Herbal Supplements for Disease Management and Prevention

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Pharmacy Times, September 2015 Specialty Pharmacy, Volume 81, Issue 9

Which OTC products should these pharmacists recommend?

CASE 1: GINKGO FOR MULTIPLE SCLEROSIS

A 33-year-old woman approaches the pharmacy counter with a question for the pharmacist. She is concerned because her mother has been battling multiple sclerosis (MS) for as long as she can remember and she recently learned there is a genetic predisposition. She asks what the pharmacist knows about the use of herbal products for prevention of MS; specifically, what is the role of ginkgo biloba, if any, in prevention of this condition? She is otherwise healthy and takes a multivitamin and fiber supplement each day. She has no known allergies to foods or medications. What information should the pharmacist provide to this woman regarding the use of ginkgo supplementation?

ANSWER

MS is a progressive, degenerative, long-term disorder affecting the brain and spinal cord. Although the exact etiology is unknown, it is believed to be an autoimmune condition whereby the immune system attacks the nerve fibers as if they are foreign. Two to 3 times as many women as men are affected by this condition, and there is a genetic or hereditary link.1 Ginkgo biloba is an herbal supplement that has been used for millennia to treat myriad medical conditions, particularly those affecting the central nervous system, including dementias, memory loss, headache, dizziness, and mood disturbance.2

Flavonoids and terpenoids are thought to be the active compounds associated with ginkgo’s effects. Small clinical studies on the use of ginkgo leaf extract and ginkgolide B, a terpenoid, in patients with MS have suggested that these constituents do not improve disability or cognitive function.3-5 At present, its use as a preventive measure for MS has not been studied. In addition, given the evidence available on its role in management of the disorder, supplementation may not be effective for this indication. Although generally considered safe at usual doses, ginkgo can increase bleeding risk, particularly in patients using antiplatelet and anticoagulant therapies. In this patient’s case, given her age, it is prudent to remind her that supplementation is not recommended if she were to become pregnant.2

CASE 2: HERBAL THERAPY FOR HEPATITIS C VIRUS

A 48-year-old man comes to the pharmacy asking about natural treatments for hepatitis C virus (HCV) infection. He was recently diagnosed with this condition, and after receiving information about currently available prescription-only therapies, he is interested in exploring natural options first. Regarding his medical history, he is a current smoker and former intravenous drug user and has had endocarditis and bloodstream infections requiring hospitalization. He also has chronic obstructive pulmonary disease and type 2 diabetes, and takes fluticasone/salmeterol 250/50 mcg twice a day, along with metformin 500 mg twice a day. He reports having an allergy to penicillin. What natural remedies, if any, should the pharmacist discuss with this gentleman?

ANSWER

Several new treatment options have emerged over the past few years for the treatment of HCV infection, a blood-borne disorder that can result in acute and chronic infection, including progression to cirrhosis and liver failure. This patient should be educated on the safety and superior efficacy of these newer agents and treatment regimens compared with natural alternatives. If he is insistent on pursuing an herbal remedy, milk thistle is touted for its effect on liver function; its biologic activity is attributed to the flavonoid complex, silymarin, which can be extracted from its seeds.6 This product appears to be safe at standard doses, and limited clinical evidence from short-term, small trials suggests it may be effective at helping patients with HCV feel better or in reducing disease progression.7-9 There are no data to suggest this agent improves quality of life, liver function tests, or mortality due to liver disease. At this time, traditional pharmacologic intervention remains the option with greatest efficacy.

CASE 3: GARLIC FOR CANCER PREVENTION

A 66-year-old woman comes to the pharmacy looking for direction on where she can find garlic supplements. Upon questioning, she says she is considering starting garlic supplementation because a friend of hers read in a consumer health magazine that garlic can reduce the risk of colon cancer. She has hyperlipidemia and hypertension, and takes atorvastatin 20 mg once daily in the evening along with enalapril 5 mg twice a day and an 81-mg aspirin tablet once a day for heart health. She has no known medication allergies. What education can the pharmacist provide about the use of garlic for cancer prevention in this woman’s case?

ANSWER

Although its mechanism of action is not fully understood, dietary or supplemental garlic contains the compound allicin, along with peptides, terpenoids, flavonoids, and other possible active ingredients. Although garlic is widely used for its antioxidant, antibacterial, and cardiovascular effects, population-based data suggest that increased dietary garlic intake may also reduce the risk of certain malignancies, including colon and gastric cancer. As with any herbal preparation, data are limited because a standardized dose or product preparation has not been evaluated in clinical analyses; in studies indicating garlic supplementation reduces cancer risk, specific preparations were evaluated. Further, in this patient’s case, it is prudent to discuss the increased risk of bleeding she could experience with supplementation since garlic could enhance the antiplatelet activity of the aspirin she takes each day.10

CASE 4: DHEA AND INFERTILITY

A 35-year-old woman wants to speak to the pharmacist about natural fertility options. She and her husband have been trying to conceive for over a year. She has tried prescription-only fertility treatments and used fertility monitors, both to no avail. She recently read on the Internet that anecdotal evidence supports supplementation with dehydroepiandrosterone (DHEA), an herbal product, as a fertility agent; however, she is concerned about the safety of this product and potential adverse effects. She would like more information before she decides to use it or ask her doctor about it. She has no known allergies and takes only a prenatal vitamin once daily. Is there evidence to support the use of DHEA for infertility? What safety data can you give her?

ANSWER

DHEA is a naturally produced hormone precursor that is secreted by the adrenal gland in men and women, as well as in the ovaries and testes.11 Clinical evidence on the use of DHEA for infertility is mixed: some clinical trials suggest that supplementation with DHEA 75 mg daily prior to treatment increases birth rate and embryo quality in women undergoing in vitro fertilization, whereas other studies did not find supplementation to increase pregnancy rates.12,13 Other study results of women taking DHEA at a dose of 50 to 75 mg daily for at least 4 months suggest that the use of the supplement may have a role in natural conception.14 Since this woman is already seeing a physician about infertility, recommend she consult her provider for guidance on DHEA supplementation before initiating it.

Got an interesting question regarding OTC medications? Contact the authors at otccasestudies@pharmacy.rutgers.edu and share the details. Your case could be featured in an upcoming column!

Dr. Mansukhani is clinical assistant professor at the Ernest Mario School of Pharmacy, Rutgers University, and transitions of care clinical pharmacist at Morristown Medical Center, Morristown, New Jersey. Dr. Bridgeman is clinical associate professor at the Ernest Mario School of Pharmacy, Rutgers University, and internal medicine clinical pharmacist at Robert Wood Johnson University Hospital, New Brunswick, New Jersey.

References

  • Multiple sclerosis. Natural Medicines Comprehensive Database website. www.therapeuticresearch.net. Accessed August 15, 2015.
  • Ginkgo monograph. Natural Medicines Comprehensive Database website.www.therapeuticresearch.net. Accessed August 15, 2015.
  • Lovera J, Bagert B, Smoot K, et al. Ginkgo biloba for the improvement of cognitive performance in multiple sclerosis: a randomized, placebo-controlled trial. Mult Scler. 2007;13(3):376-385.
  • Lovera JF, Kim E, Heriza E, et al. Ginkgo biloba does not improve cognitive function in MS: a randomized placebo-controlled trial. Neurology. 2012;79(12):1278-1284. doi: 10.1212/WNL.0b013e31826aac60.
  • Brochet B, Guinot P, Orgogona JM, Confavreux C, Rumbach L, Lavergne V. Double blind placebo controlled multicenter study of ginkgolide B in treatment of acute exacerbations of multiple sclerosis. The Ginkgolide Study Group in multiple sclerosis. J Neurol Neurosurg Psychiatry. 1995;58(3):360-362.
  • Milk thistle monograph. Natural Medicines Comprehensive Database website. www.therapeuticresearch.net. Accessed August 15, 2015.
  • Tanamly MD, Tadros F, Labeeb S, et al. Randomised double-blinded trial evaluating silymarin for chronic hepatitis C in an Egyptian village: study description and 12-month results. Dig Liver Dis. 2004;36(11):752-759.
  • Freedman ND, Curto TM, Morishima C, et al; HALT-C Trial Group. Silymarin use and liver disease progression in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis Trial. Aliment Pharmacol Ther. 2011;33(1):127-137. doi: 10.1111/j.1365-2036.2010.04503.x.
  • Fried MW, Navarro VJ, Afdhal N, et al; Silymarin in NASH and C Hepatitis (SyNCH) Study Group. Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy: a randomized controlled trial. JAMA. 2012;308(3):274-282. doi: 10.1001/jama.2012.8265.
  • Garlic monograph. Natural Medicines Comprehensive Database website. www.therapeuticresearch.net. Accessed August 15, 2015.
  • DHEA monograph. Natural Medicines Comprehensive Database website. www.therapeuticresearch.net. Accessed August 15, 2015.
  • Wiser A, Gonen O, Ghetler Y, Shavit T, Berkovitz A, Shulman A. Addition of dehydroepiandrosterone (DHEA) for poor-responder patients before and during IVF treatment improves the pregnancy rate: a randomized prospective study. Hum Reprod. 2010;25(10):2496-2500. doi: 10.1093/humrep/deq220.
  • Artini PG, Simi G, Ruggiero M, et al. DHEA supplementation improves follicular microenvironment in poor responder patients. Gynecol Endocrinol. 2012;28(9):669-673. doi: 10.3109/09513590.2012.705386.
  • Mamas L, Mamas E. Dehydroepiandrosterone supplementation in assisted reproduction: rationale and results. Curr Opin Obstet Gynecol. 2009;21:306-308.