title: Double-blind, placebo-controlled, randomized trial of octreotide in malignant bowel obstruction.
abstract: BACKGROUND
  Does octreotide reduce vomiting in cancer-associated bowel obstruction?
  
  
  OBJECTIVE
  To evaluate the net effect of adding octreotide or placebo to standardized therapies on the number of days free of vomiting for populations presenting with vomiting and inoperable bowel obstruction secondary to cancer or its treatment.
  
  
  METHODS
  Twelve services enrolled people with advanced cancer presenting with vomiting secondary to bowel obstruction where surgery or anti-cancer therapies were not indicated immediately. In a double-blind study, participants were randomized to placebo or octreotide (600 μg/24 hours by infusion). Both arms received standardized supportive therapy (infusion of ranitidine [200 mg/24 hours], dexamethasone [8 mg/24 hours], and parenteral hydration [10-20 mL/kg/24 hours]). The primary outcome was patient-reported days free of vomiting at 72 hours.
  
  
  RESULTS
  In a study that recruited to the numbers identified in its power calculation, 87 participants provided data at 72 hours (45, octreotide arm). Seventeen people (octreotide) and 14 (placebo) were free of vomiting for 72 hours (P = 0.67). Mean days free of vomiting were 1.87 (SD 1.10; octreotide) and 1.69 (SD 1.15; placebo; P = 0.47). An adjusted multivariate regression of the incidence of vomiting over the study showed a reduced number of episodes of vomiting in the octreotide group (incidence rate ratio = 0.40; 95% CI: 0.19-0.86; P = 0.019); however, people in the octreotide arm were 2.02 times more likely to be administered hyoscine butylbromide (P = 0.004), potentially reflecting increased colicky pain.
  
  
  CONCLUSIONS
  Although there was no reduction in the number of days free of vomiting, the multivariate analysis suggests that further study of somatostatin analogues in this setting is warranted.
authors.affiliation: Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia. Electronic address: david.currow@flinders.edu.au.
authors.forename: David C
authors.initials: DC
authors.lastname: Currow
authors.affiliation: Flinders Clinical Effectiveness, Flinders University, Adelaide, South Australia, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Quinn
authors.affiliation: Sacred Heart Hospice, Braeside Hospital, Sydney, New South Wales, Australia.
authors.forename: Meera
authors.initials: M
authors.lastname: Agar
authors.affiliation: Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.
authors.forename: Belinda
authors.initials: B
authors.lastname: Fazekas
authors.affiliation: Department of Palliative and Supportive Care, Mater Health Services, South Brisbane, Queensland, Australia.
authors.forename: Janet
authors.initials: J
authors.lastname: Hardy
authors.affiliation: Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia; Flinders Clinical Effectiveness, Flinders University, Adelaide, South Australia, Australia.
authors.forename: Nikki
authors.initials: N
authors.lastname: McCaffrey
authors.affiliation: Centre for Health Service Development, Australian Health Services Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.
authors.forename: Simon
authors.initials: S
authors.lastname: Eckermann
authors.affiliation: Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia; Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
authors.affiliation: Department of Palliative Care, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
authors.forename: Katherine
authors.initials: K
authors.lastname: Clark
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D001315:Australia / Q000453:epidemiology; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage; D006801:Humans; D007414:Intestinal Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D007415:Intestinal Obstruction / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000008:administration & dosage* / Q000009:adverse effects; D015990:Placebo Effect; D015995:Prevalence; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000175:diagnosis / Q000401:mortality*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D005765:Gastrointestinal Agents; D015282:Octreotide
keywords: Malignant bowel obstruction; net clinical benefit; octreotide; palliative care; randomized controlled trial; vomiting