CORRESPONDENCE

Immunotherapy vs inhaled budesonide in bronchial asthma: anopen, parallel comparative trial

Sir,We read with interest the paper of Shaikh recently publishedin the journal [1]. The study is of great importance and dealswith the comparison between allergen-specific immunother-apy and inhaled corticotherapy in bronchial asthma. Suchstudies are urgently required to give a better understandingof the importance of immunotherapy in asthma by compar-ison with the gold standard treatment [2]. The authorssuggest that budesonide is more rapidly effective thanimmunotherapy but the latter treatment lasts longer thancorticotherapy after their cessation.

It is clear that such studies are extremely difficult to carryout. However, for interpreting any immunotherapy studysome guidelines should be followed [3]. The study shouldbe double-blind, placebo-controlled and randomized;patients should be selected according to well-defined clin-ical criteria and a specific allergy diagnosis; allergenextracts need to be defined, if possible standardized, andthe dose (s) or major allergen defined; an optimal main-tenance dose is required; and data of the clinical efficacyshould use a correct statistical analysis.

Unfortunately, the study of Shaikh [1] does not fulfilthese recommendations since it is not double-blind, pla-cebo-controlled, the statistical analysis appears to be incor-rect using parametric tests without logarithmictransformation and there is no statistical analysis of theclinical data. Thus, it seems that this paper cannot beinterpreted and no conclusion can be drawn. We, however,urge the scientific community to perform such a study usinga recommended protocol.

References

1 Shaikh W. Immunotherapy vs inhaled budesonide in bronchialasthma: an open, parallel, comparative trial. Clin Exp Allergy1997; 27:1279–84.

2 International Consensus Report on Diagnosis and Managementof Asthma. Int Asthma Manage Project Allergy 1992; 47:1–61.

3 Bousquet J, Lockey R, Malling H. WHO Position Paper.Allergen Immunotherapy: Therapeutic Vaccines for allergicdiseases. 1998; in press.

JEAN BOUSQUET

Hopital de Villeneuve

295-Montpellier Cedex, France

HANS J. MALLING

National University HospitalTagensvej 10

DK-2200 Copenhagen, Denmark

Reply

Sir,In response to the concerns raised by Drs Bousquet andMalling regarding my paper, I thank them for emphasizingthat such studies are difficult to carry out. Indeed, thedifficulties in conducting a double-blind, placebo-controlledstudy involving immunotherapy, especially in a lengthy, 2year trial comparing two entirely different treatment mod-alities, have been documented in the paper. Although thestudy was an open trial, it was properly randomized andstringent, and well-defined selection criteria were appliedwhich have also been documented. The paper also mentionsthat a specific allergy diagnosis was made; all subjects hadperennial, allergic asthma with elevated total IgE levels andpositive skin-prick tests and RASTs to the house dust mite,D. farinae. Allergen extracts used in the study were properlystandardized using bioequivalent allergy units. As regardsthe optimal maintenance dose, there does not seem to be asyet any authentic consensus in the literature on how such adose is to be calculated. Under these circumstances, the topdose was mentioned in the paper. With regards to statisticalanalysis, a simplet-test revealed statistically significantdifferences between the two treatment groups and thegraphical representation as well as theP-values obtainedrepresented, in fact, a statistical analysis of the entireclinical data obtained from this study. It would certainlybe ideal to have a study using a recommended protocol.However, the aim was really to try (for the first time ever)and discover more about an area of allergy of which wecurrently know so little.

W.A. SHAIKH

Allergy ClinicBombay Hospital Institute of Medical Sciences

BombayIndia

778 q 1998 Blackwell Science Ltd

Clinical and Experimental Allergy,1998, Volume 28, page 778