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Rifaximin versus Other Antibiotics in the Primary Treatmentand Retreatment of Bacterial Overgrowth in IBS
Janet Yang Æ Hyo-Rang Lee Æ Kimberly Low ÆSoumya Chatterjee Æ Mark Pimentel
Received: 13 November 2006 / Accepted: 5 April 2007 / Published online: 23 May 2007Ó Springer Science+Business Media, LLC 2007
Previous studies demonstrate improvement in
antibiotics in the treatment and retreatment of IBS.
IBS after antibiotic therapy, with the greatest efficacy seenwith the antibiotic, rifaximin. The purpose of this study
was to compare the efficacy of rifaximin in both the
Small intestinal bacterial overgrowth Á Lactulose breath test
treatment and retreatment of IBS. Methods
A retrospective chart review was conducted on
Rome I-positive IBS patients. Charts were reviewed to
evaluate all antibiotic treatments (rifaximin, neomycin,doxycycline, amoxicillin/clavulanate, and ciprofloxacin),
Irritable bowel syndrome (IBS) is a common disorder
even those predating 1 July 2004. Data collection included
associated with bloating, altered bowel habits, and
symptoms, breath test results (pre- and post-treatment),
abdominal pain []. Although it has been reported to affect
antibiotics used, and clinical response to individual anti-
15–20% of the general population [], its etiology
biotic treatments before and after rifaximin availability in
remains unknown. There have been several hypotheses
characterizing IBS, including altered gut motility
Out of 98 eligible charts, 84 patients received one
peripheral and central [] sensory dysfunction, and an
course of rifaximin. Fifty of these (60%) had a follow-up
abnormal response to stress []. However, there has been
breath test. Among these, 31 (62%) were clinical
no single diagnostic test associated with IBS. Conse-
responders and 19 (38%) were nonresponders. Of 31
quently, clinical criteria, such as the Rome criteria, have
responders, 25 (81%) had a normal follow-up breath test
been developed to aid in diagnosing and categorizing this
compared with only 3 of the 19 nonresponders (16%)
(P < 0.001). Of participants given rifaximin, 69% (58 out
It has been noted that the symptoms of IBS are similar to
of 84) had a clinical response compared with only 38% (9
those of small intestinal bacterial overgrowth (SIBO) [
out of 24) with neomycin (P < 0.01) and 44% (27 out of
a condition caused by colonization of the small bowel with
bacteria that normally reside in the colon. Accordingly, we
Rifaximin was used as retreatment on 16 occasions, and all
have demonstrated in two recent studies that abnormal
lactulose breath tests (LBTs) are more prevalent in IBSsufferers compared with controls [We have alsoshown that antibiotic treatment in IBS sufferers leads tosymptomatic improvement []. Moreover, normali-
J. Yang Á H.-R. Lee Á K. Low Á S. Chatterjee ÁM. Pimentel (&)
zation of the LBT after antibiotic treatment correlates with
GI Motility Program, GI Motility Laboratory, Cedars-Sinai
the degree of clinical improvement [suggesting that
Burns and Allen Research Institute, Cedars-Sinai Medical
the LBT is useful in evaluating SIBO after treatment. More
Center, 8730 Alden Drive, Suite 225E, Los Angeles, CA 90048,
recent literature using glucose breath testing [] and
small bowel culture ] confirm the concept that the small
bowel of IBS patients contains more bacteria. All of these
period of FDA approval of rifaximin for traveler’s diarrhea.
studies support the association between SIBO and IBS.
Only patients with a positive LBT in addition to at least
The current standard of treatment for SIBO is empiric
one follow-up visit were included. An abnormal breath test
therapy with broad spectrum antibiotics , Tetracy-
was one in which the hydrogen or methane values rose to
clines are commonly used, though there have been few
more than 20 ppm at or before 90 min of ingestion of 10 g
controlled studies describing the most appropriate choice
of lactulose. Furthermore, patients were included if they
or duration of antibiotic therapy ]. Moreover, conven-
had at least one treatment for their IBS based on breath test
tional antibiotics often suffer from poor efficacy, with only
and at least one follow-up documenting the outcome of that
30–40% of SIBO eradication reported with the use of
treatment. In general, our approach for all patients was to
norfloxacin and amoxicillin/clavulanic acid ]. High
treat the IBS patient and positive breath test with antibiotic
rates of SIBO recurrence are another problem. For exam-
followed by nightly tegaserod to prevent recurrence.
ple, while Attar et al. was able to show in a clinical trial
Patients with inflammatory bowel disease or other GI
that both amoxicillin/clavulanic acid and norfloxacin were
effective in treating SIBO, it was also noted that diarrheaquickly recurred after withdrawal of the antibiotic
Data such as these have led to the use of rotating courses ofantibiotics. Multiple antibiotic retreatment courses are
During data extractions, note was made of any previous
concerning because they increase the likelihood of bacte-
gastrointestinal surgery or any known GI disorder besides
rial resistance and future treatment failure.
IBS. The number of visits to the center for follow-up was
Rifaximin has recently become an antibiotic of interest
also documented. Patient charts were reviewed to evaluate
in the treatment of IBS and SIBO since it has a broad
all prior antibiotic treatments, even those predating 1 July
spectrum of coverage without the associated bacterial
2004. The breath test hydrogen and methane levels during
resistance of other antibiotics [As a synthetic,
the 180 min of conventional recording were documented.
nonabsorbable derivative of rifamycin, it has virtually no
The overall clinical response in bowel function to each
systemic absorption, minimizing adverse side effects while
antibiotic was noted if available in review. Specifically, the
maintaining good luminal antibacterial activity [In a
review determined to find out if the patient was satisfied
double-blind, randomized, controlled trial comparing the
with their improvement. In most cases, the motility pro-
effects of a 7-day course of rifaximin (1,200 mg/day) and
gram recorded a percent overall improvement in symptoms
chlortetracycline (1 g/day), Di Stefano et al. demonstrated
in follow-up and, if documented, this too was recorded. In
eradication of SIBO in 70% of patients treated with rif-
aximin compared with 27% of patients treated with
chlortetracycline, based on normalization of a glucosebreath test [Furthermore, two recent controlled trials
have now demonstrated that rifaximin is superior to pla-cebo in IBS global improvement as well , Although
The percent improvement in IBS overall was noted for
rifaximin appears effective, studies on retreatment are
10 days of rifaximin 400 mg tid. This was compared with
other previously used antibiotics. The number of partici-
The objective of this study was to determine the efficacy
pants with improvement of greater than 50% was used, as
of rifaximin both in eradicating SIBO in IBS sufferers and
well as the categorical notation of improvement or no
in improving symptoms. We also aimed to compare the
improvement. If data were available, the response to a
efficacy of rifaximin to other antibiotics in initial and
specific symptom was noted. These included bloating,
diarrhea, constipation, and abdominal pain. The clinicalresponse to rifaximin was then compared between subjectswith and without normalization of their respective abnor-
mality on LBT after antibiotic treatment. This included asubanalysis to evaluate the success of rifaximin in treating
breath tests in which methane gas was present.
The clinical response to rifaximin was further compared
A retrospective chart review was conducted on consecutive
with responses of the same participant to prior antibiotic
Rome I-positive IBS patients seen at the GI Motility Pro-
use. Among participants in whom a single antibiotic had
gram (Cedars-Sinai Medical Center) between 1 July 2004,
been used on more than one occasion, the ability of the
and 31 October 2005. This interval was chosen as the time
subsequent use to improve symptoms or normalize the
breath test was compared between rifaximin and other
antibiotics. This was to evaluate antibiotic resistance andsuccess of retreatment.
In contrast to the 69% clinical response seen with rifaximintreatment, a response was seen in only 27 of the 61 patients
(44%) who in the past had received any antibiotic besidesrifaximin (P < 0.01 when compared with rifaximin;
When comparing the proportion of clinical responders
Table Since neomycin has been studied in IBS ], we
among rifaximin-treated IBS patients with those who had
specifically looked at the effect of neomycin on clinical
received other antibiotics, a Fisher’s exact test was used.
response. Prior to rifaximin, 24 participants had received
Significance was set at P < 0.05.
neomycin, with only 9 (38%) realizing a clinicalimprovement. This was significantly lower than that seenwith rifaximin (P < 0.01). Of the 20 patients who did not
respond to one or more previous trials of pre-rifaximinantibiotics, 75% (15 out of 20) still had clinical improve-
After inclusion and exclusion criteria were applied, 98
Treatment of symptom recurrence with antibiotics
participant charts were eligible and summarized. Of these,84 patients received at least one course of rifaximin. The
For cases of recurrence, 24 participants received retreat-
median duration of patient time in clinical treatment was
ment with an antibiotic. Rifaximin was used as retreatment
on 16 occasions, and all 16 had clinical improvement. Rifaximin was used a third time in 4 cases, and again, all
patients responded. In contrast, retreatment was only 25%effective (2 out of 8) when retreating with doxycycline,
Of the 84 participants who received rifaximin, 1,200 mg
augmentin, and neomycin (P < 0.0001 when compared
per day, 58 (69%) had a clinical response to therapy. Of
these 84 patients, 50 had a follow-up LBT. Among these,31 (62%) were clinical responders to rifaximin and 19(38%) were nonresponders (Table Normalization of theLBT was predictive of clinical response, since 25 of the 31
clinical responders to rifaximin (81%) normalized theirbreath test after treatment. This is in contrast to LBT
In this retrospective chart review, we found that rifaximin
normalization occurring in only 3 of the 19 participants
was superior to conventional antibiotics in producing a
(16%) who did not have a clinical response to rifaximin
clinical response among IBS patients with an abnormal
LBT. More importantly, IBS sufferers who responded to
Among the 84 participants who received rifaximin, 7
antibiotic therapy and later had a relapse of symptoms
had an abnormal breath test with methane production as
requiring retreatment universally responded to rifaximin on
well as a follow-up breath test. In these 7 methane pro-
subsequent occasions. This was not the case for other
ducers, 4 (57%) were clinical responders, and 3 of these 4
antibiotics as they were rarely successful in achieving
methane-positive responders had a normal follow-up breath
another clinical response, suggesting bacterial resistance
test. None of the three treatment failures normalized their
developed after a single course of a non-rifaximin antibi-
breath tests (P = 0.11). In cases in which a follow-up
otic. This is the first study to demonstrate the success of a
breath test was not conducted in this study, 68% had a
single agent in the treatment and retreatment of IBS
symptoms in the context of an abnormal breath test.
The link between SIBO and IBS is supported by their
similar clinical presentations. Bloating, for example, is an
Table 1 Relationship between clinical response to rifaximin andfollow-up breath tests
established feature of bacterial overgrowth, caused by thefermentation of nutrients by small bowel bacteria. IBS
sufferers also experience bloating, with studies demon-strating excessive hydrogen and methane gas production in
these individuals [Bacterial overgrowth may be the
underlying etiology of this excessive gas. The LBT has
been used to determine the presence of bacterial over-
Table 2 Comparison of rifaximin and other antibiotics in IBS symptom response rates
Initial treatment with other nonrifaximin antibiotics (61)
growth, and we recently reported in two studies that
Rifaximin is a nonabsorbed (<0.4% systemic absorp-
abnormal LBTs are more prevalent in IBS sufferers [
tion) oral antibiotic. As a rifamycin derivative, it has
compared with 20% in controls. We also showed that
antibacterial activity through the inhibition of bacterial
antibiotic treatment leads to symptomatic improvement in
RNA synthesis [and is active against Gram-positive
IBS sufferers, with an accordant normalization of the post-
and Gram-negative bacteria, including both aerobes and
treatment LBT. This suggests that the LBT can be used as
anaerobes [In particular, it is effective against anaer-
an indicator of bacterial overgrowth eradication in IBS
obes such as bacteroides, lactobacilli, and clostridia, the
sufferers [There are now a number of LBT studies
bacteria frequently responsible for gut alterations in SIBO
demonstrating an association between breath test findings
patients []. As it is poorly water-soluble and mini-
mally absorbed, it is also associated with less systemic
More specific tests for bacterial overgrowth now cor-
toxicity. Although currently approved for clinical use in the
roborate the suggestion that a subset of IBS patients may
treatment of traveler’s diarrhea due to E. coli ], it is
have bacterial overgrowth. Glucose breath testing is be-
already demonstrating utility in multiple intestinal, bacte-
lieved to be a more specific tool in identifying bacterial
rially-related disorders such as hepatic encephalopathy
overgrowth. In two studies, glucose breath testing was
]. Importantly, rifaximin does not appear to lead to
noted to be abnormal in almost 40% of IBS sufferers
bacterial resistance and has a low incidence of side effects
compared with only 5% of healthy individuals [
]. The restricted use of nonabsorbed oral antibiotics
More specifically, culture studies of the most proximal
only for enteric infections should also reduce the devel-
small bowel demonstrated >106 coliforms in aspirates of
IBS sufferers 12% of the time , ]. Even more recently,
A 1,200-mg daily dose of rifaximin for at least 10 days
mean coliform counts were found to be elevated in IBS
has been shown to be more clinically effective in the short-
term treatment of SIBO compared with the more traditional
Despite these data, the most important factor curtailing
tetracycline antibiotics. Di Stefano et al. reported normal-
the application of antibiotic therapy in IBS is the lack of
ization of the glucose breath test in 70% of participants
efficacy of conventional antibiotics. Since bacterial over-
treated with rifaximin as opposed to only 27% treated with
growth may occur from a wide range of aerobic and
chlortetracycline ]. No side effects were seen, support-
anaerobic flora, the most effective treatment includes drugs
ing rifaximin as a safe antibiotic for bacterial overgrowth
with broad spectrum antibacterial activity [However,
treatment [Lauritano et al. subsequently studied dif-
few controlled studies have evaluated the choice and
ferent dosages of rifaximin and concluded that a 7-day
duration of therapy in bacterial overgrowth. Antibiotics
course of 1,200 mg/day was a good regimen to treat SIBO
such as tetracyclines and fluoroquinolones have been
both in terms of efficacy and tolerability [In a double
shown to improve symptoms, but their widespread use has
blind study by Sharara et al., rifaximin improved clinical
been controversial because of high recurrence rates after
symptoms in patients with functional bloating and in the
antibiotic withdrawal ] as well as the increased risk of
subset with IBS ]. In this study, breath test normaliza-
bacterial resistance [We showed in a recent study that
tion was not as apparent although clinical improvement
neomycin was more effective than placebo in producing a
was seen to correlate with an improvement in breath test
clinical response ]. Among the participants treated with
measurements. In a follow-up to this, a double blind trial of
neomycin, LBT normalization correlated with a greater
rifaximin in IBS has produced lasting clinical improvement
clinical response; however, normalization was seen in only
for 10 weeks beyond the initial 10 days of therapy [
20% of the cases [These studies suggest that the cur-
The current study substantiates the results of these ear-
rent, conventional antibiotics are not adequate in eradi-
lier studies by Di Stefano et al. [and Lauritano et al.
cating bacterial overgrowth. This, with the additional
], showing that rifaximin has superior efficacy in
concern regarding systemic toxicity of traditional therapy,
treating SIBO in IBS patients compared with other anti-
has prompted the search for other antibiotics that specifi-
biotics. The majority of IBS patients treated with rifaximin
for the first time experienced greater clinical improvement
(69%) than those treated with neomycin (38%) or other
3. Thompson WG, Heaton KW (1980) Functional bowel disorders
in apparently healthy people. Gastroenterology 79:283–288
4. Kumar D, Wingate DL (1985) The irritable bowel syndrome: a
responded to rifaximin, 81% had a normal follow-up LBT.
paroxysmal motor disorder. Lancet 2:973–977
In contrast, only 16% of the rifaximin nonresponders
5. Grundy D (2000) Mechanisms for the symptoms of irritable
normalized their breath tests. The high rate of breath test
bowel disease—possible role of vagal afferents. In: Krammer
normalization in clinical responders was not seen in our
H-J, Singer MV (eds) Neurogastroenterology from the basics tothe clinics. Kluwer, Boston, pp 659–663
previous study with neomycin ], suggesting that
6. Silverman DHS, Munakata JA, Ennes H et al (1997) Regional
rifaximin is more effective in SIBO eradication. It also
cerebral activity in normal and pathological perception of visceral
confirmed that breath test normalization was predictive of
7. Whitehead WE, Crowell MD, Robinson JC et al (1992) Effects of
stressful life events on bowel symptoms: subjects with irritable
Although the above description of the current study
bowel syndrome compared with subjects without bowel dys-
supports previous data, the study goes further to suggest
that rifaximin works better than other antibiotics at
8. Thompson WG, Longstreth GF, Drossman DA et al (1999)
retreating cases of recurrence. Not only did patients treated
Functional bowel disorders and functional abdominal pain. RomeII: a multinational consensus document on functional gastroin-
with rifaximin for the first time respond, but 75% of those
who became refractory to previous antibiotics improved on
9. Longstreth G, Thompson G, Chey W et al (2006) Functional
a trial of rifaximin. Moreover, retreatment with rifaximin
bowel disorders. Gastroenterology 130:1480–1491
for recurrence of symptoms after initial success with
10. Holt PR (1990) Diarrhea and malabsorption in the elderly.
rifaximin was almost universally successful as well. In
11. Pimentel M, Chow EJ, Lin HC (2000) Eradication of small
contrast, retreatment was only 25% successful with
intestinal bacterial overgrowth reduces symptoms of irritable
neomycin, augmentin, or doxycycline. The reason for this
bowel syndrome. Am J Gastroenterol 95:3503–3506
may be that rifaximin does not develop the bacterial
12. Pimentel M, Chow EJ, Lin HC (2003) Normalization of lactulose
breath testing correlates with symptom improvement in irritable
resistance typical of other antibiotics.
bowel syndrome: a double-blind, randomized, placebo-controlled
One limitation of this study is that it was not a pro-
spective study. Another potential criticism involves the
13. Lupascu A, Gabrielli M, Lauritano EC et al (2005) Hydrogen
small percentage of patients returning for follow-up LBTs.
glucose breath test to detect bacterial overgrowth: a prevalencecase–control study in irritable bowel syndrome. Aliment Phar-
This can be refuted by the fact that the majority of these
patients did experience symptomatic improvement.
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We have demonstrated in this study that rifaximin is
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superior to other antibiotics in improving IBS symptoms
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This substantiates the results of our previous study
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17. Soudah HC, Hasier WL, Owyang C (1991) Effect of octreotide
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This study was funded through an unrestricted
antibiotic: pharmacology and clinical potential. Chemotherapy
investigator grant with Salix Pharmaceuticals.
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Interactions entre alcool et médicaments Compte tenu du nombre important de personnes consommant de l’alcool defaçon chronique ou aiguë et de personnes consommant des médicaments, lafréquence des consommations associées ne peut qu’être importante. Or cesdeux types de produits peuvent interagir avec des conséquences parfois dom-mageables. Les mécanismes des interactions éthanol-m