Patient Acceptance of Lactulose Varies Between Indian and American Cohorts: Implications for Comparing and Designing Global Hepatic Encephalopathy Trials

Abstract

There are significant variations in the acceptance of lactulose in Indian and American populations. The acceptance increases with a more favorable perceived benefit/risk profile, which is strongly influenced by socio-cultural factors. These results have important implications when designing, comparing and interpreting HE trials from different parts of the world.

Lactulose improves cognition, quality of life, and gut microbiota in minimal hepatic encephalopathy: A multicenter, randomized controlled trial

“…Lactulose also had good acceptability in the Chinese population, with only one patient developing abdominal pain and ultimately resulted in an enhanced QoL. This puts the acceptance of lactulose in line with published high‐quality studies from India, unlike that of the West, as published by Rathi et al…”

Bristol Stool Scale as a Determinant of Hepatic Encephalopathy Management in Patients With Cirrhosis

“…However, this dogma is being increasingly challenged with the recent publication from our group determining that regardless of HE or lactulose use, cognitive impairment was not associated with BM frequency (4). The focus on number of BMs and driving doses of lactulose beyond that would be tolerable to most Western patients often leads to readmissions due to nonadherence (3,9). HE remains the major cause of readmissions, many of which are driven by medication nonadherence to lactulose (10)(11)(12).…”

“…Lactulose can result in multiple GI adverse events, has a high rate of nonadherence within Western patients, and not only often leads to multiple medication changes but also can precipitate acute kidney injury, hyponatremia, and worsening of HE. Thus, caution should be applied when using bowel frequency alone as an end point for lactulose therapy (3). Moreover, this one-size-fits-all policy does not consider baseline BM frequency or consistency and is not associated with objective cognitive performance data (4).…”

Long-term management of hepatic encephalopathy with lactulose and/or rifaximin: a review of the evidence

“…Crucially, all patients who were nonadherent on lactulose therapy, and nearly two-thirds of those who were adherent, experienced OHE recurrence 10 . There is evidence to suggest that patient acceptance of lactulose is influenced by sociocultural factors; for example, in a recent survey of 100 outpatients with cirrhosis from India and the USA, who did not have previous or current experience with lactulose but who underwent dedicated education about its use for HE prevention, a significantly higher proportion of Indian versus US patients agreed to accept lactulose treatment 49 . In this context, it is perhaps noteworthy that a substantial number of the lactulose studies identified in this review were carried out in patients from the Indian subcontinent.…”