Serpil AYDIN, MD, Assistant
Professor, Adnan Menderes University, School of
Medicine, Department of Family Medicine, Aydin,
Turkey
Tankut KOSEOGLU, MD, Vice
Chief, Department of Gastroenterology, Numune
Research and Practice Hospital, Ankara, Turkey
Canan AGALAR, MD, Associate
Professor, Kirikkale University, School of Medicine,
Department of Infectious Diseases and Clinical
Microbiology, Kirikkale, Turkey
Serpil AYDIN
Mimar Sinan Mah, Sinan 4 Sok, No: 39, Dus Bahceleri
Sitesi 09100 AYDIN, TURKEY
Phone: 0090 256 219 6181
Fax: 0090 256 214 6495
Email: serpilden@yahoo.com
This study was presented as a poster
during the 2nd International Meeting on Antimicrobial
Chemotherapy in clinical practice, in Italy, November
2001.
Date of submission: May 30, 2005
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ABSTRACT
Objectives: Because the Helicobacter
pylori (Hp) infection has been the most seen infection
in the world, many research studies have been
conducted to find an effective therapy regimen
for eradication. Long-term regimens are being
replaced by short term regimens as the long-term
therapies cause more side effects and patient
adjustment is not easy. Our aim was to determine
the efficacy of a short-term therapy regimen and
patient satisfaction by conducting a telephone
survey 18 months after completion of the therapy
regimen.
Materials and Methods: The
patients with upper gastrointestinal system complaints
who had presented to the gastroenterology day
clinic in Ankara Numune Hospital were chosen for
this study. They were evaluated, taking into account
their historical, physical, laboratory, endoscopic,
and histopathological findings. Patients who were
found with Helicobacter pylori, but had no other
symptoms or disorders, were given a two-day amoxicillin,
ornidazole, and tribismuthsubcitrate therapy after
a five-day lansoprazole therapy. The evaluation
was repeated one month after the regimen. In addition,
a telephone survey was conducted 18 months after
eradication, and the patients whose upper gastrointestinal
system complaints were completely eradicated were
asked if they had any additional upper gastrointestinal
system complaints during this 18-month interval.
Results: We applied the eradication
therapy to 36 people. Complete eradication was
obtained in 31 of the 36 patients. For the follow
up telephone survey, we could not reach five of
the patients due to changes in their address and/or
telephone numbers; 15 patients indicated that
they had not taken any drug; and 12 patients had
no complaints during this 18-month period. Six
patients received H2 receptor blocker irregularly,
and five patients had taken our regimen once again
on their own. All of the patients reached during
the 18-month follow-up stated that they were satisfied
with the therapy.
Conclusion: Our regimen appears
to relieve symptoms for a long time and it is
considered to be effective from our patients'
viewpoints.
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Key Words: helicobacter pylori;
patient satisfaction; eradication therapy; telephone
survey
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Because the Helicobacter pylori (Hp) infection
has been the most seen infection in the world, many
research studies have been conducted to find an effective
therapy regimen for eradication. Long-term regimens
are being replaced by short term regimens because the
long-term therapies have been found to cause more side
effects and drug adjustment of patients is more difficult.
In developing countries like Turkey, Hp infection is
more common (1). Because of the difficulties of drug
maladjustment of patients, ineffective antibiotics,
and common usage of antibiotics, it becomes much more
difficult to eradicate Hp in developing countries. The
effectiveness of a therapy can be shown not only by
the eradication and side effect rate, but also by patient
satisfaction.
In this study, we aimed to determine (a) an effective
short-term therapy regimen that can be used by a developing
country and (b) patient satisfaction with our therapy
by following up with a telephone survey 18 months after
eradication.
We chose patients with upper gastrointestinal
system complaints, who had sought treatment at gastroenterology
day clinics at the Ankara Numune Research and Practice
Hospital during the period of December 1998-July 1999.
In our study, we accepted patients who had been cured
by earlier treatment, but who still had some complaints.
We also accepted patients, who repeated their earlier
treatments once more. After getting information about
the study, oral informed consent was taken for each
patient and they were assessed physically, clinically,
and through laboratory findings. We only accepted patients,
who had no other systemic symptoms or disorders. Any
drugs they had been taking were stopped at least 15
days before the endoscopic assessment.
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They were subjected to endoscopy
after a 12-hour period without food. Before the examination,
endotracheal Jetocaine was applied for 4 minutes. A
Pentax FG29X flexible gastroscope was used. During the
endoscopy, at least two specimens were taken from the
antrum, corpus and fundus of the stomach. Biopsy specimens
were taken for histological and urease tests, and within
a half hour, those biopsy specimens, which were placed
in a 70% alcohol solution, reached the pathology laboratory
The biopsy specimens were painted with a Hemotoxylene-
Eosine strain. One month after the therapy, all of these
applications were repeated.
We applied a regimen consisting
of a five-day-therapy of lansoprasole (30mg bid), a
two-day-therapy of tribismuthsubsitrate (300mg qid),
amoxicilin (1gram bid), and ornidazole (500mg bid) with
lansoprasole. The patients were reassessed one month
after treatment. A telephone survey was conducted at
the 18th month after eradication and patients, who were
treated successfully, were called 18 months after the
treatment and asked if they had upper gastrointestinal
system complaints after our treatment and if they had
been retreated.
42 patients were enrolled in this study.
Four patients indicated that they felt fine and did
not need to repeat the endoscopic examination. Three
patients had stopped the regimen because of side effects.
Eradication was successful in 31 out of 35 patients
(88.61%). Ulcers were seen in 11 (31.43%) patients,
whose upper gastrointestinal system complaints had been
completely eradicated after the therapy (eradication
rate was 100%). In non-ulcer patients, the eradication
rate for their upper gastrointestinal system complaints
was 83.33% (20/24 patients). Table 1 shows the distribution
of patients.
All the patients reported that their complaints
were improved after the therapy.
Eighteen months after the therapy, 31
patients were called again to determine both the effectiveness
of our therapy and patient satisfaction. We were able
to reach 26 patients. Among those, 18 had no complaints
and had not required additional treatment. Eight patients
stated that they had the same upper gastrointestinal
system complaints and only two of them reported that
these were the same as they had prior to the treatment
and because of this they needed to use the same drugs
again once (Table 2). Only five of the 26 patients needed
to use drugs again (Table 3) and two of them stated
that they had the same complaints after they underwent
surgery for other reasons and parenteral H2 receptor
blocker were prescribed for them. The remaining three
patients reported that they used the same regimen once
more and after the second application they had no complaint.
Since discovery of Hp, many research
studies have been conducted to detect its connection
with chronic gastritis, duodenal ulcer, gastric ulcer,
and adenocarcinoma (2,3,4). These observations have
led researchers to conduct therapeutic investigations.
Although the Hp microorganism is sensitive to antibiotics
invitro, it is too difficult to eradicate in vivo.
As Hp is a true pathogen, there
is an increasing inclination in the world to treat all
Hp positive patients(5). Many therapy regimens have
been tried. Among these, the eradication rates of monotherapies
vary from 0 to 44%, whereas combined therapies have
eradication rates from 33 to 94%(6,7). Although the
two-week-triple therapy regimen is the most accepted,
patients experience side effects, which is the major
disadvantage. Nowadays, researchers try to find new
therapy regimens with fewer side effects and ones that
do not affect the patient's ability to think and speak
clearly.
Amoxicillin, bismuth, and ornidazole
are found effective in different combinations. By adding
PPI, an antiasidic environment is provided, and bactericidal
effectiveness is increased. Lansoprazole has 4 to 10
times more antihelicobacteric effect and performs acid
suppression more quickly. When given two times daily,
the 24-hour medium gastric pH increased. Furthermore,
it relieves symptoms more quickly than omeprazole. It
also reduces the risk of gastrointestinal bleeding(8,9).
In a 7-day-therapy regimen, eradication
rates are greater than 90%(10). De Boer et al, recommend
that there is no need to continue. In these regimens
and in the quadruple regimens, side effect rates are
2.8%. Houben et al, make a comparison of these regimens
and find that the eradication rate of bismuth-dependence
after one or two weeks was less than 80% (11). In another
study, a four-day quadruple regimen rate is 94% in a
well-developed country (12). Our eradication rate was
lower, and we thought that the main reason is that in
developing countries infection and bacterial resistance
are higher than in developed countries. In another study
that was held in Italy, a two-day-quadruple therapy
regimen is applied, and the eradication rate is 84%
(13). It is much closer to our results and more successful
in ulcer patients, as in our study.
Also there are some limitations
of our study. We searched if our patients were satisfied
with the therapy rather than the absence of Hp at the
18th month. Further investigations in this field should
be done to determine the existence of Hp a long period
of time after a therapy regimen.
Our treatment for eradicating Hp, especially
in patients who have ulcers, is beneficial for both
the patient and society(14). We recommend that all patients,
who have a history similar to our patients, should be
identified for Hp and treated.
As the main goal of the therapy
of peptic ulcer disease is to eradicate Hp which will
decrease the recurrence rate of ulcers (15), we think
that we reached this goal by this regimen.
Our results at the eighteenth month
supported our first results. Our study shows that our
regimen was an effective one also from the viewpoint
of the patients. Our regimen appears to relieve symptoms
for a long time so it can be considered as a successful
treatment plan. We suggest that short-term treatment
is effective, causes less side effects, and results
in more coherent and satisfied patients.
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