Psychosocial characteristics and pain burden of patients with suspected sphincter of Oddi dysfunction in the EPISOD multicenter trial.
OBJECTIVE
Patients with several painful functional gastrointestinal disorders (FGIDs) are reported to have a high prevalence of psychosocial disturbance. These aspects have not been studied extensively in patients with suspected Sphincter of Oddi dysfunction (SOD).


METHODS
A total of 214 patients with post-cholecystectomy pain and suspected SOD were enrolled in seven US centers in a multicenter-randomized trial (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction). Baseline assessments included pain descriptors and burden, structured psychosocial assessments of anxiety/depression, coping, trauma, and health-related quality of life. Patients with high levels of depression, suicidal ideation, or psychosis were excluded.


RESULTS
The study population (92% female, mean age 38) reported anxiety (9%), depression (8%), past sexual trauma (18%), and physical abuse (10%). Of the total screened population (n=1460), 3.9% of the patients were excluded because of the presence of defined severe psychological problems. The mean medical outcomes study short-form-36 (SF-36) physical and mental composite scores were 38.70 (s.d.=7.89) and 48.74 (s.d.=9.60), respectively. Most subjects reported symptoms of other FGIDs. There were no correlations between the extent of the pain burden in the 3 months before enrollment and the baseline anxiety scores or victimization history. However, those with greater pain burden were significantly more depressed. There were no meaningful differences in the psychosocial parameters in subjects with or without irritable bowel, and those who had cholecystectomy for stones or functional gallbladder disease. Those declining randomization were comparable to those randomized.


CONCLUSIONS
Psychosocial comorbidity in SOD is high. However, it does not appear to differ significantly from that reported in surveys of age- and gender-matched general populations, and may be lower than reported with other FGIDs.
1] Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA [2] Ralph H. Johnson VAMC, Charleston, South Carolina, USA.
Olga
O
Brawman-Mintzer
Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Valerie
V
Durkalski
Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Qi
Q
Wu
Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Joseph
J
Romagnuolo
Indiana University, Indianapolis, Indiana, USA.
Evan
E
Fogel
Methodist Dallas Medical Center, Dallas, Texas, USA.
Paul
P
Tarnasky
Midwest Therapeutic Endoscopy Consultants, St Louis, Missouri, USA.
Giuseppe
G
Aliperti
University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Martin
M
Freeman
Virginia Mason Medical Center, Seattle, Washington, USA.
Richard
R
Kozarek
Yale University, Newhaven, Connecticut, USA.
Priya
P
Jamidar
University of Alabama, Birmingham, Alabama, USA.
Mel
M
Wilcox
University of Michigan, Ann Arbor, Michigan, USA.
Grace
G
Elta
1] Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA [2] Methodist Dallas Medical Center, Dallas, Texas, USA.
Kyle
K
Orrell
Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
April
A
Wood
Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Patrick
P
Mauldin
National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.
Jose
J
Serrano
University of North Carolina and Drossman Gastroenterology PLLC, Chapel Hill, North Carolina, USA.
Douglas
D
Drossman
National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.
Patricia
P
Robuck
Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Peter
P
Cotton
D015746:Abdominal Pain / Q000175:diagnosis / Q000523:psychology*; D000293:Adolescent; D000328:Adult; D000368:Aged; D002763:Cholecystectomy / Q000009:adverse effects / Q000523:psychology*; D015897:Comorbidity; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000523:psychology*; D046628:Sphincter of Oddi Dysfunction / Q000175:diagnosis / Q000523:psychology* / Q000601:surgery; D016717:Sphincterotomy, Endoscopic; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult