Clinical Practice Guideline
for
PEPTIC ULCER DISEASE
Developed for the
Aerospace
Medical Association
by their
constituent organization
American
Society of Aerospace Medicine Specialists
Overview: Both the
understanding and the treatment of peptic ulcer disease (PUD) have undergone
profound changes in the past decade, due to the recognition of Helicobacter pylori as etiologic for most
cases of ulcer (at least 90%). Although
spiral bacteria were noted in gastric mucosa as far back as the beginning of
the 20th century, the organism was not cultured until 1982. A strong correlation was noted between the
presence of H. pylori and both
gastritis and ulcer disease, but it was initially unclear whether the organism
played a causative role, or simply found peptic disease to be a favorable
environment for colonization. That
concern has been answered by the convincing response of gastritis to antibiotic
therapy and particularly by the profound reduction in ulcer recurrence rate
when the organism is eradicated. In the
past, relapse rates averaged 75% on no therapy, and 25% on chronic antisecretory medication, whereas recurrence after eradication
H. pylori occurs in fewer than 5%.
Colonization of the
gastric mucosa by H. pylori is far
more common than is ulcer disease, with rates of 10-60% in the
Infection with H. pylori may be documented by several
methods. If the diagnosis of PUD is made by endoscopy,
Helicobacter infection can be rapidly
established from a tissue biopsy by histopathology, culture, or urease (CLO) testing.
If PUD is diagnosed by contrast radiography, infection can be confirmed
by serologic testing. However,
documentation of eradication, which is necessary in some cases of ulcer
disease, requires endoscopy, since serologic titers
may take 6-12 months to fall after successful treatment.
Duodenal ulcers (DU)
are associated with H. pylori in the
vast majority of cases. If DU is
diagnosed by endoscopy, treatment may be withheld
until urease testing or histopathology confirms Helicobacter infection. If DU is diagnosed by radiography, IgG serology against H.
pylori should be obtained, and the patient should be started on one of the
antimicrobial regimens noted below, since serology will take about two weeks to
return, and H. pylori is the
causative agent in almost all cases.
Gastric ulceration
(GU) is not as strongly associated with H.
pylori, but if NSAID-associated GU is discounted, 60-80% of the remainder
are positive for infection. The
remaining 20-40% are still considered idiopathic,
unless associated with malignancy; gastric carcinoma is a rarity in the aviator-age
population, is usually diagnosed at upper GI or endoscopy,
and is essentially ruled out by documenting healing of the ulcer. If a benign GU is diagnosed at endoscopy, antimicrobial therapy should be instituted if urease testing or histopathology returns positive. If the diagnosis is made radiologically,
the aviator should be started on ranitidine, but antimicrobial therapy should
be withheld until serologic results are available, since about a third of such
ulcers may be idiopathic.
Aeromedical Concerns: Sudden incapacitation in flight due to hemorrhage is of
primary concern. Acute perforation is
less common, but can be catastrophic.
Chronic blood loss from PUD may lead to iron deficiency anemia. Ulcer pain may be distracting and may impair
mission completion. The stress of the
cockpit environment and of warfare itself may exacerbate ulcer disease. Many private pilots and commercial pilots are
involved in stressful occupations and the combination of disease
susceptibility, life stresses, and the stress of aviation itself can be factors
leading to actual disease.
Medical Work-up: Complicated PUD consists of ulcers associated with
hemorrhage, obstruction, or perforation.
In an aviator with a first episode of uncomplicated
duodenal or gastric ulcer, it is necessary to document healing of the ulcer
crater, but not necessary to document eradication of the organism. However, in cases of complicated ulcer
disease caused by H. pylori, it is
necessary to document eradication of the infection. Recurrence of an ulcer is usually caused by a
failure to eradicate the organism, and in the case of complicated ulcer disease
this is frequently a serious problem.
Antimicrobial treatment to eradicate H.
pylori consists of any one of the following regimens. Note that 12-14 days of therapy is sufficient
when the aim is only to eradicate the organism; such as would occur when an
aviator with a history of an ulcer is found to have positive Helicobacter serology. However, treatment of an active ulcer crater
requires extension of ranitidine or omeprazole.
TABLE 1
THERAPY DOSE DURATION
A. Bismuth
(Pepto-Bismol) two 262 mg tablets QID 14 days
Metronidazole 250 mg TID 14 days
Tetracycline (or
Amoxicillin) 500 mg QID 14 days
Ranitidine 150 mg BID
14 days
For acute ulceration,
extend ranitidine 150 mg BID for an additional 4 weeks.
B. Amoxicillin 750 mg
TID 12 days
Metronidazole 500 mg TID 12 days
Ranitidine 150 mg BID
12 days
For acute ulceration,
extend ranitidine 150 mg BID for an additional 4 weeks.
C. Omeprazole 20 mg BID 7-14 days
Clarithromycin 250 or 500 mg BID 7-14 days
Metronidazole 500 mg BID 7-14 days
For acute ulceration,
extend omeprazole at a dose of 20 mg QD for an
additional 2 weeks.
D. Ranitidine bismuth
citrate (Tritec) 400 mg BID 14 days
Clarithromycin 500 mg TID 14 days
- For acute
ulceration, institute ranitidine at a dose of 150 mg BID for an additional 4
weeks.
Aeromedical Disposition (military): Return to flying status is favorably considered when the
applicable following conditions are met.
a. Uncomplicated
PUD:
1) H. pylori positive with or without
NSAID use
a) Helicobacter eradication regimen has
been successfully completed,
b) NSAIDs if any have been discontinued,
c) Ulcer healing has
been documented by UGI or endoscopy, and
d) The aviator is
asymptomatic off medication.
If
ulcer recurs, reevaluate for H. pylori
by biopsy methods (not serology). If
positive, treat with different regimen, and document
eradication by follow-up endoscopy and repeat biopsy.
2) H. pylori negative with NSAID use
a) NSAID use has been
discontinued,
b) 6-8 weeks of antisecretory
medication has been completed,
c) Ulcer healing has
been documented by UGI or endoscopy, and
d) The aviator is
asymptomatic off medication.
If ulcer recurs
(rare) and no recent NSAID use, institute chronic ranitidine or sucralfate.
3) H. pylori negative without NSAID use
a) 6-8 weeks of antisecretory
medication has been completed,
b) Ulcer healing has
been documented by UGI or endoscopy, and
c) The aviator is
asymptomatic off medication. If ulcer
recurs, institute chronic ranitidine or sucralfate. In addition, a serum gastrin
level is recommended to screen for gastrinoma (nl < 100 pcg/ml).
b. Complicated PUD
1) H. pylori positive with or without
NSAID use
a) Helicobacter eradication regimen has
been successfully completed,
b) NSAIDs if any have been discontinued
c) Ulcer healing has
been documented by endoscopy,
d) Follow-up gastric
biopsy is negative by CLO and/or histologic staining,
and
e) Aviator is
maintained on chronic antisecretory medication.
2) H. pylori negative with NSAID use
a) NSAIDs have been discontinued,
b) 6-8 weeks of antisecretory
medication has been completed,
c) Ulcer healing has
been documented by UGI or endoscopy, and
d) The aviator is
asymptomatic without medication use.
Complicated
peptic ulcer with a negative history for NSAID use and negative work-up for Helicobacter should be treated with
chronic antisecretory medication; waiver is not
recommended. Additionally, a serum gastrin level is recommended to screen for gastrinoma. Also,
return to flying status is generally not recommended for any recurrent
complicated ulcer, except perhaps in unusual circumstances (e.g., inadvertent
NSAID use).
Aeromedical Disposition
(civilian): The above would also apply to civil airmen. In peptic ulcer disease resulting in bleeding
adequate healing must be demonstrated.
An airman with a hemoglobin less that 10 gm is
not granted certification. Surgical
treatment of peptic ulcer is allowed providing there have been no
complications. Use of prophylactic
medications, such as Carafate and H-2 or ion –pump
antagonists (Tagamet, Zantac, Prilosec,
etc.) is acceptable if there are no side effects after a trial period of 2
weeks. Annual current status follow up
from the treating physician will then be required.
Waiver Experience (military): Given the fundamental shift in understanding and treatment
of ulcer disease, the prior experience of military waivers for this condition
is probably obsolete. Of those past
cases, 10% were disqualified due to incomplete healing, residual symptoms, or
recurrent bleeds. With appropriate
therapy now available to definitively treat the vast majority of ulcer cases,
such disqualifications should become a rarity.
Most otherwise healthy aviators should be able to be returned to normal
duty.
Waiver Experience (civilian): As of the FAA has
granted medical certification to 611 First class, 813 Second class, and 2,283 Third class airmen with uncomplicated
peptic ulcer disease. There were 166
First class, 194 Second class, and 454 Third class airmen with complicated
peptic ulcer, defined as ulcers with bleeding, perforation, and obstruction
that have been granted medical certification during the same time period.
References:
NIH Consensus
Development Panel. Helicobacter pylori in
peptic ulcer disease. JAMA, 1994: 272:65-9.
Forbes GM, Glaser ME,
Culle JE, et al. Duodenal ulcer treated with Helicobacter pylori eradication:
seven-year follow-up. Lancet, 1994; 343:260-263.
Marshall BM. Helicobacter pylori. Am J Gastroenterol, 1994;
89:S116-S128.
Rayman, RB, Clinical Aviation Medicine, 3rd edition, Castle
Connolly Graduate Medical Publishing, LLC, 2000, pp. 12-14.
Walsh JH, Peterson
WL. The treatment of Helicobacter
pylori infection in the management of peptic ulcer disease.
November 27, 2001