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Treatment of the Common Cold with Echinacea

Treatment of the Common Cold with Echinacea. Christopher Theberge. Outline. Introduction Background Negative Echinacea Findings Positive Echinacea Findings Future Research Recommendations. Introduction. 2002 herbal-supplement sales of $4.28 billion dollars

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Treatment of the Common Cold with Echinacea

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  1. Treatment of the Common Cold with Echinacea Christopher Theberge

  2. Outline • Introduction • Background • Negative Echinacea Findings • Positive Echinacea Findings • Future Research Recommendations

  3. Introduction • 2002 herbal-supplement sales of $4.28 billion dollars • Echinacea was 3rd leading supplement sold • Grossed $188 million in sales • “Immune system boosting” function

  4. History • Plains Indians’ therapy for treatment of • Colds • Respiratory tract infections • Sore throats • Topically for burns and snakebites (Hobbs, C (1994) HerbalGram, 30, 33-47; Percival, SS (2000) Biochemical Pharmacology, 60, 155-158)

  5. History • Plains Indians introduced it to European settlers • 1920’s in National Formulary • Interest dwindled with advent of anti-biotics • Brought to Europe where heavily studied • Gerhard Madaus early 1900’s • First to report pharmacological activity • Pharmaceutically prepared Echinacin® (Borchers et al (2000) The American Journal of Clinical Nutrition, 72, 339-347)

  6. Echinacea • Coneflower • Spiny flower heads, and cone-like receptacle • Greek for “echinos” meaning hedgehog • Part of the Native American Daisy Family (Hobbs, C (1994) HerbalGram, 30, 33-47)

  7. Echinacea • Genus includes 9 species in US and Canada • Three primary species used medicinally • Echinacea purpurea (E. purpurea) • Echinacea angustifolia (E. angustifolia) • Echinacea pallida (E. pallida) (Borchers et al (2000) The American Journal of Clinical Nutrition, 72, 339-347)

  8. Echinacea • Most common forms taken include • Liquid extracts • Fresh juice of E. purpurea tops in ethanol • Spray or freeze-dried extracts in caps or tabs • Simple herb powders (Hobbs, C (1994) HerbalGram, 30, 33-47)

  9. Pharmacology • Not standardized • “Active” components include • Caffeic and ferulic acid derivatives • Cichoric acid • Echinacoside • Polysaccharides • Alkylamides • Glycoproteins (Hobbs, C (1994) HerbalGram, 30, 33-47; Percival, SS (2000) Biochemical Pharmacology, 60, 155-158)

  10. Pharmacology • The stimulation of non-specific defense capacities • Polymorphonuclear (PMN) neutrophil proliferation • Phagocytic and macrophage activity • Interferon production • Cytokine production • Anti-inflammation (Hobbs, C (1994) HerbalGram, 30, 33-47; Percival, SS (2000) Biochemical Pharmacology, 60, 155-158)

  11. Echinacea • Three parts used medicinally • E. purpurea root and herb • Most commonly studied • E. angustifolia root • E. pallida root (Borchers et al (2000) The American Journal of Clinical Nutrition, 72, 339-347)

  12. Echinacea • Formulations vary by preparation • Parts from roots, herb, or both, and leaves • Either 3 echinacea species • Extraction procedures • Alcohol, pressed juice, tea • Addition of other plant extracts or herbals • Commonly adulterated with Parthenium (Borchers et al (2000) The American Journal of Clinical Nutrition, 72, 339-347)

  13. Echinacea • Plants vary by • Growing conditions • Harvest time • Genetics • Storage methods and conditions (Borchers et al (2000) The American Journal of Clinical Nutrition, 72, 339-347)

  14. Previous Research: Human Studies • Positive results include • Immune system stimulation • Reduction in cold symptom severity and duration • Prophylaxis of infection and colds • Anti-inflammation • Injectible Echinacin® • Topical • Liquid extracts (most useful?) • Oral administration with other plant extracts (Hobbs, C (1994) HerbalGram, 30, 33-47; O’Hara et al (1998) Archives of Family Medicine, 7, 523-536

  15. Previous Research: Human Studies • The majority of research conducted in Germany • Mostly clinical reports • Few well-controlled human clinical trials • Heterogeneity of supplements (O’Hara et al (1998) Archives of Family Medicine, 7, 523-536)

  16. Previous Research: Human Studies • Major flaws in research by improper use or description of • Diagnostic criteria • Randomization process • Treatment interventions • Methods for assessing outcomes • Blinding assurance • Detail of results • Quality statistics (O’Hara et al (1998) Archives of Family Medicine, 7, 523-536)

  17. 1992 Commission E approved only use of • Alcoholic root extracts of Echinacea pallida • Juice pressed from E. purpurea • External wounds • Upper respiratory tract infections • Urogenital infections Say: So I chose these studies (O’Hara et al (1998) Archives of Family Medicine, 7, 523-536)

  18. Treatment of the Common Cold with Unrefined Echinacea A Randomized, Double-Blind, Placebo-Controlled Trial Barrett et al., 2002 Annals of Internal Medicine, 137(12), 939-945

  19. Purpose To determine if a dried, encapsulated, echinacea preparation would be efficacious towards treatment of the common cold

  20. Methods • Designed for 150 subjects • At least 80% power to detect • 2 day duration benefit • Average 2 point reduction in cold symptoms on a 9-point severity scale • No valid measures for common cold • Considered clinically significant (Jaeschke et al (1989) Controlled Clinical Trials, 10, 407-415)

  21. Methods: Inclusion Criteria • Registered students • Answer “Yes” to the question “Do you believe you are coming down with a cold?” • Report at least 2 of the 15 listed cold symptoms • 1 related to the respiratory tract

  22. Methods: Exclusion Criteria • Having any of the listed symptoms > 36 hours • Using antibiotics, antihistamines, or decongestants • Specified chronic diseases • HIV • Autoimmune disease

  23. Methods: Primary Outcomes • Defined by severity and duration of self-reported symptoms • Duration = number of days from enrollment to last day before subject answered “No” to “Do you think you are still sick today?” • Severity measured on 9-point Likert scale by “How sick do you feel today?” • Global severity measured by similar 9-point scale

  24. Methods: Assessments • Nine point scale used to measure severity • 1 = very mild • 3 = mild • 5 = moderate • 7 = severe • 9 = extreme • Paper and electronic version of questionnaire each day • Adverse events monitored daily

  25. Methods: Supplements Echinacea – unrefined dried preparation 25% E. purpurea root 50% E. angustifolia root Thyme Peppermint Citric Acid 25% E. purpurea herb 250 mg

  26. Methods: Supplements • Four capsules = 1 g of echinacea • 6 g for the first 24 hours • 3 g for a maximum of 10 days • Placebo contained alfalfa

  27. Methods: Statistical Analyses • Simple inspection • Frequency analysis • Analysis of variance (ANOVA) • 95% confidence intervals

  28. Descriptive Statistics for Subjects Assessed (Adapted from: Barrett et al (2002) Annals of Internal Medicine, 137(12), 939-945)

  29. Results from Echinacea Laboratory Analysis (Adapted from: Barrett et al (2002) Annals of Internal Medicine, 137(12), 939-945)

  30. Results from Echinacea Laboratory Analysis • Lab 3 • First day dose increased tumor necrosis factor (TNF) • 189 ± 23 ng/L to 3679 ± 154 ng/L • Follow-up doses increased • 2347 ± 66 ng/L

  31. Results • Mean onset time for first symptom 27 hours • Adherence rate of 92% from pill count • Results from blinding showed that • 49% in the echinacea group guessed correctly • 46% in the placebo group guessed correctly • P > 0.2

  32. Results • No difference in cold duration between both groups • Trend towards longer duration in echinacea group • Durations ranged 2 to 10 days • Largest echinacea potential benefit of 0.22 days

  33. Mean Cold Duration for Echinacea and Placebo Group 5.75 6.27 (Adapted from: Barrett et al (2002) Annals of Internal Medicine, 137(12), 939-945)

  34. Adverse Effects 15 Subjects 22 Times Echinacea 8 Subjects 13 Times Placebo 7 Subject 9 Times • sleeplessness, heartburn, • nausea, stomachache, • upset stomach, bad taste stomachache, nausea, belching, thirst, abdominal pain with diarrhea (Adapted from: Barrett et al (2002) Annals of Internal Medicine, 137(12), 939-945)

  35. Conclusions – Study 1 • Results do not support echinacea for treatment of the common cold • Effect size for 2 days’ duration and two points in average severity on 9-point scale not detected • No significant trends noted • All differences between groups could be explained by natural variability of the symptoms

  36. Conclusions – Study 1 • The number of previous echinacea users represents its widespread use • This echinacea preparation appeared to be well-tolerated

  37. Limitations – Study 1 • This study only shows that this preparation of echinacea was not effective • Preparation used not previously tested • May be ineffective because of bioavailability and phytochemical properties • Previous trials have used extracts rather than whole plant parts, and combinations with other herbs • Phytochemicals vary depending on harvest time, growing conditions, etc…

  38. Limitations – Study 1 • Subjects studied may not benefit from echinacea • Previous trials have used older adults and those with a history of frequent colds • Echinacea may benefit only those who are immunocompromised • Smokers?

  39. Limitations – Study 1 • No valid measurements for assessing the common cold • Self-reported assessments subject to bias • Alfalfa been shown effective in treatment of allerigic rhinitis (Mittman P. (1990). Planta Medica,56, 44-47)

  40. Limitations – Study 1 • Modest-size trial and an effect size of 5% to 10% may be easily lost among natural variability of symptoms in type of subjects used • Subjects were studied for 10 days maximum • Frequency of longer illnesses is unknown • Five had symptoms 36 hours prior to study • Could have masked a benefit of echinacea given earlier for treatment of colds

  41. The Efficacy of Echinacea Compound Herbal Tea Preparation on the Severity and Duration of Upper Respiratory and Flu Symptoms A Randomized, Double-Blind, Placebo-Controlled Trial Lindenmuth, G. F. & Lindenmuth, E. B. 2000. The Journal of Alternative and Complementary Medicine, 6(4), 327-334

  42. Purpose To test the efficacy of Echinacea herbal tea preparation on duration and severity of symptoms of scratchy throat, runny nose, and fever

  43. Methods: Sample • Pennsylvania nursing home • Registered nurses, dietary aids, physicians, accountants, maintenance staff, administration • Eligibility criteria • Subjects who had early symptoms of a cold • Ineligibility criteria • Allergic to coneflowers, different flowering plants and pollens • Acute infections and being treated with antibiotics

  44. Methods: Assignment • Randomized into echinacea or placebo group • Alternation for assignment to keep groups balanced • Echinacea group received Echinacea Plus® • Leaves, flowers, and stems of organically grown E. purpurea and E. angustifolia • Water soluble dry extract of E. purpurea • Flavor corrigents • 1.275 g of herbs and roots per tea bag

  45. Methods: Assignment • Eater’s Digest® herbal preparation • Peppermint leaf, sweet fennel, ginger, rose hip, papaya leaf, alfalfa leaf, cinnamon • No caffeine or recognizable differences from echinacea blend • All tea bags individually sealed • 12 lb heat sealed Saran Wrap coating • 15 lb polyethylene surlyn layer

  46. Supplement Instructions • Steep for 10 to 15 minutes in 8 fl. oz water • Drink 5 to 6 cups on first day of symptoms • Titrate to 1 cup by the fifth day

  47. Methods: Questionnaire (Adapted from: Lindenmuth, GF & Lindenmuth, EB (2000) The Journal of Alternative and Complementary Medicine, 6(4), 327-334)

  48. Methods: Statistical Analysis • Two tailed t tests • 95% Confidence Intervals • Significance set at p < 0.05

  49. 95 subjects Mean Age = 39.7 Age range = 24 to 62 Echinacea Group 48 subjects Placebo Group 47 subjects 41 Women 7 Men 40 Women 7 Men (Adapted from: Lindenmuth, GF & Lindenmuth, EB (2000) The Journal of Alternative and Complementary Medicine, 6(4), 327-334)

  50. Results from Echinacea Plus® Phenolic Compound Analysis (Adapted from: Lindenmuth, GF & Lindenmuth, EB (2000) The Journal of Alternative and Complementary Medicine, 6(4), 327-334)

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