Best Treatment Options for Severe Helicobacter pyloriInfections
Best Treatment Options for Severe Helicobacter
pyloriInfections
Gulhan Kanat Unler1, Ozgur
Hilal Erinanc2, Aydın Karakoca3, Huseyin Savas Gokturk1
1Department
of Gastroenterology, Başkent University Faculty of Medicine, Konya, Türkiye
2Department
of Pathology, Baskent University Faculty of Medicine, Konya, Türkiye
3Department
of Statistics, Necmettin Erbakan University Faculty of Science, Konya, Türkiye
Cite
this article as: Unler GK, Hilal Erinanc O, Karakoca A, Savas
Gokturk H. Best treatment options for severe helicobacter pyloriinfections.
Turk J Gastroenterol. 2025;36(12):807-812.
ABSTRACT: Background/Aims
Helicobacter pylori (H. pylori) affects half of the world’s population.
Increasing antibiotic resistance seems to be caus-ing significant clinical
problems. The efficacy of bismuth-containing sequential therapy with
clarithromycin (BSTC), bismuth-containing sequential therapy
with levofloxacin (BSTL),
and bismuth-containing quadruple
therapy (BQT) regimens
on H. pylori
eradication was investigated. The authors also investigated
whether high gastric H. pylori colonization density affected treatment success
through dif-ferent treatment regimens.
Materials and
Methods: A total
of 751 H. pylori–positive patients
were included retrospectively in
the following treatment
groups: sequential therapy with
clarithromycin, sequential therapy with levofloxacin, and bismuth-containing
quadruple therapy.
Results: There
was a significant difference between the 3 treatment protocols in terms of
treatment success rates. When the success rates of the applied treatments were
examined, the highest success rate was BSTL (85.3%), which was statistically
significantly higher than BQT (74.8%) and BSTC (74.8%). A significant
difference was found between the success rates of the protocols applied in the
group with high bacterial density (P = .003). The success rates in this group
were calculated as BSTL (88.6%), BQT (71.4%), and BSTC (79.4%).
Conclusion: It was
concluded that BSTL may be the best option for treating H. pylori infections in
first-line treatment. This regimen is particularly effective in cases of severe
H. pylori colonization.
Keywords: H.
pylori, eradication regimens, severe colonization.
INTRODUCTION
Helicobacter
pylori (H. pylori)
is a Gram-negative
bacte-rium that affects
nearly half of
the world’s population.1Helicobacter pylori infection
causes gastritis, peptic ulcer disease, mucosa-associated lymphoid
tissue lymphoma, and gastric cancer. It also plays a role in
the development of several systemic diseases, including idiopathic
throm-bocytopenia and iron deficiency anemia.2-4The prevalence
of H. pylori
is 10%-50% in developed
countries and 80%
in developing countries.1
In the TURHEP study, a population cross-sectional
study on the prevalence of H. pylori infection in Türkiye, the prevalence of H.
pylori in Türkiye was 82.5%.5 This high prevalence of H. pylori and the burden
of associated diseases have made its
eradication a challenging
issue. 6 Guidelines
for the treatment of H. pylori recommend first-line
treatment for patients in areas with high clarithromycin resistance with
bismuth quadruple therapy for 10-14 days or concurrent quadruple therapy
without bismuth. Clarithromycin-containing triple
therapy is recommended
only in areas
with low clarithromycin resistance
and only in
patients who have not received
macrolide antibiotics.6-8It is important
to understand that
H. pylori eradica-tion
rates vary among
countries, mostly due to differ-ences
in antibiotic resistance.
Therefore, each country/region should review its own
therapeutic results and the effectiveness of various eradication regimens in H.
pylori treatment.9Treatments given in the clinic in 2013 in 621 patients with
H. pylori achieved
eradication rates using
intention to treat (ITT) and per-protocol (PP) analysis by treatment
groups of 74.6% and 75.6% in classic quadruple treatment, 70.2%
and 70.4% in
sequential therapy with
clarithromycin, 88.5% and
90.3% in bismuth-enhanced sequential
therapy (ST) with
clarithromycin, 77.9% and
78.5% in sequential therapy with levofloxacin, and 76.1% and 76.2% in
hybrid treatment. In the
present study, the
efficacy of bismuth-contain-ing ST
with clarithromycin (BSTC),
bismuth-containing ST with
levofloxacin (BSTL), and
bismuth-containing
quadruple therapy (BQT)
regimens on H.
pylori eradica-tion 10 years
later was investigated. The authors investi-gated whether
high gastric H.
pylori colonization density
affected treatment success through different treatment regimens.
MATERIALS AND METHODS
Ethical approval
for this single-center retrospective study
was received from
Başkent University Ethics
Committee
(E-9460333604.01-407243/September
12, 2024). Gastroscopy
examinations of patients
who presented to
the clinic with
dyspeptic symptoms between
January 2022 and
August 2024 were
evalu-ated retrospectively. Eight
hundred seventy patients
who were detected
as having H.
pylori from pathol-ogy
reports and received
eradication treatment were
included in the study. Histopathologic analysis of endo-scopic biopsy
specimens was used
to identify H.
pyloriinfection status. H. pylori density in biopsies taken from the
antrum and corpus was evaluated according to the Sydney classification by
a single experienced
patholo-gist. The density
of H. pylori
colonization was graded
as mild, moderate,
or severe according
to the Sydney
classification.11If there was
a difference between
the 2 specimens
in terms of
density, the highest
grade was selected.A
total of 119
patients who had
prior unsuccessful empirical H.
pylori eradication therapy,
were aged under
18 years, had
allergies to antibiotics
(amoxicillin,
metro-nidazole,
clarithromycin, levofloxacin), were
on proton pump
inhibitors (PPIs) or H2 antagonists
within the last 2
weeks, were on bismuth or antibiotics (amoxicillin, met-ronidazole,
clarithromycin) within the last month, or who had missing medical information
(insufficient data about the treatment protocol) were excluded.
Main Points
·
Increasing antibiotic
resistance and the
decrease in Helicobacter
pylori (H. pylori)
eradication targets are
sig-nificant clinical problems.
·
A bismuth-containing
sequential therapy with a levofloxa-cin regimen may be preferred for the
first-line treatment of H. pylori infection.
·
Bismuth-containing
sequential therapy with a levofloxacin regimen is particularly effective in
cases of severe H. pyloricolonization.
Patients were given
detailed explanations of
the use of
the medications and
informed about possible
adverse effects. They
were also given
written information about
medication use and
a physician’s phone
number. Proton pump
inhibitors were prescribed
20 minutes before
meals, and antibiotics and bismuth were prescribed after
meals.There were BSTC,
BSTL, and BQT
regimens for H.
pylorieradication. Seven hundred
fifty-one patients consti-tuted
the 3 different
groups, as given
in Table 1.
Six weeks after
treatment ended, repeat
endoscopies were performed and graded according to the Sydney
score as before. Patients were
grouped based on
successful or failed treatment.Demographic characteristics were
compared between the 2 groups
using the Chi-square
test. Continuous and
categorical variables were
analyzed using the
Bonferroni test. A
P-value less than
.05 was considered
statistically significant.
RESULTS
A total of
751 patients were
included in the
study; 728 patients were included in the final analysis
because 23 did not complete the treatment.It
was found that
the mean ages
did not differ
between the treatment protocols
and that the treatment protocols.
Table 1.
Treatment Groups
|
Group
|
Treatment Protocol
|
|
Group 1 (BQT)
|
Bismuth quadruple therapy: 14 days
Tetracycline 500 mg qid
Metronidazole 500 mg qid
Bismuth subsalicylate 265 mg qid
Rabeprazole 20 mg bid
|
|
Group 2 (BSTC)
|
Sequential therapy with clarithromycin
and bismuth:
First 7 days:
Amoxicillin 1000 mg bid
Rabeprazole 20 mg bid
Bismuth subsalicylate 265 mg qid
Second 7 days:
Clarithromycin 500 mg bid
Metronidazole 500 mg bid
Rabeprazole 20 mg bid
Bismuth subsalicylate 265 mg qid
|
|
Group 3 (BSTL)
|
Sequential therapy with levofloxacin
and bismuth:
First 7 days:
Amoxicillin 1000 mg bid
Rabeprazole 20 mg bid
Bismuth subsalicylate 265 mg qid
Second 7 days:
Levofloxacin 500 mg bid
Rabeprazole 20 mg bid
Bismuth subsalicylate 265 mg qid
|
BQT, bismuth-containing quadruple
therapy; BSTC, bismuth-containing sequential therapy with clarithromycin; BSTL,
bismuth-containing sequential therapy with levofloxacin.
were homogeneous in terms of age (P = .959). The mean age of the patients
was 46.49 ± 0.72 (range, 18-75) years. Of the
total 751 patients,
425 were female
(56.5%) and 326 were
male (43.5%). When
the homogeneity of the
treatment groups in
terms of sex was tested, it was found that each treatment
group was homogeneous (P = .092).Analyses performed
are given for
the PP (per-protocol) treatment completed
group. Intention to treat results was not sufficient
to draw a
meaningful conclusion because the number of patients
who did not complete the treat-ment was very small (n
= 23). In the treatment groups, 8 patients in the BQT
treatment group, 9 in the BSTL group, and 6 patients in the
BSTC group could not complete the treatment due
to adverse effects.
No statistical signifi-cance was found
between the groups in terms of adverse effect frequency
(P = .601).
The most common
adverse effects were diarrhea
(n = 10), nausea and vomiting (n = 5), bitter taste in
the mouth (n = 3), skin rash (n = 3), and dizziness (n = 2).
There was a
significant difference between
the 3 treat-ment protocols
in terms of
treatment success rates (P= .003).
When the success
rates of the
applied treat-ments were examined,
the highest success rate was BSTL (85.3%), which
was statistically significantly
higher than BQT (74.8%)
and BSTC (74.8%).
Eradication rates of treatment regimens are
given in Table 2.When the success rates of the applied treatment
proto-cols were examined,
it was observed that BSTL treatment success rates
showed a significant
difference according to sex (P =
.015). BSTL had
a success rate
of 81.3% in women and
91.5% in men,
significantly higher for
men than women.
It was observed
that the success
rates of BQT (P = .931) showed no
significant difference accord-ing to sex, 75% in women and 74.5% in men. BSTC (P = .752) showed
no significant difference
according to sex with success rates of
73.8% in women and 75.7% in men.
Table 2.
Eradication Rates of Treatment Regimens
|
Treatment Regimen
|
Successful Eradication (n)
|
Total (n)
|
Eradication Rate (%)
|
|
BSTC
|
157
|
210
|
74.80
|
|
BQT
|
163
|
218
|
74.80
|
|
BSTL
|
256
|
300
|
85.30
|
BQT,
bismuth-containing quadruple therapy; BSTC, bismuth-containing sequential
therapy with clarithromycin; BSTL, bismuth-containing sequential therapy with
levofloxacin.
When the success rates of the applied treatment proto-cols were
examined to see if they
differed according to the endoscopy results,
it was found that BSTL (P = .885), BQT (P = .966), and BSTC (P = .286) did not
differ accord-ing to the endoscopy results.The authors
examined whether the
success rates of the
treatment protocols
applied according to the bacterial density were
different. No statistically
significant differ-ence was found between
the treatment protocols applied in the group with low
bacterial density (P = .582). A signif-icant difference was
found between the success rates of the protocols applied
in the group with medium bacterial density (P =
.022). In this
group, the success
rates were calculated as
BSTL (84.9%), BQT
(72.7%), and BSTC (66.2%). A significant
difference was found between the success rates
of the protocols
applied in the
group with high bacterial density
(P = .003). The success
rates in this group
were calculated as
BSTL (88.6%), BQT
(71.4%), and BSTC (79.4%).
Eradication rates of regimens accord-ing to H. pylori density are given in
Table 3.DISCUSSIONThe increasing
prevalence of antibiotic
resistance to agents used
in H. pylori treatment
complicates manag-ing the infection.6The European H. pylori study suggested that treatment
regimens should achieve
an eradication rate over
80% on ITT
analysis and 85%
on PP analy-sis to
be acceptable as
first-line therapy for H. pylorieradication.12In general,
eradication rates with
these treatment protocols
are low in the country.
Eradication rates of bismuth-containing quadruple
regimens in Türkiye vary
between 77% and
96.4%, sequential treat-ments (ST) vary between
39% and 82%,
and levofloxa-cin containing
treatments, the eradication
rates ranging from 82%
to 95%.13 According
to more recent
stud-ies,
the eradication rates
for concurrent therapy
and ST were greater initially
but dropped to 80% in the following years.14-17In Türkiye,
eradication rates of the BQT regimen were 81.1%
in the study
by Gokcan et al18 and
82.3% in the study by Uygun et
al.
Table 3.
Eradication Rates of Regimens According to Helicobacter pylori Density
|
H. pylori Intensity
|
Treatment Regimen
|
Successful Eradication (n)
|
Total (n)
|
Eradication Rate (%)
|
|
Low
|
BSTL
|
43
|
56
|
76.8
|
|
|
BQT
|
39
|
46
|
84.3
|
|
|
BSTC
|
25
|
32
|
78.1
|
|
Intermediate
|
BSTL
|
73
|
86
|
84.9
|
|
|
BQT
|
64
|
88
|
72.7
|
|
|
BSTC
|
47
|
71
|
66.2
|
|
High
|
BSTL
|
140
|
158
|
88.6
|
|
|
BQT
|
60
|
84
|
71.4
|
|
|
BSTC
|
157
|
210
|
74.8
|
BQT,
bismuth-containing quadruple therapy; BSTC, bismuth-containing sequential
therapy with clarithromycin; BSTL, bismuth-containing sequential therapy with
levofloxacin.
In the present
study, bismuth-based quadruple
therapy, and levofloxacin
and clarithromycin STs
were compared as first-line
treatment for H. pylori eradication. Bismuth-containing sequential
therapy with levofloxacin
had the highest eradication
rate for H. pylori (P = .003). In
addition, the density of H. pylori colonization was
related to eradi-cation
success; the H. pylori eradication
rate decreased as the
density of H. pylori colonization
increased in BQT and BSTC
treatments.
Bismuth-containing
sequential therapy with levofloxacin
treatment was also effective in high H. pylori density. In sequential
protocols, amoxicillin is
administered before other
antibiotics. Amoxicillin dis-rupts the bacterial
cell wall of H. pylori and allows the anti-biotics administered
later to penetrate the bacteria. Due to the
disrupted cell wall, H. pylori cannot
form a reflux pump, and the effect
of antibiotics can be preserved.20According to
a 2023 study
in Türkiye, the
overall resis-tance rates
were as follows:
clarithromycin 28.5%; met-ronidazole 44.8%;
levofloxacin 23.1%.21 In
the present study, the BQT
regimen, which also included bismuth, did not show a favorable
increase in eradication rates, but the eradication rate of
BSLT was highly acceptable. Although the BQT
results are in
parallel with these
studies, it was thought that
metronidazole resistance might be respon-sible for the lower
eradication rates in the BQT regimen.Bismuth exerts a
direct bactericidal effect on H.pylori.21-22It is a well-known
cytoprotective agent and, by increas-ing the
Prostaglandin E2 (PGE2)
level, it effectively
protects gastric
mucosa against pepsin.
It also exerts
a synergistic effect
with antibiotics and
may reduce the development of
antibiotic resistance.22 Bismuth was also used in
all 3 regimens
used in the
country due to
treat-ment resistance.Some studies
have reported that
increased H. pyloricolonization density
is associated with peptic ulcer forma-tion and
its complications.23 Moshkowitz
et al24reported that favorable
eradication rates were
only achieved in patients with low pretreatment
urease activity as assessed using urea breath tests (UBTs). In other studies,
Lai et al25and Shah et al26 investigated
the relationship between histopathologic
pretreatment H. pylori density and bacte-rial eradication and
ulcer healing rates. They found a neg-ative correlation
between density and
eradication rates, consistent with the
results. All these results may suggest that more effective
treatment options should be selected in patients
with severe H. pylori colonization
density. In the past study, it was
also found that high bacterial loads in UBTs
were negatively associated
with the achieve-ment of
eradication with triple
treatment. However, dif-ferences between
groups were not significant in patients who received a
quadruple eradication regimen in 2016.27In the present study,
it was observed that histopathologi-cally, increased H. pylori density had a
negative effect on treatment success in all 3 groups.Studies on
the CYP2C19 polymorphism
in Türkiye have shown that
the percentage of
“poor” metabolizers is 1%-5%, and
the percentage of
“homozygous exten-sive” metabolizers is
75%-84%.28 In addition, due to
the high rate
of extensive metabolizers,
it is suggested
that esomeprazole and
rabeprazole should be the preferred PPIs in Europe and
North America.29 Rabeprazole was pre-ferred in
all groups of
the study. In
addition, vonoprazan is a new proton pump
inhibitor that provides a sustained acid inhibitory effect
and is approved for the treatment of gastroesophageal
reflux disease, suggesting that increas-ing the
pH levels in
the stomach using
vonoprazan may achieve an optimum
eradication rate.30Bismuth-containing
sequential therapy with levofloxacin had a success rate of
81.3% in women and 91.5% in men, significantly higher
for men than
for women (P = .015).
In other
treatments, the results
did not change
accord-ing to gender. In this retrospective study, no
demographic data that could explain this situation could be
found. No publications on this topic in the literature were
found. In prospective studies, treatment success could be
re-eval-uated based on gender.This study
had some strengths
and weaknesses. Its strengths are that it
had a significant number of patients from a
single center and
that H. pylori detection
and post-treatment
follow-up were investigated histopatho-logically. The
main limitation of
this study was
its retro-spective nature.
Moreover, no antibiotic
resistance was investigated in this
study.A bismuth-containing ST
with levofloxacin regimen
may be
preferred for the
first-line treatment of H. Pylori infection. This
regimen is particularly
effective in cases of moderate
and severe H. pylori colonization.
Effective H. pylori eradication
could prevent severe
complications associated with this
infection and potentially reduce the risk of gastric
cancer. Future studies should focus on the long-term effects of
these treatments and the potential development of
antibiotic resistance.
Data Availability Statement: The data that support
the findings of this study are available on request from the
corresponding author.
Ethics Committee Approval: This study was
approved by the Ethics Committee
of Başkent University
(approval number: E-94603
33604.01-407243/,
date: September 12, 2024).
Informed Consent: N/A.Peer-review: Externally
peer-reviewed.
Author Contributions: Concept
– G.K.U.; Design
– G.K.U.; Supervision – H.S.G.;
Resources – G.K.U.,
O.H.İ.;
Materials – G.K.U.; Data Collection
and/or Processing –
G.K.U., O.H.İ.; Analysis
and/or Interpretation –
A.K.; Literature Search
– G.K.U., O.H.E.;
Writing – G.K.U., O.H.İ.; Critical Review –
H.S.G.
Declaration of Interests: Hüseyin
Savaş Göktürk is
an Associate Editor at
the Turkish Journal
of Gastroenterology; however,
his involvement in
the peer review
process was solely
as an author. Other authors have no
conflicts on interest.
Funding: This study received no funding.
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