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Using Ki-67, a monoclonal antibody, the proliferating capacity of 15 salivary gland tumours, including nine pleomorphic adenomas, four adenoid cystic carcinomas, one mucoepidermoid carcinoma and one acinic cell carcinoma was determined immunohistochemically, using normal salivary gland tissue as a control. The frequency of Ki-67 positive cells was 4.7 per cent in the normal salivary gland and one per cent in pleomorphic adenomas, whereas the average frequency in malignant tumours was 18.3 per cent. Among adenoid cystic carcinomas, the frequency was related to the morphological type; the solid sub-type had the highest frequency of Ki-67-positive cells. As this sub-type is recognized as the most aggressive of these tumours, this technique has the potential of providing an early indication of the clinical behaviour of a tumour.

Background There is growing evidence of the treatment efficacy of cognitive behavioral therapy (CBT) for irritable bowel syndrome (IBS). CBT is recommended by several practice guidelines for patients with IBS if lifestyle advice or pharmacotherapy has been ineffective. Manual-based CBT using interoceptive exposure (IE), which focuses on the anxiety response to abdominal symptoms, has been reported to be more effective than other types of CBT. One flaw of CBT use in general practice is that it is time and effort consuming for therapists. Therefore, we developed a set of complementary video materials that include psycho-education and homework instructions for CBT patients, reducing time spent in face-to-face sessions while maintaining treatment effects. The purpose of this study is to examine the effects of CBT-IE with complementary video materials (CBT-IE-w/vid) in a multicenter randomized controlled trial (RCT). Methods This study will be a multicenter, parallel-design RCT. Participants diagnosed with IBS according to the Rome IV diagnostic criteria will be randomized to either the treatment as usual (TAU) group or the CBT-IE-w/vid + TAU group. CBT-IE-w/vid consists of 10 sessions (approximately 30 min face-to-face therapy + viewing a video prior to each session). Patients in the CBT-IE-w/vid group will be instructed to pre- view 3- to 13-min videos at home prior to each face-to-face therapy visit at a hospital. The primary outcome is the severity of IBS symptoms. All participants will be assessed at baseline, mid-treatment, post-treatment, and follow-up (3 months after post assessment). The sample will include 60 participants in each group. Discussion To our knowledge, this study will be the first RCT of manual-based CBT for IBS in Japan. By using psycho-educational video materials, the time and cost of therapy will be reduced. Manual based CBTs for IBS have not been widely adopted in Japan to date. If our CBT-IE-w/vid program is confirmed to be more effective than TAU, it will facilitate dissemination of cost-effective manual-based CBT in clinical settings. Trial registration The trial was registered to the University Hospital Medical Information Network Clinical Trial Registry: UMIN, No. UMIN000030620 (Date of registration: December 28, 2017).

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