To evaluate the effectiveness of amidotrizoate by the percentage of patients unresponsive to their current laxative regimens who had a bowel movement within 24 hours after administration.
Intervention Characteristics/Basic Study Process
All patients with cancer admitted to an acute pain relief and palliative care unit during a one-year period were surveyed. If patients had no bowel movement for three consecutive days despite receiving regular doses of senna, lactulose, or a combination of both, they were consented to participate in the study. Patients were hydrated via IV and then given 50 ml of amidotrizoate orally. A repeat dose could be given the next day, based on clinical judgment or patient preference.
- The study reported on a sample of 99 patients (63 men and 36 women).
- Mean patient age was 65.7 years (SD = 12.2).
- Cancer sites were lung (n = 30), genitourinary (n = 19), gastrointestinal (n = 11), breast (n = 8), pancreas (n = 8), head and neck (n = 6), and other (n = 17).
- Previous treatments were chemotherapy (n = 29), surgery (n = 23), and radiation (n = 3).
- Single site
Phase of Care and Clinical Applications
The study has clinical applicability for end-of-life and palliative care.
This was a prospective trial.
- Nausea scale (0 to 3)
- Demographic information: age, gender, primary tumor, previous abdominal surgery, chemotherapy, radiotherapy in the last month, and use of opioids in the last month
- Presence of early satiety
- Reduction of fluid and food intake scale (0 to 3)
- Time to first bowel movement
- Adverse effects from amidotrizoate
- Of the evaluable patients, 80.8% were receiving opioids.
- Within 24 hours after amidotrizoate administration, 44.4% of patients had a bowel movement and patients reported significant improvement in nausea, hydration, and nutrition.
- Early satiety symptoms improved in the amidotrizoate group (p < 0.048).
- The effect of amidotrizoate on bowel movement was independent of age, Karnofsky Performance Status, days of constipation, use or dose of opioids, primary tumor, or concomitant chemotherapy or radiotherapy.
- The treatment was more effective in patients who had a history of abdominal surgery.
- The most frequent adverse effect reported was diarrhea in 19 patients.
Amidotrizoate is an effective and well-tolerated alternative therapy for patients with advanced cancer and constipation.
- The sample was small (less than 100).
- There was no blinding, with potential for bias.
- The study was performed in a specific setting (an acute palliative care unit) where patients may be at end of life; therefore, other patient populations or settings may need to be considered to avoid bias.
Amidotrizoate is used in radiology as a contrast media. Additional research is needed on the use of this agent as a laxative before it can be considered for patients with constipation.