薬理と治療

Abstract

Background　Apocynum venetum L. is a traditional herb distributed in northwestern China. Previous research suggests that A. venetum leaf extract（VENETRON®）improves sleep quality. However, there is little information on improvement of unidentified complaints related to menstruation in women. Objectives　This study aimed to investigate the efficacy of VENETRON® on unidentified complaints relating menstruation in healthy female subjects. Methods　A randomized, double–blind, placebo–controlled parallel–group comparison study was performed on 44 healthy Japanese women. The subjects were randomly allocated and ingested either the placebo（n＝22）or 50 mg/day VENETRON® as test food（n＝22）for one menstrual cycle. Menstrual Distress Questionnaire（MDQ）, Oguri–Shirakawa–Azumi Sleep Inventory for Middle–age and Aged version（OSA–MA）, Profile of Mood States 2nd Edition （POMS2）, Uchida–Kraepelin（UK）performance test, as well as the autonomic nervous system, cognitive functions, salivary biomarkers of stress, skin, anthropometric examination, original questionnaire, and female hormones were assessed. Results　Forty–two subjects completed the trial, and 21 in the test food group and 21 in the placebo group were analyzed. Results indicated that the test food significantly reduced total scores in MDQ before menstruation and during menstruation than the placebo. The scores of Autonomic Reactions, Negative Affect, Concentration, and Behavioral Change before menstruation and scores of Pain, Concentration, and Control during menstruation were significantly decreased in the test food group after ingestion of VENETRON® than in the placebo group. However, no significant changes were observed after menstruation. In OSA–MA, the results showed significant improvement inʻInitiation and maintenance of sleepʼbefore menstruation in the test food group than in the placebo group. No significant differences were observed in other outcomes. No medically problematic changes occurred with the ingestion of VENETRON®.Conclusions　VENETRON® improves unidentified complaints related to menstruation and appeared to be safe under the conditions employed in the present study. Trial Registration　UMIN–CTR: UMIN000049157 Funding　Tokiwa　Phytochemical Co., Ltd. （Jpn Pharmacol Ther 2023；51：1685‒96）