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Trials Comparing (trials + comparing)
Kinds of Trials Comparing Selected AbstractsThe contribution of active medication to combined treatments of psychotherapy and pharmacotherapy for adult depression: a meta-analysisACTA PSYCHIATRICA SCANDINAVICA, Issue 6 2010P. Cuijpers Cuijpers P, van Straten A, Hollon SD, Andersson G. The contribution of active medication to combined treatments of psychotherapy and pharmacotherapy for adult depression: a meta-analysis. Objective:, Although there is sufficient evidence that combined treatments of psychotherapy and pharmacotherapy are more effective for depression in adults than each of the treatments alone, it remains unclear what the exact contribution of active medication is to the overall effects of combined treatments. This paper examines the contribution of active medication to combined psychotherapy and pharmacotherapy treatments. Method:, Meta-analysis of randomised controlled trials comparing the combination of psychotherapy and pharmacotherapy with the combination of psychotherapy and placebo. Results:, Sixteen identified studies involving 852 patients met our inclusion criteria. The standardised mean difference indicating the differences between the combination of psychotherapy and pharmacotherapy and the combination of psychotherapy and placebo was 0.25 (95% CI: 0.03,0.46), which corresponds to a numbers-needed-to-be-treated of 7.14. No significant differences between subgroups of studies were found. Conclusion:, Active medication has a small but significant contribution to the overall efficacy of combined treatments. [source] Antibacterial efficacy of calcium hydroxide intracanal dressing: a systematic review and meta-analysisINTERNATIONAL ENDODONTIC JOURNAL, Issue 1 2007C. Sathorn Abstract Aim, To determine to what extent does calcium hydroxide intracanal medication eliminate bacteria from human root canals, compared with the same canals before medication, as measured by the number of positive cultures, in patients undergoing root canal treatment for apical periodontitis (teeth with an infected root canal system). Methodology, CENTRAL, MEDLINE and EMBASE databases were searched. Reference lists from identified articles were scanned. A forward search was undertaken on the authors of the identified articles. Papers that had cited these articles were also identified through the Science Citation Index to identify potentially relevant subsequent primary research. Review methods, The included studies were pre-/post-test clinical trials comparing the number of positive bacterial cultures from treated canals. Data in those studies were independently extracted. Risk differences of included studies were combined using the generic inverse variance and random effect method. Results, Eight studies were identified and included in the review, covering 257 cases. Sample size varied from 18 to 60 cases; six studies demonstrated a statistically significant difference between pre- and post-medicated canals, whilst two did not. There was considerable heterogeneity among studies. Pooled risk difference was ,21%; 95% CI: ,47% to 6%. The difference between pre- and post-medication was not statistically significant (P = 0.12). Conclusions, Calcium hydroxide has limited effectiveness in eliminating bacteria from human root canal when assessed by culture techniques. [source] Regular or "Super-Aspirins"?JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 4 2001A Review of Thienopyridines or Aspirin to Prevent Stroke PURPOSE: To review the evidence for the effectiveness and safety of the thienopyridines (ticlopidine and clopidogrel) compared with aspirin for the prevention of vascular events among patients at high risk of vascular disease. BACKGROUND: Atherosclerosis and resultant cardiovascular disease are important causes of morbidity and mortality in older people. In particular, atherosclerosis of the cerebral arteries can lead to transient ischemic attacks (TIAs) and stroke. Stroke ranks as the third-leading cause of death in the United States and in 1997 was responsible for over 150,000 fatalities.1 In addition to the mortality associated with this disease, stroke is also a leading source of long-term disability in survivors. Nearly 4.5 million stroke survivors are alive today,1 highlighting the fact that primary, but also secondary, prevention are extremely important for minimizing the complications of this illness. DATA SOURCES: Specialized trial registers of the Cochrane Stroke Group and the Antithrombotic Trialist's Collaboration, MEDLINE, and Embase were searched. Additional unpublished information and data were sought from Sanofi, the pharmaceutical company that developed and manufactures ticlopidine and clopidogrel, as well as the principal investigators of the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial,7 the largest of the trials identified. STUDY SELECTION CRITERIA: All unconfounded randomized trials comparing either ticlopidine or clopidogrel with aspirin among patients at high risk of vascular disease (those with symptoms of ischemia of the cerebral, coronary, or peripheral circulations) who were followed for at least 1 month for the recurrence of vascular events were included. DATA EXTRACTION: Data were extracted from four completed randomized trials completed in the past 20 years, which included 22,656 patients.7,10 Two authors independently extracted the data from these trials for the following information: the types of patients enrolled; the entry and exclusion criteria; the randomization method; the number of patients originally allocated to the treatment and control groups; the method and duration of follow-up; the number of patients in each group lost to follow-up; information on compliance with the treatment allocated; the definitions of outcome events; the number of outcome events in each treatment group; and any method used for blinding patients, treating clinicians, and outcome assessors to treatment allocation. MAIN RESULTS: Four completed trials involving a total of 22,656 patients were identified. Aspirin was compared with ticlopidine in three trials (3,471 patients)8,10 and with clopidogrel in one trial (19,185 patients).7 A recent TIA or ischemic stroke was the qualifying event in 9,840 patients, a recent myocardial infarction in 6,302 patients, and symptomatic peripheral arterial disease in 6,514 patients. The average age of the patients was approximately 63, with approximately two-thirds of the patients being male and white. The duration of follow-up ranged from 12 to 40 months. CONCLUSIONS: This systematic review demonstrates that, compared with aspirin, thienopyridines are only modestly more effective in preventing serious vascular events in high-risk patients. For patients who are intolerant of, or allergic to aspirin, the available safety and efficacy data suggest that clopidogrel is an appropriate, but more-expensive, alternative antiplatelet drug. It appears safer than ticlopidine and as safe as aspirin but it should not replace aspirin as the first-choice antiplatelet agent for all patients. Further studies are necessary to determine which, if any, particular types of patients would benefit most and least from clopidogrel instead of aspirin. [source] Meta-analysis: The efficacy and safety of monoclonal antibody targeted to epidermal growth factor receptor in the treatment of patients with metastatic colorectal cancerJOURNAL OF DIGESTIVE DISEASES, Issue 4 2009Fang NIE OBJECTIVE: To evaluate systematically the efficacy and safety of anti-epidermal growth factor receptor (EGFR) monoclonal antibody added to a chemotherapeutic regimen in the treatment of patients with metastatic colorectal cancer (mCRC). METHODS: Eligible articles were identified by searching electronic databases. All randomized trials comparing the arm with an anti-EGFR monoclonal antibody to the arm without an anti-EGFR monoclonal antibody during the treatment of mCRC were included. A statistical analysis was performed with Review Manager 4.2.8. RESULTS: Seven randomized trials (n= 4186) were identified. The pooled response rates were 25.4% and 17.6% by intention-to-treat analyses for patients with or without an anti-EGFR monoclonal antibody, respectively, the OR was 3.36 (95% CI 1.42,7.95); the incidence of grades 3,4 adverse events were 71.2% and 54.3% for two groups, respectively, the OR was 2.23 (95% CI 1.74,2.86). The incidence of diarrhea, skin toxicity, hypomagnesemia was 62.3% versus 55.7%; 79.3% versus 19.7%; 27.2% versus 5.6%; and the summary OR was 1.36 (95% CI 1.03,1.80); 33.47 (95% CI 14.81,75.61); 6.73 (95% CI 3.84,11.82), respectively. CONCLUSION: Our results confirmed that monoclonal antibody targeted to EGFR could be effective in increasing response rates and could be a key therapeutic agent in the optimal treatment of mCRC, despite a moderate increase in grades 3,4 adverse events. [source] Meta-analysis: levamisole improves the immune response to hepatitis B vaccine in dialysis patientsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2010F. Fabrizi Summary Background, Patients undergoing maintenance dialysis often fail to mount protective antibodies to hepatitis B virus surface antigen (HBsAg) following vaccination against hepatitis B virus (HBV). Some authors have suggested that levamisole improves immune response to HBV vaccine in dialysis population. However, consistent information on this issue does not exist. Aim, To evaluate efficacy and safety of levamisole as adjuvant to hepatitis B virus (HBV) vaccine in dialysis patients by performing a systematic review of the literature with a meta-analysis of clinical trials. Methods, We used the random-effects model of DerSimonian and Laird, with heterogeneity and sensitivity analyses. Only trials comparing the seroresponse rate in study subjects (levamisole plus HBV vaccine) vs. controls (HBV vaccine alone) were included. The end point of interest was the rate of patients showing seroprotective anti-hepatitis B titres at completion of HBV vaccine schedule in study vs. control groups. Results, We identified four studies involving 328 unique patients on regular dialysis. Only prospective, randomized clinical trials (RCTs) were included. Pooling of study results showed a significant increase in response rates among study (levamisole plus HBV vaccine) vs. control (HBV vaccine alone) patients; the pooled Odds Ratio was 2.432 (95% Confidence Intervals, 1.34; 4.403), P = 0.002. No study heterogeneity was found. These results did not change in various subgroups of interest. Conclusions, Our meta-analysis showed that levamisole significantly improves immune response to hepatitis B vaccine in dialysis population. The limited number of patients precluded more conclusions. [source] Systematic review and meta-analysis: is 1-week proton pump inhibitor-based triple therapy sufficient to heal peptic ulcer?ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2005J. P. Gisbert Summary Aims :,To systematically review the efficacy on ulcer healing of 1-week combination of a proton pump inhibitor plus two antibiotics and to perform a meta-analysis of randomized clinical trials to evaluate whether 7 days of proton pump inhibitor-based triple therapy is sufficient to heal peptic ulcer. Methods :,Studies where 1-week proton pump inhibitor-based triple therapy was administered to heal peptic ulcer were included. Randomized clinical trials comparing the efficacy on ulcer healing of 7-day proton pump inhibitor-based triple therapy versus this same regimen but prolonging the proton pump inhibitor for several more weeks were included in the meta-analysis. Electronic and manual bibliographical searches were conducted. Meta-analysis was performed combining the odds ratios of the individual studies. Results :,Twenty-four studies (2342 patients) assessed ulcer healing with 1-week proton pump inhibitor-based triple therapy. Mean healing rate was 86%, and 95% in Helicobacter pylori -eradicated patients. Six studies (862 patients), were included in the meta-analysis. Mean ulcer healing rate with a 7-day treatment was 91% versus 92% when proton pump inhibitor was prolonged for 2,4 more weeks (odds ratio = 1.11; 95% confidence interval = 0.71,1.74). Conclusion :,In patients with peptic ulcer and H. pylori infection, prolonging therapy with proton pump inhibitor after a triple therapy for 7 days with a proton pump inhibitor and two antibiotics is not necessary to induce ulcer healing. [source] Helicobacter pylori eradication therapy vs. antisecretory non-eradication therapy for the prevention of recurrent bleeding from peptic ulcerALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2004J. P. Gisbert Summary Aim :,To perform a meta-analysis comparing the efficacy of Helicobacter pylori eradication therapy vs. antisecretory non-eradication therapy for the prevention of recurrent bleeding from peptic ulcer. Methods :,A search was made of the Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL and several congresses for controlled clinical trials comparing the efficacy of H. pylori eradication therapy vs. antisecretory non-eradication therapy for the prevention of peptic ulcer re-bleeding. Studies with all patients taking non-steroidal anti-inflammatory drugs were excluded. Extraction and quality assessment of the studies were performed by two reviewers. Results :,In the first meta-analysis, the mean percentage of re-bleeding in the H. pylori eradication therapy group was 4.5%, compared with 23.7% in the non-eradication therapy group without long-term antisecretory therapy [odds ratio, 0.18; 95% confidence interval (CI), 0.09,0.37; ,number needed to treat' (NNT), 5; 95% CI, 4,8]. In the second meta-analysis, the re-bleeding rate in the H. pylori eradication therapy group was 1.6%, compared with 5.6% in the non-eradication therapy group with maintenance antisecretory therapy (odds ratio, 0.25; 95% CI, 0.08,0.76; NNT, 20; 95% CI, 12,100). When only patients with successful H. pylori eradication were included, the re-bleeding rate was 1%. Conclusions :,The treatment of H. pylori infection is more effective than antisecretory non-eradication therapy (with or without long-term maintenance antisecretory treatment) in the prevention of recurrent bleeding from peptic ulcer. Consequently, all patients with peptic ulcer bleeding should be tested for H. pylori, and eradication therapy should be prescribed to infected patients. [source] Glucocorticoids for the treatment of anaphylaxis: Cochrane systematic reviewALLERGY, Issue 10 2010K. J. L. Choo To cite this article: Choo KJL, Simons E, Sheikh A. Glucocorticoids for the treatment of anaphylaxis: Cochrane systematic review. Allergy 2010; 65: 1205,1211. Abstract Background:, Anaphylaxis is a serious hypersensitivity reaction that is rapid in onset and may result in death. A number of guidelines recommend glucocorticoids for the treatment of people experiencing anaphylaxis. Objectives:, We sought to assess the benefits and harms of glucocorticoid treatment during episodes of anaphylaxis. Methods:, We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 3), MEDLINE (Ovid) (1966 to September 2009), EMBASE (Ovid) (1988 to September 2009), CINAHL (EBSCOhost) (to September 2009) and The Science Citation Index Expanded (SCI-EXPANDED) (1945 to September 2009). We also searched the UK National Research Register and websites listing ongoing trials and contacted international experts in anaphylaxis in an attempt to locate unpublished material. We sought to include randomized and quasi-randomized controlled trials comparing glucocorticoids with any control (either placebo, adrenaline (epinephrine), an antihistamine, or any combination of these). Two authors independently assessed articles for inclusion. Results:, None of the 2496 reports identified satisfied the inclusion criteria. Conclusions:, We conclude that there is no evidence from high-quality studies for the use of steroids in the emergency management of anaphylaxis. Therefore, we can neither support nor refute the use of these drugs for this purpose. [source] Long-term effectiveness of diet-plus-exercise interventions vs. diet-only interventions for weight loss: a meta-analysisOBESITY REVIEWS, Issue 3 2009T. Wu Summary Diet and exercise are two of the commonest strategies to reduce weight. Whether a diet-plus-exercise intervention is more effective for weight loss than a diet-only intervention in the long-term has not been conclusively established. The objective of this study was to systemically review the effect of diet-plus-exercise interventions vs. diet-only interventions on both long-term and short-term weight loss. Studies were retrieved by searching MEDLINE and Cochrane Library (1966 , June 2008). Studies were included if they were randomized controlled trials comparing the effect of diet-plus-exercise interventions vs. diet-only interventions on weight loss for a minimum of 6 months among obese or overweight adults. Eighteen studies met our inclusion criteria. Data were independently extracted by two investigators using a standardized protocol. We found that the overall standardized mean differences between diet-plus-exercise interventions and diet-only interventions at the end of follow-up were ,0.25 (95% confidence interval [CI],0.36 to ,0.14), with a P -value for heterogeneity of 0.4. Because there were two outcome measurements, weight (kg) and body mass index (kg m,2), we also stratified the results by weight and body mass index outcome. The pooled weight loss was 1.14 kg (95% CI 0.21 to 2.07) or 0.50 kg m,2 (95% CI 0.21 to 0.79) greater for the diet-plus-exercise group than the diet-only group. We did not detect significant heterogeneity in either stratum. Even in studies lasting 2 years or longer, diet-plus-exercise interventions provided significantly greater weight loss than diet-only interventions. In summary, a combined diet-plus-exercise programme provided greater long-term weight loss than a diet-only programme. However, both diet-only and diet-plus-exercise programmes are associated with partial weight regain, and future studies should explore better strategies to limit weight regain and achieve greater long-term weight loss. [source] Anemia in children after transplantation: etiology and the effect of immunosuppressive therapy on erythropoiesisPEDIATRIC TRANSPLANTATION, Issue 4 2003Amira Al-Uzri Abstract: Anemia in children after renal transplantation is more common than previously appreciated. Multiple factors appear to play roles in the development of post-transplant anemia, the most common of which is absolute and/or functional iron deficiency anemia. Most experts recommend that iron limited anemias in transplant patients should be diagnosed using the same criteria as for chronic renal failure patients. Serum erythropoietin (EPO) levels are expected to normalize after a successful renal transplantation with a normal kidney function, yet both EPO deficiency and resistance have been reported. While no large controlled trials comparing the effect of different immunosuppressive agents on erythropoiesis after transplantation have been performed, generalized bone marrow suppression attributable to azathioprine (AZA), mycophenolate mofetil (MMF), tacrolimus, antithymocyte preparations has been reported. Pure red cell aplasia (PRCA) occurs rarely after transplantation and is characterized by the selective suppression of erythroid cells in the bone marrow. PRCA has been reported with the use of AZA, MMF, tacrolimus, angiotensin converting enzyme inhibitors (ACEI), but not with cyclosporine (CSA) use. Post-transplant hemolytic uremic syndrome has been reported with orthoclone anti T-cell antibody (OKT3), CSA and tacrolimus therapy. Viral infections including cytomegalovirus, Epstein,Barr virus and human parvovirus B19 have been reported to cause generalized marrow suppression. Management of severe anemia associated with immunosuppressive drugs generally requires lowering the dose, drug substitution or, when possible, discontinuation of the drug. Because this topic has been incompletely studied, our recommendation as to the best immunosuppressive protocol after renal transplantation remains largely dependent on the clinical response of the individual patient. [source] Psychosocial interventions and quality of life in gynaecological cancer patients: a systematic reviewPSYCHO-ONCOLOGY, Issue 8 2009Jolyn Hersch Abstract Objective: Women with gynaecological cancer are at risk of poor quality of life outcomes. Although various psychosocial interventions have been developed to address these concerns, such interventions have not yet been systematically evaluated in this population. The current review provides an up-to-date and comprehensive summary of the evidence regarding the effectiveness of psychosocial interventions in women with gynaecological cancers. Methods: Relevant studies were identified via Medline, CINAHL, and PsycINFO databases (1980 to June 2008), reference lists of articles and reviews, grey literature databases, and consultations with physicians and other experts in the field. Only controlled trials comparing a psychosocial intervention with a control group in a gynaecological cancer population, with at least one quality of life variable as a main outcome, were included in the review. Two authors independently assessed trial quality and extracted data. Results: Twenty-two studies involving 1926 participants were included. There was substantial variability in study quality and results. Evidence was mixed regarding intervention effects on social and sexual functioning, distress, depression, anxiety, attitude to medical care, self-esteem and body image. Interventions generally did not improve physical or vocational outcomes. Conclusions: There was limited evidence in support of healing touch, whereas information-based interventions seemed largely unable to provide meaningful benefits. Cognitive-behavioural interventions had some positive effects. Counselling appeared to be the most promising intervention strategy for addressing quality of life concerns for women with gynaecological cancers. Copyright © 2008 John Wiley & Sons, Ltd. [source] Hemodialysis as a Treatment of Severe Accidental HypothermiaARTIFICIAL ORGANS, Issue 3 2010Rogier Caluwé Abstract We describe a case of severe accidental hypothermia (core body temperature 23.2°C) successfully treated with hemodialysis in a diabetic patient with preexisting renal insufficiency. Consensus exists about cardiopulmonary bypass as the treatment of choice in cases of severe accidental hypothermia with cardiac arrest. Prospective randomized controlled trials comparing the different rewarming modalities for hemodynamically stable patients with hypothermia, however, are lacking. In our opinion, the choice of a rewarming technique should be patient tailored, knowing that hemodialysis is an efficient, minimally invasive, and readily available technique with the advantage of providing electrolyte support. [source] Magnification devices for endodontic therapyAUSTRALIAN DENTAL JOURNAL, Issue 4 2009M Del Fabbro Background:, After the introduction of microsurgical principles in endodontics, involving new techniques for root canal treatment, there has been a continuous search for enhancing the visualization of the surgical field. It would be interesting to know if the technical advantages for the operator brought in by magnification devices like surgical microscope, endoscope and magnifying loupes, are also associated with advantages for the patient, in terms of improvement of clinical and radiographic outcomes. Objectives:, The purpose of this systematic review was to evaluate and compare the effects of endodontic treatment performed with the aid of magnification devices versus endodontic treatment without magnification devices. We also aimed at comparing among them the different magnification devices used in endodontics (microscope, endoscope, magnifying loupes). Search strategy:, The Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE and EMBASE were searched with appropriate search strategies. Handsearching included nine dental journals. The bibliographies of relevant clinical trials and relevant articles were checked for identifying studies outside the handsearched journals. Seven manufacturers of instruments in the field of endodontics and/or endodontic surgery, as well as the authors of the identified randomized controlled trials (RCTs) were contacted in order to identify unpublished or ongoing RCTs. There were no language restrictions. The last electronic search was conducted on 2nd April 2009, and the last handsearching was undertaken on 31st January 2009. Selection criteria:, All randomized and quasi-randomized trials comparing endodontic therapy performed with or without using one or more types of magnification device, as well as randomized and quasi-randomized trials comparing two or more magnification devices used as an adjunct to endodontic therapy were considered. Data collection and analysis:, Screening of studies and data extraction were conducted independently and in duplicate. The Cochrane Collaboration statistical guidelines were to be followed for data synthesis. Main results:, No trial could be included in the present review. All of the prospective trials that were identified, all dealing with endodontic surgery, had to be excluded for various reasons. Only one RCT was identified comparing three magnificators (magnifying loupes, surgical microscope, endoscope) in endodontic surgery. No RCT was found that compared the outcome of endodontic therapy using or without using a given magnification device. Authors' conclusions:, No objective conclusion can be drawn from the results of this review as no article was identified in the current literature that satisfied the criteria for inclusion. It is unknown if and how the type of magnification device affects the treatment outcome, considering the high number of factors that may have a significant impact on the success of endodontic surgical procedure. This should be investigated by further long-term RCTs with large sample size. Technical advantages of magnificators have been widely reported in low evidence level studies, but they should be systematically addressed to know if there can be the clinical indication for using a given magnification device for specific clinical situations, such as for molar teeth, or if they can all be used interchangeably. Well-designed RCTs should also be performed to determine the true difference in terms of treatment success rates between using or not using a magnification device in both conventional and surgical endodontic treatment, if any exist. Plain language summary:, Magnification devices for endodontic therapy. There are no data to draw a sound conclusion on the effect of adopting either a microscope, an endoscope, or magnifying loupes for better visualization in endodontic therapy, in terms of clinical outcomes. Though the use of magnification devices has often been associated with technical advantages for the operator and with an improved management of the root canal due to a better visualization of the operative field, it still has to be demonstrated that their use may lead to an improved treatment success rate. More long-term well-designed randomized trials with a large sample size are urgently needed to address the issues of the present review. [source] Effectiveness of mood stabilizers and antipsychotics in the maintenance phase of bipolar disorder: a systematic review of randomized controlled trialsBIPOLAR DISORDERS, Issue 4 2007Lesley A Smith Background:, Bipolar disorder (BD) is a leading cause of disability. Systematic reviews of randomized trials for the treatment of the maintenance phase of BD are lacking. Objectives:, To determine the efficacy and tolerability of mood stabilizers and antipsychotics in the maintenance treatment of BD. Methods:, We systematically reviewed randomized controlled trials of licensed medications for the treatment of any phase of BD. We included randomized controlled trials comparing a medication to placebo or another medication. Comprehensive searches of electronic databases were conducted to March 2005. Outcomes investigated were relapse due to mania, depression or any mood episode, and withdrawal due to any reason or due to an adverse event. Data were combined through meta-analysis. Results:, Fourteen studies (n = 2,526) met the inclusion criteria. Lithium, lamotrigine, olanzapine and valproate semisodium each demonstrated evidence to support long-term use. Compared with placebo, all medications were more effective at preventing relapse because of any mood episode. Hazard ratios (HR) were 0.68 [95% confidence interval (CI) = 0.53,0.86] for lithium, 0.68 (95% CI = 0.55,0.85) for lamotrigine, and 0.82 (95% CI = 0.57,1.20) for valproate semisodium; for olanzapine, the risk ratio (RR) was 0.58 (95% CI = 0.49,0.69). Lithium and olanzapine significantly reduced manic relapses (HR = 0.53; 95% CI = 0.35,0.79 and RR = 0.37; 95% CI = 0.24,0.57, respectively). Lamotrigine and valproate semisodium significantly reduced depressive relapses (HR = 0.65; 95% CI = 0.46,0.91 and RR = 0.40; 95% CI = 0.20,0.82, respectively). Lithium significantly reduced manic relapses compared with lamotrigine (HR = 0.56; 95% CI = 0.34,0.92) and olanzapine significantly reduced manic relapses compared with lithium (RR = 1.69; 95% CI = 1.12,2.55). Withdrawal due to an adverse event was approximately twice as likely with lithium compared with valproate semisodium (RR = 1.81; 95% CI = 1.08,3.03) and lamotrigine (RR = 2.20; 95% CI = 1.31,3.70). There were few data for carbamazepine or medications given as adjunct therapy. Conclusions:, Mood stabilizers have differing profiles of efficacy and tolerability, suggesting complementary roles in long-term maintenance treatment. [source] Epidural versus Non-Epidural or No Analgesia in LabourBIRTH, Issue 1 2006Article first published online: 28 JUN 200 A substantive amendment to this systematic review was last made on 16 August 2005. Cochrane reviews are regularly checked and updated if necessary. Abstract Background:, Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain and is widely used as a form of pain relief in labour. However, there are concerns regarding unintended adverse effects on the mother and infant. Objectives:, To assess the effects of all modalities of epidural analgesia (including combined-spinal-epidural) on the mother and the baby, when compared with non-epidural or no pain relief during labour. Search strategy:, We searched the Cochrane Pregnancy and Childbirth Group Trials Register (June 2005). Selection criteria:, Randomised controlled trials comparing all modalities of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. Data collection and analysis Two of the review authors independently assessed trials for eligibility, methodological quality and extracted all data. Data were entered into RevMan and double checked. Primary analysis was by intention-to-treat; sensitivity analyses excluded trials with >30% of women receiving un-allocated treatment. Main results:, Twenty-one studies involving 6664 women were included, all but one study compared epidural analgesia with opiates. For technical reasons, data on women's perception of pain relief in labour could only be included from one study, which found epidural analgesia to offer better pain relief than non-epidural analgesia (weighted mean difference (WMD),2.60, 95% confidence interval (CI),3.82 to ,1.38, 1 trial, 105 women). However, epidural analgesia was associated with an increased risk of instrumental vaginal birth (relative risk (RR) 1.38, 95% CI 1.24 to 1.53, 17 trials, 6162 women). There was no evidence of a significant difference in the risk of caesarean delivery (RR 1.07, 95% CI 0.93 to 1.23, 20 trials, 6534 women), long-term backache (RR 1.00, 95% CI 0.89 to 1.12, 2 trials, 814 women), low neonatal Apgar scores at 5 minutes (RR 0.70, 95% CI 0.44 to 1.10, 14 trials, 5363 women), and maternal satisfaction with pain relief (RR 1.18 95% CI 0.92 to 1.50, 5 trials, 1940 women). No studies reported on rare but potentially serious adverse effects of epidural analgesia. Authors' conclusions:, Epidural analgesia appears to be effective in reducing pain during labour. However, women who use this form of pain relief are at increased risk of having an instrumental delivery. Epidural analgesia had no statistically significant impact on the risk of caesarean section, maternal satisfaction with pain relief and long-term backache and did not appear to have an immediate effect on neonatal status as determined by Apgar scores. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia on women in labour and long-term neonatal outcomes. Citation:, Anim-Somuah M, Smyth R, Howell C. Epidural versus non-epidural or no analgesia in labour. The Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD000331.pub2. DOI: 10.1002/14651858.CD000331.pub2. *** The preceding report is an abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1465,1858). Abstracts of Cochrane reviews are compiled and produced by Update Software Ltd on behalf of the publisher, John Wiley & Sons Ltd. [source] Impact of bivalirudin on in-hospital bleeding and six-month outcomes in octogenarians undergoing percutaneous coronary intervention,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2009Gilles Lemesle MD Abstract Objectives: This study aimed to analyze the impact of replacing heparin with bivalirudin in octogenarians undergoing percutaneous coronary intervention (PCI) on postprocedure hemorrhage and 6-month mortality. Background: Randomized trials comparing the antithrombin agent bivalirudin with heparin as the intraprocedural anticoagulant identify a reduction in periprocedural bleeding after PCI. Further, the occurrence of such bleeding seems to predict an increased risk of death or myocardial infarction both in-hospital and at long-term follow-up. Importantly, elderly people who are at the greatest risk of post-PCI bleeding complications are underrepresented in these randomized trials. Methods: From 2000 to 2007, 2,766 consecutive patients from our center who were ,80 years of age underwent PCI with stent implantation and were included in this analysis. Bivalirudin was used in 1,207 (43.6%) patients and heparin in 1,559 (56.4%). We compared the rates of post-PCI bleeding complications and 6-month mortality. Results: The overall in-hospital bleeding and 6-month mortality rates were 4.6% and 11.8%, respectively. By multivariate logistic regression and after adjustment by propensity score analysis, bivalirudin was associated with a significant decrease in in-hospital bleedings (HR = 0.41, 95% CI = 0.23,0.73, P = 0.003). By multivariate Cox analysis, bivalirudin was also associated with a significant decrease (HR = 0.6, 95% CI = 0.4,0.9, P = 0.01) and in-hospital bleedings with a significant increase in the 6-month mortality (HR = 2.5, 95% CI = 1.6,3.9, P < 0.001). Conclusion: This study suggests an important subset for use of bivalirudin in lieu of heparin that will benefit the very elderly. © 2009 Wiley-Liss, Inc. [source] COMPARISON OF THE EFFECTS OF TULOBUTEROL PATCH AND SALMETEROL IN MODERATE TO SEVERE ASTHMACLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 11 2006Osamu Nishiyama SUMMARY 1Although the clinical effects of the tulobuterol patch have been reported to include an increase in morning peak expiratory flow (PEF) values and a decrease of symptoms and the frequency of the rescue use of inhaled short-acting b2 -adrenoceptor agonists, no trials comparing the efficacy of the tulobuterol patch to other standard inhaled long-acting b2 -adrenoceptor agonists have yet been conducted. The aim of the present study was to compare the clinical effects of the patch formulation of tulobuterol with those of inhaled salmeterol in moderate to severe asthma. 2Fifty-four patients with moderate to severe asthma, whose conditions were suboptimally controlled despite receiving inhaled corticosteroids, were recruited. The study was a prospective, randomized trial of cross-over design comparing the effects of 4 weeks treatment with tulobuterol patch, 2 mg once daily, and salmeterol, 50 mg twice daily. The mean prebronchodilator morning PEF during the last 14 days of each treatment period and health-related quality of life (HRQoL) were the primary outcome variables. The HRQoL was assessed using the St George's Respiratory Questionnaire. 3Forty-four patients (81.5%) completed the trial and were included in the analysis. The mean morning PEF and HRQoL score were significantly improved in both the salmeterol (P < 0.0001 and P < 0.05, respectively) and the tulobuterol patch (P < 0.01 and P < 0.05, respectively) treatment periods compared with the run-in period. Although the mean morning PEF was significantly higher in the salmeterol-treated group than in the tulobuterol-treated group (P < 0.001), the HRQoL scores were comparable. 4The tulobuterol patch may be useful as a controller medication in addition to inhaled corticosteroids in moderate to severe asthma. [source] | ||||||||||