Irritable Bowel Syndrome — Efficacy and Safety of IBS Digital Behavioral Treatment
Citation(s)
Bang H, Flaherty SP, Kolahi J, Park J Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clin Res and Reg Affairs, 2010;27(2):42-51
El-Serag HB Impact of irritable bowel syndrome: prevalence and effect on health-related quality of life. Rev Gastroenterol Disord. 2003;3 Suppl 2:S3-11. Review.
Häuser W, Hagl M, Schmierer A, Hansen E The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289. Review.
Kroenke K, Spitzer RL, Williams JB, Löwe B An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
Lackner JM The role of psychosocial factors in functional gastrointestinal disorders. Quigley, Hongo, Fukuda (eds): Functional and GI Motility Disorders. 2014(33):104-16.
Lewis SJ, Heaton KW Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4.
Lovell RM, Ford AC Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
Mayer EA, Tillisch K The brain-gut axis in abdominal pain syndromes. Annu Rev Med. 2011;62:381-96. doi: 10.1146/annurev-med-012309-103958. Review.
Meyerson J, Konichezy A Out-of-illness experience: hypnotically induced dissociation as a therapeutic resource in treating people with obstinate mental disorders. Am J Psychother. 2009;63(2):133-46. Erratum in: Am J Psychother. 2009;63(4):383. Myerson, Joseph [corrected to Meyerson, Joseph].
Palsson OS, Baggish JS, Turner MJ, Whitehead WE IBS patients show frequent fluctuations between loose/watery and hard/lumpy stools: implications for treatment. Am J Gastroenterol. 2012 Feb;107(2):286-95. doi: 10.1038/ajg.2011.358. Epub 2011 Nov 8.
Palsson OS Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Am J Clin Hypn. 2015 Oct;58(2):134-58. doi: 10.1080/00029157.2015.1039114. Review.
Palsson OS Standardized hypnosis treatment for irritable bowel syndrome: the North Carolina protocol. Int J Clin Exp Hypn. 2006 Jan;54(1):51-64.
Powell RA, Gee TL The effects of hypnosis on dissociative identity disorder: a reexamination of the evidence. Can J Psychiatry. 1999 Nov;44(9):914-6.
Reilly MC, Zbrozek AS, Dukes EM The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65.
Williamson A What is hypnosis and how might it work? Palliat Care. 2019 Jan 31;12:1178224219826581. doi: 10.1177/1178224219826581. eCollection 2019.
Yeh VM, Schnur JB, Montgomery GH Disseminating hypnosis to health care settings: Applying the RE-AIM framework. Psychol Conscious (Wash D C). 2014 Jun;1(2):213-228.
The Efficacy and Safety of IBS Digital Behavioral Treatment Study
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.