Abstract
BackgroundIn this post-hoc analysis of a randomized, double blind, placebo controlled trial, we measured the sensitivity and specificity of Helicobacter pylori IgG-antibody titer changes, hematoxylin and eosin (H&E) stains, immunohistochemical (IHC) stains and culture results in NSAID using patients, following H. pylori eradication therapy or placebo.Methods347 NSAID using patients who were H. pylori positive on serological testing for H. pylori IgG-antibodies were randomized for H. pylori eradication therapy or placebo. Three months after randomization, gastric mucosal biopsies were taken for H. pylori culture and histological examination. At 3 and 12 months, blood samples were taken for repeated serological testing. The gold standard for H. pylori infection was based on a positive culture or both a positive histological examination and a positive serological test. Sensitivity, specificity and receiver operating curves (ROC) were calculated.ResultsH. pylori eradication therapy was successful in 91% of patients. Culture provided an overall sensitivity of 82%, and 73% after eradication, with a specificity of 100%. Histological examination with either H&E or IHC stains provided sensitivities and specificities between 93% and 100%. Adding IHC to H&E stains did not improve these results. The ROC curve for percent change in H. pylori IgG-antibody titers had good diagnostic power in identifying H. pylori negative patients, with an area under the ROC curve of 0.70 (95 % CI 0.59 to 0.79, P = 0.085) at 3 months and 0.83 (95% CI 0.76 to 0.89, P < 0.0001) at 12 months. A cut-off point of at least 21% decrease in H. pylori IgG-antibody titers at 3 months and 58% at 12 months provided a sensitivity of 64% and 87% and a specificity of 81% and 74% respectively, for successful eradication of H. pylori.ConclusionsIn NSAID using patients, following H. pylori eradication therapy or placebo, histological examination of gastric mucosal tissue biopsies provided good sensitivity and specificity ratios for evaluating success of H. pylori eradication therapy. A percentual H. pylori IgG-antibody titer change has better sensitivity and specificity than an absolute titer change or a predefined H. pylori IgG-antibody titer cut-off point for evaluating success of H. pylori eradication therapy.
Highlights
In this post-hoc analysis of a randomized, double blind, placebo controlled trial, we measured the sensitivity and specificity of Helicobacter pylori IgG-antibody titer changes, hematoxylin and eosin (H&E) stains, immunohistochemical (IHC) stains and culture results in non-steroidal anti-inflammatory drugs (NSAIDs) using patients, following H. pylori eradication therapy or placebo
Helicobacter pylori (H. pylori) infection has been shown to be related to the development of peptic ulcer disease, chronic gastritis, MALT lymphoma and gastric cancer [1,2,3,4]
While eradication of H. pylori infection in NSAID-naïve patients prior to NSAID therapy reduces the risk of ulcer development, it does not do so in current NSAID users [18,19,20]. This was confirmed in a recent randomized, double blind, placebo controlled clinical trial, in which we found that eradication of H. pylori infection did not reduce the incidence of endoscopic gastroduodenal ulcers in H. pylori seropositive patients currently taking NSAIDs for rheumatic diseases [21]
Summary
In this post-hoc analysis of a randomized, double blind, placebo controlled trial, we measured the sensitivity and specificity of Helicobacter pylori IgG-antibody titer changes, hematoxylin and eosin (H&E) stains, immunohistochemical (IHC) stains and culture results in NSAID using patients, following H. pylori eradication therapy or placebo. Accurate diagnosis of H. pylori infection has clinical consequences as H. pylori eradication improves infection of the gastric mucosa causes a chronic local inflammatory cell infiltration, which in turn gives rise to a serological response, in which H. pylori specific antibodies are almost always detectable [8,9]. As a result, evaluating success of H. pylori eradication therapy using repeated serological tests has only been shown to be useful if a period of several months is maintained between tests [11,12,13]. The use of immunohistochemical (IHC) stains adds time and expense to the diagnostic evaluation for H. pylori and is not routinely performed
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