Objective To assess the systematic reviews of magnesium sulfate used to treat severe asthma. Methods An electronic search was performed in The Cochrane Library (Issue 2, 2008), ACP Journal Club (1991 to June 2008), MEDLINE (1990 to June 2008), Chinese Journal Full-text Database (1979 to June 2008), Chinese Scientific and Technological Periodical Databases (VIP) (1980 to June 2008), and Chinese Bio-medicine Database (CBM) (1980 to June 2008) to collect systematic reviews of magnesium sulfate treatment for severe asthma. The retrieved systematic reviews were reassessed, and then we adopted the evidence for clinical practice. Results Nine systematic reviews were included, and all of them included 14.1 ± 2.9 items of QUOROM (the quality of reporting of Meta-analyses) on average. In general, the included systematic reviews had comparatively high quality. Evidence illustrated that intravenous infusion of magnesium sulfate could improve pulmonary function and reduce hospital admission without any serious side effects. However, no evidence could verify that patients with asthma can benefit from aerosolized and oral magnesium sulfate. In a specific case with severe asthma, we used magnesium sulfate via intravenous infusion which helped the control of symptoms with no adverse reactions. Conclusion Magnesium sulfate via intravenous infusion can improve pulmonary function and reduce hospital admission rates. Due to its effectiveness, safety, and low cost, it deserves widespread application in patients with severe asthma.
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.
Objective To explore whether the placebo-controlled trials in traditional Chinese medicine (TCM) were scientific and ethical. Method An electronic search concerned with placebo-controlled trials of TCM was performed at Chinese Journal Full-text Database, Chinese Scientific and Technological Periodical Database (VIP), Wanfang Database and Chinese Bio-medicine Database (CBM) from January 1979 to April 2008. In addition, we handsearched the trials in specialized journals of TCM. The trials were assessed regard with their scientificalness, ethic and traits of TCM of placebo-controlled trials. Results A total of 231 trials were included, occupying about 2.09% of all the randomized controlled trials (RCTs) of TCM; among which there were 79 (34.20%) with sequence generation, 10 (4.33%) with allocation concealment, 129 (55.84%) with blind methods; 106 (45.89%)with basic intervention, 13 (5.63%) with criteria of intervention quality control, 139 (60.17%) with preparation of placebo, 10 (10.33%) with aggravating scheme, 70 (30.30%) with syndrome type of TCM, 48 (20.78%) with the outcome measurement of TCM. There were 48 RCTs (20.78%) were not scientific. There were 221 RCTs without institutional review board and 187 RCTs without informed consent. Conclusion Placebo-controlled trials of TCM are not applied extensively, and some of them are not scientific. Most of than do not meet the ethical requirements.
【摘要】 目的 探索针灸治疗慢性功能性便秘的特点及规律,以期为制定针灸治疗功能性便秘优选方案提供参考。方法 运用文献计量学方法,通过回顾分析1999年—2008年的针灸治疗慢性功能性便秘文献,以中国期刊全文数据库为资料来源,对这些文献进行定量分析。结果 共纳入86篇文献,分布在41种期刊上；针灸治疗功能性便秘最常用的穴位是天枢、大肠俞、足三里、支沟、上巨虚。结论 针灸治疗本病操作方法繁多,临床研究水平普遍较低,需进一步探讨针灸治疗的优化方案。
Objective?To investigate the relationship between syndromes of traditional Chinese medicine (TCM) and lung function in patients with chronic obstructive pulmonary disease (COPD) at stable phase. MethodsBased on diagnostic criterion of TCM, five groups of symptoms of TCM about stable COPD were established including lung Qi deficiency, lung and spleen Qi deficiency, lung and kidney Qi deficiency, lung Spleen Kidney Qi deficiency, and deficiency of both Qi and Yin. A total of 300 cases which were up to the standard were differentiated into 5 groups by the symptoms. Some basic details and lung function of the patients were recorded, and then statistical analysis was performed to analyze the differences of lung function among groups. ResultsForced expiratory volume in the first second in descending order was lung Qi deficiency group, lung and spleen Qi deficiency group, lung and kidney Qi deficiency group, and lung spleen kidney Qi deficiency group (P<0.05). ConclusionThese findings suggest that with the progressing of COPD, the symptom type of TCM for COPD patients at stable phase may vary from lung Qi deficiency to lung and spleen Qi deficiency, or to lung and kidney Qi deficiency, and even lung, spleen and kidney Qi deficiency. Lung function tests help reveal substance and pathogenesis of TCM syndromes of patients with stable COPD, and provide evidence for the clinical syndrome.
ObjectiveTo investigate the clinical effect and mechanism of Chinese heat-clearing and phlegm-resolving recipe in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). MethodsA randomized controlled trial (RCT) was conducted. A total of sixty in-patients with AECOPD of phlegm heat and phlegm turbidity in lungs were randomly allocated to treatment group and control group with an equal number of patients between October 2009 and March 2010. The treatment duration was 10 days. Symptom scores of traditional Chinese medicine (TCM), pulmonary function, white blood cell count, polymorphonuclear neutrophils, C-reactive protein and the plasma concentration of bactericidal/permeability increasing protein (BPI) and interleukin (IL)-8 and IL-10 were detected. ResultsFor TCM syndrome of phlegm heat and phlegm turbidity, there was a statistical difference between the two groups after treatment (P<0.05). Cough, sputum amount, expectoration and coated tongue were improved obviously in the treatment group (P<0.05). The total explicit efficiency rate and effective rate were 56.0% and 84.0% in the control group and 82.1% and 92.9% in the treatment group respectively. The total explicit efficiency rate was significantly different between the two groups (P<0.05), while the total effective rate was not significantly different (P>0.05). Plasma concentration of IL-8 decreased markedly in the treatment group and IL-10 and BPI increased obviously. There was no significant difference in the change of BPI, IL-8 between the two groups (P>0.05), except for IL-10 (P<0.05). ConclusionChinese heat-clearing and phlegm-resolving recipe can improve signs and symptoms of TCM in the treatment of AECOPD (phlegm heat and phlegm turbidity in lungs), by the potential mechanism of increasing the level of IL-10.
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.