薬理と治療

Objective　This study aimed to verify the effects of consuming 1–g galactooligosaccharide per day on gut microbiota, particularly Bifidobacterium, in healthy Japanese adults. Methods　In this randomized, double–blind, placebo–controlled, parallel–group comparison study, 56 participants were randomly divided into two groups（active group and placebo group）, and were instructed to take one packet of test food per day for 3 weeks. The packets received by the active group contained 1–g galactooligosaccharide, while the packets received by the placebo group lacked galactooligosaccharides. The evaluation parameters included the count of Bifidobacterium genus determined by real–time PCR in the stool. Results　A total of 56 participants met the inclusion criteria, and were randomized to either the active（n＝28）or placebo group（n＝28）. The analysis dataset was full analysis set, and included 26 participants in each group. Two participants from each group were excluded for non–compliance. After 3 weeks, the logarithm count of the Bifidobacterium genus in the active group was significantly higher than the placebo group. Additionally, adverse events due to test foods were not observed. Conclusions　Consuming 1–g galactooligosaccharide per day can help maintain healthy gut microbiota by increasing the concentration of Bifidobacterium. Trial registration　UMIN000049636 Foundation　Nissin Sugar Co., Ltd.（Jpn Pharmacol Ther 2024；52：19‒29）

Objective　The aim of the present study was to evaluate the effects of ingesting Bacillus subtilis C–3102 spores（C–3102）on knee joint function. Methods　A placebo–controlled, double–blind study on 88 healthy Japanese subjects was conducted. Each subject ingested test tablets containing either C–3102 at a daily dose of more than 3.4×109 Colony Forming Unit（CFU）（C–3102 group）or placebo tablets without C–3102 （placebo group）for 12 consecutive weeks. Knee joint condition was assessed by The Japanese Knee Osteoarthritis Measure（JKOM）, a questionnaire that allows the pain and discomfort to be rated by Visual analogue scale（VAS）and some questions. Results　The total of JKOM was significantly lower in the C–3102 group than in the placebo group. Among the JKOM subcategories, the score of“daily living conditions”was also significantly lower in the C–3102 group. Conclusions　These results show that C–3102 could improve the condition of the knee joint, especially, the improvement effect may be particularly strong in tasks that affect daily life. （UMIN000049024）（Jpn Pharmacol Ther 2024；52：31‒40）

Objectives　The aim of this study was to investigate the effects of oral ingestion of foods containing sesame lignans on sleep quality. Methods　In this randomized, double–blind, placebo–controlled, parallel–group comparison study, we enrolled Japanese healthy volunteers（n＝180）who felt dissatisfied with sleep quality. Subjects were randomly assigned to 2 groups and ingested either the test foods containing 10 mg sesame lignans（including sesamin and episesamin）and 55 mg vitamin E（α–tocopherol） or placebo per day for 2 weeks. Subjects were assessed on sleep quality using sleep electroencephalogram, St. Maryʼs Hospital Sleep Questionnaire（SMH）and the Oguri–Shirakawa–Azumi sleep inventory MA（OSA–MA）version. Furthermore, the feeling of sleep restfulness upon waking up, daytime sleepiness, daily fatigue, and salivary melatonin levels were evaluated. Results　The per–protocol analysis（PPS）revealed significant improvements in subjective indicators scores of morning awakening, such as“How clear–headed?”in SMH（P＝0.021）and factor Ⅰ（sleepiness on awakening）in the OSA–MA（P＝0.016）at 2 weeks in the test foods group compared to the placebo group. In addition, subjective refreshing and sleep restfulness at 2 weeks and amount of change in the feeling of fatigue also significantly improved in the test foods group. Conclusions　The results suggested that intake of foods containing sesame lignans and vitamin E improved subjective sleep quality, such as awakening（sleepiness and clear–headed upon waking up）, sleep restfulness, refreshing, and reduced feeling of daily fatigue. As for safety, no adverse effects were observed.（UMIN ID: UMIN000048740）（Jpn Pharmacol Ther 2024；52：41‒55）

Objectives　The aim of this study was to investigate the effect of a dietary supplement containing enzymatically modified isoquercitrin（EMIQ）on skin viscoelasticity on healthy subjects. Methods　A randomized, double blind, placebo–controlled parallel–group comparison study was conducted in 47 healthy subjects（20–59 years old）. Subjects were randomly divided into two groups and ingested either the test product（22 g powder containing 42 mg EMIQ and 15.6 g soy protein in 200 mL water）or the placebo product（22 g powder 15.6 g soy protein without EMIQ in 200 mL water）per day for 8 weeks. Viscoelasticity of face was evaluated. Results　The amount of change in viscoelasticity was significantly higher in the test product group than in the placebo group. Conclusions　These result suggested that the daily supplementation of EMIQ is effective for skin viscoelasticity（. UMIN–CTR：UMIN000049979）（Jpn Pharmacol Ther 2024；52：57‒64）

治療法と時期を要因に置いた二元配置分散分析は誤りです。なぜなら，時点間には相関が伴うからです。通常の分散分析において，要因の水準は独立でなければなりません。以前詳しく書いたつもりですが1,2）あらためて解説します。どうして誤りなのか，別の簡単な理由を思いついたこともあります。そして，正しい解析法である反復測定分散分析について詳しく解説します。

CONSORT（Consolidated Standards of Reporting Trials: 臨床試験報告に関する統合基準）声明はランダム化比較試験（randomized controlled trial: RCT）の報告を改善するために，世界中で広く用いられている。Kenneth Schulzらは，新たな方法論的エビデンスと蓄積された経験に基づいて改訂した最新版CONSORT 2010を発表した。