Placebo controlled evaluation of Xilei San,a herbal preparation in patients with intractable ulcerative proctitis

Background and Aim: Topical mesalamine or corticosteroid has shown efficacy in patients with ulcerative proctitis, but patients often become refractory to these interventions. Xilei San is a herbal preparation with evidence of anti‐inflammatory effects. We evaluated the efficacy of topical Xilei San in ulcerative proctitis patients. Methods: In a double blind setting, 30 patients with intractable ulcerative proctitis despite ≥ 4 weeks of topical mesalamine or corticosteroid were randomly assigned to True (n = 15) and placebo (n = 15). Patients in True received suppository Xilei San (0.1 g/dose per day of Xilei San), the other 15 received placebo suppository. The initial efficacy was evaluated on day 14. Primary endpoint of the trial was avoiding relapse during 180 days, relapse meant recurrence of active disease. Riley's index was applied for endoscopic and histological evaluations, while patients' quality of life was evaluated by an inflammatory bowel disease questionnaire. Results: On day 14, the number of patients who achieved remission, clinical activity index ≤ 4 in True was significantly higher versus placebo (P < 0.04). Likewise, at day 180, an 81.8% of patients in True were without relapse versus 16.7% in placebo (P < 0.001). Further, significant endoscopic (P < 0.01), histological (P < 0.02) and inflammatory bowel disease questionnaire (P < 0.04) improvements were observed in True, but not in placebo. Conclusions: This is the first controlled investigation showing significant clinical and endoscopic efficacy for Xilei San in patients with intractable ulcerative proctitis. Topical Xilei San was well tolerated, and was without safety concerns.     

Contrast‐enhanced harmonic endoscopic ultrasonography for differential diagnosis of localized gallbladder lesions

Background and Aim

Differential diagnosis of localized gallbladder lesions is challenging. The aim of the present study was to evaluate the utility of contrast‐enhanced harmonic endoscopic ultrasonography (CH‐EUS) for diagnosis of localized gallbladder lesions.

Methods

One hundred and twenty‐five patients with localized gallbladder lesions were evaluated by CH‐EUS between March 2007 and February 2014. This was a single‐center retrospective study. Utilities of fundamental B‐mode EUS (FB‐EUS) and CH‐EUS in the differentiation of gallbladder lesions and sludge plug were initially compared. Thereafter, these two examinations were compared with respect to their accuracy in the diagnosis of malignant lesions. Five reviewers blinded to the clinicopathological results evaluated microcirculation patterns in the vascular and perfusion images.

Results

In the differentiation between gallbladder lesions and sludge plug, FB‐EUS had a sensitivity, specificity, and accuracy of 82%, 100%, and 95%, respectively, whereas CH‐EUS had a sensitivity, specificity, and accuracy of 100%, 99%, and 99%, respectively. FB‐EUS‐based diagnosis of carcinomas based on tumor size and/or shape had a sensitivity, specificity, and accuracy of 61–87%, 71–88%, and 74–86%, respectively. Additional information regarding irregular vessel patterns in the vascular image and/or heterogeneous enhancement in the perfusion image on CH‐EUS increased the sensitivity, specificity, and accuracy for the diagnosis of carcinomas to 90%, 98%, and 96%, respectively. There was a significant difference between FB‐EUS and CH‐EUS in terms of carcinoma diagnosis.

Conclusion

CH‐EUS was useful for the evaluation of localized gallbladder lesions.