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Clinical Therapeutics
Volume 29, Issue 7, July 2007, Pages 1354-1367
Efficacy and tolerability of adding prescription Omega-3 fatty acids 4 g/d to Simvastatin 40 mg/d in hypertriglyceridemic patients: An 8-week, randomized, double-blind, placebo-controlled study
Michael H. Davidson MD1, Evan A. Stein MD, PhD2, Harold E. Bays MD3, Kevin C. Maki PhD4, Ralph T. Doyle5, Robert A. Shalwitz MD5, Christie M. Ballantyne MD6, Henry N. Ginsberg MD7
and for the COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators
1Radiant Research, Chicago, Illinois
2Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio
3Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky
4Provident Clinical Research & Consulting, Inc., Bloomington, Indiana
5Reliant Pharmaceuticals, Inc., Liberty Corner, New Jerseyv
6Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Baylor College of Medicine, Houston, Texas
7Irving Center for Clinical Research, College of Physicians and Surgeons of Columbia University, New York, New York
Accepted 26 June 2002. Available online 4 September 2007.
Abstract
Background:
Patients with elevated serum triglyceride (TG) levels often have elevations in non-high-density lipoprotein cholesterol (non-HDL-C) levels as well. The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) has identified non-HDL-C as a secondary therapeutic target in these patients, but treatment goals may not be reached with statin monotherapy alone.
Objective:
This study evaluated the effects on non-HDL-C and other variables of adding prescription omega-3-acid ethyl esters (P-OM3; LovazaTM, formerly Omacor® [Reliant Pharmaceuticals, Inc., Liberty Corner, New Jersey]) to stable statin therapy in patients with persistent hypertriglyceridemia.
Methods:
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in adults who had received ≥8 weeks of stable statin therapy and had mean fasting TG levels ≥200 and <500 mg/dL and mean low-density lipoprotein cholesterol levels 10% above their NCEP ATP III goal. The study regimen consisted of an initial 8 weeks of open-label simvastatin 40 mg/d and dietary counseling, followed by 8 weeks of randomized treatment with double-blind P-OM3 4 g/d plus simvastatin 40 mg/d or placebo plus simvastatin 40 mg/d. The main outcome measure was the percent change in non-HDL-C from baseline to the end of treatment.
Results:
The evaluable population included 254 patients, of whom 57.5% (146) were male and 95.7% (243) were white. The mean (SD) age of the population was 59.8 (10.4) years, and the mean weight was 92.0 (19.6) kg. At the end of treatment, the median percent change in non-HDL-C was significantly greater with P-OM3 plus simvastatin compared with placebo plus simvastatin (-9.0% vs -2.2%, respectively; P < 0.001). P-OM3 plus simvastatin was associated with significant reductions in TG (29.5% vs 6.3%) and very-low-density lipoprotein cholesterol (27.5% vs 7.2%), a significant increase in high-density lipoprotein cholesterol (HDL-C) (3.4% vs -1.2%), and a significant reduction in the total cholesterol:HDL-C ratio (9.6% vs 0.7%) (all, P < 0.001 vs placebo). Adverse events (AEs) reported by ≥1% of patients in the P-OM3 group that occurred with a higher frequency than in the group that received simvastatin alone were nasopharyngitis (4 [3.3%]), upper respiratory tract infection (4 [3.3%]), diarrhea (3 [2.5%]), and dyspepsia (3 [2.5%]). There was no significant difference in the frequency of AEs between groups. No serious AEs were considered treatment related.
Conclusion:
In these adult, mainly white patients with persistent hypertriglyceridemia, P-OM3 plus simvastatin and dietary counseling improved non-HDL-C and other lipid and lipoprotein parameters to a greater extent than simvastatin alone. |
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Pharmacoepidemiology and Drug Safety
Volume 16, Issue 9 , Pages 947 – 957
National surveillance of herbal dietary supplement exposures: the poison control center experience
Brian M. Gryzlak, MA, MSW
1, Robert B. Wallace, MD, MSc
1
*, M. Bridget Zimmerman, PhD
2, Nicole L. Nisly, MD
3
1Department of Epidemiology, University of Iowa, IA, USA
2Department of Biostatistics, University of Iowa, IA, USA
3Department of Internal Medicine, University of Iowa, IA, USA
Purpose
The purpose of this report is to characterize reports to poison control centers (PCCs) involving two widely used herbal dietary supplements (HDSs), Echinacea, and St. John's wort (SJW).
Methods
We purchased data from the American Association of Poison Control Center's (AAPCC) toxic exposure surveillance system (TESS®) on reports made to PCCs in 2001 involving Echinacea or SJW. Analyses were limited to those cases in which Echinacea or SJW were the only associated products, and in which these HDSs were deemed primary to observed adverse effects. Descriptive statistics were generated for selected demographic and exposure-related variables.
Results
During 2001, PCCs were contacted regarding 406 exposures involving Echinacea and 356 exposures involving SJW. Most of the reported exposures for both HDSs occurred among children 5 years and younger, and the majority of exposures were coded as unintentional. For both HDSs, exposures among patients 20 years old were more likely to be associated with adverse effects. Intentional exposures accounted for 21% of SJW cases and 3% of Echinacea cases, with 13% of SJW exposures reported as suspected suicidal .
Conclusions
TESS® represents a potentially important means of assessing and characterizing HDS-related adverse effects. Detailed studies validating the clinical events and outcomes of a sample of exposures reported to TESS® might offer substantial insights into adverse events (AEs) that could be systematically studied with other, established pharmacoepidemiological study designs.
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Liver International Volume 27 Issue 7 Page 879-890, September 2007
Traditional Chinese herbal medicines for treatment of liver fibrosis and cancer: from laboratory discovery to clinical evaluation
John M. Luk11 Department of Surgery, The University of Hong Kong, Pokfulam, Hong Kong*, Xiaoling Wang44 Department of Cell Biology, Shanghai University of Traditional Chinese Medicine, Shanghai, China*, Ping Liu44 Department of Cell Biology, Shanghai University of Traditional Chinese Medicine, Shanghai, China, Kwong-Fai Wong11 Department of Surgery, The University of Hong Kong, Pokfulam, Hong Kong, Kwong-Leung Chan11 Department of Surgery, The University of Hong Kong, Pokfulam, Hong Kong, Yao Tong33 School of Chinese Medicine, The University of Hong Kong, Pokfulam, Hong Kong, Chi-Kin Hui22 Department of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, George K. Lau22 Department of Medicine, The University of Hong Kong, Pokfulam, Hong Kong and Sheung-Tat Fan11 Department of Surgery, The University of Hong Kong, Pokfulam, Hong Kong
Liver disease afflicts over 10% of the world population. This includes chronic hepatitis, alcoholic steatosis, fibrosis, cirrhosis and hepatocellular carcinoma (HCC), which are the most health-threatening conditions drawing considerable attention from medical professionals and scientists. Patients with alcoholism or viral hepatitis are much more likely to have liver cell damage and cirrhosis, and some may eventually develop HCC, which is unfortunately, and very often, a fatal malignancy without cure. While liver surgery is not suitable in many of the HCC cases, patients are mostly given palliative support cares or transarterial chemoembolization or systemic chemotherapies. However, HCC is well known to be a highly chemoresistant tumour, and the response rate is <10–20%. To this end, alternative medicines are being actively sought from other sources with hopes to halt the disease’s progression or even eliminate the tumours. Traditional Chinese herbal medicine has begun to gain popularity worldwide for promoting healthcare as well as disease prevention, and been used as conventional or complementary medicines for both treatable and incurable diseases in Asia and the West. In this article, we discuss the laboratory findings and clinical trial studies of Chinese herbal medicines (particularly small molecule compounds) for the treatment of liver disease ranging from fibrosis to liver cancer.
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Antiviral Research Volume 75, Issue 3, September 2007, Pages 179-187
Plant lectins are potent inhibitors of coronaviruses by interfering with two targets in the viral replication cycle
Els Keyaertsa, Leen Vijgena, Christophe Pannecouqueb, Els Van Dammec, Willy Peumansc, Herman Egberinkd, Jan Balzarinib, and Marc Van Ransta
Abstract
We describe the antiviral activity of plant lectins with specificity for different glycan structures against the severe acute respiratory syndrome coronavirus (SARS-CoV) and the feline infectious peritonitis virus (FIPV) in vitro. The SARS-CoV emerged in 2002 as an important cause of severe lower respiratory tract infection in humans, and FIPV infection causes a chronic and often fatal peritonitis in cats. A unique collection of 33 plant lectins with different specificities were evaluated. The plant lectins possessed marked antiviral properties against both coronaviruses with EC50 values in the lower microgram/ml range (middle nanomolar range), being non-toxic (CC50) at 50–100 μg/ml. The strongest anti-coronavirus activity was found predominantly among the mannose-binding lectins. In addition, a number of galactose-, N-acetylgalactosamine-, glucose-, and N-acetylglucosamine-specific plant agglutinines exhibited anti-coronaviral activity. A significant correlation (with an r-value of 0.70) between the EC50 values of the 10 mannose-specific plant lectins effective against the two coronaviruses was found. In contrast, little correlation was seen between the activity of other types of lectins. Two targets of possible antiviral intervention were identified in the replication cycle of SARS-CoV. The first target is located early in the replication cycle, most probably viral attachment, and the second target is located at the end of the infectious virus cycle.
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BMJ 2007;335:340 (18 August)
Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations
Roberto Berni Canani, assistant professor of paediatrics1, Pia Cirillo, paediatrician1, Gianluca Terrin, paediatrician1, Luisa Cesarano, paediatrician1, Maria Immacolata Spagnuolo, paediatrician1, Anna De Vincenzo, paediatrician1, Fabio Albano, paediatrician1, Annalisa Passariello, paediatrician1, Giulio De Marco, paediatrician1, Francesco Manguso, consultant physician in
gastroenterology2, Alfredo Guarino, professor of paediatrics1
1 Department of Paediatrics, University of Naples Federico II, Naples, Italy,
2 Department of Clinical and Experimental Medicine, University of Naples Federico II
Objective
To compare the efficacy of five probiotic preparations recommended to parents in the treatment of acute diarrhoea in children.
Design
Randomised controlled clinical trial in collaboration with family paediatricians over 12 months.
Setting
Primary care.
Participants
Children aged 3-36 months visiting a family paediatrician for acute diarrhoea.
Intervention
Children's parents were randomly assigned to receive written instructions to purchase a specific probiotic product: oral rehydration solution (control group); Lactobacillus rhamnosus strain GG; Saccharomyces boulardii; Bacillus clausii; mix of L delbrueckii var bulgaricus, Streptococcus thermophilus, L acidophilus, and Bifidobacterium bifidum; or Enterococcus faecium SF68.
Main outcome measures
Primary outcomes were duration of diarrhoea and daily number and consistency of stools. Secondary outcomes were duration of vomiting and fever and rate of admission to hospital. Safety and tolerance were also recorded.
Results
571 children were allocated to intervention. Median duration of diarrhoea was significantly shorter (P<0.001) in children who received L rhamnosus strain GG (78.5 hours) and the mix of four bacterial strains (70.0 hours) than in children who received oral rehydration solution alone (115.0 hours). One day after the first probiotic administration, the daily number of stools was significantly lower (P<0.001) in children who received L rhamnosus strain GG and in those who received the probiotic mix than in the other groups. The remaining preparations did not affect primary outcomes. Secondary outcomes were similar in all groups.
Conclusions
Not all commercially available probiotic preparations are effective in children with acute diarrhoea. Paediatricians should choose bacterial preparations based on effectiveness data.
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Complementary Therapies in Clinical Practice
Volume 13, Issue 3, August 2007, Pages 194-200
Complementary and alternative therapies: Survey of knowledge and attitudes of health professionals at a tertiary pediatric/women’s care facility
Janis Browna, Elizabeth Cooperb, Lyn Franktonb, Michelle Steeves-Wallb, Jane Gillis-Ringb, Wanda Barterc, Ann McCabed, and Conrad Fernandeze, Department of Interdisciplinary Research, IWK Health Centre, Halifax, NS, Canada bDivision of Pediatric Hematology/Oncology, Department of Nursing, IWK Health Centre, Halifax, NS, Canada cDepartment of Nutrition, IWK Health Centre, Halifax, NS, Canada dWomen’s and Newborn Health, IWK Health Centre, Halifax, NS, Canada eDepartment of Pediatrics, Hematology/Oncology, IWK Health Centre, Halifax, NS, Canada fDalhousie University, School of Medicine, Sir Charles Tupper Medical Building, 5849 University Avenue, Halifax, NS, Canada B3H 4H7
Summary Nurses, physicians, and allied health professionals at the IWK Health Centre, Halifax, NS, Canada, a tertiary care, regional center for a population of 2.5 million were surveyed. We examined personal attitudes and professional practice in addressing the use of complementary and alternative medicine (CAM) use by patients. We also examined the availability of CAM-related information to health professionals. The findings suggest that health professionals: (1) are supportive of the use of selected CAM therapies by patients; (2) have almost no personal experience of CAM; (3) have limited knowledge about CAM and acquire that information mainly from the Internet, friends or family rather than professional journals; (4) are uncomfortable discussing CAM with patients and; (5) rarely or never ask patients about CAM use. We have identified barriers for health professionals to effective communication about CAM use by their patients and families. Improved access to existing policies and scientific publications, and specific continuing professional development opportunities focused on speaking openly and non-judgmentally with patients are likely to enhance accurate guidance of patients in the highly prevalent use of CAM.
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Acta Oncologica
Volume 46, Issue 6 2007 , pages 717 - 722
Qigong for cancer treatment: A systematic review of controlled clinical trials
Authors: Myeong Soo Lee a; Kevin W. Chen b; Kenneth M. Sancier c; Edzard Ernst
Abstract
Qigong is a mind-body integrative exercise or intervention from traditional Chinese medicine used to prevent and cure ailments, to improve health and energy levels through regular practice. The aim of this systematic review is to summarize and critically evaluate the effectiveness of qigong used as a stand-alone or additional therapy in cancer care. We have searched the literature using the following databases from their respective inceptions through November 2006: MEDLINE, AMED, British Nursing Index, CINAHL, EMBASE, PsycInfo, The Cochrane Library 2006, Issue 4, four Korean Medical Databases, Qigong and Energy Medicine Database from Qigong Institute and four Chinese Databases. Randomised and non-randomised clinical trials including patients with cancer or past experience of cancer receiving single or combined qigong interventions were included. All clinical endpoints were considered. The methodological quality of the trials was assessed using the Jadad score. Nine studies met our inclusion criteria (four were randomised trials and five were non-randomised studies). Eight of these trials tested internal qigong and one trial did not reported details. The methodological quality of these studies varies greatly and was generally poor. All trials related to palliative/supportive cancer care and none to qigong as a curative treatment. Two trials suggested effectiveness in prolonging life of cancer patients and one failed to do so. We conclude that the effectiveness of qigong in cancer care is not yet supported by the evidence from rigorous clinical trials. |
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Menopause
14(4):624-629, July/August 2007
Effect of 6 months of exercise and isoflavone supplementation on clinical cardiovascular risk factors in obese postmenopausal women: a randomized, double-blind study.
Aubertin-Leheudre, Mylene MSc 1,2; Lord, Christine MSc 1; Khalil, Abdelouahed PhD 1,3; Dionne, Isabelle J. PhD 1,2
Objective: To investigate whether 6 months of exercise combined with isoflavone supplementation could improve clinical risk factors that predispose to cardiovascular disease in obese postmenopausal women. Design: This was a randomized, double-blind, controlled trial in which 50 healthy obese postmenopausal women were divided into two groups and assigned to isoflavone supplementation (n = 25) or a placebo (n = 25) for 1 year. For the last 6 months, both groups participated in an exercise program (three times per week), at the end of which cardiovascular disease risk factors were compared between groups. Body composition (using dual-energy x-ray absorptiometry), metabolic profile (blood lipids, fasting insulin, fasting glucose, sex hormone-binding globulin, C-reactive protein) were determined at baseline and at 6 and 12 months. Results: We observed a significant effect of exercise and isoflavone supplementation on body weight, total and abdominal fat mass (kilograms and percentage), body mass index, appendicular fat-free mass, fat-free mass/fat mass ratio, and sex hormone-binding globulin, but not with exercise alone. No difference was observed for other biochemical characteristics, although the quantitative insulin sensitivity check index increased equally in both groups. Conversely, although not significant, we observed a tendency for a treatment effect on body mass index (P = 0.07) and on absolute (kilograms) (P = 0.07) and percentage of (P = 0.053) abdominal fat mass, whereas no effect of treatment was found for other variables using the Mann-Whitney test. Conclusions: Compared to an aerobic exercise program alone, 70 mg/day of isoflavones combined with exercise may promote significant improvements in body composition parameters that are known to influence cardiovascular disease risk in postmenopausal women.
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Menopause
14(4):648-655, July/August 2007
Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study.
D’Anna, Rosario MD 1; Cannata, Maria Letizia MD 1; Atteritano, Marco MD 2; Cancellieri, Francesco MD 1; Corrado, Francesco MD 1; Baviera, Giovanni PhD 1; Triolo, Onofrio MD 1; Antico, Francesco MD 1; Gaudio, Agostino MD 2; Frisina, Nicola MD 2; Bitto, Alessandra MD 3; Polito, Francesca PhD 3; Minutoli, Letteria MD 3; Altavilla, Domenica PhD 3; Marini, Herbert MD 4; Squadrito, Francesco MD 3
Abstract:
Objective: To evaluate in a 12-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women with no adverse effect on the endometrium. Design: A total of 389 participants met the main study criteria and were randomly assigned to receive the phytoestrogen genistein (n = 198) or placebo (n = 191). About 40% of participants in both groups did not suffer from hot flushes, and the evaluation was performed in a subgroup of 247 participants (genistein, n = 125; placebo, n = 122). Reductions from baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells. Results: There were no significant differences in age, time since menopause, body mass index, and vasomotor symptoms between groups at baseline (4.4 +/- 0.33 hot flushes per day in the genistein group and 4.2 +/- 0.35 hot flushes per day in the control group). The effect was already evident in the first month and reached its peak after 12 months of genistein therapy (-56.4% reduction in the mean number of hot flushes). Furthermore, there was a significant difference between the two groups at each evaluation time (1, 3, 6, and 12 months). No significant difference was found in mean endometrial thickness and maturation value score between the two groups, either at baseline or after 12 months. Conclusions: The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on endometrium.
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Menopause
14(4):612-623, July/August 2007
Cross-sectional analysis of specific complementary and alternative medicine (CAM) use by racial/ethnic group and menopausal status: the Study of Women’s Health Across the Nation (SWAN).
Gold, Ellen B. PhD 1; Bair, Yali PhD 1; Zhang, Guili PhD 1; Utts, Jessica PhD 2; Greendale, Gail A. MD 3; Upchurch, Dawn PhD 4; Chyu, Laura MA 4; Sternfeld, Barbara PhD 5; Adler, Shelley PhD 6
Abstract:
Objective: To examine the relationships of race/ethnicity, menopausal status, health characteristics, and symptoms with use of 21 types of complementary and alternative medicine (CAM) in midlife women. Design: Cross-sectional, multiple logistic regression analyses of 2,118 women completing the sixth annual visit in the Study of Women’s Health Across the Nation, a multisite, multiethnic, longitudinal study. Results: More than half of women used some type of CAM. Use of most types of CAM differed significantly by race/ethnicity, except the use of ginkgo biloba and glucosamine. Significantly more African Americans at most sites and Chinese women used ginseng. Use of most types of CAM did not differ significantly by menopausal status or vasomotor symptoms, except the use of soy supplements, which was significantly greater among women who reported vasomotor symptoms. Women reporting somatic symptoms were significantly more likely to use glucosamine. Women reporting psychological symptoms were significantly more likely to use ginkgo biloba and soy supplements. The number of comorbidities, moderate or high socioeconomic status, number of healthy behaviors, symptom sensitivity, age, and dietary genistein intake were significantly positively associated with use of several types of CAM. Conclusions: The use of most types of CAM is not related to menopausal status or symptom reporting but to sociodemographic factors, comorbidities, and health behaviors. Given the large proportion of midlife women who use CAM and the potential for interactions with prescribed medications, healthcare practitioners should inquire about CAM use and be aware of which factors influence the use of different types of CAM.
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The Lancet: Infectious Disease
Volume 7, Issue 7, July 2007, Pages 473-480
Evaluation of echinacea for the prevention and treatment of the common cold: a meta-analysis
Sachin A Shah PharmDa, c, Stephen Sander PharmDa, c, C Michael White PharmDa, c, Mike Rinaldi PharmDa, b and Dr Craig I Coleman PharmDa, c
Summary
Echinacea is one of the most commonly used herbal products, but controversy exists about its benefit in the prevention and treatment of the common cold. Thus, we did a meta-analysis evaluating the effect of echinacea on the incidence and duration of the common cold. 14 unique studies were included in the meta-analysis. Incidence of the common cold was reported as an odds ratio (OR) with 95% CI, and duration of the common cold was reported as the weighted mean difference (WMD) with 95% CI. Weighted averages and mean differences were calculated by a random-effects model (DerSimonian-Laird methodology). Heterogeneity was assessed by the Q statistic and review of L’Abbé plots, and publication bias was assessed through the Egger weighted regression statistic and visual inspection of funnel plots. Echinacea decreased the odds of developing the common cold by 58% (OR 0•42; 95% CI 0•25–0•71; Q statistic p<0•001) and the duration of a cold by 1•4 days (WMD −1•44, −2•24 to −0•64; p=0•01). Similarly, significant reductions were maintained in subgroup analyses limited to Echinaguard/Echinacin use, concomitant supplement use, method of cold exposure, Jadad scores less than 3, or use of a fixed-effects model. Published evidence supports echinacea’s benefit in decreasing the incidence and duration of the common cold.
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HIV Medicine
Volume 8 Issue 5 Page 300Issue 5 - 305 - July 2007
Use of complementary and alternative medicines among a multistate, multisite cohort of people living with HIV/AIDS
JS Josephs11Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, JA Fleishman22Agency for Healthcare Research and Quality, Rockville, MD, and , P Gaist33National Institutes of Health, Bethesda, MD, USA and KA Gebo11Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, for the HIV Research Network
Objective:
The aim of the study was to assess the prevalence of and factors associated with use of complementary or alternative medicine (CAM) in a multistate, multisite cohort of HIV-infected patients. Methods During 2003, 951 adult patients from 14 sites participated in face-to-face interviews. Patients were asked if they received treatment from any alternative therapist or practitioner in the previous 6 months. Logistic regression was performed to examine associations between demographic and clinical variables and CAM use. Results The majority of the participants were male (68%) and African American (52%) with a median age of 45 years (range 20–85 years). Sixteen per cent used any CAM in the 6 months prior to the interview. Factors associated with use of CAM were the HIV risk factor injecting drug use [adjusted odds ratio (AOR) 0.51] compared with men who have sex with men (MSM), former drug use (AOR=2.12) compared with never having used drugs, having a college education (AOR=2.43), and visiting a mental health provider (AOR=2.76). Conclusions This study demonstrated similar rates of CAM use in the current highly active antiretroviral therapy (HAART) era compared with the pre-HAART era. Factors associated with CAM – such as education, use of mental health services, and MSM risk factor – suggest that CAM use may be associated with heightened awareness regarding the availability of such therapies. Given the potential detrimental interactions of certain types of CAM and HAART, all HIV-infected patients should be screened for use of CAM. |
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Journal of Allergy and Clinical Immunology
Volume 117, Issue 5 , May 2006, Pages 1054-1062
ARIA update: I—Systematic review of complementary and alternative medicine for rhinitis and asthma
Giovanni Passalacqua, Philippe J. Bousquet, Kai-Hakon Carlsen, James Kemp, Richard F. Lockey, Bodo Niggemann, Ruby Pawankar, David Price and Jean Bousquet
a.From Allergy and Respiratory Diseases, University of Genoa
b.Service des Maladies Respiratoires, Hopital A. de Villeneuve, Montpellier
c.Norwegian University of Sports and Physical Medicine, Oslo
d.Department of Pediatrics, University of California School of Medicine, San Diego
e.Allergy and Immunology, University of South Florida and J. A. Haley Veterans' Hospital, Tampa
f.Department of Pediatric Pneumology and Immunology, University Hospital Charitè, Berlin
g.Department of Otorhinolaryngology, Nippon Medical School, Tokyo
h.Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Center
Abstract:
Complementary-alternative medicines are extensively used in the treatment of allergic rhinitis and asthma, but evidence-based recommendations are lacking. To provide evidence-based recommendations, the literature was searched by using MedLine and the Cochrane Library to March 2005 (Key words: Asthma [OR] Rhinitis, [AND] Complementary [OR] Alternative Medicine, [OR] Herbal, [OR] Acupuncture, [OR] Homeopathy, [OR] Alternative Treatment). Randomized trials, preferably double-blind and published in English, were selected. The articles were evaluated by a panel of experts. Quality of reporting was assessed by using the scale validated by Jadad. The methodology of clinical trials with complementary-alternative medicine was frequently inadequate. Meta-analyses provided no clear evidence for the efficacy of acupuncture in rhinitis and asthma. Some positive results were described with homeopathy in good-quality trials in rhinitis, but a number of negative studies were also found. Therefore it is not possible to provide evidence-based recommendations for homeopathy in the treatment of allergic rhinitis, and further trials are needed. A limited number of studies of herbal remedies showed some efficacy in rhinitis and asthma, but the studies were too few to make recommendations. There are also unresolved safety concerns. Therapeutic efficacy of complementary-alternative treatments for rhinitis and asthma is not supported by currently available evidence.
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JAMA. 2006;295:2262-2269
Effect of Policosanol on Lipid Levels Among Patients With Hypercholesterolemia or Combined Hyperlipidemia
A Randomized Controlled Trial
Heiner K. Berthold, MD, PhD; Susanne Unverdorben, MD; Ralf Degenhardt, PhD; Michael Bulitta, Dipl-Stat; Ioanna Gouni-Berthold, MD
Context:
Policosanol is a natural substance derived from sugar cane that is advertised for its lipid-lowering effects as a nonprescription drug. More than 80 placebo-controlled or comparative trials, performed mostly by a single research institute, suggest that policosanol at doses of 5 to 40 mg/d has lipoprotein-lowering effects comparable with statins.
Objectives:
To determine the lipoprotein-lowering effects of Cuban sugar cane–derived policosanol and to establish, if effective, dose-dependency up to 80 mg/d in patients with hypercholesterolemia or combined hyperlipidemia.
Design, Setting, and Participants:
A multicenter (lipid outpatient clinics and general practitioners in Germany), randomized, double-blind, placebo-controlled, parallel-group trial conducted from September 29, 2000, to May 10, 2001, of patients with hypercholesterolemia or combined hyperlipidemia having baseline low-density lipoprotein cholesterol (LDL-C) levels of at least 150 mg/dL (3.88 mmol/L) and either no or 1 cardiovascular risk factor other than known coronary heart disease, or baseline LDL-C levels of between 150 and 189 mg/dL (3.88-4.89 mmol/L) and 2 or more risk factors.
Interventions:
Open-label 6-week placebo and diet run-in phase followed by a double-blind 12-week treatment phase after randomization to 5 groups: 10, 20, 40, or 80 mg/d of policosanol or placebo.
Main Outcome Measure:
The percentage change of LDL-C, with changes in other lipoproteins as secondary outcome measures.
Results:
A total of 143 patients were randomized to 5 equal groups and were analyzed on an intention-to-treat basis. In none of the 5 treatment groups did LDL-C levels decrease more than 10% from baseline. No statistically significant difference between policosanol and placebo was observed. A nonparametric test analyzing dose-dependency yielded nonsignificant results. In none of the secondary outcome measures, namely total cholesterol, high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, triglycerides, lipoprotein(a), and ratio of total or LDL-C to HDL-C, were there any significant effects of policosanol. Policosanol was tolerated well without serious adverse events.
Conclusion:
In patients with hypercholesterolemia or combined hyperlipidemia, the sugar cane–derived policosanol in usual and high doses does not demonstrate a reduction in lipid levels beyond placebo.
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American Journal of Therapeutics. 13(2):121-126,
March/April 2006.
Treatment of Mild to Moderate Psoriasis with Relieva, a Mahonia aquifolium Extract-A Double-Blind, Placebo-Controlled Study.
Bernstein, Steve; Donsky, Howard *; Gulliver, Wayne; Hamilton, Douglas; Nobel, Sion; Norman, Robert
Abstract:
Psoriasis is usually treated with local and systemic medications that have varying degrees of efficacy and safety profiles. We investigated the efficacy and safety of an alternative treatment from natural sources, Mahonia aquifolium, for the management of mild to moderate psoriasis. Two hundred subjects participated in a randomized, double-blind, placebo-controlled study using either the topical cream Relieva (a homeopathic product containing a proprietary M. aquifolium extract) or control (placebo) twice a day for 12 weeks. Efficacy and safety were assessed using the Psoriasis Area Severity Index (PASI) and the Quality of Life Index (QLI) questionnaires at different times throughout the 12-week study. The PASI was evaluated by the physician at the beginning (week 0) and end (week 12) of the study. The QLI was assessed by patients at weeks 0, 4, 8, and 12. The results indicate statistically significant (P < 0.05) improvements in PASI and QLI in the Mahonia-treated group, compared with the control group. The side effects reported were infrequent, < 1% and minor; the most frequent side effects were rash, a burning sensation when applying the cream, and clothing stain. These data indicate that Relieva, a proprietary form of M. aquifolium, is effective and well tolerated in patients with mild to moderate psoriasis.
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Menopause. 13(2):185-196
March/April 2006.
Effects of black cohosh (Cimicifuga racemosa) on bone turnover, vaginal mucosa, and various blood parameters in postmenopausal women: a double-blind, placebo-controlled, and conjugated estrogens-controlled study.
Wuttke, Wolfgang MD 1; Gorkow, Christoph DVM 2; Seidlova-Wuttke, Dana MD 1
Abstract:
Objectives: In this study, the effects of the Cimicifuga racemosa (CR) preparation CR BNO 1055 on markers of bone metabolism, hormones, sex hormone-binding globulin (SHBG), lipometabolism, vaginal maturity, and routine laboratory parameters were compared with those of conjugated estrogens (CE) and placebo.
Design: Sixty-two postmenopausal women were included in this double-blind study. Treatment duration with CR (daily dose corresponds to 40 mg of herbal drug), CE (0.6 mg/day), or placebo was 12 weeks. Markers of bone turnover (bone-specific alkaline phosphatase, CrossLaps), estradiol, follicle-stimulating hormone, leuteinizing hormone, SHBG, triglycerides, total cholesterol, high-density cholesterol, low-density cholesterol, and routine clinical chemistry parameters were determined from blood samples. Vaginal "maturity index" was determined from vaginal smears.
Results: The analyses of bone turnover markers indicated beneficial effects for CR and CE on bone metabolism. CR stimulated osteoblast activity, whereas CE inhibited osteoclast activity. Whereas CE showed strong estrogenic effects on vaginal mucosa, CR showed weak estrogen-like activity. No significant effects were seen on coagulation markers and liver enzymes in the blood. CR was well tolerated.
Conclusion: These results suggest that CR has beneficial bone remodeling and weak estrogen-like effects in the vaginal mucosa.
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Geriatric Nursing
Volume 27, Issue 2 , March-April 2006, Pages 118-129
Herbal, Prescribed, and Over-the-Counter Drug Use in Older Women: Prevalence of Drug Interactions
Saunjoo L. Yoon PhD, RN and Susan D. Schaffer PhD, ARNP, BC
Abstract:
Older adults are at particular risk for drug and herbal interactions because they have multiple health problems that require treatment and are generally more susceptible to adverse drug effects. This study used a database containing self-reported herbal, prescription, and over-the-counter (OTC) drugs concurrently taken by a sample of 58 women who were aged 65 years or older. Drug-drug interactions (DDIs) were identified using a Web-based pharmaceutical program. At least 1 moderate or high-risk DDI was identified in 74% of participants, with 136 total DDIs identified. Fifty-two percent (71) of total DDIs were between prescribed and OTC or herbals, with 63% (45) of these involving nonsteroidal antiinflammatory drugs (NSAIDs). It is imperative that health care providers identify all prescribed, OTC, and herbal drugs taken by their patients and assess all interactions in order to avoid the possibility of adverse drug effects.
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Leukemia Research
Volume 30, Issue 6 , June 2006, Pages 649-650
Natural products and the treatment of leukemia
Terry Hamblin
University of Southampton c/o Department of Haematology, Royal Bournemouth Hospital, Castle Lane East, Bournemouth BH7 7DW, United Kingdom
Abstract:
Plants have been the source of many medicines in the pharmacopoeia. So much so that an industry has arisen selling plant extracts as health foods. To a great degree it operates over the internet and it chiefly caters to the worried well. However, cancer patients frequently take plant extracts in addition to their prescribed medicines. These extracts are not biologically inactive, and many have important pro-apoptotic effects on cancer cell-lines in vitro. In this issue a study of the in vivo effects of green tea extract in low grade lymphomas is reported. The results are sufficiently encouraging to initiate a formal clinical trial.
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Nephrology
Volume 11 Page 137 - April 2006
Volume 11 Issue 2
Folic acid 5 or 15 mg/d similarly reduces plasma homocysteine in patients with moderate–advanced chronic renal failure
AMELIA R BERNASCONI1, ANDRÉS LISTE1, NOEMÍ DEL PINO2, GUILLERMO J ROSA DIEZ3 and RICARDO M HEGUILÉN1
Background:
Hyperhomocysteinaemia is an independent risk factor for cardiovascular disease with a remarkable prevalence in patients with chronic renal failure (CRF). Low doses of folic acid (FA) with or without vitamin B6 and B12 has been shown to effectively reduce plasma homocysteine (Hcy). The aim of this study was to compare the short-term effects of two different oral doses of FA (5 vs 15 mg/d) on plasma Hcy levels in subjects suffering from moderate–severe CRF.
Methods:
A double-blind, double-dummy, comparative, two-stage randomised study was performed. Seventeen patients aged 45–71 years, with glomerular filtration rates between 15.4–50 mL/min 1.73/m2 were randomly assigned to receive FA 5 mg/d (FA-5, n: 8) or FA 15 mg/d (FA-15, n: 9) for 30 days. At the end of this 30-day double-blind period, all the participants were placed on FA 5 mg/d (open period), for 5 additional months. Both groups were also supplemented with vitamins B1, B6 and B12 throughout the trial. Blood samples were drawn at 0, 15, 30, 90 and 180 days to assess Hcy, complete blood count (CBC) and sequential multichannel analysis (SMA). Chest X-ray and a 12-lead electrocardiogram (ECG) were also performed.
Results:
Plasma Hcy (mean ± SEM) decreased from 27.9 ± 1.4 (baseline) to 15.1 ± 0.6, 13.3 ± 0.9, 14.1 ± 0.5 and 13.8 ± 0.5 µmol/L (FA-5) and from 28.8 ± 2.7 to 15.6 ± 1.2, 14.4 ± 1.3, 13.0 ± 0.7 and 13.1 ± 0.6 µmol/L (FA-15) at days 15, 30, 90 and 180, respectively. (P < 0.01 from day 15 to 180 vs baseline for both groups with no differences between them). Renal function remained stable throughout the entire period of the study in all but one patient in whom it deteriorated to pre-end stage disease. No adverse cardiovascular events developed during the trial.
Conclusion:
Both folic acid doses induced a significant and similar decrease in plasma Hcy in subjects with moderate–severe chronic renal failure. The possible dose-related effect of this approach in reducing the risk of accelerated sclerotic vascular disease and cardiovascular events in this especially vulnerable population should be a matter of further investigation.
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The American Journal of Cardiology
Volume 97, Issue 8 , 15 April 2006, Pages 1127-1130
Effects of Omega-3 Fatty Acids on Resting Heart Rate, Heart Rate Recovery After Exercise, and Heart Rate Variability in Men With Healed Myocardial Infarctions and Depressed Ejection Fractions
James H. O’Keefe, Jr MDa, b, Hussam Abuissa MDa, b, Antonio Sastre PhDc, David M. Steinhaus MDa, b and William S. Harris PhDa, b,
a. Mid America Heart Institute, Saint Luke’s Hospital, Kansas City, Missouri, USA
b. University of Missouri–Kansas City School of Medicine, Kansas City, Missouri, USA
c. Midwest Research Institute, Kansas City, Missouri
Received18 August 2005; revised 1 November 2005; accepted 1 November 2005. Available online 3 March 2006.
We explored possible mechanisms by which recommended intakes of ω-3 fatty acids may decrease the risk for sudden cardiac death in patients with documented coronary heart disease. The cardioprotective effects of ω-3 fatty acids have been documented in epidemiologic and randomized controlled trials. These fatty acids are presumed to decrease susceptibility to fatal arrhythmias, but whether this is mediated by classic risk factors or direct cardiac mechanisms is not known. Eighteen white men with a history of myocardial infarction and ejection fractions <40% were randomized to placebo or ω-3 fatty acids (585 mg of docosahexaenoic acid and 225 mg of eicosapentaenoic acid) for two 4-month periods in a crossover design. At the end of each period, heart rate (HR), HR variability, and rate of HR recovery after exercise were determined, as were effects on arterial compliance, blood pressure, cardiac function, and fasting serum levels of lipids and inflammatory markers. Omega-3 fatty acids decreased HR at rest from 73 ± 13 to 68 ± 13 beats/min (p <0.0001) and improved 1-minute HR recovery after exercise (−27 ± 10 to −32 ± 12 beats/min, p <0.01). HR variability in the high-frequency band increased (p <0.02), but no change was noted in overall HR variability. There were no significant effects on blood pressure, arterial compliance, lipids, or inflammatory markers. These changes are consistent with an increase in vagal activity and may in part explain the observed decrease in risk for sudden cardiac death seen with ω-3 fatty acid supplementation.
This study was funded by a grant from the Saint Luke’s Hospital Foundation, Kansas City, Missouri.
Corresponding author: Tel: 816-932-8235; fax: 816-932-8278 |
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Alimentary
Pharmacology & Therapeutics, Volume 23, Number 3
February 2006, pp. 341-349(9)
Review article: complementary and alternative therapies for inflammatory bowel disease
Authors: LANGMEAD, L.1; RAMPTON, D. S.2
Summary:
Complementary and alternative medicine includes a wide range of practices and therapies outside the realms of conventional western medicine. Despite a lack of scientific data in the form of controlled trials for either efficacy or safety of complementary and alternative medicine, use by patients with inflammatory bowel disease, particularly of herbal therapies, is widespread and increasing.
There is limited controlled evidence indicating efficacy of traditional Chinese medicines, aloe vera gel, wheat grass juice, Boswellia serrata and bovine colostrum enemas in ulcerative colitis. Encouraging results have also been reported in small studies of acupuncture for Crohn's disease and ulcerative colitis. Contrary to popular belief, natural therapies are not necessarily safe: fatal hepatic and irreversible renal failure have occurred with some preparations and interactions with conventional drugs are potentially dangerous.
There is a need for further controlled clinical trials of the potential efficacy of complementary and alternative approaches in inflammatory bowel disease, together with enhanced legislation to maximize their quality and safety.
Affiliations:
1: Department of Gastroenterology, University College London Hospitals, NHS Foundation Trust, London 2: Barts and the London School of Medicine and Dentistry, Queen Mary, University of London, London, UK
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The Journal of Clinical Endocrinology & Metabolism Vol. 91, No. 3 772-780
A Critical Evaluation of the Role of Soy Protein and Isoflavone Supplementation in the Control of Plasma Cholesterol Concentrations
Antonella Dewell, Piper L. W. Hollenbeck and Clarie B. Hollenbeck
Department of Nutrition and Food Science (A.D., C.B.H.), San Jose State University, San Jose, California 95192-0058; and Department of Vascular Surgery (P.L.W.H.), Veterans Affairs Medical Center, San Francisco, California 94121-1598
Address all correspondence and requests for reprints to: Clarie B. Hollenbeck, Ph.D., Department of Nutrition and Food Science, San Jose State University, One Washington Square, San Jose, California 95192-0058. E-mail: clariebh@casa.sjsu.edu .
Context:
The purpose of this review was to critically evaluate current research on the effect of soy protein and isoflavone supplements on plasma lipoproteins and place the potential role of soy in the prevention of coronary artery disease (CAD) into a clinical perspective.
Evidence Acquisition:
An extensive literature search was performed using a variety of medical and scientific databases including Medline, PubMed, Science Direct, Ovid, NIST, and Infotrac to identify relevant articles. Journal articles were cross-referenced for additional sources of information. Articles were evaluated based on level of experimental control as well as statistical, quantitative, and clinical analysis.
Evidence Synthesis:
Soy and soy isoflavones have been the object of extensive research investigating their potential hypocholesterolemic effects and possible role in the prevention of CAD. It has been suggested that soy, especially the isoflavones contained in soy, improves lipoprotein levels, thus reducing the risk for CAD. This belief, however, is not uniformly accepted. Moreover, the experimental evidence in support of this notion is not as overwhelming as generally perceived, and the current available data reveal that the discrepancies observed are primarily statistical in nature rather than reflecting actual quantitative differences in the hypocholesterolemic effects detected.
Conclusions: A critical analysis of the investigations to date indicates the data are not quantitatively impressive and raises substantial questions about the clinical importance of the hypocholesterolemic effects observed.
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Psychogeriatrics
Volume 6 Issue 1Page 21 - March 2006
The use of alternative medicine for the treatment of insomnia in the elderly
E. Paul CHERNIACK
Abstract:
Insomnia is a frequent problem among the elderly, for which patients often self-medicate. The use of alternative medicine by individuals worldwide, including the elderly, is increasing and insomnia is a common reason for its use. Conventional treatments do not benefit all, and there is uncertainty about the effects of their long-term use. Many alternative therapies have been considered for the treatment of sleep disorders in published medical reports. These consist of pharmacological therapies, including melatonin, valerian, lavender, hops, kava, Chinese and Japanese herbal compounds, pyridoxine, St John's wort and German chamomile, and non-pharmacological therapies, including massage, acupuncture, music therapy, tai chi, magnetism and white noise. Comparison of these treatments, either with each other or with conventional therapies, is difficult because many studies inadequately define insomnia, have few subjects or lack randomization or controls. Many have not been tested specifically on elderly subjects. As a result of the problems in the trials of these treatments, drawing a definitive conclusion about the effectiveness of these therapies is difficult. Melatonin appears to be the most promising. It has been shown to produce some limited benefit by studies to date, although it has not been investigated in enough appropriate subjects to definitively conclude that there is a benefit at a sufficiently low risk. A promising role for melatonin might be in the treatment of elderly people with sleep-phase disorders. Other pharmacological treatments with potential await well-designed studies on the elderly. There are many non-pharmacological therapies that offer the potential advantages of a low side-effect profile, but the investigations of these have been even less rigorous.
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Surgical Neurology
Volume 65, Issue 4 , April 2006, Pages 326-331
ω-3 Fatty acids (fish oil) as an anti-inflammatory: an alternative to nonsteroidal anti-inflammatory drugs for discogenic pain†
Joseph Charles Maroon MD , ‡, , and Jeffrey W. Bost PAC‡
Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA
Received 3 October 2005; accepted 13 October 2005. Available online 10 March 2006.
SUMMARY:
Background:
The use of NSAID medications is a well-established effective therapy for both acute and chronic nonspecific neck and back pain. Extreme complications, including gastric ulcers, bleeding, myocardial infarction, and even deaths, are associated with their use. An alternative treatment with fewer side effects that also reduces the inflammatory response and thereby reduces pain is believed to be ω-3 EFAs found in fish oil. We report our experience in a neurosurgical practice using fish oil supplements for pain relief.
Methods:
From March to June 2004, 250 patients who had been seen by a neurosurgeon and were found to have nonsurgical neck or back pain were asked to take a total of 1200 mg per day of ω-3 EFAs (eicosapentaenoic acid and decosahexaenoic acid) found in fish oil supplements. A questionnaire was sent approximately 1 month after starting the supplement.
Results:
Of the 250 patients, 125 returned the questionnaire at an average of 75 days on fish oil. Seventy-eight percent were taking 1200 mg and 22% were taking 2400 mg of EFAs. Fifty-nine percent discontinued to take their prescription NSAID medications for pain. Sixty percent stated that their overall pain was improved, and 60% stated that their joint pain had improved. Eighty percent stated they were satisfied with their improvement, and 88% stated they would continue to take the fish oil. There were no significant side effects reported.
Conclusions:
Our results mirror other controlled studies that compared ibuprofen and ω-3 EFAs demonstrating equivalent effect in reducing arthritic pain. ω-3 EFA fish oil supplements appear to be a safer alternative to NSAIDs for treatment of nonsurgical neck or back pain in this selective group.
Keywords:
Spine pain; ω-3 EFA; Nonsteroidal anti-inflammatory drugs
Abbreviations: ALA, α-Linolenic acid; COX, Cyclooxygenase; DHA, Decosahexaenoic acid; EPA, Eicosapentaenoic acid; EFA, Essential fatty acids; FDA, Food and Drug Administration; IL, Interleukins; LOX, Lipoxygenase; MI, Myocardial infarction; NSAIDs, Nonsteroidal anti-inflammatory drugs; PG, Prostaglandin
This paper won first prize in the poster competition at the AANS Annual Meeting, New Orleans, LA, April 2005.
Corresponding author. University of Pittsburgh Medical Center, Pittsburgh, PA, USA
‡ Dr. Maroon and Mr. Bost are stockholders in Inflammation solutions, a dietary supplement retailer.
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Journal of Dermatological Science
Volume 42, Issue 1 , April 2006, Pages 13-21
Anti-inflammatory activity in skin by biomimetic of Evodia rutaecarpa extract from traditional Chinese medicine
Daniel B. Yarosha, , , Jason W. Galvinb, Stephanie L. Naya, Arely V. Peñaa, Matthew T. Canninga and David A. Browna
a. AGI Dermatics, 205 Buffalo Avenue, Freeport, NY 11520, United States
b. Department of Molecular & Cellular Biology, Stony Brook University, Stony Brook, NY 11794, United States
Received 3 August 2005; revised 15 November 2005; accepted 15 December 2005. Available online 19 January 2006.
SUMMARY:
Background:
Wu-Zhu-Yu, is an extract prepared from the small berry fruit of Evodia rutaecarpa and is reported to have anti-inflammatory and anti-nociceptic activity. Methyl nicotinate (MN) is known to induce the release of PGD2 resulting in localized erythema within 30 min after topical application to human skin.
Objective:
The purpose of this study was to determine if a defined biomimetic mixture of components of Evodia fruit extract inhibit inflammation in human cells and skin.
Methods:
In order to control the potency of the test article, we prepared a defined biomimetic mixture of synthetic and natural forms of the active components of Evodia fruit extract, containing rutaecarpine, dehydroevodiamine, and evodin. This was tested for anti-inflammatory activity in UVB-irradiated cultured cells and in the MN model of micro-inflammation in human skin.
Results:
This Evodia biomimetic mixture was a potent inhibitor of UVB-induced PGE2 released by keratinocytes in culture. We found that MN also induces release of nitric oxide from cultured keratinocytes and microvascular endothelial cells. Twice daily application of 0.1–1% Evodia biomimetic mixture for 2 weeks significantly inhibited erythema after a MN challenge. A single application of 1% Evodia biomimetic mixture also significantly inhibited MN-induced erythema when applied at 60 min before, or within 5 min after MN exposure. The Evodia biomimetic mixture was significantly more effective at inhibiting erythema than bisabolol, the active component of chamomile.
Conclusions:
These results demonstrate that compounds found in E. rutaecarpa (including the indole quinazoline alkaloids) have powerful anti-inflammatory activity when applied topically to human skin.
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European Journal of Pharmacology
Volume 532, Issue 3 , 27 February 2006, Pages 201-207
Antioxidant effects of ginsenoside Re in cardiomyocytes
Jing-Tian Xiea, b, Zuo-Hui Shaoa, c, Terry L. Vanden Hoeka, c, Wei-Tien Changc, Jing Lid, Sangeeta Mehendalea, b, Chong-Zhi Wanga, b, Chin-Wang Hsuc, Lance B. Beckera, c, Jun-Jie Yinf and Chun-Su Yuana, b, e, ,
a. Tang Center for Herbal Medicine Research, Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, USA
b. Department of Anesthesia and Critical Care, Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, USA
c. Section of Emergency Medicine, Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, USA
d. Section of gastroenterology, Department of Medicine, Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, USA
e. Committee on Clinical Pharmacology and Pharmacogenomics, Pritzker School of Medicine, University of Chicago, Chicago, IL 60637, USA
f. Center for Food Safety and Applied Nutrition, FDA, College Park, MD 20740, USA
Received 10 November 2005; revised 22 December 2005; accepted 4 January 2006. Available online 21 February 2006.
Abstract:
We have previously demonstrated that American ginseng berry extract exhibited significant protection against oxidant-mediated injury in cardiomyocytes. To extend this work, we sought to investigate the antioxidant effects of Re, a protopanaxatriols-type and single chemical integrant present in American ginseng berry extract, using the same chick cardiomyocyte model of oxidant injury as well as ESR spectroscopy in a cell-free chemical system. In cells exposed to 2 h of H2O2 (0.5 mM), pretreatment with Re (0.05, 0.1, or 0.5 mg/ml for 2 h) significantly attenuated 2′,7′-dichlorofluorescein (DCF) fluorescence by 51% (from 1345 ± 67 to 658 ± 46 a.u., P < 0.001), and remarkably reduced cell death (from 51.5 ± 3.0% to 11.8 ± 1.5%, P < 0.001, compared to the control). Similar results were also observed in cells exposed to antimycin A (100 μM), a mitochondrial electron transport chain site III inhibitor which increases endogenous oxidative stress. In the ESR study, however, Re failed to reduce the formation of the superoxide/DMPO adduct and DPPH radicals. These results suggest that ginsenoside Re functions as an antioxidant, protecting cardiomyocytes from oxidant injury induced by both exogenous and endogenous oxidants, and that its protective effects may be mostly attributed to scavenging H2O2 and hydroxyl radicals.
Keywords:
Antioxidant effect; Ginsenoside Re; ESR spectroscopy; Cardiomyocyte; Ischemia and reperfusion damage; Antimycin A; H2O2
Corresponding author. Department of Anesthesia and Critical Care, University of Chicago Medical Center, 5841 S. Maryland Avenue, MC 4028, Chicago, Illinois 60637, USA. Tel.: +1 773 702 1916; fax: +1 773 834 0601.
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American Heart Journal
Volume 151, Issue 3 , March 2006, Pages 564-570
Understanding omega-3's
Andrew P. DeFilippis MDa, , and Laurence S. Sperling MD, FACC, FACPb
a. Division of General Medicine, Emory University School of Medicine, Atlanta, GA
b. Division of Cardiology, Emory University School of Medicine, Atlanta, GA
Received 15 December 2004; accepted 26 March 2005. Available online 28 February 2006.
Omega-3 fatty acids are a subset of polyunsaturated fatty acids found in marine sources as eicosapentaenoic acid and docosahexaenoic acid and in some leafy vegetables, nuts, and oils as α-linolenic acid (ALA). The metabolism of omega-3's may explain the cardioprotective effects observed in epidemiologic and experimental studies. Although most data for cardioprotective effects come from studies of marine sources, vegetable sources of omega-3 fatty acids (α-linolenic acid) may have similar effects through in vivo conversion to eicosapentaenoic acid and docosahexaenoic acid. This document will provide an overview of omega-3 fatty acids with a focus on specific sources, metabolism, safety issues, and their potential indication for cardiovascular prevention.
Reprint requests: Andrew P. DeFilippis, MD, Division of General Medicine, Emory University School of Medicine, 49 Jessie Hill Jr Dr, Atlanta, GA 30303
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Clinical Therapeutics
Volume 28, Issue 2 , February 2006, Pages 174-183
Echinacea in the prevention of induced rhinovirus colds: A meta-analysis
MScRoland Schoop1, , , MScPeter Klein2, MScAndy Suter1 and MD, PhDSebastian L. Johnston3, 4
1A. Vogel Bioforce AG, Roggwil, Switzerland
2. DSH Statistical Services GmbH, Rohrbach, Germany
3. Department of Respiratory Medicine, National Heart and Lung Institute, Imperial College London, London, United Kingdom
4. Wright-Fleming Institute of Infection and Immunity, Imperial College London, London, United Kingdom
ABSTRACT:
Background:
The therapeutic effectiveness of Echinacea in the treatment and the prevention of colds has been debated. Studies of naturally occurring colds are hampered by variability in time from onset of symptoms to treatment and by heterogeneity in trial design. Experimental infection studies allow for the standardization of time to initiation of treatment, virus type and dose, and immune competence of volunteers.
Objective:
To determine whether the negative results obtained in previous studies of Echinacea were a consequence of efficacy or of inadequate sample size, we performed a meta-analysis of experimental rhinovirus infection studies on the efficacy of Echinacea extracts to prevent symptomatic development of an experimentally induced cold.
Methods:
We carried out a systematic search of English- and German-language literature using the MEDLINE, EMBASE, CAplus, BIOSIS, CABA, AGRICOLA, TOXCENTER, SCISEARCH, NAHL, and NAPRALERT, databases and the search terms Echinacea, black Sampson, coneflower, and Roter Sonnenbut. Matching documents were then searched for ≥1 of the following terms: rhinovirus, RV, inoculation, Inokulation, induced, induziert, artificial, and artifiziell. Suitable studies were identified and pooled for analysis. The primary end point was the development of symptomatic clinical colds, as defined by the authors of the original studies. Results were reported as differences in the proportion of subjects with symptomatic episodes of a common cold, expressed as odds ratios (ORs) and 95% CIs. The secondary outcome was the difference in total symptom severity scores between treatment groups (assessed daily by integrating the severity scores of 8 individual cold-related symptoms that were rated on a scale from 0 [absent] to 4 [very severe]).
Results:
A total of 234 articles were identified through the literature search; 231 were excluded from the analysis because they related to studies of spontaneous common colds. Three suitable studies were selected for pooling of data. Based on the analysis, the likelihood of experiencing a clinical cold was 55% higher with placebo than with Echinacea (OR, 1.55 [95% CI, 1.02–2.36]; P<0.043). The absolute difference in total symptom scores between groups was −1.96 (95% CI, −4.83 to 0.90; P=NS).
Conclusions:
This meta-analysis suggests that standardized extracts of Echinacea were effective in the prevention of symptoms of the common cold after clinical inoculation, compared with placebo. Further prospective, appropriately powered clinical studies are required to confirm this finding.
Address correspondence to: Roland Schoop, MSc, A. Vogel Bioforce AG, 9325 Roggwil, Switzerland. |
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Journal of Pediatric Gastroenterology & Nutrition. 42(5):454-475
May 2006.
Probiotics in Gastrointestinal Diseases in Children: Hard and Not-So-Hard Evidence of Efficacy.
Invited Review
Szajewska, Hania *; Setty, Mala +; Mrukowicz, Jacek ++; Guandalini, Stefano +
Abstract:
The use of probiotics, once discussed primarily in the context of alternative medicine, is now entering mainstream medicine. However, only a few of the potential health benefits attributed to probiotics have been confirmed in well-designed, well-conducted, randomized, controlled trials. This is especially true in the pediatric population. We review here the available evidence on efficacy of probiotics in children in the prevention and treatment of gastrointestinal diseases. Although we restrict our analysis to the pediatric age, whenever potentially relevant information is available only from adult studies, they are examined as well. Probiotics have been most extensively studied in the treatment of diarrheal diseases, where their efficacy can be considered well established. Studies documenting effects in other childhood gastrointestinal illnesses are few, although some preliminary results are promising. Furthermore, only a limited number of probiotic strains have been tested, and, as the effects of different probiotic microorganisms are not equivalent, results cannot be generalized. Thus, at present, we have some positive certainties, lots of exciting promises and many unanswered questions.
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Natural Health Products Directorate,
Health Canada |
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