Activating Blood Circulation to Remove Stasis Treatment of Hypertensive Intracerebral Hemorrhage:A Multi-Center Prospective Randomized Open-Label Blinded-Endpoint Trial

Objective： To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation （TRABC） in treatment of hypertensive intracerebral hemorrhage （HICH）. Methods： This was a multi-center prospective randomized open-label blinded-endpoint （PROBE） trial with HICH admitted to 12 hospitals. Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months. Primary outcome was degree of disability as measured by modified Rankin Scale （mRS）. Secondary outcomes were the absorption of hematoma and edema, National Institutes of Health Stroke Scale （NIHSS） scores and patient-reported outcome measures for stroke and Barthel activities of daily living index. Adverse events and mortality were also recorded. Results： After 3 months of treatment, the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%, respectively, and in the control group 48.1% and 63.9%, respectively, with a significant difference between groups （P〈0.01）. Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group （P=0.038）. Average Barthel scores in the treatment group after treatment was 89.11 ＋ 19.93, and in the control group 82.18 ＋ 24.02 （P=0.003）. NIHSS scores of the two groups after treatment decreased significantly compared with before treatment （P=0.001）. Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment （P〈0.05）. There were 4 deaths, 2 in each group, and 11 adverse events, 6 in the treatment group and 5 in the control group. Conclusion： The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment, without increasing intracerebral hematoma expansion and re-bleeding.

Modified Helicobacter test using a new test meal and a 13C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors

AIM To determine the sensitivity and specificity of the ^(13)C-urea breath test(UBT) in patients taking proton pump inhibitors(PPIs), using a new test meal Refex. METHODS One hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori(H. pylori) positive, 49 H. pylori negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the ^(13)C-UBT with the new test meal was performed the next morning. RESULTS The sensitivity of the ^(13)C-UBT with a cut off 2.5‰ was92.45%(95%CI: 81.79%-97.91%) by per-protocol(PP) analysis and 78.13 %(95%CI: 66.03%-87.49%) by intention-to-treat(ITT) analysis. The specificity of the ^(13)C-UBT test was 96.00 % in the ITT population(95%CI: 86.29%-99.51%) and 97.96% in the PP population(95%CI: 89.15%-99.95%).CONCLUSION The new test meal based ^(13)C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.