A Pilot Randomized, Clinical Trial of the Anti-pruritus Effect of Melatonin in Patients with Chronic Liver Disease

Document Type: Research article

Authors

1 Research Center for Experimental and Applied Pharmaceutical Sciences, Urmia University of Medical Sciences, Urmia, Iran.

2 Department of Clinical Pharmacy, School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran.

3 Department of Internal Medicine, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.

4 Liver Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran.

5 Department of Internal Medicine, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran

6 Digestive Disease Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.

7 Department of Clinical Pharmacy, School of Pharmacy, Iran University of Medical Sciences, Tehran, Iran.

8 Department of Internal Medicine, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.

9 Department of Clinical Pharmacy, school of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Abstract

Pruritus is one of the disturbing complications induced by chronic liver disease (CLD), bearing a negative impact on patient quality of life and potentially resulting in early liver transplants. Given the main role of the autotaxin enzyme in pruritus induced by CLD and the suppressive effects of melatonin on the expression of the autotaxin gene, this study was designed to evaluate the antipruritic effect of melatonin in patients with CLD. A double-blind, cross-over, randomized, placebo-controlled pilot trial was conducted on patients with CLD -induced pruritis. Patients were randomly assigned to two groups where they received melatonin 10-mg at night or placebo for 2 weeks. After a 2-week washout period, patients were then crossed over to the other group. The Visual Analog Scale (VAS) and the 12-Item Pruritus Severity Score (12-PSS) were used to assess patient response to therapy as the co-primary outcomes, while liver function tests were assayed too. Forty patients completed the study. The VAS score showed alleviation of 3.21 ± 2.24 (in pruritus) with melatonin (p-value <0.05). The study goal (a reduction of at least 20% in VAS) was achieved in 33 (82%) of study participants. In patients who received melatonin, the 12-PSS and Body Surface Area (BSA) affected by pruritus decreased on average 46.57% and 51.71%, respectively, with mood, sleep pattern and daily activity levels also demonstrating significant improvement (p-value < 0.05). Melatonin was found to be effective for managing pruritus in patients with CLD.

Graphical Abstract

A Pilot Randomized, Clinical Trial of the Anti-pruritus Effect of Melatonin in Patients with Chronic Liver Disease

Keywords