Guiding principles of sublingual immunotherapy for allergic rhinitis in Japanese patients.

OBJECTIVE: Sublingual immunotherapy (SLIT) appears to offer practical advantages for the treatment of allergic rhinitis (AR). Based on a review of the scientific literature, we present recommendations as guiding principles to administer SLIT safely. METHODS: Clinical questions concerning SLIT were prepared. Literature published between January 2003 and December 2012 was searched from PubMed, the Cochrane Library, and Japana Centra Revuo Medicina. Qualified studies were analyzed and the results were evaluated, consolidated, and codified. We answered 17 clinical questions and, based on this, presented evidence-based recommendations. RESULTS: Sublingual immunotherapy improved symptoms (e.g., quality of life [QOL]) and reduced medication scores in seasonal AR and perennial AR. Most SLIT-induced adverse effects were local oral reactions, although systemic adverse effects such as gastrointestinal symptoms, urticaria, and asthma are occasionally reported. There have been no reports of lethal anaphylactic reactions by SLIT. When SLIT is continued for 3-4 years, its effect persists long after discontinuation. CONCLUSION: A correct diagnosis of AR and sufficient informed consent from patients are required before initiating SLIT. Sublingual immunotherapy should be continued for 3 years or longer. The initial administration of SLIT during the uptitration of an allergen vaccine and the general condition of patients are critical for the safe performance of SLIT.

Efficacy and safety of sublingual immunotherapy for two seasons in patients with Japanese cedar pollinosis.

BACKGROUND: Japanese cedar (JC) pollinosis is the most common seasonal allergic rhinitis in Japan. Standardized JC pollen extract is available for subcutaneous immunotherapy, but this treatment is limited by potentially serious side effects. The aim of this double-blind, randomized comparative study was to evaluate the efficacy and safety of standardized JC pollen extract in a new oral formulation (CEDARTOLEN®, Torii Pharmaceutical Co., Ltd., Tokyo, Japan) for sublingual immunotherapy (SLIT) for JC pollinosis. METHODS: A total of 531 subjects with JC pollinosis were randomized into 2 groups at a ratio of 1:1 to receive daily sublingual administration of standardized JC pollen extract with a maintenance dose of 2,000 Japanese allergy units (JAU) or placebo for 2 consecutive pollen seasons. The efficacy was evaluated using the total nasal symptom and medication score (TNSMS) as the primary end point. Secondary end points included the total ocular symptom and medication score (TOSMS) and scores for individual symptoms and medication. RESULTS: The TNSMS was significantly lower (p < 0.0001) in the SLIT group than in the placebo group in the peak symptom period by 18 and 30% in the first and second seasons, respectively. All secondary end points were also significantly lower in the SLIT group in both seasons. No systemic anaphylaxis occurred. CONCLUSIONS: SLIT with daily administration of standardized JC pollen extract was effective for improving nasal and ocular symptoms of JC pollinosis and reducing the use of relief medication. The JC pollen extract was well tolerated with only local adverse events.

Examination, diagnosis and classification for Japanese allergic rhinitis: Japanese guideline.

Many countries throughout the world have experienced an increase in the prevalence of allergic rhinitis (AR), which has come to be a major cause of morbidity in developed countries. The pathology underlying AR is regarded as IgE-mediated type I allergy characterized by mucosal inflammation that occurs in response to allergen exposure. In Japan, AR caused by Japanese cedar pollen, the most common allergic disease, has become a salient public health challenge. Almost all primary care physicians and otorhinolaryngologists have been consulted by AR patients between February and April. Although most such patients have received treatment, numerous patients with AR have not received proper examinations for AR. Clinical guidelines are systematically developed statements that are designed to help practitioners make decisions about appropriate and effective health care. Guidelines in many countries including Japan have been published for AR. Unfortunately, those guidelines have remained untested. Moreover, they might be difficult for non-specialists to use. In this review, we specifically examine the present standard examination for diagnosis of AR and optimal classification for AR in Japan. We hope that this review would be used not only for the support of daily practice but also for selection of AR patients for clinical trials.

[Development of patient satisfaction questionnaire in allergic rhinitis].

Recent suggestions emphasize the importance of assessing medical care outcomes from the point of view of both professional opinion and patient's subject like patient satisfaction as well as quality of life. Self-administered questionnaires are often used as an instrument for this purpose. When compared with quality of life, there is less useful questionnaire for patient satisfaction. Accordingly, we here aimed to develop the questionnaire, which is disease-specific, comprehensive, simple, clinically available and satisfied psychometric validation study. The items were collected from patients and satisfaction-related literature's review, and the total 20 were selected finally from them after excluding inadequate or overlapped items. Then, we conducted validation study in 214 subjects sampled randomly from 603 patients with Japanese cedar pollinosis who had visited clinics in 2003 by mailing self-administered questionnaire in spring, 2004. The response rate was 65.3%. In factor analysis, items were divided into four domains such as doctor-patient relationship, treatment outcome, geniality in hospital and convenience of medical service. The former two domains were the most correlated well with patient satisfaction. The quality of this questionnaire such as responsiveness, reliability, construct validity, convergent/discriminate validity, and clinical validity satisfied international standard. Thus, it was verified that our newly developed questionnaire is a useful and scientific tool for examination of patient satisfaction with medical care in allergic rhinitis.

[Are otolaryngologists specialist for pollinosis?].

It is approved that ENT doctors are specialist for pollinosis. Is it true from the point of view of patients' medical care-seeking behavior? 214 patients with Japanese cedar pollinosis who had visited medical doctors in 2003 pollen-season were randomly sampled from 603 pollinosis patients registered at a disease survey company and we mailed self-evaluation questionnaire on patients' medical care-seeking behavior on the end of pollen season in 2004. Response rate was 65.3%. Patients visited clinics in approximately 90% more than hospitals. They selected ENT in 43.9% and general physicians in 31.1%. Their selections were based on others than their specialty such as easy access and previous experience of visit, because pollinosis is not serious disease like cancer. ENT doctors treated the patients by combination of two kinds of tablet or topical steroid with tablet, while general physicians did with single kind of tablet. The patient satisfaction, and its related questions including preference, wish to revisit in next year and recommendation to their friend were not different in treatment between ENT and general physician. Doctors' attitude, and communication with patients were the most important factor for patient satisfaction as well as treatment out-come. In conclusion, patients prefer agreeable and convenient treatment. If ENT doctors still want to be specialist for pollinosis, they should take care patients well and develop their own specific treatment methodology to cure this disease.