Objective To evaluate the current situation of randomized controlled trials/ clinical controlled trials (RCT/CCT) on chronic gastritis and whether it could offer reliable evidence for clinical practice in China. Method RCT/CCT on chronic gastritis from eight Chinese clinical journals were searched manually and assessed according to international standard. Results 823 issues containing 213 therapeutic articles were searched and 81 RCT/CCT were identified and assessed. Conclusions The quantity and quality of RCT/CCT on Chronic gastritis in China could not meet the need of clinical practice. RCT/CCT of western medical therapy are much better than those of traditional Chinese therapy and integrated traditional Chinese and western medical therapy ones.
针刺平行随机对照试验通常没有准确报告试验组和对照组的干预方法.为促进标准化,国际上有经验的针刺医师和研究者组成的小组制定了一些原则,即针刺临床对照试验中干预措施报告的标准(缩写为STRICTA).在征求意见过程中,一些期刊编辑协助对此标准进行了修改,使之与随机对照试验报告的标准(CON-SORT)格式一致,作为该指南对针剌研究报告的延伸.参与此事的杂志编辑已确定要发表该标准,建议其作者群按照此标准准备论文,并将邀请更多杂志采用该标准.目的是使针剌对照试验的干预措施充分报告,从而有利于对这些研究的严格评价、分析及这些措施的推广.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Objective To review the eradication rate for Helicobacter Pylori (H. pylori) eradication therapy with Ranitidine bismuth citrate (RBC). Methods A systematic review of all the relevant randomized controlled trials (RCTs) was performed according to International Cochrane Collaboration. Data Source RCTs were identified from specialized trials register of Cochrane U GDP Group, the Cochrane library, additional electronic search (including MEDLINE and CBM), handsearching, and personal contact with pharmaceutical companies. Data Selection Randomized clinical trials comparing RBC or RBC in combination with other antibiotics such as proton pump inhibitor, H2-receptor antagonist, other bismuth or placebo were included. No language and blinding limitations were applied. Inclusion criteria Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Statistics analysis was managed by using RevMan 4. 1. Results Fifteen randomized clinical trials including 3 638 patients were included, with eight trials of high methodological quality. Meta-analysis indicated that odds ratio was 3.06 (95%CI 2.62 to 3. 58, P lt; 0. 000 01) comparing RBC to controls. But the heterogeneity was significant (P lt; 0. 000 01), so we choose random effects model. Then the odds ratio was 2.05 (95%CI 1. 29 to 3. 25, P=0.002). No serious adverse effects were found. Sensitivity analysis showed that the specimens and the quality of RCT haven’t affected researching result. Conclusion RBC is more effective in Helicobacter Pylori eradication therapy than others.
Objective To assess the efficacy and safety of Zhiling decoction for vascular dementia. Methods The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched in Feb. 2004 using the term Zhiling. In addition, we handsearched 83 traditional Chinese medicine journals （1993 to 2004 ）. We included all randomized controlled trials（RCTs）of Zhiling decoction treating people with vascular dementia. We also evaluated the internal validity of the RCTs . If all included RCTs were of high quality and homogeneity, then the meta-analysis was conducted. Results Only one RCT was identified. The outcomes were listed as the followings ： ① The Hasegawa＇ s dementia scale scoring （ HDS ） scores of the patients in Zhiling decoction group were improved significantly from baseline after 8 weeks course of treatment and there was no significant difference in the control group. The HDS scores improvement was greater than control group（P 〈0.01 ）o ② The latency of P3 was shorter in both groups after treatment, and there was a significant treatment effect in Zhiling group （t = -52. 09, 95% CI -69.79 to -34.39, P 〈0. 000 01 ）. The amplitude of 173 increased in both groups after treatment, and there was a non-sigmficant treatment effect in Zhiling group for change from baseline （t =1.40, 95% CI -0.02 to 2.82, P =0.05）. ③ Brain electrical activity monitoring （BEAM） showed that benefits in those treated by Zhiling decoction were higher than those treated by Naofukang with OR9.90 （ 95% CI 3.34 to 29.38）. ④In the Zhiling group serum cholesterol （P 〈0.01 ） , serum triglyceride （P 〈0.01 ） and LPO（P 〉0. 01 ） decreased after treatment. There was an increase in the level of high density lipoprotein （HDL） and superoxide dismutase （SOD） in red blood cells compared with baseline for Zhiling groups （P 〈0.01 ）. ⑤ The cerebral blood flow decreased in both groups after treatment, and there was a significant treatment effect in favour of Zhiling （treatment effect t = -1.03, 95% CI -1.26 to -0.80, P 〈0. 00001 ）.⑥ No side effects on heart, liver or renal function were reported in Zhiling decoction group. Conclusions The currendy available evidence is insufficient to assess the potential efficacy for Zhiling decoction in the treatment of vascular dementia. Just one RCT concerning the management of Zhifing decoction versus Naofukang suggests that Zhiling decoction may be effective in treating vascular dementia. Further randomised, double-blind, placebo-controlled trials are urgendy needed .
ObjectiveTo assess the efficacy and safety of compound flumetasone ointment for neurodermatitis and chronic eczema. MethodsWe searched the Medline, Cochrane Central Register of Controlled Trials, EMbase, CBM, CNKI and Wanfang Data to collect randomized controlled trials (RCTs) of compound flumetasone ointment for neurodermatitis and chronic eczema; the retrieval time started from founded date to December 2012. The language was confined to English and Chinese. We performed meta-analyses using the Cochrane Collaboration's RevMan 5.0 Software. ResultsA total of 22 RCTs involving 2 049 patients with neurodermatitis and chronic eczema were included and assessed. At the end of the 2nd, 3rd and 4th week, the efficacy of topical compound flumetasone ointment (or combined with oral antihistamines) was obviously higher than that of other topical corticosteroid preparations[RR=1.39, 95%CI(1.30, 1.50), P<0.000 01; RR=1.25, 95%CI(1.15, 1.37), P<0.000 01; RR=1.21, 95%CI(1.11, 1.33), P<0.000 1]. Only temporary and slight adverse effects, such as erythema, desquamation, burning and tingling were observed, whereas no serious adverse effects were reported. ConclusionThe limited evidence demonstrates that topical compound flumetasone ointment (or combined with oral antihistamines) is safe and efficient. More large sampled and multiple central RCTs are required to verify these conclusions owing to the limitations of the present study.
ObjectiveTo systematically review the effect of self-management intervention on the prevention and management of lymphedema in breast cancer patients. MethodsThe Cochrane Library, Embase, PubMed, Web of Science, CINAHL, PsycINFO, SinoMed, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on self-management intervention on the prevention and management of lymphedema in breast cancer patients, from inception to June 16. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was performed using RevMan 5.4 software. ResultsA total of 37 references were included, comprising 25 randomized controlled trials (RCTs), 12 controlled clinical trials (CCTs), and a total of 3 697 patients. There were 26 studies in the meta-analysis, and the results of the meta-analysis showed that, compared with the control group, patients in the intervention group exhibited better performance in lymphedema management-related behaviors (SMD=2.65, 95%CI 1.53 to 3.78, P<0.01), symptoms related to lymphedema (SMD=−2.01, 95%CI −3.66 to −0.37, P<0.05), occurrence of lymphedema (RR=0.37, 95%CI 0.32 to 0.45, P<0.01), upper limb function (SMD=−1.88, 95%CI −2.83 to −0.92, P<0.01), quality of life (SMD=2.79, 95%CI 2.05 to 3.54, P<0.01), and the difference was statistically significant. The intervention mainly included information support, material support, emotional support and decision support. ConclusionThere are currently a variety of self-management interventions, but they mainly focus on information support. Self-management interventions can improve the self-management behavior of breast cancer patients with lymphedema and reduce the impact of lymphedema on patients.
Objective To determine the effect of closed tracheal suction system versus open tracheal suction system on the rate of ventilator-associated pneumonia in adults. Methods We searched The Cochrane Library (Issue 1, 2007), PubMed (1966 to 2006) and CBM (1980 to 2007), and also hand searched relevant journals. Randomized controlled trials involving closed tracheal suction system versus open tracheal suction system for ventilator-associated pneumonia in adults were included. Data were extracted and the quality of trials was critical assessed by two reviewers independently. The Cochrane Collaboration’s RevMan 4.2.8 software was used for data analyses. Result Five randomized controlled trials involving 739 patients were included. Results of meta-analyses showed that compared to open tracheal suction system, closed tracheal suction system did not increase the rate of ventilator-associated pneumonia (RR 0.83, 95%CI 0.50 to 1.37) or case fatality (RR 1.05, 95%CI 0.85 to 1.31). No significant differences were observed between open tracheal suction system and closed tracheal suction system in the total number of bacteria (RR 0.83, 95%CI 0.50 to 1.37), the number of SPP colony (RR 2.87, 95%CI 0.94 to 8.74) and the number of PSE colony (RR 1.46, 95%CI 0.76 to 2.77). There was no significant difference between the two groups in the duration of ventilation and length of hospital stay. Conclusion Open or closed tracheal suction systems have similar effects on the rate of ventilator-associated pneumonia, case fatality, the number of SPP and PSE colonies, duration of ventilation and length of hospital stay. However, due to the differences in interventions and statistical power among studies included in this systematic review, further studies are needed to determine the effect of closed or open tracheal suction systems on these outcomes.
Objective To evaluate the short and long term effectiveness and safety of rapamycin-based immunosuppression regimes with CsA preserving versus CsA withdrawal. Methods We searched MEDLINE, EMBASE, The Cochrane Library and CNKI from Jan. 1995 to Dec. 2005. We identified randomized controlled trials of rapamycin-hased immunosuppression regimes with CsA preserving versus CsA withdrawal for renal transplantation patients. The quality of included trials was evaluated by two reviewers. Meta-analysis was conducted on homogeneous studies. Results Ten studies （1 121 patients） undergoing renal transplantation were included. All included studies were graded in term of randomization, allocation concealment and bhnding. Six studies were graded A and the other 4 were graded B. Meta-analysis results showed CsA withdrawal in sirolimus-based therapy in renal transplantation patients survival rate OR.（95% CI ） values were 0,77（0.17, 3.52）, 1.24（0.48, 3.16）, 1.32（0.57, 3.08）, 1.21（0.60, 2.41） at the end of 6, 12, 24, 36 months respectively; renal allografts survival rate OR. （95% CI） values were 1.79 （0.63, 5.06）, 1.15 （ 0.56, 2.36） , 1.39 （0.68, 2.85）, 1.80（0.99, 3.29）, 2. 13（1.16, 3.89）, 2.01（1.15, 3.51） at the end of 6, 12, 24, 36, 48, 54 months respectively; and acute rejection OP,（95% CI） values were 0.92（0.48, 1.78）, 1.90（1.25, 2.89）, 2. 01 （0.94,4.27）, 1.93（0.93, 4.00）, 1.52（0.77, 3.02） at the end of6, 12, 24, 36, 48 months respectively. Conclusions Available evidence shows that compared with CsA preserving, CsA withdrawal in rapamycin-based immunosuppression regimes can lead to higher incidence rates of acute rejection at the end of one year while there is no statistical difference to survival rate of patients/renal allograft in cases with stabilized renal function post-transplantation. And CsA withdrawal is of benefit to allografts for long term survival rate and is helpful to recovery of renal function. Owing to high possibility of selection bias and measurement bias in included studies, there must be a negative impact on evidence intensity of our results. We expect best evidence from with high quality double blind randomized control trials.
Objective To assess the efficacy of medical expulsive therapy for ureteral calculi with tamsulosin. Methods We searched PubMed, MEDLINE, EMBASE, BIOSIS, International Pharmaceutical Abstracts (IPA) Database, The Cochrane Library and Chinese Journal Full-text Database from 1995 to September 2006, as well as the proceedings of urological scientific conferences from 2000 to 2006. Randomized controlled trials(RCTs) comparing tamsulosin and other therapies for ureteral calculi among adults were included. Data were extracted by two reviewers independently and synthesized by STATA 9.0 software. Results A total of 16 studies involving 1521 patients with distal or juxtavesical ureteral calculi were included. Compared with conservative therapy, tamsulosin showed higher expulsion rate [RR 1.50, 95%CI (1.20 to 1.87), Plt;0.0001], shorter expulsion time [SMD –1.29, 95%CI (–2.27, –0.31)] and fewer patients requiring ESWL or ureteroscopy [RR 0.40, 95%CI (0.27, 0.59), Plt;0.05]. Compared with conservative therapy, the combination of tamsulosin plus deflazacort also showed higher expulsion rate [RR 1.59, 95%CI (1.31, 1.93)], shorter expulsion time [SMD –0.8, 95%CI (–1.18, –0.42)] and fewer patients requiring ESWL or ureteroscopy [RR 0.13, 95%CI (0.06, 0.31), Plt;0.05]. Compared with deflazacort alone, the combination of tamsulosin plus deflazacort demonstrated similar expulsion rate [RR 1.31, 95%CI (0.78, 2.23), P=0.31], but significantly reduced the dosage of analgesics [SMD 15.20, 95%CI (14.98, 15.52)] and decreased the proportion of patients requiring ESWL or ureteroscopy [RR 0.09,, 95%CI (0.02, 0.47), Plt;0.05]. Compared with deflazacort plus nifedipine, the combination of tamsulosin plus deflazacort showed higher expulsion rate [RR 1.20, 95%CI (1.07, 1.35), P=0.002], but similar expulsion time [SMD –1.34, 95%CI (–3.47, 0.79)] and proportion of patients requiring ESWL or ureteroscopy [RR 0.34, 95%CI (0.05, 2.22), Pgt;0.05]. As for side effects, tamsulosin-based treatment and conservative therapy were comparable (Pgt;0.05). Conclusions Tamsulosin has a beneficial effect on the expulsion of ureteral calculi, especially for distal and juxtavesical ureteral calculi. Tamsulosin-based medical expulsive therapy at the dosage of 0.4mg daily is effective and safe for patients with distal ureteral calculi. More large-scale studies are required to define the efficacy of combination therapy of tamsulosin plus deflazacort.