The
analgesic effect of
salmon calcitonin was tested by a double-blind clinical randomized controlled trial in 40 female patients with painful osteolytic
metastases. Twenty patients were administered (daily) 100 IU of
salmon calcitonin subcutaneously over 28 days, while the other 20 were administered identical ampoules containing 2 ml of physiological
solution over the same period of time. The basic treatment (
chemotherapy,
hormone therapy) was not changed during the trial, and had to be stabilized for a minimum of 3 months prior to the trial. The effect of
calcitonin was monitored with respect to daily
analgesic consumption, duration of
pain, patient's functional capacity, patient's own assessment of
pain, and assessment of efficacy by the investigator. Statistically significant differences were established in terms of reduced
analgesic consumption, shorter duration of
pain and the patient's subjective assessment of
pain duration and intensity; the difference was not statistically significant with regard to patient's functional capacity. The objective assessment of the
analgesic effect of
calcitonin by the investigator showed the
drug to be extremely useful in 3 patients and moderately useful in 11 patients; 3 instances of 'moderately useful' were observed in the placebo group. No changes were observed in serum
calcium levels; there were likewise no skeleton changes as established by X-rays and bone scintiscans before and at the end of treatment. The trial has shown
calcitonin to produce a pronounced
analgesic effect in
breast cancer patients with painful osteolytic
metastases.