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Editor – The BMJ family highlights introduces a worrying note into
BMJ content for the 13th December edition. Rather than advertising the
impressive BMJ family, it comes across as a marketing exercise for drug
companies. Two features stand out. The first of these is the title
“Pimecrolimus cream is effective and safe in short term for children with
eczema”, which implies that a worthy, robust, study has been published.
How can this title be drawn from an open label, 25 patient study, using
blood concentrations of pimecrolimus as a proxy for safety? This study
doesn’t even compare relative efficacy with an appropriate, standard,
effective and safe comparator such as topical hydrocortisone. This feature
is even more bizarre alongside an excellent editorial in the same edition
of the BMJ describing the demise of evening primrose oil as an alternative
to topical steroids for atopic dermatitis/eczema(1).
The second feature which stands out is another title which states:
“Inhaled corticosteroids help in chronic obstructive pulmonary disease”. I
think your title arises from the promotional, pro- inhaled corticosteroid
editorial(3) rather than the meta-analysis published in Thorax (4). The
authors of the meta-analysis, which appears to selectively extract data
from the relevant studies, are more circumspect. They state that the
difference in FEV1 decline, compared to placebo, while statistically
significant, is of “debatable clinical importance”. Another recent, robust
meta-analysis drawing appropriately from similar studies reached the
opposite conclusion: inhaled corticosteroids do not help slow FEV1 decline
in chronic obstructive pulmonary disease(5). This lack of effect is hardly
surprising as four adequately powered RCTs, of more than one year’s
duration, were all negative for their primary outcome measure, FEV1
decline. See Clinical Evidence, also from the BMJ Family, for further
information and references (6).
I don’t doubt the editorial decisions to publish these studies as
they are now open to criticism and peer review. I do doubt the way they
are presented in the BMJ as if to convey robust or widely accepted
findings.
1. Allen BR, Lakhanpaul M et al. Systemic exposure, tolerability, and
efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis
Child 2003;88: 995-1000.
2. Williams HC. Evening primrose oil for atopic dermatitis. BMJ
2003;327:1358-1359.
3. Burge PS and Lewis SA. So inhaled steroids slow the rate of
decline of FEV1 in patients with COPD after all? Thorax 2003; 58(11): 911
- 913.
4. Sutherland ER, Allmers H, Ayas NT, Venn AJ, and Martin RJ. Inhaled
corticosteroids reduce the progression of airflow limitation in chronic
obstructive pulmonary disease: a meta-analysis. Thorax 2003; 58: 937-941.
5. Highland KB. Strange C, Heffner JE. Long-term effects of inhaled
corticosteroids on FEV1 in patients with chronic obstructive pulmonary
disease. A meta-analysis. Ann Intern Med 2003;138:969-73.
6. Kerstjens H and Postma D. Chronic Obstructive Pulmonary Disease.
Clin Evid 2003;10:1789-1803.
Competing interests:
None declared
Competing interests:
No competing interests
14 December 2003
Martin G Duerden
Senior Lecturer in Therapeutics
Department of Medicines Management, Keele University, Staffordshire, ST5 5BG
BMJ family highlights are misleading
Editor – The BMJ family highlights introduces a worrying note into
BMJ content for the 13th December edition. Rather than advertising the
impressive BMJ family, it comes across as a marketing exercise for drug
companies. Two features stand out. The first of these is the title
“Pimecrolimus cream is effective and safe in short term for children with
eczema”, which implies that a worthy, robust, study has been published.
How can this title be drawn from an open label, 25 patient study, using
blood concentrations of pimecrolimus as a proxy for safety? This study
doesn’t even compare relative efficacy with an appropriate, standard,
effective and safe comparator such as topical hydrocortisone. This feature
is even more bizarre alongside an excellent editorial in the same edition
of the BMJ describing the demise of evening primrose oil as an alternative
to topical steroids for atopic dermatitis/eczema(1).
The second feature which stands out is another title which states:
“Inhaled corticosteroids help in chronic obstructive pulmonary disease”. I
think your title arises from the promotional, pro- inhaled corticosteroid
editorial(3) rather than the meta-analysis published in Thorax (4). The
authors of the meta-analysis, which appears to selectively extract data
from the relevant studies, are more circumspect. They state that the
difference in FEV1 decline, compared to placebo, while statistically
significant, is of “debatable clinical importance”. Another recent, robust
meta-analysis drawing appropriately from similar studies reached the
opposite conclusion: inhaled corticosteroids do not help slow FEV1 decline
in chronic obstructive pulmonary disease(5). This lack of effect is hardly
surprising as four adequately powered RCTs, of more than one year’s
duration, were all negative for their primary outcome measure, FEV1
decline. See Clinical Evidence, also from the BMJ Family, for further
information and references (6).
I don’t doubt the editorial decisions to publish these studies as
they are now open to criticism and peer review. I do doubt the way they
are presented in the BMJ as if to convey robust or widely accepted
findings.
1. Allen BR, Lakhanpaul M et al. Systemic exposure, tolerability, and
efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis
Child 2003;88: 995-1000.
2. Williams HC. Evening primrose oil for atopic dermatitis. BMJ
2003;327:1358-1359.
3. Burge PS and Lewis SA. So inhaled steroids slow the rate of
decline of FEV1 in patients with COPD after all? Thorax 2003; 58(11): 911
- 913.
4. Sutherland ER, Allmers H, Ayas NT, Venn AJ, and Martin RJ. Inhaled
corticosteroids reduce the progression of airflow limitation in chronic
obstructive pulmonary disease: a meta-analysis. Thorax 2003; 58: 937-941.
5. Highland KB. Strange C, Heffner JE. Long-term effects of inhaled
corticosteroids on FEV1 in patients with chronic obstructive pulmonary
disease. A meta-analysis. Ann Intern Med 2003;138:969-73.
6. Kerstjens H and Postma D. Chronic Obstructive Pulmonary Disease.
Clin Evid 2003;10:1789-1803.
Competing interests:
None declared
Competing interests: No competing interests