CYBERMED LIFE - ORGANIC  & NATURAL LIVING

Cybermedlife - Therapeutic Actions Placebo Effect

Randomised clinical trial: a Lactobacillus GG and micronutrient-containing mixture is effective in reducing nosocomial infections in children, vs. placebo. 📎

Abstract Title: Randomised clinical trial: a Lactobacillus GG and micronutrient-containing mixture is effective in reducing nosocomial infections in children, vs. placebo. Abstract Source: Aliment Pharmacol Ther. 2016 Sep ;44(6):568-75. Epub 2016 Jul 28. PMID: 27464469 Abstract Author(s): E Bruzzese, M C Fedele, D Bruzzese, S Viscovo, A Giannattasio, C Mandato, P Siani, A Guarino Article Affiliation: E Bruzzese Abstract: BACKGROUND: Nosocomial infections are a major public health issue and preventative strategies using probiotics and micronutrients are being evaluated. AIM: To investigate the efficacy of a mixture of Lactobacillus GG and micronutrients in preventing nosocomial infections in children. METHODS: A randomised, double-blind, placebo-controlled trial was conducted in hospitalised children. Children (6 months to 5 years of age) received Lactobacillus GG (6× 10(9) CFU/day) together with vitamins B and C and zinc or placebo, for 15 days, starting on the first day of hospitalisation. The incidence of gastrointestinal and respiratory nosocomial infections after discharge was determined by follow-up telephone call at 7 days. After 3 months, another telephone call estimated the incidence of further infections during follow-up. RESULTS: Ninety children completed the follow-up. Of 19/90 children with a nosocomial infection (20%), 4/45 children (9%) were in the treatment group and 15/45 (33%) in the placebo group (P = 0.016). Specifically, 2/45 (4%) children in the treatment group vs. 11/45 (24%) children in the placebo group (P = 0.007) presented with diarrhoea. The duration of hospitalisation was significantly shorter in the treatment group (3.9 days± 1.7 vs. 4.9 ± 1.2; P = 0.003). At the follow-up, a total of 11/45 (24.4%) children in the treatment group had at least one episode of infection compared to 22/45 (48.9%) in the placebo group (P = 0.016). CONCLUSION: A mixture containing Lactobacillus GG and micronutrients may reduce the incidence of nosocomial infections, supporting the hypothesis that this may represent a valid strategy to prevent nosocomial infections. Article Published Date : Aug 31, 2016

Effects of Korean red ginseng on semen parameters in male infertility patients: A randomized, placebo-controlled, double-blind clinical study.

Abstract Title: Effects of Korean red ginseng on semen parameters in male infertility patients: A randomized, placebo-controlled, double-blind clinical study. Abstract Source: Chin J Integr Med. 2016 Jul ;22(7):490-5. Epub 2015 May 12. PMID: 25967606 Abstract Author(s): Hyun Jun Park, Sangmin Choe, Nam Cheol Park Article Affiliation: Hyun Jun Park Abstract: OBJECTIVE: To investigate the effects of Korean red ginseng (KRG) on semen parameters in male infertility patients in a randomized, double-blind, placebo-controlled study. METHODS: A total of 80 male infertility patients with varicocele were recruited from April 2011 to February 2012. The subjects were then divided into the following four groups: non-varicocelectomy (V)+placebo (P) group, V+P group, non-V+KRG group (1.5-g KRG daily), and V+KGR group (1.5-g KRG daily). Semen analysis was performed and hormonal levels were measured in each treatment arm after 12 weeks. RESULTS: All groups but not the non-V+P group, showed significant improvements in sperm concentrations, motility, morphology, and viability at the end of the study. However, there were no significant differences in serum follicle-stimulating hormone, luteinizing hormone, and testosterone among groups. The incidence of adverse events was low, and all events were assumed to be unrelated to the treatments administered. CONCLUSIONS: Although the exact mechanism by which KRG improves spermatogenesis remains unclear, KRG may be a useful agent for the treatment of male infertility. Nevertheless, additional studies to evaluate the optimal dose and duration of treatment are needed. Article Published Date : Jun 30, 2016

Acupuncture for joint symptoms related to aromatase inhibitor therapy in postmenopausal women with early-stage breast cancer: a narrative review.

Abstract Title: Acupuncture for joint symptoms related to aromatase inhibitor therapy in postmenopausal women with early-stage breast cancer: a narrative review. Abstract Source: Acupunct Med. 2015 Mar 2. Epub 2015 Mar 2. PMID: 25733539 Abstract Author(s): Elizabeth J Halsey, Mei Xing, Rachel C Stockley Article Affiliation: Elizabeth J Halsey Abstract: BACKGROUND: Aromatase inhibitor-induced musculoskeletal syndrome (AIMSS) leads to discontinuation of aromatase inhibitor therapy in a significant proportion of patients with breast cancer. Acupuncture is popular among cancer patients and has previously been shown to improve symptoms in a range of musculoskeletal complaints. AIM: To determine the effectiveness and safety of acupuncture for the management of AIMSS in postmenopausal women with early-stage breast cancer. METHODS: A literature search was carried out for randomised controlled trials (RCTs) on acupuncture for AIMSS in postmenopausal women with early-stage breast cancer. Characteristics of trials and outcomes were extracted from the retrieved articles, which were also assessed for risk of bias and quality of reporting. RESULTS: Four RCTs were retrieved of sample size 32-67 (totalling 190 participants). Compliance with treatment was high and rates of adverse events were low. Of the three two-arm RCTs, two found no difference between acupuncture and sham acupuncture and one found that acupuncture was statistically superior to sham acupuncture. The fourth RCT, which incorporated three arms, found acupuncture and sham acupuncture to be statistically superior to usual care but there was no difference between true and sham acupuncture. Three trials that used non-penetrating sham as the control found no effect of acupuncture over sham, but the one trial that used superficial needle insertion found acupuncture to be superior. CONCLUSIONS: Acupuncture is safe and results in improvement in AIMSS symptoms, but similar benefits are also elicited by non-penetrating sham acupuncture. Future research should seek to establish the durability of improvements. Article Published Date : Mar 01, 2015

Effect of melatonin on depressive symptoms and anxiety in patients undergoing breast cancer surgery: a randomized, double-blind, placebo-controlled trial.

Abstract Title: Effect of melatonin on depressive symptoms and anxiety in patients undergoing breast cancer surgery: a randomized, double-blind, placebo-controlled trial. Abstract Source: Breast Cancer Res Treat. 2014 Jun ;145(3):683-95. Epub 2014 Apr 23. PMID: 24756186 Abstract Author(s): Melissa V Hansen, Lærke T Andersen, Michael T Madsen, Ida Hageman, Lars S Rasmussen, Susanne Bokmand, Jacob Rosenberg, Ismail Gögenur Article Affiliation: Melissa V Hansen Abstract: Depression, anxiety and sleep disturbances are known problems in patients with breast cancer. The effect of melatonin as an antidepressant in humans with cancer has not been investigated. We investigated whether melatonin could lower the risk of depressive symptoms in women with breast cancer in a three-month period after surgery and assessed the effect of melatonin on subjective parameters: anxiety, sleep, general well-being, fatigue, pain and sleepiness. Randomized, double-blind, placebo-controlled trial undertaken from July 2011 to December 2012 at a department of breast surgery in Copenhagen, Denmark. Women, 30-75 years, undergoing surgery for breast cancer and without signs of depression on Major Depression Inventory (MDI) were included 1 week before surgery and received 6 mg oral melatonin or placebo for 3 months. The primary outcome was the incidence of depressive symptoms measured by MDI. The secondary outcomes were area under the curve (AUC) for the subjective parameters. 54 patients were randomized to melatonin (n = 28) or placebo (n = 26) and 11 withdrew from the study (10 placebo group and 1 melatonin group, P = 0.002). The risk of developing depressive symptoms was significantly lower with melatonin than with placebo (3 [11 %] of 27 vs. 9 [45 %] of 20; relative risk 0.25 [95 % CI 0.077-0.80]), giving a NNT of 3.0 [95 % CI 1.7-11.0]. No significant differences were found between AUC for the subjective parameters. No differences in side effects were found (P = 0.78). Melatonin significantly reduced the risk of depressive symptoms in women with breast cancer during a three-month period after surgery. Article Published Date : May 31, 2014

Turmeric improves post-prandial working memory in pre-diabetes independent of insulin. 📎

Abstract Title: Turmeric improves post-prandial working memory in pre-diabetes independent of insulin. Abstract Source: Asia Pac J Clin Nutr. 2014 ;23(4):581-91. PMID: 25516316 Abstract Author(s): Meei-Shyuan Lee, Mark L Wahlqvist, Yu-Ching Chou, Wen-Hui Fang, Jiunn-Tay Lee, Jen-Chun Kuan, Hsiao-Yu Liu, Ting-Mei Lu, Lili Xiu, Chih-Cheng Hsu, Zane B Andrews, Wen-Harn Pan Article Affiliation: Meei-Shyuan Lee Abstract: BACKGROUND AND OBJECTIVES: Cognitive impairment develops with pre-diabetes and dementia is a complication of diabetes. Natural products like turmeric and cinnamon may ameliorate the underlying pathogenesis. METHODS: People≥ 60 years (n=48) with newly-recognised untreated pre-diabetes were randomised to a double-blind metabolic study of placebo, turmeric (1 g), cinnamon (2 g) or both (1 g&2 g respectively), ingested at a white bread (119 g) breakfast. Observations were made over 6 hours for pre- and post-working memory (WM), glycaemic and insulin responses and biomarkers of Alzheimer's disease (AD)(0, 2, 4 and 6 hours): amyloid precursor protein (APP),γ-secretase subunits presenilin-1 (PS1), presenilin-2 (PS2), and glycogen synthase kinase (GSK-3β). Differences between natural product users and non-users were determined by Students t and chi square tests; and between pre-test and post-test WM by Wilcoxon signed rank tests. Interaction between turmeric and cinnamon was tested by 2-way ANOVA. Multivariable linear regression (MLR) took account of BMI, glycaemia, insulin and AD biomarkers in the WM responses to turmeric and cinnamon. RESULTS: No interaction between turmeric and cinnamon was detected. WM increased from 2.6 to 2.9 out of 3.0 (p=0.05) with turmeric, but was unchanged with cinnamon. WM improvement was inversely associated with insulin resistance (r=-0.418, p<0.01), but not with AD biomarkers. With MLR, the WM responses to turmeric were best predicted with an R2 of 34.5%; and with significant turmeric, BMI and insulin/glucose AUC beta-coefficients. CONCLUSIONS: Co-ingestion of turmeric with white bread increases working memory independent of body fatness, glycaemia, insulin, or AD biomarkers. Article Published Date : Dec 31, 2013

Pain as a reward: changing the meaning of pain from negative to positive co-activates opioid and cannabinoid systems.

Abstract Title: Pain as a reward: changing the meaning of pain from negative to positive co-activates opioid and cannabinoid systems. Abstract Source: Pain. 2013 Mar ;154(3):361-7. Epub 2012 Nov 21. PMID: 23265686 Abstract Author(s): Fabrizio Benedetti, Wilma Thoen, Catherine Blanchard, Sergio Vighetti, Claudia Arduino Article Affiliation: Fabrizio Benedetti Abstract: Pain is a negative emotional experience that is modulated by a variety of psychological factors through different inhibitory systems. For example, endogenous opioids and cannabinoids have been found to be involved in stress and placebo analgesia. Here we show that when the meaning of the pain experience is changed from negative to positive through verbal suggestions, the opioid and cannabinoid systems are co-activated and these, in turn, increase pain tolerance. We induced ischemic arm pain in healthy volunteers, who had to tolerate the pain as long as possible. One group was informed about the aversive nature of the task, as done in any pain study. Conversely, a second group was told that the ischemia would be beneficial to the muscles, thus emphasizing the usefulness of the pain endurance task. We found that in the second group pain tolerance was significantly higher compared to the first one, and that this effect was partially blocked by the opioid antagonist naltrexone alone and by the cannabinoid antagonist rimonabant alone. However, the combined administration of naltrexone and rimonabant antagonized the increased tolerance completely. Our results indicate that a positive approach to pain reduces the global pain experience through the co-activation of the opioid and cannabinoid systems. These findings may have a profound impact on clinical practice. For example, postoperative pain, which means healing, can be perceived as less unpleasant than cancer pain, which means death. Therefore, the behavioral and/or pharmacological manipulation of the meaning of pain can represent an effective approach to pain management. Article Published Date : Feb 28, 2013

Proanthocyanidin-rich grape seed extract reduces leg swelling in healthy women during prolonged sitting.

Abstract Title: Proanthocyanidin-rich grape seed extract reduces leg swelling in healthy women during prolonged sitting. Abstract Source: J Sci Food Agric. 2013 Feb ;93(3):457-62. Epub 2012 Jul 2. PMID: 22752876 Abstract Author(s): Atsushi Sano, Shoichi Tokutake, Akihiko Seo Article Affiliation: Atsushi Sano Abstract: BACKGROUND: Leg swelling is a modern-day affliction of sedentary working women. The aim of this study was to evaluate the effectiveness of the intake of grape seed extract (GSE) on leg swelling in healthy Japanese women while sitting. RESULTS: Single intake trials and 14 day intake trials were held in a double-blind, placebo-controlled, crossover clinical study. A prolonged sedentary position was maintained for 6 h after GSE or placebo administration. Leg volume distension, increase in body extracellular fluid, and leg water were significantly suppressed in the GSE groups. CONCLUSION: The intake of GSE is a contributing factor in the inhibition of leg swelling in healthy women during prolonged sitting. Article Published Date : Jan 31, 2013

Boswellia serrata acts on cerebral edema in patients irradiated for brain tumors: a prospective, randomized, placebo-controlled, double-blind pilot trial. 📎

Abstract Title: Boswellia serrata acts on cerebral edema in patients irradiated for brain tumors: a prospective, randomized, placebo-controlled, double-blind pilot trial. Abstract Source: Cancer. 2011 Aug 15 ;117(16):3788-95. Epub 2011 Feb 1. PMID: 21287538 Abstract Author(s): Simon Kirste, Markus Treier, Sabine Jolie Wehrle, Gerhild Becker, Mona Abdel-Tawab, Kathleen Gerbeth, Martin Johannes Hug, Beate Lubrich, Anca-Ligia Grosu, Felix Momm Article Affiliation: Simon Kirste Abstract: BACKGROUND: Patients irradiated for brain tumors often suffer from cerebral edema and are usually treated with dexamethasone, which has various side effects. To investigate the activity of Boswellia serrata (BS) in radiotherapy-related edema, we conducted a prospective, randomized, placebo-controlled, double-blind, pilot trial. METHODS: Forty-four patients with primary or secondary malignant cerebral tumors were randomly assigned to radiotherapy plus either BS 4200 mg/day or placebo. The volume of cerebral edema in the T2-weighted magnetic resonance imaging (MRI) sequence was analyzed as a primary endpoint. Secondary endpoints were toxicity, cognitive function, quality of life, and the need for antiedematous (dexamethasone) medication. Blood samples were taken to analyze the serum concentration of boswellic acids (AKBA and KBA). RESULTS: Compared with baseline and if measured immediately after the end of radiotherapy and BS/placebo treatment, a reduction of cerebral edema of>75% was found in 60% of patients receiving BS and in 26% of patients receiving placebo (P = .023). These findings may be based on an additional antitumor effect. There were no severe adverse events in either group. In the BS group, 6 patients reported minor gastrointestinal discomfort. BS did not have a significant impact on quality of life or cognitive function. The dexamethasone dose during radiotherapy in both groups was not statistically different. Boswellic acids could be detected in patients' serum. CONCLUSIONS: BS significantly reduced cerebral edema measured by MRI in the study population. BS could potentially be steroid-sparing for patients receiving brain irradiation. Our findings will need to be further validated in larger studies. Article Published Date : Aug 14, 2011

The effect of hydro alcoholic Nettle (Urtica dioica) extracts on insulin sensitivity and some inflammatory indicators in patients with type 2 diabetes: a randomized double-blind control trial.

Abstract Title: The effect of hydro alcoholic Nettle (Urtica dioica) extracts on insulin sensitivity and some inflammatory indicators in patients with type 2 diabetes: a randomized double-blind control trial. Abstract Source: Pak J Biol Sci. 2011 Aug 1 ;14(15):775-9. PMID: 22303583 Abstract Author(s): N Namazi, A T Esfanjani, J Heshmati, A Bahrami Article Affiliation: N Namazi Abstract: Type 2 diabetes is a metabolic disorder that is strongly associated with cardiovascular risk. Inflammation is a potential risk factor for cardiovascular disease. In this study, hydro alcoholic extract of Nettle (Urtica dioica) on insulin sensitivity and some inflammatory indicators in type 2 diabetic patients were studied. A randomized double-blind clinical trial on 50 men and women with type 2 diabetes was done for 8 weeks. Patients were adjusted by age, sex and duration of diabetes, then randomly divided into two groups, an intervention and control group. They received, 100 mg kg-1nettle extract or placebo in three portions a day for 8 weeks. Interleukin 6 (IL-6), Tumor Necrosis Factor-alpha (TNF-alpha), High Sensitive C-Reactive protein (hs-CRP) and Fasting Insulin concentration were measured. Insulin Sensitivity was calculated, at the beginning and the end of the study. The data were analyzed by SPSS version 18, p<0.05 was considered significant for all variables. After 8 weeks, IL-6 and hs-CRP showed a significant decrease in the intervention group compared to the control group (p<0.05). The findings showed that the hydro alcoholic extract of nettle has decreasing effects on IL-6 and hs-CRP in patients with type 2 diabetes after eight weeks intervention. Article Published Date : Jul 31, 2011

Induction of nocebo and placebo effects on itch and pain by verbal suggestions.

Abstract Title: Induction of nocebo and placebo effects on itch and pain by verbal suggestions. Abstract Source: Pain. 2011 Jul;152(7):1486-94. Epub 2011 Feb 24. PMID: 21353388 Abstract Author(s): Antoinette I M van Laarhoven, Michiel L Vogelaar, Oliver H Wilder-Smith, Piet L C M van Riel, Peter C M van de Kerkhof, Floris W Kraaimaat, Andrea W M Evers Article Affiliation: Department of Medical Psychology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. Abstract: Physical complaints, such as pain, can be effectively reduced by placebo effects through induction of positive expectations, or increased by nocebo effects through induction of negative expectations. In the present study, verbally induced nocebo and placebo effects on itch were experimentally investigated for the first time. In part 1, the role of verbal suggestions in inducing nocebo effects on itch and pain was investigated. All subjects received the same somatosensory quantitative sensory testing stimuli, that is, mechanical and electrical stimuli and application of histamine, and verbal suggestions to manipulate expectations regarding the stimuli. The suggestions were designed to produce either high expectations for itch (itch nocebo) or pain (pain nocebo) or low expectations for itch (itch nocebo control) or pain (pain nocebo control). Results showed that high itch and pain expectations resulted in higher levels of itch and pain, respectively. When comparing nocebo effects, induced by verbal suggestions, results were more pronounced for itch than for pain. In part 2, verbal suggestions designed to produce a placebo effect on itch (itch placebo) or pain (pain placebo), or neutral suggestions (itch placebo control and pain placebo control) were given regarding a second application of histamine and compared with the first application applied in part 1. Results of placebo effects only showed a significantly larger decrease in itch in the itch placebo condition than in the pain placebo condition. In conclusion, we showed for the first time that nocebo and possibly placebo responses can be induced on itch by verbal suggestions. Experiments of nocebo and placebo effects on itch and pain demonstrated that particularly nocebo effects can be induced on itch and pain by verbal suggestions. Article Published Date : Jul 01, 2011

The hypolipidemic effect of Citrullus colocynthis on patients with hyperlipidemia.

Abstract Title: The hypolipidemic effect of Citrullus colocynthis on patients with hyperlipidemia. Abstract Source: Pak J Biol Sci. 2010 Dec 15 ;13(24):1202-7. PMID: 21313901 Abstract Author(s): A R Rahbar, I Nabipour Article Affiliation: A R Rahbar Abstract: Citrullus colocynthis is one of the medical herbs that traditionally have been used as an antidiabetic medication in tropical and subtropical countries. The aim of this study was to investigate the hypolipidemic effect of Citrullus colocynthis beyond the hypoglycemic impact on human. One hundred dislipidemic patients were randomly divided into two groups namely treated (n = 50) group and placebo (n = 50) group. The subjects were treated daily by powdered seeds of Citrullus colocynthis (300 mg) and placebo for 6 weeks. The serums, TG, Chol, LDL-C, HDL-C, SGOT and SGPT were measured with enzymatic methods at the beginning and the end of the project. The significance of differences within these groups was calculated by Paired T-test and by analysis of covariance between them. There were significant differences within and between treated and placebo groups during our treatment in TG and in Cholesterol after intervention (p<0.05). A daily intake of 300 mg day(-1) of powdered seeds of Citrullus colocynthis can lower the triglyceride and cholesterol concentration significantly in nondiabetic hyperlipidemic patients. Article Published Date : Dec 14, 2010

Meta-analysis: the effects of placebo treatment on gastro-oesophageal reflux disease. 📎

Abstract Title: Meta-analysis: the effects of placebo treatment on gastro-oesophageal reflux disease. Abstract Source: Aliment Pharmacol Ther. 2010 Jul;32(1):29-42. Epub 2010 Mar 26. PMID: 20353496 Abstract Author(s): F Cremonini, D C Ziogas, H Y Chang, E Kokkotou, J M Kelley, L Conboy, T J Kaptchuk, A J Lembo Article Affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA. Abstract: BACKGROUND: There appears to be a significant placebo response rate in clinical trials for gastro-oesophageal reflux disease. Little is known about the determinants and the circumstances associated with placebo response in the treatment of gastro-oesophageal reflux disease (GERD). AIMS: To estimate the magnitude of the placebo response rate in randomized controlled trials for GERD and to identify factors that influence this response. METHODS: A meta-analysis of randomized, double-blind, placebo-controlled trials, published in English language, which included>20 patients with GERD, treated with either a proton pump inhibitor or H(2)-receptor antagonist for at least 2 weeks. Medline, Cochrane and EMBASE databases were searched, considering only studies that reported a global response for 'heartburn'. RESULTS: A total of 24 studies included 9989 patients with GERD. The pooled odds ratio (OR) for response to active treatment vs. placebo was 3.71 (95% CI: 2.78-4.96). The pooled estimate of the overall placebo response was 18.85% (range 2.94%-47.06%). Patients with erosive oesophagitis had a non-significantly lower placebo response rate than patients without it (11.87% and 18.31%, respectively; P = 0.246). Placebo response was significantly lower in studies of PPI therapy vs. studies of H(2) RAs (14.51% vs. 24.69%, respectively; P = 0.05). CONCLUSIONS: The placebo response rate in randomized controlled trials for GERD is substantial. A lower placebo response was associated with the testing of PPIs, but not the presence of erosive oesophagitis. Article Published Date : Jul 01, 2010

Placebos without deception: a randomized controlled trial in irritable bowel syndrome. 📎

Abstract Title: Placebos without deception: a randomized controlled trial in irritable bowel syndrome. Abstract Source: PLoS One. 2010 ;5(12):e15591. Epub 2010 Dec 22. PMID: 21203519 Abstract Author(s): Ted J Kaptchuk, Elizabeth Friedlander, John M Kelley, M Norma Sanchez, Efi Kokkotou, Joyce P Singer, Magda Kowalczykowski, Franklin G Miller, Irving Kirsch, Anthony J Lembo Article Affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America. Abstract: BACKGROUND: Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS). METHODS: Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47± 18 with IBS diagnosed by Rome III criteria and with a score ≥ 150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as"placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes"or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL). FINDINGS: Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2 ± 1.0 vs. 4.0 ± 1.1, p<.001) and at 21-day endpoint (5.0± 1.5 vs. 3.9 ± 1.3, p = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p = .008 and p = .03) and adequate relief (IBS-AR, p = .02 and p = .03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) atthe 21-day endpoint (p = .08). CONCLUSION: Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent. TRIAL REGISTRATION: ClinicalTrials.gov NCT01010191. Article Published Date : Dec 31, 2009

Frequency and circumstances of placebo use in clinical practice--a systematic review of empirical studies. 📎

Abstract Title: Frequency and circumstances of placebo use in clinical practice--a systematic review of empirical studies. Abstract Source: BMC Med. 2010 ;8:15. Epub 2010 Feb 23. PMID: 20178561 Abstract Author(s): Margrit Fässler, Karin Meissner, Antonius Schneider, Klaus Linde Article Affiliation: Institute of Biomedical Ethics, University of Zurich, 8008 Zurich, Switzerland. This email address is being protected from spambots. You need JavaScript enabled to view it. Abstract: BACKGROUND: The use of placebo interventions outside clinical trials is ethically, professionally and legally controversial. Little is known about the frequency and circumstances of placebo use in clinical practice. Our aim was to summarize the available empirical studies addressing these issues. METHODS: We searched PubMed and EMBASE from inception to July 2009 in order to identify cross-sectional surveys, qualitative or longitudinal studies among health care professionals, students or patients which investigated at least one of the following issues--frequency of placebo use or attitudes to, or motivations for, the use of placebo interventions. At least two reviewers extracted information on the study methods, participants and findings. Descriptive summaries were prepared in an iterative process by at least two reviewers per study. RESULTS: Twenty-two studies from 12 different countries met the inclusion criteria. Most studies had relevant shortcomings. The proportion of respondents reporting that they had applied 'pure' placebos (for example, saline injection) during their professional life varied between 17% and 80% among physicians and between 51% and 100% among nurses, but it seems that the actual frequency of such use seems to be rare. The use of 'impure' or 'active' placebos (for example, antibiotics for viral infections) is likely to be much more frequent. However, it is impossible to make a reliable estimation because there is no agreement of what an impure placebo might be. Studies using qualitative methods or asking participants to judge case examples suggest that motivations and attitudes towards placebo use are complex and health care providers are often faced with a dilemma. CONCLUSIONS: Although the available evidence is incomplete and confusing at times there can be little doubt that the prevalence of placebo use outside of clinical trials is not negligible and that views and attitudes on placebos use differ considerably among individuals, both health care professionals and patients. Further research is needed to clarify these issues. Article Published Date : Dec 31, 2009

Serum correlates of the placebo effect in irritable bowel syndrome. 📎

Abstract Title: Serum correlates of the placebo effect in irritable bowel syndrome. Abstract Source: Neurogastroenterol Motil. 2009 Dec 22. Epub 2009 Dec 22. PMID: 20028464 Abstract Author(s): E Kokkotou, L A Conboy, D C Ziogas, M T Quilty, J M Kelley, R B Davis, A J Lembo, T J Kaptchuk Abstract: Abstract Background In diseases defined primarily by the subjective nature of patient self-report, placebo effects can overwhelm the capacity of randomized controlled trials to detect medication-placebo differences. Moreover, it is unclear whether such placebo effects represent genuine psychobiological phenomena or just shifts in selective attention. Knowledge of predictors of the placebo response could improve the design of clinical trials and the delivery of personalized medical care. Methods In patients with irritable bowel syndrome (IBS), a subset of our previous study that were randomized to placebo treatment (sham acupuncture) or no-treatment group (waitlist), we tested an enriched panel of 10 serum biomarkers at the enrolment and the 3rd week of intervention, using a multiplex electrochemiluminescent immunoassay. Key Results More pronounced changes overtime in serum levels of osteoprotegerin (OPG) have been found in patients who received placebo treatment compared with the waitlist group (P = 0.039). Moreover, serum levels of OPG at baseline were found to be higher (P = 0.0167) in patients who subsequently achieved adequate relief (AR) of their IBS symptoms, independently of their treatment group. Besides, serum levels of TNF-related weak inducer of apoptosis (TWEAK) at baseline were also higher (P = 0.0144) in patients who reported AR and in particular in those who received the placebo treatment. Conclusions&Inferences These two measurable biological parameters associated with placebo, namely serum OPG and TWEAK, provide a proof of principle for discovering putative molecular signatures of placebo response in IBS and perhaps in other illnesses with patient self-reported outcomes. Article Published Date : Dec 22, 2009
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Prospective, double blinded, comparative assessment of the pharmacological activity of Cerebrolysin and distinct peptide preparations for the treatment of embolic stroke.

Related Articles Prospective, double blinded, comparative assessment of the pharmacological activity of Cerebrolysin and distinct peptide preparations for the treatment of embolic stroke. J Neurol Sci. 2019 Jan 14;398:22-26 Authors: Zhang L, Chopp M, Wang C, Zhang Y, Lu M, Zhang T, Zhang ZG Abstract BACKGROUND: Our previous work in acute ischemic stroke and TBI models focused on efficacy and pharmacological parameters of Cerebrolysin®. In this prospective, randomized, blinded, placebo-controlled study we compared efficacy of neuropeptide preparations with putative neurotrophic potential to the reference product Cerebrolysin® by assessing functional outcome and lesion volumes after embolic stroke in a rodent model. METHODS: Male Wistar rats were subjected to embolic right middle cerebral artery occlusion and were treated with: 1) Cognistar® (Cerebroprotein Hydrolysate) 2.5 ml/kg, 2) Cerebrolysat® 2.5 ml/kg, 3) Cortexin® 1.7 mg/kg, 4) Cerebrolysin® 2.5 ml/kg, or 5) 1 ml of saline according to a pre-generated randomization plan. Dosages were defined according to the packet leaflet of the corresponding preparation and were adapted to the animal model as previously described. All enrolled rats received intraperitoneal injections once daily for 10 consecutive days, starting 4 h after occlusion. Functional outcome was assessed once weekly over four weeks by using a battery of behavioral tests. Infarct volume was measured four weeks after occlusion. Generalized Estimation Equations (GEE) was performed to study the treatment effect on overall functional recovery at day 28 (primary outcome), compared to saline controls. RESULTS: Similar functional outcome was observed for saline control, Cognistar®, Cerebrolysat® and Cortexin®; in contrast, a significantly improved neurological outcome was observed with Cerebrolysin® treatment in comparison to saline as well as to the comparator drug treatment (p < .002). However, there was no significant difference in lesion volumes between rats treated with either Cortexin® (33.5 ± 1.9%), Cerebrolysat® (28.5 ± 2.4%), Cognistar® (34.7 ± 2.0%), or Cerebrolysin® (26.5 ± 2.3%) compared to saline-treated rats (30.8 ± 2.1%). CONCLUSION: Among all tested neuropeptide preparations, Cerebrolysin® was the only agent that was associated with a significant improvement of neurological outcome after stroke. PMID: 30665068 [PubMed - as supplied by publisher]

A single dose of fluoxetine reduces neural limbic responses to anger in depressed adolescents.

Related Articles A single dose of fluoxetine reduces neural limbic responses to anger in depressed adolescents. Transl Psychiatry. 2019 Jan 21;9(1):30 Authors: Capitão LP, Chapman R, Murphy SE, Harvey CJ, James A, Cowen PJ, Harmer CJ Abstract Depression in adolescence is frequently characterised by symptoms of irritability. Fluoxetine is the antidepressant with the most favourable benefit:risk ratio profile to treat adolescent depression, but the neural mechanisms underlying antidepressant drugs in the young brain are still poorly understood. Previous studies have characterised the neural effects of long-term fluoxetine treatment in depressed adolescents, but these are limited by concurrent mood changes and a lack of placebo control. There is also recent evidence suggesting that fluoxetine reduces the processing of anger in young healthy volunteers, which is consistent with its effect for the treatment of irritability in this age group, but this remains to be investigated in depressed adolescents. Here we assessed the effects of a single, first dose of 10 mg fluoxetine vs. placebo on neural response to anger cues using fMRI in a sample of adolescents with Major Depressive Disorder (MDD) who had been recently prescribed fluoxetine. As predicted, adolescents receiving fluoxetine showed reduced activity in response to angry facial expressions in the amygdala-hippocampal region relative to placebo. Activity in the dorsal anterior cingulate cortex (dACC) was also increased. No changes in symptoms were observed. These results demonstrate, for the first time in depressed adolescents, that fluoxetine has immediate neural effects on core components of the cortico-limbic circuitry prior to clinical changes in mood. The effect on anger is consistent with our previous work and could represent a key mechanism through which fluoxetine may act to alleviate irritability symptoms in adolescent depression. PMID: 30664639 [PubMed - in process]

Efficacy of Sacubitril/Valsartan in Hypertension.

Related Articles Efficacy of Sacubitril/Valsartan in Hypertension. Am J Ther. 2019 Jan 10;: Authors: Malik AH, Aronow WS Abstract BACKGROUND: Sacubitril/valsartan (LCZ696) has progressed to be one of the most promising medication since its approval for chronic heart failure with reduced ejection fraction. Recent data have suggested a superior blood pressure control with LCZ696. STUDY QUESTION: What is the antihypertensive efficacy and safety profile of sacubitril/valsartan? DATA SOURCES: Randomized controlled trials (RCTs) comparing the efficacy and safety of LCZ696 against a placebo or angiotensin receptor blocker (ARB). RCTs were identified from a comprehensive search in PubMed, Embase, Cochrane library, and clinicaltrials.gov. STUDY DESIGN: We used a change in systolic and diastolic blood pressures, both sitting as well as ambulatory, to calculate relevant effect sizes with their standard errors from the available change in mean and SD data. In addition, we also collected categorical data for the reported adverse effects from these trials. We performed a series of pairwise meta-analyses between LCZ696 versus an active comparator or a placebo. RESULTS: Eleven RCTs with a total of 6028 participants had the relevant data available. Our meta-analysis showed that LCZ696 is an effective and a safe treatment for hypertension. It outperformed ARBs in every category, and the results are consistent across the different dosages of LCZ696. Compared with ARBs, 200 mg of LCZ696 reduced systolic blood pressure and diastolic blood pressure (DBP) by 4.62 mm Hg (95% confidence interval, 3.33-5.90, P < 0.001) and 2.13 mm Hg (95% confidence interval, 1.69-2.57, P < 0.001), respectively. Similarly, 400 mg of LCZ696 reduced systolic blood pressure and diastolic blood pressure by 5.50 mm Hg (2.94-8.07, P < 0.001) and 2.51 mm Hg (1.80-3.21, P < 0.001), respectively, in comparison with ARBs. The adverse effects with LCZ696 were not significantly higher compared with ARBs or placebo. CONCLUSIONS: Sacubitril/valsartan is more effective for the management of hypertensive patients, compared with an ARB. Long-term prospective studies are required to identify whether this result translates into morbidity and mortality benefits. PMID: 30664018 [PubMed - as supplied by publisher]

Automated mechanical peripheral stimulation and postural control in subjects with Parkinson's disease and freezing of gait: a randomized controlled trial.

Related Articles Automated mechanical peripheral stimulation and postural control in subjects with Parkinson's disease and freezing of gait: a randomized controlled trial. Funct Neurol. 2018 Oct/Dec;33(4):206-212 Authors: Prusch JS, Kleiner AFR, Salazar AP, Pinto C, Marchese RR, Galli M, Pagnussat AS Abstract Individuals with Parkinson's disease (PD) and freezing of gait (FOG) have impaired postural control. Recent studies using foot sensory stimulation delivered by means of automated mechanical peripheral stimulation (AMPS) have demonstrated improvements of gait in individuals with PD. This study aimed to investigate the effects of AMPS on postural control in individuals with PD and FOG. Thirty-three subjects participated in this randomized controlled trial. Participants were allocated to two groups: AMPS and AMPS SHAM. Subjects underwent eight sessions of real (AMPS) or placebo AMPS (AMPS SHAM) once every three/four days. Postural control was assessed by means of posturography before the first and after the eighth session of treatment. We did not find positive effects of AMPS on center of pressure parameters. Thus, it seems that AMPS has no positive effect in terms of improving static postural control in individuals with PD and FOG. PMID: 30663967 [PubMed - in process]

The effect of memantine in adult patients with attention deficit hyperactivity disorder.

Related Articles The effect of memantine in adult patients with attention deficit hyperactivity disorder. Hum Psychopharmacol. 2019 Jan;34(1):e2687 Authors: Mohammadzadeh S, Ahangari TK, Yousefi F Abstract BACKGROUND: Hyperactivity disorder and attention deficit are common neurological disorders in children and adolescents. The symptoms of hyperactivity are decreased in adults, and attention deficit is more noticeable. This study was carried out to evaluate the effect of memantine on adult patients with attention deficit hyperactivity disorder (ADHD). MATERIALS AND METHODS: In a double-blind clinical trial study, 40 patients aged 18 to 45 years with ADHD were selected on the basis on the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, and randomly assigned memantine or placebo. Before starting the treatment, Conners' screening questionnaire was completed for each patient, and the subjects were entered the study after acquiring minimum acceptable score in the questionnaire. RESULTS: The mean age of patients who were receiving memantine and placebo was about 34.7 ± 4.48 and 31.5 ± 7.4 years, respectively. The results have shown a significant difference in the behavior and attention deficit between the two groups treated with memantine and placebo during 6 weeks (p < 0.001). Also, there was a significant difference in the third and sixth weeks between treatment groups in hyperactivity and attention deficit index (p = 0.001). CONCLUSION: The results of this study indicated that memantine was effective in reducing symptoms of Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability. PMID: 30663824 [PubMed - in process]

Comparing the effectiveness of Salvia officinalis, clotrimazole and their combination on vulvovaginal candidiasis: A randomized, controlled clinical trial.

Related Articles Comparing the effectiveness of Salvia officinalis, clotrimazole and their combination on vulvovaginal candidiasis: A randomized, controlled clinical trial. J Obstet Gynaecol Res. 2019 Jan 20;: Authors: Ahangari F, Farshbaf-Khalili A, Javadzadeh Y, Adibpour M, Sadeghzadeh Oskouei B Abstract AIM: To determine the effect of vaginal tablet of Salvia officinalis, alone and in combination with Clotrimazole, on the recovery of Vulvovaginal candidiasis. METHODS: In this triple-blind randomized controlled trial, 111 participants were randomly assigned into three groups of 37 patients using block randomization with block sizes of 6 and 9, and allocation ratio of 1:1:1: 100 mg vaginal tablet of Clotrimazole and Placebo (CP), 400 mg vaginal tablet of S. officinalis and Placebo (SP), and vaginal tablet of S. officinalis and Clotrimazole (SC), once daily for 7 days. On the seventh day after the treatment was ended up, Vulvovaginal candidiasis were examined by vaginal symptoms and wet test, and if positive, they were examined by culture in chrome agar Candida medium. RESULTS: Socio-demographic characteristics was similar (P > 0.05). Thirty-six, 36 and 35 patients, respectively in CP, SC and SP groups recruited in the study. The frequency of a positive wet test confirmed by Sabrodextrose agar medium 7 days after treatment was significantly lower in SC group than the reference group of CP (adjusted odds ratio = 0.09, 95% confidence interval: 0.93-0.932, P = 0.043). There was no significant difference between SP and CP group (P = 0.071, 95% confidence interval: 0.032-1.151, adjusted odds ratio = 0.192). Also, there was no significant difference between the three groups in terms of vaginal symptoms at the baseline (P > 0.05), however the statistical differences were indicated after the intervention in cheesy discharge, pruritus and Vulvovaginal edema (P < 0.05.(. CONCLUSION: S. officinalis in the form of vaginal tablet, alone and when combined with Clotrimazole, can treat the Vulvovaginal Candidiasis. PMID: 30663184 [PubMed - as supplied by publisher]

Acotiamide affects antral motility, but has no effect on fundic motility, gastric emptying or symptom perception in healthy participants.

Related Articles Acotiamide affects antral motility, but has no effect on fundic motility, gastric emptying or symptom perception in healthy participants. Neurogastroenterol Motil. 2019 Jan 20;:e13540 Authors: Masuy I, Tack J, Verbeke K, Carbone F Abstract BACKGROUND: Acotiamide, a prokinetic agent was shown to be efficacious in the treatment of functional dyspepsia (FD). The exact mechanism of action is incompletely elucidated. METHODS: This randomized, placebo-controlled, cross-over study aimed to examine the effect of acotiamide on gastric motility, measured as intragastric pressure, gastric emptying (GE) rate and gastrointestinal (GI) symptom perception in healthy volunteers (HVs). Participants were treated with acotiamide (100 mg tid) and placebo for 3 weeks, separated by a 1-week washout period. A daily symptom diary was collected during both treatments. At the end of each treatment period, GE rate and gastric motility were assessed with a 13 C-octanoic acid breath test and high-resolution manometry during nutrient infusion, respectively. GI symptom levels were scored during high-resolution manometry. Data were analyzed using mixed models. The study was registered as NCT03402984. KEY RESULTS: Twenty HVs (10 female, 25 ± 4.1 years, 22.58 ± 2.73 kg/m2 ) participated in the study. There was no difference in GE half time between both treatments (P = 0.92). Acotiamide had no effect on fundic pressures before and after nutrient infusion (P = 0.91). However, postprandial antral pressures remained significantly lower compared to placebo (P = 0.015). There was no significant difference in hunger, satiation and GI symptoms scores assessed during IGP measurement and by the daily diary (P > 0.12 for all). CONCLUSION: Acotiamide is associated with lower antral pressures after nutrient intake, whereas it has no effect on fundic pressures, GE rate and symptom perceptions in HVs. Studies in FD need to elucidate whether lower antral pressures induced by acotiamide underlie postprandial symptom improvement in FD. PMID: 30663175 [PubMed - as supplied by publisher]

Effectiveness of Therapeutic Ultrasound on Clinical Parameters and Ultrasonographic Cartilage Thickness in Knee Osteoarthritis: A Double-Blind Trial.

Related Articles Effectiveness of Therapeutic Ultrasound on Clinical Parameters and Ultrasonographic Cartilage Thickness in Knee Osteoarthritis: A Double-Blind Trial. J Med Ultrasound. 2018 Oct-Dec;26(4):194-199 Authors: Özgönenel L, Okur SÇ, Dogan YP, Çaglar NS Abstract Objective: A double-blind placebo-controlled randomized study was conducted to assess the effectiveness of therapeutic ultrasound (US) in knee OA. Patients and Methods: Thirty-three patients (mean age 54.7 ± 14.7) were randomized to receive either continuous US (n = 15) or sham US (n = 18) as a placebo. Continuous ultrasonic waves with 1 MHZ frequency and 1 watt/cm2 power were applied for 5 min for 10 sessions. The primary outcome was pain on movement assessed by visual analog scale (VAS). The secondary outcomes were WOMAC scores and measurements of distal femoral cartilage thickness by imaging US. Results: Both groups showed reduced knee pain on movement following intervention. The VAS measurements improved significantly both in the treatment and the placebo group patients (P < 0.05 and P < 0.05). WOMAC scores improved statistically significant in all domains (pain, stiffness, physical function, and total score) in the treatment group (P < 0.05). All domains of WOMAC score showed statistically significant change when compared with the placebo group (P < 0.05). There was no change in the cartilage thickness measurements of medial femoral condyle, lateral femoral condyle, and intercondylar area in both groups after intervention. Conclusion: Results suggest that US is effective treatment modality in pain relief and improvement of function in patients with knee OA; however, US had no effect on cartilage repair. PMID: 30662150 [PubMed]

The Effect of Intravenous Dexamethasone on Intraoperative and Early Postoperative Pain in Lumbar Spine Surgery: A Randomized Double-Blind Placebo-Controlled Study.

Related Articles The Effect of Intravenous Dexamethasone on Intraoperative and Early Postoperative Pain in Lumbar Spine Surgery: A Randomized Double-Blind Placebo-Controlled Study. Anesth Essays Res. 2018 Oct-Dec;12(4):803-808 Authors: Sharma M, Gupta S, Purohit S, Goyal AK Abstract Background: The surgical procedures of spine are generally associated with intense pain in the postoperative period. Opioids are commonly used for perioperative analgesia but are associated with many side effects. Co-analgesic drugs are used to decrease these side effects. One such supplemental drug is dexamethasone. Its strong anti-inflammatory effect contributes to perioperative analgesia. Aim: This study was done to evaluate the effect of intravenous (i.v.) dexamethasone on intraoperative and early postoperative pain in lumbar spine surgery. Settings and Design: This was a hospital-based randomized, double-blind, placebo-controlled study, done between June 2016 and December 2016 after permission of institutional ethical committee. Materials and Methods: This Study was conducted on 60 patients undergoing lumbar spine surgery, and randomization was done in two groups. Group A (study) received dexamethasone 2 ml (8 mg) i.v. and Group B (control) received 2 ml normal saline. Anesthesia technique and rescue analgesia regimen were standardized. Intraoperative pain was assessed by hemodynamic variability and postoperative pain by verbal rating score. All the quantitative data were analyzed using Student's t-test and all the qualitative data using Chi-square test. Results: Heart rate in the control group was significantly higher than the study group during intraoperative period. Mean pain scores in the early postoperative period were significantly higher in control group than the study group (P < 0.001). Mean time of first rescue analgesic in the postoperative period was 149.17 min and 34.33 min in the study group and control group, respectively (P < 0.001). Conclusion: Hence, we conclude that administration of 8 mg of preoperative i.v dexamethasone was effective in reducing intraoperative and early postoperative pain in the lumbar spine surgery. PMID: 30662111 [PubMed]

Effect of flaxseed or psyllium vs. placebo on management of constipation, weight, glycemia, and lipids: A randomized trial in constipated patients with type 2 diabetes.

Related Articles Effect of flaxseed or psyllium vs. placebo on management of constipation, weight, glycemia, and lipids: A randomized trial in constipated patients with type 2 diabetes. Clin Nutr ESPEN. 2019 Feb;29:41-48 Authors: Soltanian N, Janghorbani M Abstract BACKGROUND: Both flaxseed and psyllium have previously been shown to reduce constipation symptoms, weight, glycemic and lipid levels, and we postulate that treatment with flaxseed and psyllium may have similar benefits. OBJECTIVE: To compare constipation symptoms, weight, glycemia, and lipids in constipated patients with type 2 diabetes (T2D) who received baked flaxseed or psyllium versus those who received a placebo. METHODS: In a single-blinded, randomized controlled trial, 77 constipated patients with T2D were randomized into three groups. Patients received either 10 g flaxseed or psyllium pre-mixed in cookies or placebo cookies twice per day for a total of 12 weeks. The constipation symptoms, body mass index (BMI), fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), and lipid profile were determined at the beginning and end of 4, 8, and 12-week period. Constipation was assessed with the ROME III criteria score. RESULTS: The flaxseed appear to be superior to psyllium for improving constipation symptoms, weight, glycemic, and lipid control. The change from baseline of constipation symptoms (P = 0.002), stool consistency (P < 0.001), weight (P < 0.001), BMI (P < 0.001), FPG (P = 0.004), cholesterol (P = 0.010), LDLC (P = 0.031), and cholesterol/HDLC ratio (P = 0.019), was significantly improved in both flaxseed and psyllium groups than in the placebo group. The compliance was good and no adverse effects were observed. CONCLUSION: Although both flaxseed and psyllium may decrease constipation symptoms, weight, glycemic and lipid levels, treatment with flaxseed appear to be superior to psyllium. TRIAL REGISTRATION: Registered under Iranian Clinical Trials Identifier no. IRCT20110416006202N2. PMID: 30661699 [PubMed - in process]

Effects of pomegranate juice consumption on blood pressure and lipid profile in patients with type 2 diabetes: A single-blind randomized clinical trial.

Related Articles Effects of pomegranate juice consumption on blood pressure and lipid profile in patients with type 2 diabetes: A single-blind randomized clinical trial. Clin Nutr ESPEN. 2019 Feb;29:30-35 Authors: Sohrab G, Roshan H, Ebrahimof S, Nikpayam O, Sotoudeh G, Siasi F Abstract Pomegranate juice (PJ) has abundant anti-oxidative polyphenolic compounds which are assumed to have cardioprotective effects such as hypotensive properties. This study aimed to investigate the effects of PJ consumption on blood pressure and lipid profile F variables in patients with type 2 diabetes. Sixty subjects (30 in intervention group and 30 in control group) were recruited in this single-blind placebo-controlled randomized clinical trial. The volunteers were randomly assigned to one of two groups. Treatment group consumed 200 ml/day PJ for 6 weeks, while control group received no intervention. Systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) concentrations were measured following 12-14 h of fasting at baseline and at the end of the study. After 6 weeks of intervention, SBP (13.5 ± 1.5 mmHg vs. 12.3 ± 2.5, P < 0.001) and DBP (7.7 ± 1.6 vs. 7.2 ± 1.6 mmHg, P < 0.05) significantly decreased in the intervention group. Similarly, SBP and DBP in the intervention group were significantly lower than the control group after intervention (P < 0.02 and P < 0.03, respectively). At the end of the intervention, TC, TG, LDL-C and HDL-C did not significantly differ between the intervention group and the control group however, TC and LDL-C decreased significantly compared to pre-trial values within the intervention group. It is concluded that PJ consumption could decrease systolic and diastolic blood pressure in patients with diabetes while having no effect on lipid profile. A more definitive result will be obtained if future studies could conducted in hyperlipidemic individuals who might be more prone to respond to the lipid-lowering effects. PMID: 30661697 [PubMed - in process]

Consumption of yacon flour improves body composition and intestinal function in overweight adults: A randomized, double-blind, placebo-controlled clinical trial.

Related Articles Consumption of yacon flour improves body composition and intestinal function in overweight adults: A randomized, double-blind, placebo-controlled clinical trial. Clin Nutr ESPEN. 2019 Feb;29:22-29 Authors: Machado AM, da Silva NBM, Chaves JBP, Alfenas RCG Abstract BACKGROUND & AIMS: Yacon root is a natural source of fructooligosaccharides (FOS), and it has been studied for its potential effect as a functional food. However, FOS in the in natura root are rapidly hydrolyzed. Thus, the use of dehydrated products such as flour ensures stability of FOS. The effect of chronic consumption of yacon flour on body composition, food intake and of biochemical variables concentration has not yet been evaluated in humans. Thus, we evaluated the effects of yacon flour consumption on these variables associated with excess body weight. METHODS: Twenty-six adults (31.3 ± 8.5 years) with excess weight (30.4 ± 2.4 kg/m2, 40.16 ± 6.7% body fat) participated in this randomized, double-blind, six-week study. Subjects were randomly allocated to one of the experimental groups (control (n = 13) or yacon flour (n = 13)), received the prescription of energy-restricted diets (- 500 kcal/day) and daily consumed a breakfast drink not containing or containing 25 g of yacon flour (0.1 g of FOS/kg body weight). At the beginning and at the end of the study, biochemical analyses (glycemia, insulinemia, lipid profile and liver function markers), anthropometrics (weight, waist, hip and neck circumference and sagittal abdominal diameter), body composition (lean mass, total body fat, trunk fat, android fat and gynoid fat), blood pressure, intestinal function, and food intake were assessed. RESULTS: Daily yacon flour consumption was well tolerated, did not cause adverse gastrointestinal effects, increased dietary fiber consumption, promoted greater body weight, waist circumference, waist to height index, sagittal abdominal diameter, and body fat reduction, besides improving bowel function in comparison to the control group. CONCLUSIONS: Yacon flour served as a natural fiber supplement and proved to be an effective adjuvant to be used in nutritional strategies to control excess body weight. PMID: 30661690 [PubMed - in process]

Racial Differences in the Effect of Granulocyte Macrophage Colony-Stimulating Factor on Improved Walking Distance in Peripheral Artery Disease: The PROPEL Randomized Clinical Trial.

Related Articles Racial Differences in the Effect of Granulocyte Macrophage Colony-Stimulating Factor on Improved Walking Distance in Peripheral Artery Disease: The PROPEL Randomized Clinical Trial. J Am Heart Assoc. 2019 Jan 22;8(2):e011001 Authors: McDermott MM, Polonsky TS, Guralnik JM, Ferrucci L, Tian L, Zhao L, Stein J, Domanchuk K, Criqui MH, Taylor DA, Li L, Kibbe MR Abstract Background The effects of race on response to medical therapy in people with peripheral artery disease ( PAD ) are unknown. Methods and Results In the PROPEL (Progenitor Cell Release Plus Exercise to Improve Functional Performance in PAD) Trial, PAD participants were randomized to 1 of 4 groups for 6 months: supervised treadmill exercise+granulocyte-macrophage colony-stimulating factor ( GM - CSF ) (Group 1), exercise+placebo (Group 2), attention control+ GM - CSF (Group 3), or attention control+placebo (Group 4). Change in 6-minute walk distance was measured at 12- and 26-week follow-up. In these exploratory analyses, groups receiving GM - CSF (Groups 1 and 3), placebo (Groups 2 and 4), exercise (Groups 1 and 2), and attention control (Groups 2 and 4) were combined, maximizing statistical power for studying the effects of race on response to interventions. Of 210 PAD participants, 141 (67%) were black and 64 (30%) were white. Among whites, GM - CSF improved 6-minute walk distance by +22.0 m (95% CI : -4.5, +48.5, P=0.103) at 12 weeks and +44.4 m (95% CI : +6.9, +82.0, P=0.020) at 26 weeks, compared with placebo. Among black participants, there was no effect of GM - CSF on 6-minute walk distance at 12-week ( P=0.26) or 26-week (-5.0 m [-27.5, +17.5, P=0.66]) follow-up, compared with placebo. There was an interaction of race on the effect of GM - CSF on 6-minute walk change at 26-week follow-up ( P=0.018). Exercise improved 6-minute walk distance in black ( P=0.006) and white ( P=0.034) participants without interaction. Conclusions GM - CSF improved 6-minute walk distance in whites with PAD but had no effect in black participants. Further study is needed to confirm racial differences in GM - CSF efficacy in PAD . Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01408901. PMID: 30661439 [PubMed - in process]

Cerebrovascular reactivity after cessation of menopausal hormone treatment.

Related Articles Cerebrovascular reactivity after cessation of menopausal hormone treatment. Climacteric. 2019 Jan 21;:1-8 Authors: Barnes JN, Harvey RE, Eisenmann NA, Miller KB, Johnson MC, Kruse SM, Lahr BD, Joyner MJ, Miller VM Abstract OBJECTIVE: Women who are currently using menopausal hormone therapy (MHT) have higher cerebrovascular reactivity when compared with postmenopausal women who are not taking MHT; however, the effect of cessation of MHT on cerebrovascular reactivity is not known. Given that MHT can have structural and activational effects on vascular function, this study was performed to characterize cerebrovascular reactivity following cessation of MHT in women at low risk for cerebrovascular disease. METHODS: Cerebrovascular reactivity was measured in a subset of women from the Kronos Early Estrogen Prevention Study (KEEPS) 3 years after cessation of the study drug (oral conjugated equine estrogen, transdermal 17β-estradiol, or placebo [PLA]). RESULTS: Age, body mass index, and blood pressure were comparable among groups. At rest, the middle cerebral artery velocity (MCAv), cerebrovascular conductance index, mean arterial pressure, and cerebral pulsatility index did not differ among groups. Slope-based summary measures of cerebrovascular reactivity did not differ significantly among groups. However, utilizing repeated-measures modeling, there was a significant upward shift in MCAv responses (p = 0.029) in the combined MHT group compared with the PLA group. CONCLUSION: MHT has a marginal sustained effect on cerebrovascular reactivity when measured 3 years after cessation of hormone treatment. PMID: 30661405 [PubMed - as supplied by publisher]
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