Bates Method-Review of Optometry
Content
Patient Care
A Walk on
N
o doubt, you're wondering about the bright orange contraption shown above. Did you miss the announcement about a revolutionary new product to treat vision problems? Actually, what you see here is the Neu-Vita Oculizer from England, a device that was once believed to improve vision in the early 1900s. Its crank-and-puUey system rotates two soft rubber eyecups. The other end of the instrument is fitted with hard rubber eyecups with a concave-faced plunger to poke the eye when the rubber bulbs are squeezed. Vacuum can also be applied by covering an air hole and releasing the bulb. According to its accompanying instructional pamphlet, the Oculizer should be applied either at night or morning (for a few minutes only) as prescribed. "The eyeballs are thus gently massaged and the nerve centre strengthened, conditions absolutely necessary for good eyesight." Today, the Oculizer is obsolete, except as a collectors' item.
The wad Side
Patients who use non-traditional medicine may not tell you about it. Here's what they might be using. By Brian Chou, O.D.
Looking at this contraption, you may wonder how people once believed it could improve their vision. Most likely, the available information convinced them it was effective. As your patients read about nontraditional eye treatments available on the market today, they may ask you about their merit. They'll depend on you for answers about which treatments are safe and effective. cises that could improve vision without the need for glasses, contact lenses or refractive surgery. Much of the See Clearly Method was based on the techniques that William Horatio Bates, M.D., described in his best-selling 1920 book, "Perfect Sight Without Glasses." Members of the scientific community have since discredited Dr. Bates' eye exercises by demonstrating that these exercises are ineffective and conflict with known facts.'- Eor example. Dr. Bates recommended "sunning" (staring at the sun with the eyes wide open) to relax the eye. In reality, this can permanently damage vision due to solar retinopathy.' The See Clearly Method was sold nationwide since 2001 with an advertising campaign of radio, television, print ads and a Web site. With celebrity endorsement, testimonials, seemingly valid scientific references and a "risk-free" call to
Questionable Treatments
Even today, questionable eye treatments abound. Whiie these might be easy for eye-care professionals to spot, they may not be as obvious to our patients. A case in point: the See Clearly Method (Vision Improvement Technologies, LLC, now defunct). The so-called "natural" vision improvement kit included manuals, charts, videotapes and audiotapes that demonstrated various eye exer-
Pictured above )s the Neu-Vlta Oculizer, courtesy Robert Greenspan, M.D., www .CollectMedIca I Antiques, com.
REVrEW OF OPTOMETRY MARCH 1 5 , 2 0 0 8
43
Patient Care
action, the company sold up to 10,000 kits per month at approximately $350 apiece. The See Clearly kits were taken off the market per a fraud lawsuit and resulting court order in December 2006.^ just like those hopeful folks who purchased the Neu-Vita Oculizer decades ago, people who bought the See Clearly Method apparently believed it was valid, thanks in part to modern advertising. medicine." The term, "complementary" describes treatments used as an adjunct to traditional practice. "Alternative" treatments replace conventional ones. Between 1990 and 1997, consumers increasingly used these forms of treatments.^ By 2002, 36% of adults in the United States used some form of CAM, according to a survey by the National Institutes of Health.* CAM increasingly has become part of eye care. For example, the prevalence of CAM use for glaucoma is approximately 5%.^ Another study of 89 patients with inflammatory eye disease found that 37 (42%) reported using CAM to improve their eye condition.** Despite these figures, most optometric programs do not appear to offer a formal curriculum discussing non-traditional eye care treatments. In January 2007,1 conducted an informal email survey of deans and presidents of the 17 U.S. schools and colleges of optometry. Only four out of 11 respondents, or 36%, reported that their curriculum covered nontraditional eye care. Compare this to three previously published surveys of 125 schools that offer a medical doctor degree, 19 schools that offer a doctor of osteopathy degree and 585 schools that offer a nursing degree. Sixty percent of the medical schools, 95% of the osteopathic medical schools and 85% of nursing schools discussed some form of complementary and alternative medicine in their curriculum. patients will depend on us for m^ answers. And it's here where we Jw must distinguish marketing claims^j from large-scale clinical studies, ,;S such as the Age-Related Eye Disease Study (ARFDS). '^ Nutraceuticals became an esti-'<5> mated $21 billion industry in the • United States in 2006, according tO" MarketResearch.com. This is partly due to less stringent labeling requirements. More specifically, vitamins, minerals, herbs and other botanicals, amino acids, various extracts, and combinations qualify as "dietary supplements" according to the Dietary Supplement Health and Education Act (DSHEA). Congress passed the DSHEA in 1994 following intensive lobbying by manufac^ turers, and former President Bill '• Clinton signed it into law. As a result, the FDA regulates these substances as foods rather than drugs. That means manufacturers are not required to submit safety or efficacy data to the FDA before marketing dietary supplements. Although DSHEA prohibits manufacturers from claiming that they prevent, treat or cure a specific disease, it allows them to make labeling statements that describe their supplement's alleged effects on the "structure and function" or general "well-being" of the body, as long as they bear this disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." For example, with this disclaimer, a bottle of bilberry extract could have labeling that says that it has traditionally been used to reduce eyestrain and support visual functions, despite a lack of rigorous scientific evidence to substantiate such labeling."
The See Clearly Method, now off the market, promised to Improve vision without the need for glasses, contact lenses or refractive surgery.
They're not alone. Today, as an increasing number of consumers embrace a "do-it-yourself" attitude toward their own health care, employing complementary and alternative treatments. And, those who use alternative therapies often do not share this information with their health-care providers.'
Diverse Practices
The National Center for Complementary and Alternative Medicine defines complementary and alternative medicine (CAM) as "a group of diverse medical and health-care systems, practices and products that are not presently considered to be part of conventional
Dietary Supplements
Of particular interest in eye care is the use of vitamins to prevent eye disease. Again, however, our
44
REVIEW OF OPTOMETRY MARCH 1 5 , 2 0 0 8
IQUIX®
(levorioxacin opiitlialmic; solution) 1.5% BRIEF SUMMARY INDICATIONS AND USAGE lOUIX* solution IS indicated lor ihe trealment ot corneal ulcer caused bv sjsceplible slrains ot the following bacteria' GRAM-POSITIVE BACTERIA: Corynebacienum spscJes' Staphylococcus aureiis Staphylococcus epidermidis Streptococcus pneumome Vifidans group straptococci' GRAM-NEGATIVE BACTERIA: Pseudomonas aerugmosa Ssfralia marcescens'
Patient Care
CAM for Cataracts
The definitive and accepted treatment for cataract is surgical extraction followed by intraocular lens implantation, yet an Internet search for "cataract cure" produces a plethora of interesting remedies. One Web site claims that unprocessed honey is an effective treatment for cataract: "A few drops of this honey should be put in the eyes. This is an ancient Egyptian remedy which has benefitted [sic\ many patients," the authors claim.'" A literature search showed a general absence of data supporting honey as an effective treatment for cataract., aside from one Russian study." The same Web page promotes garlic as another effective home A taste of honey is worse than remedy for cataract. none at all? No studies prove "Two or three cloves that honey drops treat cataract. should be eaten raw daily," the site says. "They should be chewed slowly. Garlic helps to clean the crystalline lens of the eye." A literature search also showed an absence of support for consuming garlic as an effective treatment for cataract. However, one study did find that one of the major organosulfides in garlic oil, diallyl disulfide, prevented the development of cataracts of acetaminophen-induced cataracts in mice.'' Yet another Web site stated that it is "essential" that patients with cataract use Cineraria Cataract Eye Drops, described as "the traditional homeopathic remedy found in the Ophthalmology section of the Physicians Desk Reference for over 25 years as a treatment for cataracts."" Homeopathy is based on the medically disputed premise that infinitesimally small amounts of poisons will relieve the same symptoms they would produce in larger amounts.'^ A literature search in PubMed for Cineraria for treating cataracts came up with only a 1981 paper from hidia, which noted its inconclusive benefit when used in goat lens cultures.''
I
'Etficaty tor this organism was studied in tewer than 10 intections. CONTRAINDICATIONS IQUIX* solution is contraindicaied in patients with a history ot hypersensitivity to levotloxacin, to olhet auinalones. or to any ot ttie components in this medication. WARNINGS NOT FOR INJ£CTIO\. lOUiX® solution should not t>e iniected subconiunctlvaily, nor should It be introduced Directly into the anterior cham&er ot the e/e. in palients receiving systemic quinolones. sefious and occasionaliy latal hypersensitivity (anaphylactic) reaclions have been reported, some tollowing the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (Inciuding iaryngeai, pharyngeal or taciai edema), atrway obstruction, dyspnea, urticaria, and itching. \t an ailergic reaction to ievofloxacln occurs, disconiinue the drug Serious acute hypersensitivity reactions may requiie immediate emergency treatmerl. Oxygen and airway management should be administered as clinically indicated. PRECAUTIDNS General: As with other anti-intectives, prolangad use may result in overgrowtti of non-susceplibie organisms, including fungi. If superintecticn occurs, discontinue use and institute aiternattve therapy. Whenever clinical [iidgmenl dictates, the patient should he examined with the aid of magnification, such as slit-iamp biomicroscopy, and, where appropriate, tiuorescein staining. Patients shouid be advised not to wear contact lenses tf thay have signs and symptoms of comeal ulcer, Inlormatlon lor Palienis: Avoid contaminating the applicator tip with materlai from the eye. fingers or other source. Systemic qumolones have been associated with hypers en sitivily reactions, even following a single dose Discontinue use immediately and contact your physician at tlie tirst sign ot a rash or aiiergic reaction. Dniq Interactions: Specific drug inteiacfion studies have not been conducted with IQUiX^. However, the systemic administration Of some qumolones has been shown to elevate plasma concentrations of theophyliine. intertere with the metabotism of caffeine, and enhance the effects Of ihe orai anticoaguiant wariarin and Its derivatives, and has been associated with transient elevations in serum crea^nine in patients receiving systemic cyclcspcrine concomitantly. CarGinDganatU. Mulagenasls, impairment ol Fertillly: in a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or lumorigenic potentiai foilowing daily dietary administralion lor 2 years; the highest dose (100 mg/kg/day) was 100 times the highest recommended human ophthalmic dose. Levolloxacm was noi mutagenic in the tollowing assays Ames Bacterial mutation assay (S. typhimuiium and E coh), CHOfflGPRT forward mutation assay, mouse micranucleus test, rrouse dominant lethal test. rat unscheduled DNA synthesis assay, and the in wvo mouse sister chromatic) exchange assay It was positive m the in vitro chromosomal aberration (CHL ceil iine) and m viiro sister chromatid exchange (CHMU cell line) assays. Levofioxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, corresponding to 400 times the highest recommended human ophthalmic dose. Pragnancy: TeralngBnic Elfects. Pregnancy Calegory C: Levofloxacinat oral doses of 810 mg/kg/day in rats, which corresponds to approximately 1000 times the highest recommended human ophthalmic dose, caused decreased fetai body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed oraiiy as high as 50 mg/kg/day. wfiich corresponds to approximsteiy 60 times the highest recommended maximum human ophthalmic dose. Of when dosed miravenoiisly as high as 25 mg/kg/day, corresponding to approximately 30 times the highest recommended human ophthalmic dose There are, however, no adequate and well-controlled studies in pregnant women. Levofioxacin shouid be used during pregnancy only il the potentiai beneirt justifies the potentiai risk lo the fefus. Nuraing Mathers: Levofioxacin has not heen measured in human milk. Based upon data from ofioxacin. it can be presumed that levoiloxacln is excreied in human milk. Caution should be exercised when IQUIX* is administered to a nursing mother. Pediatric U t s : Safety and effectiveness in children beiow the age of six years have not been established. Oral adnnnistralton of systemic Quinolones has been shown to cause arihropalhy in immature animals. There is no evidence thai the ophthalmic administration of levotloxacin tiaB any effect on weijjht Searing p n t s Gsrialrjc Use: No overall differences in safety or effectiveness have been otserved between elderly and other adult patients. ADVERSE REACTIONS The most frequently reported adverse events in the overall study population were headache and a taste disturbance following instillalion Tbese events occurred in approximately B-10% of pafients. Adveise events occurring in approximately 1-2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, intection, instillation site irritation/discomfort, ocuiar infection, nausea, ocuiar pain/discomfort, and throat irritation. Other reported ocular reactions occurring in less than 1 % of patients included chemosis, comsal erosion, corneal uicer, dipiopia, floafers, iiyperemia. lid edema, and lid erythema. Rx Only Manulaclursd by: Santen Oy, P.O. Box 33, FIN-33721 Tampere, Rniand
Markelad by; VISTAKON* Pharmaceuticals, U C Jacksonville. FL 32256 USA
Licensed from: Daiichi Sankyo Co., Ltd.. Tokyo, Japan U.S. PAT, MO 5.053,407
Antioxidants for Cataracts
It sounds reasonable that antioxidants might retard the development of age-related cataract. Several such
April 2007 Version 2707IQ-O25
VISION EXPO EAST 2008
SYNEMED i
nutraceuticals are marketed on the Internet as "natural" ways to prevent and treat cataracts, suggesting that cataract surgery is unnecessarily risky. Yet at best, little legitimate evidence exists to suggest antioxidants have a significant role in preventing age-related cataract. ARF.DS evaluated 4,757 participants, of which some used a highdose antioxidant formulation (vitamin C, 500mg; vitamin E, 400IU; beta carotene, 15mg; zinc oxide, 80mg; cupric oxide, 2mg} and some were given placebo daily.'" In one portion ofthe study, the researchers found that the patients at high risk of developing advanced AMD lowered their risk hy about 25% and their risk of vision loss caused by advanced AMD by about 19%. In the cataract portion of the study, however, researchers found that the same nutrients had no significant effect on the development or progression of age-related cataract. In another clinical trial of 1,193 eligible subjects, vitamin E (500IU daily) used for four years did not reduce the incidence or progression of nuclear, cortical, or posterior subcapsular cataracts.'" The authors concluded that their findings did not support "the use of vitamin E to prevent the development or to slow the progression of age-related cataracts." Another study, the Collaborative Italian-American Clinical Trial of Nutritional Supplements and Agerelated Cataract (CTNS), is currently looking at whether a vitamin and mineral supplement [Centrum, Wyeth Consumer Healthcare) containing recommended daily allowances can prevent age-related cataract or delay its progression. Results are expected in March 2008. Two lesser-known antioxidants
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Patient Care
in the United States—pirenoxine and glutathione—are a standard treatment for cataracts in Japan. The annual domestic sales of these drops in Japan are approximately 18 billion yen ($176 million).'^ The drops are routinely prescribed by their doctors and are also covered by their national health insurance.'^ Nevertheless, evidenced-based guidelines from the Japanese government show that that pirenoxine (sold as Catalin) and glutathione eye drops lack effectiveness for treating cataracts.'"* Although Japanese doctors may know that pirenoxine and glutathione offer questionable benefit for cataracts, it is possible that they continue to prescribe them as an easy way to satisfy their patients. This would be similar to doctors continuing to prescribe antibiotics for viral upper-respiratory infections, so that patients don't feel they're leaving the office visit empty-handed.^" Regretfully, this practice doesn't encourage the public to embrace evidence-based approaches to their own health care. Another antioxidant touted on the Internet for cataracts is Nacetyl-carnosine (NAC). The majority of the scientific literature about NAC for cataracts is authored by Mark Babizhayev, Ph.D., a Russian research scientist who serves as the executive director of Innovative Vision Products (IVP), based in Delaware. IVP markets their NAC eye drop under the name Can-C. IVP claims that NAC "is effective in reducing, reversing and slowing the occurrence of senile cataract."'' In a randomized, placebo-controlled study sponsored by IVP of 49 subjects (76 cataractous eyes), 90% of NAC-treated eyes showed improved best-corrected visual acuity after six months." The authors marginal reduction in lens opacification in a substantial number of cases.'' While it is unlikely that NAC will usurp traditional surgery for treating cataracts, NAC may bold some clinical benefit for selected cataract patients in which surgery is not desirable. The company says it may also provide beneficial results for such conditions as presbyopia, primary open-angle glaucoma, dry eye syndrome and retinal disease.
Topical N-acetyl-carnosine might actually work, but it probably won't replace cataract surgery any time soon.
Acupuncture for Eyes
Acupuncture has existed as a central part of health care in China for more than 4,500 years. Acupuncturists believe that their treatment unblocks invisible life energy (called "chi") along specific pathways of the body. Acupuncture stimulation can alter neurotransmitter release, regulate blood flow and release opi-
concluded that topical NAC shows potential for treating and preventing cataracts. Corroborating these results, an independent study of topical NAC for cataracts in dogs showed some
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oid peptides to provide analgesia."-^' Acupuncture has been used to treat and alleviate various ocular conditions, including dry eye, myopia, paralytic strabismus, retinitis pigmentosa, optic atrophy, iritis, conjunctivitis and cataract." One device that attempts to capitalize on acupuncture for eyes is the Eye-Max magnetic acupressure eye massager (Endless Eorest Inc.). The Web site for Eye-Max suggests that this product is appropriate for those who experience eyestrain, bloodshot eyes, dry eyes, double vision and headaches.^^ The homepage proclaims, "Benefit could be Great!" As with many other forms of CAM, there is an absence of large scale, randomized, controlled triais of acupuncture to validate its role as an ophthalmic treatment.
Without this data, the merits of acupuncture in optometry and ophthalmology are unlikely to gain widespread acceptance. Meanwhile, acupuncture should not supplant established ophthalmic treatment. However, it may be an alternative for refractory cases or as an adjunct to established therapy.^" This article doesn't come close to reviewing all the available CAM treatments because the field is simply too vast. You can appreciate the diversity of CAM for eye care by searching the Internet, just like 80% of Americans who use it to look up health information.-'* While there are many exaggerated claims made by people with dubious credentials, O.D.s should remain open-minded about emerging treatments, especially those validated by evidence-based methods.
'Benefit couid he Great!' say the makers of the Eye-Max magnetic eye massager.
There likely are non-traditional treatments out there, albeit not yet characterized, with the potential to help our patients. • Dr. Chou is in group practice at Carmel Mountain Vision Care in San Diego. Approximately W years ago, his efforts led the Ohio Attorney General's Office and
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Patient Care
Federal Trade Commission to investigate the publisher of "Hidden Secrets to Better Vision," a book that recommended unsafe and unproven eye treatment. Fischer Publishing Corp. closed shortly thereafter.
1. Margi E. "Flashes" of clear vision and negative accommodation with telerence to Ihe Bates melhod of visual training. Am J Optom Arch Am Acad Optom 1952 Apr;29{4):167-84. 2. Gardner M. Fads and laliacies in the name ot science, Mineola, NY: Dover Publications; 1957. 3. Stokkermans TJ, Dunhar MT. Solar retinopathy in a tiospita!-based primary cate dime. J Am Optomfesoc1998 0ct;69(10):625-36 4. Iowa court ol thE attorney general. Court orders vision improvement tectinoiogies to end salES ol "See Clearly Method" i<it. Avaiiabie al: www.5tate.ia.us/governmeijl/30/ latest news/releases/nov 2Q[)6A/iT.htm|. [Accessed February 2008) 5. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results ot a foilow-up national survey. JAMA 1998 Nov 11;280(18): 1569-75, 6. Baines P, Powell-Grifier E, McFann K, Nahin R, CDC Advance Data Report #343. Complementary and alternative medicine use among adults: United States, 2002. May 27. 2004 7. Rhee OJ. Katz LJ, Spaeth GL, et al. Complementary and alternative medicine tor glaucoma. Surv Ophthalmol 2001 Jui-Aug;46(1):43-55. 8. Smith JR, Spurrier NJ, Martin JT, et al. Prevalent use ot complementary and alternative medicine by patients with intiammalory eye disease. Ocul Immunoi Intlamm 2004 Sep;12(3):203-14. 9. Canter PH, Ernst E. Anthocyanosides ot Vaccinium myrtillus (bilberry)tornigtil vision—a systematic review of placebo-controlled trials. Surv Ophthalmol 2004 JanFeb:49(1):38-50. 10. Home-remedies-tor-you.com. Cataract symptoms, cataract treatment, cataract cure. Available at' www.hom&remedies-lar-vou.com/remedy/Catafact.tilmi. (Accessed February 2008.) 11. Golychev VN, Use ol honey in conservative treatment ot senile cataracts. Vestn Ottalmol 1990 Nov-Dec;106(6):59-62. 12. Zhao C, Shicti H. Prevention ol acetaminophen-induced cataract by a combination ot diallyl disullide and N-acetylcysteine. J Ocul Pharmacoi Ttiera 1998 Aug;14(4):345-55. 13. Natural Eye Health. Cataract cure and prevention. www.naturaievecare.gom/ (Jiseases.asp?d num^2. (Accessed February 2008.) 14. Bariett S. Homeopathy: Is it medicine? In: The Health Robbers: A Close Look at Ouackery in America. Butlalo, NY: Prometheus Books; 1993.191-202. 15. Albai MV, Chandorkar AG. Biitakh PM. Evaluation ol catalin, Succus Cineraria maritima and Catobell in goat lens cuitures. Indian J Ophthalmol 1981 Oct;29(3):147-9, 16. Age-Related Eye Disease Study Research Group. A randomized, piacebo-controlied, clinical trial ot high-dose supplementation with vitamins C and E and beta carotene tor age-ieiated cataract and vision loss: AREDS report no. 9. Arch Ophthalmol 2001 Od;119(10): 1439-42 17. McNeil JJ, Robman L, Tikellis G, et al. Vitamin E supplementation and cataract; randomized controlled trial. Ophlhaimology2004Jan;1l1(1):75-84 18. MedMK.com. Annual sales ot domestic pharmaceutical companies. Available at; www.medmk.com/mm/add/ ml add.htm. (Accessed June 2007.) 19. Sekimoto M, tmanaka Y, Kitano N, et al. Why are pliysictans not persuaded by scientitic evidence? A grounded theory interview study. BMC Health Serv Res 2006 Jui 27; 6;92. 20. Butter CC, Roilnick S, Pill R, et al. tJnderstanding the culture ol prescribing; qualitative study ot general practitioners' and patients' perceptions of antibiotics tor sore throats. BMJ 1998:317;637-642. 21. Can-C cataract eye drops. Available at; www.can-c.net, (Accessed Fehruary 2008.) 22. Babizhayev MA, Deyev Al, Yermakova VN, et al. Etficacy of N-acetylcarnosine in the treatment of cataracts. Drugs R D 2002;3(2).87-103, 23. Williams DL, Munday P. The etfect ol a topical antioxidant tormulation including N-acetyl carnosine on canine cataract; a preliminary study. Vet Ophthalmol 2006 SepGct;9(5):311-6. 24. NJH Consensus Conterence. Acupuncture, JAMA 1998 Nov 4;280(17):1518-24. 25. Leake R, Broderick JE. Treatment etiicacy ol xupuncSjre; a review of the research literature. Integr Med 1998; 1.107-115. 26. Astbury N, Alternative eye care. Br J Ophthalmol 2001 JuI;85|7);767-8. 27. Eye-Max Available at: wwv,eyemassage.com. (Accessed February 2008.) 28. American Academy ot Ophthalmology Complementary TTierapy Task Force: Acupuncture tor Ccular Conditions and Headxhes. Aprii 2003. Available at: www.aao.org/eyecare/ treatment/alternative-ttieraoies/acuDunlure-ocular.cfm. (Accessed February 2008.) 29. Fox S. Online Health Search 2006. Washington DC; PEW Internet & American Lite Project: 2006 M 29:2.
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5O REVtEW OF OPTOMETRY MARCH 15, 2008
A Walk on
N
o doubt, you're wondering about the bright orange contraption shown above. Did you miss the announcement about a revolutionary new product to treat vision problems? Actually, what you see here is the Neu-Vita Oculizer from England, a device that was once believed to improve vision in the early 1900s. Its crank-and-puUey system rotates two soft rubber eyecups. The other end of the instrument is fitted with hard rubber eyecups with a concave-faced plunger to poke the eye when the rubber bulbs are squeezed. Vacuum can also be applied by covering an air hole and releasing the bulb. According to its accompanying instructional pamphlet, the Oculizer should be applied either at night or morning (for a few minutes only) as prescribed. "The eyeballs are thus gently massaged and the nerve centre strengthened, conditions absolutely necessary for good eyesight." Today, the Oculizer is obsolete, except as a collectors' item.
The wad Side
Patients who use non-traditional medicine may not tell you about it. Here's what they might be using. By Brian Chou, O.D.
Looking at this contraption, you may wonder how people once believed it could improve their vision. Most likely, the available information convinced them it was effective. As your patients read about nontraditional eye treatments available on the market today, they may ask you about their merit. They'll depend on you for answers about which treatments are safe and effective. cises that could improve vision without the need for glasses, contact lenses or refractive surgery. Much of the See Clearly Method was based on the techniques that William Horatio Bates, M.D., described in his best-selling 1920 book, "Perfect Sight Without Glasses." Members of the scientific community have since discredited Dr. Bates' eye exercises by demonstrating that these exercises are ineffective and conflict with known facts.'- Eor example. Dr. Bates recommended "sunning" (staring at the sun with the eyes wide open) to relax the eye. In reality, this can permanently damage vision due to solar retinopathy.' The See Clearly Method was sold nationwide since 2001 with an advertising campaign of radio, television, print ads and a Web site. With celebrity endorsement, testimonials, seemingly valid scientific references and a "risk-free" call to
Questionable Treatments
Even today, questionable eye treatments abound. Whiie these might be easy for eye-care professionals to spot, they may not be as obvious to our patients. A case in point: the See Clearly Method (Vision Improvement Technologies, LLC, now defunct). The so-called "natural" vision improvement kit included manuals, charts, videotapes and audiotapes that demonstrated various eye exer-
Pictured above )s the Neu-Vlta Oculizer, courtesy Robert Greenspan, M.D., www .CollectMedIca I Antiques, com.
REVrEW OF OPTOMETRY MARCH 1 5 , 2 0 0 8
43
Patient Care
action, the company sold up to 10,000 kits per month at approximately $350 apiece. The See Clearly kits were taken off the market per a fraud lawsuit and resulting court order in December 2006.^ just like those hopeful folks who purchased the Neu-Vita Oculizer decades ago, people who bought the See Clearly Method apparently believed it was valid, thanks in part to modern advertising. medicine." The term, "complementary" describes treatments used as an adjunct to traditional practice. "Alternative" treatments replace conventional ones. Between 1990 and 1997, consumers increasingly used these forms of treatments.^ By 2002, 36% of adults in the United States used some form of CAM, according to a survey by the National Institutes of Health.* CAM increasingly has become part of eye care. For example, the prevalence of CAM use for glaucoma is approximately 5%.^ Another study of 89 patients with inflammatory eye disease found that 37 (42%) reported using CAM to improve their eye condition.** Despite these figures, most optometric programs do not appear to offer a formal curriculum discussing non-traditional eye care treatments. In January 2007,1 conducted an informal email survey of deans and presidents of the 17 U.S. schools and colleges of optometry. Only four out of 11 respondents, or 36%, reported that their curriculum covered nontraditional eye care. Compare this to three previously published surveys of 125 schools that offer a medical doctor degree, 19 schools that offer a doctor of osteopathy degree and 585 schools that offer a nursing degree. Sixty percent of the medical schools, 95% of the osteopathic medical schools and 85% of nursing schools discussed some form of complementary and alternative medicine in their curriculum. patients will depend on us for m^ answers. And it's here where we Jw must distinguish marketing claims^j from large-scale clinical studies, ,;S such as the Age-Related Eye Disease Study (ARFDS). '^ Nutraceuticals became an esti-'<5> mated $21 billion industry in the • United States in 2006, according tO" MarketResearch.com. This is partly due to less stringent labeling requirements. More specifically, vitamins, minerals, herbs and other botanicals, amino acids, various extracts, and combinations qualify as "dietary supplements" according to the Dietary Supplement Health and Education Act (DSHEA). Congress passed the DSHEA in 1994 following intensive lobbying by manufac^ turers, and former President Bill '• Clinton signed it into law. As a result, the FDA regulates these substances as foods rather than drugs. That means manufacturers are not required to submit safety or efficacy data to the FDA before marketing dietary supplements. Although DSHEA prohibits manufacturers from claiming that they prevent, treat or cure a specific disease, it allows them to make labeling statements that describe their supplement's alleged effects on the "structure and function" or general "well-being" of the body, as long as they bear this disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." For example, with this disclaimer, a bottle of bilberry extract could have labeling that says that it has traditionally been used to reduce eyestrain and support visual functions, despite a lack of rigorous scientific evidence to substantiate such labeling."
The See Clearly Method, now off the market, promised to Improve vision without the need for glasses, contact lenses or refractive surgery.
They're not alone. Today, as an increasing number of consumers embrace a "do-it-yourself" attitude toward their own health care, employing complementary and alternative treatments. And, those who use alternative therapies often do not share this information with their health-care providers.'
Diverse Practices
The National Center for Complementary and Alternative Medicine defines complementary and alternative medicine (CAM) as "a group of diverse medical and health-care systems, practices and products that are not presently considered to be part of conventional
Dietary Supplements
Of particular interest in eye care is the use of vitamins to prevent eye disease. Again, however, our
44
REVIEW OF OPTOMETRY MARCH 1 5 , 2 0 0 8
IQUIX®
(levorioxacin opiitlialmic; solution) 1.5% BRIEF SUMMARY INDICATIONS AND USAGE lOUIX* solution IS indicated lor ihe trealment ot corneal ulcer caused bv sjsceplible slrains ot the following bacteria' GRAM-POSITIVE BACTERIA: Corynebacienum spscJes' Staphylococcus aureiis Staphylococcus epidermidis Streptococcus pneumome Vifidans group straptococci' GRAM-NEGATIVE BACTERIA: Pseudomonas aerugmosa Ssfralia marcescens'
Patient Care
CAM for Cataracts
The definitive and accepted treatment for cataract is surgical extraction followed by intraocular lens implantation, yet an Internet search for "cataract cure" produces a plethora of interesting remedies. One Web site claims that unprocessed honey is an effective treatment for cataract: "A few drops of this honey should be put in the eyes. This is an ancient Egyptian remedy which has benefitted [sic\ many patients," the authors claim.'" A literature search showed a general absence of data supporting honey as an effective treatment for cataract., aside from one Russian study." The same Web page promotes garlic as another effective home A taste of honey is worse than remedy for cataract. none at all? No studies prove "Two or three cloves that honey drops treat cataract. should be eaten raw daily," the site says. "They should be chewed slowly. Garlic helps to clean the crystalline lens of the eye." A literature search also showed an absence of support for consuming garlic as an effective treatment for cataract. However, one study did find that one of the major organosulfides in garlic oil, diallyl disulfide, prevented the development of cataracts of acetaminophen-induced cataracts in mice.'' Yet another Web site stated that it is "essential" that patients with cataract use Cineraria Cataract Eye Drops, described as "the traditional homeopathic remedy found in the Ophthalmology section of the Physicians Desk Reference for over 25 years as a treatment for cataracts."" Homeopathy is based on the medically disputed premise that infinitesimally small amounts of poisons will relieve the same symptoms they would produce in larger amounts.'^ A literature search in PubMed for Cineraria for treating cataracts came up with only a 1981 paper from hidia, which noted its inconclusive benefit when used in goat lens cultures.''
I
'Etficaty tor this organism was studied in tewer than 10 intections. CONTRAINDICATIONS IQUIX* solution is contraindicaied in patients with a history ot hypersensitivity to levotloxacin, to olhet auinalones. or to any ot ttie components in this medication. WARNINGS NOT FOR INJ£CTIO\. lOUiX® solution should not t>e iniected subconiunctlvaily, nor should It be introduced Directly into the anterior cham&er ot the e/e. in palients receiving systemic quinolones. sefious and occasionaliy latal hypersensitivity (anaphylactic) reaclions have been reported, some tollowing the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (Inciuding iaryngeai, pharyngeal or taciai edema), atrway obstruction, dyspnea, urticaria, and itching. \t an ailergic reaction to ievofloxacln occurs, disconiinue the drug Serious acute hypersensitivity reactions may requiie immediate emergency treatmerl. Oxygen and airway management should be administered as clinically indicated. PRECAUTIDNS General: As with other anti-intectives, prolangad use may result in overgrowtti of non-susceplibie organisms, including fungi. If superintecticn occurs, discontinue use and institute aiternattve therapy. Whenever clinical [iidgmenl dictates, the patient should he examined with the aid of magnification, such as slit-iamp biomicroscopy, and, where appropriate, tiuorescein staining. Patients shouid be advised not to wear contact lenses tf thay have signs and symptoms of comeal ulcer, Inlormatlon lor Palienis: Avoid contaminating the applicator tip with materlai from the eye. fingers or other source. Systemic qumolones have been associated with hypers en sitivily reactions, even following a single dose Discontinue use immediately and contact your physician at tlie tirst sign ot a rash or aiiergic reaction. Dniq Interactions: Specific drug inteiacfion studies have not been conducted with IQUiX^. However, the systemic administration Of some qumolones has been shown to elevate plasma concentrations of theophyliine. intertere with the metabotism of caffeine, and enhance the effects Of ihe orai anticoaguiant wariarin and Its derivatives, and has been associated with transient elevations in serum crea^nine in patients receiving systemic cyclcspcrine concomitantly. CarGinDganatU. Mulagenasls, impairment ol Fertillly: in a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or lumorigenic potentiai foilowing daily dietary administralion lor 2 years; the highest dose (100 mg/kg/day) was 100 times the highest recommended human ophthalmic dose. Levolloxacm was noi mutagenic in the tollowing assays Ames Bacterial mutation assay (S. typhimuiium and E coh), CHOfflGPRT forward mutation assay, mouse micranucleus test, rrouse dominant lethal test. rat unscheduled DNA synthesis assay, and the in wvo mouse sister chromatic) exchange assay It was positive m the in vitro chromosomal aberration (CHL ceil iine) and m viiro sister chromatid exchange (CHMU cell line) assays. Levofioxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, corresponding to 400 times the highest recommended human ophthalmic dose. Pragnancy: TeralngBnic Elfects. Pregnancy Calegory C: Levofloxacinat oral doses of 810 mg/kg/day in rats, which corresponds to approximately 1000 times the highest recommended human ophthalmic dose, caused decreased fetai body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed oraiiy as high as 50 mg/kg/day. wfiich corresponds to approximsteiy 60 times the highest recommended maximum human ophthalmic dose. Of when dosed miravenoiisly as high as 25 mg/kg/day, corresponding to approximately 30 times the highest recommended human ophthalmic dose There are, however, no adequate and well-controlled studies in pregnant women. Levofioxacin shouid be used during pregnancy only il the potentiai beneirt justifies the potentiai risk lo the fefus. Nuraing Mathers: Levofioxacin has not heen measured in human milk. Based upon data from ofioxacin. it can be presumed that levoiloxacln is excreied in human milk. Caution should be exercised when IQUIX* is administered to a nursing mother. Pediatric U t s : Safety and effectiveness in children beiow the age of six years have not been established. Oral adnnnistralton of systemic Quinolones has been shown to cause arihropalhy in immature animals. There is no evidence thai the ophthalmic administration of levotloxacin tiaB any effect on weijjht Searing p n t s Gsrialrjc Use: No overall differences in safety or effectiveness have been otserved between elderly and other adult patients. ADVERSE REACTIONS The most frequently reported adverse events in the overall study population were headache and a taste disturbance following instillalion Tbese events occurred in approximately B-10% of pafients. Adveise events occurring in approximately 1-2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, intection, instillation site irritation/discomfort, ocuiar infection, nausea, ocuiar pain/discomfort, and throat irritation. Other reported ocular reactions occurring in less than 1 % of patients included chemosis, comsal erosion, corneal uicer, dipiopia, floafers, iiyperemia. lid edema, and lid erythema. Rx Only Manulaclursd by: Santen Oy, P.O. Box 33, FIN-33721 Tampere, Rniand
Markelad by; VISTAKON* Pharmaceuticals, U C Jacksonville. FL 32256 USA
Licensed from: Daiichi Sankyo Co., Ltd.. Tokyo, Japan U.S. PAT, MO 5.053,407
Antioxidants for Cataracts
It sounds reasonable that antioxidants might retard the development of age-related cataract. Several such
April 2007 Version 2707IQ-O25
VISION EXPO EAST 2008
SYNEMED i
nutraceuticals are marketed on the Internet as "natural" ways to prevent and treat cataracts, suggesting that cataract surgery is unnecessarily risky. Yet at best, little legitimate evidence exists to suggest antioxidants have a significant role in preventing age-related cataract. ARF.DS evaluated 4,757 participants, of which some used a highdose antioxidant formulation (vitamin C, 500mg; vitamin E, 400IU; beta carotene, 15mg; zinc oxide, 80mg; cupric oxide, 2mg} and some were given placebo daily.'" In one portion ofthe study, the researchers found that the patients at high risk of developing advanced AMD lowered their risk hy about 25% and their risk of vision loss caused by advanced AMD by about 19%. In the cataract portion of the study, however, researchers found that the same nutrients had no significant effect on the development or progression of age-related cataract. In another clinical trial of 1,193 eligible subjects, vitamin E (500IU daily) used for four years did not reduce the incidence or progression of nuclear, cortical, or posterior subcapsular cataracts.'" The authors concluded that their findings did not support "the use of vitamin E to prevent the development or to slow the progression of age-related cataracts." Another study, the Collaborative Italian-American Clinical Trial of Nutritional Supplements and Agerelated Cataract (CTNS), is currently looking at whether a vitamin and mineral supplement [Centrum, Wyeth Consumer Healthcare) containing recommended daily allowances can prevent age-related cataract or delay its progression. Results are expected in March 2008. Two lesser-known antioxidants
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in the United States—pirenoxine and glutathione—are a standard treatment for cataracts in Japan. The annual domestic sales of these drops in Japan are approximately 18 billion yen ($176 million).'^ The drops are routinely prescribed by their doctors and are also covered by their national health insurance.'^ Nevertheless, evidenced-based guidelines from the Japanese government show that that pirenoxine (sold as Catalin) and glutathione eye drops lack effectiveness for treating cataracts.'"* Although Japanese doctors may know that pirenoxine and glutathione offer questionable benefit for cataracts, it is possible that they continue to prescribe them as an easy way to satisfy their patients. This would be similar to doctors continuing to prescribe antibiotics for viral upper-respiratory infections, so that patients don't feel they're leaving the office visit empty-handed.^" Regretfully, this practice doesn't encourage the public to embrace evidence-based approaches to their own health care. Another antioxidant touted on the Internet for cataracts is Nacetyl-carnosine (NAC). The majority of the scientific literature about NAC for cataracts is authored by Mark Babizhayev, Ph.D., a Russian research scientist who serves as the executive director of Innovative Vision Products (IVP), based in Delaware. IVP markets their NAC eye drop under the name Can-C. IVP claims that NAC "is effective in reducing, reversing and slowing the occurrence of senile cataract."'' In a randomized, placebo-controlled study sponsored by IVP of 49 subjects (76 cataractous eyes), 90% of NAC-treated eyes showed improved best-corrected visual acuity after six months." The authors marginal reduction in lens opacification in a substantial number of cases.'' While it is unlikely that NAC will usurp traditional surgery for treating cataracts, NAC may bold some clinical benefit for selected cataract patients in which surgery is not desirable. The company says it may also provide beneficial results for such conditions as presbyopia, primary open-angle glaucoma, dry eye syndrome and retinal disease.
Topical N-acetyl-carnosine might actually work, but it probably won't replace cataract surgery any time soon.
Acupuncture for Eyes
Acupuncture has existed as a central part of health care in China for more than 4,500 years. Acupuncturists believe that their treatment unblocks invisible life energy (called "chi") along specific pathways of the body. Acupuncture stimulation can alter neurotransmitter release, regulate blood flow and release opi-
concluded that topical NAC shows potential for treating and preventing cataracts. Corroborating these results, an independent study of topical NAC for cataracts in dogs showed some
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oid peptides to provide analgesia."-^' Acupuncture has been used to treat and alleviate various ocular conditions, including dry eye, myopia, paralytic strabismus, retinitis pigmentosa, optic atrophy, iritis, conjunctivitis and cataract." One device that attempts to capitalize on acupuncture for eyes is the Eye-Max magnetic acupressure eye massager (Endless Eorest Inc.). The Web site for Eye-Max suggests that this product is appropriate for those who experience eyestrain, bloodshot eyes, dry eyes, double vision and headaches.^^ The homepage proclaims, "Benefit could be Great!" As with many other forms of CAM, there is an absence of large scale, randomized, controlled triais of acupuncture to validate its role as an ophthalmic treatment.
Without this data, the merits of acupuncture in optometry and ophthalmology are unlikely to gain widespread acceptance. Meanwhile, acupuncture should not supplant established ophthalmic treatment. However, it may be an alternative for refractory cases or as an adjunct to established therapy.^" This article doesn't come close to reviewing all the available CAM treatments because the field is simply too vast. You can appreciate the diversity of CAM for eye care by searching the Internet, just like 80% of Americans who use it to look up health information.-'* While there are many exaggerated claims made by people with dubious credentials, O.D.s should remain open-minded about emerging treatments, especially those validated by evidence-based methods.
'Benefit couid he Great!' say the makers of the Eye-Max magnetic eye massager.
There likely are non-traditional treatments out there, albeit not yet characterized, with the potential to help our patients. • Dr. Chou is in group practice at Carmel Mountain Vision Care in San Diego. Approximately W years ago, his efforts led the Ohio Attorney General's Office and
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Patient Care
Federal Trade Commission to investigate the publisher of "Hidden Secrets to Better Vision," a book that recommended unsafe and unproven eye treatment. Fischer Publishing Corp. closed shortly thereafter.
1. Margi E. "Flashes" of clear vision and negative accommodation with telerence to Ihe Bates melhod of visual training. Am J Optom Arch Am Acad Optom 1952 Apr;29{4):167-84. 2. Gardner M. Fads and laliacies in the name ot science, Mineola, NY: Dover Publications; 1957. 3. Stokkermans TJ, Dunhar MT. Solar retinopathy in a tiospita!-based primary cate dime. J Am Optomfesoc1998 0ct;69(10):625-36 4. Iowa court ol thE attorney general. Court orders vision improvement tectinoiogies to end salES ol "See Clearly Method" i<it. Avaiiabie al: www.5tate.ia.us/governmeijl/30/ latest news/releases/nov 2Q[)6A/iT.htm|. [Accessed February 2008) 5. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results ot a foilow-up national survey. JAMA 1998 Nov 11;280(18): 1569-75, 6. Baines P, Powell-Grifier E, McFann K, Nahin R, CDC Advance Data Report #343. Complementary and alternative medicine use among adults: United States, 2002. May 27. 2004 7. Rhee OJ. Katz LJ, Spaeth GL, et al. Complementary and alternative medicine tor glaucoma. Surv Ophthalmol 2001 Jui-Aug;46(1):43-55. 8. Smith JR, Spurrier NJ, Martin JT, et al. Prevalent use ot complementary and alternative medicine by patients with intiammalory eye disease. Ocul Immunoi Intlamm 2004 Sep;12(3):203-14. 9. Canter PH, Ernst E. Anthocyanosides ot Vaccinium myrtillus (bilberry)tornigtil vision—a systematic review of placebo-controlled trials. Surv Ophthalmol 2004 JanFeb:49(1):38-50. 10. Home-remedies-tor-you.com. Cataract symptoms, cataract treatment, cataract cure. Available at' www.hom&remedies-lar-vou.com/remedy/Catafact.tilmi. (Accessed February 2008.) 11. Golychev VN, Use ol honey in conservative treatment ot senile cataracts. Vestn Ottalmol 1990 Nov-Dec;106(6):59-62. 12. Zhao C, Shicti H. Prevention ol acetaminophen-induced cataract by a combination ot diallyl disullide and N-acetylcysteine. J Ocul Pharmacoi Ttiera 1998 Aug;14(4):345-55. 13. Natural Eye Health. Cataract cure and prevention. www.naturaievecare.gom/ (Jiseases.asp?d num^2. (Accessed February 2008.) 14. Bariett S. Homeopathy: Is it medicine? In: The Health Robbers: A Close Look at Ouackery in America. Butlalo, NY: Prometheus Books; 1993.191-202. 15. Albai MV, Chandorkar AG. Biitakh PM. Evaluation ol catalin, Succus Cineraria maritima and Catobell in goat lens cuitures. Indian J Ophthalmol 1981 Oct;29(3):147-9, 16. Age-Related Eye Disease Study Research Group. A randomized, piacebo-controlied, clinical trial ot high-dose supplementation with vitamins C and E and beta carotene tor age-ieiated cataract and vision loss: AREDS report no. 9. Arch Ophthalmol 2001 Od;119(10): 1439-42 17. McNeil JJ, Robman L, Tikellis G, et al. Vitamin E supplementation and cataract; randomized controlled trial. Ophlhaimology2004Jan;1l1(1):75-84 18. MedMK.com. Annual sales ot domestic pharmaceutical companies. Available at; www.medmk.com/mm/add/ ml add.htm. (Accessed June 2007.) 19. Sekimoto M, tmanaka Y, Kitano N, et al. Why are pliysictans not persuaded by scientitic evidence? A grounded theory interview study. BMC Health Serv Res 2006 Jui 27; 6;92. 20. Butter CC, Roilnick S, Pill R, et al. tJnderstanding the culture ol prescribing; qualitative study ot general practitioners' and patients' perceptions of antibiotics tor sore throats. BMJ 1998:317;637-642. 21. Can-C cataract eye drops. Available at; www.can-c.net, (Accessed Fehruary 2008.) 22. Babizhayev MA, Deyev Al, Yermakova VN, et al. Etficacy of N-acetylcarnosine in the treatment of cataracts. Drugs R D 2002;3(2).87-103, 23. Williams DL, Munday P. The etfect ol a topical antioxidant tormulation including N-acetyl carnosine on canine cataract; a preliminary study. Vet Ophthalmol 2006 SepGct;9(5):311-6. 24. NJH Consensus Conterence. Acupuncture, JAMA 1998 Nov 4;280(17):1518-24. 25. Leake R, Broderick JE. Treatment etiicacy ol xupuncSjre; a review of the research literature. Integr Med 1998; 1.107-115. 26. Astbury N, Alternative eye care. Br J Ophthalmol 2001 JuI;85|7);767-8. 27. Eye-Max Available at: wwv,eyemassage.com. (Accessed February 2008.) 28. American Academy ot Ophthalmology Complementary TTierapy Task Force: Acupuncture tor Ccular Conditions and Headxhes. Aprii 2003. Available at: www.aao.org/eyecare/ treatment/alternative-ttieraoies/acuDunlure-ocular.cfm. (Accessed February 2008.) 29. Fox S. Online Health Search 2006. Washington DC; PEW Internet & American Lite Project: 2006 M 29:2.
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