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 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 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.
ObjectiveTo systematically review the impact of side-to-side esophagogastric anastomosis on postoperative anastomostic leak, fibrosis stricture and stroesophageal reflux. MethodsWe searched PubMed, EMbase, The Cochrane Library (Issue 4 2015), Web of Science, CNKI, CBM, Wanfang Database and VIP up to April 2015. Randomized controlled trials involving the complications after side-to-side esophagogastric anastomosis were included. Data were extracted and methodological quality was evaluated by two reviewers independently with a designed extraction form. Then RevMan 5.3 software was used for meta-analysis. ResultsA total of 7 studies involving 684 patients were included. The results of meta-analysis showed that comparing with traditional anastomosis, side-to-side esophagogastric anastomosis could reduce the incidence of fibrosis stricture with RR=0.20 and 95% CI 0.11 to 0.36 (P<0.000 01). There was no statistical difference in incidence of postoperative anasotmostic leaks with RR=0.71 and 95% CI 0.43 to 1.19 (P=0.19) or stroesophageal reflux with RR=0.74 and 95% CI 0.50 to 1.11 (P=0.15) between the two groups. ConclusionComparing with traditional anastomosis, side-to-side esophagogastric anastomosis could reduce the incidences of fibrosis stricture, but there is no statistical difference in anastomostic leak or stroesophageal reflux.
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.
Objective To systematically review the efficacy of different exercises on inflammatory cytokines in individuals with overweight or obesity. Methods The CNKI, WanFang Data, VIP, PubMed, EBSCO, Cochrane Library, Web of Science and Embase databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy of exercise on inflammatory cytokines in individuals with overweight or obesity from January, 2000 to April, 2021. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. The network meta-analysis was then performed using Stata 16.0 software. Results A total of 63 RCTs were included, 49 of which reported the changes in IL-6, 47 of which reported the changes in TNF-α, and 16 of which reported the changes in IL-10. The results of the network meta-analysis found that compared with those in the control group, aerobic exercise (AE) (SMD=−0.9, 95%CI −1.4 to −0.5, P<0.01) and high-intensity interval training (HIIT) (SMD=−1.3, 95%CI −2.3 to −0.3, P=0.011) significantly reduced IL-6. AE (SMD=−1.3, 95%CI −1.7 to −0.9, P<0.01), combined exercise (COM) (SMD=−0.7, 95%CI −1.3 to −0.1, P=0.02), and HIIT (SMD=−1.8, 95%CI −2.6 to −0.9, P<0.01) significantly reduced TNF-α; AE (SMD=0.8, 95%CI 0.1 to 1.5, P=0.03) significantly increased IL-10. The cumulative probability ranking results showed that HIIT was the most effective in reducing IL-6 and TNF-α and increasing IL-10, followed by AE and COM, and resistance training (RT) was the least effective. Conclusion Different exercise types have different effects on improving inflammation in individuals with overweight or obesity. HIIT can be suggested as the best exercise program to improve chronic inflammation in individuals with overweight or obesity. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
ObjectiveTo systematically review efficacy application of fibrin glue (FG) after thyroidectomy.MethodsPubMed, EMbase, The Cochrane Library, ClinicalTrials.gov, CBM, CNKI, WanFang Data and VIP databases were searched to collect randomized controlled trials (RCTs) regarding the use of FG after thyroidectomy from inception to October 29th, 2019. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 15 RCTs involving 2 406 patients were included. The results of meta-analysis showed that compared with non-FG group, the use of FG could reduce postoperative drainage amount at the initial 24 hours (MD=−17.98, 95%CI −28.35 to −7.60, P=0.000 7), total amount of wound drainage (MD=−40.92, 95%CI −46.25 to −35.59, P<0.000 01), and postoperative discomfort (RR=0.48, 95%CI 0.35 to 0.66, P<0.000 01), as well as shorten drainage time (MD=−9.99, 95%CI −15.74 to −4.23, P=0.000 7) and stitches removal time (MD=−1.49, 95%CI −2.1 to −0.87, P<0.000 01). However, there was no statistically significant difference concerning postoperative short-term complications such as swelling (RR=0.78, 95%CI 0.48 to 1.28, P=0.32), recurrent laryngeal nerve injury (RR=0.83, 95%CI 0.21 to 3.29, P=0.79) and wound infection (RR=0.28, 95%CI 0.07 to 1.21, P=0.09) between two groups.ConclusionsThe current evidence shows that FG can reduce postoperative drainage amount and shorten postoperative recovery time in thyroidectomy. Due to the limited quality and quantity of included studies, more high quality studies are required to verify above conclusions.