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Background: Practitioners of traditional Chinese medicine know that auricular point acupressure (APP) using vaccaria seeds on the large intestine point (CO7) has a significant effect on postoperative gastrointestinal dysfunction. A standardized, clinical, research design will transform this clinical experience into scientific evidence, thus providing a basis to promote the wider use of this therapy. We aim to carry out a double-blind, randomized, controlled trial (RCT) to evaluate the efficacy and safety of APP treatment for gastrointestinal dysfunction after laparoscopic cholecystectomy.Methods/design: This study is a randomized, double-blind, controlled, single-center, clinical, pilot trial. It has been designed according to the Consolidated Standards of Reporting Trials (CONSORT 2010) guidelines as well as the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). Study subjects are being selected from among hospitalized patients who have undergone laparoscopic cholecystectomy at the Department of Minimally Invasive Surgery of Tianjin Nankai Hospital. Qualified subjects will be assigned randomly either to the APP group or to the APP sham stimulation group on the basis of random numbers generated using SPSS 19.0. A specifically appointed investigator will be responsible for the randomization. The APP therapy (or sham stimulation) will be performed 6 h after surgery and every 12 h subsequently; six sessions will be conducted, each lasting 3 min. The first evaluation will be performed immediately before the first treatment (6 h after surgery) and, then, every 12 h for seven evaluations. The primary outcome is the time to first passage of flatus after surgery; the secondary outcome measures are abdominal distension, nausea, vomiting, time to first defecation, psychological status, and quality of life.Discussion: This pilot trial is a standardized, scientific, clinical trial designed to evaluate the efficacy and safety of APP treatment-using vaccaria seeds on CO7-for gastrointestinal dysfunction after laparoscopic cholecystectomy. We aim to provide objective evidence to promote this therapy in clinical practice.Trial Registration: Chinese Clinical Trial Registry, ChiCTR-IPR-15007643 . Registered on 14 December 2015. [ABSTRACT FROM AUTHOR]

Background: It has been suggested that coffee may affect the gut-brain axis with conflicting outcomes. Moreover, there is insufficient evidence to determine whether the type or temperature of coffee consumed will have a different impact on the gut-brain axis. The purpose of this study was to investigate the effects of acute coffee consumption on the following: 1. self-reported GI symptoms and salivary gastrin, 2. stress indices [salivary cortisol and alpha-amylase (sAA)] and psychometric measures, and 3. blood pressure (BP), in healthy, daily coffee consuming individuals in non-stressful conditions.Methods: This was a randomized, double blind, crossover clinical trial, in which 40 healthy individuals (20 men, 20 women), 20-55 years of age, randomly consumed four 200 ml coffee beverages containing 160 mg caffeine (hot and cold instant coffee, cold espresso, hot filtered coffee), 1 week apart. Salivary samples and psychometric questionnaires were collected at baseline and post-coffee consumption at 15,30, and 60 min for salivary gastrin and sAA measurements and at 60,120, and 180 min for cortisol measurements. BP was measured at beginning and end of each intervention. ClinicalTrials.gov ID: NCT02253628 RESULTS: Coffee consumption significantly increased sAA activity (P = 0.041), with significant differences only between cold instant and filter coffee at 15 and 30 min post-consumption (P < 0.05). Coffee temporarily increased salivary gastrin, without differences between coffee types. Coffee did not affect salivary cortisol or self-reported anxiety levels. Coffee consumption significantly increased BP, within the healthy physiological levels, in a gender specific manner at the end of the experimental periods, without differences between coffee types.Conclusion: Acute coffee consumption in non-stressful conditions activated sAA and BP but not salivary cortisol, indicating activation of the sympathetic nervous system. Post-coffee sAA increase without a concomitant cortisol increase may also indicate that coffee may have some anti-stress properties. [ABSTRACT FROM AUTHOR]