Retrieve Randomized Controlled Trials Research Articles

Dyspnea and Reversibility Profile of P2Y12 Antagonists: Systematic Review of New Antiplatelet Drugs

Dyspnea has been consecutively reported in some trials evaluating new P2Y₁₂ inhibitors. We aimed to review and quantify the global risk of dyspnea of recent P2Y₁₂ inhibitor drugs, and evaluate its association with the reversibility profile of P2Y₁₂ inhibitors. A database search (March 2013) retrieved randomized controlled trials (RCTs) comparing new antiplatelet drugs (ticagrelor, prasugrel, cangrelor, elinogrel) with clopidogrel. The primary outcome was the incidence of dyspnea. Placebo-controlled trials were excluded. Meta-analysis was performed and estimates were expressed as risk ratio (RR) and 95% confidence intervals (95% CIs). Dyspnea incidence was evaluated according to the reversibility profile of P2Y₁₂ antagonists. We found eight RCTs including 41,289 patients. Prasugrel was not associated with an increased risk of dyspnea (RR 1.09, 95% CI 0.93-1.27), whereas ticagrelor (RR 1.95, 95% CI 1.37-2.77), cangrelor (RR 2.42, 95% CI 1.36-4.33), and elinogrel (RR 3.25, 95% CI 1.57-6.72) showed an increased risk of dyspnea. Reversible inhibitors significantly increased the risk of dyspnea compared with the irreversible inhibitor, prasugrel, through adjusted indirect comparison (RR 1.99, 95% CI 1.40-2.82). The reversible P2Y₁₂ antagonists ticagrelor, cangrelor, and elinogrel have an increased incidence of dyspnea in increasing order when compared with irreversible P2Y₁₂ inhibitors such as clopidogrel or prasugrel.

The Effects of Wenxin Keli on P-Wave Dispersion and Maintenance of Sinus Rhythm in Patients with Paroxysmal Atrial Fibrillation: A Meta-Analysis of Randomized Controlled Trials

Objective. To evaluate the beneficial and adverse effects of Wenxin Keli (WXKL), alone or combined with Western medicine, on P-wave dispersion (Pd) and maintenance of sinus rhythm for the treatment of paroxysmal atrial fibrillation (PAF). Methods. Seven major electronic databases were searched to retrieve randomized controlled trials (RCTs) designed to evaluate the clinical effectiveness of WXKL, alone or combined with Western medicine, for PAF, with Pd or maintenance rate of sinus rhythm as the main outcome measure. The methodological quality of the included studies was assessed using criteria from the Cochrane Handbook for Systematic Review of Interventions, version 5.1.0, and analysed using RevMan 5.1.0 software. Results. Fourteen RCTs of WXKL were included. The methodological quality of the trials was generally evaluated as low. The results of meta-analysis showed that WXKL, alone or combined with Western medicine, was more effective in Pd and the maintenance of sinus rhythm, compared with no medicine or Western medicine alone, in patients with PAF or PAF complicated by other diseases. Seven of the trials reported adverse events, indicating that the safety of WXKL is still uncertain. Conclusions. WXKL, alone or combined with Western medicine, appears to be more effective in improving Pd as well as maintenance of sinus rhythm in patients with PAF and its complications.

Mixed Treatment Comparison of the Treatment Discontinuations of Biologic Disease-Modifying Antirheumatic Drugs in Adults with Rheumatoid Arthritis

Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has considerably changed treatment options for rheumatoid arthritis (RA) over the past decade. Very little information is available on comparative discontinuation rates of the biologics. To compare treatment discontinuations for 9 biologic DMARDs in adults with RA. We searched electronic databases through May 2012 to retrieve randomized controlled trials (RCTs) of patients with RA that compared biologic DMARDs with placebo or another biologic DMARD. The primary outcome was treatment discontinuation during the blinded phase of the trials, measured as overall withdrawals, withdrawals resulting from lack of efficacy, and withdrawals resulting from adverse events. Random-effects meta-analysis estimated the effect size for individual agents, and adjusted indirect comparisons were made between biologics using mixed treatment comparisons (MTC) meta-analysis. Forty-four trials were included in the analysis. In comparison with placebo, biologics were less likely to be withdrawn because of lack of efficacy (OR 0.22, 95% CI 0.17 to 0.27) and more likely to be withdrawn because of an adverse event (OR 1.41, 95% CI 1.16 to 1.70). Based on the MTC, certolizumab had the most favorable overall withdrawal profile, followed by etanercept and rituximab. Certolizumab had lower relative withdrawal rates resulting from lack of efficacy than adalimumab, anakinra, and infliximab. Anakinra had higher relative withdrawal rates resulting from lack of efficacy than most other biologics. Certolizumab and infliximab had more, while etanercept had fewer, withdrawals because of adverse events than most other drugs. Based on MTC using data from RCTs, differences in discontinuation rates were observed, generally favoring certolizumab, etanercept, and rituximab over other biologic DMARDs. These potential differences need to be further explored in head-to-head trials or well-conducted observational studies.

Microendoscopic discectomy versus microscopic discectomy for treatment of lumbar disc herniations: a systematic review of randomized controlled trials

Objective To compare the effectiveness and safety of microendoscopic discectomy (MED) versus microscopic discectomy (MD) for treatment of lumbar disc herniations. Methods Key words were defined as microendoscopic discectomy, microscopic discectomy, lumbar disc herniation, etc. The electronic databases (PubMed, EMbase, Cochrane Central Register of Controlled Trials, CNKI, and Wanfang) were searched in order to retrieve randomized controlled trials (RCTs) about comparing MED and MD for the treatment of lumbar disc herniations. We also applied manual searching to screen out relevant journals. Data were extracted and evaluated by two reviewers independently. The quality of the included trails was evaluated by Jadad scales. Cochrane collaboration's RevMan 5.0.24 were used for data analysis. Results Four RCTs involving 1069 patients were included in the Meta⁃analysis. Results of Meta⁃analysis showed that: the Oswestry dysfunctional index (ODI) after operation in MED group was not significantly different from that in the MD group (MD = ⁃ 0.170, 95%CI: ⁃ 3.590-3.260; P = 0.920); dural tears in MED group were higher than those of MD group (RR = 3.040, 95%CI: 1.170-7.890; P = 0.020); there were no significant difference between MED group and MD group in terms of root injury (RR = 5.130, 95% CI: 0.890-29.420; P = 0.070) and recurrent herniation (RR = 2.320, 95%CI: 0.970-5.520; P = 0.060); there were significant difference between MED group and MD group in terms of surgical time (MD = 10.780, 95%CI: 7.180-14.370; P = 0.000), size of incision (MD = ⁃ 0.950, 95%CI: ⁃ 1.840-0.070; P = 0.030) and length of hospital stay (MD = 0.210, 95%CI: ⁃ 0.080-0.340; P = 0.002). There was no significant difference between MED group and MD group in terms of blood loss (MD = 27.420, 95% CI: ⁃ 8.840-63.680; P = 0.140). Conclusion According to present knowledge, the two techniques were found to be effective for the treatment of lumbar disc herniations, but recurrent herniations were significantly more common in MED group. As for the safety of the two techniques, dural tears and root injuries were significantly more common in MED group. Because of the limitation of the quality and amount for the RCTs included, the results of this systematic review should be prudently cited, and more high quality RCTs are needed to be performed. DOI：10.3969/j.issn.1672⁃6731.2012.04.006

Purine analogues compared with mesalamine or 5-ASA for the prevention of postoperative recurrence in Crohn’s disease: a meta-analysis

Objective: To use a meta-analysis approach to evaluate the efficacy and safety of purine analogues, azathioprine (AZA) and 6-mercaptopurine (6-MP), in the prevention of postoperative recurrence of Crohn's disease (CD), as compared with mesalamine or 5-aminosalicylic acid (5-ASA). Methods: The Pubmed, Cochrane Library, and Embase literature databases were searched for relevant studies with the key words "azathioprine", "6-mercaptopurine", "purine analogue", "mesalamine", or "5-ASA". The efficacy and safety of purine analogues in the retrieved randomized controlled trials (RCTs) were evaluated with RevMan 5.0.25 (The Cochrane Collaboration, Oxford, England) and STATA 12.0 (Stata Corporation, College Station, TX, USA). The outcome measures of AZA and 6-MP, compared to mesalamine and 5-ASA (control arms), were: clinical recurrence, endoscopic recurrence, and adverse event rates. Results: Five RCTs, comprised of 429 patients, were analyzed. The effect of purine analogues for preventing clinical recurrence for year 1 and 2 were similar to controls (year 1: n = 390; recurrence rate: 18.6% vs. 20.9%; RR: 0.88, 95% CI: 0.60-1.30, p = 0.53; year 2: n = 270; recurrence rate: 29.9% vs. 38.2%; RR: 0.76, 95% CI: 0.55-1.05, p = 0.10). In contrast, purine analogues were more effective than controls in preventing severe endoscopic recurrence (i2-4) for year 1 (n = 289; 32.4% vs. 46.1%; RR: 0.71, 95% CI: 0.53-0.94, p = 0.02). However, purine analogues were associated with more adverse events leading to drug withdrawal than the controls (20.1% vs. 7.9%; RR: 2.57, 95% CI: 1.47-4.51, p = 0.0010). Conclusion: Purine analogues are more effective than controls in preventing endoscopic postoperative recurrence in CD, but are associated with more adverse events.

Moxifloxacin monotherapy for treatment of complicated intra-abdominal infections: a meta-analysis of randomised controlled trials

To evaluate the efficacy and safety of moxifloxacin monotherapy for treatment of complicated intra-abdominal infections. PubMed, EMBASE, Science Direct, ClinicalTrials.gov and Cochrane Central Register of Controlled Trials were searched to retrieve randomised controlled trials (RCTs) compared moxifloxacin monotherapy with other antibiotics in the treatment of complicated intra-abdominal infections from January 1999 to July 2011. A meta-analysis of all included randomised controlled trials was performed. Four randomised controlled trials including a total of 2444 patients with complicated intra-abdominal infections were included for meta-analysis. The results of the meta-analysis indicated that the moxifloxacin was associated with similar clinical cure rate (four RCTs, 1934 patients, OR = 0.80, 95% CI: 0.61, 1.04, p = 0.09), bacteriological success rates (four RCTs, 1484 patients, OR = 0.79, 95% CI: 0.59, 1.05, p = 0.11) and mortality (four RCTs, 2227 patients, OR = 0.91, 95% CI: 0.45, 1.83, p = 0.79) compared with the control group. The overall incidence of adverse events of moxifloxacin was significantly higher than that in the control group (three RCTs, 1367 patients, OR = 1.33, 95% CI: 1.07, 1.63, p = 0.008), although the incidence of drug-related adverse events (three RCTs, 1601 patients, OR = 1.13, 95% CI: 0.69, 1.85, p = 0.63) and serious adverse events (three RCTs, 1815 patients, OR = 1.23, 95% CI: 0.59, 2.60, p = 0.58) were similar between the compared treatment groups. Moxifloxacin is an effective and relatively safe option for the treatment of patients with intra-abdominal infections. Moxifloxacin monotherapy has similar efficacy to combination therapy.

Microdebrider vs. electrocautery for tonsillectomy: A meta-analysis

Objective Tonsillectomy remains to be an ordinary operative process in otorhinolaryngology. Although there are a plenty of surgical means adopting in otorhinolaryngology, the advantage of one method over another has not been systematically demonstrated. The aim of designing this systematic review is to evaluate the efficiency of electrocautery tonsillectomy (ECT) compared with the microdebrider intracapsular tonsillotomy (MIT). Methods We retrieved randomized controlled trials (RCTs) from PubMed, EMBASE, Cochrane Library, CBM. Two reviewers extracted the information of included trials independently. The quality of included trials was assessed according to the criteria provided by Cochrane Handbook 5.0.1. Results Four researches were meeting the inclusive criteria which contained 501 participants, 253 in microdebrider tonsillotomy group and 248 in electrocautery tonsillectomy group. Systematic review illustrated that MT group had the recovery to normal activity and diet faster than ECT group [ χ 2 = 1.02, P < 0.00001, 95% CI (−1.74, −1.30)] and [ χ 2 = 0.01, P < 0.0001, 95% CI (−2.56, −0.92)]. There was a statistically significant in blood loss between microdebrider tonsillotomy and electrocautery tonsillectomy, the mean difference of 5.0 ml [ P = 0.01, 95% CI (3.4, 26.6)]. There was no statistical significance in surgical time. Conclusions Compared with the electrocautery tonsillectomy, microdebrider tonsillotomy could significantly speed up the time to return to normal activity and normal diet. Two groups were similar in terms of surgical time of tonsillectomy. This conclusion is needed to be further supported by large-scale, high-quality, placebo-controlled, double-blind trials between microdebrider tonsillotomy and other techniques in the surgery time and blood loss of operation.

Early Versus Delayed Cholecystectomy for Acute Cholecystitis: A Meta-analysis of Randomized Controlled Trials

We performed a meta-analysis of randomized controlled trials to determine the optimal timing of laparoscopic cholecystectomy and open cholecystectomy for acute cholecystitis. We retrieved randomized controlled trials (RCTs) that compared early with delayed cholecystectomy for acute cholecystitis by systematically searching Medline and the Cochrane Library for studies published between 1966 and 2003. The outcomes of primary interest were mortality and morbidity. The ten trials we analyzed comprised 1 014 subjects; 534 were assigned to the early group and 480 assigned to the delayed group. The combined risk difference of mortality appeared to favor open cholecystectomy in the early period (risk difference, -0.02; 95% confidence interval, -0.44 to -0.00), but no differences were found among laparoscopic procedures or among all procedures. The combined risk difference of morbidity showed no differences between the open and laparoscopic procedures. The combined risk difference of the rate of conversion to open surgery showed no differences in the included laparoscopic studies; however, the combined total hospital stay was significantly shorter in the early group than in the delayed group. There is no advantage to delaying cholecystectomy for acute cholecystitis on the basis of outcomes in mortality, morbidity, rate of conversion to open surgery, and mean hospital stay. Thus, early cholecystectomy should be performed for patients with acute cholecystitis.