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ODs face increasing need for knowledge of nonpharmaceutical treatments

A growing number of patients are using complementary and alternative treatments, many of which have not been clinically studied.

by Milton M. Hom, OD, FAAO

This course is jointly sponsored by PCON, The State University of New York State College of Optometry and Vindico Medical Education. It is COPE-approved for 2 continuing education credits.

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When I was authoring Mosby’s Ocular Drug Consult a few years ago, the notion of covering herbals was unheard of. Today, conversations about herbals and alternative treatments are commonplace in the exam room. I have become more aware of alternative treatments less because of personal interest and more because of patient interest. However, it may be in our optometric heritage to have a certain amount of skepticism about prescribing alternative treatments.

Evidence based medicine

A study by Heller and colleagues showed that only 54% of the physicians surveyed were familiar with the supplements their patients were taking. Apparently, optometrists are not alone in this knowledge gap.

However, the question exists: Do alternative treatments work?

Complementary, alternative medicine has been gaining

Whether or not you believe in prescribing nonpharmaceutical treatments, a growing number of your patients believe in them. According to Barnes and colleagues, out of 31,044 adults interviewed, 36% used some form of complementary and alternative medicine (CAM) therapy (excluding prayer) during the past 12 months. For those patients, natural products (18.9%) was the most commonly used therapy. Based on this data, roughly one out of three or four of your patients uses CAM therapy.

In the Heller study, two groups were compared: 100 patients preparing for cosmetic surgery and 100 patients from the general public. Herbal medicines/supplements were used in 55% of the cosmetic group vs. 24% in the general public group. The sales for herbal therapies have been increasing 20% per year since the early 1990s. Herbs may be sold and marketed without Food and Drug Administration approval. Some experts, including Mar and Bent, feel the popularity of herbs leads to increases in patient self-diagnosis and delays in the use of more effective therapy.

Surveys have generally found that individuals more likely to use complementary and alternative medicine are female, live in the western United States, are likely to have a health complaint and have a higher socioeconomic status than do nonusers. Nahin and colleagues say that those engaging in positive health behaviors and exhibiting fewer health risk factors are more likely to use CAM. CAM users tend to pursue generally healthy lifestyles, suggesting that they may be open to additional recommendations toward optimizing their health.

CAM-related definitions

Nonpharmaceutical approaches have been used throughout history. Many terms are used to describe this area of increasing interest.

Complementary and alternative medicine (CAM) is considered to comprise healing practices and modalities not taught, practiced or integrated in the current Western biomedical model of medicine. Complementary medicine is used together with conventional medicine. Alternative medicine is used in place of conventional medicine.

According to CAM basics, CAM includes five concepts or domains: manipulative and body-based systems (chiropractic, osteopathic and massage), mind-body medicine (meditation, prayer, art, music and dance); biological-based systems (herbs, vitamins and natural products); energy therapies (biofield, touch, Qigong and bioelectromagnetic) and alternative medical systems (homeopathy, naturopathy, traditional Chinese medicine and Ayurveda).

Integrative medicine combines conventional medical treatments with the CAM treatments that have some high-quality scientific evidence. It is viewed by its advocates as the best of complementary medicine.

Ethnobotany is the study of the relationship between plants and people; it includes plants used for food and medicine.

Ethnomedicine is the study of traditional medicines, especially those whose knowledge and practices have been orally transmitted over the centuries.

Homeopathy is a controversial form of complementary and alternative medicine created in the late 18th century by German physician Samuel Hahnemann. Homeopathic remedies are made from substances that cause symptoms similar to the disease they aim to treat. These substances are serially diluted, with shaking at each stage that enhances “spirit-like medicinal powers held within a drug.”

In a meta-analysis on placebo-controlled trials of homoeopathy by Shang and colleagues, 110 homoeopathy trials and 110 matched conventional-medicine trials were analyzed. Weak evidence for effectiveness of homoeopathic remedies was found. There was strong evidence in favor of conventional interventions. The authors concluded that the clinical effects of homoeopathy are placebo effects.

Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients, according to Sackett and colleagues.

Trend toward evidence-based approach

A recent trend has been an emphasis on an evidence-based approach. Much of what has been written about many alternative therapies is based on experience and not scientific data. Often there is a gap in knowledge between anecdotal and scientific for many of the nonpharmaceutical treatments.

The U.S. Preventive Services Task Force has defined the evidence-based approach in more detail. See the accompanying tables showing the task force’s ranking system regarding effectiveness and the categories of recommendations according to level.

Categories of recommendations from the U.S. Preventive Services Task Force

One major criticism of evidence-based medicine is many effective approaches have not been studied and are not considered evidenced-based. Lack of evidence and lack of benefit are not the same.

Commonly used herbals

Let us consider the most commonly used herbals your patients may be taking. According to Heller and colleagues, the top four herbal/supplements for cosmetic patients were chondroitin (18%), ephedra (18%), Echinacea (14%) and glucosamine (10%). The top four used by the general public were Echinacea (8%), garlic (6%), ginseng (4%) and ginger (4%). For many of these herbals, drug interactions may occur with the oral versions of many ocular medications.

Chondroitin for osteoarthritis

Chondroitin is used as an alternative medicine to treat osteoarthritis. It is commonly sold together with glucosamine. Most chondroitin appears to be made from extracts of cartilaginous cow and pig tissues (cow trachea and pig ear and nose), but other sources such as shark, fish and bird cartilage are also used.

According to Verges and colleagues, in Europe, chondroitin sulfate formulation is approved as a drug, with evidenced efficacy and safety demonstrated by clinical trials in osteoarthritic patients.

Glucosamine also used for osteoarthritis

Glucosamine is also commonly used for the treatment of osteoarthritis. It may help rebuild cartilage and treat arthritis. Several prospective controlled clinical trials have shown positive results.

Glucosamine is usually derived from shellfish. Meta-analysis of randomized clinical trials by Richy and colleagues found efficacy for glucosamine on VAS (visual analog scale) and WOMAC (Western Ontario and McMaster University Osteoarthritis Index) pain, Lequesne index and VAS mobility and good tolerability.

A review by Bruyere and colleagues concluded that glucosamine and chondroitin sulfate act as valuable symptomatic therapies for osteoarthritis.

In a National Institutes of Health 6-month trial, patients taking glucosamine HCl, chondroitin sulfate or a combination of the two had no statistically significant improvement in their symptoms compared to patients taking a placebo.

Exploratory analysis of a subgroup of patients with moderate to severe pain suggested glucosamine and chondroitin sulfate may be significantly more effective than placebo, according to Clegg and colleagues.

Ephedra used for a number of maladies

Ephedra is traditionally used for treatment of the common cold, flu, various allergic symptoms, bronchitis, low blood pressure, fever, asthma, arthritis and fluid retention. It acts as a sympathomimetic agent and possesses positive ionotropic and chronotropic responses.

Ephedra also has bacteriostatic and antitussive actions. It is a cardiovascular stimulant (acts as an α- or β-adrenergic agonist) and is a potent bronchodilator. Because it increases metabolic rate, ephedra is contained in many over-the-counter slimming preparations.

Numerous fatalities have been linked to its use, and these deaths have been attributed to a lack of standardization in the formulation. Sale of the herb was banned in several states, including New York.

Echinacea used for colds, respiratory infections

Echinacea is generally used for colds and upper respiratory infections. Echinacea are members of the daisy family and grow widely throughout North American plains, prairies and woodlands. Echinacea possess significant immunostimulation properties due to enhanced phagocytosis and nonspecific T-cell stimulation.

In a randomized, double-masked, placebo-controlled study involving 302 volunteers taking Echinacea vs. placebo, two Echinacea compounds had subjective beneficial effects with regard to upper respiratory infection. Although there appeared to be a trend toward a reduction of upper respiratory tract infections, the observations failed to achieve statistical significance. Similar trials have been conducted with outcomes essentially in agreement.

The herb has also been used to aid in wound healing.

The most common side effect of Echinacea is an unpleasant taste sensation.

With respect to drug interactions, the immunostimulatory effects may offset the immunosuppressive actions of corticosteroids and cyclosporine. Most of the interactions are concerned with oral dosing of the medications. The effect on topical medications is not known.

Garlic used for cholesterol, hypertension

The active ingredient of garlic is allicin, which contains sulfur and, combined with breakdown products, gives garlic its characteristic smell. Several studies have targeted its vasodilator and hypocholesterolemic activity. Garlic derivatives are also frequently used for antiplatelet, antioxidant and fibrinolytic effects.

A meta-analysis in the United Kingdom combined the results of 16 clinical trials and demonstrated garlic to be effective in reducing total cholesterol by 12%. Serum triglyceride levels were also decreased. Other studies have found no improvement in serum lipid profiles of patients with hypercholesterolemia taking garlic.

The evidence supporting the use of garlic for hypertension is less substantial, with a few clinical trials showing modest decreases in systolic and diastolic blood pressure with the use of garlic supplements. Garlic may augment the effects of warfarin, heparin, nonsteroidal anti-inflammatory agents (NSAIDs) and aspirin and may result in an abnormal bleeding time. Interactions with topical NSAIDs are not known.

Ginseng used for anti-aging, energy

In ancient times, ginseng was used as an aphrodisiac, for anti-aging and as an energy-boosting tonic. It is also used as an antioxidant and by athletes to increase their energy levels. The herb is extremely popular and has been labeled as an adaptogenic, augmenting adrenal steroidogenesis via a centrally mediated mechanism.

Ginseng’s immunomodulatory effects have been described and studies have shown a ginseng-induced hypoglycemic effect. The use of ginseng should be avoided in patients on drugs such as warfarin, heparin, NSAIDs and aspirin. Interactions with topical NSAIDs are not known.

Ginger used for nausea, vertigo

Ginger (Zingiber officinale) has been described as an effective adjuvant against nausea, vomiting, motion sickness and vertigo. Anti-vertigo effects of ginger have been observed as compared to placebo with no study subjects experiencing nausea. In comparing the effects of diphenhydrinate and of ginger in the treatment of motion sickness, results demonstrated that ginger exerted a superior anti-motion sickness response.

Ginger has been found to be a potent inhibitor of thromboxane synthetase enzyme, which can prolong bleeding time. Use of ginger may increase bleeding time and may affect anticoagulants such as warfarin and heparin or drugs such as NSAIDs and aspirin. Interactions with topical NSAIDs are not known.

St. John’s wort used for anxiety, sleep disorders

St. John’s wort (Hypericum perforatum) is approved in Germany for the treatment of anxiety, depression, sleep related disorders and vitiligo. Although with considerable statistical flaws, a meta-analysis showed St. John’s wort to be more promising in the treatment of mild to moderate depression as compared to placebo.

Side effects described for St. John’s wort include dry mouth, dizziness, fatigue, constipation and nausea. The most prominent adverse effect, attributed to its hypericin component, is photosensitivity. Concomitant use of St. John’s wort is not recommended with photosensitization drugs such as tetracycline. It lowers the blood concentration of cyclosporine.

Alternative treatments for allergy

Numerous nonpharmaceutical treatments are available for allergy. Cold compresses, lubrication and the use of daily disposable contact lenses are viable treatments.

 
Lid hygiene and massage

A major problem for ocular allergy patients is wearing contact lenses. When the pollen counts are high, contact lens patients are miserable if they suffer from seasonal allergies. Changing to daily disposable contact lenses is a viable treatment option.

In a study by Hayes and colleagues, 67% of the 128 subjects agreed that daily disposable lenses provided improved comfort when compared to habitual lenses. Only 18% liked the new pair of habitual lenses better. For objective findings, daily disposable lenses showed greater improvement than new habitual lenses in slit-lamp findings compared to baseline.

Certain herbs including Euphrasia officinalis, Petasites hybridus and Argemone mexicana have been evaluated in control studies for the treatment of ocular allergy. Butterbur is a petasine that comes from a plant native to Europe, northern Africa and southwest Asia. Studies by Bielory, Lee, Schapowal and their colleagues have found it to have effects similar to Zyrtec (cetirizine, McNeil) on ocular allergy symptoms. It does not have the drawback of drowsiness. Butterbur can be found at Whole Foods; dosing is one capsule per day.

Honey is no more effective than placebo in the treatment of ocular allergy. According to Bielory and colleagues, acupuncture used regularly has demonstrated some positive trends in ocular allergy sufferers.

One allergy drop touted as a homeopathic remedy, Similasan Eye Drops, #2 for Allergy Eyes (Similasan, Highlands Ranch, Colo.), consists of honey bee, eyebright and cevadillas. Similasan depends on using microdilutions of the active ingredients to jump-start the immune system. The active ingredients attempt to stimulate a physiological reaction of the body’s healing mechanisms, according to the company’s Web site.

In a study by Abelson and colleagues, researchers subjected 47 patients to an antigen and then treated them with either Similasan #2 or a saline control. Both the Similasan and the placebo showed decreased hyperemia and itching. However, there were no statistically significant differences between the two.

As mentioned before, a previous meta-analysis by Shang and colleagues concluded that the clinical effects of homeopathy trials in general are nothing more than placebo effects.

Alternative treatments for dry eye

Many nonpharmaceutical treatments exist that are effective for dry eyes. One major cause of dryness is lid disease. The core treatment for lid disease is lid hygiene (scrubs, massages and soaks).

In a study by Paugh and colleagues, 21 patients with contact lens intolerance were treated in one eye with lid hygiene for meibomian gland dysfunction. After 2 weeks of treatment, fluorescein breakup time was improved an average of 4 seconds compared to the control eye. These objective results were corroborated by reports of improved subjective comfort with contact lens wear after therapy.

One of the most effective methods of lid hygiene and massage is using uncooked rice and a sock. See the accompanying table for details. Microwaving a sock with uncooked rice and massaging the lids works very well. Flaxseed (not the oil) can be used in place of uncooked rice. Placing a wet sterile gauze under the sock can enhance the process with moist heat.

I like to add lid expression after the massage for those patients with meibomian gland dysfunction. Some experts like to use microwaved potatoes or boiled eggs for heat and lid massage. I prefer not to use them because of the limited shelf life of food products.

Current thinking is that lid disease that does not go away with conventional treatment is most likely ocular Demodex. Demodex has been targeted as a potential cause of ocular surface inflammation, meibomian gland dysfunction and lash abnormalities.

Tea tree oil shampoo has been shown to be effective for Demodex. A study by Gao and colleagues involving 11 patients showed that lid scrubs with tea tree oil shampoo can effectively eradicate ocular Demodex and result in subjective and objective improvements.

Nutritional supplements such as omega-3 and omega-6 fatty acids are increasingly prescribed for dry eye. One especially large study involved 32,470 women, ages 45 to 84 years old, with information on diet and dry eye syndrome cross-sectionally studied. Miljanović and colleagues suggested that a higher dietary intake of omega-3 fatty acids is associated with a decreased incidence of dry eye syndrome in women.

Is supplementation effective? In a study by Creuzot and colleagues, 71 patients with mild to moderate dry eye syndromes were given supplements or placebo capsules twice a day for 6 months. Schirmer’s test, tear break-up time, fluorescein staining and lissamine green staining were improved with treatment when compared to placebo, but the difference was not statistically significant.

Numerous artificial tears are on the market. For the most part, they offer effective and safe treatment for dry eye. One novel treatment with no additives or preservatives is Nature’s Tears EyeMist (Bio-Logic Aqua Technologies, Grants Pass, Ore.). It is described on the company’s Web site as pure pH-compatible water with mineral content that is misted into the eye. Because there are no demulcents, surfactants or viscosity agents, the residence time in the tear film is probably shorter than other artificial tears on the market.

In the preface of a keratoconus book written several years ago, authors Zadnik and Barr describe the book as, “very data-driven; we have concentrated on presenting what we definitely know about keratoconus rather than what we anecdotally believe.” Within the scope of contact lenses, most of what appears in the textbooks has not been subject to clinical study and may be considered as anecdotal.

I believe this applies to many of the treatments we use in eye care today. Although many of the therapies have not undergone the rigor of a clinical trial, they do deliver benefit nonetheless. Not every treatment has to be evidence-based.

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