Actual Use Research, a new method for evaluating the effectiveness of OTC Kampo drugs and its application to Kamishoyosan formulation

抄録

Actual Use Research (AUR) is a new pharmacist-centered research system to evaluate the usefulness of OTC Kampo medicine. The system uses a commercially available OTC drug. First, after an explanatory meeting of the AUR system, a pharmacist (or pharmacy) is contracted by the AUR implementation committee. The pharmacist invites the customers of the pharmacy to participate in AUR. After consent and answering several questions from the pharmacist, the AUR participant purchased the test OTC drug and begins to keep a daily use record of dosage and time of intake, the condition of disease and use of other drugs. After a predetermined number of days, or when the symptoms of the disease disappear, the participant returns to the pharmacy, and submits the daily record to the pharmacist, and answers a questionnaire evaluating the usefulness of the drug as well as some questions from the pharmacist. The participant then receives a gratuity. Independent from the participant evaluation, the pharmacist evaluates the usefulness of the drug on the basis of information obtained by the interview with the participant at the second meeting. Then, the pharmacist submits the daily record and the questionnaire from the participant, and also his/her evaluation to the AUR implementation committee. In this report, we describe the first trial of AUR using the commercially available OTC "Kamishoyosan" (a Kampo formula used to treat women with painful tension in the shoulders, who tire easily, suffer from fear, neuro-psychic disturbance, have a tendency toward constipation, sensitivity to cold, and/or dysmenorrheal and/or oligomenorrhea).