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Three Part Question

In [adults and children with bronchial asthma] is [homeopathy better than placebo] at [reducing symptoms and improving respiratory function]?

Clinical Scenario

In the course of an allergologic visit, I prescribed to Peter, a lively seven years old child, with a history of weekly wheezing and exercise induced asthma, a two months treatment with inhaled steroids, but his mother, worried about the possible side effects of corticosteroids, would prefer to see her son treated in a more natural way and asked my opinion about a homeopathic medicine suggested by her chemist. I told her at once that I disagreed with this therapeutic method, but as I realized not to know much about it, I requested her to wait a few days in order to get further information.

Search Strategy

The search was conducted independently by two reviewers (the authors).
Medline 1966 to January 2005 using OVID interface, Cochrane Library (2005), We hand-searched the reference list of published reviews and papers and asked the Centre for Homeopathic Medicine of Milan for further trials not presented in "official" databases.
PubMed clinical queries using "Homeop* AND bronchial asthma". Limits: Systematic Reviews OR Meta-Analysis OR Randomized Controlled Trial.

Search Outcome

1 systematic review (McCarney), 12 studies found, 6 were relevant (see table).

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Reilly et al. 1994 The United Kingdom	28 adults, age > 16 yrs with allergic asthma, > 1 yr history of asthma Forced Expiratory Volume in 1 second > 15% after beta2. Isopathy (ultramolecolar diluitions of individual allergen, mostly House dust mite) vs. placebo, 3 doses of globules within 24 hrs (once). 4 wks treatment phase + 4 wks optional follow-up	Double blind RCT (level 1b) Jadad score: 4 Allocation concealment adequate Intention to treat: no	Change of subjective symptoms measured on a 100 mm visual analogue scale	Mean Difference of visual analogue scale score: -14.80 mm (95% CI -23.4 to -6.2)	Small study, but with a good internal validity
Freitas et al 1995 Brazil	69 children, age 1-12 yrs , with > 2 episodes of wheezing with intervals of 3 months or less. Blatta officinalis CH6 vs. placebo, 2 globules 3 times a day X 6 months	Double blind RCT (level 1b) Jadad score: 4 Allocation concealment adequate Intention to treat: no	Frequency, duration and intensity of wheezing episodes and a score combining these 3 measures	No significant difference	Is it real asthma ? Lost to follow-up: > 20% Inclusion criteria, type of conventional treatment, outcome measures inadequately reported
Matusiewicz et al 1995 Poland	40 adults, age 24-48 yrs, with inhaled steroid dependent asthma (triamcinolone 4-8 mg/day). Complex remedy vs. placebo 1 injection subcutaneously at intervals of 5 to 7 days X 6 months	Double blind RCT (level 1b) Jadad score: 1 Allocation concealment unclear Intention to treat : no	Lung function, medication use	Change in Forced Expiratory Volume in 1 second. Clear difference reported between treatment (improving from 1.7 litres at baseline to 2.4 L) and placebo (reduction from 1.9 to 1.8 L) but no SD described	Insufficient data reported. Internal validity uncertain
Matusiewicz et al 1999 Poland	84 adults, age 36-70 yrs, with chronic asthma. Complex remedy vs. placebo 1 injection subcutaneously at intervals of 5 to 7 days X 9 months	Double blind RCT (level 1b) Jadad score: 2 Allocation concealment unclear Intention to treat: no	Lung function, medication use	Reduction in inhaled triamcinolone doses: -2.21 mg (95% CI –3.24 to –1.18)	Insufficient data reported. Internal validity uncertain
Lewith et al 2002 The United Kingdom	242 adults, age 18-55 yrs, with mild to severe asthma, Skin Prick Test + for House dust mite, Forced Expiratory Volume in 1 second > 15% after beta2 and at least two among: score > 1, Peak Expiratory Flow > 15%, use of inhaled salbutamol on at least 7/14 days. Isopathy (House Dust Mite ultradiluted) vs. placebo, 3 doses of globules within 24 hrs (once). 16 wks follow-up	Double blind RCT (level 1b) Jadad score: 5 Allocation Concealment adequate Intention to treat: no	Change of subjective symptoms measured on a 100 mm visual analogue scale, lung function, medication use	No significant difference of: Visual analogue scale, Forced Expiratory Volume in 1 second: -0.07 L/sec (95% CI -0.18 to 0.04); Standardized Mean Difference in bronchodilators use: 0.39 (95% CI -0.06 to 0.84)
White A 2003 The United Kingdom	93 children, age 5-15 yrs, with physician asthma diagnosis and beta2 or inhaled steroid prescription < 3 months Individual remedy vs. placebo X 52 wks	Double blind RCT (level 1b) Jadad score: 5 Allocation concealment adequate Intention to treat: yes	Lung funtion, Quality of life, school days lost, use of inhalers	No significant difference: Number of patients with Peak Expiratory Flow > 15% RRR 24% (95% CI -40 to 59); school days lost RRI 7% (95% IC –35 to 78); Standardized Score Difference in Active Quality of Life 1.32 (95% CI –3.98 to 6.62). Adverse events RRI 33% (95% CI –35 to 172)	Both groups appear relatively healthy: near normal respiratory function, no wheezing exacerbation in the last 12 months in homeopathic group: possible any improvement ?

Comment(s)

This overview found a number of trials heterogenous in terms of age, severity of asthma, route of administration, type and duration of homeopathic treatment; the latter was always compared to placebo added to a "traditional treatment" (bronchodilator or steroids) and this fact may have confounded the final results. Overall the methodological quality of the included studies was not satisfactory (even if four out of six obtained a Jadad score > 2, only half of them (Reilly, Lewith and White) presented data in a statistical adequate way. We found no statistical difference between homeopathic remedies and placebo regarding improvement in lung function and quality of life, in reducing "inhalers" and bronchodilator use and school days lost because of asthma. A high quality but small study (Reilly) reported with homeopathy an improvement in asthma symptoms, but this result was not confirmed by a larger subsequent trial (Lewith) with a similar design and a longer follow-up. Another trial (Matusiewicz, 1995) found out a reduction of inhaled steroid doses, but its methodological quality was "poor". Only one study (White) allowed investigators to choose an individual remedy based on the personal characteristics of patients and to change it, if necessary, during the study time. This was also the only one which evaluated the possible side effects of treatment, finding no significant difference with placebo.

Clinical Bottom Line

There is no evidence to recommend homeopathy in the treatment of bronchial asthma either in children or adults. Larger randomized controlled trials are needed in future, with a more "classic" homeopathic approach (individualized remedies, with the possibility of changing them in the course of subsequent consultations).

References

1. Reilly D, Taylor MA, Beattle NGM. Is evidence for homeopathy reproducible ? Lancet Lancet 1994;344:1601-6.
2. Freitas LAS, Goldenstein E, Sanna OM. The indirect doctor-patient relationship and the homeopathic treatment of asthma in children. Rev Homeopatia 1995;60:26-31.
3. Matusiewicz R. Wirksamkeit von Engystol N bei Bronchialasthma unter kortikoidabhangiger Therapie. Biol Med 1995;24:242-6.
4. Matusiewicz R, Wasniewski J, Sterna-Bazanska A, Hulsberg M. Behandlung des chronischen asthma bronchiale mit einem homoopathischen komplexmittel. EHK 1999;6:367-74.
5. Lewith GT, Watkins AD, Hyland ME, Shaw S,Broomfield JA, Dolan. G, Holgate ST Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ 2002;324:1-5.
6. White A, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax 2003;58:317-21.
7. McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. The Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD000353. DOI: 10.1002/14651858.CD000353.pub2.