|
- Corsetti M, Tack J. FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome? Neurogastroenterol Motil 2013;25:453-457.
- Spiegel B, Hays RD, Bolus R, et al. Development of the NIH Patient Reported Outcomes Measurement Information System (PROMIS®) gastrointestinal symptom scales. Am J Gastroenterol 2014;109:1804-1814.
- Lembo AJ, Schneier HA, Shiff SJ, et al. Two randomized trials of linaclotide for chronic constipation. N Engl J Med 2011;365:527-536.
- Camilleri M, Kerstens R, Rykx A, et al. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med 2008;358:2344-2354.
- Macdougall J, Johnston J, Lavins B, et al. An evaluation of the FDA Responder Endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials. Neurogastroenterol Motil 2013;25:481-e365.
- Johanson JF, Drossman DA, Panas R, et al. Clinical trial: phase 2 study of lubiprostone for irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2008;27:685-696.
- Camilleri M, Chey WY, Mayer EA, et al. A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome. Arch Intern Med 2001;161:1733-1740.
- Chey WD, Pare P, Viegas A, et al. Tegaserod for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial. Am J Gastroenterol 2008;103:1217-1225.
- Matsueda K, Hongo M, Tack J, et al. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut 2012;61:821-828.
- Tack J, Camilleri M, Chang L, et al. Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders. Aliment Pharmacol Ther 2012;35:745-767.
- Camilleri M, Beyens G, Kerstens R, et al. Safety assessment of prucalopride in elderly patients with constipation: a double-blind, placebo-controlled study. Neurogastroenterol Motil 2009;21:1256-e117.
- Muller-Lissner S, Rykx A, Kerstens R, et al. A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterol Motil 2010;22:991-998, e255.
- Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol 2009;104 Suppl 1:S1-35.
- Holtmann G, Kutscher SU, Haag S, et al. Clinical presentation and personality factors are predictors of the response to treatment in patients with functional dyspepsia; a randomized, double-blind placebo-controlled crossover study. Dig Dis Sci 2004;49:672-679.
- Gerson C, Gerson M, Awad R, et al. Irritable bowel syndrome: an international study of symptoms in eight countries. Eur J Gastroenterol Hepatol 2008;20:659-667.
- Babu J, Kumar S, Babu P, et al. Frequency of lactose malabsorption among healthy southern and northern Indian populations by genetic analysis and lactose hydrogen breath and tolerance tests. Am J Clin Nutr 2010;91:140-146.
- Asmawi M, Seppo L, Vapaatalo H, et al. Hypolactasia & lactose intolerance among three ethnic groups in Malaysia. Indian J Med Res 2006;124:697-704.
- Spiller RC. Potential biomarkers. Gastroenterology Clin North Am 2011;40:121-139.
- Pimentel M, Morales W, Rezaie A, et al. Development and validation of a biomarker for diarrhea-predominant irritable bowel syndrome in human subjects. PLoS One 2015;10:e0126438.
- Chiarioni G, Whitehead WE, Pezza V, et al. Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology 2006;130:657-664.
- Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997;32:920-924.
- Spiller RC. Problems and challenges in the design of irritable bowel syndrome clinical trials: experience from published trials. Am J Med 1999;107:91S-97S.
- Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, et al. Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol 1996;91:660-673.
- Hahn B, Watson M, Yan S, et al. Irritable bowel syndrome symptom patterns: frequency, duration, and severity. Dig Dis Sci 1998;43:2715-2718.
- Palsson OS, Baggish J, Whitehead WE. Episodic nature of symptoms in irritable bowel syndrome. Am J Gastroenterol 2014;109:1450-1460.
- Palsson OS, Baggish JS, Turner MJ, et al. IBS patients show frequent fluctuations between loose/watery and hard/lumpy stools: implications for treatment. Am J Gastroenterol 2012;107:286-295.
- Drossman DA, Thompson WG. The irritable bowel syndrome: review and a graduated multicomponent treatment approach. Ann Intern Med 1992;116:1009-1016.
- Whitehead WE. Control groups appropriate for behavioral interventions. Gastroenterology 2004;126:S159-S163.
- Camilleri M. Safety concerns about alosetron. Arch Intern Med 2002;162:100-101.
- Sackett DL. Bias in analytic research. J Chronic Dis 1979;32:51-63.
- Detsky AS, Sackett DL. When was a “negative” clinical trial big enough? How many patients you needed depends on what you found. Arch Intern Med 1985;145:709-712.
- Jamshidian F, Hubbard AE, Jewell NP. Accounting for perception, placebo and unmasking effects in estimating treatment effects in randomised clinical trials. Stat Methods Med Res 2011;23:293-307.
- Miller LE, Stewart ME. The blind leading the blind: use and misuse of blinding in randomized controlled trials. Contemp Clin Trials 2011;32:240-243.
- Spilker B. External influences on protocol design. Epilepsy Res Suppl 1993;10:115-124.
- Govani SM, Higgins PD. How to read a clinical trial paper: a lesson in basic trial statistics. Gastroenterol Hepatol (N Y) 2012;8:241-248.
- Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000;31:73-86.
- Altman DG. Randomisation. BMJ 1991;302:1481-1482.
- Chalmers TC, Celano P, Sacks HS, et al. Bias in treatment assignment in controlled clinical trials. N Engl J Med 1983;309:1358-1361.
- Altman DG. Comparability of randomised groups. The Statistician 1985;34:125-136.
- Spilker B. How to improve the quality of clinical trials and their publications. Med Clin (Barc) 1992;98:303-304.
- Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 2000;20:765-786.
- Tinmouth JM, Steele LS, Tomlinson G, et al. Are claims of equivalency in digestive diseases trials supported by the evidence? Gastroenterology 2004;126:1700-1710.
- Temple RJ. When are clinical trials of a given agent vs. placebo no longer appropriate or feasible? Control Clin Trials 1997;18:613-620; discussion 661-666.
- Manheimer E, Wieland LS, Cheng K, et al. Acupuncture for irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol 2012;107:835-847; quiz 848.
- Gensini GF, Conti AA, Conti A. Past and present of ‘’what will please the lord’’: an updated history of the concept of placebo. Minerva Med 2005;96:121-124.
- Thompson WG. Placebos: a review of the placebo response. Am J Gastroenterol 2000;95:1637-1643.
- Bernstein CN. Placebos in medicine. Semin Gastrointest Dis 1999;10:3-7.
- Musial F, Klosterhalfen S, Enck P. Placebo responses in patients with gastrointestinal disorders. World J Gastroenterol 2007;13:3425-3429.