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Nutriceuticals and the Eye Bruce E. Onofrey, OD, RPh, FAAO Lovelace Medical Center Albuquerque, New Mexico CAM Complementary and Alternative Medicine CAM treatments and healthcare practices: •not taught in medical schools •not used in hospitals •not reimbursed by medical insurance INTEGRATIVE MEDICINE Combine best of Western medicine with complementary techniques that have proven efficacy CAM •33.8% in 1990 •42.7% in 1997 •62.0% in 2002 •39% - disclosure to doctors •84.9% used herbs •76.3% used megavitamins You Can Never Be…... •Too thin •Too young •Too Rich •Have too much hair P.T. BARNUM WAS RIGHT Buzz Words •All natural = SAFE AND BETTER •“Cures” •Strengthens the immune system •Non-pharmaceutical therapy •Greater energy/youth •Harmless •Lose weight WITHOUT dieting MOST CLAIMS ARE FALSE •No current botanical cure for: •Obesity •Baldness •Arthritis •Cancer •HIV •Aging The Top Selling Herbal Supplements •Ginkgo: Alzheimers, memory loss, tinnitis •St. John’s Wort: Depression •Ginseng: Stimulant •Garlic: Decrease cholesterol •Echinacea: “colds”, flu, viral disease •Saw Palmetto: Enlarged prostate •Kava: Anxiety •Valerian: Sedative/sleep aid The Myths: Nutriceuticals are not drugs •Nutriceuticals contain chemicals that produce physiologic changes (Both good and bad) •THAT’s A DRUG •FDA just pulled Amcon antihypertensive pills-reserpine,diazapam,promethiazine, HCTZ •Gosh the only thing left out was the kitchen sink Nutriceuticals are monitored for safety and efficacy by the FDA •They tried to, but congress was inundated with lobbying against FDA control: A billion dollar industry-LOTS of CLOUT •Dietary supplement health and education act: Allows advertisement that includes “potential” therapeutic benefits of the drug-must have disclaimer of no FDA approval for TX of any disease •No oversight for safety or efficacy •Frequently claim a conspiracy by the major pharmaceutical companies to discredit them The benefits of nutriceuticals are well documented A single “study” or testimonial campaign can launch a whole industry There are NO adverse effects associated with nutriceuticals •1994: Jin Bu Huan herbal tablets for sedative effect produced cases of fatal liver toxicity •1992: Gum guar tablets produced fatal esophageal obstruction •Ma-huang/ephedra related deaths: See the latest “JOURNAL” articles •Arnica (leopards bane): for arthritis produced fatal cardiotoxicity If a little bit is good a lot is better Megadosing common in patients with chronic/fatal disorders ie cancer, AIDS If a food improves something put the active ingredient in a pill and it will provide the same benefit •Sometimes the act of changing ones diet (ie increased fruits and vegetable) in place of high fat foods provides the benefit instead of taking a pill containing a substance like beta-carotene or lutein, etc What’s on the label is in the bottle •Absolutely no assurance of purity or content or standardized quantity of active substance in the herb •Therefore no way to standardize a dosage Herbs and the Eye •Ginkgo: Glaucoma, vascular disease •Bilberry/Antioxidants/Lutein: ARMD •Flaxseed oil: Dry eye/blepharitis •Herbal GLC TX BILBERRY VACCINIUM MYRTILLUS •flavonoid anthocyanosides •Improved night vision-Britain? •bilberry + vitamin E – stops cataract •improves vision in diabetics •glaucoma – facilitates aqueous outflow Bilberry Study Carotene and Cancer Beta Carotene and Cancer AREDS •21 published reports •likely to benefit from formula: -extensive intermediate-size drusen -at least one large drusen -noncentral geographic atrophy -advanced AMD -vision loss in one eye ARED (Age related eye disease) Study results Archives of Ophthalmology-October 2001 •4,757 participants age 55-80 •Patients enrolled from 11/92-4/200 and followed until 4/2001 avg patient TX X 6.3 years •Categories •1. NO AMD 2. Mild AMD •3. Moderate AMD •4. Advanced AMD ARED Study results Archives of Ophthalmology-October 2001 •1. Patients over 55 years should have DFE to be evaluated for risk of AMD. •2. If extensive intermed. Drusen, at least 1 large druse, non-central geographic atrophy in 1 or both eyes or advanced AMD and no contraindications-TX •3. Vit C 500mg, Vit E 400IU, Beta carotene 15mg + Zinc 80mg and Copper 2mg (Oxides) •8% decrease of progression from Cat 3 to 4 •Reduced visual acuity loss by 19% in Cat 3 and 4 IMPORTANT TO NOT TAKE THIS TOO FAR •DID NOT PREVENT AMD •DID NOT REVERSE AMD The Bottom Line on ARMD/AREDS 1 •DON’T BE Northern European •DON’T GET OLDER •DON’T SMOKE •DON’T GIVE SMOKERS ANTIOX •DO INCREASE INTAKE OF LUTEIN RICH FOODS •CONTROL VASCULAR DISEASE RISK FACTORS •SUPPLEMENTS DON’T REPLACE A BAD LIFESTYLE AREDS For Smokers •no beta-carotene for smokers •substitute lutein for beta-carotene •LAST study – vision improvement •take zinc only – delays progression but not vision loss AREDS 2 •xanthophylls – lutein 10 mg and zeaxanthin 2 mg •omega-3 polyunsaturated fatty acids •eliminate beta-carotene •reduce zinc to 40 mg/day TOZAL STUDY •named for nutritional elements •taurine •omega-3 fatty acids •zinc •antioxidants •lutein TOZAL STUDY •37 patients •mean age: 76.3 years •TOZAL supplement vs. placebo •2 capsules TID for 6 months •56.7% showed improved BCVA •20.0% maintained BCVA •placebo: 1.5 lines of vision loss WAFACS Women’s Antioxidant Folic Acid Cardiovascular Study •double-blind, placebo-controlled •5,442 female health professionals •aged 40 or more years •pre-existing cardiovascular disease •OR ≥ 3 coronary risk factors WAFACS •AMD and CVD – similar mechanisms and risk factors •5,205 studied (no AMD at start of study) •folic acid (2.5 mg qd) •vitamin B6 (50 mg qd) •vitamin B12 (1mg qd) WAFACS •↓ folic acid, vitamin B = homocysteine •hyperhomocysteinemia - endothelial dysfunction - impaired vascular reactivity - inflammatory processes - causes atherosclerosis •all involved with AMD WAFACS •7.3 years tx and follow-up •137 cases of AMD •70 visually significant AMD •Tx – 55; placebo – 82 (AMD) •Tx – 26; placebo – 44 (v.s. AMD) •Tx reduced risk AMD – 34% •Tx reduced risk v.s. AMD – 41% RETINITIS PIGMENTOSA •vitamin A palmitate, 15,000 IU qd •slows progression by 2% per year •beta-carotene – unreliably converted •vitamin E decreases benefit of vitamin A •omega-3 FA, DHA – slows disease •vitamin A + DHA – 20 additional years of useful vision if started in 30’s HYPERVITAMINOSIS A •pseudotumor cerebri •often associated with liver ingestion • PTC in Eskimos – polar bear liver •RDA is 5,000 IU/day; > 10,000 IU/day – toxic •Preservision – 14,320 IU, 286% of RDA GINKGO BILOBA •flavonoids, ginkgolide B •antioxidant for retina, brain • retina, brain circulation 30% •protects nerve cells from ischemia •NAION, vasculopathic CN palsy •60 mg BID or 40 mg TID (max. 130 mg/d) •most recommended drug in Europe GINKGO BILOBA •Bleeding complications: - hyphema - subdural hematoma - subarachnoid hemorrhage - increased bleeding time - caution with coumadin, ASA, Plavix OPHTHALMIC SURGERY BLEEDING COMPLICATIONS •Dong quai (angelica sinensis) •Echinacea (purple cone flower) •Ephedra (ma-huang) •Feverfew (tanacetum parthenium) •Garlic (allium sativum) •Ginger (zingiber officinale) •Ginkgo biloba (duck foot) •Kava kava (intoxicating pepper) •St. John’s wort (hypericum perforatum) •Valerian (passion flower) Documented Warfarin Interactions: •Danshen (salvia miltiorrhiza) •Devil’s claw (harpagophytum procumbens) •Green tea (camellia sinensis) •Ginseng (panax ginseng) •Papain (carica papaya) Miscellaneous Bleeding Agents •vitamin E •flaxseed oil •fish oil ST. JOHN’S WORT •seratonin syndrome •pupil dilation, visual hallucinations, oculogyric crisis, nystagmus •ataxia, hypereflexia, tremor •seizures, confusion, agitation •hyperthermia, tachycardia, hypertension Key to Management •Find the Cause, if possible •Identify exacerbating factors and cut them out •STAGE the disease •Step Therapy Flaxseed oil and OSD •Flaxseed oil composed of : Alpha-linoleic acid omega 3 (57%) Linoleic acid omega 6 (15%) Oleic acid omega 9 (18%) Flaxseed Oil and OSD •A single 3 year study (200 patients) presented by CF Boerner at the American Society of Cataract and refractive surgery •Report of 85% success of complete resolution of dry eye symptoms (burning and stinging) •Marked decrease in artificial tear use Flaxseed Oil and OSD •Improved CL tolerance •Improved VDT tolerance •Improved post-op Lasik comfort •Improved meibomian oil “quality”-clearer and less viscosity-less meibomian stasis •Improvement in Rosacea blepharitis •No help in Sjogrens or drug induced dry eye DRY EYE •omega-3 fatty acids - EPA, eicosapentaenoic acid - DHA, docosahexaenoic acid •flaxseed oil •cod liver oil, fish oil •Am J Clin Nutr 2005; 82: 887-93. MARIJUANA •↓IOP 25% to 30% •IOP reduction lasts 3-4 hours •smoke joint 4 – 6 times daily •Institute of Medicine – rejected use for glaucoma •Jamaica – Canasol (Cannabis sativa) ganja-based drops for glaucoma THE END THANK YOU