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1.
Clinical and Immunological Efficacy of Mangosteen and Propolis Extracted Complex in Patients with Gingivitis: A Multi-Centered Randomized Controlled Clinical Trial.
Park, JY, Ko, KA, Lee, JY, Oh, JW, Lim, HC, Lee, DW, Choi, SH, Cha, JK
Nutrients. 2021;(8)
Abstract
BACKGROUND Mangosteen and propolis extracts (MAEC) have been potential therapeutic agents known to exhibit powerful antioxidant and anti-inflammatory properties. The aim of the current study was to evaluate the clinical and immunological efficacy of MAEC as well as safety and patient-reported outcomes (PROMs) on gingivitis and incipient periodontitis. METHODS This study was performed on 104 patients diagnosed with gingivitis or incipient periodontitis. At baseline, the participants were randomly allocated to either the test group, with daily intake of a single capsule containing 194 mg of MAEC for eight weeks, or control group, with placebo. Clinical periodontal evaluation and immunological parameters from saliva and gingival sulcular fluid were assessed at baseline, four, and eight weeks. Individual PROMs were assessed by OHIP-14 questionnaires. RESULTS There was a significant difference of modified gingival index at four and eight weeks between the test and control groups. In the test group, crevicular interleukin (IL)-6 was reduced, and the salivary matrix metalloproteinase (MMP)-9 was increased after eight weeks. PROMs were improved up to four weeks compared to placebo. CONCLUSION Oral administration of MAEC would have a potential to reduce gingival inflammation clinically and immunologically in the patients with gingivitis and incipient periodontitis.
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2.
Limited effects of long-term daily cranberry consumption on the gut microbiome in a placebo-controlled study of women with recurrent urinary tract infections.
Straub, TJ, Chou, WC, Manson, AL, Schreiber, HL, Walker, BJ, Desjardins, CA, Chapman, SB, Kaspar, KL, Kahsai, OJ, Traylor, E, et al
BMC microbiology. 2021;(1):53
Abstract
BACKGROUND Urinary tract infections (UTIs) affect 15 million women each year in the United States, with > 20% experiencing frequent recurrent UTIs. A recent placebo-controlled clinical trial found a 39% reduction in UTI symptoms among recurrent UTI sufferers who consumed a daily cranberry beverage for 24 weeks. Using metagenomic sequencing of stool from a subset of these trial participants, we assessed the impact of cranberry consumption on the gut microbiota, a reservoir for UTI-causing pathogens such as Escherichia coli, which causes > 80% of UTIs. RESULTS The overall taxonomic composition, community diversity, carriage of functional pathways and gene families, and relative abundances of the vast majority of observed bacterial taxa, including E. coli, were not changed significantly by cranberry consumption. However, one unnamed Flavonifractor species (OTU41), which represented ≤1% of the overall metagenome, was significantly less abundant in cranberry consumers compared to placebo at trial completion. Given Flavonifractor's association with negative human health effects, we sought to determine OTU41 characteristic genes that may explain its differential abundance and/or relationship to key host functions. Using comparative genomic and metagenomic techniques, we identified genes in OTU41 related to transport and metabolism of various compounds, including tryptophan and cobalamin, which have been shown to play roles in host-microbe interactions. CONCLUSION While our results indicated that cranberry juice consumption had little impact on global measures of the microbiome, we found one unnamed Flavonifractor species differed significantly between study arms. This suggests further studies are needed to assess the role of cranberry consumption and Flavonifractor in health and wellbeing in the context of recurrent UTI. TRIAL REGISTRATION Clinical trial registration number: ClinicalTrials.gov NCT01776021 .
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3.
Effectiveness and Safety Profile of Ginkgo biloba Standardized Extract (EGb761®) in Patients with Amnestic Mild Cognitive Impairment.
Băjenaru, O, Prada, G, Antochi, F, Jianu, C, Tudose, C, Cuciureanu, A, Docu, AA, Perrot, V, Avram, M, Tiu, C
CNS & neurological disorders drug targets. 2021;(4):378-384
Abstract
BACKGROUND Ginkgo biloba is a common symptomatic treatment for cognitive impairment, although data on its efficacy are controversial. OBJECTIVE The aim of the current study was to evaluate the effectiveness of standardized Ginkgo biloba extract EGb761® (Tanakan®) for the improvements of cognitive functions over 24 months in a local cohort of patients diagnosed with amnestic mild cognitive impairment (aMCI). METHODS This multicentre non-interventional study included 500 eligible patients with a MCI treated with 120 mg/day standardized Ginkgo biloba extract EGb761® (Tanakan®). Patients were evaluated using several scales for assessment of cognition, memory, activities of daily living, and depression (MMSE, FAQ, CGI, HAM-D) at baseline and every 6 months after that for a 24-month period. The median change in MMSE at the 24-month follow-up was the primary outcome of the study. RESULTS A statistically significant increase of 2 points in the median MMSE score was obtained. In patients with other concomitant cognitive disorders, the improvement in MMSE was less significant. Tanakan® improved memory impairment (using the delayed recall test) and the ability to accomplish activities of daily living (mean FAQ score, 1.7); it also decreased the severity of depression (mean HAM-D score, 2.4) at the end of the study. More than 80% of the patients showed minimal improvement of their condition as assessed by the CGI-Improvement Scale. CONCLUSION The administration of EGb761® (Tanakan®) led to a significant improvement of cognitive decline, memory, activities of daily living, and depression in subjects with aMCI over 24 months.
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4.
Vascular effects of combined enriched Korean Red ginseng (Panax Ginseng) and American ginseng (Panax Quinquefolius) administration in individuals with hypertension and type 2 diabetes: A randomized controlled trial.
Jovanovski, E, Lea-Duvnjak-Smircic, , Komishon, A, Au-Yeung, F, Zurbau, A, Jenkins, AL, Sung, MK, Josse, R, Vuksan, V
Complementary therapies in medicine. 2020;:102338
Abstract
BACKGROUND Type 2 diabetes is known to abrogate the vascular response. Combination of two commonly consumed ginseng species, American ginseng (AG) and a Korean Red ginseng (KRG), enriched with ginsensoide Rg3, was shown to concomitantly improve glucemic control and blood pressure. We evaluated the hypothesis that improvements in central hemodynamics, vascular function and stiffness markers are involved in observed benefits of co-administration. METHODS In this randomized, placebo controlled, two-center trial, patients with type 2 diabetes and hypertension were assigned to either 2.25 g ginsenoside Rg3-enriched KRG&AG co-administration or a control 3 times daily for 12-weeks, treated by standard of care. The effects on central hemodynamics, pulse wave velocity (PWV) and endothelial function over the 12-week administration were analyzed. RESULTS In intent-to-treat analysis of 80 individuals, a reduction in central systolic BP (-4.69 ± 2.24 mmHg, p = 0.04) was observed with co-administration of Rg3-KRG + AG relative to control at 12-weeks, which was characterized by a decrease in end-systolic pressure (-6.60 ± 2.5 mmHg, p = 0.01) and area under the systolic/diastolic BP curve (-132.80 ± 65.1, p = 0.04, 220.90 ± 91.1, p = 0.02, respectively). There was no significant change in reactive hyperemia index (0.09 ± 0.11, p = 0.44), PWV (-0.40 ± 0.28 %, p = 0.17), and other related pulse wave analysis components. CONCLUSION Co-administration of complementary ginseng species improved central systolic BP and components of pulse waveform without a direct effect on endothelial function, when added to background pharmacotherapy in individuals with diabetes. These data support potential utility of ginseng for modest blood pressure benefit to broaden its role in diabetes management.
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5.
Efficacy of a topical herbal and mineral formulation (Dynamiclear) for the treatment of herpes simplex labialis in the community setting: study protocol for a randomised, double-blind placebo-controlled trial.
Armour, M, Semprini, A, Ee, C, MacCullagh, L, Shortt, N
BMJ open. 2020;(1):e031876
Abstract
INTRODUCTION Herpes simplex labialis (HSL) is a common infection that can cause painful lesions on the oral mucosa, commonly referred to as cold sores. Current biomedical treatments include topical aciclovir, which reduces the episode duration by an average of 0.5 days. This study will examine the efficacy and tolerability of an over-the-counter topical treatment, Dynamiclear in reducing duration and severity of HSL episodes. METHODS AND ANALYSIS This prospective, randomised, double-blind, placebo-controlled, multi-centre trial will recruit a minimum of 292 adult participants across Australia and New Zealand who present with a cold sore within 48 hours of onset. They will be randomly allocated in a 2:1 ratio to receive either topical Dynamiclear (active) or placebo. Dynamiclear's active ingredients are Hypericum perforatum, Calendula Officinalis and copper sulfate. A single topical treatment of active or placebo will be applied by a pharmacy-based investigator, and participants will be provided with a viral swab kit to confirm presence of herpes virus 1 or 2 from ulcerated lesions. Participants will receive reminders by email and/or SMS to complete an online daily diary assessing their cold sore lesion using a visual guide, and recording other symptoms on numeric scales until healed. The primary outcome variable is median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin. Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration. ETHICS AND DISSEMINATION Australian ethics approval from Western Sydney University Human Research Ethics Committee, ref: H12776. New Zealand Ethics approval from The Health and Disability Ethics Committees (HDEC) ref: 18/CEN/151. Results will be published in a peer-reviewed academic journal, presented at academic meetings and reported to participants TRIAL REGISTRATION NUMBERS Australia and New Zealand Clinical Trials Registry (ACTRN12618000890235); Universal Trial Number (UTN) (U1111-1233-2426).
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6.
The effect of TJ-28 (Eppikajutsuto) on the prevention of hand-foot syndrome using Capecitabine for colorectal cancer: The Yokohama Clinical Oncology Group Study (YCOG1102).
Watanabe, K, Ishibe, A, Watanabe, J, Ota, M, Fujii, S, Ichikawa, Y, Oba, MS, Endo, I
Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology. 2020;(2):204-210
Abstract
BACKGROUND Eppikajututo (TJ-28, a Kampo medicine) is effective against rheumatoid arthritis and eczema. We conducted a randomized comparative trial to assess the efficacy of TJ-28 for preventing hand-foot syndrome (HFS) as a complication of adjuvant chemotherapy using capecitabine. METHODS The present study was a multi-institutional randomized-controlled trial (UMIN000005899). Colorectal cancer patients scheduled to receive capecitabine chemotherapy as adjuvant therapy were randomly assigned to receive TJ-28 (7500 mg/day) or oral pyridoxine (60 mg/day). Patients were monitored for the development of grade ≥ 2 HFS according to the National Cancer Institute Common Toxicity Criteria until chemotherapy completion. RESULTS Twenty-two patients were enrolled in this study. The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group. Grade ≥ 2 HFS developed in 6 (50.0%) of 12 TJ-28 patients and in 4 (40.0%) of 10 pyridoxine patients. Chemotherapy treatment failure was observed in seven patients, mainly due to HFS, liver dysfunction, diarrhea, and neutropenia. Chemotherapy treatment failure due to HFS occurred in none of the TJ-28 group and 2 patients (20.0%) in the pyridoxine group (p = 0.114). CONCLUSION Capecitabine-associated HFS was not markedly prevented by TJ-28 compared with pyridoxine. However, TJ-28 might support the continuation of chemotherapy with capecitabine. Further studies are warranted to clarify the benefits of TJ-28.
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7.
Effects of Colloidal Oatmeal Topical Atopic Dermatitis Cream on Skin Microbiome and Skin Barrier Properties.
Capone, K, Kirchner, F, Klein, SL, Tierney, NK
Journal of drugs in dermatology : JDD. 2020;(5):524-531
Abstract
Atopic dermatitis is characterized by dry, itchy, inflamed skin with a dysbiotic microbiome. In this clinical study (NCT03673059), we compared the effects of an eczema cream containing 1% colloidal oat and a standard moisturizer on the skin microbiome and skin barrier function of patients with mild to moderate eczema. Patients were randomly assigned to treatment with 1% colloidal oat eczema cream or a standard, non-fragranced daily moisturizer. Treatment lasted 14 days, followed by a 7-day regression period. Of 61 patients who completed the study, 30 received the 1% colloidal oat eczema cream and 31 received the standard moisturizer. At 14 days, the 1% colloidal oat eczema cream reduced mean Eczema Area Severity Index and Atopic Dermatitis Severity Index scores by 51% and 54%, respectively. Unlike treatment with the standard moisturizer, treatment with the 1% colloidal oat eczema cream was associated with trends towards lower prevalence of Staphylococcus species and higher microbiome diversity at lesion sites. The 1% colloidal oat eczema cream significantly improved skin pH, skin barrier function, and skin hydration from baseline to day 14, whereas the standard moisturizer improved hydration. Overall, the results demonstrate that topical products can have differing effects on the skin barrier properties and the microbiome. Importantly, we show that the use of a 1% colloidal oat eczema cream improves microbiome composition and significantly repairs skin barrier defects. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.4924.
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8.
HL301 versus Umckamin in the treatment of acute bronchitis: a phase III, randomized, controlled, double-blind, multicenter study.
Kim, WY, Park, MJ, Rhee, CK, Lee, SY, Kim, DJ, Kim, DG, Choi, CM, Kim, DK, Kim, YH, Yoon, HJ, et al
Current medical research and opinion. 2020;(3):503-508
Abstract
Objective: HL301 is a combination product of seven medicinal plants that has been proven effective in acute bronchitis by two phase II studies. In the present study, its efficacy and safety compared with those of Umckamin in the treatment of acute bronchitis were evaluated in phase III, randomized, controlled, double-blind, multicenter trial design.Methods: A total of 246 acute bronchitis patients were randomized to receive either HL301 (600 mg/day) or Umckamin (333 mg/day) for seven days. The primary outcome was the difference in their baseline (visit 2) and end of treatment (visit 3) bronchitis severity score (BSS). Other efficacy variables included the change in each BSS component (cough, sputum, dyspnea, chest pain, and crackle), response rate, improvement rate, and satisfaction rate with treatment.Results: A full analysis set and per protocol set analysis of both groups revealed that the difference of BSS between visit 2 and visit 3 in the HL301 and Umckamin group was not significantly different (4.58 ± 1.79 versus 4.29 ± 1.88, p = .37 and 4.60 ± 1.81 versus 4.33 ± 1.88, p = .42, respectively). The change in five BSS components (cough, sputum, dyspnea, chest pain, and crackle) of the HL301 and Umckamin groups did not differ after treatment. HL301 or Umckamin treated participants showed an equal level of response, improvement, and satisfaction rates with treatment. Both the HL301 group and Umckamin group showed the same safety profile.Conclusions: HL301 (600 mg/day) was as effective and safe as Umckamin (333 mg/day) in treating acute bronchitis.
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9.
An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis.
Popovych, VI, Beketova, HV, Koshel, IV, Tsodikova, OA, Kriuchko, TA, Abaturov, AE, Vakulenko, LI, Gavrylenko, IV
American journal of otolaryngology. 2020;(5):102564
Abstract
UNLABELLED Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis. METHODS 292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), "therapeutic benefit" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants. RESULTS The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a "therapeutic benefit" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs. CONCLUSION The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant "therapeutic benefit" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.
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10.
The effects of six months Persicaria minor extract supplement among older adults with mild cognitive impairment: a double-blinded, randomized, and placebo-controlled trial.
Lau, H, Shahar, S, Mohamad, M, Rajab, NF, Yahya, HM, Din, NC, Hamid, HA
BMC complementary medicine and therapies. 2020;(1):315
Abstract
BACKGROUND Persicaria minor extract exhibits antioxidant and anti-inflammatory properties and has potential effects on cognitive function and mood. However, the effects of P.minor on brain activation and biomarkers have not been studied among older adults. This multicentre, randomized, double-blinded, placebo-controlled study aimed to investigate the effect of 6 months P.minor extract supplement (Biokesum®) on cognition, mood, biomarkers, and brain activation among older adults with Mild Cognitive Impairment (MCI). METHOD A total of 36 Malaysian community-dwelling older adults with MCI (60-75-year-old) were randomized into Biokesum® (n = 18) and placebo group (n = 18). Each subject consumed one capsule of Biokesum® (250 mg/capsule) or placebo (maltodextrin, 280 mg/capsule) twice daily for 6 months. Cognitive function and mood were assessed at baseline, 3rd, and 6th-month using neuropsychological tests (MMSE, Digit Span, RAVLT, Digit Symbol, and Visual Reproduction) and Profile of Mood State (POMS) questionnaire. Blood lipid profile, fasting blood glucose, and biomarkers (MDA, LPO, COX-2, iNOS, and BDNF) were measured at baseline and 6th month. By the end of the intervention, there were 30 compliers (Biokesum®: N = 15; Placebo: N = 15) and 6 dropouts. For brain activation assessment, 15 subsamples (Biokesum®: N = 8; Placebo: N = 7) completed N-back and Stroop tasks during fMRI scanning at baseline and 6th month. The dorsolateral prefrontal cortex (Brodmann's area 9 and 46) was identified as a region of interest (ROI) for brain activation analysis using SPM software. RESULTS Two-way mixed ANOVA analysis showed significant improvements in Visual Reproduction II (p = 0.012, partial η2 = 0.470), tension (p = 0.042, partial η2 = 0.147), anger (p = 0.010, partial η2 = 0.207), confusion (p = 0.041, partial η2 = 0.148), total negative subscales (p = 0.043, partial η2 = 0.145), BDNF (p = 0.020, partial η2 = 0.179) and triglyceride (p = 0.029, partial η2 = 0.237) following 6 months of Biokesum® supplementation. Preliminary finding also demonstrated significant improvement at 0-back task-induced right DLPFC activation (p = 0.028, partial η2 = 0.652) among subsamples in Biokesum® group. No adverse events were reported at the end of the study. CONCLUSION Six months Biokesum® supplementation potentially improved visual memory, negative mood, BDNF, and triglyceride levels among older adults with MCI. Significant findings on brain activation at the right DPLFC must be considered as preliminary. TRIAL REGISTRATION Retrospectively registered on 30th August 2019 [ ISRC TN12417552 ].