Glucocorticoid treatment for nasal polyps. The use of topical budesonide powder, intramuscular betamethasone, and surgical treatment.

BACKGROUND: The treatment of nasal polyps is controversial, and medical treatment alone has been little investigated to our knowledge. OBJECTIVE: To examine the efficacy of therapy using only topical budesonide powder and topical budesonide powder supplemented with surgical removal or intramuscular betamethasone. DESIGN: Randomized, double-blind comparison of 2 dosages and additional treatment, if therapy failed. After 1 year, treatment with medication was stopped, and the demand for renewed treatment was monitored for another year. PATIENTS: Patients with bilateral nasal polyps who demanded treatment were consecutively enrolled in a hospital outpatient clinic or specialty private practice. During a 15-month period from 1990 to 1992, a total of 126 patients entered the 2-year study. INTERVENTIONS: In phase 1, randomized and double-blind treatment with a topical medication, budesonide powder, 800 micrograms or 400 micrograms daily, or a placebo was given for 1 month. In phase 2, randomized and double-blind treatment with budesonide powder, 800 micrograms or 400 micrograms daily, was given. At the end of phase 1, failed therapy was supplemented by randomly assigned treatment of either surgical removal or a single injection of sustained released betamethasone. In phase 3, treatment with the medication was discontinued, and patients were monitored for another year. The time when treatment was required again was noted. The present article deals with phases 2 and 3. MAIN OUTCOME MEASURES: Patients' scores of treatment efficacy as well as symptoms and signs. Semiquantitative measurement of sense of smell and calculation of peak expiratory flow rate index based on nasal and oral peak expiratory flow. RESULTS: In all outcome measures, a comparison of the data before treatment with the corresponding figures during phase 2 showed statistically significant efficacy. The clinical course was described at the end of phase 2. About 85% of the patients, including those who received additional therapy because the initial therapy failed, rated total or substantial control over the symptoms. The 2 dosages investigated showed equal results. These findings were consistent with the signs recorded and the peak expiratory flow rate index. The results of phase 3 showed that 50% of patients had demanded treatment after 4 months, while 34% managed without medication after 1 year. CONCLUSIONS: The clinical course in this study showed that most patients with nasal polyps do well with medical treatment. Therefore, surgery was required in few patients. However, the potential of medical treatment should be further explored in future studies.

Effect of local tranexamic acid gel in the treatment of epistaxis.

In patients with nosebleedings, the hemostatic effect of local application of tranexamic acid gel or placebo was compared in a randomized, double-blind, multicenter clinical trial with parallel groups. The times needed to arrest the initial bleeding were recorded, as well as any rebleedings within 10 days. The results showed no significant differences in any of the efficacy variables. Tranexamic acid was no better than placebo in the early treatment of nose bleedings, but the gel itself seemed to have a beneficial effect. The gel preparations were easy to insert into the nasal cavity and caused no discomfort to the patients.

Efficacy of topical corticosteroid powder for nasal polyps: a double-blind, placebo-controlled study of budesonide.

Budesonide has been used for a number of years as a topical nasal corticosteroid in the treatment of nasal allergy and nasal polyps. Recently, a new device for powder insufflation where no constituents or preservatives are included has been developed (Rhinocort Turbuhaler, Astra Draco AB, Sweden). The present investigation was designed in order to study the efficacy of topical budesonide powder as the only treatment of nasal polyps. A total of 126 patients entered the study. The medical history and clinical recordings included symptoms and signs, a semiquantitative test of smell and measurement of nasal expiratory peak flow index. Medication was either 200 or 400 micrograms of budesonide powder b.i.d. or placebo. After 1 month an overall assessment of treatment efficacy was made to determine whether the treatment had been a success or a failure. The results showed a statistically significant improvement of symptoms and signs in the actively treated groups. The increase in expiratory peak flow index was about 60% in the actively treated groups as opposed to 16% in the placebo group. The overall assessment of treatment efficacy showed success in about 82% of actively treated patients as opposed to about 43% in the placebo group. It is concluded that budesonide powder is useful in the treatment of nasal polyps.

Nasal decongestant effect of oxymetazoline in the common cold: an objective dose-response study in 106 patients.

Oxymetazoline has been used as decongesting nosedrops for more than 25 years but so far no objective dose-response study of the drug has been published. In this double-blind clinical trial the decongestant effect on the nasal mucosa by the doses and concentrations traditionally used of oxymetazoline were studied. In 106 men with acute infectious rhinitis, a significant dose-response relationship was found when the decongestant effect was measured objectively by anterior rhinomanometry and subjectively by symptom scores. The concentration and volumes of the drug recommended from clinical experience seem to be adequate.

Effect of terfenadine and placebo on symptoms after nasal allergen provocation.

Terfenadine (60 mg b.i.d.) was compared with placebo in a randomized, double-blind, cross-over study in twenty-three patients with birch pollen allergy. The patients were treated during two 7-day periods separated by a 2-week wash-out period during a season free from birch pollen. Nasal provocations with birch pollen extracts were made at study entry and after each treatment period. Blockage (rhinomanometry), secretion (weight) and sneezings (number) were compared between treatments. The results showed a significant inhibitory effect of terfenadine on secretion and sneezing, but no significant difference between treatments with regard to blockage. Terfenadine showed no signs of sedative properties or inhibition of salivation.

Chronic maxillary sinusitis. Definition, diagnosis and relation to dental infections and nasal polyposis.

Various definitions have been proposed for the term 'chronic sinusitis' but too often reports on chronic sinusitis lack a definition. In order to improve the diagnosis and treatment of this disease, and also to facilitate comparisons between clinical investigations, definitions of 'chronic maxillary sinusitis' of either rhinogenous or dental origin are proposed. It is suggested that the differential diagnosis should be based upon the duration of symptoms, ENT and dental examinations, sinus radiographs and/or sinoscopy, and results of conservative treatment. In a study conducted over a 5-year period, 198 patients with 244 affected sinuses fulfilled the proposed criteria. The incidence of chronic maxillary sinusitis in the population was 0.02%. A dental cause was found in 40.6% of the sinuses. The dental cause could be confirmed by routine dental examination in only 43 of 99 cases, while an extended maxillo-dental examination was conclusive in the other cases (56/99). Marginal periodontitis was found as frequently as periapical granuloma and together they constituted 83% of all dental causes. Sinusitis of dental origin was rare before the age of 30. Every sixth patient was found to have nasal polyposis. When related to the number of affected sinuses, the incidence of nasal polyposis was 13.1% in sinusitis of dental origin and 23.4% in that of rhinogenous origin. The importance of close cooperation between the ENT specialist and the oral surgeon is stressed.

Treatment of perennial secretory rhinitis.

Patients with a history of nonallergic perennial secretory rhinitis of many years' duration were selected for a comparative study investigating the effects of the topical application of ipratropium (an anticholinergic drug) and budesonide (a glucocorticoid). According to the patient's daily registration of nasal symptoms, there was a significant effect of budesonide on nasal secretion and sneezes. Since budesonide proved superior to ipratropium, it is concluded that the secretion in this type of rhinitis might be regulated by mechanisms other than cholinergic.

Acute epiglottitis treated by intubation.

Acute epiglottitis is a severe disease which is especially common in children and may be fatal if not treated. The main problem in these patients is to secure a free airway. During the last decade there has been much debate as to whether one should perform a tracheotomy or secure the airway by means of long-term intubation. During the last 12 years we have treated 86 patients with acute epiglottitis by long-term intubation to secure the airway. Three of these patients have been tracheotomized. All patients have been investigated by direct laryngotracheoscopy about 3 months after recovery. During the last 8 years we have had no complications whatsoever and we consider long-term intubation to be a safe and convenient way of securing the airway in acute epiglottitis.

The effect of a local decongestant in acute rhinitis as related to body position.

In different forms of rhinitis a recumbent position aggravates nasal congestion. An earlier study has shown how a recumbent position strongly reduces the effect of oral decongestants. Now the effect of a local decongestant, oxymetazolinchlorid, in acute rhinitis as related to body position has been studied by means of rhinomanometry. The effect of this local decongestant seems not to be affected by body position.

A randomized trial of intranasal beclomethasone dipropionate after polypectomy.

Beneficial effects of intranasal beclomethasone dipropionate (Bdp) in patients with nasal polyposis have been reported earlier. This study was carried out to investigate whether long-term treatment with Bdp after polypectomy could prevent formation of new polyps and reduce the number of surgical removals. Forty consecutive patients without laboratory or other clinical signs of allergy but with severe nasal polyposis were included in the study. Twenty patients were treated with intranasal Bdp and twenty patients received no treatment after polypectomy. All patients were followed for at least 2.5 years. The size of the polyps that recurred was estimated at different time-intervals by the examining doctor. After six months there was already a significant difference in favour of the group treated with intranasal Bdp. Further results of the study and the clinical implications are discussed.

Budesonide and beclomethasone dipropionate in hay fever - a single blind comparison.

93 patients with seasonal allergic rhinitis took part in a single blind randomized clinical comparison of budesonide and beclomethasone dipropionate (Becotide Nasal). All patients were sensitive to either birch or grass pollen, their sensitivity being confirmed by a skin prick test. The total daily dose was 400 micrograms for both drugs. Budesonide was administered twice a day and Becotide Nasal four times a day. Symptoms were assessed over a four-week period starting with a run-in period of one week. There was no placebo control group. Daily pollen counts were measured throughout the trial. The patients' diary cards revealed that both drugs had a beneficial therapeutic effect, and that budesonide was significantly more active than Becotide Nasal. The side effects of both drugs were few and transient.

Budesonide - a new nasal steroid.

39 patients with seasonal rhinitis entered a double-blind study comparing nasal sprays of budesonide 400 micrograms/day and placebo. Symptoms were assessed over a treatment of of three weeks. There were statistically significant differences in favour of the active spray on all measures of assessment. Side effects were mild and the incidence was negligible.

Peroral chromones. A new way to treat allergic rhinitis?

Disodium chromoglycate (DSCG) is well documented in the topical treatment of allergic rhinitis. Its use does not lead to any major side effects. FPL 57579 is a new chromone compound which is well absorbed after oral administration. In a clinical trial, patients with allergic rhinitis underwent a nasal challenge before and after ingestion of FPL 57579. the effect on nasal airway resistance (NAR) was determined by rhinomanometry. In all cases there was a smaller increase in NAR after the intake of FPL 57579.

DSCG eye drops in allergic rhino-conjunctivitis.

Thirty patients with allergic rhinoconjunctivitis were treated with eye drops containing 2% DSCG during the pollen season of 1977. Sixteen patients were treated with active substance and 14 with placebo. The results show a statistically significant difference in favour of the DSCG drops. DSCG in eye drops seems to be a valuable complement to the drugs available today for the treatment of allergic rhinoconjunctivitis.

Treatment of vasomotor rhinitis with intranasal disodium cromoglycate (SCG). Results from a double-blind cross-over study.

The effect of SCG powder (Lomudalr, Intalr) intranasally in vasomotor rhinitis has been studied on 49 adult volunteers in a double-blind cross-over study during 13 weeks in January--April 1973. The dose of SCG was 40 mg/day. Although a substantial number of results were obtained, no significant difference between the effects of SCG and placebo treatment, on variables measured, was detected. However, some patients experienced relief with, and preferred, the treatment with SCG. The results from this investigation are discussed in comparison with those from other studies including patients with vasomotor rhinitis.

Microbiology in serous otitis media.

It is now established that serous otitis media (SOM) is an inflammatory reaction of the mucosa of the middle ear. A number of microbiological factors are contributory causes. It is clear, among other things, that the microbiologic environment in the nasopharynx in SOM is the same as that in acute otitis media. Neither adenoidectomy and tonsillectomy nor treatiment with conventional chemotherapeutics has proved effective for eradicating pathogenic bacteria from the nasopharynx. Intense research to find new antibiotics and effective means may be one way of getting us out of our present therapeutic dilemma. Other possibilities are to try to produce polyvalent bacterial vaccines and to increase our knowledge of the immunology of the nasopharynx.

Gas tension and pH in middle ear effusion.

The composition of gases and the gas tension in middle ear effusion in patients with serous otitis media have been investigated. By using a specially designed micro-method, very small amounts of middle ear fluid could be analyzed. The effusion was obtained by puncturing the air cells of the mastoid process. The average value of P-O2 was 41 mm Hg; Pco2 was 58 mm Hg, pH 7.24. The possible mechanism for the impaired perfusion of the mucous membranes is discussed as well as some clinical consequences.