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 US, the rate increasing with age.  While nearly all infected individuals show evidence of gastritis on biopsy, ulcers occur only in a minority, implicating other factors such as strain virulence and host susceptibility.  Variations in the latter probably account for the "classic" risk factors of PUD, e.g., smoking.

 

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. N Engl J Med, 1995; 333:984-91.

 

 

November 27, 2001