After 48 weeks, nonalcoholic fatty liver disease activity scores (NAS) improved in 13 out of 19 patients who used the NASH app developed by CureApp, according to Masaya Sato of the University of Tokyo and colleagues.
If confirmed by a controlled trial, these preliminary results could show promise for digital therapeutics, the researchers stated in an article published in The American Journal of Gastroenterology.
“The widespread use of smartphones, which can process and communicate data in real time, makes them an ideal platform for therapeutic interventions,” they said.
Although lifestyle changes can reduce NASH activity, many patients have difficulty keeping up these changes. Not enough counselors are available to guide patients in healthy practices, and hiring the counselors is expensive, the researchers wrote.
Smartphone applications aimed at instilling healthy behavior have been tried in diabetes, smoking, hypertension, alcoholism, and even cancer, they noted. They wanted to see whether something similar could be done with NASH.
The researchers recruited 19 patients with biopsy-confirmed NASH who consumed no more than moderate amounts of alcohol and had a body mass index (BMI) of at least 25 kg/m2. Their mean age was 52 years, mean BMI was 32, and mean NAS was 5.0.
The patients downloaded the NASH app onto their phones and entered their baseline profile information, including age, gender, diet and exercise practices, and social characteristics. On the basis of this information and daily weight measurements, the system proposed lifestyle improvement programs tailored to each individual. Its chatbot presented them in the form of behavioral goals and lectures from virtual nurses.
While patients used the app for 48 weeks, they also received standard outpatient care for NASH from live physicians, who also promoted the use of the app and provided additional education related to NASH.
The patients underwent liver biopsies within 90 days prior to beginning the study and at the end of 48 weeks. The researchers compared the changes in these patients versus those in a hypothetical control group, which they based on the placebo group in a previous study.
In the patients who used the app, the mean NAS change from baseline to week 48, the main endpoint, was –2.05 (95% confidence interval, –3.00 to –1.11). This result was statistically significant compared with the hypothetical control group, in which the mean change in NAS was –0.7 (P < .001).
In 11 of the patients, NAS decreased by at least 2 points without worsening of liver fibrosis. In eight patients, the researchers observed resolution of steatohepatitis, which they defined as disappearance of hepatocyte ballooning.
In 12 patients with stage F2 or F3 fibrosis, the average stage went from 2.5 to 2.0 (P = .02). No patient with stage F1 fibrosis showed a reduction in fibrosis stage. The scores for steatosis decreased in 11 patients, for lobular inflammation in 9 patients, and for ballooning in 10 patients.
The patients lost an average of 8.3% of their body weight, which was significant, compared with their baseline (P < .001). The patients also notched significant reductions in average serum levels of AST, ALT, gamma-glutamyltransferase, alkaline phosphatase, and triglycerides.
The researchers noted that the lack of a real control group and the small size of the study population limited the importance of their findings. A larger randomized, controlled trial is needed to confirm their results.
During the study, physicians browsed the patients’ data and provided them with feedback about it, the researchers wrote. But the study did not measure the amount of time the physicians spent on this activity.
CureApp founded the study, and one of the authors is a consultant for the company.
A version of this article first appeared on Medscape.com.
