Improvement of Platelet Count after Helicobacter Pylori Screening and Eradication in Immune Thrombocytopenia Patients: A Randomized Open-Label Study

Abstract

Background:Helicobacter pylori (HP) has been known as a secondary cause of immune thrombocytopenia (ITP). Previous studies have demonstrated platelet count improvement after HP eradication in ITP. However, the impact of HP screening in adults with ITP remains unclear. Methods: We conducted a randomized open-label study to evaluate the benefit of HP screening to improve platelet count in ITP patients. Persistent or chronic ITP patients with ≥ 18 years of age who had platelet count below 150 x109/L were eligible. Patients were excluded if there were HIV or hepatitis C virus infection, active cancer, history of HP eradication within 1 year, or antibiotics/bismuth use within one month before enrollment. Patients were allocated in a 3:1 ratio to the HP screening arm or non-screening arm. Patients in the HP screening arm underwent 2 methods of HP screening: urea breath test (UBT) and HP serology test (Assure® H. pylori Rapid Test). Patients who had positive HP results by either test were received HP eradication with a 14-day course of proton pump inhibitor-based triple therapy. Treated patients were subsequently confirmed HP eradication by stool antigen test at 1 month. Dose modifications of treatments for ITP were allowed according to the treating physician's decision. Platelet count and 3-month cumulative dose of prednisolone were measured at baseline, 3 months, and 6 months. Quality of life using the Thai version of EQ-5D-5L was assessed at baseline and 6 months. The primary outcome was the mean difference in platelet count at 6 months. Key secondary outcomes were the prevalence of HP infection in adult ITP patients and improvement of EQ-5D-5L score at 6 months. Other outcome was the diagnostic accuracy of the HP serology test. Results: A total of 64 patients were enrolled. Forty-nine patients were assigned to the HP screening arm and 15 patients to the non-screening arm. Mean age was 47.2 years (SD 15.7). Fifty patients (78%) were female. Forty patients (62.5%) were using prednisolone with a mean dose of 8.5 mg/day. Mean platelet count at baseline was 73.8 x109/L (SD 29.5). Baseline characteristics were balanced (Table 1). All of the patients, except one, in the HP screening arm completed 2 methods of screening. Twenty-three of 48 patients had HP positive results by UBT, as a result, the prevalence of HP was 47.9%. All HP-positive patients completed an HP eradication course. One patient had a positive result of stool antigen test after HP eradication, which was successfully eradicated with levofloxacin-based treatment. At 6 months follow-up, patients in the HP screening arm had a significant improvement in platelet count as compared to baseline with a mean difference of 21.8 x109/L (95% CI 22.2 - 41.3, p=0.030) (Table 2). In addition, the EQ-5D-5L score revealed a significant improvement at 6 months as compared to baseline in the HP screening arm with a mean difference of 4.2 points (95% CI 0.8 - 7.6, p=0.016) (Table 2). Patients in the non-screening arm had no significant changes in platelet count or EQ-5D-5L score. A 3-month cumulative dose of prednisolone and dose adjustments of concomitant ITP treatments at 6 months in both arms were not significantly changed. Of 23 UBT-positive patients, only 11 patients had positive results with HP serology. All 25 UBT-negative patients also had negative results with HP serology. The sensitivity and specificity of the HP serology test were 47.8% and 100%, respectively. Conclusion: The prevalence of HP infection in adult Thai ITP patients was 47.9%. HP screening is effective in the improvement of platelet count and quality of life at 6 months in adult ITP patients with platelet count below 150 x 109/L. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal