Dr. newman bionase

ANNALS OF ALLERGY, ASTHMA &
IMMUNOLOGY April, 1997 Volume 78, Number 4
Guest Editorial
Trends in US Asthma Mortality: Good News and Bad News David M Lang, MD Clinical Allergy-Immunology Rounds
, hronic Diarrhea and Pneumonia Leonard Bielory, MD; Frank Basile MD; Maria Palmisano, MD; John Oppenheimer, MD; and Michael Orenstein, M Original Articles
Immediate Rhinoconjunctivitis Induced by Metamizole and
Metronidazole B Annibarro, MD and J L Fontela, MD
Stabilization of Asthma Morality R Michael Sly and Regina O’Donnell
Comparative Efficacy and Safety of Twice Daily Fluticasone
Propionate Powder Versus Placebo in the Treatment of Moderate
Asthma David S Pearlman, MD; Michael J Noonan, MD; Donnald P
Tashkin, MD; Marc F Goldstein, MD; Abbas G Hamedani; Donald J
Kellerman, PharmD; and Amy Schaberg, RN
Development of IgG1 and IgG4 Antibodies Against β- Healthy and
Atopic Children K Duchen, MD; R Einarsson, PhD; G Hattevig, MD,
PhD; and B Bjorksten, MD, PhD
Hymenoptera Hypersensitivity in an Imported Fire Ant Endemic Area Theodore
M Freeman, MD
Care of Asthma: Allergy Clinic Versus Emergency Room Cleveland M
Moore, MD; Imtiaz Ahmed, MD; Raja Mouallem, MD; Warren Mary,
PhD; Mohammad Ehlayel, MD; and Ricardo U Sorensen, MD
Predominant Tree Aeroallergens of the Washington DC Area: a Six Year Survey
(1989-1994) Susan E Kosisky, MA and Gary B Carpenter, MD
Blood Sample Processing Effect on Eosinophil Cationic Protein Concentration
Nuria Rubira, MD; Ma Jose Rodrigo, MD; Manuel Pena, MD; Carmen Nogueiras,
MD; Ma Jesus Cruz; and Alvaro Cadahia, MD
Narrow-Band Red Light Phototherapy in Perenial Allergic Rhinitis and Nasal
Polyposis Ittai Neuman, MD annd Yehuda Finkelstein, MD
Bee and Wasp Venom Allergy in Turkey A Fuat Kalyoncu, MD; A Ugur Demir,
MD; Umit Ozcan, MD; Cumhur Ozkuyumcu, MD; A Altay Sahin, MD; annd Y
Izzettin Baris, MD
Official Publication of the American College of Allergy, Asthma & Immunology
November 6, 1997: 9th Annual Food Allergy Symposium, San Diego, CA
November 7-12, 1997: ACAAI Annual Meetinng, San Diego, CA
Narrow-band red light photography in perennial allergic rhinitis Ittai neuman, MD and Yehuda Finkelstein, MD__________________________________________________________________________________ Background: Allergic rhinitis and nasal polyposis are common nasal
. iseases, but the available treatment modalities have only limited success
Objective: To assess the therapeutic affect of low-energy narrow-
band red light phototherapy on nasal clinic symptoms of allergic rhinitis . nd nasal polyposis
Methods: In a double-bind randomized prospective study, 50 patients
with allergic rhinitis and 10 with nasal polyposis received intranasalillumination at 660 nm for 4.4 minutes three times a day for 14 days (totaldose 6 joules per day). Twenty-nine rhinitic patients and one patient withpolyposis received equivalent sham illumination as placebo. Evaluationwas based on symptom scores and a clinical assessment that included pre- . reatment and post-treatment videotaped rigid and flexible nasendoscopy
Results: Following treatment, improvement of symptoms was
reported by 72% of the allergic rhinitis patients and objective
improvement was endoscopically demonstrated in 70% of them as
compared with 24% and 3%, respectively, in the placebo group. These
differences were significant. No improvement was obtained in any of the
. atients with polyposis
Conclusions: Allergic rhinitis, if uncomplicated by polyps or chroni
sinusitis, can be effectively treated by narrow-band red light illuminationof the nasal mucosa at 660 nm, with marked alleviation of clinicalsymptoms. Whenever possible, candidates for phototherapy should be . nn Allergy Asthma Immunol 1997;78:399-40 INTRODUCTION
Allergic rhinitis is the most common of all the IgE- mediated allergic
diseases. Its incidence may be as high as 10% in children and 20% to30% in adolescents. Patients who suffer from annoying symptoms are commonly treated by daily medication with antihistamines,decongestants, topical or systemic corticosteroids, nasal disodiumcromoglycate, levocabastine or ipratropium bromide, or byhyposensitization with specific allergens. Treatment by daily medication is aimed at reducing symptoms caused by allergen triggers and inflammation.
Although commonly used, these drugs are far from ideal. For example,antihistamine administration may result in symptomatic improvement in37% to 83% of patients,3-10 but there are Food and Drug Associationwarnings of side effects or after effects and the cost is often prohibitive.
The presence of nasal polyps, which are sometimes related to chronicinflammation and to allergic states, 11 further aggravates the symptomsand may require repeated surgical intervention. Current research effortsare therefore aimed at devising effective new approaches for the relief of a Low-energy narrow-band illumination has been used successfully as atherapeutic measure in a number of medical situations.12-16 Low-energynarrow-band light in the visible and infrared ranges has variousbiochemical, cellular, histologic and functional effects.17-25Reactiveoxygen species in human blood were found to be suppressed after diodelaser illumination at 660, 820, 880 and 950 nm, 21 possibly as a result ofactivation of super-oxide dismutase 22 or activation of catalase.23 Severalauthors have reported and measured changes in Ca2+ transport due tovisible and infrared light.20.24.25 Since allergic symptoms are largelydependent on oxygen radical formation18-25 and Ca2+ mobility, 26 weconsidered it worth investigating the effects of a 660-nm light-emittingdiode (LED) on patients with allergic rhinitis and nasal polyposis.
The aim of the present study was to investigate the efficacy ofintranasal illumination at 660 nm in the treatment of perennial allergicrhinitis and nasal polyposis. The rhinologic status of patients before andafter treatment was evaluated by the use of videotaped nasendoscopy,which is the “gold standard” for diagnostic evaluation of nasal diseases.
PATIENTS AND METHODS
The study group consisted of 50 patients with perennial allergic rhinitis
and 10 with nasal polyposis (Table 1). Patients’ ages ranged from 12 to
68 years (mean 26.5 years) and the male:female ration was 30:20. All
patients had daily symptoms despite antihistamines and local steroid
spray treatments. Twenty patients had concomitant asthma symptoms.
The control group consisted of 29 patients with perennial allergic rhinitis
and one with polyposis (Table 2). Patients’ ages ranged from 12 to 52
years (mean 24 years), the male:female ratio was 18:11, and 12 patients
had bronchial asthma. Patients with severe deviation of the nasal septum
causing bilateral nasal obstruction were excluded from the study.
Table 1. Estimated Pre-treatment Severity of Symptoms of AllergicRhinitis in the Study Group and Their Improvement After IntranasalPhototherapy (n=50) Total improvement 20/29=69%* Deterioration.
Table 2. Estimated Pre-treatment Severity of Symptoms of AllergicRhinitis in the Control Group and Their Improvement After ShamTreatment (n=29) Total improvement 3/13=21%* Deterioration.
Candidates in whom nasendoscopy revealed purulent postnasal dripflowing from an edematous and hyperemic infundibulum or with streaksof purulent discharge flowing across the eustachian tube orifice werediagnosed as suffering from sinusitis and were excluded from the study.
Also excluded were patients who were convalescing from an upperrespiratory tract infection or had used nasal or oral corticosteroids lessthan 30 days before the start of the study. The study was done during theearly summer months and both the control and the study patients wererun simultaneously.
The diagnosis of allergic rhinitis was based on definite symptoms ofnasal itching, rhinorrhea, sneezing, nasal obstruction or mouth breathing,as well as positive reactions to epicutaneous tests to perennial inhalantantigens. Skin prick testing was performed with the most concentratedglycerinated extract available: house dust mite, cockroach, molds,feathers, grass pollen, weed pollens, sage, pollen and local tree pollens.
Criteria for positive skin prick test responses were a wheel of 3 mm orgreater diameter with erythema of at least 5 mm. Histamine control skintests were read at ten minutes, allergen and negative control skin testswere read at 15 minutes. The duration of nasal symptoms ranged from 1to 16 years (mean 5 years). Pretreatment severity of rhinitis symptomswas determined according to a standardized severity scale. 25 A score of 0(no symptoms) to 3 (severe symptoms) was assigned for each of thefollowing rhinitis symptoms: nasal stuffiness, rhinorrhea, nasal itching,sneezing, headache, and cough (postnasal drip). Post-treatmentsymptomatic improvement of one grade was regarded as mild whileimprovement of two or more grades was regarded as marked.
After recording their symptoms in a diary for 2 weeks as a run-inperiod, all candidates for inclusion in the study underwentvideoendoscopic examination of the nose. The videoendoscopic systemconsisted of a xenon light source (Karl Storz PR-50), Contec-MedicalEndo-Camera and a video recording apparatus. Each patient wasexamined by the use of a rigid endoscope (Storz Hopkins 4-mmtelescope) introduced as deeply as possible into the nostril for closeexamination of the mucosa and intranasal structures. In addition, aflexible endoscope (Olympus ENF-P3) was used to penetrate the narrowintranasal passages not accessible by the rigid endoscope, thus enablingclose examination of the nasopharynx for postnasal drip.
Nasal endoscopy facilitates qualitative evaluation of the mucosa,diagnosis of polyposis or polypoid disease, and characterization of thesecreted discharges as watery, thick, mucoid, purulent, white, yellowish,or green. It also provides the examiner with a close view of the intranasal structures and the interrelationships between them, enabling diagnosis ofanatomic abnormalities of the septum and middle meatus that mayocclude sinusal ostia 26,27 When the endoscopic examination was equivocal and sinusitis couldnot be excluded, computed tomography or the sinuses in coronal sectionswas performed. The diagnosis of sinusitis is based on the characteristicendoscopic 26,27 and radiologic findings. 28,29 Patients in whom theendoscopic examination was equivocal and CT revealed sinus diseasewere also exceeded from the study.
The study was designed as a double-blind, randomized, parallel-grouptrial. The study protocol was approved by the Helsinki Committee on theuse of human subjects in research. Informed consent was obtained inwriting from all patients prior to their participation. Patients were randomly assigned to receive either intranasalillumination at 660 nm or sham illumination as a placebo. Theinstrument used was, a Bionase unit (Amcor Ltd, Israel), which emits redlight at 660 ± 5 nm. The unit consists of a control box and two light-emitting diode probes for intranasal use (fig.1).
Fig 1. The Bionase unit, consisting of a control box containing theelectronic circuit and a battery, and two light-emitting units forintranasal use. Note the push button on the control box. A push-button switch on the control box activates the probes for 4.4minutes, during which time 1 joule of light energy is delivered from eachunit. Patients were instructed to introduce the probe into their nostrils asdeeply as possible and to press the push button. Each nostril wassubjected to low-energy stimulation (4mW) for 4.4 minutes (1 joule pertreatment session) three times a day for 14 consecutive days (Fig.1).
Bionase devices with internally disconnected light emitting diode probeswere used for the sham illusion in the placebo group.
Patients were instructed to record their rhinitis symptoms daily in theevening throughout the study period. Illumination treatment was startedimmediately after the initial videoendoscopic examination. Nomedications were allowed during the 2 weeks of phototherapy. Twoweeks after the start of the treatment, patients presented themselves for areview of their scores and an objective assessment of rhinitis symptomsby videotaped endoscopy. The ear, nose and throat specialist (YF), whoperformed this examination was not informed of the kind of illumination(660 nm or sham) each patient had received. The videotapes of each patient before and after treatment were compared and evaluated by theauthors upon termination of the treatment.
STATISTICAL ANALYSIS
Differences between the placebo and test groups were evaluated by the
Mann-Whitney nonparametric test. The chi square test was performed to
detect differences between the two groups in the various symptom-related
variables (nasal obstruction, rhinorrhea, nasal itching, cough and
headache) and in endoscopic findings (nasal mucosa, secretions, nasal
passage and ethmoid appearance). The Spearman correlation test was
used to ascertain differences in age, gender, and the presence of bronchial
asthma as independent variable and in the improvement in patients’
various symptoms and the endoscopic findings as dependent variables. A
probability of less than .05 was considered significant.
Fig 2. Typical rigid endoscopic views of the nasal mucosa of a patientwith allergic rhinitis, before (top), and after (bottom) treatment. Top:edematous congestion of the inferior turbinates (arrows). Small drops ofmucoid discharge are scattered on the septal (curved arrows) andturbinates’ hyperemic mucosa. Bottom: endoscopic views of the nose ofthe same patient after successful phototherapy. The inferior turbinate(arrow), the middle turbinate (empty arrow) and the nasal mucosaappear normal. RESULTS
There were no significant differences in gender or age between patients in
the study and the placebo groups. The degrees of severity of
symptomatology prior to treatment of the patients with allergic rhinitis in
the study and placebo groups are summarized in Tables 1 and 2,
respectively. Nasal obstruction caused by edematous congestion of the
inferior turbinates was the most common pretreatment finding on
nasendoscopic examination. (Tables 1 and 2, Figs 2 and 3). In second
place among the findings clearly observed by the rigid endoscope were
droplets of mucoid or watery discharge scattered on the septal and
turbinate mucosa (figs 2 and 3). These findings, together with the streaks
of mucoid discharge flowing across the eustachian tube orfice, were
obtained to varying extents in almost all patients.
Table 3. Number (%) of Patients in the Study Group ShowingImprovement or Deterioration After Intranasal Phototherapy.
number
(n=50) †
Total
Percent †
________________________________________________________* Sub = subjective and Obj = objective† Only the patients with allergic rhinitis are included in thecalculation.
Table 4. Number of Patients in the Control Group Showing Improvementor Deterioration After Sham Treatment.
number†
(n=29)
Total
Percent †
________________________________________________________* Sub = subjective and Obj = objective† Only the patients with allergic rhinitis are included in the calculation.
Only one patient in the study group had normal nasal mucosa (Table1, “nasal obstruction”). Only two patienrts in the study group (Table 1:“rhinorrhea”) and one patient in the placebo group (Table 2 -:rhinorrhea”) did not show watery or mucoid discharge. Edema of themiddle turbinate with mucoid or watery discharge was found in 50 of the79 patients with allergic rhinitis.
Figure 3. A typical rigid endoscopic view of the nasal mucosa in apatient with allergic rhinitis. Top: before treatment the mucosa of theseptum (curved arrows) and inferior turbinate (arrowhead) and middleturbinate (empty arrow) is hyperemic, congested and shows scatteredsmall drops of mucoid discharge. Bottom: normal mucosa, inferior andmiddle turbinates in the same patient after successful phototherapy. The results obtained in the two groups after 2 weeks of treatment aresummarized in Tables 3 and 4, respectively. Mild overall improvement ofsymptoms was experienced by 44% and marked improvement by 29% ofthe patients with allergic rhinitis in the active treatment group. Patientswith accompanying septal deviation reported a lower rate ofimprovement. Of the ten patients with nasal polyposis only oneexperienced mild improvement in rhinorrhea, but none showedanyobjective improvement (Table 3). When the patients with nasal polyposiswere excluded and the various symptoms were induvidually evaluatedafter phototherapy in patients with allergic rhinitis only, an improvementin nasal obstruction was reported by 80% and an improvement inrhinorrhea was reported by 81% of the patients in the active treatmentgroup versus 31% and 14% in the sham group (Table 1 and 2).
Considering only the patients with allergic rhinitis, mild objectiveimprovement in nasal obstruction was endoscopically demonstrated afterphototherapy in 41% (in 9 patients with moderate and in 11 patients withsevere nasal obstruction). Marked objective improvement was found in20% (in one patient with mild, two patients with moderate, and in sevenpatients with severe nasal obstruction) (Table 1). Objective improvementin rhinorrhea was mild in 35% of these patients and marked in 29%. Mildor marked objective improvement of edema of the middle turbinate wasseen in 48%. Subjective improvements in nasal itching, headache, andcough were reported by 60%, 70% and 69% of these patients,respectively.
Of the 29 patients with allergic rhinitis in the placebo group (Tables 2and 4), seven (24%) reported mild or marked improvement; and objectiveevaluation showed only mild improvement in six patients (21%) (Table4).
When allergic rhinitis symptoms in the placebo group were evaluatedindividually subjective improvement in nasal obstruction was reported by31% of the patients and objective improvement was found in 21%. Thecorresponding findings for rhinorrhea were 14% and 7%. The objectiveimprovement in edema of the middle turbinate and the subjectiveimprovements in nasal itching, headache, and cough are recorded inTable 2.
Subjectively experienced improvement in the study group of patientswith allergic rhinitis was significantly greater than in the placebo groupwith respect to the following variables: nasal obstruction (P = .016), headache, (P = .023), nasal itching (P = .019), cough (P = .004), rhinorrhea (P= .0004), and overall subjective improvement (.021). Objectivelyrecorded improvement was also significantly greater in the study groupwith regard to the appearance of the nasal mucosa (P=0.17), ethmoidaledema (P=.0007), nasal passage (P=.022), and overall objectiveimprovement (P=.0006). In patients with allergic rhinitis only, ascompared with those with allergic rhinitis accompanied by septaldeviation, improvements in the mucosal appearance and nasal passagewere less significant (P=.04 and .02 respectively) in the study group thanin the placebo group, and differences in improvement in nasal dischargewere of borderline significance (P=.06). Improvements insymptomatology and in endoscopic findings were not correlated with sex,age, coexistance of bronchial asthma, or previous response to medicaltreatment or condition.
DISCUSSION
The findings of this study demonstrate that exposure of the congested
nasal mucosa of patients with allergic rhinitis to narrow-band red light
illumination at 660 nm results in a significant alleviation of symptoms,
except in those cases aggravated by the presence of polyps or by a
deviated nasal septum. In many cases the clinical improvement, though
significant, was only partial. Nevertheless, in some instances
phototherapy proved beneficial where all attempts at other types of
conservative treatment had failed. Many of our patients had not
responded to previous conservative treatment with antihistamines or local
steroids. Others had suffered side effects that precluded the use of
antihistamines, so that phototherapy was their only resource. No adverse
side effects of the treatment were observed in this study.
Low-energy narrow-band phototherapy may therefore be viewed as a
useful additional approach in the treatment of allergic rhinitis. Although
the resulting improvement may be only partial, this treatment could be of
value after surgical procedures such as inferior turbinectomy and
correction of septal deviation. Further, since sinusitis amy be a sequela ofupper respiratory tract infection, malformed intranasal structures, or chronic mucosal disease such as allergic rhinitis, polypoid disease orpolyposis, the routine use of phototherapy in patients with allergic rhinitscould possibly reduce the occurrence of secondary sinusitits in thesepatients. Phototherapy had no effect in patients with nasal polyposis. Polypsoriginate in the ethmoidal cells, out of reach of the diode’s beam.
Candidates for phototherapy should therefore be selected on the basis ofan accurate nasal examination in order to exclude patients with polyposisand/or other conditions not amenable to such treatment.
In the present study, both patient selection and objective therapeuticassessments were based mainly on videoendoscopy. The use ofendoscopy and of computed tomograohy have changed completely themethods of diagnosis and treatment of sinusitis. 26-29 Patients withequivocal endoscopic findings were excluded from our study if CTdemonstrated sinus disease. CT scanning provides information about the3 dimensional structure of the paranasal sinus complex. Endoscopy,however, also yields useful information on the appearance of the mucosaand may even allow detection of small areas of pathologic involvementnot usually revealed by CT. Endoscopic findings of purulent dischargeare indicative of sinusitis even if the radiographic examination is normal,and its cause should be determined. Endoscopy together with CTtherefore appears to be a useful diagnostic procedure in the selection ofpatients for phototherapy. In addition, the video equipment allowsconvenient documentation of the findings.
Low-energy illumination therapy has proved effective in a number ofclinical situations such as pain relief 30 and wound healing. 13 Illuminationat both the visible (380 to 770 nm) and the infrared (700 to 1000 nm)range were shown to be of therapeutic benefit, but these two types ofillumination differ markedly in their photochemical and photophysicalproperties. The visible light probably initiates the cascade of metabolicevents at the level of the respiratory chain of the mitochondria, includingthe formation of reactive oxygen species, through a photochemicalreaction, 9 whereas infrared illumination does so by activating enzymes,and probably also Ca 2+ channels in the membranes. 31 Karu et al 21 foundthat diode lasers (660,820,880 and 950 nm) suppress the release ofreactive oxygen species in human blood. Czuba et al 32 recently reported adecrease in neutrophil chemiluminescence, considered a sensitive indicator of cellular oxidative metabolism, during exposure of the cells tolow-power infrared illumination. Yamaha et al 33 described theproduction of reactive oxygen species in human neutrophils followingtheir illumination at 830 nm. Another recent finding is the activation ofcatalase and superoxide dismutase by red light. 22,23 Catalase is known toregulate H 2O2 concentration in the cell and superoxide dismutase to suppress O2 formation. Activation of these enzymes by red light might
explain how red light acts to suppress the oxygen radicals formed in
allergic reactions. As for the effect of light illumination on Ca 2+
transport, accelerated influx of Ca 2+ into cells was reported following
illumination at 633 and 660 nm. 17,24,25 Since allergic symptoms are
strongly dependent on formation of reactive oxygen species 34-41 and on
transient [Ca 2+ ] changes in participant neutophils, eosinophils or mast
cells, 42 it seems likely that these cells are affected by light of the
appropriate wavelength, intensity and energy. Accordingly, on the basis
of findings in previous studies, 31,43,44 the illumination selected for our
study was red light at 660 nm.
The patients who participated in the present study were followed up for
approximately 1 year, and none exhibited any adverse side effects of the
phototherapy. Those patients who had responded favorably to the
treatment showed continuing benefit throughout the year. In some
patients, illumination seemed to act synergistically with antihistamines,
local steroids, or disodium cromoglycate. We believe that many patients
can obtain relief of symptoms with this new therapeutic protocol, either
by itself or in combination with other modes of treatment. On the basis of
the findings in our study, although further more detailed follow-up and
comparisons with conventional therapy are needed, we suggest
illumination at a wavelength of 660 nm for the treatment of symptoms of
allergic rhinitis.
In conclusion, allergic rhinitis, when uncomplicated by polyps,
deviated nasal septum or chronic sinusitis, may be treated effectively by
red light illumination of the nasal mucosa at 660 nm, leading in many
cases to marked alleviation of symptoms. Wherever possible, candidates
should be selected by endoscopic examination to rule out polyposis and
sinusitis.
ACKNOWLEDGEMENT
We express our appreciation to Ms. Nava Yellin for help with the
statistical work, to Rachel Lobart PhD from the Physics Department, Bar
Ilan University, Ramat Gan for her assistance in preparing the
manuscript, to Eng. Emanuel Mendes for the technical assistance, and to
Ms. Shirley Smith for editing the manuscript.
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