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Welcome to the Dyspepsia
File
Patients all over the world
have used the information in The Dyspepsia File since 1992, when
the Center for Current Researchone of the first 80 companies
on the Internetwas founded. Our highly trained researchers
(all of whom hold Ph.D.s) have searched the advanced medical
database at the National Library of Medicine and compiled a comprehensive
collection of research descriptions on Dyspepsia and its care.
As you will see, the following research descriptions detail the
findings published in the most respected journals in the field.
Because the research descriptions are written in medical terms,
most people will bring all or parts of the Dyspepsia File to
their doctor for further explanation and discussion. Often your
doctor will have access to full-text articles and other information
that could be useful in planning a successful course of treatment
and prevention. Note that the titles of the journals are abbreviated
according to the National Library of Medicine's format; your
doctor can provide the full title if you need it.
Thank you for accessing the Dyspepsia File. We truly hope the
information fosters better health.
Sincerely,
Gregory A. Fraser, Ph.D.
Director of Research
Important Note: The following information
is provided for your education. It should not be relied upon for
personal diagnosis or treatment. If you believe that a
particular therapy applies to you or someone you care about, be
sure to consult a doctor before trying it.
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Previous Dyspepsia
Research: 2002-2006
The
Dyspepsia File also contains summaries of past
research that has shown promise and may still be standard
practice among many physicians.
To
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research findings on
Dyspepsia, click
HERE.
Latest Research on
Dyspepsia
Curr Med Res Opin. 2008 Jul;24(7):2009-18. Epub 2008 Jun 4.
Efficacy and safety of pantoprazole 20 mg once daily treatment in
patients with ulcer-like functional dyspepsia.
van Rensburg C, Berghöfer P, Enns R, Dattani ID, Maritz JF, Gonzalez Carro P,
Fischer R, Schwan T.
Tygerberg Academic Hospital, Cape Town, South Africa. c.j.vr@telkomsa.net
OBJECTIVE: To investigate the efficacy of pantoprazole 20 mg once daily (o.d.)
in relieving epigastric pain associated with ulcer-like functional dyspepsia.
RESEARCH DESIGN AND METHODS: In this double-blind, placebo-controlled,
multicentre study, patients experiencing ulcer-like functional dyspepsia, with
epigastric pain as the predominant symptom, were randomised to receive
pantoprazole 20 mg or placebo o.d. for 28 days. Primary endpoint was the
complete relief (i.e. absence) from epigastric pain after 28 days' treatment.
The odds ratio (OR) for pantoprazole/placebo and its 95% confidence intervals (CIs)
were determined. Significant superiority of pantoprazole was concluded if the
value 1.0 was above this interval. RESULTS: Of 419 patients (intention-to-treat
[ITT]) randomised to treatment, 207 received pantoprazole and 212 received
placebo. Epigastric pain relief was achieved after 28 days' treatment in 55% of
pantoprazole recipients and 45% of placebo recipients (per-protocol [PP]: 58%
and 47%, respectively). Pantoprazole demonstrated statistically significant
superiority compared with placebo in the ITT (OR: 0.68; 95% CI: 0.46-0.99) and
PP populations (OR: 0.64; 95% CI: 0.42-0.98). Pantoprazole was more efficacious
than placebo in relieving heartburn and acid regurgitation after 7, 14 and 28
days of treatment. The sum score of gastrointestinal symptoms after 28 days was
statistically significantly lower in the pantoprazole than placebo group. Fewer
patients receiving concomitant psychotropic medication experienced relief from
epigastric pain than those not receiving such medication. Adverse events did not
significantly differ between pantoprazole and placebo. CONCLUSIONS: Results of
this study suggest that pantoprazole 20 mg is more efficacious than placebo, and
is a well-tolerated treatment for relieving epigastric pain in patients with
ulcer-like functional dyspepsia. Further research is needed to confirm these
findings.
------
Nippon Rinsho. 2008 Jul;66(7):1379-84.
[Diagnosis and pathogenesis in functional dyspepsia]
[Article in Japanese]
Haruma K, Imamura H, Kusunoki H, Manabe N, Hata J.
Division of Gastroenterology, Kawasaki Medical School.
Functional gastrointestinal disorders (FGID) such as functional dyspepsia (FD)
and irritable bowel syndrome are common gastrointestinal diseases in clinical
practice. FGID is not life-threatened disease, but it is an important disease
because the patients with FGID have a poor QOL. Recently the Rome criteria for
the diagnosis of FGID has been established in Western countries, however,
whether the criteria is suitable for clinical practice in Japan or not has not
fully discussed. Many factors including gastrointestinal dysmotility,
abnormality of acid secretion, visceral hypersensitivity, Helicobacter pylori
infection or stress might play in the pathogenesis of FD. Our previous studies
using ultrasonography indicate the decrease in gastric emptying and antral
motility and the increase in duodenogastric reflux in patients with FD. In the
treatment of FD, prokinetic agents, acid-suppressive drugs and antidepressants
have been widely used.
------
Am J Health Syst Pharm. 2008 Jun 1;65(11):1057-61.
Comparison of metoclopramide oral tablets and solution in
treatment of dysmotility-like dyspepsia.
Banani SJ, Lankarani KB, Taghavi A, Bagheri MH, Sefidbakht S, Geramizadeh B.
Department of Internal Medicine, Namazi Hospital, Shiraz University of Medical
Sciences, Shiraz, Iran. sjbanani@yahoo.com
PURPOSE: The clinical effects of metoclopramide oral solution and tablets in
patients with dysmotility-like dyspepsia (DLD) were compared. METHODS: In a
prospective study, 63 patients with DLD, selected according to Rome II criteria
and randomly divided into three groups, received metoclopramide tablets 5 mg
t.i.d., metoclopramide oral solution 2 mg t.i.d., or placebo for one week.
Assessment was based on symptom score determined by interviews and on gastric
emptying time measured by ultrasonography before and after drug consumption. Two
antral and stomach body biopsies were taken to evaluate infection with
Helicobacter pylori and the intensity of gastritis. RESULTS: Symptom score and
gastric emptying time were significantly reduced in both metoclopramide groups
(p < 0.05) but not in the control group. Patients receiving the oral solution
had a greater reduction in the symptom score than those receiving tablets (p <
0.05). The absence or presence of and intensity of gastritis or H. pylori
infection had no correlation with the symptom scores or gastric emptying times.
CONCLUSION: Metoclopramide oral solution 2 mg t.i.d. was at least as effective
as metoclopramide tablets 5 mg t.i.d. in reducing symptoms of DLD and gastric
emptying time.
------
Gastroenterol Clin North Am. 2008 Jun;37(2):383-95, vi.
Functional gastrointestinal disorders and the potential role of
eosinophils.
Walker MM, Talley NJ.
Department of Histopathology, Imperial College London, Norfolk Place, London W2
1PG, United Kingdom. mm.walker@imperial.ac.uk
The eosinophil-mast cell-neural pathway may be important in the pathophysiology
of functional gastrointestinal disorders characterized by unexplained abdominal
pain, disordered defecation, or meal-related discomfort. There is evidence that
duodenal eosinophils are increased in functional dyspepsia, whereas mast cells
are increased in the lower gut in irritable bowel syndrome, directly supporting
a role for a hypersensitivity-type reaction in these disorders. The trigger may
be a pathogen, food, or other allergen in the gut mucosa. This trigger may evoke
eosinophils, mast cells, and other components to cascade to up-regulate
serotonin release, with modulation of the enteric and central nervous systems,
creating a vicious cycle. If correct, this theory suggests treatment should
specifically target the eosinophil-mast cell pathway.
------
Phytomedicine. 2008 Jun;15(6-7):391-9. Epub 2008 May 7.
Efficacy of the natural antioxidant astaxanthin in the treatment
of functional dyspepsia in patients with or without Helicobacter pylori
infection: A prospective, randomized, double blind, and placebo-controlled
study.
Kupcinskas L, Lafolie P, Lignell A, Kiudelis G, Jonaitis L, Adamonis K, Andersen
LP, Wadström T.
Kaunas University of Medicine, 50009 Kaunas, Lithuania. limas.kupcinskas@kmu.lt
OBJECTIVES: The aim of this study was to evaluate the efficacy of the natural
antioxidant astaxanthin in functional dyspepsia in different doses and compared
with placebo. DESIGN: The study was a controlled, prospective, randomized, and
double blind trial. PARTICIPANTS: Patients with functional dyspepsia, divided
into three groups with 44 individuals in each group (placebo, 16mg, or 40mg
astaxanthin, respectively). INTERVENTIONS: Participants were asked to accept
gastroscopy before treatment, together with questionnaires: GSRS and SF-36. Urea
breath test (UBT) was done before the treatment. MAIN OUTCOME: The primary
objective was to test the hypothesis that the antioxidant astaxanthin at two
doses regimens compared to placebo should ameliorate gastrointestinal discomfort
measured as GSRS in patients with functional dyspepsia, who were either positive
or negative for Helicobacter pylori, after 4 weeks of treatment. RESULTS: At the
end of therapy (week 4) no difference between the three treatment groups was
observed regarding mean Gastrointestinal Symptom Rating Scale (GSRS) scores of
abdominal pain, indigestion and reflux syndromes. The same results were observed
at the end of follow-up. However reduction of reflux syndrome before treatment
to week 4 was significantly pronounced in the higher (40mg) dose compared to the
other treatment groups (16mg and placebo, p=0.04). CONCLUSION: In general, no
curative effect of astaxanthin was found in functional dyspepsia patients.
Significantly greater reduction of reflux symptoms were detected in patients
treated with the highest dose of the natural antioxidant astaxanthin. The
response was more pronounced in H. pylori-infected patients.
------
Prescrire Int. 2008 Jun;17(95):121-3.
Herbal remedies for dyspepsia: peppermint seems effective.
[No authors listed]
(1) Functional dyspepsia is extremely common, yet few if any treatments have
been shown to be effective. This review examines the potential benefits and
risks of using herbal products in treating symptoms of dyspepsia. (2) About
forty plants have been approved in France in the composition of products
traditionally used for dyspepsia. (3) The clinical efficacy of most of these
plants has not been assessed. Some essential oils can cause severe adverse
effects, including seizures. Herbal teas appear to be safe when used
appropriately. (4) A few randomised controlled clinical trials suggest that
peppermint essential oil is effective in reducing abdominal pain, flatulence and
diarrhea in patients with "irritable bowel syndrome". Peppermint tea, containing
essential oil, has no known adverse effects. (5) There is no sound reason to
discourage patients from using herbal teas made from plants such as lemon balm,
German chamomile or star anise.
------
Eur J Gastroenterol Hepatol. 2008 May;20(5):441-9.
Helicobacter pylori infection upregulates endothelial nitric
oxide synthase expression and induces angiogenesis in gastric mucosa of
dyspeptic patients.
Lazaraki G, Kountouras J, Metallidis S, Vrettou E, Tzioufa V, Germanidis G,
Chatzopoulos D, Zavos C, Giannoulis K, Nikolaidis P.
First Department of Internal Medicine, Gastroenterology Clinic, AHEPA University
, Aristotle University of Thessaloniki, Thessaloniki, Greece. lazarakg@yahoo.com
BACKGROUND: Helicobacter pylori (H. pylori) infection induces nitric acid (NO)
overproduction through inducible NO synthase (NOS) expression, subsequent DNA
damage and enhanced antiapoptosis signal transduction sequence in the human
gastric mucosa, whereas its possible effect on endothelial nitric oxide synthase
(eNOS) expression has not as yet been investigated. The aim of this study was to
evaluate the effect of H. pylori infection in the expression of eNOS in gastric
mucosa. PATIENTS AND METHODS: We prospectively studied 30 nonsmoking dyspeptic
patients (12 men, 18 women, mean age 54.26+/-12.89 years). The diagnosis of H.
pylori infection was based mainly on histology. The histological grading of H.
pylori infection was evaluated according to the modified Sydney classification.
Histological grading of eNOS expression and microvessel density as estimated by
CD34 expression were determined by immunohistochemistry (degree 0-3) and
correlated with H. pylori infection and histological degree of gastritis.
RESULTS: Twelve patients were H. pylori-positive and 18 patients were H.
pylori-negative. The two groups were matched for age (P=0.139), sex (P=0.342)
and similar degree of gastritis. Intensity of eNOS and CD34 expression in the
corpus and antrum were significantly correlated (P<0.001). eNOS expression was
correlated with H. pylori infection in the mucosa of the body and antrum
(P=0.013 and 0.037, respectively) but not with gastric inflammation and activity
(P=0.848 and 0.871, respectively, for the corpus and P=0.565 and 0.793,
respectively, for the antrum). H. pylori-positive patients showed higher
expression of CD34-positive blood vessels in the mucosa of the antrum (P=0.048).
CD34 expression was correlated with gastric inflammation and activity (P=0.03
and 0.044, respectively) in the mucosa of the antrum of H. pylori-positive
patients. CONCLUSION: H. pylori infection upregulates eNOS, and induces
angiogenesis, contributing to H. pylori-associated pathophysiology in gastric
mucosa.
------
Expert Opin Drug Saf. 2008 May;7(3):271-81.
Helicobacter pylori eradication therapy: indications, efficacy
and safety.
Kwok A, Lam T, Katelaris P, Leong RW.
Concord Hospital, Department of Gastroenterology and Hepatology, Ambulatory Care
Endoscopy Unit, Level 1 West, Hospital Road, Concord NSW 2139, Sydney,
Australia. rupertleong@hotmail.com
BACKGROUND: Helicobacter pylori infects up to half of the world's population. It
remains the major cause of peptic ulcer disease and is recognised as a
carcinogen for its role in gastric carcinogenesis. Successful eradication of the
bacteria is associated with improved health outcomes including fewer dyspeptic
symptoms, reduced peptic ulcer recurrence and rebleeding, reduced peptic ulcer
risk with NSAIDs and as a cure for low-grade gastric MALT lymphoma. The risk of
gastric cancer is reduced in those without premalignant mucosal abnormalities at
the time of eradication. OBJECTIVE: This review outlines the current indications
and options for therapy of H. pylori with particular reference to drug-induced
adverse events associated with treatment. METHODS: The indications for H. pylori
eradication are evidence-based and in accordance with recent consensus
statements and recommendations. The eradication treatment is based on numerous
clinical trials and meta-analyses. RESULTS/CONCLUSION: Eradication therapy, in
general, is safe and well tolerated. Antibiotic therapy may be associated with
significant drug adverse reactions, especially gastrointestinal symptoms.
------
Eur J Endocrinol. 2008 Apr;158(4):491-8.
Repeated administration of ghrelin to patients with functional
dyspepsia: its effects on food intake and appetite.
Akamizu T, Iwakura H, Ariyasu H, Hosoda H, Murayama T, Yokode M, Teramukai S,
Seno H, Chiba T, Noma S, Nakai Y, Fukunaga M, Nakai Y, Kangawa K, FD Clinical
Study Team.
Ghrelin Research Project, School of Health Sciences, Faculty of Medicine, Kyoto
University, Kyoto 606-8507, Japan. akamizu@kuhp.kyoto-u.ac.jp
BACKGROUND: Ghrelin plays a major role in the regulation of food intake (FI),
which makes it a strong candidate for the treatment of anorexia. OBJECTIVE: We
attempted to evaluate the clinical response to repeated ghrelin administration
in patients with anorexia caused by functional disorders, such as functional
dyspepsia (FD). SUBJECTS AND METHODS: Subjects included in this study were those
who 1) were diagnosed with functional anorexia, including FD and other eating
disorders with the exception of anorexia nervosa; 2) were lean (body mass index
(BMI)<22 kg/m(2)); and 3) exhibited decreased FI. Subjects received an i.v.
infusion of ghrelin (3 microg/kg) for 30 min twice a day (before breakfast and
dinner) for 2 weeks. We investigated the effects of ghrelin administration on FI,
appetite, hormones, and metabolic parameters. RESULTS: Six patients with FD were
enrolled in this study. Ghrelin administration tended to increase daily FI in
comparison with levels before and after completion of treatment, but this
difference that was the primary endpoint of this study did not reach statistical
significance (P=0.084). Hunger sensation was significantly elevated at the end
of drip infusion (P<0.0001). No severe adverse effects were observed.
CONCLUSIONS: These results suggest that ghrelin administration is safe and that
this treatment has stimulatory effects on appetite in patients with FD. Further
studies are necessary to confirm the efficacy of ghrelin treatment for
anorexia-related disorders.
------
Gend Med. 2008 Mar;5(1):62-73.
Functional dyspepsia affects women more than men in daily life: a
case-control study in primary care.
Welén K, Faresjö A, Faresjö T.
Department of Medicine and Health/General Practice and Primary Care, Faculty of
Health Sciences, Linköping University, Linköping, Sweden.
BACKGROUND: Little is known about possible gender differences among patients
with functional dyspepsia (FD). Few studies have measured health-related quality
of life (HRQoL) in patients with FD using a population-based control group as a
reference. OBJECTIVES: This study aimed to determine the degree of HRQoL
impairment among patients with FD, to assess the self-reported health impact
resulting from the disease, and to analyze any gender differences. METHODS: A
questionnaire that included the HRQoL Short Form 36 (SF-36) Health Survey,
Hospital Anxiety and Depression Scale, and other measurements was mailed to
patients with FD identified from medical records. The control group was randomly
selected from the general population in the same geographical area. Responses to
the SF-36 were transferred to a standard scale ranging from 0 (the worst
possible score) to 100 (the best possible score). RESULTS: Responders were
assigned to 2 gender-specific subgroups, each with 88 patients with FD and 344
randomly matched controls, all aged 18 to 65 years. Compared with the controls,
the HRQoL of patients with FD was impaired in all SF-36 dimensions except one --
role limitations caused by emotional problems. Female patients with FD had a
significantly lower SF-36 score in the physical functioning dimension than did
male patients (82.4 vs 90.5, respectively; P < 0.01). Both groups of patients
with FD had impaired HRQoL compared with their respective control group in the
dimensions of bodily pain (women: 69.3 vs 80.6, P < 0.001; and men: 75.8 vs
84.8, P < 0.001) and general health (women: 62.0 vs 75.6, P < 0.001; and men:
70.6 vs 78.6, P < 0.001). Additionally, women with FD had significant impairment
compared with their respective control group in the dimensions of physical
functioning (82.4 vs 89.3; P < 0.01) and physical role limitations (72.1 vs
85.9; P < 0.001). Depression was significantly more common among male patients
with FD than among male controls (6.8% vs 2.0%, respectively; P < 0.05). More
gastrointestinal comorbidity was reported among patients of both sexes compared
with controls. CONCLUSIONS: This population-based case-control study reported
HRQoL impairment overall among patients with FD. This impairment was more
apparent in female patients than in female controls. Females with FD tended to
be more negatively affected in their daily life than their male counterparts.
These gender differences should be investigated further in future studies.
------
Dig Dis. 2008;26(3):218-24. Epub 2008 May 6.
Failed therapy and directions for the future in dyspepsia.
Holtmann G, Gapasin J.
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital,
University of Adelaide, Adelaide, Australia. gerald.holtmann@health.sa.gov.au
Functional gastrointestinal disorders including functional dyspepsia are highly
prevalent. Their clinical course is benign without disease-associated mortality.
On the other hand, the impact can be substantial for the affected patients with
regard to the decrease of quality of life, and for society with regard to the
economical implications. Functional dyspepsia is a clinical syndrome with
various underlying pathophysiologies. Thus, it is understandable that there is
no single cure available. Reassurance by ruling out relevant differential
diagnoses, explanation, and general advice with regard to the underlying causes
and dietary and life-style measures are important components of the management
of these patients. Well established medical treatments include Helicobacter
pylori eradication, acid inhibitory agents and prokinetics. The overall gain
over placebo ranges from less than 5% for H. pylori eradication to 15% for
antisecretory agents and prokinetics. Thus, even considering a substantial
proportion of patients with spontaneous remissions (usually addressed as placebo
response in clinical trials), there are 20 to 40% of patients who do not respond
properly to these measures. In these patients, other treatment modalities need
to be considered. These second- or third-line measures include herbal medicines
and psychotropic agents. Some of the herbal preparations have been well studied
in controlled clinical trials with sufficient scientific evidence to assume
efficacy. Psychotropic drugs on the other hand have, as yet, not been
specifically tested in functional dyspepsia. Medications such as clonidine,
buspirone or octreotide can be helpful in few selected patients. However, a very
careful assessment of potential risks and benefits needs to be undertaken on a
case-by-case basis. Other evidence-based measures include psychological
interventions such as psychotherapy and hypnotherapy. Copyright 2008 S. Karger
AG, Basel.
------
Dig Dis. 2008;26(3):215-7. Epub 2008 May 6.
Proton pump inhibitors for dyspepsia.
Vakil N.
University of Wisconsin School of Medicine and Public Health, Madison, Wisc.,
USA. nvakil@facstaff.wisc.edu
Proton pump inhibitors are widely used in many upper gastrointestinal disorders.
Dyspepsia is a common problem in primary care and endoscopy is neither feasible
nor affordable in the majority of patients. Helicobacter pylori eradication has
been shown to be effective, but with the declining prevalence of H. pylori
infection in Western countries, alternate strategies are necessary. Proton pump
inhibitor therapy is one such alternative and has already been adopted in
dyspepsia management guidelines in the USA, UK and Canada. Cost-effectiveness
studies suggest that in young patients acid suppression alone is more
cost-effective than either endoscopy or testing and treatment for H. pylori in
areas with a low prevalence of H. pylori. Copyright 2008 S. Karger AG, Basel.
------
Dig Dis. 2008;26(3):210-4. Epub 2008 May 6.
Dyspepsia and Helicobacter pylori.
Selgrad M, Kandulski A, Malfertheiner P.
Department of Gastroenterology, Hepatology and Infectious Diseases, Otto von
Guericke University Magdeburg, Magdeburg, Germany.
Dyspepsia is defined as a chronic or recurrent pain centered in the upper
abdomen. Dyspeptic symptoms have a high prevalence in the population and
represent a common reason for patients to see a primary care physician.
Therefore, dyspepsia displays a major health care burden and produces high
socioeconomic costs. The etiology of dyspeptic symptoms is various and complex
and has opened a wide spectrum of putative mechanisms. In a subset of patients
dyspeptic symptoms are likely to originate from Helicobacter pylori infection.
Population-based studies have demonstrated that H. pylori is detected more
frequently in dyspeptic patients compared to controls. H. pylori eradication
therapy gives modest but significant benefit in non-ulcer dyspepsia and leads to
long-term symptom improvement. It also reduces the risk of developing peptic
ulcer disease and other H. pylori-related gastric pathologies (i.e. atrophic
gastritis, gastric cancer). The main therapeutic strategy for managing dyspepsia
in patients under the age of 45 years is 'test and treat'. H. pylori eradication
is recommended in patients with dyspepsia and no other gastroduodenal
abnormalities than H. pylori induced gastritis. In patients presenting with
alarm features a prompt upper endoscopy should be performed to exclude peptic
ulcer disease, esophageal and gastric malignancies or other more rare upper
gastrointestinal diseases. Copyright 2008 S. Karger AG, Basel.
------
Curr Gastroenterol Rep. 2007 Dec;9(6):447-55.
Dyspepsia in childhood and adolescence: insights and treatment
considerations.
Perez ME, Youssef NN.
Center for Pediatric Irritable Bowel and Motility Disorders, Goryeb Children's
Hospital at Atlantic Health, 100 Madison Avenue, Internal Box 82, Morristown, NJ
07962, USA.
Functional dyspepsia (FD) is common in children, with as many as 80% of those
being evaluated for chronic abdominal pain reporting symptoms of epigastric
discomfort, nausea, or fullness. It is known that patients with persistent
complaints have increased comorbidities such as depression and anxiety. The
interaction with psychopathologic variables has been found to mediate the
association between upper abdominal pain and gastric hypersensitivity. These
observations suggest that abnormal central nervous system processing of gastric
stimuli may be a relevant pathophysiologic mechanism in FD. Despite increased
understanding, no specific therapy has emerged; however, recent
nonpharmacological-based options such as hypnosis may be effective. Novel
approaches, including dietary manipulation and use of nutraceuticals such as
ginger and Iberogast (Medical Futures Inc., Ontario, Canada), may also be
considered.
------
Aliment Pharmacol Ther. 2008 Feb 15;27(4):346-54. Epub 2007 Nov 12.
Empirical rescue therapy after Helicobacter pylori treatment failure: a 10-year
single-centre study of 500 patients.
Gisbert JP, Gisbert JL, Marcos S, Jimenez-Alonso I, Moreno-Otero R, Pajares JM.
Gastroenterology Unit, Hospital Universitario de la Princesa and Ciberehd,
Universidad Autónoma, Madrid, Spain. gisbert@meditex.es
BACKGROUND: Several 'rescue' therapies have been recommended to eradicate
Helicobacter pylori, but they still fail in >20% of the cases, and these
patients constitute a therapeutic dilemma. AIM: To evaluate the efficacy of
different 'rescue' therapies empirically prescribed during 10 years to 500
patients in whom at least one eradication regimen had failed to cure H. pylori
infection. METHODS: DESIGN: Prospective single-centre study. Patients:
Consecutive patients in whom at least one eradication regimen had failed.
Intervention: Rescue regimens included: (i) quadruple therapy with
omeprazole-bismuth-tetracycline-metronidazole; (ii) ranitidine bismuth
citrate-tetracycline-metronidazole; (iii) omeprazole-amoxicillin-levofloxacin;
and (iv) omeprazole-amoxicillin-rifabutin. Antibiotic susceptibility was unknown
(rescue regimens were chosen empirically). Outcome: Eradication was defined as a
negative (13)C-urea breath test 4-8 weeks after completing therapy. RESULTS:
Five hundred
patients were included (76% functional dyspepsia, 24% peptic ulcer). Compliance
rates with first-, second- and third-line regimens were 92%, 92%, and 95%,
respectively. Adverse effects were reported by 30%, 37%, and 55% of the patients
receiving second-, third-, and fourth-line regimens. Overall, H. pylori cure
rates with the second-, third-, and fourth-line rescue regimens were 70%, 74%,
and 76%, respectively. Cumulative H. pylori eradication rate with four
successive treatments was 99.5%. CONCLUSION: It is possible to construct an
overall treatment strategy to maximize H. pylori eradication, on the basis of
administration of four consecutive empirical regimens; thus, performing
bacterial culture even after a second or third eradication failure may not be
necessary.
-----
J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):54-8.
Tegaserod use in children: a single-center experience.
Liem O, Mousa HM, Benninga MA, Di Lorenzo C.
Department of Pediatric Gastroenterology and Nutrition, Emma Children's
Hospital, Academic Medical Center, Amsterdam, The Netherlands. liemo@chi.osu.edu
BACKGROUND: Tegaserod is increasingly prescribed by pediatric
gastroenterologists even though there are few published data concerning its use
in children. The aim of this study was to describe the authors' experience with
tegaserod in children. PATIENTS AND METHODS: Patients treated with tegaserod
from 2004 through 2006 were included in this study. Defecation and fecal
incontinence frequency and global assessment of relief of symptoms were
assessed. RESULTS: Seventy-two patients (44 girls) ranging in age from 1.1 to
18.3 years constitute the patient sample of this report. The median age was 10
years and the median follow-up after initiation of tegaserod treatment was 11.3
months (range 2.3-45.2 months). Indications to prescribe tegaserod were
constipation (58%) and a variety of other conditions including functional
dyspepsia or inflammatory bowel disease (42%). Defecation frequency increased
after tegaserod use (1 vs 7/week, P < 0.001) and presence of fecal incontinence
decreased (47% vs 23%, P < 0.001) in the constipation group. Parents rated relief of
constipation as moderate or significant in 71% of cases in the constipation
group. In the group with other indications to start tegaserod therapy, moderate
or significant relief of abdominal pain and bloating was noted in 64% and 68% of
patients, respectively. The median dose of tegaserod prescribed was 0.22 mg x kg
x day (range 0.05-0.87 mg x kg(-1) x day(-1)). Adverse events were observed in
32% of the patients. The most common side effects were self-limiting diarrhea
(20%) and abdominal pain (8%). Only one patient discontinued tegaserod because
of side effects; this patient experienced pain at his cecostomy site.
CONCLUSIONS: Tegaserod seems to relieve a variety of functional gastrointestinal
symptoms in children. Further randomized controlled studies are needed to
support the specific pediatric target of prescribing tegaserod.
-----
Psychiatr Danub. 2007 Dec;19(4):327-31.
[Psychotherapy in somatic diseases—for example gastrointestinal disorders]
[Article in German]
Moser G.
Universitätsklinik für Innere Medizin III, Währinger Gürtel 18-20, 1090 Wien,
Austria. gabriele.moser@univie.ac.at
The functional gastrointestinal disorders (FGID) are the most frequent clinical
conditions seen in practice. Up to 60% of these patients is also suffering from
psychosocial problems. Therefore it is important to define the patient's
complaints in terms of a biopsychosocial disorder, to acknowledge the relevance
of the psychosocial aspects and to provide an integrated psychosomatic treatment
or a psychotherapy if indicated. Most of the research on psychotherapy in FGID
to date has focused on the irritable bowel syndrome and different methods of
treatments were studied (e.g., cognitive-behavioral therapy, dynamic
psychotherapy, hypnotherapy, and relaxation). Randomised controlled studies have
shown that psychotherapy is superior to conventional medical therapy.
Hypnotherapy is successful not only for irritable bowel syndrome but also for
functional dyspepsia. Predictors of a positive response to psychological
treatment generally are: (1) awareness that stress exacerbates their
bowel symptoms, (2) at least mild anxiety or depression, (3) the predominant
bowel symptom is abdominal pain or diarrhea and not constipation, (4) the
abdominal pain waxes and wanes in response to eating, defecation, or stress
rather than being constant pain, and 5) the symptoms are of relatively short
duration. Benefits persist over years, and in the long run, clinic visits and
health care costs can be reduced.
-----
Aliment Pharmacol Ther. 2007 Dec;26(11-12):1537-42. Epub 2007 Sep 28.
The effectiveness of rifabutin triple therapy for patients with
difficult-to-eradicate Helicobacter pylori in clinical practice.
Van der Poorten D, Katelaris PH.
Gastroenterology Department, University of Sydney, Concord Hospital, Sydney,
Australia.
BACKGROUND: Failure of first line and subsequent Helicobacter pylori eradication
therapy is a significant problem and alternative treatments are few. AIMS: To
evaluate the efficacy of a rifabutin-based triple therapy in clinical practice
and determine the optimal strategy for its use. METHODS: Patients referred after
first or subsequent treatment failure were prescribed rifabutin triple therapy
consisting of standard dose proton pump inhibitor, amoxicillin 1 g and rifabutin
150 mg each b.d. for 10 days. RESULTS: In 67 patients, the main indications for
treatment were dyspepsia (55%), peptic ulcer disease (24%) and increased gastric
cancer risk (18%). The median number of previous treatments was 2 (range: 1-9).
Eradication of Helicobacter pylori was achieved in 76% (48/63) per protocol and
72% (48/67) on an intention-to-treat basis. When used as second line therapy,
95% (18/19) achieved eradication compared with 68% (30/44) when two or more
previous treatments had been used (P= 0.03). Outcome was independent of age, ethnicity, gender or indication for
treatment. Adverse events were reported in 10%. CONCLUSION: Rifabutin triple
therapy is a well tolerated and effective second line therapy in the treatment
of persistent Helicobacter pylori; however, its efficacy decreases with
increasing number of failed previous therapies.
-----
Schweiz Rundsch Med Prax. 2007 Nov 21;96(47):1849-55.
[Functional gastrointestinal disorders]
[Article in German]
Vogt W.
Zentrum für Endoskopie, Klinikum Esslingen, Akademisches Lehrkrankenhaus der
Universität Tübingen.
Functional gastrointestinal disorders particularly dyspepsia an irritable bowel
syndrome are frequent problems for the general practitioner and also for the
specialist. Both are diseases and not only a kind of discomfort. The high
frequency of dispepsia and irritable bowel syndrome induces very high direct and
indirect charges. Both diseases depend on a number of factors or causes, for
whom the evidence is not good. But there are good experimental data for the
visceral hypersensitivity as one of the main factors. Gastroscopy is the most
important examination in the diagnosis of dyspepsia. Endoscopy has to be done in
all patients with alarm symptoms an in all patients older than 45 years. The
therapy of dyspepsia is an empirical one. The eradication of Helicobacter pylori
is a therapeutical option, but only 8% of the patients will have benefit for a
long time. Other therapeutical options are the use of proton-pump inhibitors,
prokinetics or phytotherapeutics. The therapy of the irritable bowel syndrome depends on the subtype of the disease (diarrhea,
constipation, abdominal pain, bloating). First of all a good doctor-patient
relationship is mandatory. Furthermore the use of dietary fibre,
antidiarrhoeics, laxatives and muscle relaxants may be beneficial. And
phytotherapeutics can be an additional therapeutic approach.
-----
Medicina (B Aires). 2007;67(4):379-88.
[Functional dyspepsia. New pathophysiologic knowledge with therapeutic
implications]
[Article in Spanish]
Hernando-Harder AC, Franke A, Singer MV, Harder H.
Servicios de Gastroenterología, Hepatologia e Infectología, Hospital
Universitario Mannheim, Universidad de Heidelberg, Alemania. h.harder@web.de
Functional dyspepsia (FD) is a heterogeneous, highly prevalent symptom complex
in the community and general practice. FD is defined as the presence of symptoms
considered as originated in the gastroduodenal region, in the absence of any
organic, systemic, or metabolic disease that is likely to explain the symptoms.
Pathogenetic features include disturbed gastric accommodation and emptying,
duodenal dysmotility, heightened sensitivity, notably psychosocial disturbances
and an association with a postinfective state. Increasing efforts are made to
determine the etiopathogenesis of the disease, including new molecular and
genetic aspects. However, the exact etiopathologic mechanism that causes the
symptoms in an individual patient remains to be identified. The new Rome III
criteria redefine and sub-characterize FD patients according to their main
symptoms and this can be of value for standardized research, development and
control of new therapeutic strategies and calculated therapeutic recommendations in the clinical practice. Various treatment modalities
have been employed including dietary modifications, pharmacological agents
directed at different targets within the gastrointestinal tract and central
nervous system and psychological therapies including hypnotherapy.
Unfortunately, to date, all of these therapies have yielded only marginal
results. After excluding organic diseases, it is essential that the patient be
assured about the benign nature and prognosis of the disease, and this can be
sometimes the most helpful inversion for the patient and his/her physician.
-----
Surg Endosc. 2007 Nov 20; [Epub ahead of print]
Long-term comparative outcome between laparoscopic total Nissen
and Toupet fundoplication: Symptomatic relief, patient satisfaction and quality
of life.
Sgromo B, Irvine LA, Cuschieri A, Shimi SM.
Department of Surgery and Molecular Oncology, University of Dundee, Ninewells
Hospital and Medical School, Dundee, Scotland, DD1 9SY, UK, s.m.shimi@dundee.ac.uk.
BACKGROUND: Laparoscopic antireflux surgery has become an established method of
treatment of gastroesophageal reflux disease. This study compares the long-term
outcome of total (Nissen) and partial (Toupet) fundoplication, performed in a
single institution, by evaluating symptoms and quality of life. METHODS: 266
patients who underwent laparoscopic Nissen or Toupet fundoplication completed a
preoperative reflux symptom questionnaire. Postsurgery symptom evaluation,
patient satisfaction and quality of life in reflux and dyspepsia (QOLRAD)
questionnaires were sent to these patients in December 2004. The two groups were
compared for each item nonparametrically. RESULTS: Completed questionnaires were
received from 161 patients (61%) of whom 99 had a laparoscopic Nissen
fundoplication and 62 laparoscopic Toupet fundoplication. Both procedures were
equivalent in improving reflux symptom scores in the long term, 79/99 (80%) and
56/62 (90%) were either symptom free or had obtained significant symptomatic
relief. Both groups had equivalent QoL scores on the QOLRAD questionnaire. An
equivalent number of patients (86% and 83.9% after Nissen and Toupet,
respectively) were sufficiently satisfied to recommend antireflux surgery to a
friend or relative complaining of reflux symptoms. CONCLUSION: In conclusion, in
patients who have returned the questionnaire, long-term satisfaction, general
symptom scores, and quality of life are equivalent after laparoscopic Nissen
(complete) or Toupet (partial) fundoplication. There is however, a significant
increased prevalence of persistent heartburn after laparoscopic Toupet
fundoplication.
-----
Aliment Pharmacol Ther. 2007 Nov 12; [Epub ahead of print]
Empirical rescue therapy after H. pylori treatment failure. A
10-year single centre study of 500 patients.
Gisbert JP, Gisbert JL, Marcos S, Jimenez-Alonso I, Moreno-Otero R, Pajares JM.
Gastroenterology Unit, Hospital Universitario de la Princesa and Ciberehd,
Universidad Autónoma, Madrid, Spain.
AIM: To evaluate the efficacy of different "rescue" therapies empirically
prescribed during 10 years to 500 patients in whom at least one eradication
regimen had failed to cure H. pylori infection. METHODS:Design: Prospective
single-center study. Patients: Consecutive patients in whom at least one
eradication regimen had failed. Intervention: Rescue regimens included: 1)
Quadruple therapy with omeprazole-bismuth-tetracycline-metronidazole; 2)
ranitidine bismuth citrate-tetracycline-metronidazole; 3)
omeprazole-amoxicillin-levofloxacin; and 4) omeprazole-amoxicillin-rifabutin.
Antibiotic susceptibility was unknown (rescue regimens were chosen empirically).
Outcome: Eradication was defined as a negative (13)C-urea breath test 4-8 weeks
after completing therapy. RESULTS: Five-hundred patients were included (76%
functional dyspepsia, 24% peptic ulcer). Compliance with 1(st), 2(nd) and
3(rd)-line regimens was 92%, 92%, and 95%. Adverse effects were reported by 30%,
37%, and 55% of the patients receiving 2(nd), 3(rd), and 4(th)-line regimens.
Overall, H. pylori cure rates with the 2(nd), 3(rd), and 4(th)-line rescue
regimens were 70%, 74%, and 76%. Cumulative H. pylori eradication rate with 4
successive treatments was 99.5%. CONCLUSION: It is possible to construct an
overall treatment strategy to maximize H. pylori eradication, based on the
administration of four consecutive empirical regimens; thus, performing
bacterial culture even after a second or third eradication failure may not be
necessary.
-----
Gut. 2007 Oct 26; [Epub ahead of print]
Itopride in functional dyspepsia: Results of two phase III
multicenter, randomized, double-blind, placebo-controlled trials.
Talley NJ, Tack J, Ptak T, Gupta R, Giguere M.
United States.
BACKGROUND: Functional dyspepsia (FD) is a common disorder but there is
currently little efficacious drug therapy. Itopride, a prokinetic approved in
several countries, showed promising efficacy in FD in a Phase IIb trial. We
aimed to test the efficacy and safety of this drug in FD. METHODS: Two similar
placebo-controlled clinical trials were conducted (International and North
America). Males and females, 18 to 65 years, with a diagnosis of FD (Rome II)
and the absence (by upper endoscopy) of any relevant structural disease were
recruited. All were negative for H. pylori and, if present, heartburn could not
exceed one episode per week. Following screening, patients were randomized to
itopride 100 mg three times daily or identical placebo. The co-primary endpoints
were: 1) Global Patient Assessment of efficacy (GPA); 2) Leeds Dyspepsia
Questionnaire (LDQ). Symptoms were evaluated at weeks 2, 4 and 8. Secondary
measures of efficacy included Nepean Dyspepsia Index (NDI) quality of life.
RESULTS: The GPA responder rates at week 8 on Itopride versus placebo were
similar in both trials (50.2% vs. 49.8% and 41.8 vs. 39.1%; respectively; P=NS).
A significant benefit of itopride over placebo was observed for the LDQ
responders in the International (62% vs. 53%, P=0.04) but not the North American
trial (47% vs. 45%). The safety and tolerability profile were comparable to
placebo, with the exception of prolactin elevations, which occurred more
frequently on itopride (18/579) than placebo (1/591). CONCLUSION: In this
population with FD, itopride did not show a difference in symptom response from
placebo.
-----
Ann Intern Med. 2007 Oct 16;147(8):553-62.
Meta-analysis: duration of first-line proton-pump inhibitor based
triple therapy for Helicobacter pylori eradication.
Fuccio L, Minardi ME, Zagari RM, Grilli D, Magrini N, Bazzoli F.
University of Bologna, Bologna, Italy. franco.bazzoli@unibo.it
BACKGROUND: Proton-pump inhibitor (PPI)-based triple therapy is the recommended
first-line treatment for Helicobacter pylori infection. A consensus on treatment
duration is lacking. PURPOSE: To summarize the benefits and harms of different
durations of PPI-based triple therapy. DATA SOURCES: PubMed, EMBASE, the
Cochrane Library, and proceedings of major meetings through May 2007. STUDY
SELECTION: English-language reports of randomized, controlled trials that
compared duration (7, 10, or 14 days) of triple therapy and in which adequate
testing confirmed the initial H. pylori infection and its eradication. DATA
EXTRACTION: Two authors independently extracted data on study design, treatment,
number of patients enrolled and number of patients with successful eradication,
disease at enrollment, testing, adverse effects, year of publication,
publication format, and country. DATA SYNTHESIS: Of 21 included studies, 11
compared 7-day therapy with 10-day therapy, and 13 compared 7-day therapy with
14-day therapy. Meta-analysis yielded relative risks (RRs) for eradication of
1.05 (95% CI, 1.01 to 1.10) for 7-day compared with 10-day
amoxicillin-containing triple therapy (10 studies) and 1.07 (CI, 1.02 to 1.12)
for 7-day compared with 14-day therapy (11 studies). Meta-analysis of the 3
studies that compared 7-day with 14-day metronidazole-containing therapy yielded
an RR of 1.08 (CI, 0.96 to 1.22). The 7-day versus 10-day comparisons yielded
RRs of 1.03 (CI, 0.97 to 1.10) for peptic ulcer disease and 1.10 (CI, 1.02 to
1.20) for nonulcer dyspepsia. For the 7-day versus 14-day comparisons, the RRs
were 1.04 (CI, 0.99 to 1.09) and 1.03 (CI, 0.88 to 1.20), respectively. The RRs
for frequency of adverse events were 0.98 (CI, 0.85 to 1.14) and 1.08 (CI, 0.84
to 1.40) for 7-day therapy compared with 10- and 14-day therapy, respectively.
Diarrhea and taste disturbance were the most frequently reported adverse events
(5%). LIMITATIONS: Subgroup analyses were limited by the few studies evaluating
different drug regimens and disease at enrollment. Seventeen of the included
studies had poor methodological quality or inadequate reporting. CONCLUSION:
Available data suggest that extending triple therapy beyond 7 days is unlikely
to be a clinically useful strategy.
-----
Z Gastroenterol. 2007 Oct;45(10):1041-8.
[Assessment of the efficacy and safety of the phytopharmacon STW
5 versus metoclopramide in functional dyspepsia--a retrolective cohort study]
[Article in German]
Raedsch R, Hanisch J, Bock P, Sibaev A, Vinson B, Gundermann KJ.
St.-Josefs-Hospital, Med. Klinik II, Gastroenterologie, Wiesbaden/Deutschland.
rraedsch@joho.de
AIM: The objective of this study was to assess the efficacy and safety of the
phytopharmacon STW 5 versus metoclopramide in functional dyspepsia. METHODS: A
retrolective, epidemiological cohort study with parallel groups in 23 randomised
centres where both drugs were used routinely was performed. The main outcome
variable was improvement of 10 dyspepsia-specific symptoms of a valid
gastrointestinal symptom score (GIS) during therapy. For inclusion, patients had
to suffer from at least three of these symptoms before therapy. Secondary
outcome variables were change of single symptoms, time till complete symptom
relief, investigators' judgement of efficacy and tolerability, duration of
inability to work and occurrence of adverse events. RESULTS: The per protocol
collective comprised 490 STW 5 and 471 MCP patients. Anamnestic data were
comparable. 439 of patients had taken MCP as drops. There was no relevant
difference in median treatment duration. Significantly more patients were
symptom-free after STW 5 treatment (71.6 vs. 62.8% p = 0,012). Additionally, the
extent of symptom improvement (excluding nausea and vomiting) and median
duration of inability to work (1 vs. 3 days) were significantly different in
favour of STW 5. More physicians assessed STW 5 as effective (71.6 vs. 63.1%
p<0.01) and very well tolerated (90 vs. 70.6% p<0.001). Adverse drug reactions
were documented only under MCP. CONCLUSION: The present study illustrates a
comparable to higher efficacy of STW 5 vs. MCP with better tolerability in
treating functional dyspepsia under practice conditions, especially regarding
complete symptom improvement, symptom duration and quality of life. The study
confirms the results of prospective trials for STW 5 as being an appropriate
alternative to the frequently administered antacids and prokinetics.
-----
Aliment Pharmacol Ther. 2007 Sep 28; [Epub ahead of print]
The effectiveness of rifabutin triple therapy for difficult to
eradicate Helicobacter pylori in clinical practice.
van der Poorten D, Katelaris PH.
Gastroenterology Dept, University of Sydney, Concord Hospital, Sydney,
Australia.
Background Failure of first line and subsequent Helicobacter pylori eradication
therapy is a significant problem and alternative treatments are few. Aims To
evaluate the efficacy of a rifabutin based triple therapy in clinical practice
and to determine the optimal strategy for its use. Methods Patients referred
after first or subsequent treatment failure were prescribed rifabutin triple
therapy consisting of standard dose proton pump inhibitor, amoxicillin 1g and
rifabutin 150mg each twice daily for 10 days. Results In 67 patients the main
indications for treatment were dyspepsia (55%), peptic ulcer disease (24%), and
increased gastric cancer risk (18%). The median number of previous treatments
was 2 (range 1-9). Eradication of H. pylori was achieved in 76% (48/63) per
protocol and 71.6% (48/67) on an intention to treat basis. When used as second
line therapy 95% (18/19) achieved eradication compared with 68% (30/44) when two
or more previous treatments had been used (p=0.03). Outcome was independent of
age, ethnicity, gender or indication for treatment. Adverse events were reported
in 9.6%. Conclusion Rifabutin triple therapy is a well tolerated and effective
second line therapy in the treatment of persistent H pylori, however its
efficacy decreases with increasing numbers of failed previous therapies.
-----
Scand J Gastroenterol. 2007 Sep;42(9):1054-62.
Breathing exercises with vagal biofeedback may benefit patients
with functional dyspepsia.
Hjelland IE, Svebak S, Berstad A, Flatabø G, Hausken T.
Institute of Medicine, University of Bergen, Division of Gastroenterology,
Medical Department, Haukeland University Hospital, Bergen, Norway. ina.hjelland@med.uib.no
OBJECTIVE: Many patients with functional dyspepsia (FD) have postprandial
symptoms, impaired gastric accommodation and low vagal tone. The aim of this
study was to improve vagal tone, and thereby also drinking capacity,
intragastric volume and quality of life, using breathing exercises with vagal
biofeedback. MATERIAL AND METHODS: Forty FD patients were randomized to either a
biofeedback group or a control group. The patients received similar information
and care. Patients in the biofeedback group were trained in breathing exercises,
6 breaths/min, 5 min each day for 4 weeks, using specially designed software for
vagal biofeedback. Effect variables included maximal drinking capacity using a
drink test (Toro clear meat soup 100 ml/min), intragastric volume at maximal
drinking capacity, respiratory sinus arrhythmia (RSA), skin conductance (SC) and
dyspepsia-related quality of life scores. RESULTS: Drinking capacity and quality
of life improved significantly more in the biofeedback group than in the control
group (p=0.02 and p=0.01) without any significant change in baseline autonomic
activity (RSA and SC) or intragastric volume. After the treatment period, RSA
during breathing exercises was significantly correlated to drinking capacity
(r=0.6, p=0.008). CONCLUSIONS: Breathing exercises with vagal biofeedback
increased drinking capacity and improved quality of life in FD patients, but did
not improve baseline vagal tone.
-----
Aliment Pharmacol Ther. 2007 Aug 1;26(3):495-500.
First-line triple therapy with levofloxacin for Helicobacter
pylori eradication.
Gisbert JP, Fernández-Bermejo M, Molina-Infante J, Pérez-Gallardo B,
Prieto-Bermejo AB, Mateos-Rodríguez JM, Robledo-Andrés P, González-García G.
Gastroenterology Unit, Hospital Universitario de la Princesa, Madrid, Spain.
Background At present, the efficacy of proton pump inhibitor-clarithromycin-amoxicillin
regimen is relatively low. Aim To evaluate the efficacy and tolerability of a
first-line triple clarithromycin-free regimen including ranitidine bismuth
citrate, levofloxacin and amoxicillin. Methods Design: Prospective study.
Patients: Helicobacter pylori-positive patients complaining of dyspeptic
symptoms referred for gastroscopy. Intervention: Levofloxacin (500 mg b.d.),
amoxicillin (1 g b.d.) and ranitidine bismuth citrate (400 mg b.d.) was
prescribed for 10 days. Outcome: Eradication was confirmed by a (13)C-urea
breath test 8 weeks after therapy. Compliance with therapy was determined by
questioning and the recovery of empty envelopes of medications. Incidence of
adverse effects was evaluated by means of a specific questionnaire. Results
Sixty-four patients were included (30% peptic ulcer, 70% functional dyspepsia).
Almost all (97%) patients took all the medications correctly. Per-protocol and
intention-to-treat eradication rates were 88.5% (95% CI =78-95%) and 84.4
(74-91%). Adverse effects were reported in 9.5% of the patients, mainly
including diarrhoea (7.9%); none of them were severe. Conclusion This new 10-day
levofloxacin-based combination represents an alternative to clarithromycin-based
therapy, as it meets the criteria set for regimens used as primary H. pylori
treatment: effectiveness (>80%), simplicity (twice-daily dosing and excellent
compliance) and safety (low incidence of adverse effects).
-----
Am J Gastroenterol. 2007 Jun 29; [Epub ahead of print]
American College of Gastroenterology Guideline on the Management
of Helicobacter pylori Infection.
Chey WD, Wong BC; Practice Parameters Committee of the American College of
Gastroenterology.
University of Michigan Medical Center, Ann Arbor, Michigan, USA.
Helicobacter pylori (H. pylori) remains a prevalent, worldwide, chronic
infection. Though the prevalence of this infection appears to be decreasing in
many parts of the world, H. pylori remains an important factor linked to the
development of peptic ulcer disease, gastric malignanc and dyspeptic symptoms.
Whether to test for H. pylori in patients with functional dyspepsia,
gastroesophageal reflux disease (GERD), patients taking nonsteroidal
antiinflammatory drugs, with iron deficiency anemia, or who are at greater risk
of developing gastric cancer remains controversial. H. pylori can be diagnosed
by endoscopic or nonendoscopic methods. A variety of factors including the need
for endoscopy, pretest probability of infection, local availability, and an
understanding of the performance characteristics and cost of the individual
tests influences choice of evaluation in a given patient. Testing to prove
eradication should be performed in patients who receive treatment of H. pylori
for peptic ulcer disease, individuals with persistent dyspeptic symptoms despite
the test-and-treat strategy, those with H. pylori-associated MALT lymphoma, and
individuals who have undergone resection of early gastric cancer. Recent studies
suggest that eradication rates achieved by first-line treatment with a proton
pump inhibitor (PPI), clarithromycin, and amoxicillin have decreased to 70-85%,
in part due to increasing clarithromycin resistance. Eradication rates may also
be lower with 7 versus 14-day regimens. Bismuth-containing quadruple regimens
for 7-14 days are another first-line treatment option. Sequential therapy for 10
days has shown promise in Europe but requires validation in North America. The
most commonly used salvage regimen in patients with persistent H. pylori is
bismuth quadruple therapy. Recent data suggest that a PPI, levofloxacin, and
amoxicillin for 10 days is more effective and better tolerated than bismuth
quadruple therapy for persistent H. pylori infection, though this needs to be
validated in the United States.
-----
Expert Opin Pharmacother. 2007 May;8(7):975-88.
Esomeprazole: prevention and treatment of NSAID-induced symptoms
and ulcers.
Morgner A, Miehlke S, Labenz J.
Medical Department I, University Hospital, Dresden, Germany.
Non-steroidal anti-inflammatory drugs (NSAIDs) represent one of the most widely
used drug classes. However, many patients complain of dyspeptic symptoms
impairing their quality of life: ~ 20% of patients taking NSAIDs show endoscopic
ulcers with or without symptoms, and up to 2% of chronic NSAID users will
develop serious complications each year, such as bleeding or perforation, which
are the cause of death in many patients. Coprescription of a proton pump
inhibitor is one established option for the healing and prevention of NSAID-associated
lesions of the upper gastrointestinal tract in patients at risk. Recent studies
evaluated the clinical efficacy of esomeprazole in the management of
gastrointestinal problems associated with the intake of selective and
non-selective NSAIDs and aspirin.
-----
Ann Intern Med. 2007 Apr 17;146(8):556-63. Summary for patients in:
Ann Intern Med. 2007 Apr 17;146(8):I20.
Sequential therapy versus standard triple-drug therapy for
Helicobacter pylori eradication: a randomized trial.
Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V,
Tampieri A, Morini S.
University of Bologna, Bologna, Italy. vairadin@med.unibo.it
BACKGROUND: Antimicrobial resistance has decreased eradication rates for
Helicobacter pylori infection worldwide. OBJECTIVE: To determine whether
sequential treatment eradicates H. pylori infection better than standard
triple-drug therapy for adults with dyspepsia or peptic ulcers. DESIGN:
Randomized, double-blind, placebo-controlled trial. SETTING: Two Italian
hospitals between September 2003 and April 2006. PATIENTS: 300 patients with
dyspepsia or peptic ulcers. MEASUREMENTS: (13)C-urea breath test, upper
endoscopy, histologic evaluation, rapid urease test, bacterial culture, and
assessment of antibiotic resistance. INTERVENTION: A 10-day sequential regimen
(40 mg of pantoprazole, 1 g of amoxicillin, and placebo, each administered twice
daily for the first 5 days, followed by 40 mg of pantoprazole, 500 mg of
clarithromycin, and 500 mg of tinidazole, each administered twice daily for the
remaining 5 days) or standard 10-day therapy (40 mg of pantoprazole, 500 mg of
clarithromycin, and 1 g of amoxicillin, each administered twice daily). RESULTS:
The eradication rate achieved with the sequential regimen was significantly
greater than that obtained with the standard treatment in the intention-to-treat
analysis (89% vs. 77%; P = 0.0134; difference, 12% [95% CI, 3% to 20%]), the
modified intention-to-treat analysis (91% vs. 78%; P = 0.0022; difference, 13%
[CI, 5% to 21%]), and the per-protocol analysis (93% vs. 79%; P = 0.0013;
difference, 14% [CI, 6% to 21%]). Sequential therapy was significantly more
effective in patients with clarithromycin-resistant strains (89% vs. 29%; P =
0.0034). The incidence of major and minor side effects did not differ between
therapy groups (17% in both groups). One patient (0.7%) in the standard therapy
group discontinued treatment because of side effects. LIMITATIONS: Follow-up was
incomplete in 4.6% and 2.7% patients in the sequential therapy and standard
therapy groups, respectively. The results may not be generalizable to other
countries. Sequential therapy may be more effective because it includes 1
additional antibiotic (tinidazole) that is not contained in standard therapy.
CONCLUSIONS: Sequential therapy is statistically significant compared with
standard therapy for eradicating H. pylori infection and is statistically
significantly more effective in patients with clarithromycin-resistant strains.
Side effects are similar with both treatment regimens and are rarely severe
enough to cause discontinuation of therapy. ClinicalTrials.gov registration
number: NCT00403364.
-----
Curr Treat Options Gastroenterol. 2007 Mar;10(2):157-68.
Current treatments in functional dyspepsia.
McNally MA, Talley NJ.
Nicholas J. Talley, MD, PhD Mayo Clinic College of Medicine, Division of
Gastroenterology, Dyspepsia Center, 200 First Street SW, PL-6-56, Rochester, MN
55905, USA. talley.nicholas@mayo.edu.
By nature of the definition of functional dyspepsia (FD), organic causes have to
be ruled out before therapy can be directed. However, in uninvestigated
dyspepsia in the absence of alarm features, Helicobacter pylori "test and treat"
or an empiric trial of acid suppression therapy for 4 to 8 weeks is reasonable.
If alarm symptoms or signs are present, or if the dyspepsia symptoms first occur
in those aged greater than 55 years, prompt esophagogastroduodenoscopy is
mandatory to exclude serious disease and positively diagnose FD. Empiric acid
suppression with H(2)-receptor antagonists or proton-pump inhibitors is superior
to placebo in treatment of FD, but those patients with meal-related symptoms are
least likely to respond. Helicobacter pylori eradication in FD benefits a
minority of cases but is worthwhile, as response may be maintained. There is
increasing evidence that some prokinetics may be superior to placebo in
treatment of FD, but probably only a minority respond; those with meal-related
symptoms may have the best response. Antidepressant therapy may have a place in
management of difficult cases, but adequate randomized controlled trials are
unavailable.
-----
Aliment Pharmacol Ther. 2007 Apr 15;25(8):973-86.
Is there a benefit from intensified medical and psychological
interventions in patients with functional dyspepsia not responding to
conventional therapy?
Haag S, Senf W, Tagay S, Langkafel M, Braun-Lang U, Pietsch A, Heuft G, Talley
NJ, Holtmann G.
Department of Gastroenterology and Hepatology, and Clinic for Psychosomatic
Medicine and Psychotherapy, University Hospital Essen, Essen, Germany.
AIM: In a prospective randomized, controlled trial, to compare the long-term
outcome of intensive medical therapy (with or without cognitive-behavioural or
muscle relaxation therapy) vs. standard medical therapy in patients with
refractory functional dyspepsia (FD), referred to a tertiary referral medical
center. METHODS: A total of 100 consecutive FD patients were allocated to a
standardized symptom-oriented 4 month therapy (SMT, n = 24), intensive medical
therapy (IMT, medical therapy with testing-for and targeting-of abnormalities of
motor-and-sensory function, n = 28) or IMT plus psychological interventions
(either progressive-muscle relaxation (IMT-MR, n = 20) or cognitive-behavioural
therapy (IMT-CBT, n = 28). The symptom intensity (SI) and health-related
quality-of-life (HRQoL) after 12 months were prespecified primary outcome
parameters. RESULTS: After 12 months, significantly greater improvement of SI
occurred in patients with IMT-all (with or without psychological interventions)
compared with SMT (P < 0.025 vs. IMT-all). IMT, IMT-MR and IMT-CBT alone also
resulted in significantly better improvement of the primary outcome parameters
(P all < 0.025 vs. SMT). HRQoL significantly improved in all groups with
intensive medical therapy but not standard medical therapy. Differences between
intensive medical therapy-all and standard medical therapy were not significant.
Concomitant anxiety and depression was improved significantly by IMT-CBT (vs.
SMT) but not other treatments. CONCLUSIONS: In FD patients with refractory
symptoms, intensified medical management involving function testing and
psychological intervention yields superior long-term-outcomes. Additional CBT
may be effective for the control of concomitant anxiety and depression.
-----
Aliment Pharmacol Ther. 2007 Mar;25(5):585-592.
Helicobacter pylori eradication in long-term proton pump
inhibitor users in primary care: a randomized-controlled trial.
Raghunath AS, Hungin AP, Mason J, Jackson W.
School for Health, University of Durham, Queen's Campus, Wolfson Research Unit,
University Boulevard, Stockton-on-Tees, UK.
Background Two-thirds of proton pump inhibitor prescribing in the UK is for
long-term therapy. Aim To determine the impact of eradication in long-term
proton pump inhibitor users infected with Helicobacter pylori. Methods A total
of 184 H. pylori-positive patients were randomly assigned to true or placebo
eradication therapy. The primary outcome was the change in proton pump inhibitor
usage measured by prescriptions; secondary outcomes were changes of proton pump
inhibitor doses, dyspepsia symptoms, general practitioner consultations and
quality of life measures. Results In the year following H. pylori eradication
proton pump inhibitor prescriptions fell compared with placebo (-1.7, 95% CI:
-2.3 to -1.1, P < 0.001); when adjusted to full-dose equivalent prescriptions
the reduction was more marked (-2.2, 95% CI: -3.0 to -1.4, P < 0.001). Both
general practitioner consultations (-1.0, 95% CI: -1.8 to -0.1, P = 0.026) and
symptoms measured on the Leeds Dyspepsia Questionnaire (-3.1, 95% CI: -5.3 to
-0.9, P = 0.005) were reduced. Quality of life and self-rating measures also
favoured eradication (EQ-5D: 0.09, P = 0.08 and VAS: 5.6, P = 0.002). The
Carlsson and Dent Reflux Questionnaire found no difference between groups (-0.3,
P = 0.65), possibly balancing decreased overall symptoms with increased
prominence of heartburn in the eradication group. Conclusions Helicobacter
pylori eradication in infected, long-term proton pump inhibitor users in primary
care reduced both the overall severity of symptoms and use of health care.
-----
Am Fam Physician. 2007 Feb 1;75(3):351-8.
Update on Helicobacter pylori treatment.
Ables AZ, Simon I, Melton ER.
Spartanburg Family Medicine Residency Program, Spartanburg, South Carolina
29303, USA. azables@srhs.com
One half of the world's population has Helicobacter pylori infection, with an
estimated prevalence of 30 percent in North America. Although it is unclear
whether eradication of H. pylori improves symptoms in patients with nonulcer
dyspepsia, there is strong evidence that eradication of this bacteria improves
healing and reduces the risk of recurrence or rebleeding in patients with
duodenal or gastric ulcer. A "test-and-treat" strategy is recommended for most
patients with undifferentiated dyspepsia. With this approach, patients undergo a
noninvasive test for H. pylori infection and, if positive, are treated with
eradication therapy. This strategy reduces the need for antisecretory
medications as well as the number of endoscopies. The urea breath test or stool
antigen test is recommended. Until recently, the recommended duration of therapy
for H. pylori eradication was 10 to 14 days. Shorter courses of treatment (i.e.,
one to five days) have demonstrated eradication rates of 89 to 95 percent with
the potential for greater patient compliance. A one-day treatment course
consists of bismuth subsalicylate, amoxicillin, and metronidazole, all given
four times with a one-time dose of lansoprazole. In children with documented H.
pylori infection, however, all regimens should continue to be prescribed for
seven to 14 days until short-course treatment is studied and its effectiveness
has been established in this population.
-----
Expert Opin Pharmacother. 2007 Feb;8(3):329-50.
Treatment and dosing of Helicobacter pylori infection: when
pharmacology meets clinic.
Treiber G, Malfertheiner P, Klotz U.
Otto-von-Guericke University Hospital, Department of Gastroenterology/Hepatology/Infectious
Diseases, Leipziger Str. 44, D-39120 Magdeburg, Germany.
Helicobacter pylori infection is a major cause of diseases located in the upper
gastrointestinal tract. Successful eradication of the bacteria may improve H.
pylori-related symptomatic complaints in functional dyspepsia, cure peptic ulcer
disease and prevent gastric cancer. As vaccines are not available, the search
for the optimal drug regimen has dominated the last decade. Today, most
countries prefer a 7- to 10-day regimen containing a proton pump inhibitor,
clarithromycin and amoxicillin as first-line treatment. An alternative (or
second-line) treatment contains a proton pump inhibitor, bismuth, tetracycline
and metronidazole. This review also highlights the impact of new drugs, new drug
combinations, and their optimal dosing required to maximise clinical outcome.
-----
Nat Clin Pract Gastroenterol Hepatol. 2007 Jan;4(1):35-42.
How to manage the difficult-to-treat dyspeptic patient.
Talley NJ.
Mayo Clinic, 200 First Street SW, Plummer 6-56, Rochester, MN 55905, USA.
talley.nicholas@mayo.edu
The main causes of dyspepsia are unexplained gastroduodenal symptoms (i.e.
functional dyspepsia), peptic ulcer disease, reflux disease and, rarely,
malignancy. A careful clinical evaluation and upper endoscopy will exclude most
of the major causes of dyspepsia. The absence of alarm features is reassuring.
The yield of other diagnostic tests in this clinical situation is low, and
repeat endoscopy is unlikely to be cost-effective. By definition, the
difficult-to-treat patient with functional dyspepsia has already had
Helicobacter pylori infection excluded or eradicated, has failed to respond to
an adequate trial of acid-suppression therapy that used appropriate doses and,
therefore, seeks other solutions. It is likely that patients who have failed to
respond to previous trials of a PPI will not experience therapeutic gains with
high-dose PPI therapy. A major gastroduodenal motor disorder should be suspected
if there is severe early satiation (inability to finish a normal-sized meal),
postprandial fullness, or persistent nausea and vomiting; here, an assessment of
gastric emptying or gastric accommodation can be considered, to tailor therapy.
Antidepressants (especially low-dose tricyclic agents) and psychological
therapies can be useful. Creation of a logical management plan that includes
patient education and support remains key.
-----
Am J Gastroenterol. 2006 Dec;101 Suppl 3:S644-53.
Is functional dyspepsia of particular concern in women? A review
of gender differences in epidemiology, pathophysiologic mechanisms, clinical
presentation, and management.
Flier SN, Rose S.
Department of Medicine, Division of Gastroenterology, Mount Sinai School of
Medicine, New York, New York.
Dyspepsia is a remarkably common symptom in the general population. Although
multiple definitions have been used to describe the symptom, the most common
explanation is that of chronic or recurrent pain or discomfort (a subjective
negative feeling that may be associated with early satiety, fullness, bloating,
or nausea) centered in the upper abdomen. When a thorough evaluation of a
dyspeptic patient fails to identify a cause for her symptoms, the label of
nonulcer or functional dyspepsia is applied. Functional dyspepsia is a
heterogeneous disorder characterized by relapsing and remitting symptoms.
Treatment strategies should focus on alleviating the most bothersome symptom and
can be based on the proposed underlying pathophysiology. The effect of gender on
mechanisms of disease, symptom presentation, and treatment response is an area
of increasing interest and study. As with other functional gastrointestinal
disorders, there appear to be some gender-specific features of functional
dyspepsia. Specifically, gender-related differences have been observed in some
studies of both the prevalence of individual dyspepsia symptoms, and in gastric
emptying and proximal gastric motor function. There also appear to be gender
differences in the psychosocial realm, with dyspeptic women experiencing a
lesser sense of well-being than dyspeptic men, as well as an association of an
abuse history with functional dyspepsia. This review will highlight specific
gender differences related to the symptom presentation, pathophysiology, and
approach to treatment of functional dyspepsia.
Previous Dyspepsia
Research: 2002-2006
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Dyspepsia File also contains summaries of past
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