Effect of herbal extract granules combined with otilonium bromide on irritable bowel syndrome with diarrhoea: a study protocol for a randomised controlled trial.

INTRODUCTION: Irritable bowel syndrome (IBS), known as a functional and organic gastrointestinal disorder, is a collection of symptoms that occur together and generally include pain or discomfort in the abdomen and changes in bowel movement patterns. Due to the limitations of conventional treatments, alternative IBS treatments are used by many patients worldwide. Samryungbaekchulsan (SRS), a herbal formula, has long been used for alleviating diarrhoea-predominant IBS (D-IBS) in traditional Korean medicine. Otilonium bromide (OB) is an antimuscarinic compound used to relieve spasmodic pain in the gut, especially in IBS. Although herbal formulae and Western drugs are commonly coadministered for various diseases in Korea, few clinical studies have been conducted regarding the synergic effects of these treatments for any disease, including D-IBS. METHODS AND ANALYSIS: This trial is a randomised, double-blinded, placebo-controlled, double-dummy, four-arm, parallel study. After a 2-week preparation period, 80 patients with D-IBS will be randomly assigned to one of four treatment groups consisting of SRS (water extract granules, 5 g/pack, three times a day) with OB (tablet form, one capsule three times a day) or their placebos, with treatment lasting for 8 weeks. Post-treatment follow-up will be conducted 4 weeks after the end of treatment. The primary outcome is the finding obtained using the Subject's Global Assessment of Relief method. The secondary outcomes are the severity of symptoms related to D-IBS, determined using a 10-point scale, and the change in symptoms. ETHICS AND DISSEMINATION: This trial has full ethical approval of the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS15MISV0033) and the Korean Ministry of Food and Drug Safety (30769). The results of the study will be disseminated through a peer-reviewed journal and/or conference presentations. TRIAL PROTOCOL VERSION: IS15MISV0033 version 4.0 (25 July 2016). TRIAL REGISTRATION NUMBER: KCT0001621 (approval date: 10 August 2015).

Local Anesthesia for Endovascular Treatment of Unruptured Intracranial Aneurysms: Feasibility, Safety, and Periprocedural Complications.

OBJECTIVE: The aim of the study is to report the feasibility, safety, and outcomes associated with endovascular treatment (EVT) of unruptured intracranial aneurysms (UIAs) under local anesthesia. METHODS: Between March 2011 and December 2016, 184 consecutive patients with 198 UIAs were treated with coil embolization under local anesthesia at the author's center. The data about medical comorbidities according to American Society of Anesthesiologists grade, procedural details, and clinical and radiographic outcomes were reviewed. RESULTS: A total of 388 procedures were performed under local anesthesia, and 198 procedures with UIA were included. The mean age was 63.8 ± 12.5 years, and 118 (59.6%) cases had a risk status of American Society of Anesthesiologists class III or IV. Of those 198 procedures, 196 procedures (99.0%) were completed successfully. The overall procedure-related event rate was 5% (10/198). The rates of morbidity and mortality were 0.5% (1 of 198) and 0% at 1 month, respectively. Among the 3 recurred cases (1.5%), two (1%) underwent EVT again. The mean intensive care unit stay was 0.99 ± 0.1 days, and the mean postoperative hospital stay was 3.6 ± 7.2 days. CONCLUSIONS: Local anesthesia in the EVT of UIA is feasible and safe. It could be considered as an alternative for the patients with high risk of general anesthesia.