The therapeutic effects of the Tong Luo Kai Bi Tablets [symbol: see text] in 120 patients with rheumatoid arthritis were observed in this clinical trial by the randomized double blind method. Both the observed group a...The therapeutic effects of the Tong Luo Kai Bi Tablets [symbol: see text] in 120 patients with rheumatoid arthritis were observed in this clinical trial by the randomized double blind method. Both the observed group and the control group each had 60 patients. In the observed group treated with the Tong Luo Kai Bi Tablets, 1 case (1.7%) was cured clinically, 27 cases (45.0%) improved markedly, 26 cases (43.3%) improved, with a total effective rate of 90.0%. In the control group treated with Rheumatic Semen Strychni Tablets [symbol: see text], no case was cured, 16 cases (26.7%) improved markedly, 33 cases (55.0%) improved, with a total effective rate of 81.7%. Statistical data showed the Tong Luo Kai Bi Tablets had much better therapeutic effectiveness clinically than the Rheumatic Semen Strychni Tablets (P展开更多
Objective:The Consolidated Standards for Reporting of Trials(CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials(RCTs).However,most of the Chinese me...Objective:The Consolidated Standards for Reporting of Trials(CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials(RCTs).However,most of the Chinese medical journals have not endorsed the CONSORT statement.The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear.The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals.Methods:We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals(Journal type 1) without adoption of CONSORT and Chinese Journal of Evidence-based Medicine(Journal type 2) which adopted CONSORT in 2004.We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report,gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items.The reporting quality of RCT trials from 2001 to 2003(pre-adoption period) was compared with that from 2004 to 2006(post-adoption period).Results:The average reporting quality of RCTs was moderate(mean score,15.18),and the mean score of the 6 core items was low(mean score,1.09) in 5 leading journals.The difference in the total score and the score of the 6 core items between pre-adoption period(2001-2003) and post-adoption period(2004-2006) was statistically significant(P=0.003;P=0.000).Interaction between journal type and period was not significant(F=0.76;P=0.383).We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different.But as to the core items of sequence concealment and intention-to-treat analysis,the increases were greater for Journal type 2 when evaluated against Journal type 1(P=0.038;P=0.016).Conclusion:The reporting quality of RCT trials in 5 leading Chinese medical journals is improving.However,the lack of important items in RCT trials remains a serious problem.We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.展开更多
文摘The therapeutic effects of the Tong Luo Kai Bi Tablets [symbol: see text] in 120 patients with rheumatoid arthritis were observed in this clinical trial by the randomized double blind method. Both the observed group and the control group each had 60 patients. In the observed group treated with the Tong Luo Kai Bi Tablets, 1 case (1.7%) was cured clinically, 27 cases (45.0%) improved markedly, 26 cases (43.3%) improved, with a total effective rate of 90.0%. In the control group treated with Rheumatic Semen Strychni Tablets [symbol: see text], no case was cured, 16 cases (26.7%) improved markedly, 33 cases (55.0%) improved, with a total effective rate of 81.7%. Statistical data showed the Tong Luo Kai Bi Tablets had much better therapeutic effectiveness clinically than the Rheumatic Semen Strychni Tablets (P
文摘Objective:The Consolidated Standards for Reporting of Trials(CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials(RCTs).However,most of the Chinese medical journals have not endorsed the CONSORT statement.The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear.The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals.Methods:We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals(Journal type 1) without adoption of CONSORT and Chinese Journal of Evidence-based Medicine(Journal type 2) which adopted CONSORT in 2004.We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report,gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items.The reporting quality of RCT trials from 2001 to 2003(pre-adoption period) was compared with that from 2004 to 2006(post-adoption period).Results:The average reporting quality of RCTs was moderate(mean score,15.18),and the mean score of the 6 core items was low(mean score,1.09) in 5 leading journals.The difference in the total score and the score of the 6 core items between pre-adoption period(2001-2003) and post-adoption period(2004-2006) was statistically significant(P=0.003;P=0.000).Interaction between journal type and period was not significant(F=0.76;P=0.383).We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different.But as to the core items of sequence concealment and intention-to-treat analysis,the increases were greater for Journal type 2 when evaluated against Journal type 1(P=0.038;P=0.016).Conclusion:The reporting quality of RCT trials in 5 leading Chinese medical journals is improving.However,the lack of important items in RCT trials remains a serious problem.We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.
