Seeking New Options for a Stomach Disorder

Nortriptyline unhelpful for gastroparesis symptoms

(RxWiki News) Sometimes a medication approved for one purpose can be used to treat a completely different condition. But then again, sometimes the medication doesn't help as expected.

A recent study found that a particular antidepressant did not help the symptoms of gastroparesis.

Gastroparesis is a gastrointestinal disorder in which the stomach is not emptied at the rate it should be.

The disorder slows or stops food from moving to the small intestine from the stomach.

The antidepressant used in the study was nortriptyline, which goes by the brand name Pamelor.

"Ask about gastroparesis treatment options."

The study, led by Henry P. Parkman, MD, of the Gastroenterology Section at Temple University School of Medicine, looked at whether nortriptyline could successfully treat the symptoms of gastroparesis.

The researchers split 130 patients with gastroparesis into two equal groups of 65 participants.

For 15 weeks, the participants in one group received nortriptyline while the participants in the other group received a placebo, or fake pill.

Neither the patients nor the researchers giving the medication knew which participants were receiving the real drug versus the placebo.

The patients who received nortriptyline received 10 mg during the first three weeks of the study, followed by 25 mg at six weeks, 50 mg at nine weeks and 75 mg at 12 weeks.

To compare the symptoms in the two groups, the researchers used scores on the Gastroparesis Cardinal Symptom Index (GCSI), a diagnostic scale that rates symptoms from mild to moderate to severe.

The symptoms rated on the GCSI included nausea, vomiting, bloating and fullness after eating.

The researchers did not find that one group's symptoms improved more than the other group's.

While 15 of the participants, or 23 percent of them, experienced improvement in the nortriptyline group, 14 patients receiving placebos, or 21 percent of them, experienced symptom improvement.

In addition, significantly more participants stopped their treatment in the nortriptyline group: 19 patients compared to only 6 in the placebo group.

However, the side effects reported in the nortriptyline group and the placebo group were similar.

Regardless, the study revealed that nortriptyline was not helpful in improving symptoms of gastroparesis.

The study was published December 24 in the journal JAMA. The research was funded by the National Institute of Diabetes and Digestive and Kidney Diseases.

Nine authors reported some form of financial relationship, receiving grants and/or serving as a consultant or adviser, with a number of pharmaceutical, food or medical industry companies.

These companies included Tranzyme Pharma, Evoke Pharma, GlaxoSmithKline, Prostrakan, Medtronic, Ironwood-Forest Pharma, Salix Pharma, Rhythm Pharma, Novartis, Red Hill Pharma, Takeda Pharma, UpToDate, Theravance, SmartPill, First Aid Beverages and Neurogastrx.

One author provided expert testimony in a legal case, and one holds a patent related to gastroparesis and stock options in Neurogasrx.

Review Date: 
December 24, 2013