Homeopathic drops for allergy: Ready or not?

Issue: May 1996

BREMERTON, Wash.—A lack of scientific studies on homeopathic medicine prompts many practitioners in the United States to question its use, but an optometrist here believes the approach of "like cures like" has a place in treating mild allergic conjunctivitis.

Robert E. Black, OD, in private group practice, is an allergy sufferer and contact lens wearer who for years has used and prescribed homeopathic eye drops to relieve chronic, low-grade allergy symptoms.

Developed by German physician and chemist Samuel Hahnemann, homeopathic medicine holds that a diluted form of an agent that induces complaints in healthy individuals that are similar to those of the patient can be used to cure the patient.

Black was introduced to the homeopathic treatment of mild allergies nearly 10 years ago and admits he was skeptical initially. However, after trying the drops himself, Black found they were convenient and improved his symptoms. He then tested the drops on his patients and found the majority responded favorably. "The drops did not always solve the acute attacks, and sometimes we had to go to the big guns, but for the majority of patients, compliance and comfort were excellent," he said.

Placebo effect problematic

Bruce Onofrey, OD, RPh, head of primary care eye services at Lovelace Medical Center, Montgomery Eye Clinic in Albuquerque, said he is not against homeopathic treatments, but believes clinicians should have the benefit of double-blind, controlled studies that demonstrate their clinical significance. The studies that have been done, he said, do not take into account the placebo effect of eye drops, "which means if you put anything in your eye, artificial tears or whatever, 50% of people will feel better."

Unless a homeopathic agent showed efficacy in a rigorous study, he noted, he would not see any reason to use it.

A preliminary study, conducted in 1992 and published last December in Contact Lens Spectrum, concluded that Similasan Eye Drops #2, manufactured by Similasan Corp., Kent, Wash., may be a successful alternative treatment for acute allergic conjunctivitis by reducing the hyperemia and itching associated with ocular allergy.

In the study, researchers challenged 47 subjects with increasing doses of an antigen to which they were sensitized until they responded with at least 2+ itching, as graded on a scale of 0 to 4. Zero represented no symptoms and 4 represented a severe response that required eye rubbing. Each subject was given two masked bottles, one containing drug, the other containing placebo (saline, as control), and was instructed to administer one to two drops of the appropriate liquid into the assigned eye four times daily for 14 days.

Following 2 weeks of dosing, researchers found similar reduction in hyperemia and itching in both the placebo-treated and the homeopathic-treated groups. Concerning itching, subjects reported grade levels of 2.97 and 3.05 on two visits prior to treatment.

Following treatment, they reported grade levels of 1.89 with placebo (saline) and 2.00 with the homeopathic drop.

Onofrey said the results of the preliminary study indicated no significant difference between Similasan drops and placebo in reducing itching. "Itching is subjective, and that leads to a placebo effect," he said. "This study tells me that Similasan proved no better than placebo, which, in this case, was saline."

Follow-up study conducted

Lead researcher Mark B. Abelson, MD, said this preliminary clinical work was followed by a second study conducted 1 year later, the results of which have not been tabulated and published. Abelson, a clinical senior scientist at Schepens Eye Research Institute, Harvard Medical School, said the follow-up study addressed a potential crossover effect from the initial results.

"We designed the second study as a parallel group; the first one indicated a crossover effect, because placebo was more effective than usual," Abelson said. "We wanted to compare two groups of patients this time, not the right eye to the left eye as was done initially."

In the follow-up study, 77 identically screened patients were placed into two separate groups. One group used only placebo drops (saline), while the other group used only homeopathic drops.

"The results of the parallel trial showed that both the active and placebo formulation significantly inhibited hyperemia and itching induced by antigen in a challenge mode," Abelson said, "however, an analysis of a subgroup of the population also showed that the active formulation was statistically more effective than placebo in patients who suffer from more severe ocular allergic reactions."

This same statistical difference was not found in patients who suffer from milder allergic conjunctivitis, he said. "There is a hint of something happening," Abelson continued. "You do not have to believe in the entire homeopathic concept to appreciate a positive effect with a medication. We found statistical differences that favored Similasan over placebo with the more severe allergy."

Differing interpretations

Brian Banks, marketing director at Similasan Corp., said the studies are a step toward answering objections from practitioners about homeopathy. "Optometrists need to research the facts and try the medications, just like they do with other drugs such as steroids or beta-blockers," he said.

A common objection to homeopathic treatment, Banks continued, is that the precise mechanism of action is unknown. He said this same concern can be expressed of traditional allergy drugs. "If you look at other allergy medications, for example those listed in the Physicians' Desk Reference, it states that the precise mechanism of action is also unknown," Banks said.

Abelson agreed, saying, "While we do not know how this works, science is replete with drugs being used to treat diseases before we understood how they worked. I would rather know if something worked than how it worked."

The ingredients of Similasan Eye Drops #1 are belladonna, euphrasia and mercurius, while Similasan Eye Drops #2 contain apis, euphrasia and sabadilla. Both drops are processed in a sterile, pH-balanced (non-buffered), isotonic solution. They have a potency level of 6x, which means the ingredient has been diluted and processed one part to 10, six times.

Appropriate applications

For patients who suffer from mild allergy, Black will recommend Similasan's homeopathic drops. "These drops are more comfortable because there is no burning or stinging," he said. "In mild allergy if you go to the prescription ocular steroids, the mast cell stabilizers or the NSAIDs, the patient often becomes noncompliant because the drops are irritating."

Optometrists can upgrade treatment to one of the above group, Black said, if the homeopathic drops do not bring relief. He currently prescribes Similasan Drops #1 for dry eye patients who have low tear volume and recommends Similasan Drops #2 for chronic or low-grade allergies. These drops, he said, are often significantly less expensive than ocular steroids, mast cell stabilizers and NSAIDs.

Black said he would not recommend Similasan drops for an acute allergy attack with chemotic bulbar conjunctivae or for patients who want their appearance helped immediately. "In cases like that, I would use an ocular steroid or a non-steroidal anti-allergy prescription like Acular (ketorolac tromethamine, Allergan) along with cold compresses and an antihistamine," he said.

Clinicians should understand that homeopathic eye drops are not part of the standard treatment protocol in many formularies.

Call for studies

According to Randall Thomas, OD, in group practice in Concord, N.C., only controlled scientific studies can validate the use of homeopathic medicine for ocular allergy. Testimonials in support of homeopathic treatment are not enough, he said.

"Let's be professional and have some studies," Thomas said. "Give us some legitimate, scientific validity with which to embark upon a course of homeopathy."

For example, Thomas said, there are studies that document how H1 receptor blockers function as antihistamines and, thus, have a valid role in allergy therapy. "Similasan might really be the best thing in the world for ocular allergy," he said, "but doctors need scientific studies to guide us in proper prescribing."

Acknowledging that homeopathic medicine is not taken seriously by many doctors today, Black said, "Some of our more drug-oriented doctors have to have the science, and if the pharmaceutical companies are not doing the double-blind studies, we practitioners should be doing them."

Black said homeopathic eye drops allow him to "give the patient the best, regardless of whether it is homeopathic or drug-related. The proof is in patient compliance and satisfaction."