Evidence based advertising?BMJ 1997; 315 doi: http://dx.doi.org/10.1136/bmj.315.7122.1621 (Published 13 December 1997) Cite this as: BMJ 1997;315:1621
*The editor comments on these letters in his footnote to the cluster below (p 1625).
Advertisement for nifedipine does not mention admitted shortcomings of study
- Luc Blondeel, General practitionera
- a Projekt Farmaka, Jozef Vervaenestraat 14, 9050 Ghent, Belgium
- b Bayer, Pharmaceutical Division, Newbury, Berkshire RG14 1JA
- c Centre Hospitalier de l'Université de Montréal, Pavillon Hôtel-Dieu, Montreal, Quebec, Cnada H2W 1T8
- d Department of Public Health Medicine and Epidemiology, University Hospital, Queen's Medical Centre, Nottingham NG7 2UH
- e Leeds General Infirmary, Leeds LS1 3EX
- f St James's University Hospital, Leeds LS9 7TF
Editor—I am concerned about an advertisement for nifedipine (Adalat) that appeared in the BMJ in the issue of 12 April: referring to the STONE study, it says “This prospective placebo-controlled clinical intervention trial has demonstrated for the first time a significant reduction in severe clinical outcomes with the dihydropyridine nifedipine.” This text is the last sentence of the discussion in an article in the Journal of Hypertension.1
The shortcomings of the study are mentioned by the authors themselves. At the end of their introduction they state: “It is our belief, however, that within the stated restrictions the study design and execution warrant publication of the results in an international journal.” At the start of the discussion they again mention the shortcomings: “Because of its unorthodox design (single-blinded sequential assignment with transfer of severely hypertensive subjects from placebo to active treatment group), we decided to approach the data via different types of analysis to limit overinterpretation bias.”
Readers of the advertisement, however, are not aware of the shortcomings on which it is based. They will thus suppose that it concerns a prominent clinical study which may have consequences in clinical practice—in this case, the adjustment of treatment in patients with moderate hypertension. The BMJ strongly advocates controlled clinical trials and is dismissive of attempts to use statistical fireworks to overcome a study's shortcomings. I presume that it would agree that, according to its own criteria, nothing is shown by the publication cited in the advertisement.
The BMJ should make clear to its readers that, currently, scientifically founded data on the treatment of hypertension are available only for thiazide diuretics and ßbeta; lytics and that the effects of using calcium entry blockers are still unknown. …
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