Haruka Amitani: Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Ryusei Nishi: Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Kenichiro Sagiyama: Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Takamasa Fukumoto: Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Kouta Funakoshi: Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Naomi Takayanagi: Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Hiroko Watanabe: Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Masayuki Hirose: Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Koshiro Tagawa: Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Keiko Ota: Center for Clinical Research and Innovation, Osaka City University Hospital, Osaka, Japan.
Yoichi M Ito: Data Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Sapporo, Japan.
Akihiro Asakawa: Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan. asakawa@m2.kufm.kagoshima-u.ac.jp.
BACKGROUND: Anxiety disorder is the most prevalent psychiatric disorder. Benzodiazepines, which are often used for anxiety in patients with anxiety disorder, have various side effects. Lavender, one of the most commonly used essential oils in aromatherapy, has the potential to reduce benzodiazepine use for anxiety disorders. METHODS: This study is a multicenter, double-masked, randomized, placebo-controlled clinical trial. The study will recruit patients aged 20-59 years old with generalized anxiety disorder and panic disorder among anxiety disorders. The bottle containing the test solution (lavender aroma essential oil or distilled water) will be given to the patients. Patients will carry the bottles with them in their daily life and use the drops on tissue paper when anxious. The primary endpoint is the number of times anxiolytics used in 28 days. DISCUSSION: If the use of benzodiazepines could be reduced by sniffing lavender aroma, which is inexpensive and safe, it would contribute not only to the risks associated with benzodiazepine use but also to the health care economy and could even be added as a standard treatment. TRIAL REGISTRATION: University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), ID: UMIN000034422 Registered 17 January 2019.
