Dana Ullman

Section Two

Clinical Research with Individualized Care

Some people incorrectly assume that research using homeopathic medicines is impossibly complicated because each medicine must be individualized to the patient. The following studies disprove this simplistic belief.

A recent clinical trial evaluating homeopathic medicine was a unique study of the treatment of asthma.6 Researchers at the University of Glasgow used conventional allergy testing to discover which substances these asthma patients were most allergic to. Once this was determined, the subjects were randomized into treatment and placebo groups.

Those patients chosen for treatment were given the 30c potency of the substance to which they were most allergic (the most common substance was house dust mite). The researchers called this unique method of individualizing remedies "homeopathic immunotherapy" (homeopathic medicines are usually prescribed based on the patient's idiosyncratic symptoms, not on laboratory analysis or diagnostic categories). Subjects in this experiment were evaluated by both homeopathic and conventional physicians.

This study showed that 82% of the patients given a homeopathic medicine improved, while only 38% of patients given a placebo experienced a similar degree of relief. When asked if they felt the patient received the homeopathic medicine or the placebo, both the patients and the doctors tended to guess correctly.

The experiment was relatively small, with only 24 patients. As noted, for statistically significant results, small experiments must show a large difference between those treated with a medicine and those given a placebo. Such was the case in this study.

Along with this recent asthma study, the authors performed a meta-analysis, reviewing all the data from three studies they performed on allergic conditions, which totaled 202 subjects. The researchers found a similar pattern in the three studies. Improvement began within the first week and continued through to the end of the trial four weeks later. The results of this meta-analysis were so substantial (P=0.0004) that the authors concluded that either homeopathic medicines work or controlled clinical trials do not. Because modern science is based on controlled clinical trials, it is a more likely conclusion that homeopathic medicines are effective.

Another recent study, published in the American journal Pediatrics, tested homeopathic medicine for the treatment of a condition recognized to be the most serious public health problem today, childhood diarrhea.7 Over 5 million children die each year as the result of diarrhea, mostly in nonindustrialized countries. Conventional physicians prescribe oral rehydration therapy (ORT, a salt solution that helps children maintain fluid balance), but this treatment does not fight the infection that underlies the diarrhea.

Conducted in Nicaragua in association with the University of Washington and the University of Guadalajara, this randomized double-blind, placebo-controlled study of 81 children showed that an individually chosen remedy provided statistically significant improvement of the children's diarrhea as compared to those given a placebo. Children given the homeopathic remedy were cured of their infection 20% faster than those given a placebo, and the sicker children responded most dramatically to the homeopathic treatment. A total of 18 different remedies were used in this trial, individually chosen based on each child's symptoms.

A study of the homeopathic treatment of migraine headache was conducted in Italy.8 Sixty patients were randomized and entered into a double-blind, placebo-controlled trial. Patients regularly filled out a questionnaire on the frequency, intensity, and characteristics of their head pain. They were prescribed a single dose of a 30c remedy at four separate times over two-week intervals. Eight remedies were considered, and prescribers were allowed to use any two with a patient. While only 17% of patients given a placebo experienced relief of their migraine pain, an impressive 93% of patients given an individualized homeopathic medicine experienced good results.

A randomized double-blind, placebo-controlled trial was performed on 175 Dutch children suffering from recurrent upper respiratory tract infections.9 Children in the treatment group were prescribed a "constitutional medicine" for their overall health as well as acute medicines to treat the acute respiratory infections they developed. The study found that the children given homeopathic medicines had a 16% better daily symptom score than children given a placebo.

This study also found that the number of children given a placebo who had to undergo adenoidectomy was 24% higher than for the children given homeopathic remedies. A 54.8% reduction in the use of antibiotics in the children given homeopathic medicines was reported, while the children who received a placebo experienced a 37.7% reduction in antibiotic use. (This reduction in both groups was determined to be the result of the normal growth and development of the child, dietary changes - the study provided written nutritional advice to the parents - and the change in expectations as the result of being under medical care.)

The statistical possibility of these results happening by chance was 6% (P=0.06). Because statistical significance in science is recognized when there is a 5% or less chance of results happening at random, the researchers concluded that homeopathic medicine seem to add little to the treatment of upper respiratory tract infections. This more conservative conclusion appeared to be influenced by the fact that the authors sought and received publication of their study in the British Medical Journal. They should have more accurately said that homeopathic medicines provided benefit to children with upper respiratory infections, but there is a small chance (6%) that these good results happened at random.

Considering the closeness of these results to 5%, considering the other improvements in the homeopathic group's health, and considering the increasingly widespread desire to avoid antibiotics, it makes sense for physicians and parents to consider seeking homeopathic care for children's upper respiratory infections.

Another study that involved individualized homeopathic care was in the treatment of rheumatoid arthritis.10 The study involved 46 patients. Two homeopathic physicians prescribed individually chosen medicines to each patient, though only half of them were given the real remedy, while the other half were given a placebo. The study found that 82% of those given an individualized homeopathic remedy experienced some relief of symptoms, while 21% of those given a placebo experienced a similar degree of relief.

One other very interesting trial that utilized semi-individualization of care was in the treatment of primary fibromyalgia (also called fibrositis).11 Patients with fibrositis were admitted into a trial in which homeopathic physicians chose between three possible remedies, Arnica, Rhus tox, and Bryonia. Half of the patients were given one of these remedies, and the other half were given a placebo. There was no discernible difference between these groups. However, as an integral part of the experiment's design, a panel of homeopaths evaluated the accuracy of each prescription. This analysis found that those patients whom the panel considered to have received the correct remedy experienced a statistically significant improvement in symptoms as compared to those patients given the "incorrect" remedy or the placebo.

These same researchers next conducted a more sophisticated trial in the treatment of primary fibromyalgia.12 This double-blind, placebo-controlled, crossover trial admitted only those patients who fit the symptoms of Rhus tox. The researchers found that this constituted 42% of the patients interviewed. One-half of these 30 patients were given Rhus tox 6c during the first phase of the experiment, while the other half were given a placebo. During the second phase, those patients initially given the medicine were given a placebo, and those patients initially given a placebo were now given the homeopathic remedy. Researchers determined at the beginning of the experiment that improvement in pain and sleeplessness were the outcome measures most important in evaluating the results of this trial, and the results showed that 25% more of the patients experienced pain relief when taking the homeopathic remedy compared to when they were given a placebo and almost twice as many had improved sleep when taking the remedy.

This type of crossover design is considered a sophisticated type of research because it compares each person when using a treatment with the same person when using a placebo. Most other research compares two supposedly similar groups of people, but researchers commonly acknowledge that it is difficult and perhaps impossible to get two exactly similar groups of people. The limitation of the crossover design for homeopathic treatment, however, is that most homeopathic medicines provide long-term benefits, so that once a person stops taking a homeopathic remedy he or she may still continue to improve, even in the placebo stage of the trial. Low-potency medicines, such as the 6c used in the above described experiment, generally have short-acting effects, while higher potency medicines generally have increasingly longer-term effects.

Clinical Research with Non-individualized Care

In addition to the studies on homeopathy in which individualized remedies are prescribed, there is also a body of research testing single remedies to people given in a non-individualized manner. Such research is potentially problematic because homeopaths acknowledge that the remedies require some degree of individualization to be effective. The results of a nonindividualized study, either positive or negative, can be misunderstood by people who do not know basic principles of the homeopathic method.

One study using nonindividualized homeopathic treatment was sponsored by the British government during World War II and was conducted in 1941-42 on volunteers whose skin was burned with mustard gas.13 The study showed the efficacy of Mustard gas 30c as a preventive or Rhus tox 30c and Kali bichromicum 30c as therapy. The study was double-blind, placebo-controlled, and was conducted at two centers (London and Glasgow), both showing similarly positive results. A more recent analysis of the data further substantiated the statistical significance of this study.14

It should, however, be mentioned that the researchers also tested the efficacy of Opium 30c, Cantharis 30c, and Variolinium 30c, none of which provided any noticeable benefit. If this trial had tested only these medicines, the researchers might have concluded that homeopathic medicines were ineffective in treating mustard gas burns. Finding the correct remedy is the key to making homeopathy work.

Some skeptics and journalists inaccurately report that homeopathy is primarily used to treat minor health problems. Homeopaths today primarily treat various chronic ailments for which conventional medicine has not provided effective treatment. One example of a chronic and serious problem shown by a controlled study to be effective treated by homeopathy is diabetic retinitis15 (retinitis is a common complication of diabetes in which there is an inflammation of the retina causing impairment of sight, perversion of vision, swelling, discharge from the eye, and sometimes hemorrhages into the retina).

This double-blind, randomized, placebo-controlled study on 60 patients used Arnica 5c. The results of this study showed that 47% of patients given Arnica 5c experienced improvement in central blood flow to the eye, while only 1% of patients given the placebo experience this improvement. Further, 52% of patients given Arnica 5c experienced improvement in blood flow to other parts of the eye, while only 1.5% of those given the placebo experienced a similar degree of improvement.

The best-selling flu remedy in France is actually a homeopathic medicine. Anas barbariae 200c, commonly marketed under the trade name Oscillococcinum TM, is also popular in the U.S. and is effective primarily at the first signs of influenza. A double-blind, placebo-controlled study with 478 patients suffering from influenza was conducted, making this the largest trial yet performed testing a homeopathic medicine.16 This trial showed that almost twice as many people who took the homeopathic remedy got over the flu after 48 hours as compared to those given a placebo.

Although this remedy was found to work for all age groups, it was considerably more effective for people under 30 than for those over 30. However, it was not found to be effective when subjects had severe flu symptoms. In severe cases of the flu, a more individualized homeopathic remedy may be indicated.

In addition to various studies on human health, there have also been some animal studies. British researchers have conducted trials showing that homeopathic medicines, specifically Caulophyllum 30c, could lower the rate of stillbirths in pigs.17 Pigs given a placebo had 103 births and 27 stillbirths (20.8%), while those given Caulophyllum 30c had 104 births and 12 stillbirths (10.3%).

Not all studies show efficacy of homeopathic medicines, not because they don't work but mostly because the studies were poorly designed. One such study tested a single homeopathic medicine in the treatment of osteoarthritis.18 This study consisted of 36 patients, of whom one third were given Rhus tox 6c, one third were given a conventional drug (fenoprofen, a nonsteroidal anti-inflammatory drug), and one third were given a placebo.

Those patients given the conventional drug experienced some relief of symptoms, but those given the homeopathic remedy and the placebo had a similar lack of response to treatment. While some people would erronously conclude that homeopathic medicines are ineffective in the treatment of osteoarthritis, it would be more appropriate and accurate to conclude that Rhus tox 6c is an ineffective remedy when given without individualization to people with osteoarthritis.

One of the confounding variables from this trial was that 2 of the 12 patients given the homeopathic medicine were withdrawn from the trial because they experienced an aggravation of symptoms after taking the medicine. Because homeopathic medicines sometimes cause a temporary increase in chronic symptoms before significant improvement, it was disappointing that the researchers did not follow their status. Because this trial lasted only two weeks, it did not allow time for the homeopathic remedy to be adequately evaluated. If, for instance, these 2 patients experienced the significant relief that is common after an initial aggravation of symptoms, the results of the trial would have been different.

Further, it is unfair to compare a fast-acting conventional drug that has side effects with a slower acting homeopathic medicine that is considerably safer. Finally and of great significance is the fact that while Rhus tox is a common remedy for rheumatoid arthritis, it is less common for osteoarthritis.

Next - Clinical Research with Homeopathic Combination Remedies