Clinical effects of octreotide compared to placebo in patients with gastrointestinal neuroendocrine tumours. Report on a double-blind, randomized trial.
J Intern Med
; 237(3): 269-75, 1995 Mar.
Article
in En
| MEDLINE
| ID: mdl-7534331
ABSTRACT
OBJECTIVES:
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.DESIGN:
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.SETTING:
The study was performed in a tertiary referral centre.SUBJECTS:
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.INTERVENTIONS:
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. MAIN OUTCOMEMEASURES:
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.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Quality of Life
/
Octreotide
/
Biomarkers, Tumor
/
Neuroendocrine Tumors
/
Gastrointestinal Neoplasms
/
Hydroxyindoleacetic Acid
Type of study:
Clinical_trials
/
Observational_studies
Aspects:
Patient_preference
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Intern Med
Journal subject:
MEDICINA INTERNA
Year:
1995
Document type:
Article
Affiliation country:
Norway