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A systematic review of research investigating the physiological and psychological effects of combining Ginkgo biloba and Panax ginseng into a single treatment in humans: Implications for research design and analysis.
Reay, JL, van Schaik, P, Wilson, CJ
Brain and behavior. 2019;(3):e01217
Abstract
BACKGROUND AND PURPOSE The traditional herbal supplements Panax ginseng and Ginkgo biloba are self-medicated by members of the general public and prescribed by healthcare professionals in some EU countries for numerous health complaints. Clinical evidence is mixed and mechanisms of action are not fully understood. There is clinical interest into the synergistic effects of combining both herbs. METHODS We systematically review the literature investigating the effects of combination treatments on physiological and psychological outcomes in humans. We identified all studies meeting inclusion criteria: (a) written in English; (b) peer-reviewed; (c) conducted in humans; (d) including either a proprietary Panax ginseng/Ginkgo biloba treatment or a study preparation containing both; (e) placebo-controlled; (f) utilizing standardized extracts. We critically discuss each trial; calculate standardized effect sizes where possible and provide recommendations for research design and analysis. RESULTS Eight studies were identified and all investigated a proprietary combination treatment, Gincosan® . Studies are of high quality and robust; however, practice effects, choice of statistical model, and reliance upon null-hypothesis significance testing hinder generalized estimates of effect. The most consistent results are benefits to aspects of the circulatory/cardiovascular system in patient populations and "secondary memory" performance in patient and healthy populations. Two studies demonstrate synergy in healthy populations following a single dose; however, synergy in patient populations and following repeated dosing has not yet been directly tested. CONCLUSIONS A Panax ginseng and Ginkgo biloba combination treatment can improve aspects of physiological and cognitive function in humans; however, evidence for synergy requires further investigation and future research should directly investigate synergy following repeated dosing.
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The attention-enhancing effects of spearmint extract supplementation in healthy men and women: a randomized, double-blind, placebo-controlled, parallel trial.
Falcone, PH, Nieman, KM, Tribby, AC, Vogel, RM, Joy, JM, Moon, JR, Slayton, CA, Henigman, MM, Lasrado, JA, Lewis, BJ, et al
Nutrition research (New York, N.Y.). 2019;:24-38
Abstract
Previous studies have demonstrated that chronic supplementation with a proprietary spearmint extract (PSE) can improve cognitive performance in individuals 50-70 years of age with age-related memory issues. In the present study, our hypothesis was that chronic supplementation of PSE would improve cognitive performance in young, active individuals. Using a randomized, double-blind, placebo-controlled, parallel design, healthy, recreationally active men and women (N = 142) received 900 mg of PSE or placebo (PLA) daily for 90 days. Cognition was assessed via cognitive test battery (CNS Vital Signs) that resulted in 10 cognitive domains. Sleep, mood, and quality of life were assessed via validated questionnaires. Measurements were evaluated on days 0, 7, 30, and 90 of supplementation. Significant (P < .05) treatment effects were observed for sustained attention, wherein PSE improved sustained attention vs PLA at day 30 (PSE: 33.3 ± 0.54 vs PLA: 31.2 ± 0.98; P = .001) and day 90 (PSE: 34.0 ± 0.44 vs PLA: 32.7 ± 0.75; P = .007). Significant (P < .05) treatment × visit interactions were observed for complex attention, wherein PSE improved complex attention compared to PLA at day 7 (PSE: 8.0 ± 2.22 vs PLA: 7.6 ± 0.57; P = .016). Significant (P < .05) improvements were observed in 2 individual tests: the shifting attention test and the 4-part continuous performance test. No significant differences were observed in mood, sleep, or quality of life. The current study demonstrates that chronic supplementation with 900 mg of PSE improves cognitive performance in a young, active population, further supporting PSE as an efficacious nootropic.
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Flower Pollen Extract in Association with Vitamins (Deprox 500®) Versus Serenoa repens in Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Comparative Analysis of Two Different Treatments.
Macchione, N, Bernardini, P, Piacentini, I, Mangiarotti, B, Del Nero, A
Anti-inflammatory & anti-allergy agents in medicinal chemistry. 2019;(2):151-161
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Abstract
OBJECTIVE Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is reported in the literature ranging from 1 to 14.2%. The aim of the present study was to assess the impact on patient's quality of life and symptoms of Flower pollen extract in association with vitamins (Deprox 500®) in comparison with Serenoa repens 320 mg (Permixon 320 mg® by Pierre Fabre) in patients with CP/CPPS. METHODOLOGY All consecutive patients, with a diagnosis of CP/CPPS, referred to our center from January to August 2016, were screened to be enrolled in this single-center, randomized, controlled trial. The main outcome measure was the evaluation of IPSS/NIHCPSI (International Prostatic Symptom Score/NIH-Chronic Prostatitis Symptom Index) score variation and the assessment of the quality of life and symptoms at the end of the therapy. The second outcome measure was the evaluation of the comorbidity role in the CP/CPPS therapy. 63 patients were analyzed; patients were randomized into two groups: 29 patients were treated with Deprox 500® 2 tablets/day for 6 weeks and 34 patients with Serenoa repens 320 mg, 1 tablet/day for 6 weeks. RESULTS The mean score variation for IPSS was -12.7 ± 4.3 in the Deprox 500® group and -7.8 ± 4.7 in the Serenoa repens group (p=0.0005) while for NIH-CPSI was -17.3±3.1 in the Deprox 500® group and -13.6±4.8 in the Serenoa repens group (p=0.0016). By accounting only the symptoms part of NIH-CPSI questionnaire, the mean score variation reported was -11.5±2.5 in the Deprox 500® group and -9.02±4.0 in the Serenoa repens group (p=0.009321). Furthermore, analyzing the comorbidity subgroups, in patients with hypertension, the mean IPSS score variation was -14.3±3.2 in the Deprox 500® group and - 9.02±4.0 in the Serenoa repens group. CONCLUSION In conclusion, in patients with CP/CPPS, Deprox 500® improves IPSS and NIH-CPSI scores up to 74.5% and 84.5% respectively. Furthermore, in patients with hypertension, the antioxidant effect of Deprox 500® reduces the mean IPSS score of 82.7%.
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Successful Control of Dasatinib-related Chylothorax by the Japanese Herbal Medicine "Goreisan".
Sasaki, H, Kimizuka, Y, Ogata, H, Okada, Y, Ota, S, Sano, T, Watanabe, C, Maki, Y, Yamamoto, T, Tagami, Y, et al
Internal medicine (Tokyo, Japan). 2019;(21):3139-3141
Abstract
Dasatinib-related chylothorax is a rare adverse event, and the mechanism underlying its occurrence is still not fully understood. We herein report the case of a 73-year-old woman with chronic myeloid leukemia (CML) who developed dasatinib-related chylothorax refractory to conventional treatments, except for steroids. To the best of our knowledge, this is the first case of dasatinib-related chylothorax which was successfully controlled by combining diuretics with the Japanese herbal medicine "Goreisan." "Goreisan" is known to inhibit aquaporin channels and regulate the water flow. Our findings showed that "Goreisan" is an effective treatment option for uncontrollable dasatinib-related chylothorax.
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Pleiotropic Effects of French Maritime Pine Bark Extract to Promote Healthy Aging.
Rohdewald, P
Rejuvenation research. 2019;(3):210-217
Abstract
Extension of the healthy life span is of primary importance for the aging society. Among exercise, healthy nutrition, and mental training, food supplements are widely used as preventive measures to postpone the diverse symptoms of aging. The extract from the bark of the French maritime pine, Pycnogenol, rich on flavonoids, has anti-inflammatory and antioxidative property, proven in in vivo studies. The extract reduces oxidative stress and improves endothelial health. Its antithrombotic properties are based on inhibition of platelet aggregation. In double-blind, placebo-controlled clinical studies, Pycnogenol shows diverse positive effects. With respect to cardiovascular symptoms, the extract has an antihypertensive effect, slows down the progression of atherosclerosis, and prevents venous thrombosis. As reported in studies in China and the United States, type 2 diabetes and diabetic retinopathy is improved with Pycnogenol. The extract restores mobility of seniors in case of patients suffering from osteoarthritis, Pycnogenol reduces pain and stiffness and use of analgesics. Furthermore, cognitive functions of elderly people, especially spatial memory, are significantly ameliorated. Climacteric symptoms are significantly alleviated by the pine bark extract. Urinary symptoms of benign prostatic hyperplasia are reduced by Pycnogenol. In combination with L-arginine, Pycnogenol restores erectile function in men with erectile dysfunction. The sum of these positive effects on relevant symptoms of aging suggests using Pycnogenol for a more extended period of healthy aging.
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The effect of an oral ginger supplementation on NF-κB concentration in peripheral blood mononuclear cells and anthropomorphic data of patients with type 2 diabetes: A randomized double-blind, placebo-controlled clinical trial.
Mohammadzadeh Honarvar, N, Zarezadeh, M, Khorshidi, M, Makhdoomi Arzati, M, Yekaninejad, MS, Abdollahi, M, Effatpanah, M, Hashemi, R, Saedisomeolia, A
Complementary therapies in medicine. 2019;:7-11
Abstract
INTRODUCTION The complications of diabetes are extensive which can be caused by excessive oxidative stress, inflammation and impaired insulin system. Plant-sourced bioactive compounds can reduce inflammation and oxidative stress. The aim of present study was to determine the effect of ginger supplementation on diabetic complications. METHODS The present study is a randomized double blind clinical trial which is conducted with 48 diabetic patients. The participants were randomly divided into two intervention and placebo groups which were received 2 g ginger powder and 2 g wheat flour respectively for 10 weeks. Nuclear factor kappa B (NF-κB) concentration and anthropometric measurements were evaluated at the baseline and at the end of study. RESULTS The effect of ginger supplementation on hip circumference was marginal and there was no significant effect on BMI and waist circumference. Mean NF-κB p65 concentrations were reduced in ginger supplementation group, however, the amount was not statistically significant. CONCLUSION Ginger supplementation had significant effects on anthropometric evaluations. Ginger supplementation decreased mean NF-κB concentration in comparison with placebo, however the significance level was marginal. In order to achieve reliable information, more researches should be complemented with uptake of other diagnostic tools.
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The effect of Cornus mas fruit extract consumption on lipid profile, glycemic indices, and leptin in postmenopausal women- A randomized clinical trial.
Gholamrezayi, A, Aryaeian, N, Rimaz, S, Abolghasemi, J, Fallah, S, Moradi, N, Taghizadeh, M
Phytotherapy research : PTR. 2019;(11):2979-2988
Abstract
Menopause, which occurs following a declined ovarian activity and reduced estrogen levels, can lead to long-term changes in lipid and glycemic profiles and increases the risk of cardiovascular disease and osteoporosis. Cornelian cherry (Cornus mas) is rich in phytochemicals and antioxidants, which appears to be useful in reducing the postmenopausal complications. This interventional, double-blinded, randomized clinical trial carried out on 84 menopaused women aged 45-60 years old. They were randomly divided into two groups. The treatment group received three capsules of 300 mg of Cornus mas extract (CME), and control group received three capsules of 300 mg of starch powder per day for 8 weeks. Then, BMI, waist circumference, glycemic indices, lipid profile, serum apoproteinase, apoprotein B100, fibrinogen, and leptin were measured. The dietary intakes were evaluated using 24-hr dietary recall questionnaire. The consumption of CME in comparison with the control group resulted in a significant reduction in weight, body mass index, waist circumference, LDL to HDL ratio, total cholesterol to HDL ratio, and fibrinogen. There was also a significant increase in HDL and ApoA1 levels in the treatment group. Furthermore, there was a significant decrease in BMI, waist circumference, fasting insulin, and insulin resistance index after 8 weeks of using CME. Summing up the results, it can be concluded that CME can have possible effects on decreasing BMI, waist circumference, and improving some aspects of lipid profile and glycemic indices in postmenopausal women.
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Consumption of plant extract supplement reduces platelet activating factor-induced platelet aggregation and increases platelet activating factor catabolism: a randomised, double-blind and placebo-controlled trial.
Gavriil, L, Detopoulou, M, Petsini, F, Antonopoulou, S, Fragopoulou, E
The British journal of nutrition. 2019;(9):982-991
Abstract
Platelet-activating factor (PAF) is a potent mediator of inflammation that plays a crucial role in atherosclerosis. The purpose of this study was to evaluate the effect of a dietary supplement containing mainly plant extracts on PAF actions and metabolism in healthy volunteers. A double-blind, placebo-controlled, 8 weeks' duration study was performed. Healthy volunteers were randomly allocated into the supplement or the placebo group and fifty-eight of them completed the study. The supplement contained plant extracts (Aloe gel, grape juice, Polygonum cuspidatum) and vitamins. The activities of PAF metabolic enzymes: the two isoforms of acetyl-CoA:lyso-PAF acetyltransferase, cytidine 5'-diphospho-choline:1-alkyl-2-acetyl-sn-glycerol cholinephosphotransferase (PAF-cholinephosphotransferase) and platelet-activating factor-acetylhydrolase (PAF-AH) in leucocytes and lipoprotein associated phospholipase-A2 in plasma were measured along with several markers of endothelial function. Platelet aggregation against PAF, ADP and thrombin receptor activating peptide was measured in human platelet-rich plasma by light transmission aggregometry. No difference was observed on soluble vascular cell adhesion molecule-1, sP-selectin and IL-6 levels at the beginning or during the study period between the two groups. Concerning PAF metabolism enzymes' activity, no difference was observed at baseline between the groups. PAF-AH activity was only increased in the supplement group at 4 and 8 weeks compared with baseline levels. In addition, supplement consumption led to lower platelet sensitivity against PAF and ADP compared with baseline levels. However, a trial effect was only observed when platelets were stimulated by PAF. In conclusion, supplementation with plant extracts and vitamins ameliorates platelet aggregation primarily against PAF and secondarily against ADP and affects PAF catabolism by enhancing PAF-acetylhydrolase activity in healthy subjects.
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Effect of cream, prepared with Tripterygium wilfordii Hook F and other four medicinals, on joint pain and swelling in patients with rheumatoid arthritis: a double-blinded, randomized, placebo controlled clinical trial.
Jiao, J, Tang, X, Gong, X, Yin, H, Jiang, Q, Wei, C
Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan. 2019;(1):89-96
Abstract
OBJECTIVE To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis (RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F (TwHF), Mangxiao (Nalrii Sulfas), Chuanxiong (Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang (Olibanum), and stir-frying with liquid adjuvant Moyao (Myrrh). METHODS Patients were 1∶1 randomized to add-on TwHF cream twice a day or placebo for 4 weeks. The primary endpoint was achievement rate of 20% improvement in American College of Rheumatology criteria (ACR20) at week 4. Secondary endpoints were ACR50, 28-joint count Disease Activity Score (DAS28) improvement and safety profiles. Statistical analyses were performed using intention to treat analysis (ITT) set. RESULTS A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3% (12/35) in TwHF cream group and 11.4% (4/35) in placebo group (P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1% (6/35) comparing to it in placebo group with 2.9% (1/35) (P = 0.046). The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed. CONCLUSION On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA.
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Effect of cimicifuga racemosa on menopausal syndrome caused by LHRH-a in breast cancer.
Wang, C, Huang, Q, Liang, CL, Zhang, YW, Deng, DH, Yu, Y, Chen, DB, Yang, HJ, Yu, XF
Journal of ethnopharmacology. 2019;:111840
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Cimicifuga racemose is previously proved effective on nature menopausal syndrome (MPS). However, its clinical value in treating with MPS induced by luteinizing-hormone releasing hormone analogue (LHRH-a) therapy of pre-/peri-menopausal breast cancer patients is still unknown. AIM OF STUDY This perspective randomised-design study is to investigate the effect and safety of cimicifuga racemosa on MPS induced by LHRH-a in breast cancer (clinical trial registered: NCT03339882). MATERIALS AND METHODS Breast cancer patients planning for LHRH-a treatment were randomly divided into 2 groups. The control group which was being treated with the standard treatment of LHRH-a. The other group was being treated with Remifemin, the commercialized product of cimicifuga racemose extract, combined with LHRH-a, called Remifemin group. Our main endpoint was Kupperman menopause index (KMI). Hormone levels in peripheral blood and gynecological complications were also evaluated. RESULTS Totally, 85 patients (42 in Remifemin group and 43 in control group) were enrolled in Zhejiang Cancer Hospital. At the 4th, 8th and 12th week after using LHRH-a, the KMI were all significantly lower in Remifemin group than in control group (P < 0.01), while the hormone levels, including estradiol (E2), follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were similar in the two groups. In addition, the incidence of cervical cyst in Remifemin group was higher than that in control group (P = 0.02), and there was no significant difference in the other gynecological complications, including endometrial thickening, ovarian cyst or uterine fibroid (P > 0.05). CONCLUSIONS Cimicifuga racemose is effective, oncological safe and reliable for treatment of MPS caused by LHRH-a in breast cancer.