[show abstract][hide abstract] ABSTRACT: OBJECTIVE:To evaluate the efficacy of bioidentical progesterone cream in the treatment of menopause-related vasomotor symptoms.DATA SOURCES:A systematic search (from time of inception to September 2012) of PubMed, EMBASE, International Pharmaceutical Abstracts, International Journal of Pharmaceutical Compounding, Cochrane, and CINAHL was conducted using the terms progesterone, vasomotor symptoms, night sweats, hot flash or flush, and randomized controlled trials (RCTs). Hand-searching of citations from relevant articles was also performed.STUDY SELECTION AND DATA EXTRACTION:Articles selected for inclusion described RCTs evaluating the use of bioidentical progesterone cream for the treatment of menopause-related vasomotor symptoms. Studies included were placebo controlled and participants were postmenopausal women experiencing vasomotor symptoms.DATA SYNTHESIS:Searching identified 3 published RCTs. Only one study, which used a bioidentical progesterone cream specifically compounded for the trial, found that the bioidentical progesterone was more effective than placebo in relieving menopause-related vasomotor symptoms. The 2 studies using manufactured bioidentical progesterone creams found that the creams were no more effective than placebo. Vaginal bleeding and headaches were the most commonly reported adverse effects in the studies.CONCLUSIONS:Available evidence from RCTs does not support the efficacy of bioidentical progesterone cream for the management of menopause-related vasomotor symptoms. Adverse effects appear to be mild and self-limiting.
Annals of Pharmacotherapy 12/2012; · 2.57 Impact Factor
[show abstract][hide abstract] ABSTRACT: To investigate Nova Scotia (NS) pharmacists' knowledge and beliefs regarding the use of bioidentical hormones (BHs) for the management of menopause related symptoms.
Using Dillman's tailored design methodology, an invitation to complete the web-based questionnaire was emailed to pharmacists in NS as part of the Dalhousie College of Pharmacy Continuing Pharmacy Education Department's (CPE) weekly email update. Data was analyzed using descriptive statistics.
Of approximately 1300 e-mails sent, 113 pharmacists completed the questionnaire (response rate 8.7%). The majority of respondents (94%) knew that BHs were not free from adverse drug reactions. More than 50% were aware that conjugated equine estrogens and medroxyprogesterone acetate were not examples of BHs. For seven of eleven knowledge questions, 33-45% indicated that they did not know the answer. When asked about their beliefs regarding BHs, many believed that BHs were similar in efficacy (49%) or more effective (21%) than conventional hormone therapy (CHT) for vasomotor symptoms. Most respondents also believed that both BHs and CHT had similar safety profiles. Additionally, responding pharmacists indicated that more education would be helpful, especially in the area of safety and efficacy of BHTs compared to CHT.
NS pharmacists knew BHs were not free of adverse effects, however knowledge was lacking in other areas. This may reflect the level of coverage of this topic in pharmacy school curriculums and in the pharmacy literature. Results indicate a need for additional education of NS pharmacists with respect to BHs, which could be accomplished through modification of undergraduate pharmacy programs and supplementary CPE.
[show abstract][hide abstract] ABSTRACT: Preparations of green tea are used as aids in weight loss and weight maintenance. Catechins and caffeine, both contained in green tea, are each believed to have a role in increasing energy metabolism, which may lead to weight loss. A number of randomised controlled trials (RCTs) evaluating the role of green tea in weight loss have been published; however, the efficacy of green tea preparations in weight loss remains unclear.
To assess the efficacy and safety of green tea preparations for weight loss and weight maintenance in overweight or obese adults.
We searched the following databases from inception to specified date as well as reference lists of relevant articles: The Cochrane Library (Issue 12, 2011), MEDLINE (December 2011), EMBASE (December 2011), CINAHL (January 2012), AMED (January 2012), Biological Abstracts (January 2012), IBIDS (August 2010), Obesity+ (January 2012), IPA (January 2012) and Web of Science (December 2011). Current Controlled Trials with links to other databases of ongoing trials was also searched.
RCTs of at least 12 weeks' duration comparing green tea preparations to a control in overweight or obese adults.
Three authors independently extracted data, assessed studies for risk of bias and quality, with differences resolved by consensus. Heterogeneity of included studies was assessed visually using forest plots and quantified using the I(2) statistic. We synthesised data using meta-analysis and descriptive analysis as appropriate; subgroup and sensitivity analyses were conducted. Adverse effects reported in studies were recorded.
Due to the level of heterogeneity among studies, studies were divided into two groups; those conducted in Japan and those conducted outside Japan. Study length ranged between 12 and 13 weeks. Meta-analysis of six studies conducted outside Japan showed a mean difference (MD) in weight loss of -0.04 kg (95% CI -0.5 to 0.4; P = 0.88; I(2) = 18%; 532 participants). The eight studies conducted in Japan were not similar enough to allow pooling of results and MD in weight loss ranged from -0.2 kg to -3.5 kg (1030 participants) in favour of green tea preparations. Meta-analysis of studies measuring change in body mass index (BMI) conducted outside Japan showed a MD in BMI of -0.2 kg/m(2) (95% CI -0.5 to 0.1; P = 0.21; I(2) = 38%; 222 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed a reduction in BMI ranging from no effect to -1.3 kg/m(2) (1030 participants), in favour of green tea preparations over control. Meta-analysis of five studies conducted outside Japan and measuring waist circumference reported a MD of -0.2 cm (95% CI -1.4 to 0.9; P = 0.70; I(2) = 58%; 404 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed effects on waist circumference ranging from a gain of 1 cm to a loss of 3.3 cm (1030 participants). Meta-analysis for three weight loss studies, conducted outside Japan, with waist-to-hip ratio data (144 participants) yielded no significant change (MD 0; 95% CI -0.02 to 0.01). Analysis of two studies conducted to determine if green tea could help to maintain weight after a period of weight loss (184 participants) showed a change in weight loss of 0.6 to -1.6 kg, a change in BMI from 0.2 to -0.5 kg/m(2) and a change in waist circumference from 0.3 to -1.7 cm. In the eight studies that recorded adverse events, four reported adverse events that were mild to moderate, with the exception of two (green tea preparations group) that required hospitalisation (reported as not associated with the intervention). Nine studies reported on compliance/adherence, one study assessed attitude towards eating as part of the health-related quality of life outcome. No studies reported on patient satisfaction, morbidity or cost.
Green tea preparations appear to induce a small, statistically non-significant weight loss in overweight or obese adults. Because the amount of weight loss is small, it is not likely to be clinically important. Green tea had no significant effect on the maintenance of weight loss. Of those studies recording information on adverse events, only two identified an adverse event requiring hospitalisation. The remaining adverse events were judged to be mild to moderate.
[show abstract][hide abstract] ABSTRACT: To reach consensus on core competency statements for natural health products (NHPs) for Canadian pharmacy students.
Four rounds of a modified Delphi method were used to achieve consensus on core competency statements for NHPs. Pharmacy educators from Canada and the United States, and representatives from Canadian pharmacy organizations ranked their agreement using a 5-point Likert scale.
Consensus was achieved on 3 NHP-related core competency statements: (1) to incorporate NHP knowledge when providing pharmaceutical care; (2) to access and critically appraise NHP-related information sources; and (3) to provide appropriate education to patients and other health care providers on the effectiveness, potential adverse effects, and drug interactions of NHPs.
Consensus was reached among leaders in NHP education on 3 NHP-related core competency statements. Implementation of these competencies would ensure that graduating Canadian pharmacists would be able to fulfill their professional responsibilities related to NHPs.
American journal of pharmaceutical education 04/2010; 74(3):45. · 1.21 Impact Factor
[show abstract][hide abstract] ABSTRACT: With Canadians increasing their use of the Internet to find health-related information, especially regarding natural health products (NHPs), there is a need for high-quality, evidence-based information on Web sites to aid consumers in making informed decisions regarding the appropriate and safe use of NHPs.
To determine the quality of Web sites that target consumers and advocate the use of NHPs in the management of osteoporosis in postmenopausal women.
Web sites were identified via the Google search engine using the key words "natural treatment osteoporosis." The first pages of the first 91 Web sites identified were assessed for relevance based on the following criteria: (1) written in English, (2) contained consumer information, and (3) claimed a benefit of a single NHP in the management of osteoporosis. This task was completed by 2 investigators; differences were resolved by consensus after discussion with the third investigator. Quality of relevant sites was assessed using an expanded DISCERN instrument that also examined the evidence supporting the claim of benefit. Additionally, readability of the sites was assessed.
Thirty-eight Web sites met the inclusion criteria. Using the DISCERN instrument, we found that many of the sites scored low, suggesting serious or extensive shortcomings. On many Web sites, benefit claims regarding calcium, vitamin D, phytoestrogens, dehydroepiandrosterone and vitamin K were consistent with empirical evidence. However, for other NHPs, many of these same sites made effectiveness claims that were not supported by current evidence from randomized controlled trials. Twenty-five sites did not provide information as to what resources were used to support their claims. The average reading grade score was grade 11.9 (based on US school grades) and the mean Flesch Reading Ease Score was 41.7. (A higher score out of 100 indicates ease of reading.)
Due to the poor quality and content from unknown sources found on some Web sites, consumers who access Web sites for information regarding the use of NHPs in osteoporosis should do so cautiously and discuss results with their healthcare providers.
Annals of Pharmacotherapy 06/2009; 43(5):899-907. · 2.57 Impact Factor
[show abstract][hide abstract] ABSTRACT: The efficacy of natural products (NPs) is being evaluated using randomized controlled trials (RCTs) with increasing frequency, yet a search of the literature did not identify a widely accepted critical appraisal instrument developed specifically for use with NPs. The purpose of this project was to develop and evaluate a critical appraisal instrument that is sufficiently rigorous to be used in evaluating RCTs of conventional medicines, and also has a section specific for use with single entity NPs, including herbs and natural sourced chemicals.
Three phases of the project included: 1) using experts and a Delphi process to reach consensus on a list of items essential in describing the identity of an NP; 2) compiling a list of non-NP items important for evaluating the quality of an RCT using systematic review methodology to identify published instruments and then compiling item categories that were part of a validated instrument and/or had empirical evidence to support their inclusion and 3) conducting a field test to compare the new instrument to a published instrument for usefulness in evaluating the quality of 3 RCTs of a NP and in applying results to practice.
Two Delphi rounds resulted in a list of 15 items essential in describing NPs. Seventeen item categories fitting inclusion criteria were identified from published instruments for conventional medicines. The new assessment instrument was assembled based on content of the two lists and the addition of a Reviewer's Conclusion section. The field test of the new instrument showed good criterion validity. Participants found it useful in translating evidence from RCTs to practice.
A new instrument for the critical appraisal of RCTs of NPs was developed and tested. The instrument is distinct from other available assessment instruments for RCTs of NPs in its systematic development and validation. The instrument is ready to be used by pharmacy students, health care practitioners and academics and will continue to be refined as required.
BMC Complementary and Alternative Medicine 05/2009; 9:11. · 2.08 Impact Factor
[show abstract][hide abstract] ABSTRACT: As many women experiencing symptoms of premenstrual syndrome (PMS) seek relief from natural products (NP), health care providers should have quality information available to aid women in making evidence-based decisions regarding use of these products.
To identify herbs, vitamins and minerals advocated for the treatment of PMS and/or PMDD and to systematically review evidence from randomized controlled trials (RCTs) to determine their efficacy in reducing severity of PMS/PMDD symptoms.
Searches were conducted from inception to April 2008 in Clinical Evidence, The Cochrane Library, Embase, IBID, IPA, Mayoclinic, Medscape, MEDLINE Plus, Natural Medicines Comprehensive Database and the Internet to identify RCTs of herbs, vitamins or minerals advocated for PMS. Bibliographies of articles were also examined. Included studies were published in English or French. Studies were excluded if patient satisfaction was the sole outcome measure or if the comparator was not placebo or recognized therapy.
Sixty-two herbs, vitamins and minerals were identified for which claims of benefit for PMS were made, with RCT evidence found for only 10. Heterogeneity of length of trials, specific products and doses, and outcome measures precluded meta-analysis for any NP. Data supports the use of calcium for PMS, and suggests that chasteberry and vitamin B6 may be effective. Preliminary data shows some benefit with ginkgo, magnesium pyrrolidone, saffron, St. John's Wort, soy and vitamin E. No evidence of benefit with evening primrose oil or magnesium oxide was found.
Only calcium had good quality evidence to support its use in PMS. Further research is needed, using RCTs of adequate length, sufficient sample size, well-characterized products and measuring the effect on severity of individual PMS symptoms.
The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique 01/2009; 16(3):e407-29.
[show abstract][hide abstract] ABSTRACT: To determine fourth-year Canadian pharmacy students' knowledge of herbal medicine and whether that knowledge is associated with mandatory instruction in herbal medicine.
Standardized multiple-choice tests assessing students' herbal knowledge were distributed to all fourth-year BSc pharmacy students at 5 pharmacy schools in Canada.
The Quebec response rate was too low to include in the analysis. Herbal knowledge test scores were positively associated with having previously taken an herbal medicine class and completion of a pharmacy practicum. However, postsecondary education, age, and gender were not associated with herbal knowledge test scores. Students at the University of British Columbia had the highest score, followed by Alberta, Nova Scotia, and Ontario.
Pharmacy students' knowledge of herbal medicine varies depending on the school attended and higher herbal knowledge test scores appear to be most closely related to mandatory herbal instruction.
American journal of pharmaceutical education 09/2008; 72(4):75. · 1.21 Impact Factor
[show abstract][hide abstract] ABSTRACT: Natural health products (NHPs) such as herbs, vitamins and homeopathic medicines, are currently available for sale in most Canadian pharmacies. However, most pharmacists report that they have limited knowledge about these products which have been regulated in Canada as a specific sub-category of drugs. In this paper, consumers' and practicing pharmacists' perceptions of pharmacists' professional responsibilities with respect to NHPs are examined.
A total of 16 focus groups were conducted with consumers (n = 50) and pharmacists (n = 47) from four different cities across Canada (Vancouver, Edmonton, Toronto, and Halifax).
In this paper, we illustrate the ways in which pharmacists' professional responsibilities are impacted by changing consumer needs. Many consumers in the study utilized a wide range of information resources that may or may not have included pharmacists. Nevertheless, the majority of consumers and pharmacists agreed that pharmacists should be knowledgeable about NHPs and felt that pharmacists should be able to manage drug-NHPs interactions as well as identify and evaluate the variety of information available to help consumers make informed decisions.
This paper demonstrates that consumers' expectations and behaviour significantly impact pharmacists' perceptions of their professional responsibilities with respect to NHPs.
BMC Complementary and Alternative Medicine 08/2008; 8:40. · 2.08 Impact Factor
[show abstract][hide abstract] ABSTRACT: The purpose of this project was to conduct a systematic review to identify instruments designed to evaluate the quality of randomized controlled trials (RCTs) of natural health products (NHPs). Instruments were examined for inclusion of items assessing methods, identity and content of the NHP, generalizability of results and instructions for use. Online databases, websites, textbooks and reference lists were searched to identify instruments. Relevance assessment and data extraction of articles were completed by two investigators and disagreements were settled by the third investigator. Data were analyzed using descriptive statistics. Of the 4442 citations identified, 29 were potentially relevant with 16 meeting the criteria for inclusion. None of the instruments stated they were validated; content in the four areas of interest varied considerably. The most common items included randomization sequence generation (100%), blinding (100%), allocation concealment (75%) and participant flow (75%). Only nine of the NHP instruments included at least one item to appraise the specific content of the NHP. The CONSORT Statement for Herbal Interventions most closely addressed the four areas of interest; however, this instrument was specific for herbs. There is a need for the development of a validated instrument for assessment of the quality of RCTs that would be useful for herbs as well as other NHPs.
Evidence-based Complementary and Alternative Medicine 02/2008; 6(4):441-8. · 1.72 Impact Factor
[show abstract][hide abstract] ABSTRACT: Objective: Although natural health products (NHPs) are widely sold in pharmacies, the professional responsibilities of pharmacists with respect to these products have not been well defined. This study addressed the question: what are the pharmacist and consumer perspectives on the professional responsibilities of pharmacists with respect to NHPs?
[show abstract][hide abstract] ABSTRACT: This article reviews the body of work aimed at elucidating the mechanisms of action by which natural products of plant origin exert a vasodilatory effect at the level of the vasculature. The search was restricted to 4 mechanisms: the nitric oxide system and (or) reactive oxygen species, the eicosanoid system, potassium channel function, and calcium channel function. The National Library of Medicine database was searched using "PubMed" without restriction to language. The search generated 266 references on 15 November 2005. Most studies were in vitro in nature and of these, most involved studies in the rat aorta. Many of the natural products evoked vasodilatation through an endothelium-dependent mechanism. The vasodilatation was attenuated or abolished by a nitric oxide synthase inhibitor and, in some of these studies, by an inhibitor of guanylate cyclase. A few studies reported a cyclooxygenase component, but most found no effect of the cyclooxygenase inhibitor, indomethacin. The vasorelaxation evoked by several natural products was attenuated by various potassium channel blocking agents, suggesting that some natural products exerted their effect either directly or indirectly through activation of potassium channels. Finally, a significant number of natural products evoked vasodilatation either through blockade of calcium channels or by inhibiting the release of calcium from intracellular stores. Many natural products evoked vasodilatation through multiple mechanisms. The information in this review on mechanisms of action should facilitate good clinical practice by increasing the predictive capabilities of the practitioner, notably the ability to predict adverse effects and interactions among medications. The knowledge should also help to provide leads to the ultimate goal of developing new therapeutic medications.
Canadian Journal of Physiology and Pharmacology 10/2006; 84(8-9):803-21. · 1.56 Impact Factor
[show abstract][hide abstract] ABSTRACT: The root of Heracleum maximum Bartr. (Umbelliferae), known to possess direct antifungal and anti-mycobacterial properties, has been reported anecdotally to possess antiviral properties. It was therefore hypothesized that the plant may have immunostimulant properties. This hypothesis was tested using a macrophage activation assay to evaluate the ability of aqueous extracts of the root of Heracleum maximum to stimulate IL-6 production. All Heracleum maximum extracts were found to stimulate IL-6 and produced a steep dose-response curve. With the assay performed twice in the absence of the macrophage primer, IFN-gamma, the mean IL-6 production in the setting of the strongest extract was 3648pg/ml (95% CI 3361-3935) and 5430pg/ml (95% CI 4976-5885) as compared to 2722pg/ml (95% CI 2620-2824) and 6772pg/ml (95% CI 6282-7262) produced by the LPS positive control, respectively. In the presence of IFN-gamma, the strongest extract produced a mean concentration of IL-6 of 21804pg/ml (95% CI 19755-23854) surpassing the 14893pg/ml (13159-16628) produced by the LPS+IFN-gamma positive control. These positive results confirm the hypothesis of immunostimulation and thus support the anecdotal reports of antiviral activity.
Journal of Ethnopharmacology 08/2006; 106(3):360-3. · 2.76 Impact Factor
[show abstract][hide abstract] ABSTRACT: Consumers are increasingly looking to natural health products to manage specific diseases such as osteoporosis. As a result, healthcare providers need evidence-based information on which to base recommendations regarding use and efficacy.
To identify natural health products (NHPs, ie, dietary supplements) advocated for the prevention and treatment of osteoporosis and systematically review the evidence from randomized controlled trials for the effect of NHPs on bone mineral density (BMD)/fracture rate in women.
MEDLINE, Natural Medicines Comprehensive Database, and the Internet were initially searched to identify NHPs advocated for prevention and treatment of osteoporosis. For NHPs having evidence to support their claim, the aforementioned sources, along with International Pharmaceutical Abstracts, the Cochrane Library, the International Bibliographic Information on Dietary Supplements, the Cumulative Index to Nursing & Allied Health, and HerbMed, were searched to locate randomized controlled trials published in English between 1966 and October 2004. Bibliographies of identified articles were also searched. Randomized controlled trials were selected if they evaluated the use of a single NHP in women, using BMD/fracture rate as the outcome measure. NHPs were excluded from further evaluation if a review had already been published. Data were extracted using predetermined criteria and studies appraised using the Jadad scale. Forty-five NHPs were identified that the authors claimed to be beneficial in prevention and treatment of osteoporosis, with 15 having evidence to support their claim. Calcium; copper; evening primrose oil; fish oils; fluoride; magnesium; manganese; strontium; vitamin D; and black, green, and oolong tea did not meet study criteria.
Results from randomized controlled trials evaluating dehydroepiandrosterone (DHEA), phytoestrogens, and vitamin K2 (menaquinone or menatetrenone) were promising; however, study limitations suggest the need for confirmatory evidence.
Although no definitive conclusions can be drawn, the relative safety of phytoestrogens, DHEA, and vitamin K2 at the studied doses, as well as preliminary positive results from randomized controlled trials, provides some initial support for the use of these NHPs in the prevention and treatment of osteoporosis in women.
Annals of Pharmacotherapy 05/2006; 40(5):836-49. · 2.57 Impact Factor
[show abstract][hide abstract] ABSTRACT: To review the scientific literature to identify reports of the effects of natural health products (NHPs) on blood pressure.
Electronic databases (MEDLINE [1965-May 2004] via PubMed, the Cochrane Library [1995-May 2004], International Pharmaceutical Abstracts [1970-May 2004], Iowa Drug Information Services [1965-May 2004]) were searched using the key words medicine, herbal plants, medicinal plant preparations, phytotherapy, angiosperms/therapeutic use, gymnosperms/therapeutic use, ethnopharmacology, pharmacognosy, blood pressure, hypertension, hypotension, and diuretic. Searches were not limited by date, language, or publication type. Review articles and texts, as well as reference lists of relevant articles, were used to identify additional reports.
Articles (English-language after 1980) were assigned to the following categories: human study, case report, animal study, in vitro study, or theoretical prediction based on chemical constituents. Discussions of mechanisms of action were noted.
A comprehensive search of the scientific literature identified NHPs capable of affecting blood pressure. Case reports and clearly defined mechanisms of action provided strong evidence for the ability of ephedra and licorice to increase blood pressure. Coenzyme Q(10) was reported to decrease systolic and diastolic blood pressure, although the mechanism is unclear. The clinical significance of the blood pressure effects of other NHPs is unclear due to lack of conclusive in vivo data, as well as substantial variability in the chemical content of preparations of NHPs.
Among published information, there is little definitive evidence with regard to the impact of NHPs on blood pressure. Additionally, effects may vary in a given patient with the formulation and standardization of a particular product. Until research better characterizes the effect of NHPs on blood pressure, patients should be encouraged to talk with their healthcare provider before starting or stopping any herbal product.
Annals of Pharmacotherapy 05/2005; 39(4):712-20. · 2.57 Impact Factor