Randomized trial internal treatment

The IPPPSH Collaborative Group. Cardiovascular risk and risk factors in a randomized trial of treatment based on the beta-blocker oxprenolol the International Prospective Primary Prevention Study in Hypertension (IPPPSH). J Hypertens I985 3(4) 379-92. 

The definitive landmark trial that tested IM in patients with CML was the International Randomized trial of IFN-a and STI-571 (IRIS). In this study, 1106 patients, 553 in each arm, were randomized to receive IM at 400 mg daily or IFN-a with low-dose cytarabine. Crossover to the other arm of treatment was allowed for intolerance or lack of efficacy. The initial report with a median follow-up of 19 months showed an MCR... 

EUis M, Spence D, de Pauw B, Meunier F, Marinus A, Collette L, Sylvester R, Meis J, Boogaerts M, SeUeslag D, Krcmety V, von Sinner W, MacDonald P, Doyen C, Vandercam B. An EORTC international multicenter randomized trial (EORTC number 19923) comparing two dosages of liposomal amphotericin B for treatment of invasive aspergillosis. Clin Infect Dis 1998 27(6) 1406-12. 

Buller HR, Davidson BL, Decousus H, et al. Fondaparinux or enoxa-parin for the initial treatment of symptomatic deep venous thrombosis A randomized trial. Ann Intern Med 2004 140 867-873. 

PagUaro L, D Amico G, Sorensen TA, et al. Prevention of first bleeding in cirrhosis A meta-analysis of randomized trials of nonsurgical treatment. Ann Intern Med 1992 117 59-70. 

Cohn, D. L., Fisher, E., Franchino, B., et al. (1996). Comparison of two doses of clarithromycin in a randomized trial of four 3-drug regimens for treatment of disseminated Mycobacterium avium complex disease in AIDS Excess mortality associated with high dose clarithromycin. Presented at 11th International Conference on AIDS (Vancouver, B.C., Canada). 

Goebel A, Baranowski A, Maurer K, Ghiai A, McCabe C, Ambler G. Intravenous immunoglobulin treatment of the complex regional pain syndrome a randomized trial. Ann Intern Med 2010 152 (3) 152-8. 

Another Raf kinase inhibitor, sunitinib (Sutent), was approved in 2006 based on a multi-center, international randomized trial enrolling 750 patients with treatment-naive metastatic renal cell carcinoma (Motzer et al. 2007). In that study, patients were randomized to receive either Sutent or interferon-a (IFN-a). Common metastatic sites included lung, lymph nodes, bone, and liver. There were 96 events (25.6%) of progression/death on Sutent compared with 154 events (41.1%) on IFN-a. Median progression-free survival was 47.3 weeks for Sutent-treated patients and 22.0 weeks for patients treated with IFN. Objective response rate on the Sutent arm was 27.5 vs 5.3% on IFN-a arm. 

Clarke, R., Halsey, J., Lewington, S., Lonn, E., Armitage, J., Manson, J.E., Bonaa, K.H., Spence, J.D., Nygard, O., Jamison, R., Gaziano, J.M., Guarino, P., Bennett, D., Mir, F., Peto, R., and Collins, R., 2010. B-Vitamin Treatment Trialists Collaboration. Effects of lowering homocysteine levels with B vitamins on cardiovascular disease, caneer, and cause-specific mortality meta-analysis of 8 randomized trials involving 37485 individuals. Archives of Internal Medicine. 170 1622-1631. 

Eidelman R, Hollar D, Hebert P, Lamas G, Hennekens C. Randomized trials of vitamin E in the treatment and prevention of cardiovascular disease. Arch Intern Med 2004 164(14) 1552-56. 

Megraud F, Lamouliatte H. The treatment of refractory Helicobacter pylori infection. Aliment Pharmacol Ther 2003 17 1333-1343. Silverstein FE, Graham DY, Senior IR, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving non-steroidal anti-inflammatory drugs a randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995 123 241-249. 

C.Y.C. Pak, K. Sakheee, B. Adams-Huet, V. Piziak, R.D. Peterson, J.R. Poindexter, Treatment of postmenopausal osteoporosis with slow-release sodium fluoride Final report of a randomized controlled trial, Ann. Intern. Med. 123 (1995) 401-408. 

Braunstein GD, Sundwall DA, Katz M, Shifren JL, Buster JE, Simon JA, Bachman G, Aguirre OA, Lucas JD, Rodenberg C, Buch A, Watts NB. Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women a randomized, placebo-controlled trial. Arch Intern Med 2005 165 1582-9. 

Wulffele MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van den Burg B, Donker AJM, Stehouwer CDA. Effects of short-term treatment with metformin on serum concentrations of homocysteine, folate and vitamin B12 in type 2 diabetes mellitus a randomized, placebo- controlled trial. J Intern Med 2003 254 455-63. 

Lipophilic extracts of sabal fruit (Serenoa repens syn. Sabal seruulata) are used in the treatment of benign prostatic hyperplasia (BPH) (see Chapter 55). The hexane extract of the pulp and seed contains a complex mixture of free fatty acids and their esters, small quantities of phytosterols (such as [3-sitosterol), aliphatic alcohols, and polyprenic compounds. The efficacy of this extract was recently compared with that of the 5a-reductase inhibitor finasteride for 6 months, in a randomized, double-blind trial involving almost 1100 men with moderate BPH. Dwarf palm and finasteride reduced the International Prostate Symptom Score by 37 and 39% and increased urinary peak flow by 2.7 and 3.2 ml/sec, respectively. In contrast to finasteride, dwarf palm had little effect on prostate volume. 

The first phase I clinical trial of coronary angiogenesis demonstrated the safety of intramyocardial injection of 0.01 mg/kg of FGF-I (79), A total of 40 patients undergoing CABG of the internal mammary artery (IMA) to left anterior descending coronary artery (LAD) were randomized to receive intramyocardial injections of either 0,01 mg FGF-1 or placebo. All the patients had further stenoses of the LAD distal to the anastomosis, Coronary angiography 12 weeks after treatment showed increased capillary refill in patients... 

Beebe HG, Dawson DL, Cutler BS, et al, A new pharmacological treatment for intermittent claudication results of a randomized, multicenter trial, Arch Intern Med 1999 159 2041-2050. 

McCloskey, R.V., Straube, R.C., Sanders, C., Smith, S.M., Smith, C.R. Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo-controlled trial. CHESS Trial Study Group. Ann Intern Med 121 (1994) 1-5. 

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