A proof-of-concept study has found that home-delivered meals that are both low in sodium and high in protein is not only feasible in patients with refractory ascites, but may also reduce their need for therapeutic paracentesis and improve their quality of life.
Although the primary therapy for ascites is restriction of salt in the diet, only about 10% of patients respond well to the treatment, according to Elliot B. Tapper, MD, an assistant professor of medicine at the University of Michigan Hospital in Ann Arbor.
“If you don’t control [sodium], patients end up requiring paracentesis to drain the abdomen. So, our thought here was that by standardizing patients’ meals, they might do better in the long run,” Tapper said.
To help test the hypothesis, Tapper and his colleagues enrolled 40 patients into the trial (mean age 54 years; 54% male). All had cirrhosis and ascites at the time of an outpatient paracentesis or hospitalization with symptomatic ascites. The participants were randomly assigned to receive the institution’s standard-of-care—an educational handout regarding low-sodium diets—or three daily home-delivered meals. Each day’s worth of home-delivered meals had less than 2,000 mg of sodium, more than 2,100 kilocalories and at least 80 g of protein, as well as a nightly protein supplement.
The food intervention took place for four weeks. The study’s primary outcome was the number of paracenteses performed during a 12-week follow-up period.
In an abstract submitted to the 2020 Digital International Liver Congress (SAT122), Tapper’s group reported that 44% of participants percent were diabetic, and 44% fully ADL-independent. Their mean score on the Model of End Stage Liver Disease-Na was 18 (range, 11-23), while mean albumin was 2.7 (range, 2.5-3.3). At baseline, patients had undergone a median of two paracenteses in the preceding four weeks.
The researchers found that after 12 weeks, patients who received the delivered food required a mean of 0.34 paracenteses per week (range, 0.14-0.54), compared with 0.45 (range, 0.25-0.64) for those receiving standard of care.
Similarly, ascites-specific quality of life was improved to a greater degree in the food arm (25%) than in the standard-of-care group (13%). Although frailty measures were unchanged in both groups, patients in the food-delivery group experienced improved grip strength relative to the others, which Tapper said might reflect improved nutritional status.
The researchers found it notable that patients in both groups improved. “So, even though improvements were greater in the in food-delivery arm, the other patients did really well, too,” Tapper told Gastroenterology & Endoscopy News. “This is likely because we were calling them regularly to check in, which isn’t really standard of care.”
The gains seen in the standard-of-care group highlight the role of improved education and closer monitoring among patients with ascites, he added.
The food-delivery intervention was well received by most patients, who had ‘excellent’ adherence to the meal schedule, Tapper’s team reported. Patients with poor dentition and lactose intolerance suggested the need for a wider variety of meal choices.
Those options will probably come in the next iteration of the study, which the investigators say will be a multicenter effort comprising some 200 patients. “We’re going to feed them longer and analyze outcomes in a slightly different way to see whether or not it could be saving lives at the same time as preventing ascites,” Tapper said.
Russell Rosenblatt, MD, MS, an assistant professor of medicine at Weill Cornell Medicine in New York City, called the food-delivery concept simple, elegant and smart.
“We always talk about decreasing salt intake, but the food just tastes terrible,” Rosenblatt said. “Patients knows this and they have such a hard time complying with it. This is such a novel and simple concept, which is what I really love about it. It gives food directly to patients, and which would certainly help those who may be struggling financially because they’re sick and can’t earn a living.”
Although some health systems may be deterred by the apparent cost of offering home-delivered meals to these patients, Rosenblatt said such services would prove financially viable in the long run. “If compare the cost of one hospital and ICU admission for hepatorenal syndrome with the cost of this, then the intervention pays for itself,” he said. “I’m a fan of simple things that can help patients, save us all money and time, and unburden the system. And this checks all those boxes.”
—Michael Vlessides
Tapper and Rosenblatt reported no relevant financial disclosures.
This article is from the May 2021 print issue.