Loperamide Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial.
BACKGROUND
Fecal incontinence is a devastating condition with few US Food and Drug Administration-approved pharmacologic treatment options. Loperamide and psyllium, both first-line treatments, have different mechanisms of action without any comparative data.


OBJECTIVE
The purpose of this study was to examine the effectiveness and tolerability of loperamide compared with psyllium for reducing fecal incontinence. We hypothesized that psyllium fiber supplementation would be more effective than loperamide for reducing fecal incontinence episodes and have fewer adverse effects.


METHODS
We conducted a randomized, double-blind, placebo-controlled crossover trial comparing loperamide (followed by psyllium) with psyllium (followed by loperamide).


METHODS
Our sites included outpatient clinics within a Veterans Affairs medical center and university affiliate.


METHODS
Participants included community-dwelling adults (n = 80) with at least 1 fecal incontinent episode on a 7-day bowel diary.


METHODS
Participants received either daily loperamide (plus placebo psyllium powder) or psyllium powder (plus loperamide placebo) for 4 weeks. After a 2-week washout, participants crossed over to 4 weeks of alternate treatment.


METHODS
The primary outcome was the number of fecal incontinence episodes from 7-day bowel diaries. Secondary outcomes included symptom severity, quality of life, and tolerability.


RESULTS
Mean age was 60.7 ± 10.1 years; 68% were men. After determining nonsignificant carryover effects, combined analyses showed no differences between the loperamide and psyllium groups for reducing fecal incontinent episodes, symptom severity, or quality of life. Within each group, both loperamide and psyllium reduced fecal incontinent episodes and improved symptom severity and quality of life. Constipation occurred in 29% of participants for loperamide vs 10% for psyllium.


CONCLUSIONS
Limitations include the washout period length and dropout rate after crossing over to the second intervention.


CONCLUSIONS
Both loperamide and psyllium improve fecal incontinence. Loperamide was associated with more adverse effects, especially constipation.
1 Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Birmingham Department of Veterans Affairs Medical Center, Birmingham, Alabama 2 Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama 3 Division of Gastroenterology, Department of Medicine, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 4 Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama 5 Division of Gastroenterology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama 6 School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.
Alayne D
AD
Markland
Kathryn L
KL
Burgio
William E
WE
Whitehead
Holly E
HE
Richter
C Mel
CM
Wilcox
David T
DT
Redden
Timothy M
TM
Beasley
Patricia S
PS
Goode
D000368:Aged; D000930:Antidiarrheals / Q000008:administration & dosage / Q000009:adverse effects; D002400:Cathartics / Q000008:administration & dosage / Q000009:adverse effects; D003248:Constipation / Q000209:etiology*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005242:Fecal Incontinence / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D005260:Female; D006801:Humans; D008139:Loperamide / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011620:Psyllium / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D063189:Symptom Assessment; D016896:Treatment Outcome
D000930:Antidiarrheals; D002400:Cathartics; D008139:Loperamide; D011620:Psyllium