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Detail-Document #251112
−This Detail-Document accompanies the related article published in− PHARMACIST’S LETTER / PRESCRIBER’S LETTER
November 2009 ~ Volume 25 ~ Number 251112 Supplements for Prevention and Treatment of Colds and Influenza
Background
Orally, elderberry fruit extract seems to be When flu season begins, healthcare well-tolerated when used for up to five days. No professionals commonly are asked about natural adverse effects have been reported in clinical remedies for prevention or treatment of colds and trials in adults and children. However, the raw flu. This article reviews information on the and unripe fruit (as opposed to the extract) might efficacy and safety of common products patients cause nausea, vomiting, or severe diarrhea. might inquire about. A complete review of Weakness, dizziness, numbness, and stupor have supplements for colds and flu is available in our been reported following ingestion of elderberry Special Report: Natural Medicines in the Clinical juice from unripe fruit. Elderberry pollen might cause an allergic reaction characterized by rhinitis and dyspnea in some patients who are allergic to Elderberry
There has been some press about elderberry experience an allergic reaction to elderberry (Sambucus nigra) and influenza. Elderberry might be useful for treating the flu. Elderberry has both antiviral and immunomodulating effects. effective for treatment of flu symptoms [Evidence Elderberry seems to increase production of level B; lower quality RCT].2,3,4,5 But there is not inflammatory cytokines, such as interleukins and enough high-quality evidence to recommend it for tumor necrosis factor. It also seems to prevent viral attachment to cells, similar to the neuraminidase inhibitors (Tamiflu, Relenza). Probiotics
Elderberry has evidence of activity against both A study of healthy children (n=571) ages one seasonal influenza A and B.1 But keep in mind to six years attending daycare get fewer and less there is no evidence it is effective against the severe respiratory infections when given milk that contains a specific strain of Lactobacillus rhamnosus, Lactobacillus GG (Culturelle). These elderberry juice (Sambucol, Nature’s Way) taken children also seem to have fewer days of illness- orally seems to reduce the symptoms and duration of influenza infection when given within 48 hours of initial symptoms. Significant symptom relief Lactobacillus and Bifidobacterium (Howaru seems to occur within two to four days of Protect with L. acidophilus NCFM and B. lactis treatment for most patients.2 On average, this Bi-07) is possibly effective for preventing cold elderberry extract seems to reduce the duration of and flu symptoms during the winter months in children ages three to five years. In this study, 1 A proprietary elderberry extract lozenge gram of the probiotic powder, providing 5 billion (ViraBLOC) 175 mg daily for two days was bacteria, was administered twice daily in milk compared to placebo for treatment of 64 patients from November until May (n=112). Comparators with flu-like symptoms. Patients used a visual analogue scale (1 to 10) to record symptom Lactobacillus alone (n=110). Relative to the severity. While most elderberry-treated patients placebo group, the combination probiotic group improved within 48 hours, most placebo-treated experienced fewer episodes of fever (p=0.0009), patients remained the same or worsened.4,5 cough (p=0.005), runny nose (p=0.03), and antibiotic use (p<0.0001). Lactobacillus alone Copyright 2009 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #251112: Page 2 of 5)
also reduced episodes of fever (p=0.0085), cough and contains many constituents. It is thought that (p=0.027), and antibiotic use compared to placebo the antioxidant properties of honey may have a role. Another theory is that the sweetness of significantly reduced by the probiotics.8 The honey naturally causes reflex salivation and may Howaru Protect formulation is expected to be also induce secretion of airway mucus, which available in various products (e.g., supplements, soothes the pharynx and larynx and reduces cough. It is also suggested that ingestion of sweet In a small (n=20) placebo-controlled study in elite athletes, Lactobacillus fermentum VRI 003 production. The interaction between the opioid- (PCC) 12 billion units daily reduced the reported responsive sensory fibers and nerves may help to number of days of respiratory symptoms during produce the antitussive effects of sweet substances the winter months (30 days vs 72 days, p=.00006). via a central nervous system mechanism.10 Reported illness severity was reduced and gamma In children >12 months of age, honey can be interferon levels were increased by the probiotic.9 used as an alternative to OTC cough medications Specific probiotics are possibly effective and [Evidence Level B; lower quality RCT].9 Do not safe for preventing respiratory symptoms in recommend honey for infants <12 months of age otherwise healthy children attending daycare due to the risk of botulism.6 The approximate during the winter months [Evidence level A; high- honey doses are half a teaspoon for children quality RCT].7,8 However, there is not enough between two to five years, one teaspoon for evidence to recommend them for most children. children six to 11 years, and two teaspoons for Honey
In a recently published study (n=150), children Vitamin D
between the ages of two and 18 years, with upper respiratory tract infections and nighttime cough prevention of upper respiratory infections. were randomly assigned to receive artificially Vitamin D may affect immune function through its effects on cathelicidin, an antimicrobial approximated typical OTC labeled dosages, protein. Data from a large epidemiologic study in buckwheat honey, or no treatment.10 The no the U.S., the Third National Health and nutrition treatment group was not blinded to their treatment Examination Survey (NHANES III) found an arm, whereas the honey and dextromethorphan inverse relationship between vitamin D levels and group were blinded. A single dose of either self-reported upper respiratory tract infection. honey-flavored dextromethorphan or honey was Patients with 25-hydroxyvitamin D levels of given 30 minutes prior to patient going to bed. 10 ng/mL to <30 ng/mL had 27% greater odds of Surveys were given to parents to assess nighttime having had a recent upper respiratory tract cough and sleep difficulty at baseline and after hydroxyvitamin D level <10 ng/mL, the odds The results showed those who received honey were 55% higher. But randomized controlled had a mean 1.89-point improvement as rated by trials are needed to determine if vitamin D their parents compared with a 1.39-point change supplementation prevents colds or the flu.11 for those receiving dextromethorphan and a 0.92- point change for those who had no treatment American Ginseng
(p<0.001). The severity of cough also improved: A specific American ginseng (Panax 1.80 points with honey, 1.30 points with quinquefolius) product (Cold-fX) 200 mg twice dextromethorphan, and 1.11 points with no daily over a three to four month period during treatment (p<0.001). In addition, patients who influenza season might modestly decrease the risk received honey had a better night of sleep of developing symptoms of an upper respiratory compared to those who received tract infection such as the common cold or flu in adults aged 18 to 65 and older (n=564).12-14 This extract also seemed to reduce the symptom relieve cold symptoms are unclear. Honey may be made from the pollen of many different plants, Copyright 2009 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #251112: Page 3 of 5)
infections do occur.13,14 There is also preliminary Reishi mushroom extract is purported to
evidence that this same extract might reduce the enhance immune function, and is used as a flu risk of influenza in institutionalized elderly remedy. It is combined with American ginseng in patients (n=198). Taking the extract 200 mg the product Immunity-FX. However, there is no twice daily orally over a 12-week period during proof that reishi mushroom is effective for influenza season seemed to reduce the risk of laboratory confirmed influenza or respiratory Supplemental zinc seems to improve cell-
syncytial virus (RSV) infections. But it did not mediated immune response in elderly people, but seem to reduce the appearance of influenza-like it doesn’t seem to have a significant effect on symptoms, symptom severity, or symptom antibody response and incidence of flu infection duration in these patients.12 Health Canada, after reviewing more than ten supplementation in patients on hemodialysis, who years of research, which included seven clinical have a high risk of zinc deficiency, doesn’t seem trials, confirmed that patients may expect a to improve response to influenza vaccine. modest benefit in preventing or reducing cold and However, there is preliminary evidence that flu symptoms. The National Health Products suggests zinc along with selenium might reduce Directorate, a division of Health Canada, has the incidence of infections in institutionalized issued a product license along with a natural older patients. Taking zinc supplements orally is product number (NPN) for Cold-fX. The product unlikely to improve immune function in people has been reported to be used safely in adults for without risk factors for zinc deficiency.6 Advise patients not to use zinc-containing nasal products, which have been recalled (i.e., Zicam Cold glucose. Theoretically, use with glucose-lowering Remedy Nasal Gel, Zicam Cold Remedy Nasal agents could predispose to hypoglycemia. It also Swabs, Zicam Cold Remedy Nasal Swabs, Kid seems to reduce INR in warfarin patients, so Size) due to risk of permanent loss of smell or advise warfarin patients not to use it. Also avoid taste.16 Side effects of oral zinc include nausea, American ginseng in patients with autoimmune vomiting, and a metallic taste. There is concern disorders, patients taking immunosuppressives, that doses over 40 mg daily may interfere with women with hormone sensitive cancers, pregnant Oscillococcinum is a homeopathic dilution of
Four patients would need to take Cold-fX daily duck liver and heart extract. It is so dilute that it for four months to prevent one cold [Evidence contains no active ingredient, and therefore is not level B; lower quality RCT].13 Patients who effective, and could be dangerous if patients rely frequently get colds might find it worthwhile. But on it to treat the flu. Homeopathy is based on the there is not enough high-quality evidence to principles that “like treats like” and that the more dilute a substance, the more effective it is. Oscillococcinum was first formulated based on Other Natural Products
the mistaken belief that “oscillococci” were the Clinical research shows that isotonic saline
cause of the 1917 Spanish flu. Because of a 1938 nasal irrigation significantly reduces symptoms
U.S. law allowing sale of certain homeopathic of the common cold including rhinitis, sore throat, cough, and nasal obstruction and secretion in oscillococcinum.6 Health Canada also permits its children with the common cold or flu. Nasal sale, but homeopathic medicines are not held to irrigation also reduced the use of other the same safety and efficacy standards as other medications including antipyretics, decongestants, Taking echinacea orally might modestly
Conclusion
reduce cold symptom severity and duration, and When patients inquire about natural medicines influenza symptoms. However, there is not for colds or flu, remind them about simple enough specific evidence to know if echinacea is prevention tactics. Avoid people with upper respiratory symptoms as much as possible. Wash hands frequently, especially when around infected Copyright 2009 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #251112: Page 4 of 5)
patients or in public places. Avoid touching the elderberry extract in the treatment of influenza A eyes or nose to prevent self-inoculation of and B virus infections. J Int Med Res 2004;32:132-40. viruses.18 Tell people at high risk for flu 4. Kong F. Pilot clinical study on a proprietary complications, such as seniors or those with elderberry extract: efficacy in addressing influenza asthma or severe symptoms, not to rely on symptoms. Online J Phrmacol Pharmacokin supplements to treat or prevent the flu. Encourage vaccination, and be vigilant for patients who may 5. Press release. Herbal Science releases results of pilot clinical study on efficacy of its proprietary elderberry extract in addressing flu-like symptoms. October 6, 2009. http://www.prnewswire.com/ news-releases/63590957.html. (Accessed October Users of this document are cautioned to use their own professional judgment and consult any other necessary 6. Jellin JM, Gregory PJ, et al. Natural Medicines or appropriate sources prior to making clinical Comprehensive Database. http://www.natural judgments based on the content of this document. Our database.com. (Accessed October 6, 2009). editors have researched the information with input 7. Hatakka K, Savilahti E, Ponka A, et al. Effect of from experts, government agencies, and national long term consumption of probiotic milk on organizations. Information and Internet links in this infections in children attending day care centres: article were current as of the date of publication. double blind, randomised trial. BMJ 2001;322:1327. 8. Leyer GJ, Li S, Mubasher ME, et al. Probiotic Levels of Evidence
effects on cold and influenza-like symptom In accordance with the trend towards Evidence-Based incidence and duration in children. Pediatrics Medicine, we are citing the LEVEL OF EVIDENCE
9. Cox AJ, Pyne DB, Saunders PU, Fricker PA. Oral administration of the probiotic Lactobacillus Level Definition
fermentum VRI-003 and mucosal immunity in High-quality randomized controlled trial (RCT) endurance athletes. Br J Sports Med 2008;Feb 13 High-quality meta-analysis (quantitative 10. Paul IM, Beiler J, McMonagle A, et al. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc 11. Ginde AA, Mansbach JM, Camargo CA Jr. Association between serum 25-hydroxyvitamin D level and upper respiratory tract infection in the Third National Health and Nutrition Examination Survey. Arch Intern Med 2009;169:384-9. 12. McElhaney JE, Gravenstein S, Cole SK, et al. A placebo-controlled trial of a proprietary extract of Adapted from Siwek J, et al. How to write an evidence-based North American ginseng (CVT-E002) to prevent clinical review article. Am Fam Physician 2002;65:251-8. acute respiratory illness in institutionalized older adults. J Am Geriatr Soc 2004;52:13-9. Project Leader in preparation of this Detail-
13. Predy GN, Goel V, Lovlin R, et al. Efficacy of an Document: Melanie Cupp, Pharm.D., BCPS
extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized References
controlled trial. CMAJ 2005;173:1043-8. 1. Barak V, Halperin T, Kalickman I. The effect of 14. McElhaney JE, Goel V, Toane B, et al. Efficacy of Sambucol, a black elderberry-based, natural COLD-fX in the prevention of respiratory symptoms product, on the production of human cytokines: I. in community-dwelling adults: a randomized, Inflammatory cytokines. Eur Cytokine Netw double-blinded, placebo controlled trial. J Altern 2. Zakay-Rones Z, Varsano N, Zlotnik M, et al. 15. Pilieci V, Mathieu E. Cold-fX gets Health Canada Inhibition of several strains of influenza virus in stamp of approval. CanWest News Service; vitro and reduction of symptoms by an elderberry extract (Sambucus nigra L.) during an outbreak of http://www.canada.com/nationalpost/financialpost/s influenza B Panama. J Altern Complement Med d3285c640194&k=93503&p=2. (Accessed October 3. Zakay-Rones Z, Thom E, Wollan T, Wadstein J. Randomized study of the efficacy and safety of oral Copyright 2009 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #251112: Page 5 of 5)
16. U.S. Food and Drug Administration. Loss of sense 18. Centers for Disease Control and Prevention. CDC of smell with intranasal cold remedied containing says “Take 3” actions to fight the flu. zinc. Public Health Advisory. June 16, 2009. http://www.cdc.gov/flu/protect/preventing.htm http://www.fda.gov/Drugs/DrugSafety/PublicHealth Advisories/ucm166059.htm (Accessed October 8, 17. Health Canada. Evidence for homeopathic medicines guidance document. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/ehmg- nprh-eng.php (Accessed October 12, 2009).
Cite this Detail-Document as follows: Supplements for prevention and treatment of colds and influenza.
Pharmacist’s Letter/Prescriber’s Letter 2009;25(11):251112.

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