The study is mainly conducted for determining the effectiveness and the adverse effects caused by Dan Shen agents. The study was mainly conducted to determine the ability of Dan Shen agent in increasing the disability-free survival in patients suffering from acute ischemic stroke. It was also conducted to study the effectiveness of Dan Shen agents in treating neurological problems and in improving the quality of life. The study was basically an RCT and a quasi-RCT in which Dan Shen agents were compared to placebos.
•usefulness and/or scope of the resource – Although there were some issues regarding certain disagreements regarding determining the quality, extracting the data, etc, the trial demonstrated that Den Shen agents could potentially help acute ischemic stroke patient’s recover from neurological deficits. However, the author has also said that larger scale trials are required to help establish or rule out the results that have been obtained from this trial. There may be several limitations in this trial, note by the author, and future trials need to overcome these limitations.
•limitations of the resource – The trial was a systematic review conducted across several databases including the Cochrane Database, Medline, EMBASE, Chinese Biological Medicine Database, CINAHL, etc. The methodological quality of the study seemed to be very poor indeed. The quality of randomization of two trials was rather poor as the participants were allocated according to the manner in which they were admitted to the hospital. The manner in which the subjects were allocated was not mentioned in three trials.
A clear process of randomization was performed in one trial only. However, the manner in which allocation concealment was conducted was not mentioned. The use of a blinded method of outcome determination was not mentioned in the trials. Even the intention to treat analysis was not given. The trials were conducted for short durations and hence the long-term effects could not be conducted. On the whole, evidence supporting potential benefits through the routine use of Dan Shen for treating patients with acute ischemic stroke was not provided by this study.
Future trials need to concentrate on providing adequate concealment of allocation, blinding the outcome assessors and should conduct a more scientifically based long-term study. Only very few trials demonstrated the adverse effects of Dan Shen, and for assessing these larger long-term trials need to be conducted. •reliability and/or credentials of the author – The results obtained from this trial may not be reliable as it is a review of several other trials which have been conducted in the past. The trial was conducted by three Chinese doctors by names Wu B, Liu M, Zhang S in Sichuan China.
The trial assessed previous studies that were conducted in China itself. Wu B. conducted the first protocol, and the other two authors reviewed the quality of the data independently. As there were no external reviewers in the trial some amount of bias may exist as Dan Shen is a Chinese drug. •intended audience – the intended audience for the results of this trial are the western medical community, to whom the benefits of Dan Shen need to be demonstrated so that their potential benefits could be identified and they could be subjected to several other studies in the Western community.
•significant or special features of the work – The trials were a systematic meta-analysis of previous RCT’s and quasi-RCT’s conducted previously in China. It included about 6 trials and involved about 494 participants. The trial demonstrated improvements in the neurological deficits following acute ischemic stroke after using Dan Shen, but there poor methodological quality of the trial suggested that this was not a reliable finding. In a way the study helped to justify the use of Dan Shen in Chinese medicine for the last 30 years.
Initially in the study 11 trials were included, but only those which meet with minimum criteria were selected. The others were excluded as they did not meet with certain quality criteria. •validity, reliability and relevance – All the studies were conducted in China, and hence the results may not be very accurate as they may not possess similar results in other nations. The type of patients that formed a part of the study across the several trials assessed was not uniform. Hence, the results could also be faulty.
The adverse effects were only reported and determined in two trials, and that too, only the short term adverse effects were studied. The findings of this study may not be relevant as it does not point out the long-term effects of the trial. As a poor methodological quality was utilized in the trial, the reliability of the trial seems to also be poor. To make the results of this study more valid, longer term and high quality trials need to be conducted. • the value of the research to practice – No evidence is provided to support the routine use of Dan Shen agents in treating patients suffering from acute ischemic stroke.
To certain extents, it can be found that Dan Shen agents could be utilized to improve n neurological deficit, but longer-term and higher-quality studies need to be conducted to confirm or rule out this results. •flaws and limitations inherent in the work – Some of the flaws of the current study include:- 1. Poor methodological quality 2. The method of allocation and concealment was not clear in all the trials. 3. The study included only short term trials in which treatment were provided for 14 to 28 days. However, recover after stroke often takes months or years.
Hence, the long-term effects of Dan Shen agents was not assessed 4. The outcome assessors of the trial were not blinded 5. The trials tried to concentrate on the leave of neurological functioning and not at the primary outcome measures 6. Only a few trials tried to study the adverse effects of Dan Shen agents
Wu, B. , Liu, M, & Zhang, S. (2007). “Dan Shen agents for acute ischemic stroke. ” Cochrane Database Syst Rev. 18;(4): CD004295. http://www. ncbi. nlm. nih. gov/entrez/utils/fref. fcgi? PrId=3058&itool=AbstractPlus-def&uid=15495099&db=pubmed&url=http://dx. doi. org/10. 1002/14651858. CD004295. pub2