With Comments from John La Puma, MD, FACP
Sources: Lewith GT, et al. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: Double blind randomised controlled clinical trial BMJ 2002;324:520.
Feder G, Katz T. Randomised controlled trials for homoeopathy. Who wants to know the results? BMJ 2002;324:498-499.
To evaluate the efficacy of homeopathic immunotherapy on lung function and respiratory symptoms in asthmatic people allergic to house dust mite, a double-blind randomized controlled trial was conducted in 38 general practices in Hampshire and Dorset.
Of 242 people with asthma and positive results to skin prick test for house dust mite, 202 completed clinic-based assessments, and 186 completed diary-based assessments. After a four-week baseline assessment, participants were randomized to receive oral homeopathic immunotherapy or placebo and then assessed over 16 weeks with three clinic visits and diary assessments every other week. The following clinic-based assessments were conducted: forced expiratory volume in one second (FEV1), quality of life, and mood. Diary-based assessments included: morning and evening peak expiratory flow, visual analogue scale of severity of asthma, quality of life, and daily mood.
There was no difference in most outcomes between placebo and homeopathic immunotherapy. There was a different pattern of change over the trial for three of the diary assessments: morning peak expiratory flow (P = 0.025), visual analogue scale (P = 0.017), and mood (P = 0.035). At week three there was significant deterioration for visual analogue scale (P = 0.047) and mood (P = 0.013) in the homeopathic immunotherapy group compared with the placebo group. Any improvement in participants’ asthma was independent of belief in complementary medicine.
Homeopathic immunotherapy is not effective in the treatment of patients with asthma who are allergic to house dust mite. The different patterns of change between homeopathic immunotherapy and placebo over the course of the study are unexplained.
Comment
This confusing and criticized study has ignited a pollen cloud of inner sanctum disagreement, confusing many clinicians further. An editorial didn’t help much: Both editorialists had been paid by companies invested in manufacturing or advancing homeopathy, and found, in part, that "randomization and blinding of participants substantially distorts the context of homeopathic prescribing, potentially weakening its effect."
Designed to replicate the landmark, positive study by Reilly et al of the homeopathic treatment of asthma with larger numbers, more power, and broader outcome variables, the investigators actually tested effectiveness of placebo vs. (nontraditionally prepared) homeopathic preparation. Both groups improved symptomatically and in FEV1, but because no third arm of active, conventional treatment was tested, it’s impossible to know how they compare with prescription medication.
Homeopathic physicians have a different and sometimes effective way of diagnosing and treating patients, and may easily, much to the puzzlement of allopathic and osteopathic physicians, come up with 100 different prescriptions for 100 different patients with the same biomedical condition. But a well-known meta-analysis of four years ago showed a greater-than-placebo effect in a number of conditions, including asthma. And homeopathy is popular: Two in five adults in Australia, one in 12 adults in the United Kingdom, and one in 25 in the United States use homeopathy.
The argument that this current trial tested isopathic preparation ("the use of homeopathically prepared allergens to treat allergies" and absent molecules) not homeopathy (with its focus on long, deliberate visits, multifaceted history and assessment, and few molecules of active ingredient in its dilutions) is probably correct, though this is certainly particle splitting in the world of the randomized controlled trial.
Recommendation
Asthma has effective conventional treatments. Offer them first to patients with moderate-to-severe disease. Homeopathic treatment may not be better than placebo, but both consistently result in symptomatic improvement. Asthmatic, allergic patients who want to try homeopathy can be encouraged: A visit to a homeopathic physician for a long, attentive visit may in itself be helpful.
La Puma J. Homeopathic immunotherapy and asthma. Altern Med Alert 2002;5(9):111.
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