Research Design Characteristics of Published Pharmacologic Randomized Clinical Trials for Irritable Bowel Syndrome and Chronic Pelvic Pain Conditions: An ACTTION Systematic Review

Overview

Journal J Pain

Specialties Neurology
Psychiatry

Date 2018 Feb 8

PMID 29412183

Citations 4

Authors

Jennifer S Gewandter

Jenna Chaudari

Katarzyna B Iwan

Rachel Kitt

Sawsan As-Sanie

Gloria Bachmann

Quentin Clemens

H Henry Lai

Frank Tu

G Nicholas Verne

Katy Vincent

Ursula Wesselmann

QiQi Zhou

Dennis C Turk

Robert H Dworkin

Shannon M Smith

Affiliations

Soon will be listed here.

Abstract

Perspective: This article summarizes entry criteria and outcome measures and the clarity of reporting of these important design features in RCTs of irritable bowel syndrome and 3 common chronic pelvic pain conditions. These results can be used to improve design of future trials of these largely unaddressed pain conditions.

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References

Drossman D, Hasler W . Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016; 150(6):1257-61. DOI: 10.1053/j.gastro.2016.03.035. View

Canavan C, West J, Card T . The epidemiology of irritable bowel syndrome. Clin Epidemiol. 2014; 6:71-80. PMC: 3921083. DOI: 10.2147/CLEP.S40245. View

Dworkin R, Turk D, Peirce-Sandner S, Baron R, Bellamy N, Burke L . Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain. 2010; 149(2):177-193. DOI: 10.1016/j.pain.2010.02.018. View

Pukall C, Bergeron S, Brown C, Bachmann G, Wesselmann U . Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials. Clin J Pain. 2016; 33(8):756-765. DOI: 10.1097/AJP.0000000000000453. View

Clemens J, Meenan R, OKeeffe Rosetti M, Gao S, Calhoun E . Prevalence and incidence of interstitial cystitis in a managed care population. J Urol. 2004; 173(1):98-102. DOI: 10.1097/01.ju.0000146114.53828.82. View

Dalpiaz O, Kerschbaumer A, Mitterberger M, Pinggera G, Bartsch G, Strasser H . Chronic pelvic pain in women: still a challenge. BJU Int. 2008; 102(9):1061-5. DOI: 10.1111/j.1464-410X.2008.07771.x. View

Giamberardino M, Costantini R, Affaitati G, Fabrizio A, Lapenna D, Tafuri E . Viscero-visceral hyperalgesia: characterization in different clinical models. Pain. 2010; 151(2):307-322. DOI: 10.1016/j.pain.2010.06.023. View

Bogart L, Berry S, Clemens J . Symptoms of interstitial cystitis, painful bladder syndrome and similar diseases in women: a systematic review. J Urol. 2007; 177(2):450-6. DOI: 10.1016/j.juro.2006.09.032. View

Petersen C, Lundvall L, Kristensen E, Giraldi A . Vulvodynia. Definition, diagnosis and treatment. Acta Obstet Gynecol Scand. 2008; 87(9):893-901. DOI: 10.1080/00016340802323321. View

10.

GILLENWATER J, Wein A . Summary of the National Institute of Arthritis, Diabetes, Digestive and Kidney Diseases Workshop on Interstitial Cystitis, National Institutes of Health, Bethesda, Maryland, August 28-29, 1987. J Urol. 1988; 140(1):203-6. DOI: 10.1016/s0022-5347(17)41529-1. View

11.

Gewandter J, Smith S, McKeown A, Burke L, Hertz S, Hunsinger M . Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain. 2013; 155(3):461-466. DOI: 10.1016/j.pain.2013.11.009. View

12.

Akehurst R, Kaltenthaler E . Treatment of irritable bowel syndrome: a review of randomised controlled trials. Gut. 2001; 48(2):272-82. PMC: 1728206. DOI: 10.1136/gut.48.2.272. View

13.

Sperber A, Dumitrascu D, Fukudo S, Gerson C, Ghoshal U, Gwee K . The global prevalence of IBS in adults remains elusive due to the heterogeneity of studies: a Rome Foundation working team literature review. Gut. 2016; 66(6):1075-1082. DOI: 10.1136/gutjnl-2015-311240. View

14.

Lai H, Jemielita T, Sutcliffe S, Bradley C, Naliboff B, Williams D . Characterization of Whole Body Pain in Urological Chronic Pelvic Pain Syndrome at Baseline: A MAPP Research Network Study. J Urol. 2017; 198(3):622-631. PMC: 5562525. DOI: 10.1016/j.juro.2017.03.132. View

15.

Priya K, Rajaram S, Goel N . Comparison of combined hormonal vaginal ring and low dose combined oral hormonal pill for the treatment of idiopathic chronic pelvic pain: a randomised trial. Eur J Obstet Gynecol Reprod Biol. 2016; 207:141-146. DOI: 10.1016/j.ejogrb.2016.10.026. View

16.

Harlow B, Kunitz C, Nguyen R, Rydell S, Turner R, MacLehose R . Prevalence of symptoms consistent with a diagnosis of vulvodynia: population-based estimates from 2 geographic regions. Am J Obstet Gynecol. 2013; 210(1):40.e1-8. PMC: 3885163. DOI: 10.1016/j.ajog.2013.09.033. View

17.

Bengtson M, Aamodt G, Vatn M, Harris J . Co-occurrence of IBS and symptoms of anxiety or depression, among Norwegian twins, is influenced by both heredity and intrauterine growth. BMC Gastroenterol. 2015; 15:9. PMC: 4321711. DOI: 10.1186/s12876-015-0237-y. View

18.

Nickel J, Downey J, Hunter D, Clark J . Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 2001; 165(3):842-5. View

19.

Foster D, Kotok M, Huang L, Watts A, Oakes D, Howard F . The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009; 113(4):825-832. PMC: 2756618. DOI: 10.1097/AOG.0b013e31819bda7c. View

20.

Naliboff B, Stephens A, Afari N, Lai H, Krieger J, Hong B . Widespread Psychosocial Difficulties in Men and Women With Urologic Chronic Pelvic Pain Syndromes: Case-control Findings From the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network. Urology. 2015; 85(6):1319-27. PMC: 4479402. DOI: 10.1016/j.urology.2015.02.047. View