Evaluating the Quality of Randomized Controlled Trials that Examine the Efficacy of Natural Health Products: A Systematic Review of Critical Appraisal Instruments

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

Development and evaluation of an instrument for the critical appraisal of randomized controlled trials of natural products

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p

Defining bioidentical hormones for menopause-related symptoms

In the last decade, the use of bioidentical hormones (BHs) to treat menopause-related symptoms has become increasingly popular. However, the many different definitions of BHs have led to a great deal of confusion often making it difficult for health care providers to discuss this area with patients. Objective: The purpose of this paper was to produce a concise definition of bioidentical hormones, based on a review of the literature. Methods: Searches, using systematic review methodology, were conducted from inception to June 2010 in PubMed, EMBASE, IPA, The Journal of International Compounding and the Internet to identify definitions of bioidentical hormones. There were no restrictions on type, date or language of publication. Included papers/website included those that contained a definition of BHs. Definitions were extracted, similarities and differences summarized, and these were then examined to produce a concise definition. Results: Sixty-three definitions were found. Based on the analysis of similarities and differences, the following definition, comprised of three components (term being defined; category to which term belongs; distinctive characteristics of term) was produced: "Bioidentical hormones are chemical substances that are identical in molecular structure to human hormones". Conclusions: This definition clearly and concisely explains the meaning of BHs which should lead to a common understanding of the term and limit confusion among health care providers, the general public and the scientific community.En la década pasada, se ha vuelto popular el uso de hormonas bioidenticas (HB) para tratar los síntomas asociados a la menopausia. Sin embargo, las muchas definiciones de HB han llevado a una gran confusión haciendo, a menudo, difícil para los profesionales de la salud discutir esto con los pacientes. Objetivo: El propósito de este artículo es producir una definición concisa de hormonas bioidenticas, basándose en una revisión de la literatura. Métodos: Para identificar definiciones de HB, sSe realizaron búsquedas en PubMed, EMBASE, IPA, Journal of International Compounding e Internet desde su inicio hasta junio de 2010, utilizando metodología de revisión sistemática. No hubo restricciones en cuanto al tipo, fecha o idioma de las publicaciones. Los artículos/páginas web incluidas comprendían aquellas que contenían una definición de HB. Se extrajeron las definiciones, y se resumieron las similitudes y diferencias, y después se examinaron éstas para producir una definición concisa. Resultados: Se encontraron 63 definiciones. Basándose en el análisis de similitudes y diferencias, se produjo la siguiente definición, que comprendía tres componentes (término bien definido; categoría a la que pertenece el término; características distintivas del término): "Hormonas bioidenticas son substancias químicas que son idénticas en estructura molecular a las hormonas humanas". Conclusiones: Esta definición explica clara y resumidamente el significado de HB lo que debería llevar a un entendimiento común del término y reducir la confusión entre los profesionales de la salud, el público en general y la comunidad científica

Bioidentical hormone therapy: Nova Scotia pharmacists´ knowledge and beliefs

Objectives: To investigate Nova Scotia (NS) pharmacists´ knowledge and beliefs regarding the use of bioidentical hormones (BHs) for the management of menopause related symptoms. Methods: Using Dillman´s tailored design methodology, an invitation to complete the webbased 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. Results: 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. Conclusion: 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.Objetivos: Investigar los conocimientos y creencias de los farmacéuticos de Nueva Escocia (NS) sobre el uso de hormonas bioidénticas (BH) para el manejo de los síntomas relacionados con la menopausia. Métodos: Utilizando el diseño metodológico de Dillman, se envió por email a los farmacéuticos de NS una invitación a completar un cuestionario online como parte de las actualizaciones semanales del Departamento de Formación Continua de la Facultad de Farmacia de la Universidad de Dalhousie. Los datos se analizaron con estadística descriptiva. Resultados: De los aproximadamente 1300 emails enviados, 113 farmacéuticos completaron el cuestionario (tasa de respuesta 8,7%). La mayoría de los respondientes (94%) sabían que las BH no estaban libres de reacciones adversas. Más del 50% conocían que los estrógenos conjugados equinos y la medroxiprogesterona acetato no eran ejemplos de BH. Para 7 de las 11 preguntas, del 33-45% indicó que no conocía la respuesta. Cuando se les preguntó sobre sus creencias sobre las BH, muchos creían que las BH eran similares en eficacia (49%) o más eficaces (21%) que la terapia hormonal convencional (CHT) para los síntomas vasomotores. La mayoría de los respondientes también creían que las BH y las CHT tenían perfiles de seguridad similares. Además, los farmacéuticos respondientes indicaron que sería útil más educación, especialmente en el área de seguridad y eficacia de las BH comparadas con las CHT. Conclusión: Los farmacéuticos de NS sabían que las BH no estaban libres de efectos adversos, sin embargo carecían de conocimientos en otras áreas. Esto puede reflejar la cobertura de este asunto en los currículos de las facultades de farmacia y en la literatura farmacéutica. Los resultados indican una necesidad de educación adicional de los farmacéuticos de NS en relación a las BH, lo que podría conseguirse mediante la modificación de los programas de pregrado y la formación continua suplementaria

Exploring consumer and pharmacist views on the professional role of the pharmacist with respect to natural health products: a study of focus groups

Background: 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. Methods 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). Results 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. Conclusion This paper demonstrates that consumers' expectations and behaviour significantly impact pharmacists' perceptions of their professional responsibilities with respect to NHPs.Pharmaceutical Sciences, Faculty ofNon UBCReviewedFacult