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

Pharmaceutical Biology

Ashril Yusof¹  Annie George²  Jay K. Udani³ 

[1] Centre for Sports and Exercise Sciences, Exercise Science, University of Malaya, Kuala Lumpur, Malaysi;Institute of Biological Sciences, Faculty of Science, University of Malaya, Kuala Lumpur, Malaysia;Biotropics Malaysia Berhad, Selangor, Malaysia;Medicus Research LLC, Northridge, CA, USA;

关键词: Antioxidant;    inflammation;    immunomodulatory;    intoxication;    alcohol;    interleukin;    clinical;   

DOI  :  10.1080/13880209.2019.1585460

来源: Taylor & Francis

【 摘 要 】

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.

【 授权许可】

CC BY