Passionflower Extract Improves Diurnal Quality of Life in Japanese Subjects with Anxiety: A Randomized, Placebo-controlled, Double-blind Trial

Background and objective: Passiflora incarnata (passionflower) has traditionally been used to treat insomnia and anxiety. We recently reported that an aqueous ethanol extract of passionflower (PFE) and its flavonoid glycosides enhanced the expression of Period (Per) 2, a clock gene, in mouse liver and fibroblasts. However, the influence of PFE on daily activities or emotions has not been examined in humans. Therefore, we conducted a clinical trial of PFE supplementation in healthy Japanese subjects.Methods: This randomized, double-blind, placebo-controlled study examined the effects of PFE (200 mg daily) containing 3% flavonoid glycosides (6 mg daily). We enrolled 44 Japanese men and women who were reluctant to work or doing house chore or engaging in irregular flame works. All subjects were randomly allocated into either the PFE group (n=22) or the placebo group (n=22) using a computerized random-number generator. Capsules containing either PFE or placebo were administered for 12 weeks between August 2017 and January 2018. Emotional status and sleep quality were evaluated by using the Japanese version of Medical Outcomes Study Short-Form 36-Item Health (SF-36) questionnaire and the Oguri-Shirakawa-Azumi (OSA) sleep inventory score at 6- and 12-week of ingestion.Results: The per protocol set comprised 20 subjects in the PFE group and 18 subjects (20 subjects for OSA and safety evaluation) in the placebo group. After intake of PFE (200 mg/day) for 6 weeks, some of the SF-36 domain scores were significantly improved compared with those of the placebo group, including the scores for role/social component summary, social functioning, and role-emotional. After 12 weeks, the scores for mental component summary and vitality showed significant improvement in the subjects taking PFE (200 mg/day) compared to those taking placebo. In contrast, none of the OSA sleep score parameters were significantly improved by PFE compared with placebo. Laboratory tests did not reveal any abnormalities suggesting adverse effects of PFE.Conclusions: Intake of PFE (200 mg/day for 12 weeks) improved several emotional parameters related to daytime social and mental activities. PFE was suggested to be useful for improving anxiety.

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Moriche Palm (Aguaje) Extract improves indefinite complaints in Japanese females: a randomized, placebo-controlled, double-blind trial

Functional Foods in Health and Disease ◽

10.31989/ffhd.v10i9.742 ◽

2020 ◽

Vol 10 (9) ◽

Author(s):

Hiroshi Shimoda ◽

Tsuyoshi Takara ◽

Kazuo Yamamoto ◽

Naoko Suzuki ◽

Shinichiro Yamashita ◽

...

Keyword(s):

Placebo Group ◽

Short Form ◽

Random Number Generator ◽

Japanese Version ◽

Summary Score ◽

Controlled Study ◽

Clinical Effects ◽

Double Blind ◽

Sf 36 ◽

Menstrual Distress

Background and objective: The fruit of Mauritia flexuosa (moriche palm), which is known as “Aguaje,” has been used for beverages and processed foods. Recently, we found that several methoxyflavans are contained in the fruit and they exhibit estrogenic activities. Therefore, moriche palm extract (MPE) may function as a phytoestrogen and improve the symptoms induced by estrogen deficiency. However, the clinical effects of MPE on females has not yet been reported. We conducted a clinical trial of MPE on undefined complaints related to premenstrual syndrome (PMS) in healthy Japanese females.Methods: This randomized, double-blind, placebo-controlled study examined the effects of MPE (100 mg daily) containing 12.6  g of 5,4'-dihydroxy-7-methoxy-6-methylflavan. Forty-four Japanese women with indefinite complaints in premenstrual and menstrual periods were enrolled in the study. All subjects were randomly allocated into either the MPE (100 mg) group (n=22) or the placebo group (n=22) using a computerized random-number generator. Capsules containing either MPE (100 mg) or placebo were administered for 8 weeks between October and December in 2018. The severity of uncertain complaints and emotional status were evaluated using the Japanese version of the menstrual distress questionnaire (MDQ) as a primary outcome, and Medical Outcomes Study Short-Form 36-Item Health (SF-36) questionnaire at 4 and 8 weeks of ingestion. Blood, urine, and body parameters were also evaluated.Results: Forty-three subjects completed the trial, and the per protocol set comprised 21 subjects in the MPE (100 mg) group and 22 subjects in the placebo group. After ingesting MPE for 4 weeks, arousal in the premenstrual period significantly improved in the MPE (100 mg) group. After 8 weeks, the summary score, water retention, impaired concentration and control during menstrual period significantly improved in the MPE (100 mg) group. Contrarily, among SF-36 domain scores, significant ameliorating effects of MPE were not observed compared with those of the placebo group. Laboratory tests revealed no abnormalities suggesting adverse effects of MPE.Conclusions: MPE (100 mg/day for 8 weeks) improved several indefinite complaint parameters related to mensuration. MPE was suggested to be useful for improving anxiety related to PMS.Keywords: Menstrual distress questionnaire; SF-36 questionnaire; moriche palm; methoxyflavan; indefinite complaint

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Curcuma longa extract improves serum inflammatory markers and mental health in healthy participants who are overweight: a randomized, double-blind, placebo-controlled trial

Nutrition Journal ◽

10.1186/s12937-021-00748-8 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Ryusei Uchio ◽

Kengo Kawasaki ◽

Chinatsu Okuda-Hanafusa ◽

Ryosuke Saji ◽

Koutarou Muroyama ◽

...

Keyword(s):

Mental Health ◽

Placebo Group ◽

Inflammatory Markers ◽

Curcuma Longa ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Sf 36 ◽

Anti Inflammatory ◽

Serum Inflammatory Markers

Abstract Background The dietary spice Curcuma longa, also known as turmeric, has various biological effects. Both a water extract and a supercritical carbon dioxide extract of C. longa showed anti-inflammatory activities in animal studies. However, the anti-inflammatory effect in humans of a mixture of these two C. longa extracts (CLE) is poorly understood. Therefore, we investigated the effect of CLE containing anti-inflammatory turmeronols on chronic inflammation and general health. Methods We performed a randomized, double-blind, placebo-controlled study in healthy subjects aged 50 to 69 years with overweight. Participants took two capsules containing CLE (CLE group, n = 45) or two placebo capsules (placebo group, n = 45) daily for 12 weeks, and serum inflammatory markers were measured. Participants also completed two questionnaires: the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) and the Profile of Mood States (POMS) scale. Treatment effects were analyzed by two way analysis of variance followed by a t test (significance level, p < 0.05). Results After the intervention, the CLE group had a significantly lower body weight (p < 0.05) and body mass index (p < 0.05) than the placebo group and significantly lower serum levels of C-reactive protein (p < 0.05) and complement component 3 (p < 0.05). In addition, the CLE group showed significant improvement of the MOS SF-36 mental health score (p < 0.05) and POMS anger-hostility score (p < 0.05). Conclusion CLE may ameliorate chronic low-grade inflammation and thus help to improve mental health and mood disturbance. Trial registration UMIN-CTR, UMIN000037370. Registered 14 July 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042607

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P133 Filgotinib in patients with RA with inadequate response to methotrexate: FINCH 1 52-week efficacy and patient reported outcomes data

Rheumatology ◽

10.1093/rheumatology/keab247.129 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

David Walker ◽

Alan Kivitz ◽

Yoshiya Tanaka ◽

Susan Lee ◽

Lei Ye ◽

...

Keyword(s):

Short Form ◽

Pain Scale ◽

Janus Kinase ◽

Controlled Study ◽

Stock Ownership ◽

Inadequate Response ◽

Research Support ◽

Double Blind ◽

Sf 36 ◽

Patient Reported

Abstract Background/Aims Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy, safety and patient reported outcome (PRO) data in patients (pts) with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX-IR). We report data through week 52 (W52) of the FINCH 1 study. Primary outcome results at week (W)12 and W24 were previously reported. Methods This global, phase 3, double-blind, active- and placebo (PBO)-controlled study randomised MTX-IR pts with active RA on a background of stable MTX 3:3:2:3 to oral FIL 200 mg or FIL 100 mg once daily, subcutaneous adalimumab (ADA) 40 mg every 2W, or PBO up to W52; pts receiving PBO at W24 were re-randomised to FIL 100 or 200 mg. Efficacy was assessed using clinical, radiographic, and pt-reported outcomes; W52 comparisons were not adjusted for multiplicity, and nominal p-values are reported. Safety endpoints included types and rates of adverse events (AEs) and laboratory abnormalities. PRO assessment included the HAQ-DI and VAS pain scale, SF-36, and FACIT-Fatigue questionnaire. Change from baseline (CFB) at various time points was assessed up to W52 for each treatment group. Results Of 1,755 treated pts, 1,417 received study drug through W52. FIL efficacy was sustained through W52 with DAS28(CRP) <2.6 remission rates of 54%, 43%, and 46% of pts receiving FIL 200 and 100 mg and ADA, respectively, (nominal p for FIL 200 vs ADA = 0.024) (Table 1). FIL safety profile through W52 was consistent with W24 data. AEs of interest were infrequent and balanced among treatments. As early as W2, through W24, pts receiving either dose of FIL experienced nominally significantly greater (p < 0.001) CFB in HAQ-DI and VAS pain scale than those receiving PBO. These improvements were sustained up to W52. In general, CFB for HAQ-DI, VAS pain scale, and FACIT-Fatigue observed for the FIL groups was higher or comparable to ADA through W52 (Table 1). P133 Table 1:Efficacy and PRO outcomes at Week 52Efficacy OutcomeFIL 200 mg (n = 475)FIL 100 mg (n = 480)ADA (n = 325)ACR20/50/70, %a78/62/4476/59/3874/59/39DAS28(CRP) ≤3.2, %a66+5959mTSSb,c0.18+++0.450.61HAQ-DIc,d−0.93+−0.85−0.85VAS pain scalec,d−42−40−40SF-36 PCSc,d12.011.512.4FACIT-Fc,d11.912.211.7aNon-responder imputation,bLeast squares mean change from baseline,cObserved case,dMean change from baseline.+nominal p < 0.05, +++nominal p < 0.001 vs ADA ADA, adalimumab; FACIT-F, Functional Assessment of Chronic Illness Therapy Fatigue; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire-Disability Index; mTSS, modified van der Heijde TSS; SF-36, 36-Item Short Form Survey. Conclusion Through W52, both FIL 200 and 100 mg showed sustained efficacy, rapid and sustained improvement in patient QoL based on clinical and pt-reported outcomes and were well tolerated in MTX-IR pts with RA. Disclosure D. Walker: Consultancies; Lilly, Pfizer, Novartis, Roche. A. Kivitz: Consultancies; AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences, Inc. Shareholder/stock ownership; Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences, Inc., Novartis. Member of speakers’ bureau; Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. Y. Tanaka: Honoraria; AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead Sciences, Inc., GlaxoSmithKline, Janssen, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sanofi and Y. Grants/research support; AbbVie, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Takeda and UCB. S. Lee: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. L. Ye: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. H. Hu: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. F. Matzkies: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. B. Bartok: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. B. Bartok: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. Y. Guo: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. J.S. Sundy: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. A. Jahreis: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. R. Besuyen: Shareholder/stock ownership; Galapagos BV. Other; Employee of Galapagos BV. B. Combe: Other; Reports research support, honoraria, consulting and speaker fees from AbbVie; Bristol-Myers Squibb; Eli Lilly & Co.; Gilead Sciences, Inc.; Janssen; Novartis; Pfizer; Roche-Chugai; Sanofi; and UCB. D. van der Heijde: Consultancies; AbbVie; Amgen; Astellas; AstraZeneca; Bristol-Myers Squibb; Boehringer Ingelheim; Celgene; Cyxone; Daiichi-Sankyo; Eisai; Eli Lilly & Co.; Galapagos; Gilead Sciences, Inc.; Glaxo-Smith-Kline; Janssen;, Merck; Novartis; Pfizer; Regeneron; Roche; Sanofi; Takeda; and UCB. J. Simon-Campos: None. H.S.B. Baraf: Grants/research support; AbbVie; Horizon; Gilead Sciences, Inc.; Pfizer; Janssen; and Merck. U. Kumar: None. C. Tasset: Shareholder/stock ownership; Galapagos NV. Other; Employee of Galapagos NV. N. Mozaffarian: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. R.B.M. Landewé: Consultancies; AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Gilead Sciences, Inc.; Galapagos NV; Novartis; Pfizer; and UCB. S. Bae: None. E. Keystone: Other; Reports research support, consulting, and speaker fees from AbbVie; Amgen; AstraZeneca; Bristol-Myers Squibb; Celltrion; F. Hoffman-La Roche Ltd.; Genentech, Inc; Gilead Sciences, Inc.; Janssen; Lilly, ; Merck; Myriad Autoimmune; Pfizer; PuraPharm; Sandoz; Sanofi-Genzyme; Samsung Bioepsis; and UCB. P. Nash: Other; Reports research support, consulting, and speaker and personal fees from AbbVie; Bristol-Myers Squibb; Celgene; Eli Lilly & Co.; Gilead Sciences, Inc; Janssen; Merck Sharp & Dohme; Novartis; Pfizer;, Roche; Sanofi; and UCB.

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Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-Blind, Randomized Controlled Trial

Cartilage ◽

10.1177/1947603519865304 ◽

2019 ◽

pp. 194760351986530 ◽

Cited By ~ 4

Author(s):

Hwa Sung Lee ◽

Kwang Jun Oh ◽

Young Wan Moon ◽

Yong In ◽

Han Jun Lee ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Placebo Group ◽

Knee Pain ◽

Short Form ◽

Controlled Trial ◽

Cartilage Defects ◽

Type I ◽

Double Blind ◽

Randomized Controlled ◽

Sf 36

Objective Collagen disruption is one of the underlying causes of knee pain in patients with osteoarthritis and/or diverse cartilage defects. Atelocollagen is a type of collagen that lacks telopeptides and thus has reduced antigenicity. The intra-articular injection of type I atelocollagen supplements collagen levels in the disrupted articular cartilage. This randomized controlled trial evaluated the effects of the intra-articular injection of atelocollagen for the management of knee pain. Design Two hundred patients with osteoarthritis, chondromalacia, or other cartilage defects were randomly assigned to receive a 3-mL intra-articular injection of atelocollagen (BioCollagen group) or saline (Placebo group). Clinical improvement was evaluated over a 24-week period using the 100-mm visual analogue scale (VAS), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the 36-item Short-Form Health Survey (SF-36). Results VAS scores were significantly better in the BioCollagen group as compared with the Placebo group at 24 weeks. More patients in the BioCollagen group reported exceeding 20% and 40% VAS improvements. The WOMAC and SF-36 scores were also significantly improved from baseline after the intra-articular injection of atelocollagen; although, the differences between the BioCollagen and Placebo groups were not significant. There were no unexpected or severe adverse events reported for either group. Conclusions The results show that an intra-articular injection of atelocollagen effectively alleviates knee pain, as intended. Therefore, the intra-articular injection of atelocollagen can be considered an alternative solution to controlling knee pain due to osteoarthritis and diverse cartilage defects.

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Effects of Consumption of Probiotic Powder Containing Lactobacillus Plantarum Dad-13 on Fecal Bacterial Population in School-Age Children in Indonesia

International Journal of Probiotics and Prebiotics ◽

10.37290/ijpp2641-7197.14:1-8 ◽

2019 ◽

Vol 14 (1) ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Banin Maghfirotin Marta ◽

Utami Tyas ◽

Cahyanto Muhammad Nur ◽

Widada Jaka ◽

Rahayu Endang Sutriswati

Keyword(s):

Placebo Group ◽

Gut Microbiota ◽

Lactobacillus Plantarum ◽

Coliform Bacteria ◽

School Age Children ◽

Controlled Study ◽

School Age ◽

Double Blind ◽

Probiotic Group ◽

E Coli

Consumption of probiotics is known to influence the gut microbiota. The aim of this study was to assess the effect of probiotic powder containing Lactobacillus plantarum Dad-13 on bacterial composition in the gut by examining fecal samples of school-age children in Yogyakarta, Indonesia. This is a randomized, double-blind, placebo-controlled study. A total of 40 healthy subjects were recruited for this study and were divided into two groups: placebo group and probiotic group. The placebo group consumed skim milk and the probiotic group consumed probiotic powder containing L. plantarum Dad-13 (2 × 109 CFU/g) for 65 days. The results showed that placebo intake had no significant effect on gut microbiota; however, probiotic caused a significant increase in L. plantarum and Lactobacillus population, while decreasing the population of E. coli and non-E. coli coliform bacteria by 55% and 75%, respectively and Bifidobacteria count did not change significantly. The study concluded that consumption of probiotic powder L. plantarum Dad-13 could increase propionic acid thereby decreasing the gut pH which has an effect on the microbial population.

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Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041666 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1666 ◽

Cited By ~ 1

Author(s):

Paulo Fávio Macedo Gouvêa ◽

Zélia Maria Nogueira Britschka ◽

Cristina de Oliveira Massoco Salles Gomes ◽

Nicolle Gilda Teixeira de Queiroz ◽

Pablo Antonio Vásquez Salvador ◽

...

Keyword(s):

Quality Of Life ◽

Knee Osteoarthritis ◽

Short Form ◽

Serum Levels ◽

Double Blind ◽

Sf 36 ◽

Radiographic Grade ◽

Physical Functions ◽

Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

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DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis. A single-center, randomized, double-blind, placebo-controlled study.

10.21203/rs.2.23503/v2 ◽

2020 ◽

Author(s):

Dawei Chen ◽

Yanwei Yin ◽

Jin Shi ◽

Fen Yang ◽

Kehua Wang ◽

...

Keyword(s):

Placebo Group ◽

Single Photon ◽

Photon Emission ◽

Cerebral Hypoperfusion ◽

Controlled Study ◽

Emission Computed Tomography ◽

Single Center ◽

Double Blind ◽

Double Blind Placebo ◽

Atherosclerotic Stenosis

Abstract Background: DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis. Methods: In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200mg or 20mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively. Results: 48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5%±11.4% vs. 85.8%±12.5%, p=0.000), whereas no change was found in placebo group (86.9%±11.6% vs. 87.8%±11.7%, p=0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p=0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2=5.247, OR=3.31, p=0.022). Conclusions: NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered ( http://www.chictr.org.cn/index.aspx ).

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Effects of luteolin-rich chrysanthemum flower extract on purine base absorption and blood uric acid in Japanese subjects

Functional Foods in Health and Disease ◽

10.31989/ffhd.v12i1.863 ◽

2022 ◽

Vol 12 (1) ◽

pp. 12

Author(s):

Tsuyoshi Takara ◽

Kazuo Yamamoto ◽

Naoko Suzuki ◽

Shin-ichiro Yamashita ◽

Shin-ichiro Iio ◽

...

Keyword(s):

Uric Acid ◽

Placebo Group ◽

Serum Uric Acid ◽

Random Number Generator ◽

Double Blind ◽

Japanese Men ◽

Purine Base ◽

Flower Extract ◽

Before And After ◽

Body Parameters

Background and objective: Chrysanthemum flowers are consumed as fresh condiments, herbal teas, and processed foods in Japan and Taiwan. They contain luteolin as a major polyphenol and are traditionally used for eye care. We previously demonstrated that the ingestion of Chrysanthemum flower extract (CFE) for 1 month reduced serum uric acid levels. However, the findings obtained were considered to be biased because the study was performed by a CFE manufacturer. Therefore, we herein conducted a clinical trial on CFE on a larger scale and examined its effects on purine base absorption from the intestines, which represents an effective approach for reducing serum uric acid levels. Methods: Both studies were performed as randomized, double-blind, placebo-controlled trials and CFE (100 mg) containing 1 mg of luteolin was used as the active sample. We enrolled 44 healthy Japanese men and women with 6.0 to 7.9 mg/dL serum uric acid. All subjects were randomly allocated to an active group (n=22) or placebo group (n=22) using a computerized random number generator. In the purine base absorption study, CFE was ingested with a purine base-rich diet and serum uric acid levels were measured chronologically. In the 12-week consecutive ingestion study, CFE or placebo was administered between January and April 2021. Serum uric acid levels after 12 weeks were assessed as the primary outcome, and uric acid were measured before and after 4 weeks of the intervention as secondary outcomes. Blood, urine and body parameters were examined to evaluate the safety of CFE. Results: Thirty-nine subjects completed the trial, and the per protocol set comprised 18 and 21 subjects in the active and placebo groups, respectively. In the single dosing study of CFE on subjects loaded by the purine base-rich diet, no significant changes were observed between the CFE and placebo groups. On the other hand, in the 12-week ingestion study, serum uric acid levels were significantly lower in the CFE group than in the placebo group. Laboratory tests revealed no abnormalities to suggest any side effects of CFE.Conclusions: CFE (100 mg/day) containing 1 mg of luteolin reduced serum uric acid levels. CFE may be beneficial for improving hyperurichemia. Trial Registration: UMIN-CTR: UMIN000042327Foundation: The present study was funded by Oryza Oil & Fat Chemical Co., Ltd. Keywords: Chrysanthemum, luteolin, uric acid, purine base

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A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

JOURNAL FOR CLINICAL AND DIAGNOSTIC RESEARCH ◽

10.7860/jcdr/2021/46341.14400 ◽

2021 ◽

Author(s):

Victor Ifeanyichukwu Modekwe ◽

Jideofor Okechukwu Ugwu ◽

Okechukwu Hyginus Ekwunife ◽

Andrew Nwankwo Osuigwe ◽

Jideofor Chukwuma Orakwe ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Categorical Variables ◽

Paediatric Surgery ◽

Peripheral Oxygen Saturation ◽

Double Blind ◽

Oral Ketamine ◽

The Mean ◽

Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

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Can Simvastatin reduce COPD Exacerbations? A Randomised Double Blind Controlled Study

European Respiratory Journal ◽

10.1183/13993003.01798-2020 ◽

2021 ◽

pp. 2001798

Author(s):

Peter Schenk ◽

Alexander O. Spiel ◽

Felix Hüttinger ◽

Micheline Gmeiner ◽

Josefine Fugger ◽

...

Keyword(s):

Placebo Group ◽

Lung Function ◽

Tertiary Care ◽

Controlled Study ◽

Rank Test ◽

Chronic Obstructive ◽

Single Center ◽

Double Blind ◽

Exacerbation Rate ◽

Simvastatin Group

Several studies have shown that statins have beneficial effects in chronic obstructive pulmonary disease (COPD) regarding lung function decline, rates and severity of exacerbations, hospitalisation and need for mechanical ventilation.We performed a randomised double-blind placebo-controlled single-center trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for COPD criteria II-IV at a tertiary care pulmonology department in Austria. Scheduled treatment duration was 12 months and main outcome parameter was time to first exacerbation.Overall 209 patients were enrolled. In the 105 patients taking simvastatin, time to first exacerbation was significantly longer compared to the 104 patients taking placebo: median 341 versus 140 days, log-rank test p<0.001. Hazard ratio for risk of first exacerbation for the simvastatin group was 0.51 (95% CI 0.34–0.75; p=0.001). Rate of exacerbations was significantly lower with simvastatin: 103 (41%) versus 147 (59%), p=0.003. The annualised exacerbation rate was 1.45 per patient-year in the simvastatin group and 1.9 in the placebo group (IRR 0.77, 95% CI 0.60 to 0.99).We found no effect on quality of life, lung function, 6-minute walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 versus 29).In our single-center RCT, simvastatin at a dose of 40 mg daily significantly prolonged time to first COPD exacerbation and reduced exacerbation rate.

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