Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study

Pharm Biol. 2019 Dec;57(1):145-153. doi: 10.1080/13880209.2019.1585460.

Abstract

Context: Phyllanthus amarus Schumach. and Thonn. (Euphorbiaceae) is traditionally known to improve general liver health. However, its effect on hangover is unknown.

Objective: This study evaluated PHYLLPRO™, a standardized ethanol extract of P. amarus leaves for protection against oxidative stress and recovery from hangover symptoms.

Material and methods: Ten days daily oral supplementation of 750 mg/day followed by intoxication was evaluated in a randomized placebo-controlled (containing only excipient), crossover study in 15 subjects (21-50 years old), for oxidative stress, liver damage, alleviating hangover symptoms (Hangover Severity Score: HSS) and mood improvement (Profile-of-Mood-Scores: POMS).

Results: PHYLLPRO™ was able to remove blood alcohol in the active group while the placebo group still had 0.05% at 12 h post-intoxication (p < 0.0001). For HSS, the active group showed reduced hangover symptoms while there were higher levels of nausea, headache, anorexia, tremulousness, diarrhoea and dizziness in the placebo group (p < 0.05) at hour 10 post-intoxication. Increased fatigue at hour 2 and tension (p > 0.05) from baseline to hour 22 was reported in the placebo group using POMS. Significant anti-inflammatory group effect favouring the active group, by the upregulation of cytokines IL-8 (p = 0.0014) and IL-10 (p = 0.0492) and immunomodulatory effects via IL-12p70 (p = 0.0304) were observed. The incidence of adverse events was similar between groups indicating the safety of PHYLLPRO™.

Discussion and conclusion: Preliminary findings of PHYLLPRO™ in managing hangover, inflammation and liver functions following intoxication, is demonstrated. Future studies on PHYLLPRO™ in protecting against oxidative stress and hangover in larger populations is warranted.

Keywords: Antioxidant; alcohol; clinical; immunomodulatory; inflammation; interleukin; intoxication.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Alcohol Drinking / adverse effects
  • Alcohol Drinking / blood
  • Alcoholic Intoxication / blood
  • Alcoholic Intoxication / drug therapy*
  • Biomarkers / blood
  • Cross-Over Studies
  • Cytokines / blood
  • Dietary Supplements
  • Double-Blind Method
  • Ethanol / blood
  • Female
  • Headache / blood
  • Headache / drug therapy
  • Headache / etiology
  • Humans
  • Male
  • Middle Aged
  • Phyllanthus*
  • Phytotherapy / methods*
  • Placebos
  • Plant Extracts / pharmacology
  • Plant Leaves
  • Substance Withdrawal Syndrome / drug therapy*
  • Substance Withdrawal Syndrome / etiology

Substances

  • Biomarkers
  • Cytokines
  • Placebos
  • Plant Extracts
  • Ethanol

Grants and funding

This study was funded by Biotropics Malaysia Berhad.