薬理と治療

Abstract

Objectives Recently, compounds of collagen, glucosamine, chondroitin and methylsulfonylmethane（MSM）, considered effective for knee osteoarthritis（OA）, have been marketed asfunctional foods. However, practically no study has been done to examine the safety of thesefoods, which are used mainly by middle− to advanced−aged people many of whom may bereceiving treatments for‘lifestyle−related diseases’. We thus investigated the clinical safetyof one of these marketed functional foods, particularly taking drug interactions into account.Methods Subjects were outpatients of internal medicine with knee OA pain. Two differentmethods were employed to assess the safety of the compound：a detailed study conducted ina small number of patients comparing their conditions before and after a 12−week intakeperiod；and a simple survey with a questionnaire sent out together with the compound to alarge number of patients, and collected after a 4−week intake period.Results Of the 44 subjects in the detailed study, adverse events were noted in 3 cases（dermatologicalsymptoms（1）；epigastric discomfort, inappetence（1）；constipation（1））. Therewere no abnormal values in the laboratory test results. Of the 210 subjects in the simplequestionnaire survey, there were 12 cases of gastrointestinal symptoms, 5 cases of dermatologicalsymptoms, and 10 other cases（pain in the lower extremity, lassitude（3）；frequent urination（2）；headache（1）；unknown symptoms（4））. No drug interactions were detected ineither study.Conclusions The results suggested that the functional food used in this study was safeeven for outpatients of internal medicine with‘lifestyle−related diseases’.（Jpn Pharmacol Ther 2009；37：613−8）KEY WORDS Safety, Collagen, Glucosamine, Chondroitin sulfate, MSM, Patients