu, Y, Xu, Q, Chen, X
BioMed research international. 2014;:941085
Abstract
OBJECTIVE This study aimed to evaluate the efficacy and safety of silymarin on chronic hepatitis C virus- (HCV-) infected patients. METHODS Randomized controlled trials (RCTs) of silymarin in chronic HCV-infected patients up to April 1, 2014 were systematically identified in PubMed, Ovid, Web of Science, and Cochrane Library databases. RESULTS A total of 222 and 167 patients in five RCTs were randomly treated with silymarin (or intravenous silibinin) and placebo, respectively. Serum HCV RNA relatively decreased in patients treated with silymarin compared with those administered with placebo, but no significance was found (P = 0.09). Meta-analysis of patients orally treated with silymarin indicated that the changes of HCV RNA are similar in the two groups (P = 0.19). The effect on alanine aminotransferase (ALT) of oral silymarin is not different from that of placebo (P = 0.45). Improvements in quality-of-life (Short Form-36) in both silymarin and placebo recipients were impressive but relatively identical (P = 0.09). CONCLUSION Silymarin is well tolerated in chronic HCV-infected patients. However, no evidence of salutary effects of oral silymarin has yet been reported based on intermediate endpoints (ALT and HCV RNA) in this population. Moreover, intravenous administration of silymarin should be further studied.
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Tripterygium wilfordii Hook F (a traditional Chinese medicine) for primary nephrotic syndrome.
Chen, Y, Gong, Z, Chen, X, Tang, L, Zhao, X, Yuan, Q, Cai, G
The Cochrane database of systematic reviews. 2013;(8):CD008568
Abstract
BACKGROUND Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herbal medicine used as an immunosuppressive agent, has been prescribed in China for patients with primary nephrotic syndrome (NS) for more than two decades. Although patients with primary NS in China have benefited from TwHF treatment, its properties have not yet been fully understood. OBJECTIVES To assess the benefits and harms of TwHF for patients with primary NS. SEARCH METHODS We searched the Cochrane Renal Group's specialised register (August 2012), Cochrane Register of Controlled Trials (CENTRAL, The Cochrane Library 2012, Issue 8), EMBASE (1966 to August 2012), and MEDLINE (1966 to August 2012). We also searched CBM (Chinese Biological Medical Database) (1978 to November 2010), CNKI (Chinese National Knowledge Infrastructure) (1979 to November 2010), VIP (ChongQing WeiPu Chinese Science and Technology Periodical Database) (1989 to November 2010), WanFang Database (1980 to November 2010), and reference lists of articles (6 November 2010). SELECTION CRITERIA Only randomised controlled trials (RCTs) were included. Two standardised preparations of TwHF were investigated: ethanol-ethyl acetate extract and chloroform-methanol extract. All other TwHF preparations were excluded because of reported toxicities. Other traditional Chinese herbal medicines were also excluded. All included RCTs had a follow-up of at least three months. DATA COLLECTION AND ANALYSIS Data extraction and risk of bias assessment were undertaken independently by two authors. Where details of randomised sequence generation and allocation concealment were absent or inadequately reported, we contacted original study investigators for verification and details of the procedure. For dichotomous outcomes (remission and drug-related adverse events) we used risk ratio (RR) with 95% confidence intervals (95% CI) and mean difference (MD) for continuous outcomes (urinary protein excretion, serum albumin and serum creatinine). MAIN RESULTS Ten studies enrolling 630 participants were included. Overall, the quality of evidence was suboptimal due to the small number of included studies enrolling small numbers of participants; short follow-up in each study; only a few studies in each comparison category; and major concerns with methodological bias. Four studies (293 participants) contributed to the comparison of TwHF versus non-TwHF. TwHF significantly increased complete remission (RR 1.46, 95% CI 1.18 to 1.80) and complete or partial remission (RR 1.26, 95% CI 1.10 to 1.44) without escalating the adverse events profile at the last follow-up (12 to 16 months). Four studies (223 participants) compared TwHF with prednisone. There were no statistically significant differences between complete remission, partial remission, and complete or partial remission. Two studies (114 participants) contributed to the comparison of TwHF versus cyclophosphamide (CPA) at the last follow-up (3 to 12 months). There were no statistically significant differences between complete, partial, or complete or partial remission. One study (46 participants) reported TwHF was associated with a significantly lower serum creatinine compared with CPA (MD -14.00 μmol/L, 95% CI -26.43 to -1.57). No serious adverse events of TwHF were observed. One study (37 participants) reported TwHF was associated with a significantly lower risk of psychosis when compared to prednisone (RR 0.11, 95% CI 0.01 to 0.75), and two studies showed a significantly lower risk of hair loss with TwHF when compared to CPA ((2 studies, 114 participants): RR 0.11, 95% CI 0.02 to 0.59). AUTHORS' CONCLUSIONS TwHF may have an add-on effect on remission in patients with primary NS. There was insufficient evidence to assess if TwHF was as effective as prednisone or CPA. More methodologically sound and sufficiently powered studies, with adequate follow-up would help to better inform management options for the use of TwHF for primary NS. TwHF should be further directly compared with other widely used immunosuppressive agents after the superiority over placebo or no treatment has been clearly established.
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Sanchi for acute ischaemic stroke.
Chen, X, Zhou, M, Li, Q, Yang, J, Zhang, Y, Zhang, D, Kong, S, Zhou, D, He, L
The Cochrane database of systematic reviews. 2008;(4):CD006305
Abstract
BACKGROUND Currently very few drugs are supported for routine use for acute ischaemic stroke. Sanchi is one of the most widely used herbal medicines for ischaemic stroke in China. OBJECTIVES To assess the effectiveness and safety of sanchi in the treatment of acute ischaemic stroke. SEARCH STRATEGY We searched the Cochrane Stroke Group Trials Register (last searched January 2008), the Chinese Stroke Trials Register (searched February 2007), the Cochrane Complementary Medicine Field trials register (searched February 2007), the Chinese Cochrane Centre Controlled Trials Register (last searched February 2007). We also searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2007), MEDLINE (1966 to February 2007), EMBASE (1980 to February 2007), CINAHL (1982 to February 2007), AMED (1985 to February 2007), CNKI (1979 to February 2007), CBM-disc (1979 to February 2007), Chinese scientific periodical database of VIP INFORMATION (1989 to February 2007), Wanfang Data (1982 to February 2007), CISCOM (1980 to February 2007), and TCMLARS (1984 to February 2007). SELECTION CRITERIA Randomised controlled trials comparing sanchi with placebo or no treatment for acute ischaemic stroke within 30 days of onset. DATA COLLECTION AND ANALYSIS Two review authors extracted data and assessed trial quality. MAIN RESULTS Eight trials involving 660 participants were included. Seven of the eight studies were of poor quality. Follow-up time was less than one month in six trials. Only two trials provided data for the number of participants who were dead or dependent at the end of 28 days of treatment, indicating a significantly lower rate of death and dependency in the sanchi group than in the control group (relative risk (RR) 0.63, 95% confidence interval (Cl) 0.45 to 0.88). One trial reported higher Barthel index scores in the sanchi group. Pooled analysis of seven trials indicated that sanchi might improve neurological deficit more than control with a significant difference (RR 0.29, 95%Cl 0.18 to 0.47). The total case fatality rate was lower than 1% indicating that participants probably had mild strokes. Few adverse events were reported. Data were limited in respect of stroke recurrence and quality of life. AUTHORS' CONCLUSIONS Sanchi appears to be beneficial and safe for acute ischaemic stroke in this review, but the small sample and inferior quality of studies prevented a definite conclusion. More well-designed randomised controlled trials are required.
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Chinese medicinal herbs for acute bronchitis.
Wei, J, Ni, J, Wu, T, Chen, X, Duan, X, Liu, G, Qiao, J, Wang, Q, Zheng, J, Zhou, L
The Cochrane database of systematic reviews. 2008;(1):CD004560
Abstract
BACKGROUND Acute bronchitis is one of the most common diagnoses made by primary-care physicians. It is traditionally treated with antibiotics (although the evidence for their effectiveness is weak and modest at best), and other even less effective treatments. Chinese medicinal herbs have also been used as a treatment. OBJECTIVES This review aimed to summarise the existing evidence on the comparative effectiveness and safety of Chinese medicinal herbs for treating uncomplicated acute bronchitis. SEARCH STRATEGY We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2007, Issue 1), which includes the Cochrane Acute Respiratory Infections Group's specialised register; MEDLINE (1966 to March Week 1, 2007); EMBASE (1988 to January 2007); The Chinese Cochrane Centre's Controlled Trials Register (up to January 2007); and the Chinese Biomedical Database (CBM) (1980 to January 2007). SELECTION CRITERIA Randomised controlled trials (RCTs) comparing Chinese medicinal herbs with placebo, antibiotics or other Western medicines for the treatment of uncomplicated acute bronchitis. DATA COLLECTION AND ANALYSIS At least two review authors independently extracted data and assessed trial quality. MAIN RESULTS No studies met the inclusion criteria for this review. One study with 300 participants but uncertain randomisation was analysed . The study showed that treatment with the Chinese medicinal herb Huoke granules leads to a shorter duration of cough, fever and sputum compared to using penicillin and Xiaoer Shangfeng Zhike tangjiang syrup. However, the study also lacked allocation concealment and blinding. There was a high possibility of conflict of interest as the Huoke granules were made by the trial author's hospital. AUTHORS' CONCLUSIONS There is insufficient quality data to recommend the routine use of Chinese herbs for acute bronchitis. Study-design limitations of the individual studies meant that no conclusion about the benefits of Chinese herbs could be taken. In addition, the safety of Chinese herbs is unknown due to the lack of toxicological evidence on these Chinese herbs, though adverse events were reported in some case reports.
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Chinese medicinal herbs for acute bronchitis.
Wu, T, Chen, X, Duan, X, Juan, N, Liu, G, Qiao, J, Wang, Q, Wei, J, Zhen, J, Zhou, L
The Cochrane database of systematic reviews. 2005;(3):CD004560
Abstract
BACKGROUND Acute bronchitis is one of the most common diagnoses made by primary-care physicians. It is traditionally treated with antibiotics, (although the evidence for their effectiveness is weak and modest at best), and other even less effective treatments. Chinese medicinal herbs have been also used as treatment. OBJECTIVES This review aims to summarise the existing evidence on the comparative effectiveness and safety of Chinese medicinal herbs for treating uncomplicated acute bronchitis. SEARCH STRATEGY We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2005), which includes the Cochrane Acute Respiratory Infections Group's specialised register; The Chinese Cochrane Centre's Controlled Trials Register (up to December 2004); MEDLINE (1966 to March Week 1, 2005); EMBASE (1988 to December 2004); and the Chinese Biomedical Database (CBM) (1980 to December 2004). SELECTION CRITERIA Randomised controlled trials comparing Chinese medicinal herbs with placebo, antibiotics or other Western medicines for the treatment of uncomplicated acute bronchitis. DATA COLLECTION AND ANALYSIS At least two authors extracted data and assessed trial quality. MAIN RESULTS Four trials reported the time to improvement of cough, fever, and rales associated with bronchitis and showed that patients treated with Chinese herbs had a shorter duration of signs and symptoms. Two trials reported the proportion of patients with improved signs and symptoms at follow up and showed that Chinese herbs were beneficial in terms of relief of signs and symptoms. Thirteen trials analysed the data on physician global assessment of improvement at follow up. Nine of thirteen trials showed that Chinese herbs were superior to routine treatment and the other four trials showed a similar effect to routine treatment. In general, Chinese herbs appeared beneficial. Only one trial reported on adverse effects during treatment. AUTHORS' CONCLUSIONS There is insufficient quality data to recommend the routine use of Chinese herbs for acute bronchitis. The benefit found in this systematic review could be due to publication bias and study-design limitations of the individual studies. In addition, the safety of Chinese herbs is unknown due to the lack of toxicological evidence on these Chinese herbs, though adverse events are rarely reported. Chinese herbs should be used carefully.