Mari Maeda-Yamamoto, Hiroshi Nagai*, Kaori Ema, Emi Kanda, Norihisa Okada and Masaaki Yasue**

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1 584 Nippon Shokuhin Kagaku Kogaku Kaishi Vol. /,, No.+,, /2. /3- (,**/) 32 * ** * ** E#ects and Safety of Consecutive Intake of Benifuuki Green Tea and Enhancement of the E#ect by Ginger Extract in Subjects with Japanese Cedar-pollinosis Mari Maeda-Yamamoto, Hiroshi Nagai*, Kaori Ema, Emi Kanda, Norihisa Okada and Masaaki Yasue** National Institute of Vegetable and Tea Science, NARO,103 Kanaya, Shizuoka.,2 2/*+ * Beverage Research&Development Laboratory, Asahi Soft Drinks Co., Ltd, + +,+ Midori, Moriya, Ibaraki -*, *+*0 ** Fundamental Research Laboratory, Asahi Breweries, Ltd. + +,+ Midori, Moriya, Ibaraki -*, *+*0 A double-blind clinical study was carried out on subjects with Japanese cedar pollinosis for the evaluation of the e#ects and safety of!benifuuki green tea, which contains epigallocatechin---o-(--omethyl)-gallate (O-methylated catechin), and a combination of!benifuuki green tea and ginger extract, with!yabukita green tea as a placebo. First, the e#ect of the combination of!benifuuki green tea and various vegetable extracts on cytokine production inhibition was investigated using mast cells ; the simultaneous use of!benifuuki green tea and ginger extract was found to suppress cytokine (TNF-a or MIP+-a) production to a remarkable extent. Subjects were given +./ gof!benifuuki green tea,!benifuuki green tea containing -* mg of ginger extract, or!yabukita green tea with water twice every day for +- weeks. As cedar pollen scattering increased, the severity of pollinosis symptoms among the groups was observed to increase in the following order : placebo group Benifuuki group Benifuuki and ginger group. Eleven weeks after the beginning of treatment, during the most severe cedar pollen scattering period, symptoms of runny nose and itchy eyes were significantly relieved among the!benifuuki group compared with the placebo group (p *.*/). In the!benifuuki and ginger group, runny nose, itchy eyes and nose symptom scores were significantly reduced at the eleventh week, and nasal congestion, sore throat and nose symptom medication scores were significantly reduced at the thirteenth week compared with the placebo group. Among all test groups, hematological examination, general biochemical examination, determination of total IgG, CMV antibody titer, and serum iron content, and interviews throughout the intake period found no changes related to clinical problems. These results suggest that intake of!benifuuki green tea over one month is useful in reducing some of the symptoms of Japanese cedar pollinosis, and did not a#ect normal immune response in subjects with Japanese cedar-pollinosis. It was also found that the addition of ginger extract enhanced the e#ect of!benifuuki green tea. (Received Jul. +,,,**/ ; Accepted Sep. +0,,**/) +33, *.,2 2/*+,103 * -*, *+*0 + +,+ ** -*, *+*0 + +,+ Corresponding author marimy@a#rc.go.jp *, 20* +31* **,*** 2,/

2 33 : 585 T B E IgE I FceRI, IgE FceRI IgE IgE MBP, ECP, EDN - IL-. IL-/ Th,. 0 IL-. IgE 1 2 LPS lipopolysaccharide TNF-a 3 - O EGCG - O ECG +* +, +- - O - O : EGCG- Me +. +/ IgE +3,* IgE,+ Camellia sinensis L. +.,, +,./ g,/ ml +*,- + +* 1 /* g / g / ml /* 0 *** g +/ + +* 1 /* l BMMC -* ng ml IL-- / FBS Invitrogen, USA RPMI+0.*. BMMC DNP-IgE Sigma Aldrich, USA + *./ g, +* 0 cells +* DNP-HSA Cosmo-Bio, Tokyo -** ng ml, Bio-plex Bio-Rad, USA IL-+a IL-+b IL-, IL-- IL-. IL-/ IL-0 IL-+* IL-+, p.* IL-+, p1* IL-+1 IFN-g TNF-a g-csf KC MIP+-a RANTES, IgE,1,- /3 +2.* IgE / 2/ 23 30,*** *,

3 586 /, +,,**/ +, 34 + BF n 3 BF n 3 n 3 IgE cm kg M:n 1 F:n, / /4. 0-4* +,43-4. *43 M:n / F:n * * / +4+ M:n / F:n , , /34/ *42 IgE / BF : BF : :, - O - O - O +4.3,4-2 / * *,42, / + +

4 35 : 587,**. / 3 BF /*,* m, +./ g -* mg BF +./ g, + +,,.-/ mg,**. 0 +./ g, 1/ ,,, + +3,2, +0 / WBC RBC MCV MCH MCHC BCG GOT GPT ALP go g-gtp UV TG T-chol HDL HDL-chol IgG IgE Eosionophil cationic protein : ECP FEIA CD,- CMV,**. +,,0,**/. 2 + / + / + +,. Symptom Score, Medication Score Symptom Medication Score,**/, Mann-Whitney U Wilcoxon and Bonferroni t - Dunnet + BMMC, IL-/ IL-0 IL-+1 GM-CSF TNF-a MIP-+a - TNF-a MIP-+a IL-0 BF BF TNF-a, TNF-a BF BF

5 588 /, +,,**/ +, 36 BF TNF-a.* TNF-a 1* BF, TNF-a 3/ MIP-+a BF TNF-a,/,0 +, E, 0,1, BF BF BF BF. IgE, IgE, ECP CD,- /0 BF 20 CD,- IgE - DNP BMMC pg ml DNP IL-/ IL-0 GM-CSF IL-+1 TNF-a MIP-+a /24. +,21 +-4* +.** *40,4- *4-,14., *, TNF-a

6 37 : 589. /,/ /0 20 ( / ) +**. g dl +**. g dl g dl GOT IU l GPT IU l ALP IU l g-gtp IU l HDL IgG IU ml --** 3*** BF BF -2* /1* BF BF ++4/ +14/ BF BF -.42 /,4. BF BF /* /3* BF BF BF BF BF BF -42 BF BF +*.* BF BF /./ BF BF +** -,/ BF BF 2* BF BF * BF BF 14* BF BF +,*,+3 BF BF -* +.3 BF BF.* 1/ BF BF 21* +1** BF BF 0/++ +0-, / **,++* / +/4+ +4/ *,4+./4* -4,.* *4* /4+, *40* / ,,/4,.43,043 /4+,/41 / *4-14, *4-14- *4..41 *4-.40 *4,.40 *4/,+4, /4,,.4* 242,*41.42, /,34/,*4/ *4,,+3 /-4+,.3 2*40,** * -,4*, * -.4*.+4/ *421 *4+ *41+ *4+0 *412 *4+ / / / * -,4/ , , +3/,0- +3, -+42 / / /34* 143 +,.-,2* +++,,+3 +,.-,10 0*,, +0,+ 0-** +0-3 /, , /.22,343 +/4, +4, +.4.,4* +-42,4+./43, *.42 +,,4, 3143,*/4/ *040 +*042,.4, -4,,24..40,.4/ * * *4-.40 *4,.42 *4-.41 *4-,,43 041,.4+ +,4/,+4-.42,.4, ++4/ -*4-,,4- +/4. 04*,+. //4.,/- 1341,/ * * -,4. *42- *4+ *41* *4+, *41. *4+, 04* *4+ 04* +4+ /4+ *42 +2/ --43,+1 -* ,./,13 +* * /24. +*42 +,32 -,. +, *1 0+/0 +,00 00,, +22/ /*-- +,*3.2*.+41.0, /+43.2* ,,4*..4/ -4/.,4/.4..*43 /4* / ,41,04,.41,340 /41,14/ /40 14/ * *4-14. *4-.41 *4,.43 *4,.40 *4.,,42 04,, *4, +14-, , 043,,*.04.,0. 124*,*,./4,.24*.,4- -*4.,*4* -* *423 *4++ *41/ *4+0 *42, *4+/ /41 +4, /4/ +4* +2/ -*40 +32, , ,4, / +,* /,4* / /14- +,41 / ,-,, ,-1,0+ 0, *3 /0** ++/ / *.,4. +/4+ +4, +-42, ,4+./41,40.,4*.4/.,4. / /40 +/ *4* 3*4+,/4.,43,24* 04.,/4, /4* 14/ *4-14. *4-14. *4-.41 *4-.42 *4,.41 *4.,-4. 14,,-4* ,141 +/41, ,,*4, +*4.,,0.343, *,* *, * *43+ *4++ *412 *4+- *42+ * / , /4/ +4* * /- 0+43,--,2. +-, /342 /140 +*4, /04* +.4, / ,+., ,++ +,,/,01

7 590 /, +,,**/ +, 38. /,/ /0 20 ng ml ECP mg ml CD,- ml IgE RAST IgE RAST /*,** BF BF,1*.,/ BF BF +.* --* BF BF *4, BF BF +.41 BF BF,** BF BF BF BF BF BF +,.4-0/4-3*4- -04* 3+43 /.4* /+4. 0,4+ -/.4+ /14-,0,4,.041,,/4* 0042, *41. *4,- *411 *4+3 *403 *4-* 14*3 041/ 043/ 04/1 /4., -4/1 +/ / +./42 214* -4/0 * *41+.4** *421,4** +4**,4++ *412,4-- * /+43 ++*4+ /*4, 2-4/ *.,40 -/ /43.34-,0,4-0343,.*4, 0-4-,.24. +*0 *400 *4+2 *43, *4-. *41- *4-, 140- / /42- / /4/ -/4/ +++4, / * *412,4** +4**,4++ *412,4-- * *, * ,4+ -/ /.4*..4+,034, /04.,/04+ /24/, *4-1 *4-1 *4// *4-/ *4-1 *4,* /411.4/3-4/.,4/0 +,,4, 224/ / / +/*4+ -4/ *4/-.4** *41+,4** +4**,4** *41+,4.. *41- +*-41,04-234,.* / /24* 1*4* ,//4+ /141,.*4* /,40, *4// *4*3 +4*, *4/3 *402 *4, *1 /4* * +,34, +*.41 +,+41..4, * * * *412,4** +4**,4** *41+,4-- *41+ * p *4*/ BF : BF : :. IgG, CMV - GOT, GPT, ALP, g-gtp, HDL 20 BF , - +/ + +/ -a - b - c - d symptom score - e symptom medication score - f BF ++ BF symptom score ++ symptom medication score , +, symptom medication score,. symptom

8 39 : : BF : BF : * p *.*/ ** p *.*+

9 592 /, +,,**/ +, 40 medication score BF BF BF + -,2 -* CD,- symptom score, symptom medication score IgE -+ T BF FceRI BF BF symptom score, symptom medication score BF IgE, ECP BF BF + +,.3,***, Mita, H., Yasueda, H., Ishii, T. and Akiyama, K., IgEmediated basophil releasability is influenced by intrinsic factors and by IgE on the cell surface, Allergy., /*, 3/, 3/2 - Capron, M.,,- 03, 1*, Hart, P.H., Regulation of the inflammatory response in asthma by mast cell products, Immunol Cell Biol., 13, +.3 +/-,**+ / Ferrer, M., Luquin, E., Sanchez-Ibarrola, A., Moreno, C., Sanz, M.L. and Kaplan, A.P., Secretion of cytokines, histamine and leukotrienes in chronic urticaria. Int. Arch. Allergy. Immunol., +,3,,/.,0*,**, 0 Church, M. and McGill, J.I., Human ocular mast cells. Curr Opin Allergy Clin Immunol.,,,.+3.,,,**, 1 Lorentz, A. and Bischo#, S.C., Regulation of human intestinal mast cells by stem cell factor and IL-., Immunol. Rev., +13, /1 0*,**+ 2 Boyce, J.A., Mast cells : beyond IgE. J. Allergy. Clin. Immunol., +++,,. -,,** * Matsuo, N., Yamada, K., Shoji, K., Mori, M. and Sugano, M., E#ect of tea polyphenols on histamine release from rat basophilic leukemia (RBL-,H-) cells ; structureinhibitory activity relationship, Allergy, /,, / Ohmori, Y., Ito, M., Kishi, M., Mizutani, H., Katada, T.

10 41 : 593 and Konishi, H., Antiallergic constituents from oolong tea stem, Biol. Pharm. Bull., +2, 02-02/ +33/ +,., 3/, 3/2 +33/ +- Akagi, M., Fukuishi, N., Kan, T. and Sagesaka, Y.M., Anti-allergic e#ect of tea-leaf saponin (TLS) from tea leaves (Camellia sinensis var. sinensis), Biol. Pharm. Bull.,,*, /0/ / O - O ,**+ +/ Sano, M., Suzuki, M., Miyase, T., Yoshino, K. and Maeda- Yamamoto, M., Novel antiallergic catechin derivatives isolated from oolong tea. J. Agric. Food Chem.,.1, +3*0 +3+* Suzuki, M., Yoshino, K., Maeda-Yamamoto, M., Miyase, T. and Sano, M., Inhibitory e#ects of tea catechins and O-methylated derivatives of ( )-epigallocatechin---ogallate on mouse Type-IV allergy, J Agric Food Chem..2, /0.3 /0/-,*** +1 Maeda-Yamamoto,M., Inagaki, N., Kitaura, J., Chikumoto, T., Kawahara, H., Kawakmi, Y., Sano, M., Miyase, T., Tachibana, H., Nagai, H. and Kawakami, T., O- methylated catechins from tea leaves, inhibit multiple protein kinases in mast cells, J. Immunology, +1,, ,,**. +2 Maeda-Yamamoto, M., Kawahara, H., Matsuda, N., Nesumi, K., Sano, M., Tsuji, K., Kawakami, Y. and Kawakami, T., E#ects of tea infusions of various varieties or di#erent manufacturing types on inhibition of mouse mast cell activation. Biosci. Biotech. Biochem. 0,,,,11,, Fujimura, Y., Tachibana, H., Maeda-Yamamoto, M., Miyase, T., Sano, M. and Yamada, K., Antiallergic tea catechin, : ( )-epigallocatechin---o-(--o-methyl)-gallate, suppresses FcepsilonRI expression in human basophilic KU2+, cells. J Agric Food Chem., /*, /1,3 /1-.,**,,* Tachibana, H., Sunada, Y., Miyase, T., Sano, M., Maeda- Yamamoto, M. and Yamada, K., Idenfication of a methylated epigallocatechin gallate as an inhibitor of degranulation in human basophilic KU2+, cells. Biosci. Biotech. Biochem., 0.,./,./.,***,+ Tachibana, H., Kubo, T., Miyase, T., Tanino, S., Yoshimoto, M., Sano, M., Maeda-Yamamoto, M. and Yamada, K., Identification of an inhibitor for interleukin.-induced e germline transcription and antigenspecific IgE production in vivo. Biochem. Biophys. Res. Commun.,,2*, /- 0*,**+,, 1 // 1*,**.,-, ,,.,+ EBM,**, 2-1,**,,/ Thomson, M., Al-Qattan, K.K., Al-Sawan, S.M., Alnaqeeb, M.A., Khan. I. and Ali, M., The use of ginger (Zingiber o$cinale Rosc.) as a potential anti-inflammatory and antithrombotic agent, Prostaglandins Leukot Essent Fatty Acids, /.12,**,,0 Grzanna, R., Lindmark, L., Frondoza, C.G., Ginger -an herbal medicinal product with broad anti-inflammatory actions, J. Med. Food., 2, +,/ +-,,**/,1 Young, H.Y., Luo, Y.L., Cheng, H.Y., Hsieh, W.C., Liao, J. C., Peng, W.H., Analgesic and anti-inflammatory activities of [0]-gingerol, J. Ethnopharmacol. 30 +,,*1,+*,**/,2 10,0 -/ +33/,3 Sato, K., Nakazawa, T., Sahashi, N. and Kochibe, N., Yearly and seasonal changes of specific IgE to Japanese cedar pollen in a young population, Ann Allergy Asthma Immunol., 13, / *.3 //2 /0+,*** +33/ -+,2+,21,** ,

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