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Trial Shows (trial + shows)
Selected AbstractsEffects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women With Hysterectomy: Results From the Women's Health Initiative Randomized TrialJOURNAL OF BONE AND MINERAL RESEARCH, Issue 6 2006Rebecca D Jackson MD Abstract Further analyses from the Women's Health Initiative estrogen trial shows that CEE reduced fracture risk. The fracture reduction at the hip did not differ appreciably among risk strata. These data do not support overall benefit over risk, even in women at highest risk for fracture. Introduction: The Women's Health Initiative provided evidence that conjugated equine estrogen (CEE) can significantly reduce fracture risk in postmenopausal women. Additional analysis of the effects of CEE on BMD and fracture are presented. Materials and Methods: Postmenopausal women 50,79 years of age with hysterectomy were randomized to CEE 0.625 mg daily (n = 5310) or placebo (n = 5429) and followed for an average 7.1 years. Fracture incidence was assessed by semiannual questionnaire and verified by adjudication of radiology reports. BMD was measured in a subset of women (N = 938) at baseline and years 1, 3, and 6. A global index was used to examine whether the balance of risks and benefits differed by baseline fracture risk. Results: CEE reduced the risk of hip (hazard ratio [HR], 0.65; 95% CI, 0.45,0.94), clinical vertebral (HR, 0.64; 95% CI, 0.44,0.93), wrist/lower arm (HR, 0.58; 95% CI, 0.47,0.72), and total fracture (HR, 0.71; 95% CI, 0.64,0.80). This effect did not differ among strata according to age, oophorectomy status, past hormone use, race/ethnicity, fall frequency, physical activity, or fracture history. Total fracture reduction was less in women at the lowest predicted fracture risk in both absolute and relative terms (HR, 0.86; 95% CI, 0.68,1.08). CEE also provided modest but consistent positive effects on BMD. The HRs of the global index for CEE were relatively balanced across tertiles of summary fracture risk (lowest risk: HR, 0.81; 95% CI, 0.62,1.05; mid risk: HR, 1.09; 95% CI, 0.92,1.30; highest risk: HR, 1.04; 95% CI, 0.88,1.23; interaction, p = 0.42). Conclusions: CEE reduces the risk of fracture and increases BMD in hysterectomized postmenopausal women. Even among the women with the highest risk for fractures, when considering the effects of estrogen on other important health outcomes, a summary of the burden of monitored effects does not indicate a significant net benefit. [source] Role of diclofenac in reducing post-endoscopic retrograde cholangiopancreatography pancreatitisJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 7pt2 2008Manouchehr Khoshbaten Abstract Background and Aims:, Acute pancreatitis following endoscopic retrograde cholangiography presents a unique opportunity for prophylaxis and early modification of the disease process because the initial triggering event is temporally well defined and takes place in the hospital. We report a prospective, single-center, randomized, double-blind controlled trial to determine if rectal diclofenac reduces the incidence of pancreatitis following cholangiopancreatography. Methods:, Entry to the trial was restricted to patients who underwent endoscopic retrograde pancreatography. Immediately after endoscopy, patients were given a suppository containing either 100 mg diclofenac or placebo. Estimation of serum amylase level and clinical evaluation were performed in all patients. Results:, One hundred patients entered the trial, and 50 received rectal diclofenac. Fifteen patients developed pancreatitis (15%), of whom two received rectal diclofenac and 13 received placebo (P < 0.01). Conclusions:, This trial shows that rectal diclofenac given immediately after endoscopic retrograde cholangiopancreatography can reduce the incidence of acute pancreatitis. [source] Loss of HBsAg antigen during treatment with entecavir or lamivudine in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B,JOURNAL OF VIRAL HEPATITIS, Issue 1 2010R. G. Gish Summary., This retrospective analysis was conducted to describe the characteristics of nucleoside-naïve hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B, who achieved hepatitis B surface antigen (HBsAg) loss during entecavir or lamivudine therapy. HBeAg-positive adults with chronic hepatitis B, elevated serum alanine aminotransferase, and compensated liver disease were randomized to double-blind treatment for up to 96 weeks with entecavir 0.5 mg/day or lamivudine 100 mg/day. HBsAg and hepatitis B virus (HBV) DNA were measured at regular intervals during and off-treatment follow-up. Through a maximum duration of 96 weeks on-treatment and 24 weeks off-treatment, HBsAg loss was confirmed in 18/354 (5.1%) patients treated with entecavir and 10/355 (2.8%) patients treated with lamivudine. Among the 28 patients with confirmed HBsAg loss, 27 (96%) achieved HBV DNA <300 copies/mL, and 27 (96%) achieved confirmed HBeAg loss. All entecavir recipients with HBsAg loss had HBV DNA <300 copies/mL. Caucasian patients, and those infected with HBV genotype A or D, were significantly more likely to lose HBsAg. This retrospective analysis of data from a randomized, global phase three trial shows that confirmed loss of HBsAg occurred in 5% of nucleoside-naïve HBeAg-positive patients treated with entecavir, and that HBsAg loss is associated with sustained off-treatment suppression of HBV DNA. [source] Oral ciprofloxacin or trimethoprim reduces bacteriuria after flexible cystoscopyBJU INTERNATIONAL, Issue 4 2007Mark I. Johnson OBJECTIVE To report a large prospective, pragmatic, double-blind randomized controlled trial to determine whether oral prophylactic antibiotics reduce the risk of bacteriuria after flexible cystoscopy (FC), as up to 10% of patients develop urinary infection afterwards, with significant morbidity and costs for health services. PATIENTS AND METHODS In all, 2481 patients were recruited into a three-arm placebo controlled trial and 2083 completed it. Patients were randomly assigned to one of three treatments; (i) placebo; (ii) one oral dose of trimethoprim (200 mg); or (iii) one oral dose of ciprofloxacin (500 mg), each administered 1 h before a FC under local anaesthetic. A mid-stream urine specimen was taken before and 5 days after FC; significant bacteriuria was defined as a pure growth of >105 colony-forming units/mL. RESULTS The rate of bacteriuria after FC was reduced from 9% in the placebo group to 5% and 3% in patients receiving trimethoprim and ciprofloxacin prophylaxis, respectively. When rates of bacteriuria before FC were considered the odds of developing bacteriuria after FC relative to baseline were 5, 2 and 0.5 for placebo, trimethoprim and ciprofloxacin, respectively. CONCLUSION This large trial shows clearly that one dose of oral ciprofloxacin significantly reduces bacteriuria after FC. [source] | ||||||||||