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H. Pylori
Helicobacter Pylori
Does Helicobater pylori initiate or perpetuate immune
thrombocytopenic purpura?
Marc Michel, Nichola Cooper, Christelle Jean, Christine Frissora,
and James B. Bussel
From the Department of Pediatrics, Division of Hematology/Oncology,
and Department of Medicine, Division of Gastroenterology, Weill
Medical College of Cornell University, New York–Presbyterian
Hospital, New York, NY.
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ITP
To determine the prevalence of Helicobacter pylori (H pylori)
infection in North American patients with immune thrombocytopenic
purpura (ITP) and the effect of H pylori eradication on the platelet
count, a prospective study was performed. Seventy-four patients aged
10 years and older (mean age of 41 years) with chronic ITP and a
platelet count below 60 x 109/L were enrolled. H pylori infection
was found in 22% of patients by means of a breath test and could not
be predicted by gastrointestinal symptoms. H pylori–positive
patients (52.5 years of age) were older than H pylori–negative
patients (38.5 years of age; P = .0035). Fifteen of the 16 H
pylori–positive patients were treated and the bacteria was
eradicated in 14 (93%). After 3 months, a significant response
(platelet count > 50 x 109/L and doubling the initial count) was
observed in only one patient. After a median follow-up of 11.5
months, none of the 14 patients had responded. Ten H pylori–negative
patients treated with the same regimen also did not increase their
platelet counts. In conclusion, unlike several previous reports,
this study does not implicate H pylori in the pathogenesis of ITP
since the prevalence of H pylori infection was low and eradication
of H pylori did not positively influence the course of the ITP
.
Helicobacter pylori (H pylori), a ubiquitous Gram-positive
bacterium, was initially discovered in 1982 as an infectious cause
of peptic ulcers. Following discovery of its causative role in
gastritis and peptic ulcer disease, subsequent studies implicated H
pylori in the pathogenesis of gastric adenocarcinoma and
mucosa-associated lymphoid tissue (MALT) lymphoma. More recently, H
pylori has been suspected to be involved in various autoimmune
disorders including pernicious anemia and immune thrombocytopenic
purpura (ITP).1-8
In 1998, Gasbarrini et al2 reported a substantial increase in the
platelet count in all 8 H pylori–positive adults with immune
thrombocytopenic purpura (ITP) in whom H pylori was eradicated.
Subsequent uncontrolled studies from Italy3-5 and Japan6-8 all
showed an apparently higher-than-expected prevalence of H pylori9,10
in patients with ITP. Furthermore, 38%7 to 73%4 of H pylori–positive
patients with ITP achieved a partial or complete platelet recovery
after H pylori eradication. On the other hand, additional studies
have not supported a role for H pylori in ITP. The prevalence of H
pylori infection was not increased in French patients with ITP when
compared with age-matched controls,11 and while the prevalence of H
pylori was high, no significant improvement of the platelet count
was observed after H pylori eradication in a report from Spain.12
We therefore conducted a prospective study to assess the prevalence
of H pylori infection in North American patients with ITP and the
efficacy of H pylori eradication on the platelet count. If
eradication of H pylori was not achieved with the initial regimen,
treatment was pursued with alternative regimens. To determine if the
H pylori eradication regimen could have nonspecific effects on the
platelet count, 10 ITP patients whose H pylori test was negative
were also treated with the same eradication regimen. In addition, a
short questionnaire was completed by the patients at the time of
testing to see if H pylori–infected patients with ITP could be
identified by symptoms referable to their gastrointestinal (GI)
tract.
Patients
All patients with ITP, defined according to the criteria set forth
in the American Society of Hematology (ASH) Guidelines,13 who
attended the Weill-Cornell center over the 12 month study period
were eligible to enroll in this study if they fulfilled the
following inclusion criteria: age of 10 years and older, a platelet
count of less than 60 x 109/L within 2 weeks of H pylori testing,
and no knowledge of a positive HIV test. Patients who were treated
by immunosuppressive treatments or other drugs for their ITP at the
time of inclusion were eligible if the doses of the ongoing
medications were stable for at least 4 weeks before inclusion. After
inclusion, both intravenous immunoglobulins (IVIg's) and intravenous
anti-D (IV anti-D) were allowed as a rescue therapy if clinically
required (ie, very low platelet count, grade III or IV bleeding
symptoms, or scheduled invasive procedures). Patients were not
eligible for the study if they had been treated for H pylori within
2 years or if they had been treated with either an antibiotic,
lansoprazole (or another proton pump inhibitor), or bismuth within
the past 4 weeks.
In order to see if the status of H pylori could be predicted by
gastrointestinal symptoms or past medical history, all patients were
asked to complete a short standardized questionnaire at the time of
the breath test (Table 1).
Approval for this study was obtained from the Institutional Review
Board of the New York Hospital–Cornell Medical Center and informed
consent was provided by all subjects or their parents according to
the Declaration of Helsinki. Patients 10 to 18 years of age provided
their assent.
H pylori infection testing
All enrolled patients underwent at time of inclusion a BreathTek
Urea breath test commercially available from Prometheus (San Diego,
CA). In H pylori–positive patients, eradication was assessed by
another urea breath test performed 1 to 2 months after completion of
treatment. Patients not responding to eradication treatment had a
third test performed after a subsequent treatment regimen was
completed. The breath test initially required a 4-hour fast before
it could be performed. This led several otherwise eligible patients
to decline to participate.
H pylori eradication regimen
Patients infected with H pylori were treated according to a standard
H pylori treatment protocol currently in use in the United States
(referred to as the Prevpac, TAP Pharmaceutical Products, Lake
Forest, IL). For patients older than 12 years of age, this consisted
of lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1000
mg taken together twice a day for 2 weeks. Children 10 to 12 years
of age received lansoprazole 30-mg capsules, clarithromycin tablets
at a dose of 15 mg/kg/day to a maximum dose of 500 mg/day, and
amoxicillin 500-mg tablets at a dose of 45 mg/kg/day to a maximum
dose of 1000 mg/day. The penicillin-allergic patients were not given
amoxicillin. If H pylori was not eradicated after initial treatment,
the patient was referred to the study gastroenterologist (C.F.) to
determine an alternative therapy.
Control groups
To see if there was an effect on the platelet count after the
Prevpac administration, all of the initial patients enrolled began
treatment "blindly" at the time of the breath test screening before
the results had returned. After 10 patients whose H pylori test was
subsequently found to be negative had been treated (ITP treatment
control group), only patients whose breath test was positive
received the Prevpac. Nine of the 10 control patients received the
Prevpac; 1 was penicillin allergic. In order to compare the
prevalence of H pylori infection in our population of ITP patients
to the prevalence in healthy individuals, recent epidemiologic data
available in a North American population14,15 was used.
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