title: The influence of duodenally-delivered Shakuyakukanzoto (Shao Yao Gan Cao Tang) on duodenal peristalsis during endoscopic retrograde cholangiopancreatography: a randomised controlled trial.
abstract: BACKGROUND
  Anti-cholinergic agents may be used to inhibit duodenal peristalsis, but they may have adverse effects. Shakuyakukanzoto (Shao Yao Gan Cao Tang) has an anti-spasmodic effect and has been used before for oesophagogastroduodenoscopy and colonoscopy. This randomised clinical trial aimed to evaluate the inhibitory effect of Shakuyakukanzoto on duodenal peristalsis, and its usefulness when administered into the duodenum just before endoscopic retrograde cholangiopancreatography (ERCP).
  
  
  METHODS
  Participants were recruited between June 2008 and December 2010. All were aged ≥18 years and provided written informed consent. Exclusion criteria were: acute pancreatitis, a history of ischemic heart disease, prostatic hypertrophy or glaucoma, and altered/postsurgical upper gastrointestinal anatomy. The recruited participants were randomly assigned to the Shakuyakukanzoto group and control group. Shakuyakukanzoto 100 mg/mL solution or placebo (warm water) was administered directly as a spray into the duodenum during endoscopy. Efficacy was evaluated by observing the extent of duodenal peristalsis and assessing the difficulty of cannulating the common bile duct, the required time (RT) from administration to inhibition of duodenal peristalsis and the stop duration time (DT, the duration for which peristalsis was inhibited). Side effects were evaluated by measuring serum potassium concentration after ERCP.
  
  
  RESULTS
  Of 28 participants, 15 were assigned to the Shakuyakukanzoto group and 13 to the control group. Duodenal peristalsis was inhibited in eight of the 10 eligible participants (80.0%) in the Shakuyakukanzoto group and none (0%) of the nine eligible participants in the control group (P= 0.026). In the Shakuyakukanzoto group, mean RT (±standard deviation) was 76.0 ± 23.9 s and DT was 11.3 ± 4.2 min. No adverse effects were observed in the Shakuyakukanzoto group during or after ERCP.
  
  
  CONCLUSIONS
  Duodenal peristalsis can be inhibited by spraying Shakuyakukanzoto solution directly into the duodenum.Trial registrationUMIN Clinical Trials Registry (UMIN-CTR) UMIN000011469.
authors.affiliation: Department of Endoscopy, Toyama University Hospital, Toyama, Japan.
authors.forename: Haruka
authors.initials: H
authors.lastname: Fujinami
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine and Pharmaceutical Science, University of Toyama, Sugitani 2630, Toyama City, Toyama 930-0194 Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Kajiura
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine and Pharmaceutical Science, University of Toyama, Sugitani 2630, Toyama City, Toyama 930-0194 Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Nishikawa
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine and Pharmaceutical Science, University of Toyama, Sugitani 2630, Toyama City, Toyama 930-0194 Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Ando
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine and Pharmaceutical Science, University of Toyama, Sugitani 2630, Toyama City, Toyama 930-0194 Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Sugiyama