薬理と治療

Objective　The study aimed to verify that continuous intake of a dietary supplement containing agrimols derived from Agrimonia pilosa Ledeb. would affect the quality of life(QOL). Methods　A randomized, double–blind, placebo–controlled, parallel–group trial was conducted on 82 healthy volunteers aged 40 to 60 years. Subjects intook the dietary supplement containing 0.2 mg of agrimols derived from Agrimonia pilosa Ledeb. or placebo for 12 consecutive weeks. The primary effects of the dietary supplement on QOL was evaluated by the Profile of Mood States 2nd edition(POMS2). The safety of an intake of the agrimols derived from Agrimonia pilosa Ledeb. was evaluated by the physical measurements, blood tests, urinalysis and adverse events. Results　Intake of the dietary supplement containing agrimols derived from Agrimonia pilosa Ledeb. significantly improved fatigue–inertia and vigor–activity of the POMS2 after 12 consecutive weeks. However, no significant improvements were observed in other endpoints. No adverse events related to intake of the agrimols derived from Agrimonia pilosa Ledeb. occurred. Conclusions　These results indicate that the dietary supplement containing agrimols derived from Agrimonia pilosa Ledeb. improved fatigue–inertia and vigor–activity which are both part of QOL, after 12 consecutive weeks of intake. Altogether, these findings imply that the intake of the supplement showed slight positive effects on QOL. No safety problem was observed in an intake of the agrimols derived from Agrimonia pilosa Ledeb. under the present evaluation condition. (UMIN ID: UMIN000051493)(Jpn Pharmacol Ther 2024;52:775‒89)

Objectives　This study aimed to investigate the effects of Lactiplantibacillus plantarum 22A–3 (LP22A–3)on liver function through the modulation of intestinal permeability in healthy individuals. Methods　In this open study, 12 healthy Japanese men and women with higher liver function–related indexes and body mass index of 23-<30.0 kg/m2 were enrolled. The participants consumed the test food containing 40 mg of LP22A–3 daily for 12 weeks. Results　Regulatory T cells and zonulin levels showed significant changes following the intake of LP22A–3. It was observed that LP22A–3 improved intestinal permeability by suppressing inflammation in the lamina propria and maintained intestinal homeostasis. Moreover, no safety issues were observed with the use of LP22A–3 under the study conditions. Conclusion　These findings suggest that LP22A–3 improves intestinal permeability in healthy participants, thereby contributing to the maintenance of intestinal homeostasis. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry.(UMIN ID: UMIN000048757)(Jpn Pharmacol Ther 2024;52:791‒7)

Objectives　To investigate the effects of black ginseng extract(BGE)containing ginsenoside Rg3, which is expected to exhibit antifatigue properties, on fatigue in healthy Japanese adults. Methods　A randomized, placebo–controlled, double–blind, parallel–group comparison trial was conducted. The study included healthy Japanese adults with a visual analogue scale(VAS) of fatigue of 50–80 mm on the screening test and a change in VAS of fatigue of 10–20 mm before and after a stressful task using the Uchida–Kraepelin performance test. Participants were randomly assigned to two group(n=64/group)using a computer and given either 3 BGE tablets or placebo. The food intervention lasted 8 weeks. The endpoints were the VAS for fatigue, OSA Sleep Questionnaire MA version, Profile of Mood States 2nd Edition Japanese version, and salivary amylase. The primary outcome was the VAS of fatigue before the stressful task following an 8–week intervention. Results　There were 4 and 2 dropouts in the BGE and placebo groups, respectively, leaving 122 participants(60 and 62 in the BGE and placebo groups, respectively)in the study. The VAS of fatigue before stressful task following the 8–week intervention was significantly lower in the BGE group than in the placebo group( BGE group 39.9±18.6 mm,Placebo group 46.4±17.7 mm, P=0.037), indicating that fatigue was reduced. The other endpoints were unaffected by BGE intake. This study found that no adverse events were associated with the consumption of the test food. Conclusions　The results of the effect of continuous intake of BGE for 8 weeks on reducing the subjective fatigue in healthy Japanese adults suggest that BGE reduces the subjective fatigue that occurs on a daily basis. Trial registration　UMIN000048301 Foundation　NIHON PHARMACEUTICAL CO., LTD.(Jpn Pharmacol Ther 2024;52:801‒18)

Objective　To investigate the effects of consumption of beverages containing rice bran fermented products on bowel movement and intestinal environment in healthy Japanese adults who defecate three to five times per week. Methods　A total of 34 participants were randomly stratified into two groups at a 1:1 ratio using a computer program. They were asked to drink one pack each before breakfast and dinner( two packs per day)of the test beverage or placebo for 2 weeks. A bottle of the test beverage contained 1.1×108 CFU Lactobacillus paracasei TLPT, 8.8×107 CFU Saccharomyces cerevisiae TSCT and 4.9×106 CFU Pichia membranifaciens TPMT. Assessment items included defecation frequency, number of defecations, defecation volume, stool form, stool smell, satis-faction after defecation and the Japanese version of the constipation assessment scale. Defecation frequency in period Ⅲ(8–14 days of consumption)was the primary outcome. Results　The efficacy analysis dataset was the intention to treat, and 17 participants were included in each group. The defecation frequency(Placebo group 5.0±2.0 times, Test beverage group 6.6±2.2 times, P=0.007)and number of defecations(Placebo group 4.4±1.4 days, Test beverage group 5.4±1.4 days, P=0.042)in period Ⅲ were significantly higher in the Test beverage group than in the Placebo group. No adverse events were reported. Conclusions　Consuming a beverage containing LBS symbiotic fungus for 2 weeks enhanced bowel movement of healthy Japanese adults who defecate three to five times per week. Trial registration　UMIN000047765 Foundation　Litanial Bio Science. Co., Ltd. (Jpn Pharmacol Ther 2024;52:819‒31)

Objective　To verify the effects of Lactiplantibacillus plantarum TWK10(mentioned as TWK10 hereafter)on muscle and body fat in healthy middle–aged Japanese. Methods　This was a randomized, double–blind, placebo–controlled, parallel–group comparative study. Among 119 individuals who provided informed consent, 56 participants(aged 40–64 years)who met the eligibility criteria were randomly assigned to two groups(allocation ratio 1:1)using a computer: a group consuming the test food containing either sterilized TWK10 powder(at least 300×108 cells/day; TWK10 group)or placebo(placebo group). Participants were instructed to consume one capsule of either food daily for 12 weeks. The evaluation parameters were physical measurements, including body composition, and visceral fat area, subcutaneous fat area, and total fat area in transverse section of umbilical region, as measured using X–ray and computer tomography scan. The primary outcome was lean body mass after the 12–week intervention. Results　The analysis included 53 participants(26 and 27 in the TWK10 and placebo groups, respectively);3 participants were excluded for noncompliance. Following the 12–week intervention, the lean body mass and muscle mass(whole body and trunk)in the TWK10 group were significantly higher than those in the placebo group. In the subgroup aged≥50 years, the lean body and muscle mass were significantly higher, and the body fat percentage in the TWK10 group tended to be lower than that in the placebo group. No adverse events were observed. Conclusions　These results suggest that consuming TWK10 can help maintain muscle mass in healthy middle–aged Japanese, and reduce body fat especially in those aged≥50 years. Trial registration　UMIN000050371 Foundation　Nakahara Co., Ltd.(Jpn Pharmacol Ther 2024;52:833‒46)

私は実務統計家ですが,常々自分の仕事は医師の診察に似ていると感じていました.英語で言うと,統計相談と診察はどちらもコンサルテ-ションだと気づいたのです.

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.