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Combined Oral and Intranasal Corticosteroid Therapy: An Advance in the Management of Nasal Polyposis?

Joaquim Mullol, MD, PhD; and Isam Alobid, MD, PhD
[+] Article, Author, and Disclosure Information

From Rhinology Unit and Smell Clinic, Hospital Clínic i Universitari, IDIBAPS, CIBERES, 08036 Barcelona, Spain.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-0153.

Requests for Single Reprints: Joaquim Mullol, MD, PhD, Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic i Universitari, IDIBAPS, Villarroel 170, 08036 Barcelona, Catalonia, Spain; e-mail, jmullol@clinic.ub.es.

Current Author Addresses: Ds. Mullol and Alobid: Rhinology Unit and Smell Clinic, ENT Department, Hospital Clínic i Universitari, IDIBAPS, Villarroel 170, 08036 Barcelona, Catalonia, Spain.

Ann Intern Med. 2011;154(5):365-367. doi:10.7326/0003-4819-154-5-201103010-00011
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In this issue, Vaidyanathan and colleagues' trial demonstrates the effectiveness of a short course of oral steroids for patients with chronic rhinosinusitis with nasal polyposis who have not had an adequate response to intranasal steroids alone. The editorialists assert that the strategy for oral steroid courses in patients with severe or uncontrolled chronic rhinosinusitis with nasal polyposis should be an initial daily dose of 0.5 to 1.0 mg/kg, followed by tapered administration for 2 to 3 weeks. Long-term intranasal corticosteroids, given after or in addition to oral steroids, should be the main therapeutic strategy, and clinicians should be alert to adverse effects of oral steroid use.

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Incorrect assumptions in the editorial
Posted on April 11, 2011
Siram Vaidyanathan
Asthma and Allergy Research Group, Division of Cardiovascular and Lung Biology, University of Dundee
Conflict of Interest: None Declared

We thank Mullol and colleague for bringing to prominence a much ignored but debilitating illness. We would like to take the opportunity to discuss several points raised by the editorial.

First, the editorial proposes that differences between groups in the co-primary outcomes of polyp size and olfaction do not endure at 28 weeks. Our interpretation of the data is that there are significant overall differences over the 28 week period of -1.1 units (-1.5, -0.6; <0.001) for polyp score and 15.40mm (-25.85, -4.95; 0.004) for hyposmia score (Table 2). These differences were calculated post hoc as requested by the journal using a longitudinal mixed model analysis (see methods). Moreover, this interpretation was supported using the a priori analysis of an ANCOVA: the differences between groups at 28 weeks were -0.9 units (-1.7 - - -0.1; 0.04) and P < 0.02 for hyposmia score (95%CI not calculable as a square-root transform was applied). We feel it is imperative not to ignore the significant overall trend between groups over the entire treatment period due to a P value falling on the 'wrong' side of an arbitrary numeral. Of course further research is needed before generalizability of this study can be fully understood. But the data show a significant difference over the entire study period.

Second, our study did not evaluate combined oral and topical steroids but sequential therapy. While combined therapy in patients with nasal polyposis may cause significant side-effects due to additive overall steroid burden, we have demonstrated there is no lasting effect on HPA axis or osteoblastic activity in patients treated sequentially. Indeed, almost 50% of our subjects had asthma and were on inhaled corticosteroids. With this in mind, it is unclear why the editorial recommends a 3 month trial of intranasal corticosteroids in patients with moderate to large sized nasal polyps. This approach was not supported by our data and we believe patients with this severity of disease will inevitable have some degree of ostiomeatal complex obstruction, which is the principal cause for disease perpetuation. Nasal steroid sprays do not relieve this obstruction and we routinely and safely treat patients with grade 2 and 3 polyps with an initial oral steroid burst followed by sequential topical therapy in the form of nasal drops and then spray. Using a tapered oral dosing regimen may not provide any benefit as there is a long experience in the UK of treating patients with asthma and COPD with a single daily dose of 25-50 mg without tapering. If anything, a tapering approach could lead to prolonged steroid exposure with increased risk of long term harm. Of course, no trial result will or should replace judicious clinical assessment of each individual patient by their physician. We also acknowledge that our patients were a selected cohort from a specialty clinic and that approach may not be applicable to patients with milder disease.

Third, we agree that there may be a loss of efficacy when switching from drops to nasal spray. While availability of nasal drops is not universal and they are more expensive; in our clinical practice in patients with severe disease we routinely step down therapy from fluticasone nasal drops 400 mcg bid to 200 mcg bid rather than switching to sprays. Nasal drops have been shown in cadaveric studies to access the middle meatus rather than nasal spray which mainly deposits on the inferior turbinates. Nasal drops also have lower systemic bioavailability in head to head comparison with nasal sprays.

Conflict of Interest:

Authors of main articles

Short courses of oral steroids in nasal polyposis
Posted on April 19, 2011
Joaquim Mullol
Hospital Clinic de Barcelona
Conflict of Interest: None Declared

We thank Dr. Sriram Vaidyanathan and coworkers for the discussion on several points of our editorial to their magnificent clinical trial on sequential oral intranasal steroids treatment of chronic rhinosinusitis and nasal polyps published in the March 1st issue of Annals of Internal Medicine.

During the last decade our group has been working and publishing several papers on the usefulness of adding short courses of oral steroids, combined with intranasal steroids, when treating severe nasal polyposis. Thus, at any moment our intention was to disagreeing with the overall importance of the published study but to note that since clinical studies only take a picture of reality, caution should be taken when recommending short courses of oral steroids to be used by doctors, mainly Primary Care physicians, and even by the same patients.

In addition, we think that some discussion is necessary on the points raised by Dr. Sriram Vaidyanathan and coworkers in the editorial's comment to provide a wider information to the readers. Although we are aware that steroid-phobia often represents a barrier for the compliance of patients to steroid treatment, we think that cannot go from this current steroid- phobia to the indication of oral steroid courses without caution.

FIRST POINT. We agree in that P value is not the only issue to be considered. However, when efficacy overall trends are taken in account, side effect tendencies should also be considered since the study also shows a tendency to lower bone metabolism outcomes during the topical corticosteroid treatment.

SECOND POINT. The authors report that the study has been done using the EP3OS criteria. EP3OS guidelines recommend short courses of oral steroids only in "severe" nasal polyposis assessed by VAS (the only tool currently validated to assess severity) and this classification is not reported as to be used in the study. Then, probably mild and moderate patients (nasal polyp size has not been validated to assess severity) were included in the study although oral steroids are not recommended in these lower degrees of severity. Moreover, nasal polyp patients will probably receive during their lives (even 2-3 times per year) several short courses of steroids and their accumulative impact on side effects cannot be addressed by a single study. Finally, we don't really believe that steroid sequential and combination therapies make a real difference since when giving 25 mg/day of oral prednisolone, adding 0.8 and 0.4 mg of a intranasal corticosteroid (with a bioavailability of less than 1%) cannot add a great impact on safety. Concerning to patient's safety, intranasal and oral steroids can never be compared.

THIRD POINT. The decrease in efficacy from drops to spray probably is not only due to the change of the type of steroid administration but also to the reduction to half of the dosage used in the treatment. Moreover and with no doubt, studies done in cadavers are not at all comparable to studies performed in vivo.

To sum up and following the EP3OS recommendations, treatment of nasal polyps, mainly with mild and moderate severity, can be also done by specialists other than otorhinolaringologists such as general practitioners, chest physicians, or allergologists. That is why giving the message that "short courses of oral steroids can really help in the disease control of nasal polyp patients" is very important, and we totally agree on that with Dr. Sriram Vaidyanathan and coworkers, but we think that it should never be misunderstood as a recommendation of using short courses of oral steroids as a first line of treatment in nasal polyposis.

Conflict of Interest:

None declared

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