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1.
Evaluation of the effect of Silybum marianum extract on menopausal symptoms: A randomized, double-blind placebo-controlled trial.
Saberi, Z, Gorji, N, Memariani, Z, Moeini, R, Shirafkan, H, Amiri, M
Phytotherapy research : PTR. 2020;(12):3359-3366
Abstract
The tendency to use herbs to manage menopausal symptoms has increased in recent years. The purpose of this study was to evaluate the effect of Silybum marianum (L.) compared with placebo in women with hot flashes. Eighty women were randomly allocated into two equal groups (S. marianum extract [400 mg/d] or placebo capsules). Hot flashes frequency and severity were evaluated in 12 weeks with the Greene Climacteric Scale (GCS) and the Hot Flash Related Daily Interference Scale (HFRDIS). The data were analyzed in SPSS software using t-test, Mann-Whitney, chi-square test and repeated measure analysis. Hot flashes frequency and severity decreased from 4.32 ± 0.20/day to 1.31 ± 0.15/day and from 5.25 ± 0.22 to 1.62 ± 0.08, respectively, during the study in test group (p < .001) which were significantly better than effects of placebo in all steps of study (p < .001). Significant decreases in GCS and HFRDIS scores were also detected in S. marianum group compared with placebo after 4, 8 and 12 weeks (p < .001). The results showed that S. marianum can decrease frequency and severity of hot flashes significantly. Considering the safety and high consumption of this herbal medicine worldwide, its use in women with menopausal symptoms can be helpful.
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2.
Antihypertensive efficacy and safety of a standardized herbal medicinal product of Hibiscus sabdariffa and Olea europaea extracts (NW Roselle): A phase-II, randomized, double-blind, captopril-controlled clinical trial.
Elkafrawy, N, Younes, K, Naguib, A, Badr, H, Kamal Zewain, S, Kamel, M, Raoof, GFA, M El-Desoky, A, Mohamed, S
Phytotherapy research : PTR. 2020;(12):3379-3387
Abstract
Hypertension is a public health concern that needs immediate attention upon diagnosis. The demand for natural alternatives is on the rise; Hibiscus sabdariffa and Olea europaea are traditionally used for hypertension management in Egypt. In this study, we aimed to investigate the antihypertensive efficacy and safety of two doses of an herbal product of Hibiscus sabdariffa calyxes and Olea europaea leaves (NW Roselle) in Egyptian patients with grade 1 essential hypertension. We equally randomized 134 patients to receive captopril 25 mg, low-dose NW Roselle, or high-dose NW Roselle BID for 8 weeks. No significant decrease was found in systolic blood pressure or diastolic blood pressure when we compared low-dose NW Roselle and high-dose NW Roselle to captopril (p > .05). In all groups, mean reduction in BP at 8 weeks was significant; 16.4/9.9 mmHg (p < .0001), 15.4/9.6 mmHg (p < .0001), and 14.9/9.4 mmHg (p < .0001) with captopril, low-dose NW Roselle, and high-dose NW Roselle respectively. In addition, low-dose NW Roselle induced a significant reduction in the mean level of triglycerides (17.56 mg/dL; p = .038). In conclusion, NW Roselle had comparable antihypertensive efficacy and safety to captopril in Egyptian patients with grade 1 essential hypertension.
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3.
Antihypertensive Indigenous Lebanese Plants: Ethnopharmacology and a Clinical Trial.
Samaha, AA, Fawaz, M, Salami, A, Baydoun, S, Eid, AH
Biomolecules. 2019;(7)
Abstract
Hypertension is highly prevalent among the Lebanese adult population and is indeed the major cause of mortality in Lebanon. Traditional use of antihypertensive medicinal plants has long been practiced. The aim of this study is to document this traditional knowledge and clinically test the antihypertensive capacity of three of the most commonly used wild plant species Mentha longifolia, Viola odorata and Urtica dioica. Ethno-pharmacological data was collected by personal interviews with herbalists and traditional healers using a semi structured survey questionnaire and assessing relative frequency of citation (RFC). The clinical study was conducted by a randomized, blind, placebo-controlled trial in 29 subjects with mild hypertension distributed in four groups, three plant extract treatments and one placebo. Systolic (SBP) and diastolic blood pressures (DBP) as well as mean arterial blood pressures (MAP) were monitored at weeks 4, 8, 12 and 16 during the treatment with 300 mL/day of plant extract. Results showed that M. longifolia, U. dioica and V. odorata exhibited the highest values of RCF (0.95) followed by Allium ampeloprasum (0.94), Apium graveolens (0.92) and Crataegus azarolus (0.90). The clinical trial revealed dose- and duration-dependent significant reductions in SBP, DBP and MAP of subjects treated with M. longifolia, U. dioica or V. odorata. Our findings indicate that extracts of these plants present an effective, safe and promising potential as a phyto-therapuetical approach for the treatment of mild hypertension. More research on the phytochemistry, pharmacological effects and the underlying mechanisms is necessary.
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4.
Dietary supplementation with turmeric polyherbal formulation decreases facial redness: a randomized double-blind controlled pilot study.
Vaughn, AR, Pourang, A, Clark, AK, Burney, W, Sivamani, RK
Journal of integrative medicine. 2019;(1):20-23
Abstract
BACKGROUND Facial redness is multifactorial in nature and may be a sign of many different conditions, including rosacea, photo damage and flushing. Herbal medicines have been used for thousands of years to treat a variety of dermatological conditions. Turmeric (Curcuma longa) and its constituents have been shown to mediate dilation and constriction of peripheral arterioles and have demonstrated anti-oxidant, anti-inflammatory and wound-healing properties. OBJECTIVE To investigate the effects of turmeric and turmeric-containing polyherbal combination tablets versus placebo on facial redness. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS This was a prospective, double-blind, randomized pilot study. Thirty-three healthy participants were recruited from the dermatology clinic at the University of California, Davis and nearby community from 2016 to 2017. Thirty participants were enrolled, and 28 participants completed the study. The enrolled participants were randomized to receive one of three interventions (placebo, turmeric or polyherbal combination tablets) and were told to take the intervention tablets by mouth twice daily for 4 weeks. Facial redness was assessed at baseline and 4 weeks after intervention by clinical grading and by image-based analysis. MAIN OUTCOME MEASURES The primary outcome measure was image-based facial quantification of redness using a research camera and software analysis system. The investigators performed an intention-to-treat analysis by including all subjects who were enrolled in the trial and received any study intervention. Differences were considered statistically significant after accounting for multiple comparisons. Effect sizes for clinical grading were calculated with a Hedges' g where indicated. RESULTS Twenty-eight participants completed the study and there were no reported adverse events. Based on clinical grading, facial redness intensity and distribution down trended in the polyherbal combination group after 4 weeks (P = 0.1). Under photographic image analysis, the polyherbal combination group had a significant decrease in redness of 40% compared to baseline (P = 0.03). The placebo and turmeric groups had no statistically significant changes in image analysis-based facial redness. CONCLUSION Polyherbal combination tablet supplementation improved facial redness compared to the turmeric or placebo. Overall, our findings suggested further investigations into the effects of turmeric and polyherbal formulations in skin conditions associated with facial redness would be warranted. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT03065504.
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5.
The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial.
Huang, YH, Chen, ST, Liu, FH, Hsieh, SH, Lin, CH, Liou, MJ, Wang, CC, Huang, CH, Liu, GH, Lin, JR, et al
PloS one. 2019;(8):e0221199
Abstract
BACKGROUND In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly controlled type 2 diabetes. YH1 is a concentrated Chinese herbal extract formula that combines Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San. This randomized, double-blind, placebo-controlled pilot study evaluated YH1 as an add-on medication for poorly controlled type 2 diabetes. METHODS Forty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation. RESULTS At week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of β cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial. CONCLUSIONS This pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and β-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification.
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6.
Controlling type 2 diabetes mellitus with herbal medicines: A triple-blind randomized clinical trial of efficacy and safety.
Mirfeizi, M, Mehdizadeh Tourzani, Z, Mirfeizi, SZ, Asghari Jafarabadi, M, Rezvani, HR, Afzali, M
Journal of diabetes. 2016;(5):647-56
Abstract
BACKGROUND The use of alternative medicines is common in patients with diabetes mellitus. The primary aim of the present study was to determine the effects of cinnamon and Caucasian whortleberry (Vaccinium arctostaphylos L.) on blood glucose control, lipid profile and body mass index (BMI) in patients with type 2 diabetes (T2DM). METHODS In all, 105 T2DM patients were recruited to the present randomized triple-blinded clinical trial. Patients were randomly divided into three groups and administered either placebo, cinnamon or whortleberry supplements (1 g/day) for 90 days. Fasting blood glucose (FBG), serum insulin, lipid profiles, and HbA1c were measured before and after the study. RESULTS There were no significant differences in baseline characteristics among the three groups. After treatment, FBG, 2-h blood postprandial glucose and homeostasis model assessment of insulin resistance (HOMA-IR) scores were significantly reduced in patients in the whortleberry group, but not in the placebo group. After treatment, there was a significant difference in BMI between the cinnamon and control groups (P = 0.02). There were no significant differences in any variables between the cinnamon and whortleberry groups (P>0.05 for all). In addition, there was a significant decrease in all indices of glucose control in all the cinnamon and whortleberry groups (P < 0.05). CONCLUSIONS There were no significant differences in blood glucose levels, insulin sensitivity or lipid profile among the three groups. However, the use of cinnamon and whortleberry in addition to conventional medical treatment is recommended to adjust weight and blood glucose levels in patients with T2DM, respectively.
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7.
LICHENS' B-OLIGOSACCHARIDES IN THE CORRECTION OF METABOLIC DISORDERS IN TYPE 2 DIABETES MELLITUS.
Kershengolts, BM, Sydykova, LA, Sharoyko, VV, Anshakova, VV, Stepanova, AV, Varfolomeeva, NA
Wiadomosci lekarskie (Warsaw, Poland : 1960). 2015;(4):480-2
Abstract
INTRODUCTION Lichens of the genus Cladonia are used as medicinal plants in folk medicine. Biologically active food supplement (BAFS) on the basis of lichens p. Cladonia was derived by mechanical-chemical biotechnology in the Educational-Research-Engineering Laboratory "Mechanical-Chemical Biotechnology" of the North-Eastern Federal University (NEFU). As a result of biotech impact, the solid β-glycoside bonds are destructed on β-oligosaccharide molecules, and other groups of lichen BAS is mobilized. The content of hydrolysable carbohydrates in samples of lichen increased 8 times after mechanical activation. AIM: The aim of investigation was to study the effects of BAFS "Yagel-Detox" in patients with type 2 diabetes mellitus (DM 2). MATERIALS AND METHODS The 150 patients (group 1--100 patients receiving "Yagel-Detox", group 2--50 patients receiving placebo) with a diagnosis DM 2 were examined. The research included: general clinical and instrumental examination, biochemical and clinical blood tests. "Yagel-Detox" was used 1 capsule 3 times a day, the rate of admission was 3 months. RESULTS Clinical trials have shown that 3-month intake of BAFS "Yagel-Detox" reduces the concentration of blood glucose 1.3 1.6 times (in the control group--1.2 ÷ 1.4 times), glycosylated hemoglobin--from 9.8 ÷ 11.4% to 7.6% (in the control group--1.0%). The concentration of low-density lipoprotein (LDL) reduced on 1.3% through 6 months. Patients of both groups were on the similar tablet glucose-lowering therapy (randomized treatment), which have not been adjusted. CONCLUSIONS The obtained results allow us to recommend BAFS "Yagel-Detox" as an additional remedy to normalize blood glucose concentration in patients with DM 2.
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8.
Assessment of protective role of polyherbal preparation, Livina, against anti-tubercular drug induced liver dysfunction.
Gulati, K, Ray, A, Vijayan, VK
Indian journal of experimental biology. 2010;(3):318-22
Abstract
The present study evaluated the possible protective role of Livina (a polyherbal preparation) against anti-tubercular therapy (ATT)-induced liver dysfunction in patients of pulmonary tuberculosis. Patients were given intensive phase treatment with 4-drugs (rifampicin, INH, pyrazinamide and ethambutol) used for anti-tubercular therapy for 2 months, followed by a 4-month continuous phase treatment with 2 drugs (rifampicin and INH) under clinical advice and supervision. Both qualitative and quantitative measures of liver function were assessed, at different time intervals, before and after ATT. Analysis of data showed that the incidence of qualitative manifestations of liver dysfunction were greater in the placebo treated group as compared to the test drug group. None of the patients of either group showed clinical jaundice. Most signific changes ant were observed in the SGOT and SGPT levels in the placebo group, wherein the levels of both enzymes were higher at 4 and 8 weeks post-ATT, as compared to the respective baseline (0 week) values. When Livina (2 capsules twice daily) was given with ATT drugs, incidence of qualitative manifestation of liver dysfunction was insignificant and SGOT and SGPT levels were also significantly lower than the placebo+AITT drugs treated group. These results indicate that the test drug (Livina) was efficacious, against ATT-induced hepatic dysfunction in patients of pulmonary tuberculosis.
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9.
In vivo enhancement of natural killer cell activity through tea fortified with Ayurvedic herbs.
Bhat, J, Damle, A, Vaishnav, PP, Albers, R, Joshi, M, Banerjee, G
Phytotherapy research : PTR. 2010;(1):129-35
Abstract
The effect of a tea fortified with five herbs selected from Indian traditional medicine (Ayurveda) for their putative immunoenhancing effect (Withania somnifera, Glycyrrhzia glabra, Zingiber officinale, Ocimum sanctum and Elettaria cardamomum) on innate immunity was investigated. Ex vivo natural killer (NK) cell activity was assessed after consumption of fortified tea compared with regular tea in two independent double-blind intervention studies. Both studies were conducted in India with healthy volunteers (age >or= 55 years) selected for a relatively low baseline NK cell activity and a history of recurrent coughs and colds. In a pilot study conducted with 32 volunteers, the consumption of Natural Care tea significantly improved the NK cell activity of the volunteers in comparison with a population consuming regular tea. These results were validated in an independent crossover study with 110 volunteers. Data from these two studies indicate that regular consumption of the tea fortified with Ayurvedic herbs enhanced NK cell activity, which is an important aspect of the (early) innate immune response to infections.
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10.
[Clinical study on Shen Shuai Fang in treating chronic renal failure].
Wu, XL, Li, ZJ, Zhang, WJ, Ao, QX, Xu, YW
Zhong yao cai = Zhongyaocai = Journal of Chinese medicinal materials. 2008;(5):796-8
Abstract
OBJECTIVE To explore the effect of Shen Shuai Fang in treating Chronic Renal Failure (CRF) of deficiency of spleen and kidney with turbid damp and blood stagnation symptom. METHODS 125 patients with CRF of deficiency of spleen and kidney with turbid damp and blood stagnation symptom were randomly divided into two groups, 75 patients in treatment group were treated with Shen Shuai Fang adding western medicine and the other patients in control group were treated only with western medicine. We observed the effect and indexes change including renal function, Hb, proteinuria, lipid before and after treatment. RESULTS After six months' treatment, the general effective rate in treatment group was 77.33%, which was higher than that in control group obviously (44.00%, P < 0.01). So treatment group was obviously better than control group on decreasing proteinuria, improving renal function, increasing Hb, ameliorating lipid metabolism (P < 0.05 or P < 0.01). CONCLUSION Shen Shuai Fang is effective to treat CRF of deficiency of spleen and kidney with turbid damp and blood stagnation symptom.