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

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 a...

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Autores principales:	Annie George, Jay K. Udani, Ashril Yusof
Formato:	article
Lenguaje:	EN
Publicado:	Taylor & Francis Group 2019
Materias:	antioxidant inflammation immunomodulatory intoxication alcohol interleukin clinical Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/495cbe524663475a8e2ccc36f5f215b4
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spelling	oai:doaj.org-article:495cbe524663475a8e2ccc36f5f215b42021-11-17T14:21:56ZEffects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study1388-02091744-511610.1080/13880209.2019.1585460https://doaj.org/article/495cbe524663475a8e2ccc36f5f215b42019-01-01T00:00:00Zhttp://dx.doi.org/10.1080/13880209.2019.1585460https://doaj.org/toc/1388-0209https://doaj.org/toc/1744-5116Context: 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.Annie GeorgeJay K. UdaniAshril YusofTaylor & Francis GrouparticleantioxidantinflammationimmunomodulatoryintoxicationalcoholinterleukinclinicalTherapeutics. PharmacologyRM1-950ENPharmaceutical Biology, Vol 57, Iss 1, Pp 145-153 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	antioxidant inflammation immunomodulatory intoxication alcohol interleukin clinical Therapeutics. Pharmacology RM1-950
spellingShingle	antioxidant inflammation immunomodulatory intoxication alcohol interleukin clinical Therapeutics. Pharmacology RM1-950 Annie George Jay K. Udani Ashril Yusof Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study
description	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.
format	article
author	Annie George Jay K. Udani Ashril Yusof
author_facet	Annie George Jay K. Udani Ashril Yusof
author_sort	Annie George
title	Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study
title_short	Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study
title_full	Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study
title_fullStr	Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study
title_full_unstemmed	Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study
title_sort	effects of phyllanthus amarus phyllprotm leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study
publisher	Taylor & Francis Group
publishDate	2019
url	https://doaj.org/article/495cbe524663475a8e2ccc36f5f215b4
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Effects of Phyllanthus amarus PHYLLPROTM leaves on hangover symptoms: a randomized, double-blind, placebo-controlled crossover study

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