A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin

Bossi, Paolo; Cortinovis, Diego; Fatigoni, Sonia; Rocca, Maria Cossu; Fabi, Alessandra; Seminara, Patrizia; Ripamonti, Carla; Alfieri, Salvatore; Granata, Roberta; Bergamini, Cristiana; Agustoni, Francesco; Bidoli, Paolo; Nolè, Franco; Pessi, Maria Adelaide; Macchi, Fabio; Michellini, L.; Montanaro, Federica; Roila, Fausto

doi:10.1093/annonc/mdx315

Cited by 56 publications

(67 citation statements)

References 17 publications

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“…Additionally, the shortcomings in the current ginger clinical trials across domains need to be specified. First, the group size was generally small and rarely exceeded 100 participants per group (only five studies) [30,37,80,91,92]. Thirty-six studies conducted clinical trials group sizes of less than 20 patients.…”

Section: Discussionmentioning

confidence: 99%

Ginger on Human Health: A Comprehensive Systematic Review of 109 Randomized Controlled Trials

et al. 2020

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Clinical applications of ginger with an expectation of clinical benefits are receiving significant attention. This systematic review aims to provide a comprehensive discussion in terms of the clinical effects of ginger in all reported areas. Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline, randomized controlled trials on the effects of ginger were investigated. Accordingly, 109 eligible papers were fully extracted in terms of study design, population characteristics, evaluation systems, adverse effects, and main outcomes. The reporting quality of the included studies was assessed based on the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials and integrated together with studies that investigated the same subjects. The included studies that examined the improvement of nausea and vomiting in pregnancy, inflammation, metabolic syndromes, digestive function, and colorectal cancer’s markers were consistently supported, whereas other expected functions were relatively controversial. Nevertheless, only 43 clinical trials (39.4%) met the criterion of having a ‘high quality of evidence.’ In addition to the quality assessment result, small populations and unstandardized evaluation systems were the observed shortcomings in ginger clinical trials. Further studies with adequate designs are warranted to validate the reported clinical functions of ginger.

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Section: Discussionmentioning

confidence: 99%

Ginger on Human Health: A Comprehensive Systematic Review of 109 Randomized Controlled Trials

et al. 2020

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“…Especially, ginger is a key component of XBXT, which have been used for treating CINV in clinic [15]. Pinellia, another key component of XBXT, is used for the treatment of cough, phlegm, and vomiting in pregnant women [49].…”

Section: Discussionmentioning

confidence: 99%

“…Ginger is a key component of XBXT, which is believed to play an important role in treating nausea and emesis. It is reported that ginger extract can counteract CINV in a randomized, double-blind, placebo-controlled, multicenter study [15]. Heba Abdel-Aziz et al considered that different extracts of ginger, such as [6]-, [8]-, [10]-gingerol and [6]-shogaol acted on the 5-HT3 receptor ion-channel complex and inhibited 5-HT3 receptor function to exert their antiemetic effect [16,17].…”

Section: Introductionmentioning

confidence: 99%

The Antiemetic Effect of Xiao-Ban-Xia-Tang Formula is Associated With Regulating CaM/CaMKII/ERK1/2 Signaling Pathway in Cisplatin and 1-phenylbiguanide Hydrochloride Induced Rat Pica Models

Xia¹,

Xian²,

Feng³

et al. 2020

Preprint

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Background: Xiao-Ban-Xia-Tang (XBXT) formula is a traditional Chinese herbal formula for treating emesis. Chemotherapy-induced nausea and vomiting (CINV) are serious side effects of chemotherapy, which was closely related to the activation of 5-hydroxytryptamine 3 receptor (5-HT3R). In this paper, the effect of XBXT on cisplatin- and 1-phenylbiguanide hydrochloride (1-PBG, a selective 5-HT3R agonist)- induced pica behavior in male Wistar rats and inhibition of calmodulin/calmodulin-dependent protein kinase II/extracellular signal-regulated kinase 1/2 (CaM/CaMKII/ERK1/2) signaling pathway were investigated. Methods: XBXT (1.6 g/kg, twice daily) was orally administered from day 1 after intraperitoneal injection of cisplatin (6 mg/kg) and 1-PBG (25 mg/kg) to day 3. Pica behavior (consumption of kaolin, a type of clay) was recorded every 24 h. The expression and co-localization of CaM and 5-HT3R in small intestine and brain were detected by immunofluorescence. The expression of CaMKII, pCaMKII, ERK1/2, and pERK1/2 proteins were detected by Western blot. Results: XBXT treatment significantly decreased kaolin ingestion (pica) of rats after treatment of cisplatin and 1-PBG during both 0 - 24 h (respectively, from 1.57 g to 0.87 g; from 1.04 g to 0.11 g) and 0 - 72 h (respectively, from 2.98 g to 1.85 g; from 2.29 g to 0.35 g) periods. The fluorescence expression of CaM and 5-HT3R and expression of CaMKII, pCaMKII, ERK1/2 and pERK1/2 in the small intestine and brain of cisplatin- and 1-PBG-treated rats were remarkably suppressed by XBXT.Conclusions: The present study implies that inhibiting CaM/CaMKII/ERK1/2 signaling is an underlying mechanism of XBXT for treating CINV. These insights provide an experimental basis of XBXT for the clinical treatment of CINV.

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“…Regarding the influence of this intervention on the control of nausea and vomiting in the acute phase, 11 publications were detected that analyzed nausea in the acute phase (15)(16)(22)(23)(24)(25)(26)(27)(28)(29)(30) , among which 8 (23)(24)(25)(26)(27)(28)(29)(30) detected advantages, but only 6 investigations had statistically significant results with p < 5% (p = 0.002 (23) ; p = 0.0001 (24) ; p = 0.04 (26) ; p = 0.0003 (27) , p = 0.003 (29)(30) ). Regarding emesis, 8 studies analyzed the acute stage (14,18,(21)(22)24,(27)(28)34) ; of these, 6 (19,23,25,28,34) observed the therapeutic effect of ginger, but only 2 had significant results considering significance level of 5% (p = 0.002 (29) ; p = 0.04 (35) ). Regarding the influence on the control of nausea and vomiting in the delayed phase, 6 studies (15)(16)(22)(23)(28)…”

Section: Note: Flie: Functional Living Index Emesismentioning

confidence: 99%

“…The type of cancer was addressed in 18 studies, of which 12 (15)(16)(17)(19)(20)22,24,(26)(27)30,32,35) analyzed the breast; and 4, the lung (18,27,30,34,36) . The pathology stage was addressed only in 4 studies (14,(16)(17)(18) , and in 2 of them, phase II presented a higher occurrence (14,17) . Seventeen studies exposed the chemotherapy protocol investigated, of which 6 (15)(16)(22)(23)31,35) evaluated those who had emetogenic potential from moderate to high but did not mention the names of the drugs.…”

Section: Note: Flie: Functional Living Index Emesismentioning

confidence: 99%

Benefits of ginger in the control of chemotherapy-induced nausea and vomiting

et al. 2020

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Objectives: To identify and discuss scientific evidence of the effects of ginger use on the management of chemotherapy-induced nausea and vomiting. Methods: This is an integrative reviewperformed by Ganong’s reference. Results: We included 24 studies, highlighting three thematic categories, namely 1) antiemetic action of ginger - nausea (13 articles; of these, nine significant) and emesis (10 studies; of these, six significant); 2) action in the control of nausea (11 articles; of these, six significant) and vomiting (8 articles; of these, three significant) in the acute phase; 3) action in the control of nausea (6 articles; of these, three significant) and vomiting (6 articles; of these, three significant) in the delayed phase. There were divergences of the methods used. Final considerations: This complementary therapy has low cost and easy access, but no statistical confirmation of its effectiveness in the management of nausea and vomiting in cancer patients was found.

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A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin

Abstract: In patients treated with high-dose cisplatin, the daily addition of ginger, even if safe, did not result in a protective effect on CINV. The favorable effect observed on nausea in subgroups at particular risk of nausea (females; HNC) deserves specific investigation.

Cited by 56 publications

References 17 publications

Ginger on Human Health: A Comprehensive Systematic Review of 109 Randomized Controlled Trials

Ginger on Human Health: A Comprehensive Systematic Review of 109 Randomized Controlled Trials

The Antiemetic Effect of Xiao-Ban-Xia-Tang Formula is Associated With Regulating CaM/CaMKII/ERK1/2 Signaling Pathway in Cisplatin and 1-phenylbiguanide Hydrochloride Induced Rat Pica Models

Benefits of ginger in the control of chemotherapy-induced nausea and vomiting

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