Determining whether a test for Helicobacter pylori and treatments improves dyspepsia

symptoms in patients and reduce medical costs

Naoki Chiba et. al
4 March 2015
742 Evergreen Terrace Springfield Il.
555-867-5309
Chibamebaby@noccd.edu

Abstract
Several tests will be used to investigate if a test and treat strategy for Helicobacter
pylorin is effective for patients afflicted with dyspepsia. It is hypothesized that those
afflicted with dyspepsia will show improved symptoms with the proposed method.
Testing will occur throughout Canadian practices amongst patients with moderate
dyspepsia symptoms. Patients will be placed into two similar groups, and be administered
either a mixture of drugs for treatment or receive only placebos. If supported, the test
and treat procedure would result in improved patient health and deliver a new medical
treatment that reduces total cost to medical facilities.
Keywords: dyspepsia, Helicobacter pylori, placebos, test and treat strategy,
Project Description

The objective of this research is to test if a non-invasive H. pylori treatment will

help or cure uninvestigated dyspepsia. Patients with a non-placebo are to be given
omeprazole, metronidazole and clarithromycin to treat the bacteria(Chiba, 2002). To
determine H. pylori status, C-urea breath tests will be used. By testing for H. pylori
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before investigating dyspepsia symptoms, this could save time and money for the patients
if the symptoms are the result of the bacteria. This discovery would lead to many benefits
for both the patient and for medical practitioners globally. Current knowledge of
dyspepsia sees it as a common medical issue and -when investigated- may be costly and
lead to invasive procedures (Thomson, 2001). It has been shown previously that patients
with uninvestigated dyspepsia who received treatment for H. pylori were faced with less
invasive procedures, such as endoscopy (Chiba, 2002). Our research will utilize
randomized controlled trials to determine if the test for H. pylori and treat strategy is
consistent with what's already known and if symptoms show improvement. If the results
are supportive, it contributes to the long-term goal--to achieve a quicker and more
effective treatment of this bacteria.
Rationale for patient selection
Canadian family care facilities show high numbers of patients suffering with
dyspepsia (Chiba, 1998). Over the course of two years, participants will be selected from
primary care facilities throughout the most populated areas of Canada. Patients are going
to be selected and screened over several qualities. First and foremost, under whom are
eighteen years of age will be excluded since no legal consent can be given. Secondly,
patients whose symptoms were not of a severe enough degree or number, or those who
are diagnosed with simple reflux disease will similarly be excluded as they are deemed

irrelevant to the trails. We must also give consideration and remove those who had
eradication of H. pylori at least twice within the precipitating ten years as this may
improperly alter the experiment. Furthermore, those who had gastrointestinal surgery
within six months before beginning treatment will be removed from the patient pool for
similar reasons as before. The last characteristic screened for was the obvious removal of
those tested negative for H. pylori, as treating someone who is uninflected is both
unethical and improper. Finally, women of childbearing age must provide negative
pregnancy tests before entering the trial. Lastly, all patients will first need to sign a
consent and release form that both informs them of the tests and all possible side effects
before consideration and randomization.
Randomization and Interventions
A computer will separate patients randomly into groups of four and each specific
center will be given control of the groups assigned to it. The medicinal and placebo pills
are identical in size and appearance, and no personnel will be privy to which pills they
are distributing to the groups. Only after the trial has taken place will the information
about the computer generated groups and the pills each person took become available.
Patients will be considered to have followed the instructions of the trials only if a
minimum of 12 of 14 doses were taken during treatment. Missing more than one days
worth of doses or three doses of pills within the week period will result in automatic
removal from the trial and the striking of the data from any considerations.
After the week has transpired, normal monthly interviews will be conducted either
in person or via telephone as dictated by the patients availability. Repeat tests for H.
pylori will occur at three months, and the personnel that performs the test will not be

aware of the test results. During the follow up meetings participants will comply to their
usual practitioners dictations, and measures for eradication or gastrointestinal surgeries
may occur but will not affect the inclusion of that patient's data. All information about
drugs prescribed and consumed, tests run and their results, and all other adverse
consequences will be recorded and their be made of use within the results. All data about
the patient will be made available to the patient, after the trials have concluded and work
verified, however the patient is only privy to their own specific data. The patient will not
be made privy to the data of any other participant regardless of relationship, or if consent
has been given. Several workers will verify all data and no manipulation or removal of
some or any data is allowed or tolerated.
Outcome measures
We will assess severity of dyspepsia symptoms by using the seven-point Likerttype scale (GOS scale). This is a global scale that will effectively allow assessment of
symptoms that the patient is feeling (Junghard, 1998). We will also use a quality of life in
reflux and dyspepsia (QOLRAD) instrument to aid in assessment. This instrument also
uses a Likert-type scale in which a higher rating equates a higher quality of life (Wiklund,
1998). The gastrointestinal symptom rating scale (GSRS) has additionally been selected
for use as it has been well validated and is able to be self-administered (Svedlund, 1988).
This scale will be used to rate gastrointestinal symptoms.
Use of C-urea breath test
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H. pylori creates ammonia and carbon dioxide when breaking down urea (Mock,
1999). Researchers found using this breath test will allow us to measure and determine if

H. pylori is present, and if so, the severity of infection. This test is non-invasive, and is
comparable to the urea blood test (Chiba,1999).
Purpose
This experiment will provide many benefits for those that suffer from dyspepsia
and care facilities by reducing the medical costs of treating it. The participants in the
experiment that suffer from dyspepsia will play a great role in providing an unbiased
outcome which will determine whether a test and treat strategy will improve the
symptoms in patients with uninvestigated dyspepsia. For instance, to ensure an unbiased
outcome, a randomized placebo controlled trial was used. Having a trial that utilizes a
placebo as the control group will allow us to compare the results with the treatment
group. If the placebo controlled trial works, then we should question the success of the
treatment group. Likewise, it would imply that the eradication treatments for H. pylori
had no effect on treating dyspepsia. In this case, more studies would be done to test other
types of the causative bacterium for dyspepsia. The randomization of participants for the
control group and the treatment group avoids any bias in the results in regards to age,
race, or lifestyle. A bias free result allows for a better representation of the general
population.
Another important factor in choosing the participants involves having a large
sample size and patients that have been tested positive for H. pylori. The bigger the
sample size, the more accurate the results will be, hence the reason we are using over 250
participants. Having a big group minimizes the likelihood of any outliers that would
distort the outcome. Moreover, having a large sample size provides a better reflection of
the average population. A smaller sample size will disclude many other variables such as

different lifestyles, gender, or health problems that would affect the results. Also, the
importance of making sure the participants test positive for H. pylori is crucial to ensure
the experimental results are kept consistent. Since the experiment examines the benefits
of the test for H. pylori and treat strategy, it will narrow down the causes of dyspepsia
in patients. This is more efficient because it allows us to know specifically what works
and what does not.
Furthermore, conducting a double-blind trial at multiple random clinics plays an
important part in providing the most accurate results. Having the participants and
investigators unaware to aspects such as placebo medications will help provide unbiased
results. It allows the objective assessment of the effects in both treatments without the
participants or investigators being influenced by branding or other variables unrelated to
the test (Moorman). Moreover, conducting this experiment using multiple random clinics
also aids in maximizing the differences or outliers in the results. It further randomizes the
participants and, again, creates a better representation of the population as a whole.
Impact
Hopefully, the eradication medicine shows improvement for dyspepsia symptoms
over the course of 12 months. Such that if the trial, experimentation, and findings were
successful and coherent, our research will be able to reduce medical costs and improve
the quality of life for many. Having a readily available form of medicine for those who
are unable to afford it before will provide a long time relief and lower healthcare costs.
Biographical Sketch
We, (Lisette Garcia, Tina Nguyen, Mellanda Orn, and Craig Reeves) as students
at California State University, Fullerton are studying in the field of biological sciences.

Our expected graduation date will be in 2016 and 2017. As third and fourth year students,
we have taken various biology courses that mainly focus in genetics and microbiology.
Within our college education we conducted research on improving the cost of treating
GERD in geriatric patients. We used a double-blind trial on a large sample of geriatric
patients in multiple nursing homes around Orange County, CA. This project further led to
interest in using primary health care patients to study uninvestigated dyspepsia.

Works Referenced
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Uninvestigated Dyspepsia: The Canadian Adult Dyspepsia Empiric treatment
Helicobacter Pylori Positive (CADET-Hp) Randomised Controlled Trial. BMJ:
British Medical Journal 324.7344 (2002): 1012. Print.
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Cutler, Allen F., and Phillip Toskes. "Comparison of [13C]urea Blood Test to [13C]urea
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