Drossman DA, Dumitrascu DL Rome III: New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41. Review.
Francis CY, Morris J, Whorwell PJ The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.
Kroenke K, Spitzer RL, Williams JB The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66.
Li Q, Yang GY, Liu JP Syndrome differentiation in chinese herbal medicine for irritable bowel syndrome: a literature review of randomized trials. Evid Based Complement Alternat Med. 2013;2013:232147. doi: 10.1155/2013/232147. Epub 2013 Mar 11.
Rabin R, de Charro F EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. Review.
Saad RJ, Hasler WL A technical review and clinical assessment of the wireless motility capsule. Gastroenterol Hepatol (N Y). 2011 Dec;7(12):795-804.
Sisson G, Ayis S, Sherwood RA, Bjarnason I Randomised clinical trial: A liquid multi-strain probiotic vs. placebo in the irritable bowel syndrome--a 12 week double-blind study. Aliment Pharmacol Ther. 2014 Jul;40(1):51-62. doi: 10.1111/apt.12787. Epub 20
Zigmond AS, Snaith RP The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.
Randomized Placebo Controlled Trial of Traditional Chinese Medicine for Treatment of Irritable Bowel Syndrome
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.
