Use of antidepressant does not improve symptoms from stomach disorder

December 24, 2013

Among patients with idiopathic (of unknown cause) gastroparesis, use of the antidepressant nortriptyline compared with placebo for 15 weeks did not result in improvement in overall symptoms, according to a study appearing in the December 25 issue of JAMA. Gastroparesis is a disease of the muscles of the stomach or the nerves controlling the muscles that causes the muscles to stop working, which can result in inadequate grinding of food by the stomach and poor emptying of food from the stomach into the intestine.

Gastroparesis remains a challenging syndrome to manage, with few effective treatments and a lack of rigorously controlled trials. One possible approach to treatment is based on the hypothesis that some of the symptoms (e.g., nausea, pain) arise because of changes in certain nerves. Tricyclic antidepressants are a category of drug often used to treat refractory (not yielding readily to treatment) symptoms of nausea, vomiting, and abdominal pain, according to background information in the article.

Henry P. Parkman, M.D., of Temple University, Philadelphia, and colleagues randomized 130 patients with idiopathic gastroparesis to nortriptyline (n = 65) or placebo (n = 65) to determine whether treatment with the tricyclic antidepressant nortriptyline would result in improvement of symptoms. Study drug dose was increased at 3-week intervals. The primary outcome measure was a decrease in the patient's Gastroparesis Cardinal Symptom Index (GCSI) score of at least 50 percent on 2 consecutive visits during 15 weeks of treatment.

The researchers found that the proportion of patients experiencing symptomatic improvement on 2 visits did not differ between the treatment groups: 15 (23 percent) in the nortriptyline group vs. 14 (21 percent) in the placebo group. There were also no treatment group differences in measures of nausea, fullness or early satiety, or bloating. Treatment was stopped more often in the nortriptyline group (29 percent) than in the placebo group (9 percent), but numbers of adverse events were not different.

"Our results raise general doubts about the utility of tricyclic antidepressants in low doses as a strategy for the treatment of idiopathic gastroparesis," the authors conclude.
-end-
(doi:10.l001/jama.2013.282833; Available pre-embargo to the media at http://media.jamanetwork.com)

Editor's Note: This trial, from the Gastroparesis Clinical Research Consortium, is supported by National Institute of Diabetes and Digestive and Kidney Diseases grants. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

The JAMA Network Journals

Related Placebo Articles from Brightsurf:

Effect of fluvoxamine vs placebo on clinical deterioration in outpatients with symptomatic COVID-19
This randomized trial compares the effects of fluvoxamine, a selective serotonin reuptake inhibitor with immunomodulatory effects, versus placebo on a composite of dyspnea or pneumonia and oxygen desaturation among adult outpatients with polymerase chain reaction-confirmed mild COVID-19 illness.

Hydroxychloroquine no more effective than placebo in preventing COVID-19
Clinical trial with COVID-19 testing of participants shows health care workers in contact with coronavirus patients who took hydroxychloroquine each day did not reduce their rate of infection.

Compared to placebo, vitamin D has no benefit for severe asthma attacks
Contrary to earlier observational results, vitamin D supplements do not prevent severe asthma attacks in at-risk children, according to the first placebo-controlled clinical trial to test this relationship.

UMN trial shows hydroxychloroquine has no benefit over placebo in preventing COVID-19
Today, University of Minnesota Medical School researchers published the results from the first randomized clinical trial testing hydroxychloroquine for the post-exposure prevention of COVID-19.

The placebo effect and psychedelic drugs: tripping on nothing?
A new study from McGill suggests that, in the right context, some people may experience psychedelic-like effects from placebos alone.

Methotrexate reduces joint damage progression over placebo in erosive hand OA
According to new research findings presented at the 2019 ACR/ARP Annual Meeting, methotrexate did not demonstrate superior efficacy over placebo for pain relief and function evolution at three and 12 months in patients with erosive hand osteoarthritis, but did significantly reduce the progression of joint damage over placebo and seems to facilitate bone remodeling in these patients.

Botulinum toxin reduces chronic migraine attacks, compared to placebo
A growing body of evidence supports the effectiveness of botulinum toxin injections in reducing the frequency of chronic migraine headaches, concludes an updated review and analysis in the January issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Opioids vs. placebo, nonopioid alternatives for chronic noncancer pain
An estimated 50 million adults in the United States were living with chronic noncancer pain in 2016 and many of them were prescribed opioid medications, even though a clinical benefit is uncertain.

Probiotic no better than placebo for acute gastroenteritis in children
While probiotics are often used to treat acute gastroenteritis (also known as infectious diarrhea) in children, the latest evidence shows no significant differences in outcomes, compared to a placebo.

Most common shoulder operation is no more beneficial than placebo surgery
In a landmark study published this week in the BMJ, Finnish researchers show that one of the most common surgical procedures in the Western world is probably unnecessary.

Read More: Placebo News and Placebo Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.