Objective To investigate the efficacy and safety of nebulized budesonide for acute exacerbation of chronic obstructive pulmonary disease, and to formulate an evidence-based treatment protocol for a patient with acute exacerbation of chronic obstructive pulmonary disease. Methods We searched The Cochrane Library (Issue 4, 2009), MEDLINE (1990 to February 2010), ACP Journal Club (1991 to February 2010) and Chinese Journal Full-text Database (1979 to February 2010), and critically appraised the available evidence. Results Four randomized controlled trials were included, and all were of relatively high quality. Evidence showed that nebulized budesonide could alleviate symptoms, improve pulmonary function without any serious side effects. Given the current evidence, we used nebulized budesonide which helped the control of symptoms with no adverse effects. Conclusion Nebulised budesonide may be an effective and safe alternative to systemic corticosteroids in the treatment of acute exacerbation of chronic obstructive pulmonary disease.
Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35±1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.
The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
Objective To investigate the current situation of randomized controlled trials (RCTs) on compound salvia pellet (CSP) for angina pectoris and assess whether there is adequate evidence for clinical practice. Methods We collected all the published clinical studies on CSP for angina pectoris from 1994 to December 2005, and assessed each included report using the Jadad scale, the revised CONSORT statement and other self-edited items. Results We finally identified 115 RCTs. Among which, 1 scored 3 points, 6 scored 2 points, 106 scored 1 points and 2 socred 0 points. No RCT performed allocation concealment according to the CONSORT criteria, only 4 RCTs (3.5%) described the generation of the randomization sequence, among which 2 were quasi-randomized. No RCT provided randomization implementation,1 RCT (0.9%) carried out placebo control, 1 RCT (0.9%) reported endpoint, 9 RCTs (7.8%) adopted single blinding, 4 RCTs (3.5%) reported double blinding, 11 RCTs (9.6%) calculated statistical values, 2 RCTs (1.7%) provided the record of follow-up, 1 RCT (0.9%) reported negative outcome, 25 RCTs (21.8%) described adverse events, no RCT described how the sample size was estimated, and how an intent-to-treat (ITT) analysis and correlation analysis were reported, 1 RCT (0.9%) was multi-center, no RCT completed ethical approval and informed consent, 27 RCTs (23.5%) described syndrome type of TCM. Conclusion Currently, the methodology and reporting of studies on CSP for angina pectoris are not good enough to provide reliable evidence for clinical practice.
Objective To evaluate the effectiveness and safety of Lianpu granule (LPG) in the treatment of common cold (Feng-Re syndrome). Methods The clinical trials were conducted by good clinical practice (GCP). In the phaseⅡ, a double-blind controlled trial involving 48 patients with common cold (Feng-Re syndrome) allocated by a random number table to receive LPG (n=24) or compound oral liquid of Shuanghuanglian (SHL) (n=24) as conducted; the other 80 patients included in the phase Ⅲ, multi-center randomized and controlled trial were divided into the LPG group (n=60) and SHL group (n=20) by a random number table. We didn’t evaluate the allocation concealment. LPG was administered as a dose of 8 g, three times a day, and SHL, as a dose of 10 ml, three times a day. The treatment duration for both groups was 3 days. All data were analyzed by using stata 7.0 for per-protocol population. Results In the Lianpu granule group, the good improvement rates were 90.00% (18/20) and 85.00% (51/60), and the improvement rates were 95.00% (19/20) and 98.33% (59/60); the good improvement rates for traditional Chinese medicine syndromes were 85.00% (17/20) and 85.00% (51/60), and the improvement rates were 95.00% (19/20) and 98.33% (59/60); the good improvement rates for fever were 85.00% (17/20) and 86.05% (37/43), and the improvement rates were 95.00% (19/20) and 95.35% (41/43) in the phase Ⅱ and Ⅲ respectively. Meanwhile for the compound oral liquid of SHL group, the good improvement rates were 85.71% (18/21) and 80.00% (16/20), and the improvement rates were 95.24% (20/21) and 95.00% (19/20); the good improvement rates for traditional Chinese medicine syndromes were 85.71% (18/21) and 80.00% (16/20), and the improvement rates were 95.24% (20/21) and 95.00% (19/20); the good improvement rates for fever were 85.71% (18/21) and 80.00% (12/15), and the improvement rates were 90.48% (19/21) and 93.33% (14/15) in the phase Ⅱ and Ⅲ respectively. No significant differences were seen between LPG and SHL groups on treatment duration, clinical effect and improvement rate for fever (all P ＞0.05). No adverse effects were seen in this study. Conclusion LPG has showed a definite clinical effect on common cold (Feng-Re syndrome) with no observed adverse effects.
Objective To systematically review the clinical effectiveness and safety of Lianhuaqingwen capsule in the treatment of influenza. Methods Databases including MEDLINE, The Cochrane Library, PubMed, VIP, WanFang Data, CNKI and CBM were searched to collect the randomized controlled trials (RCTs) on Lianhuaqingwen capsule treating influenza published from 2000 to 2011. The studies were screened according to the inclusion and exclusion criteria, the data were extracted, the quality of the included RCTs was assessed, and meta-analysis was performed using RevMan 5.0 software. Results Among 12 RCTs included, 11 were in Chinese and 1 was in English. The results of meta-analyses based on stratified therapeutic strategies showed that: a) Lianhuaqingwen caspule vs. other traditional Chinese medicinals (TCM): A total of 5 RCTs were included. Compared with the Lingyangganmao capsule, significant differences were found in the clinically marked effective rate (RR=1.32, 95%CI 1.15 to 1.52), the marked effective rate of temperature (RR=1.31, 95%CI 1.10 to 1.55), and the time of defervescence (RR=3.98, 95%CI –4.81 to –3.15); compared with the Kugan granules, significant differences were found in the clinically marked effective rate (RR=1.33, 95%CI 1.08 to 1.64) and the marked effective rate of temperature (RR=1.58, 95%CI 1.20 to 2.09); compared with the TCM decoction, the time of defervescence was significantly different (WMD=5.52, 95%CI 0.32 to 10.72); and b) Lianhuaqingwen capsule vs. western drugs: A total of 9 RCTs were included. Compared with ribavirin, the clinically marked effective rate was significantly different (RR=1.52, 95%CI 1.15 to 2.02); compared with Phosphate oseltamivir, the clinically marked effective rate was not significantly different (RR=0.96, 95%CI 0.77 to 1.18), and the WMDs (95%CI) of such indexes as the time of defervescence, the duration of cough, sore throat, myalgia, expectoration and headache, and the time of viral shedding were –4.50 (–8.83, –0.17), –10.38 (–13.89, –6.87), –13.92 (–19.81, –8.04), –16.44 (–26.50, –6.39), –10.80 (–18.98, –2.63), –9.24 (–17.92, –0.57), and 1.39 (–7.24, 10.02), respectively. Except for the time of viral shedding, all the other indexes showed significant differences between the two groups. No obvious adverse reactions related to Lianhuaqingwen capsule were reported. Conclusion Current evidence shows that Lianhuaqingwen capsule is more effective than other Chinese medicinals and western drugs in alleviating flu-like symptoms when treating influenza. Due to the low methodological quality of the included RCTs, more high-quality large-scale RCTs need to be conducted to verify this conclusion.
Objective To systematically assess the effectiveness of traditional Chinese medicines (TCM) in treating upper airway cough syndrome (UACS) or postnasal drip syndrome (PNDS). Methods Such databases as MEDLINE (1950 to 2011), PubMed (1996 to 2011), VIP (1989 to 2011), WanFang Data (1998 to 2011), CNKI (1979 to 2011) and CBM (1978 to 2011) were searched for collecting the randomized controlled trials (RCT) or quasi-RCTs about TCM treating UACS/PNDS. The trials were screened according to the inclusive and exclusive criteria, and then after the quality assessment and data extraction were conducted, the statistical analysis was conducted by using RevMan 5.0 software. Results A total of 10 RCTs and quasi-RCTs in Chinese were identified. The results of analysis showed that: a) The integrated Chinese and western medicine was superior to western medicine alone, either for adults and children with UACS, or for adults with PNDS. However the effectiveness had to be further assessed due to lack of high-quality literatures; b) TCM alone was probably more effective than western medicine alone for adults with PNDS, but not for adults and children with UACS. No obvious adverse reaction related to TCM was reported. Conclusion The recent research outcomes show that the integrated Chinese and western medicine is superior to western medicine alone, either for adults and children with UACS, or for adults with PNDS, but no definite evidence is found to support the superiority of TCM in treating UACS/PNDS. More high-quality RCTs with large scale need to be conducted in future to verify this conclusion due to the overall low methodological quality and significantly different intervention of the included trials.
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treatingchronic obstructive pulmonary disease (COPD) in a stable stage. Methods We searched MEDLINE (1950 to July 2008), PubMed (1996 to July 2008), VIP (1989 to July 2008), WanFang (1998 to July 2008), CNKI (1979 to July 2008), and CBM (1978 to July 2008)for randomized control trials about TCM to treat stable COPD. Trial screening, quality assessment of included trials, and data extract were conducted. Statistical analysis was conducted by using RevMan 4.2.7 software. Results A total of 30 randomized controlled trials (RCTs) in the Chinese language were identified. No pooled analysis was performed because of the significant heterogeneity among the included trials. (1) For TCM alone versus blank therapy or placebo: 3 RCTs reported the clinical effective rate and only 1 indicated TCM was more effective; 5 RCTs reported forced expiratory volume in one second (FEV1)% after treatment and 2 indicated TCM alone as more effective in improving lung function; 4 RCTs reported quality of life after therapy and 2 indicated TCM alone was more effective in improving quality of life after therapy. (2) For integrated tradtional and western medicine versus western medicine alone: 11 RCTs included the clinical effective rate, 3 RCTs showed that integrated traditional and western medicine was more effective. Of 8 RCTs reporting FEV1%, 2 RCTs suggested that integrated traditional and western medicine was more effective. There were 3 RCTs studying 6 minute walking distance and 4 RCTs about quality of life, which also showed that integrated traditional and western medicine was more effective. No obvious adverse reaction to TCM was reported.Conclusions The current evidence shows TCM tends to relieve the symptoms and improve quality of life for patients with stable COPD without obvious adverse reaction. Due to the low methodological quality of trials included, more RCTsof high quality and large scale are required.
Objective To assess the effect and safety of Dalitong Granule in the treatment of the Piman syndrome (functional dyspepsia). Method The double-blind, double-dummy and randomized controlled method was adopted. 120 patients were randomized to the treatment group (n=90, Dalitong Granule 6 g, tid) and the control group (n=30, treated with cisapride 5 mg, tid). The therapeutic course for both groups was 2 weeks. Results All the results were analyzed on the basis of intention-to-treat and per-protocol population. In the treatment group, the markedly effective rates were 62.37% and 64.45% respectively. The effective rates were 99.55% and 96-67% respectively. In the control group, the markedly effective rates were 58-08% and 60.00% respectively. The effective rates were 90.33% and 93.33% respectively. There was no significant difference between two groups (Pgt;0.05). For effects on Piman syndrome, in the treatment group, the markedly effective rates were 53.76% and 55.56% respectively. The effective rates were 86.02% and 88.89% respectively. In the control group, the markedly effective rates were 48.38% and 50.00% respectively. The effective rates were 80.64% and 83.33% respectively. The results showed no statistical significance difference between two groups (Pgt;0.05). For effects on gastric emptying function (PP population), in the treatment group, the markedly effective rate and effective rate were 72.42% and 79.32%. In the control group those were 64.28% and 64.28%. There was no significant difference between the two groups (Pgt;0.05). ITT and PP analysis revealed similar results. No adverse effect was found in the observation. Conclusions Dalitong granule has the same clinical effect as cisapride with no obvious toxic-adverse effects.
Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM) paste in treating chronic obstructive pulmonary disease (COPD) in stable stage. Methods We electronically searched databases including PubMed, EMbase, The Cochrane Library (Issue 12, 2016), VIP, WanFang Data, CNKI and CBM to collect randomized controlled trials (RCTs) regarding TCM paste in combination with conventional Western therapy versus Western therapy alone in treating stable COPD from inception to December 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. The meta-analysis was conducted by RevMan 5.3 software. Results A total of 9 RCTs involving 605 Chinese patients were included. The results of meta-analysis showed that: when compared with conventional Western medicine alone, TCM paste combined with the conventional Western medicine significantly improved clinical effective rate (RR=1.20, 95% CI 1.10 to 1.31,P<0.000 1), decreased SGRQ score (MD=–4.53, 95% CI –5.41 to –3.65,P<0.000 01) and CAT score (MD=–2.45, 95% CI –3.38 to –1.51,P<0.000 01), increased FEV1% (MD=3.80, 95% CI 0.40 to 7.20,P=0.03), and reduced the frequency of acute exacerbation (P<0.05). No serious adverse reaction occurred in both groups. Conclusion The current evidence shows that combination of TCM paste and conventional Western medicine may improve clinical effective rate, quality of life, increase FEV1%, and reduce the frequency of acute exacerbation in patients with stable COPD. Due to the limited quality and quantity of included studies, the above results are needed to verify by more studies.