Daniel F. McCarter, MD

ABSTRACT

BACKGROUND: Many individuals with asthma are allergic to house dust mites. The incidence and severity of asthma is increasing. More people are seeking complementary medical care, including homeopathy. Homeopathy attempts to mitigate disease by diluting the treatment without diluting the effect.

POPULATION STUDIED: The investigators recruited 1000 asthmatic outpatients from 38 general practices in Hampshire and Dorset, England. Of these, 327 tested positive for house dust mite allergy. Eighty-five patients were excluded for asthma that was either too mild or too well-controlled. Thus 242 subjects between 18 and 55 years old were randomized into the study. This group included both sexes; no note was made of race.

STUDY DESIGN AND VALIDITY: A double-blind, randomized control design was used. A French manufacturer of homeopathic products prepared the active agent by making 30 sequential 1:100 dilutions of a house dust mite allergen (this “ultramolecular” is a highly diluted solution of allergen molecules). After a 4-week period to assess baseline symptoms, subjects were randomized to receive either an oral homeopathic immunotherapy preparation or a similarly prepared placebo in 3 doses over 24 hours. They were then followed for 16 weeks with 3 clinic visits and every-other-week symptom diaries.

OUTCOMES MEASURED: Primary outcomes were change in lung function as measured by forced expiratory volume in 1 second (FEV₁) and quality of life as measured by proportion of symptom-free days in each 7-day diary period. Other outcomes included peak expiratory flow, scores for asthma visual analogue scale, and average mood scores.

RESULTS: This homeopathic therapy showed no significant improvement over placebo with regard to FEV₁ (0.136 L/sec active agent vs 0.414 L/sec placebo, 95% confidence interval [CI] =0.136–0.693) or mean improvement in quality of life (0.090 active agent vs 0.117 placebo, 95% CI = –.096 to .0150). Neither was there any significant difference in any of the secondary outcomes. These results were independent of the subjects’ belief in complementary medicine. Interestingly, at different times during the study improvement was noted in both the active therapy and placebo groups in FEV₁, quality of life, and mood.

ABSTRACT

BACKGROUND: Many individuals with asthma are allergic to house dust mites. The incidence and severity of asthma is increasing. More people are seeking complementary medical care, including homeopathy. Homeopathy attempts to mitigate disease by diluting the treatment without diluting the effect.

POPULATION STUDIED: The investigators recruited 1000 asthmatic outpatients from 38 general practices in Hampshire and Dorset, England. Of these, 327 tested positive for house dust mite allergy. Eighty-five patients were excluded for asthma that was either too mild or too well-controlled. Thus 242 subjects between 18 and 55 years old were randomized into the study. This group included both sexes; no note was made of race.

STUDY DESIGN AND VALIDITY: A double-blind, randomized control design was used. A French manufacturer of homeopathic products prepared the active agent by making 30 sequential 1:100 dilutions of a house dust mite allergen (this “ultramolecular” is a highly diluted solution of allergen molecules). After a 4-week period to assess baseline symptoms, subjects were randomized to receive either an oral homeopathic immunotherapy preparation or a similarly prepared placebo in 3 doses over 24 hours. They were then followed for 16 weeks with 3 clinic visits and every-other-week symptom diaries.

OUTCOMES MEASURED: Primary outcomes were change in lung function as measured by forced expiratory volume in 1 second (FEV₁) and quality of life as measured by proportion of symptom-free days in each 7-day diary period. Other outcomes included peak expiratory flow, scores for asthma visual analogue scale, and average mood scores.

RESULTS: This homeopathic therapy showed no significant improvement over placebo with regard to FEV₁ (0.136 L/sec active agent vs 0.414 L/sec placebo, 95% confidence interval [CI] =0.136–0.693) or mean improvement in quality of life (0.090 active agent vs 0.117 placebo, 95% CI = –.096 to .0150). Neither was there any significant difference in any of the secondary outcomes. These results were independent of the subjects’ belief in complementary medicine. Interestingly, at different times during the study improvement was noted in both the active therapy and placebo groups in FEV₁, quality of life, and mood.

ABSTRACT

BACKGROUND: Many individuals with asthma are allergic to house dust mites. The incidence and severity of asthma is increasing. More people are seeking complementary medical care, including homeopathy. Homeopathy attempts to mitigate disease by diluting the treatment without diluting the effect.

POPULATION STUDIED: The investigators recruited 1000 asthmatic outpatients from 38 general practices in Hampshire and Dorset, England. Of these, 327 tested positive for house dust mite allergy. Eighty-five patients were excluded for asthma that was either too mild or too well-controlled. Thus 242 subjects between 18 and 55 years old were randomized into the study. This group included both sexes; no note was made of race.

STUDY DESIGN AND VALIDITY: A double-blind, randomized control design was used. A French manufacturer of homeopathic products prepared the active agent by making 30 sequential 1:100 dilutions of a house dust mite allergen (this “ultramolecular” is a highly diluted solution of allergen molecules). After a 4-week period to assess baseline symptoms, subjects were randomized to receive either an oral homeopathic immunotherapy preparation or a similarly prepared placebo in 3 doses over 24 hours. They were then followed for 16 weeks with 3 clinic visits and every-other-week symptom diaries.

OUTCOMES MEASURED: Primary outcomes were change in lung function as measured by forced expiratory volume in 1 second (FEV₁) and quality of life as measured by proportion of symptom-free days in each 7-day diary period. Other outcomes included peak expiratory flow, scores for asthma visual analogue scale, and average mood scores.

RESULTS: This homeopathic therapy showed no significant improvement over placebo with regard to FEV₁ (0.136 L/sec active agent vs 0.414 L/sec placebo, 95% confidence interval [CI] =0.136–0.693) or mean improvement in quality of life (0.090 active agent vs 0.117 placebo, 95% CI = –.096 to .0150). Neither was there any significant difference in any of the secondary outcomes. These results were independent of the subjects’ belief in complementary medicine. Interestingly, at different times during the study improvement was noted in both the active therapy and placebo groups in FEV₁, quality of life, and mood.