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1.
Development of an Affordable, Sustainable and Efficacious Plant-Based Immunomodulatory Food Ingredient Based on Bell Pepper or Carrot RG-I Pectic Polysaccharides.
McKay, S, Oranje, P, Helin, J, Koek, JH, Kreijveld, E, van den Abbeele, P, Pohl, U, Bothe, G, Tzoumaki, M, Aparicio-Vergara, M, et al
Nutrients. 2021;(3)
Abstract
The prevalence of acute respiratory infections and their impact on quality of life underlies the need for efficacious solutions that are safe, sustainable and economically viable. Polysaccharides in several (traditional) plant extracts have been shown to be immunostimulatory, and some studies suggest beneficial effects against respiratory infections. The aim of this study was to (i) identify the active polysaccharide constituents from affordable and renewable crops (bell pepper and carrot) using activity-guided fractionation, (ii) evaluate in vitro effects on innate immune responses (phagocytosis and cytokine secretion), microbiota modulation and production of short chain fatty acids, followed by (iii) the evaluation of effects of a bell pepper extract enriched for the active component in a human proof of concept study. We identified rhamnogalacturonan-I (RG-I) as the nutricophore responsible for the immunostimulatory activity with substantial structural and functional equivalence between bell pepper (bp) and carrot (c). The in vitro studies showed that bpRG-I and cRG-I comprise similar immune- and microbiota modulatory potential and the human study demonstrated that bpRG-I was well tolerated and enhanced innate immune responsiveness in vivo. This is an important step towards testing the efficacy of RG-I from bpRG-I or cRG-I in an infection trial in humans.
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2.
Randomized, double-blind, placebo-controlled clinical trial studying the effects of Turmeric in combination with mefenamic acid in patients with primary dysmenorrhoea.
Hesami, S, Kavianpour, M, Rashidi Nooshabadi, M, Yousefi, M, Lalooha, F, Khadem Haghighian, H
Journal of gynecology obstetrics and human reproduction. 2021;(4):101840
Abstract
Primary dysmenorrhea (PDM) is one of the common complaints in women. This study aimed to assess the effects of turmeric and mefenamic acid and a combination compared with placebo on PDM. This clinical trial was conducted on dormitory students with PDM. Subjects completed the visual analog scale (VAS) before randomization. One hundred twenty-eight patients, randomly assigned to one of following groups: Turmeric group (n=32), mefenamic acid group (n=32), turmeric and mefenamic acid group (n=32), and placebo group (n=32). Turmeric and mefenamic acid were administrated in 500mg and 250mg, respectively. Pain severity was assessed in the baseline and the end line by VAS. Statistical analysis was performed using SPSS software. The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups. Our results illustrated that combination of turmeric and mefenamic acid would be better in pain alleviation in PDM.
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3.
The comparison of therapeutic effect of Clobetasol propionate lotion and squill extract in alopecia areata: a randomized, double-blind clinical trial.
Moosavi, ZB, Aliabdi, M, Golfakhrabadi, F, Namjoyan, F
Archives of dermatological research. 2020;(3):173-178
Abstract
Alopecia areata is a chronic inflammatory disease that characterized by round or oval patches of non-scarring hair loss. From the past, Urginea maritima (white squill) was used for the treatment of hair loss in Iranian traditional medicine. We aimed the comparison of Clobetasol lotion and squill extract efficacy in treatment of alopecia areata in a randomized, double-blind clinical trial. The 42 patients were randomized into two groups. Both groups received topical squill and clobetasol lotion twice daily lotion for 12 weeks. Clinical evaluation included size of patches (using 1×1 cm2 schablone), total number of grown hair and number of terminal hair was performed every 2 weeks. Re-growth of terminal coarse hairs was evaluated using a semi-quantitative regrowth score (RGS) (0: no regrowth, 1: growth of <25%, 2: growth of 25-50%, 3: growth of 51-75%, 4: growth of >75%). There were significant differences between RGS4 in two groups after 2- and 3-month treatment (P<0.05). At the end of follow-up period, the mean hair growth rates increased significantly from 6.5 to 11.3 in squill group (P = 0.031) and it improved significantly from 10.3 to 17.9 in clobetasol group (P = 0.001). There were no significant differences between mean hair growth rates in two groups after 3-month treatment (P = 0.969). The lotion 2% of U. maritima bulbs extract showed good effect in 45% patients with patchy alopecia areata and showed moderate effect on re-growth of terminal hairs.
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4.
Herbal medicine for acute bronchitis: A qualitative interview study of patients' and health professionals' views.
Soilemezi, D, Leydon, GM, Yan, R, Simpson, C, Bell, M, Bostock, J, Moore, M, Willcox, M
Complementary therapies in medicine. 2020;:102613
Abstract
BACKGROUND Antibiotics are widely prescribed for acute bronchitis in the UK. Herbal medicine could be used instead to provide symptom relief. AIM: To explore the views of patients and health professionals on using herbal medicine for acute bronchitis instead of antibiotics. DESIGN AND SETTING This was a nested qualitative study, conducted alongside a feasibility randomised clinical trial which ran from July 2018 to May 2019 in 20 GP practices in Wessex, UK. METHOD We conducted telephone semi-structured interviews with patients and with health professionals. The interview data were transcribed and analysed thematically. RESULTS Overall, 40 interviews were conducted with 29 patients, six GPs and five nurses. While some patients believed antibiotics are more effective, most were aware of resistance and were keen to try an alternative, including herbal medicine. Several patients believed herbals would be "less intrusive" than antibiotics, whereas a few disliked the taste or experienced side-effects after taking a herbal. Professionals were concerned about potential interactions with conventional medicines. Many patients trusted herbals because of their long history of use, while some did not understand them. Availability of herbals without a prescription enables patients to use them for self-care, but their cost was a barrier for some. Many patients were willing to take a herbal if advised by their GP. Most GPs were happy to recommend a herbal, if endorsed by evidence-based guidelines. CONCLUSION Many patients and health professionals would consider using herbal medicine for acute bronchitis, if based on trustworthy advice and evidence-based guidelines respectively.
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5.
Hypoglycemic efficacy and safety of Momordica charantia (bitter melon) in patients with type 2 diabetes mellitus.
Kim, SK, Jung, J, Jung, JH, Yoon, N, Kang, SS, Roh, GS, Hahm, JR
Complementary therapies in medicine. 2020;:102524
Abstract
INTRODUCTION Momordica charantia (bitter melon) is widely used for its glucose-lowering effects. This study was conducted to assess the efficacy and safety of M. charantia as an adjuvant treatment in patients with type 2 diabetes. METHODS We performed a randomized, placebo-controlled study. Blood glucose levels, lipid profile, and adverse events were investigated after 12 weeks of treatment. Ninety subjects were included in the final analysis for glucose lowering efficacy of bitter melon. RESULTS There were no differences in age, sex, or glycated hemoglobin (HbA1c) levels between the bitter melon extract and placebo groups. After treatment with bitter melon extract for 12 weeks, the HbA1c levels of the bitter melon and placebo groups remained unchanged; however, the average fasting glucose level of the bitter melon group decreased (p = 0.014). No serious adverse events were reported during the treatment period. CONCLUSIONS Our data showed that bitter melon has effects of glucose lowering in patients with type 2 diabetes.
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6.
A double-blind, randomized pilot study for comparison of Melissa officinalis L. and Lavandula angustifolia Mill. with Fluoxetine for the treatment of depression.
Araj-Khodaei, M, Noorbala, AA, Yarani, R, Emadi, F, Emaratkar, E, Faghihzadeh, S, Parsian, Z, Alijaniha, F, Kamalinejad, M, Naseri, M
BMC complementary medicine and therapies. 2020;(1):207
Abstract
BACKGROUND Depression has rapidly progressed worldwide, and the need for an efficient treatment with low side effect has risen. Melissa officinalis L and Lavandula angustifolia Mill have been traditionally used in Asia for the treatment of depression. Many textbooks of traditional Persian medicine refer to these herbs for the treatment of depression while there are no adequate clinical trials to support this claim. The present study aimed to evaluate the efficacy of M. officinalis and L. angustifolia compared to fluoxetine for the treatment of mild to moderate depression in an 8-week randomized, double-blind clinical trial. METHODS Forty-five adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for major depression, were randomly assigned to 3 groups to daily receive either M. officinalis (2 g) or L. angustifolia (2 g) or fluoxetine (20 mg) and were assessed in weeks 0, 2, 4 and 8 by the Hamilton Rating Scale for Depression (HAM-D) including 17 items. RESULTS Our study showed that M. officinalis and L. angustifolia effect similar to fluoxetine in mild to moderate depression. (F = 0.131, df = 2,42, p = 0.877). CONCLUSION Due to some restrictions in this study including absence of placebo group, large-scale trials are needed to investigate the anti-depressant effect of these two herbs with more details. TRIAL REGISTRATION IRCT2014061718126N1 . Registration date: 2015-06-04-"Retrospectively registered".
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7.
Multicenter Clinical Trials Analyzing Efficacy and Safety of Topical Cortex Phellodendri Compound Fluid in Treatment of Diabetic Foot Ulcers.
Liu, Y, Li, Y, Du, Y, Huang, T, Zhu, C
Medical science monitor : international medical journal of experimental and clinical research. 2020;:e923424
Abstract
BACKGROUND The aim of this study was to analyze the clinical application of cortex phellodendri compound fluid (CPCF) in the treatment of diabetic foot ulcers. MATERIAL AND METHODS From January 2012 to December 2015, a total of 720 cases of diabetic foot ulcers (DFU) were randomly assigned into an experimental group (n=540) that was treated by CPCF and a control group (n=180) that was treated by a Kangfuxin solution (KFS). After 4 weeks of treatment, their ulcer area, serum growth factor, clinical total effective rate, and incidence of adverse events were assessed. RESULTS There were 720 patients who completed the trial. The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05). There was no significant difference in the adverse events rates between the 2 groups. CONCLUSIONS CPCF external treatment of diabetic foot ulcer can promote ulcer healing and increase the concentration of growth factors, and it is safe and reliable.
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8.
Evaluating the efficacy and safety of the myrtle (Myrtus communis) in treatment and prognosis of patients suspected to novel coronavirus disease (COVID-19): study protocol for a randomized controlled trial.
Azimi, M, Hasheminasab, FS
Trials. 2020;(1):978
Abstract
BACKGROUND Since December 2019, the outbreak of coronavirus pneumonia was observed in China and quickly propagate in all of the world. Nowadays, many trials are underway on this disease in which the efficacy of various therapeutic remedies including chemical or natural agents as well as different non-pharmacological methods such as acupuncture are evaluated. This study aims at investigating the effect of M. communis fruit for treatment of COVID-19 disease. METHODS We are performing an open-label randomized controlled trial on outpatients clinically suspected to COVID-19 disease in the age range of 18-65 years old with mild to moderate symptoms and without respiratory distress. Patients in both groups (M. communis and control) receive conventional therapy, but those in M. communis group get M. communis preparation in addition to conventional therapy. Intervention will continue for 5 days and the study outcomes including clinical status as well as mortality rate and adverse effects will be measured up to 14 days. DISCUSSION The protocol describes the design of an ongoing randomized controlled trial to establish the evidence for the usage of water extract of M. communis fruit in clinically suspected COVID-19 disease and identify any safety concerns. TRIAL REGISTRATION The trial has been registered at the Iranian Registry of Clinical Trials website under the code IRCT20180923041093N3 on March 28th, 2020 ( https://www.irct.ir/trial/46721 ). The results will be disseminated through manuscript publications and presentations to scientific meetings.
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9.
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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10.
Effectiveness of Echium amoenum on premenstrual syndrome: a randomized, double-blind, controlled trial.
Farahmand, M, Khalili, D, Ramezani Tehrani, F, Amin, G, Negarandeh, R
BMC complementary medicine and therapies. 2020;(1):295
Abstract
BACKGROUND The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo. METHODS The present study was a randomized double-blind controlled clinical trial. A checklist questionnaire was completed by 120, 18 to 35-year-old, college students. And then, 84 eligible women (20 to 35 years old) were enrolled in the trial; they were randomly assigned to two groups of intervention (EA) and control (placebo), with 42 participants in each group. Participants in the intervention group received 450 mg capsules of EA per day (three times a day) from the 21st day of their menstrual cycle until the 3rd day of their next cycle for two consecutive cycles. The severity of PMS was measured and ranked using the premenstrual symptoms screening tool (PSST). The generalized estimating equation was used to compare the total score of the severity of PMS between the two groups. RESULTS Sixty-nine women with regular menstrual cycles suffering from PMS completed the study. The mean scores of the symptoms in the EA group were 35.3 and 16.1 (P ≤ 0.001) at baseline and after 2 months, respectively, while the mean scores of the symptoms in the placebo group were 31.0 and 28.3 (P = 0.09) at baseline and after 2 months, respectively. The evaluation of the first and the second follow-ups in the intervention group showed that, after being adjusted for age and body mass index (P ≤ 0.001), the mean scores of the premenstrual syndrome, using GEE analysis, have decreased to 6.2 and 11.6, respectively. CONCLUSION Based on the results, in comparison with the placebo group, EA was found to be more effective in improving the symptoms of PMS, and is highly recommended for treatment of this syndrome. TRIAL REGISTRATION IRCT2015110822779N3 ; Registration date: 2015-11-27.