title: Clinical effects of octreotide compared to placebo in patients with gastrointestinal neuroendocrine tumours. Report on a double-blind, randomized trial.
abstract: OBJECTIVE
  To compare the effect of octreotide with f placebo on symptoms, tumour marker and quality of life in patients with gastrointestinal neuroendocrine tumours and liver metastases.
  
  
  METHODS
  A blinded, placebo-controlled, cross-over study was performed. The number of flushing epidodes and diarrhoea episodes were registered for 1 week prior to the study and for the 8-week duration of the study. Quality of life and 24-h urinary 5-hydroxyindoleacetic acid (5-HIAA) excretion were measured before the start, and at 4 and 8 weeks. Quality of life was registered with the Psychosocial Adjustment to Illness Scale (PAIS) and 5-HIAA measured by high-performance chromatography with electrochemical detection. 5-HIAA values exceeding 45 mumol 24 h-1 were considered to be elevated.
  
  
  METHODS
  The study was performed in a tertiary referral centre.
  
  
  METHODS
  Twelve patients were approached; eleven patients were included, with a mean age of 56.5 (range 30-72) years. The primary tumour originated from the small intestine in nine and from the pancreas in two patients. The main symptoms were diarrhoea, flushing and nausea. The 24-h excretion of 5-HIAA was increased in all patients.
  
  
  METHODS
  Patients were treated for 4 weeks with octreotide (100 micrograms) subcutaneously, twice daily, and for 4 weeks on placebo (octreotide vehicle) in random starting order.
  
  
  METHODS
  The main outcome measures were the number of episodes of the main clinical symptom(s) and 24-h 5-HIAA excretion.
  
  
  RESULTS
  Octreotide lowered diarrhoea and flushing frequency significantly compared to placebo. 5-HIAA excretion was reduced during treatment with the active drug. Two domains of the PAIS were significantly improved, indicating that the reduction of tumour marker and symptoms were clinically important.
  
  
  CONCLUSIONS
  The clinical effect of octreotide on symptoms in patients with neuroendocrine tumours was demonstrated in a controlled, prospective trial.
authors.affiliation: Medical Department A. Rikshospitalet, University of Oslo, Norway.
authors.forename: M B
authors.initials: MB
authors.lastname: Jacobsen
authors.forename: L E
authors.initials: LE
authors.lastname: Hanssen
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D000368:Aged; D014408:Biomarkers, Tumor / Q000652:urine*; D004311:Double-Blind Method; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D006801:Humans; D006897:Hydroxyindoleacetic Acid / Q000652:urine*; D008113:Liver Neoplasms / Q000556:secondary / Q000652:urine; D008297:Male; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000556:secondary / Q000652:urine; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D014408:Biomarkers, Tumor; D006897:Hydroxyindoleacetic Acid; D015282:Octreotide