Are claims of equivalency in digestive diseases trials supported by the evidence?

Gastroenterology

Volumn 126, Issue 7, 2004, Pages 1700-1710

  Tinmouth, Jill M ^a   Steele, Leah S ^a   Tomlinson, George ^b   Glazier, Richard H ^a  

^a ST MICHAEL'S HOSPITAL   (Canada)

^b TORONTO GENERAL HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; NAPROXEN;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DIGESTIVE SYSTEM DISEASE; EVIDENCE BASED MEDICINE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL INFECTION; HEALTH CARE QUALITY; HELICOBACTER PYLORI; HUMAN; INTERMETHOD COMPARISON; MEDICAL LITERATURE; MEDLINE; OUTCOMES RESEARCH; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; SYSTEMATIC REVIEW;

EID: 2942538319     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.gastro.2004.03.005     Document Type: Article

References (16)

1. Feinstein AR. Clinical biostatistics. XXXIV. The other side of "statistical significance": alpha, beta, delta, and the calculation of sample size. Clin Pharmacol Ther 1975;18:491-505.
2. Taubes G. Use of placebo controls in clinical trials disputed. Science 1995;267:25-26.
3. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med 1994;331:394-398.
4. D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med 2003;22:169-86.
5. Hauschke D, Steinijans VW. The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based pharmaceutical company. Stat Med 2000; 19:2769-2774.
6. Moher D, Dulberg CS, Wells GA. Statistical power, sample size and their reporting in clinical trials. JAMA 1994;272:122-124.
7. Freiman JA, Chalmers TC, Smith H, Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized controlled trial. N Engl J Med 1978;299:890-894.
8. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996;313:36-39.
9. Landow L. Current issues in clinical trial design: superiority versus equivalency studies. Anesthesiology 2000;92:1814-1820.
10. McAlister FA, Sackett DL. Active-control equivalence trials and antihypertensive agents. Am J Med 2001;111:553-558.
11. Greene WL, Concato J, Feinstein AR. Claims of equivalence in medical research: are they supported by the evidence? Ann Intern Med 2000;132:715-722.
12. Ardizzone S, Petrillo M, Molteni P, Desideri S, Bianchi Porro G. Coated oral 5-aminosalicylic acid (Claversal) is equivalent to sulfasalazine for remission maintenance in ulcerative colitis. A double-blind study. J Clin Gastroenterol 1995;21:287-289.
13. Ramon JM, Bou R, Oromi J. Low-dose intramuscular revaccination against hepatitis B. Vaccine 1996;14:1647-1650.
14. Ford EG, Hull SF, Jennings LM, Andrassy RJ. Clinical comparison of tolerance to elemental or polymeric enteral feedings in the postoperative patient. J Am Coll Nutr 1992;11:11-16.
15. Chan FK, Chung SC, Suen BY, Lee YT, Leung WK, Leung VK, Wu JC, Lau JY, Hui Y, Lai MS, Chan HL, Sung JJ. Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med 2001;344:967-973.
16. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. N Engl J Med 2000;133:455-463.