TITLE

Maintenance Treatment of Ulcerative Proctitis With Mesalazine Suppositories: A Double-Blind Placebo-Controlled Trial

AUTHOR(S)
D'Albasio, G.; Paoluzi, P.; Campieri, M.; Porro, G. Bianchi; Pera, A.; Prantera, C.; Sturniolo, G. C.; Miglioli, M.
PUB. DATE
May 1998
SOURCE
American Journal of Gastroenterology;May1998, Vol. 93 Issue 5, p799
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Objectives: A multicenter double-blind placebo-controlled clinical study was conducted to evaluate the efficacy and tolerability of two different therapeutic schedules of mesalazine suppositories in patients with ulcerative proctitis. Methods: From 1990 to 1993, 111 patients with ulcerative proctisis in remission, limited to the rectum (≤ 15 cm from anus), were enrolled. After obtaining informed consent, patients were randomized to three treatment groups: 500 mg mesalazine b.i.d. (36 patients), 500 mg mesalazine u.i.d. (40 patients), and placebo (35 patients). The treatment lasted 1 yr. Follow-up consisted of periodic clinical, endoscopic, and histological assessments. An endoscopic score > 1 according to the Baron scale defined relapse occurrence. The three groups were homogeneous as regards main demographic, diagnostic, and prognostic features. Results: The cumulative relapse rates at 12 months were 10% (95% confidence interval [CI]: 0-21) in the mesalazine b.i.d, group, 32% (95% CI: 16-49) in the mesalazine u.i.d. group, and 47% (95% Ch 29-65) in the placebo group. The comparison between the mesalazine b.i.d. group and the mesalazine u.i.d, group cumulative relapse rates gave a p value of 0.0334, whereas the corresponding comparison between the mesalazine b.i.d. group and the placebo group gave a p value of 0.007 (log-rank test). The dose-response relationship was statistically significant (p = 0.008 by Cox analysis). Two patients in the mesalazine b.Ld. group, two patients in the mesalazine u.i.d. group, and one patient in the placebo group withdrew from the study due to nonserious adverse events; four, three, and four patients per group, respectively, dropped out because of poor compliance. Two patients in the mesalazine u.i.d, group and two in the placebo group were lost to follow-up. Conclusions: The results of this study confirm the therapeutic effic...
ACCESSION #
16071004

 

Related Articles

  • Informed consent and placebo effects.  // Australian Journal of Pharmacy;Nov2012, Vol. 93 Issue 1110, p99 

    The article discusses a study on the informed consent and the effects of placebo in the participants in randomised control trials (RCT). The study employs a content analysis of Participant Information Leaflets (PILs), Results reveal that PILs from the clinical trials underscores the benefits and...

  • The ethics of placebo treatments in clinical practice: a reply to Glackin. Barnhill, Anne; Miller, Franklin G // Journal of Medical Ethics;Aug2015, Vol. 41 Issue 8, p673 

    In ‘Placebo treatments, informed consent, and “the grip of a false picture”’ Shane Nicholas Glackin argues that if a physician offers a patient an inert placebo with the following disclosure, this is compatible with informed consent and is not deceptive: ‘I would...

  • First Once-Daily Oral Medication Approved for Schizophrenia.  // Journal of Psychosocial Nursing & Mental Health Services;Feb2007, Vol. 45 Issue 2, p14 

    The article reports that Invega (paliperidone) extended-release tablets have been approved by the U.S. Food and Drug Administration for the medication of schizophrenia. The effectiveness of Invega compared to placebo for relieving symptoms of schizophrenia are discussed. The side effects of the...

  • The experiment must go on. McGovern, Celeste // Report / Newsmagazine (National Edition);10/22/2001, Vol. 28 Issue 20, p46 

    Focuses on the deaths of several women who used the abortion drug RU486 from complications not listed on informed consent forms. Reasons for the exclusion of warnings by Searle pharmaceutical company; Approval of the drug for sale in the United States, and pending approval of it in Canada;...

  • The experiment must go on. McGovern, Celeste // Report / Newsmagazine (Alberta Edition);10/22/2001, Vol. 28 Issue 20, p46 

    Focuses on the deaths of several women who used the abortion drug RU486 from complications not listed on informed consent forms. Reasons for the exclusion of warnings by Searle pharmaceutical company; Approval of the drug for sale in the United States, and pending approval of it in Canada;...

  • The experiment must go on. McGovern, Celeste // Report / Newsmagazine (BC Edition);10/22/2001, Vol. 28 Issue 20, p46 

    Focuses on the deaths of several women who used the abortion drug RU486 from complications not listed on informed consent forms. Reasons for the exclusion of warnings by Searle pharmaceutical company; Approval of the drug for sale in the United States, and pending approval of it in Canada;...

  • Informed consent has 'nocebo' effect.  // New Zealand Doctor;8/14/2013, p38 

    The article reports on the claim of Auckland University professor of psychological medicine Keith Petrie that the informed consent process can lead to expectations of adverse drug side effects.

  • Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital. Dahan, R.; Caulin, C.; Figea, L.; Kanis, J.A.; Caulin, F.; Segrestaa, J.M. // British Medical Journal (Clinical Research Edition);8/9/1986, Vol. 293 Issue 6543, p363 

    Examines the impact of written informed consent on the results of clinical trial. Effect of placebo administered to patients with or without consent; Disadvantages inherent in acquiring informed consent; Concerns on the alteration of the outcome of the clinical trial.

  • Placebo and Criminal Law. Joerden, Jan C. // Science & Engineering Ethics;Jan2004, Vol. 10 Issue 1, p65 

    This article considers issues concerning cases where the use of placebo is lawful or is not lawful under aspects of German criminal law. It will differentiate between cases of individual therapy and cases of supervised experiments within the scope of medical tests. Thereby, it reveals that a...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics