NHPs for PHM101 2024 Evidence-Based Approach to NHPs PDF

Evidence-based Approach to NHPs: Common Cold Examples Heather Boon, BScPhm, PhD Professor, Leslie Dan Faculty of Pharmacy Vice-Provost, Faculty & Academic Life University of Toronto [email protected] 1  Objectives At...

Evidence-based Approach to NHPs: Common Cold Examples Heather Boon, BScPhm, PhD Professor, Leslie Dan Faculty of Pharmacy Vice-Provost, Faculty & Academic Life University of Toronto [email protected] 1  Objectives At the end of this session, students should be able to: Identify evidence-based information sources related to NHPs Explain how and why NHPs should be assessed as part of the pharmaceutical care process Evaluate the safety and efficacy of popular NHPs used by Canadians to prevent and treat the common cold 2 Outline for Today Review the role of the pharmacist with respect to NHPs Explore the evidence related to the safety and efficacy of NHPs for the common cold: Echinacea Elderberry Garlic Ginseng Oil of Oregano Zinc Vitamin C Reference Tools and Discussion What is the role of the pharmacist? 4 Communication foster open communication and create a non-threatening environment where patients can disclose CAM/NHP use and ask questions Include in your medication review: What else are you doing/taking to take care of your health? 5 Help patients make informed choices Evidence-based NHP information Standards of evidence are the same Few NHPs have enough evidence to be routinely recommended Weigh safety/efficacy of NHP options in comparison with conventional treatment options Amount of literature is quickly increasing Ref: Frenkel & Borkan. Family 6 Practice 2003; 20(3):324-332 Let’s look at some examples… 7 http://www.cobleskill.edu/courses/orht321/Echinacea%20purpurea%200104.jpg  Echinacea (Echinacea purpurea; Echinacea angustifolia; Echinacea pallida) Pharmacology Exact mechanism of action unclear; appears to target both nonspecific and specific immune function 4 groups of compounds appear to contribute to immunomodulatory activity: alkamides (alkylamides), glycoproteins, polysacchardies and caffeic acid derivatives (CADs) Alkamides have anti-inflammatory properties and are found in roots of E. angustifolia and the roots + aeriel parts of E. purpurea - may also have some immunomodulatory potential glycoproteins, polysacchardies and CADs (found in aeriel parts) have been shown in mice to: activate macrophages and NK cells; anti-viral activity Toselli F et al. Life Sciences 2009; 85:97-106 Efficacy for the Common Cold 24 RCTs including 33 comparisons of echinacea with a control group (n= 4631) Treatment and/or prevention Wide variety of echinacea preparations studied Ref: M. Karsch-Völk , B Barrett , D Kiefer et al. Cochrane Review 2014 Treatment of Colds Cochrane review 2014: Treatment: 15 trials (20 tx comparisons) “Of the seven treatment trials reporting data on the duration of colds, only one showed a significant effect of Echinacea over placebo.” Conclusion: Echinacea products have not been shown to provide benefits for treating colds, although, it is possible there is a weak benefit from some Echinacea products Ref: M. Karsch-Völk , B Barrett , D Kiefer et al. Cochrane Review 2014  Prevention of Colds Prevention: investigated in 10 trials (12 treatment comparisons) Ref: M. Karsch- Völk , B Barrett , D Kiefer et al. Cochrane Review 2014  Prevention of Colds Cochrane Review (2014): Prevention: “None of the 12 prevention comparisons reporting the number of patients with at least one cold episode found a statistically significant difference. However a post hoc pooling of their results, suggests a relative risk reduction of 10% to 20%.” Clinical significance? Ref: M. Karsch-Völk , B Barrett , D Kiefer et al. Cochrane Review 2014 Echinacea: Cautions Generally well-tolerated with few AEs reported Theoretical caution in: cases of chronic immune dysfunction and autoimmune conditions Adverse reactions: uncommon, but include allergic reactions which vary from mild to anaphylatic Drug Interactions: theoretically may interfere with immunosuppressant therapy (e.g., cyclosporin, prednisone); reports of changes in CYP enzymes (likely not clinically significant) Echinacea: Dose Depends on the dosage form and standardization Very wide range tested in studies including: Capsules (of powdered herb): 500-1000mg three times daily, for five to seven days Expressed juice: 6-9mL daily in divided doses, for five to seven days. Tincture (1:5): 0.75 to 1.5mL, gargled then swallowed, 2- 5 times per day, for five to seven days (daily dose should have equivalent of 900mg dried Echinacea root). Tea: 2 tsp. (4g of Echinacea) of coarsely powdered herb simmered in 1 cup of boiling water for 10 minutes, daily for 5-7 days. Elderberry (Sambucus nigra) 16 Effectiveness for Cold & Flu Possibly effective in adults: May reduce duration and severity Noticeable symptom relief in 2-4 days May work best if taken within first 48 hours of symptoms (J Altern Complement Med 1995;1:361-9; J Int Med Res 2004;32:132- 40; Nutrients, 2016, 8(4), 182; Online Journal of Pharmacology and Pharmacokinetics 2009;5:32-43) RCT (n=60) reported duration of symptoms reduced by 56% on average (J Int Med Res 2004;32:132-40) 17 Effectiveness for Children Possible ineffective for children RCT, n=87 children aged 4+ years with