| 1. What
are nasal polyps and what are the main treatment options? |
Figure
1. Typical endoscopic appearance of nasal polyps showing well
defined polyps in the middle meatus. (Clinical Vision, UK)
Nasal
polyps are common in patients with asthma, allergic rhinitis, cystic
fibrosis and triad
asthma
and sensitivity to aspirin.
They are benign lesions in the nose or sinuses that can obstruct
nasal passages (Figure 1). Polyps typically originate from the
ethmoid sinuses and are characterised by eosinophilic
and neutrophilic inflammation (Pawankar 2003).
These
immunological features may contribute to the efficacy of
corticosteroids in the treatment of nasal polyps, as some inflammatory cells
are extremely sensitive to steroid anti-inflammatory effects.
Indeed, Mastruzzo et al (2003) demonstrated that Rhinocort®
Turbuhaler® 280 µg/day, given for 8 weeks in patients with
nasal polyposis, increased CD8(+) cells, decreased cells expressing
interleukin 4 and 5 and restored the damaged epithelium, which is
possibly mediated by an increase in transforming growth factor-beta
(TGF-ß).
Guidelines
on the management of nasal polyps (Naclerio & Mackay 1997)
advocate two main treatment options for nasal polyposis, namely,
regular treatment with nasal corticosteroids and surgical removal of
polyps.
|
| 2. How
does medical treatment of nasal polyps compare with surgery plus
medical treatment? |
Regular
treatment with a topical intranasal corticosteroid forms the basis of
medical nasal polyp management. As well as being relatively
inexpensive, intranasal corticosteroids are simple and convenient for
patients to use. Several surgical approaches to remove nasal polyps
are now available and treatment is usually an outpatient procedure.
However, surgical removal will not prevent polyps from reoccurring.
Guidelines
on the management of nasal polyps (Naclerio & Mackay 1997)
recommend initial treatment with a topical corticosteroid, followed
by surgery if patients do not respond to steroid treatment. This
approach is supported by several clinical studies (Lildholdt et al
1997; Blomqvist et al 2001; Bonfils et al 2003).
As
well as proving efficacious, initial treatment with Rhinocort®
has been shown to be more cost-effective than surgery (Table 1),
being the least expensive way to generate treatment successes as
measured by clinical study data (Berggren & Johansson 2003).
Table
1. Rhinocort® is more cost-effective than surgery for the
treatment of nasal polyps (Berggren & Johansson 2003)
|
| 3. Can
Rhinocort® effectively reduce polyp size? |
Several
studies have demonstrated that Rhinocort® can significantly
reduce nasal polyp size (Tos et al 1998; Filiaci et al 2000;
Jankowski et al 2001).
An
8-week, randomised, double-blind clinical study was conducted in 157
patients with symptomatic bilateral nasal polyposis (Filiaci et al
2000). Patients were randomised to Rhinocort® Turbuhaler®
140 µg once or twice-daily, or 280 µg once daily. The
study showed that Rhinocort® Turbuhaler® 280 µg/day
significantly reduced both polyp size and nasal polyp mass score,
compared with placebo (Figure 2).
Figure
2. Mean change in nasal polyp size from baseline following 8 weeks
treatment with Rhinocort® Turbuhaler® (140 µg once or
twice daily or 280 µg once daily) or placebo (Filiaci et al
2000)
Another
8-week, randomised, double-blind clinical study in 183 patients with
symptomatic, moderate-sized, nasal polyps looked at the effect of
Rhinocort® Aqua™ on nasal polyp size (Jankowski et al
2001). Patients received Rhinocort® Aqua™ 128 or 256 µg
in the morning plus placebo in the evening, Rhinocort® Aqua™
128 µg twice daily or placebo twice daily. The study
demonstrated that all doses of Rhinocort® Aqua™
significantly (p<0.01) reduced nasal polyp size compared with
placebo (Figure 3).
Figure
3. Reduction in nasal polyp size following 8 weeks of treatment
(n=183) with either Rhinocort® Aqua™ or placebo (Jankowski
et al 2001)
|
| 4. Can
Rhinocort® effectively reduce symptom scores? |
Jankowski
and colleagues (2001) investigated the effect of Rhinocort® Aqua™
(128 µg once or twice daily and 256 µg once daily) on
nasal symptoms, measured using a 4-point scale (where 0 indicates no
symptoms and 3 denotes severe symptoms interfering with normal
activities or sleep). The study demonstrated a significant (p<0.001)
reduction in nasal symptom scores compared with placebo (Figure 4) in
this 8-week, randomised clinical study.
Figure
4. Reduction in combined symptom score following 8 weeks treatment
with Rhinocort® Aqua™ or placebo in 183 patients with nasal
polyps (Jankowski et al 2001)
An
8-week, randomised study demonstrated that approximately 70% of
patients receiving Rhinocort® Turbuhaler® 280 µg/day
(140 µg once or twice daily or 280 micrograms once daily) had
substantial or total control of symptoms by the end of the treatment
period, compared with 45% of placebo-treated patients (Filiaci et al
2000, Figure 5). This study also used a 4-point scale to
assess the severity of nasal symptoms.
Figure
5. Combined nasal symptom score in patients with nasal polyps
following 8-weeks treatment with Rhinocort® Turbuhaler® or
placebo (Filiaci et al 2000). Note: Delivered doses of Rhinocort Turbuhaler 140µg and 280 µg corresponds to nominal 200µg and 400µg respectively.
|
| 5. Is
Rhinocort® effective against post-operative polyp recurrence? |
Rhinocort® is effective at reducing polyp size and recurrence following polypectomy, as shown by three studies (Hartwig et al 1988; Lildholdt et al 1995; 1997).
Hartwig and colleagues (1988) performed a double-blind, placebo-controlled study in 73 patients with nasal polyps. The study demonstrated that Rhinocort® 400 µg/day pMDI was effective at preventing polyp recurrence in patients with a history of recurrent polyposis after previous polypectomy (p<0.01) (Hartwig et al 1988; Figure 6).
Figure 6. Nasal polyp and nasal blockage scores after treatment with Rhinocort® pMDI 400 µg or placebo in 73 post-polypectomy patients (Hartwig et al 1988).
The long-term efficacy of Rhinocort® Turbuhaler® was assessed in a 2-year study of 126 patients with bilateral polyposis (Lildholdt et al 1995; 1997). The study had 3 phases and the results at the end of each stage are as follows. (1) 4 weeks’ treatment with Rhinocort® Turbuhaler® (400 or 800 µg) provided total or substantial symptom control in the majority of patients with nasal polyps with no difference between the two doses (Lildholdt et al 1995). (2) After 1-year of open-label Rhinocort® Turbuhaler® treatment 85% of patients (responders to Rhinocort® in phase 1, and failures who were treated with Rhinocort plus surgery or sustained release betamethasone), had total or substantial control of symptoms (Lildholdt et al 1997). Furthermore, similar effects were seen on peak expiratory flow (Figure 7a) and polyp size (Figure 7b). (3) Patients could elect to stop taking further treatment in phase 3, and if they did, they were followed for a second year. Of the remaining 105 patients 75% discontinued Rhinocort® treatment. After 6 months, 40-50% of these patients required no further treatment for nasal polyposis, and 34% still required no treatment after 1 year (Lildholdt et al 1997). Rhinocort® provides long-term relief of symptoms of nasal polyposis and effective control of nasal polyps after surgical removal.
Figure 7a.
Figure 7b
Figure 7. (a) Peak expiratory flow rate index and (b) mean polyp size in patients with nasal polyps following treatment with Rhinocort® Turbuhaler® for 1 year. Patients were divided into 2 groups after 1 month according to the effectiveness of Rhinocort. "Successes" continued on Rhinocort, while "Failures" received systemic corticosteroids or surgery in addition to Rhinocort (Lildholdt et al 1997).
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| 6. References |
Berggren
F, Johansson L. Cost effectiveness of nasal budesonide versus
surgical treatment for nasal polyps. Pharmacoeconomics 2003;
21: 351–356.
Blomqvist
EH, Lundblad L, Änggård A, Haraldsson PO, Stjärne P. A
randomized controlled study evaluating medical treatment versus
surgical treatment in addition to medical treatment of nasal
polyposis. J Allergy Clin Immunol 2001; 107: 224–228.
Bonfils
P, Nores JM, Halimi P, Avan P. Corticosteroid treatment in nasal
polyposis with a three-year follow-up period. Laryngoscope
2003; 113: 683–687.
Filiaci
F, Passali D, Puxeddu R, Schrewelius C. A randomized controlled
trial showing efficacy of once daily intranasal budesonide in nasal
polyposis. Rhinology 2000; 38: 185–190.
Hartwig
S, Linden M, Laurent C, Vargo AK, Lindqvist N. Budesonide nasal
spray as prophylactic treatment after polypectomy (a double blind
clinical trial). J Laryngol Otol 1988; 102: 148–151.
Jankowski
R, Schrewelius C, Bonfils P et al. Efficacy and tolerability of
budesonide aqueous nasal spray treatment in patients with nasal
polyps. Arch Otolaryngol Head Neck Surg 2001; 127: 447–452.
Lildholdt
T, Rundcrantz H, Lindqvist N. Efficacy of topical corticosteroid
powder for nasal polyps: a double-blind, placebo-controlled study of
budesonide. Clin Otolaryngol 1995; 20, 26–30.
Lildholdt
T, Rundcrantz H, Bende M, Larsen K.
Glucocorticoid treatment for nasal polyps.
The use of topical budesonide powder, intramuscular betamethasone,
and surgical treatment. Arch Otolaryngol Head Neck Surg
1997; 123: 595–600.
Mastruzzo
C, Greco LR, Nakano K et al. Impact of intranasal budesonide on
immune inflammatory responses and epithelial remodeling in chronic
upper airway inflammation. J Allergy Clin Immunol 2003; 112:
37–44.
Naclerio
RM, Mackay IS. Guidelines for the management of nasal polyposis. In:
Mygind N, Linholdt T, eds. Nasal polyposis. An inflammatory disease
and its treatment. Copenhagen: Munksgaard; 1997: 177–180.
Pawankar
R. Nasal polyposis: an update: editorial review. Curr Opin
Allergy Clin Immunol 2003; 3: 1–6.
Tos
M, Svendstrup F, Arndal H et al. Efficacy of an aqueous and a
powder formulation of nasal budesonide compared in patients with
nasal polyps. Am J Rhinol 1998; 12: 183–189.
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