Eradication
of Small Intestinal Bacterial Overgrowth Decreases
Symptoms in Fibromyalgia:
A Double Blind Randomized Study
M. Pimentel, D. Hallegua,
D. Wallace, G. Bonorris, E. Chow, S. Tabibzadeh, H.C. Lin,
Los Angeles, California
BACKGROUND:
Bloating, the chief complaint of patients with small intestinal bacterial
overgrowth (SIBO), is a common symptom in patients with fibromyalgia (FM).
AIM: The aim of this
study is to test the hypothesis that 1. SIBO is associated with FM and
2. SIBO treatment reduces FM symptoms.
METHODS: Forty-six
patients with FM (ACR criteria) entered a double blind randomized placebo
controlled trial. A lactulose hydrogen breath test (LHBT) to diagnose
SIBO, a tenderpoint examination and questionnaire were performed at baseline
and at every subsequent visit. Subjects were randomized to receive neomycin
500 mg twice daily (liquid) or matched placebo for 10 days. After completion
of this treatment, subjects with persistent SIBO received antibiotics
(open label) until eradication was confirmed by LHBT. T-test was used
to compare the symptom scores of patients who were eradicated vs. not
eradicated for SIBO.
RESULTS: 1) Forty-two
of 46 FM patients (91.3%) were found to have SIBO; 2) only 6 out of 20
patients (30%) in the neomycin group achieved eradication in the blinded
arm; 3) with only 6 responders, there was no difference in the score before
and after the 10 d treatment; 4) 28 patients went on to open label treatment
with 17 (60.7%) achieving eradication; 5) when scores after eradication
on double blind or open treatment were compared to baseline, there was
significant improvement in Tender Points, Tender Point Score, Hamilton
Depression Scale, FIQ, Beck Depression Scale, Health Assessment Questionnaire
(HAQ), VAS-Pain, VAS-Memory/Concentration and IBS-QOL (selections shown
in table).
|
|
|
Eradicated
(n=25) |
|
|
Not
Eradicated
(n=15) |
|
Eradicated
vs.
Not Eradicated |
| Observation
|
Baseline
|
Eradicated
|
p-value
|
Baseline
|
Eradicated
|
p-value
|
(p-value)
|
Tender Points (TP) |
13.3
±2.9 |
10.3
±4.2 |
0.01
|
13.6
±2.0 |
12.1
±4.1 |
NS
|
NS
|
TP Score |
20.3
±7.0 |
15.0
±9.1 |
0.01
|
23.7
±8.0 |
19.9
±9.7 |
NS
|
NS
|
FIQ |
66.8
±18.2 |
49.5
±17.7 |
0.0001
|
72.7
±19.9 |
64.1
±20.9 |
0.04
|
0.02
|
VAS-pain (mm) |
80.7
±22.7 |
52.4
±28.5 |
0.00005
|
87.5
±19.6 |
76.2
±25.2 |
NS
|
0.01
|
HAQ |
42.4
±10.5 |
37.7
±10.1 |
0.005
|
45.1
±11.2 |
43.9
±12.1 |
NS
|
NS
|
CONCLUSIONS: 1. SIBO
is associated with fibromyalgia, 2. Eradication of SIBO decreases symptoms
in fibromyalgia.
KEYWORDS: Fibromyalgia
American College of Rheumatology Meeting, November 13-17, 1999, Boston,
MA - Poster Session F: Soft Tissue & Regional Musculoskeletal Disorders
II (12:30 PM-2:00 PM)