Objective To evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic cor pulmonale. Design A systematic review of randomized clinical trials. Method Randomized trials comparing Salviae miltiorrhizae Injection plus routine treatment versus muting treatment alone were identified by electronic and manual searches. No blinding and language limitations were applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n=2 161) were identified. The methodological quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1.15 to 1.26). Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not b. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Injection may have positive effect on symptom scores in patients with chronic cor pulmonale. But for mortality, the markers of blood rheology and oxidants/antioxidants, there is no reliable conclusion. However, the evidence is not b due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important markers. Further large trials are needed.
Objective To investigate the status of clinical practices and side effects related to Shenfu injection.Method We searched the China National Knowledge Infrastructure (CNKI) database using the key word “Shenfuinjection”. Original clinical studies of Shenfu injection which were published from January 1993 to December 2008 inChinese magazines were included. Results A total of 576 relevant clinical studies were identified. There were 21 496 cases in the study group and excluding the control group patients. We investigated and analyzed the side effects of Shenfu injection. For cases with side effects, the medication dosage, the diseases for treatment, the method of medication, the menstruum, and course of treatment for the side effects were evaluated. All the side effects were mild except one case of anaphylactic shock. Conclusion Shenfu injection has been widely used in clinical patients since it came into the market in 1993. However, systematic evaluation of its clinical application is lacking, and there are some unsolved problems and deficiency in selecting and expanding diseases for treatment, evaluating the dosage and treatment method, and investigating the side effects of the drug. Therefore, it is imperative to enhance the evaluation drugs and good clinical application after the drugs come into the market with evidence-based medicine.
【摘要】 目的 观察利胆清微丸治疗慢性胆囊炎湿热蕴结兼血瘀证患者的疗效及安全性，进一步为临床研究提供依据。 方法 2001年4—7月，采用双盲、双模拟、随机平行对照临床试验，将40例患者随机分为试验组（20例）及对照组（20例）。试验组服用利胆清微丸3.5 g/次，3次/d，同时服用胆宁片模拟剂；对照组服用胆宁片3片/次，3次/d，同时服用利胆清微丸模拟剂。 结果 试验组痊愈1例，显效12例，有效5例，无效2例，显效率65%，有效率90%；对照组痊愈2例，显效10例，有效7例，无效1例，显效率60%，有效率95%，两组疗效比较差异无统计学意义（Pgt;0.05）。试验过程中未发现明显不良反应。 结论 利胆清微丸对于治疗慢性胆囊炎湿热蕴结兼血瘀证有良好效果，是一种安全有效的药物。【Abstract】 Objective To observe the safety and efficacy of Lidanqing pellet on chronic cholecystitis with damp and hot accumulate knot including blood stasis, and to provide a basis for further clinical trials. Methods A double-blind, double dummy, randomized, and controlled clinic trial was undertaken between April and July 2001. A total of 40 patients were randomly divided into trail group and control group. The trial group was given Lidanqin pellet 3.5 g per time, and three times per day; simultaneously taking Danning tablet simulation agent. The control group was given 3 tablets of Danning tablet per time and three times per day; simultaneously taking taking Lidanqing pellets simulation agent. Results In the trail group, one patient was cured, the therapeutic effect was obvious in 12, basically effective in five and invalid in two (with the rate of obvious effect of 65.00% and rate of basic effect of 90.00%). In the control group, two patients was cured, the therapeutic effect was obvious in 12, basically effective in 10, effective in seven and invalid in one (with the rate of basic effect of 60.00% and the rate of obvious effect of 95.00%). The difference between the two groups was significant (Pgt;0.05). Adverse reaction was not found in the trial group. Conclusion Lidanqing pellet, a safe medication, is effective on chronic cholecystitis with damp and hot accumulate knot including blood stasis.
Objective To assess the quality of reporting of randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) in China from 1999 to 2004 by CONSORT statement and Jadad scale. Methods We randomly selected 13 journals of TCM including Chinese Journal of Integrated Chinese and Western Medicine,ect using stratified sampling from about 100 journals of TCM in mainland China, and all issues of selected journals published from 1999 to 2004 were hand-searched according to the hand-search guideline developed by Cochrane Collaboration. All reviewers were trained in the method of evaluating RCTs . A comprehensive quality assessment of each RCT was completed using methods including the revised consolidated standards of reporting trials (CONSORT) checklist and Jadad scale. Disagreements were resolved by consensus. Results A total of 7422 RCTs were identified, and the percentage of RCTs was significantly increased by 18.6%, 23.9%, 27.5%, 28.8%, 33.0% and 35.6% from 1999 to 2004. The mean Jadad score was 1.03 ± 0.61 in all trials with 1 RCT with 5 points, 14 with 4 points, and 102 with 3 points, from 1999 to 2004, the mean Jadad score was 0.85±0.53 (n=746), 0.82±0.63 (n=941), 0.90±0.61 (n=1 243), 1.03±0.60 (n=1 325), 1.12±0.58 (n=1 533) and 1.20±0.62 (n=1 634) respectively, which was improved continuously but slowly. 39.4% of the items in CONSORT, which was equivalent to 11.82 (standard deviation=5.78) of a total of 30 items, were reported across those trials. Some important methodological components of RCTs such as sample size calculation (1.1%), randomization sequence (7.9%), allocation concealment (0.3%), implementation of the random allocation sequence (0.0%) , analysis of intention to treat (0.0%), were incompletely reported. Conclusion Our study suggests that the quality of reporting has been improved but still in poor status, which would urgently promote the establishment of the CONSORT for TCM.
Objective To assess the quality of published systematic reviews and meta-analyses on Traditional Chinese Medicine (TCM) published in Chinese journals. Methods We searched CNKI, CMB from January 1995 to December 2006 and The Cochrane Library (Issue 4, 2006) for systematic reviews and meta-analyses on TCM. We extracted details of the interventions used in the treatment and control groups, analyzed the validity of included studies and investigated whether the reports used QUOROM statement or not. Results We identified 111 reports, of which 1 on prevention, 1 on adverse events, 1 on risk factors and premonitory symptoms, 2 on physiochemical parameters, and 106 on effectiveness and safety assessment. In total, 42 types of diseases were involved, and 41 reports were related to cerebrovascular diseases. As for the investigated interventions, 25 studies assessed TCM and 12 assessed acupuncture. Two had no control intervention design control in the group, 15 did not describe the interventions in the control group, 50 used active control (26 for western medicine, 12 for Chinese medicine, 12 for western plus Chinese medicine), 14 used blank control, 17 used baseline control, 4 used sham acupuncture or acupoint injection control etc., 5 used placebo control and 4 used "mutual control". The interventions used in the treatment and control groups varied widely. The number of trials included in the reviews and meta-analyses ranged from 1 to 35, and 24 studies included non-randomized controlled trials. Of the 111 reports, 14 were Cochrane reviews, 16 did not assess the quality of included randomized trials and a further 22 performed only simple and nonstandard quality assessment of the included trials. None of the reviews or meta-analyses used the QUOROM statement to report their results. Conclusions Because of the unique characteristics of TCM, systematic reviews of TCM should focus on a specific topic, avoid the selection of too many drugs, address the target indications of the test drugs and pay attention on intervention evaluation. High quality systematic reviews of TCM are needed but they will only be produced through the concerted efforts of clinicians, TCM practitioners and methodologists.