P. Juul-hansen et al., High-dose proton-pump inhibitors as a diagnostic test of gastrooesophagealreflux disease in endoscopic-negative patients, SC J GASTR, 36(8), 2001, pp. 806-810
Background: To evaluate a high dose of a proton-pump inhibitor as a diagnos
tic test in endoscopy-negative patients presenting with symptoms indicating
gastro-oesophageal reflux disease. Methods: 64 patients were studied in a
prospective, randomized, double-blind study, using a cross-over design. Aft
er a run-in period with the diary registration of basic CORD symptoms and r
ecording of the consumption of antacid tablets, the patients were given eit
her 60 mg of lansoprazole once daily or placebo in randomized order. Sympto
ms were recorded, as well as antacid tablets taken in order to relieve pain
. CORD was determined by 24-h oesophageal pH monitoring. The test was consi
dered positive when consumption of antacid tablets was reduced greater than
or equal to 75% compared to pretreatment. Results: In the GORD group, 29 (
85%) tested positive during active treatment compared to 3 (9%) when on pla
cebo. Corresponding figures for the non-GORD patients were 50% and 27%, giv
ing a test sensitivity and specificity of 85% and 73%, respectively. During
active treatment, VAS scores for acid regurgitation, heartburn and over al
l were significantly lowered in CORD patients, compared to heartburn only i
n the non-GORD group. Conclusions: 60 mg lansoprazole once daily for 5 days
is an easy to use method fur diagnosing CORD in endoscopy-negative patient
s. Using 24-h oesophageal pH monitoring as the reference method, the sensit
ivity was relatively high, while the specificity was lower. Further studies
are needed to determine how a PPI could be used as a diagnostic test in GO
RD.