Helicobacter pylori eradication in dyspeptic primary care patients: a randomized controlled trial of a pharmacy intervention.
OBJECTIVE
To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a standard drug treatment regimen.


METHODS
Randomized controlled clinical trial.


METHODS
Nonprofit group-practice health maintenance organization (HMO).


METHODS
HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing (UBT).


METHODS
Those whose tests were positive for H pylori (23.3%) were provided a standard antibiotic regimen and randomly assigned to receive either usual-care counseling from a pharmacist or a longer adherence counseling session and a follow-up phone call from the pharmacist during drug treatment. All subjects were given the same 7-day course of omeprazole, bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (OBMT). Dyspepsia symptoms were recorded at baseline and following therapy.


RESULTS
The main outcome was eradication of H pylori as measured by UBT at 3-month follow-up. Secondary outcomes were patient satisfaction and dyspepsia symptoms at 3-month follow-up.


RESULTS
Of the 333 participants randomly assigned to treatment, 90.7% completed the 3-month follow-up UBT and questionnaires. Overall eradication rate with the OBMT regimen was 80.5% with no significant difference in eradication rates between the 2 groups (P=0.98). Conclusions In this study, additional counseling by pharmacists did not affect self-reported adherence to the treatment regimen, eradication rates, or dyspepsia symptoms but did increase patient satisfaction.
Stevens
Victor J
VJ
Kaiser Permanente Center for Health Research, 3800 North Interstate Ave Portland, OR 97227, USA. victor.j.stevens@kpchr.org
Shneidman
Robert J
RJ
Johnson
Richard E
RE
Boles
Myde
M
Steele
Paul E
PE
Lee
Nancy L
NL
D000293:Adolescent; D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010353:Patient Education as Topic; D010595:Pharmacists; D011795:Surveys and Questionnaires; D016896:Treatment Outcome