title: Effect of short-term oral immunotherapy with Cry j1-galactomannan conjugate on quality of life in Japanese cedar pollinosis patients: A prospective, randomized, open-label study.
abstract: OBJECTIVE
  We have recently reported that a new regimen of short-term oral immunotherapy (OIT) with the Cry j1-galactomannan conjugate for Japanese cedar pollinosis (JCP) is effective to the improvement in the symptoms and medication use during the pollen season and relatively safe. The effect of OIT on quality of life (QOL) of JCP patients has not been assessed. Therefore, we evaluated for the first time the effect of OIT on QOL during the Japanese cedar/cypress pollen season.
  
  
  METHODS
  A prospective, randomized, open-label trial was conducted over a period of 4 months. Participants were randomly divided into two groups. The OIT and control groups comprised 23 and 24 subjects, respectively. The build-up phase was initiated 1 month before the expected pollen season. The maintenance phase was continued for 51 days during the peak of the cedar pollen season. The QOL score in the Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) No. 1 and visual analog scale (VAS) throughout the pollen season were evaluated.
  
  
  RESULTS
  Participants receiving OIT showed significant improvements in the total QOL score and VAS throughout the pollen season compared with the control group. In addition, the mean total QOL score and VAS correlated in both groups during the pollen season.
  
  
  CONCLUSIONS
  The new regimen of short-term OIT using the Cry j1-galactomannan conjugate results in meaningful improvements in QOL of JCP patients. Our findings suggest that short-term OIT using allergen-galactomannan conjugates, as well as sublingual and subcutaneous immunotherapy, improves QOL of patients with pollinosis. The study was registered in UMIN-CTR (UMIN000013408) as the name of "a prospective, randomized, open study of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy".
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Otorhinolaryngology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan. Electronic address: muradai@qent.med.kyushu-u.ac.jp.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Murakami
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Sawatsubashi
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Otorhinolaryngology, Saitama Medical University Hospital, Saitama, Japan.
authors.forename: Sayaka
authors.initials: S
authors.lastname: Kikkawa
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Otorhinolaryngology, Kitakyushu Municipal Medical Center, Fukuoka, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Ejima
authors.affiliation: Biobusiness Propulsion Group, Biobusiness Propulsion Division, Wako Filter Technology Co., Ltd., Ibaraki, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Saito
authors.affiliation: Department of Biological Chemistry, Yamaguchi University, Yamaguchi, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Kato
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Shizuo
authors.initials: S
authors.lastname: Komune
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D052179:Antigens, Plant / Q000627:therapeutic use*; D032485:Cryptomeria / Q000276:immunology; D003888:Desensitization, Immunologic / Q000379:methods*; D005260:Female; D005690:Galactose / Q000031:analogs & derivatives; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007564:Japan; D008297:Male; D008351:Mannans / Q000627:therapeutic use*; D008875:Middle Aged; D010940:Plant Proteins / Q000627:therapeutic use*; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology; D011795:Surveys and Questionnaires; D064232:Visual Analog Scale; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D052179:Antigens, Plant; C065290:Cry j I protein, Cryptomeria japonica; D008351:Mannans; D010940:Plant Proteins; C012990:galactomannan; D007073:Immunoglobulin E; D005690:Galactose
keywords: Cry j1–galactomannan conjugate; Japan Rhinoconjunctivitis Quality of Life Questionnaire; Japanese cedar pollinosis; Oral immunotherapy; Quality of life; Visual analog scale