Prescript-Assist probiotic-prebiotic treatment for
irritable bowel syndrome:
a methodologically
oriented, 2-week, randomized, placebo-controlled,
double-blind clinical study.
Battelle
Seattle Research Center, Washington, USA. drbittner@comcast.net
BACKGROUND:
The symptomatic efficacy of Prescript-Assist (Safer
Medical, Inc., Fort Benton, Montana), a treatment
combining probiotic and prebiotic components, has
previously been evaluated clinically only in an
open-label study in patients with various
gastrointestinal conditions, including irritable bowel
syndrome (IBS).
OBJECTIVES:
This study was conducted primarily to compare the
effects of Prescript-Assist with placebo in patients
with a diagnosis of IBS. Toward this objective, a
secondary methodologic goal was to determine the number
and nature of symptom clusters ("subsyndromic factors")
that characterize IBS.
METHODS:
This was a double-blind, placebo-controlled clinical
study in which patients were randomly assigned to
receive either Prescript-Assist one 500-mg capsule BID
or 1 placebo capsule BID for 2 weeks. Thirteen IBS
symptoms identified from the clinical literature were
embedded in a larger research instrument. Using a scale
from 0 to 5, patients rated the intensity of these
symptoms for the 7-day period immediately before the
start of treatment, at the end of each study week, and
after each of the 2 subsequent weeks (during which all
patients received open-label Prescript-Assist as part of
a larger study evaluating methodologic approaches to
enhancing assessments of medication efficacy/safety).
The symptom-intensity data were subjected to maximum
likelihood factor analysis with varimax rotation to
identify any IBS subsyndromic factors, and the effect of
treatment on each of the identified factors was
evaluated using analyses of covariance with appropriate
baseline-week assessments as covariate controls.
RESULTS: The
study included 25 patients with IBS (23 women, 2 men;
age range, 20-70 years). Three subsyndromic factors were
identified that together accounted for 60.2% of total
IBS symptom variance: factor 1, general ill
feelings/nausea; factor 2, indigestion/flatulence; and
factor 3, colitis. Treatment with Prescript-Assist was
associated with significant reductions in each of the
subsyndromic factors. Factor 1 was significantly reduced
by 0.345 standard score units (F(1,46) = 4.26; P =
0.042), factor 2 by 0.544 standard score units (F(1,46)
= 7.83; P = 0.008), and factor 3 by 0.826 standard score
units (F(1,46) = 10.20; P = 0.003).
CONCLUSIONS:
This study identified 3 subsyndromic factors of IBS:
general ill feelings/nausea, indigestion/flatulence, and
colitis. In this methodologically oriented double-blind
study in patients with IBS, combined probiotic-prebiotic
treatment with Prescript-Assist was associated with
significant reductions in these factors.
PMID:
16117982 [PubMed - indexed for MEDLINE]
Reference
page:
http://www.ncbi.nlm.nih.gov/pubmed/16117982