Lin Et Al-2003-The Laryngoscope

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    The LaryngoscopeLippincott Williams & Wilkins, Inc., Philadelphia

     © 2003 The American Laryngological,Rhinological and Otological Society, Inc.

    Radiofrequency for the Treatment of 

     Allergic Rhinitis Refractory to MedicalTherapy

    Hsin-Ching Lin, MD; Pei-Wen Lin, MD; Chih-Ying Su, MD; Hsueh-Wen Chang, PhD

    Objectives/Hypothesis: The ideal treatment for al-lergic rhinitis refractory to medical therapy is stilllacking. The aim of the study is to evaluate the effi-cacy of turbinate surgery with radiofrequency for thetreatment of allergic rhinitis that is unresponsive tomedical therapy.  Study Design:   A prospective, non-randomized clinical study.   Methods:   From February2000 to April 2002, 108 consecutive patients (45 menand 63 women [mean age, 29.5 y]) with allergic rhini-tis refractory to medical therapy who underwent ra-diofrequency turbinate surgery were enrolled in thestudy. Postoperative follow-up ranged from 12 to 26months. A standard 0-to-10 visual analogue scale withan anchor was used to assess the pain and the allergicsymptoms, including nasal obstruction, rhinorrhea,sneezing, itchy nose, and itchy eyes, preoperativelyand postoperatively at the end of weeks 1 and 2 andmonths 1, 3, 6, and 12 after surgery. Statistical analy-sis was determined by repeated measures of ANOVA.

     Results: None of the 108 patients had obvious discom-

    fort other than mild numbness over the premaxillaryarea (24 of 108 [22.2%]) during operation. Also, noadverse reactions including bleeding, infection, adhe-sion, or a worsening of allergic symptoms were en-countered. One hundred one patients were includedin the final statistical analysis. Only nine patientsreported no improvement at all after treatment. Theresponse rate of radiofrequency turbinate surgery forallergic rhinitis refractory to medical therapy was91.1% (92 of 101). At 1 year after the treatment, thedegree of nasal obstruction had changed on the visualanalogue scale (mean SD) from 6.84 2.09 to 2.47 1.60, an improvement of 63.9%. The degree of rhinor-rhea had changed from 5.74   2.75 to 2.57   2.31, an

    improvement of 55.2%. The degree of sneezing hadchanged from 5.30    2.80 to 2.59   2.13, an improve-ment of 51.1%. The degree of itchy nose had changedfrom 3.74     3.16 to 1.82     2.27, an improvement of 51.3%. The degree of itchy eyes had changed from 3.17   3.09 to 1.68    2.38, an improvement of 47.0%. Thevisual analogue scale scores for nasal obstruction,rhinorrhea, sneezing, itchy nose, and itchy eyes de-creased significantly with time, from preoperativescores to scores at 1 year after surgery. Other addi-tional effects and improvements, including headache,lumpy throat, night cough, and tinnitus, were alsoreported by the patients. Most of the patients statedthat they would consider repeating this procedure if necessary and would recommend the new method totheir friends with the same problems.  Conclusions:The study demonstrates that radiofrequency appearsto be an effective and safe tool for treating allergicrhinitis with poor response to medical therapy. In thefuture, radiofrequency has the potential to be one of 

    the most popular surgical modalities for the treat-ment of allergic rhinitis refractory to medical ther-apy.   Key Words:   Radiofrequency, allergic rhinitis,nasal turbinate.

     Laryngoscope, 113:673– 678, 2003

    INTRODUCTION Allergic rhinitis, one of most common otolaryngolog-

    ical disorders, is a bothersome but not a life-threatening 

    disease. It not only interferes with the quality of a pa-

    tient’s daily life but also induces intangible loss on his or

    her physical, emotional, and even socioeconomic function-

    ing. Most of the patients have been treated with conven-

    tional pharmacotherapy such as antihistamines, decon-

    gestants, anticholinergic agents, mast cell stabilizers,

    intranasal steroid sprays, and allergen desensitization.1

    However, some intractably allergic patients remain, as

    well as some inconvenience for those who have used these

    medicines over a long term. When conservative therapy

    has failed to relieve the symptoms of allergic rhinitis,

    many turbinate surgical procedures such as cryosurgery,

    electrocautery, laser turbinectomy, partial or total turbi-

    nectomy, and vidian neurectomy have been employed with

     various effects. Because of direct mucosal manipulation

    during those surgical procedures, adverse events includ-

    Presented in part at the 105th Annual Meeting of the American Academy of Otolaryngology—Head and Surgery, Denver, CO, September9–12, 2001.

    From the Departments of Otolaryngology (H-C.L., C- Y .S.) and Ophthal-mology (P-W.L.), Chang Gung University, Chang Gung Memorial Hospital,Kaohsiung Medical Center, and the Department of Biological Sciences(H-W.C.), National Sun Yat-Sen University, Kaohsiung, Taiwan.

    Editor’s Note: This Manuscript was accepted for publication Decem-ber 5, 2002.

    Send Correspondence to Chih-Ying Su, MD, Department of Otolar-yngology, Chang Gung Memorial Hospital, Kaohsiung Medical Center, No.123, Ta-Pei Road, Niao-Sung Hsiang, Kaohsiung Hsien, 833, Taiwan.E-mail: [email protected]

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    ing bleeding, pain, crusting, foul odor, nasal dryness, syn-

    echia or bone necrosis, and the need for nasal packing may

    occur.2–8

    In recent years, radiofrequency (RF) surgery has

    been widely applied to various otolaryngological disorders

    including simple snoring, sleep-related disorders, nasal

    obstruction due to turbinate hypertrophy, and obstructive

    tonsillar hypertrophy.9–19 The safety and efficacy of RF

    turbinate surgery for hypertrophied turbinate has been

    well demonstrated with respect not only to subjective im-

    provement of the symptoms, but also to objective changes

    in nasal function.20 Compared with the traditional surgi-

    cal procedures, the main advantages of RF surgery are the

    sparing of the overlying mucosa and the decrease in oper-

    ative morbidity and postoperative complications. To the

    best of our knowledge, the feasibility and efficacy of RF

    turbinate surgery in patients with nasal allergy has not

    been fully addressed in the literature.

    PATIENTS AND METHODS

     PopulationsFrom February 2000 to April 2002, 108 consecutive patients

    (45 men and 63 women) with allergic rhinitis refractory to med-ical treatment were prospectively enrolled in the study. All of the

    patients underwent RF surgery of the inferior turbinates and

    were observed postoperatively for more than 1 year. The age of 

    the patients ranged from 11 to 70 years (mean age, 29.5 y).

     Evaluation All of our patients with allergic rhinitis had typical clinical

    symptoms and signs, as well as a high titer of specific immuno-

    globulin E (IgE) antibodies for house dust and/or other antigens.

    They had been previously treated with conventional medical

    management without satisfactory improvement for at least 3

    months. Patients with systemic disease, previous turbinate sur-

    gery, severe nasal septal deviation, nasal polyposis or sinusitis,

    upper respiratory tract infection within a week preoperatively, a

    history of radiotherapy, or oral steroid use were excluded. The

    patients were also assessed by an ophthalmologist to exclude any

    ophthalmological disorder that may induce the symptom of eye

    pruritus such as trichiasis, entropion, blepharitis, blepharocon-

     junctivitis, keratoconjunctivitis, or dry eye syndrome, as well as

    the use of topical eyedrops of antihistamine, corticosteroid, or

    mast cell stabilizer.

    Objective evaluations of the intranasal findings were inves-

    tigated by anterior rhinoscope or endoscopic examinations. A 

    standard visual analogue scale (VAS) with an anchor (ranging 

    from 0 to 10, with 0 representing no symptoms and 10 represent-

    ing the most severe symptoms) was used to assess the allergic

    patients’   subjective symptoms including nasal obstruction, rhi-

    norrhea, sneezing, itchy nose, and itchy eyes preoperatively and

    at the end of weeks 1 and 2 and months 1, 3, and 6, and 12 after

    surgery.Postoperative pain was also graded on a VAS ranging from

    0 to 10. The patients were asked not to use oral steroids, antihis-

    tamines, decongestants, or topical nasal sprays containing corti-

    costeroids or mast cell stabilizers during the follow-up period.

    Surgical Procedure All surgical procedures were performed by the first author

    (H-C.L.) in an outpatient facility. The operation was performed

    with the patient under local anesthesia consisting of sprays with

    10% lidocaine (two puffs per nostril) and infiltration with 2%

    lidocaine (total amount, 2– 4 mL) injected into the anterior por-

    tion of each inferior turbinate. Radiofrequency energy was deliv-

    ered at a frequency of 465 Hz by an RF generator (model S2

    radiofrequency control unit, Somnus Medical Technologies, Inc.,

    Sunnyvale, CA) and an SP 1100 turbinate handpiece (40-mm-

    long needle electrode consisting of a 10-mm active portion, 30-mm

    insulated part, and two thermocouples). The active 10-mm por-

    tion of the electrode and at least 2 mm of the insulation were

    placed submucosally within the anterior portion of each inferior

    turbinate (two punctures per turbinate, one facing to the common

    meatus and parallel to the septum and the other facing the

    inferior meatus and parallel to the nasal floor) under direct vision

    using a fiberoptic headlight and nasal speculum (Figs. 1 and 2).

    The energy (mean SD) delivered for puncture site A was 365.3

     76.8 J and for puncture site B was 425.0    71.4 J; total dose

    was 1580.1     277.1 J with an approximate duration of 1 to 2

    minutes at a plateau temperature of 75°C and low-level energy of 

    10 W. All patients underwent a single RF turbinate surgery with

    four punctures. After completion of the procedure, cotton pledgets

    soaked with a mixture of 4% lidocaine and 0.1% epinephrine (1:1)

    were temporarily placed over the puncture sites for 5 to 10 min-

    utes. Each patient was discharged without any limitation of nor-

    mal daily activities. No nasal packing was administered, nor were

    antibiotics, antihistamines, analgesics, or nasal spray prescribed.

    Local findings of the nasal cavities and assessment of treatment

    efficacy were recorded in detail at each follow-up session.

    Fig. 1. Coronal view of radiofrequency energy being delivered. Twopunctures per turbinate are performed: point  A   faces the commonmeatus and parallels the septum and point   B   faces the inferiormeatus and parallels the nasal floor.

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    Statistical AnalysisResults were expressed as mean     SD. Comparisons of 

    scores for the common symptoms of allergic rhinitis (including 

    nasal obstruction, rhinorrhea, sneezing, itchy nose, and itchy

    eyes) generated with VAS preoperatively and postoperatively

    were made using repeated measures of ANOVA. When significant

    differences were noted, individual means were compared using 

    the Scheffe test. Differences were considered to be statistically

    significant when the  P  value was less than .05.

    RESULTS

    None of the 108 patients reported obvious discomfort

    other than a mild numbness over the premaxillary area

    (24 of 108 [22.2%]) during operation, which immediatelysubsided when the delivery of RF energy was finished.

     Also, no other adverse reactions including crusting, bleed-

    ing, infection, adhesion, dryness, or synechia were encoun-

    tered (Fig. 3). There were 13 patients (12.0%) who re-

    ported having mild postoperative pain, which was scored

    at 2 or less. A transient worsening of symptoms in nasal

    obstruction and/or nasal secretion was reported by 67

    patients (62.0%), all cases occurring only within the first 3

    postoperative days. No analgesics were prescribed in the

    entire study, and no analgesics were requested by the

    patients.

    Of the seven cases excluded from the study, one pa-

    tient developed hepatoma 3 months after surgery, two

    patients received a local application of Chinese herbal

    drugs during the early postoperative period, and four pa-

    tients were lost in follow-up. One hundred one patients

    were enrolled in the final related long-term statistical

    analysis. In the series of 101 patients with allergic rhini-

    tis, only 9 patients reported no improvement of any aller-

    gic rhinitis symptoms after treatment. The response rate

    of RF turbinate surgery for these patients with allergic

    rhinitis refractory to medicine was 91.1% (92 of 101). The

    RF treatment outcome assessments for the common symp-

    toms of allergic rhinitis in the 92 patients at each

    follow-up time are summarized in Table I and shown in

    Figure 4. The follow-up period ranged from 12 to 26

    months, with a mean follow-up period of 19.4 months.

     Nasal ObstructionThe VAS scores (mean SD) for nasal obstruction as

    graded by the patients changed from a preoperative score

    of 6.84     2.09 to postoperative scores of 4.24    2.45 at 1

    week, 3.32 2.06 at 2 weeks, 2.64 1.79 at 1 month, 2.46

    1.61 at 3 months, 2.45 1.62 at 6 months, and 2.47

    1.60 at 12 months. The average degrees of improvement of 

    nasal obstruction at the end of weeks 1 and 2 and months

    1, 3, 6, and 12 were 38.0,% 51.5,% 61.4,% 64.0,% 64.2,%and 63.9%, respectively.

     RhinorrheaThe VAS scores (mean     SD) for rhinorrhea as

    graded by the patients changed from a preoperative score

    of 5.74     2.75 to postoperative scores of 4.03    2.69 at 1

    week, 3.46 2.38 at 2 weeks, 2.90 2.19 at 1 month, 2.66

    2.25 at 3 months, 2.60 2.34 at 6 months, and 2.57

    2.31 at 12 months. The average degrees of improvement of 

    rhinorrhea at the end of weeks 1 and 2 and months 1, 3, 6,

    and 12 were 29.8%, 39.7%, 49.5%, 53.7%, 54.7%, and

    55.2%, respectively.

    SneezingThe VAS scores (mean SD) for sneezing as grade by

    the patients changed from a preoperative score of 5.30  

    2.80 to postoperative scores of 3.38 2.41 at 1 week, 3.13

    2.29 at 2 weeks, 2.85 2.15 at 1 month, 2.55 2.13 at

    3 months, 2.52 2.17 at 6 months, and 2.59 2.13 at 12

    months. The average degrees of improvement of sneezing 

    at the end of weeks 1 and 2 and months 1, 3, 6, and 12

    were 36.2%, 40.9%, 46.2%, 51.9%, 52.5%, and 51.1%,

    respectively.

    Fig. 2. Sagittal view of radiofrequency energy being delivered. The active 10-mm portion of the electrode and at least 2 mm of the insulationare inserted submucosally within the anterior portion of the inferior turbinate and an ovoid lesion is created.

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     Itchy NoseThe VAS scores (mean SD) for itchy nose as graded

    by the patients changed from a preoperative score of 3.74  3.16 to postoperative scores of 1.82     2.37 at 1 week,

    1.73 2.29 at 2 weeks, 1.59 2.05 at 1 month, 1.61 2.04

    at 3 months, 1.67 2.00 at 6 months, and 1.82 2.27 at

    12 months. The average degrees of improvement of itchy

    nose at the end of weeks 1 and 2 and months 1, 3, 6, and

    12 were 51.3%, 53.7%, 57.5%, 57.0%, 55.3%, and 51.3%,

    respectively.

     Itchy EyesThe VAS scores (mean SD) for itchy eyes as graded

    by the patients changed from a preoperative score of 3.17

     3.09 to postoperative scores of 1.78     2.60 at 1 week,

    1.60 2.35 at 2 weeks, 1.29 2.00 at 1 month, to 1.47

    2.18 at 3 months, 1.32 2.00 at 6 months, and 1.68 2.38

    at 12 months. The average degree of improvement of itchy

    eyes at the end of weeks 1 and 2 and months 1, 3, 6, and

    12 were 43.8%, 49.5%, 59.3%, 53.6%, 58.4%, and 47.0%,

    respectively.

    In the present series, the VAS scores for nasal ob-

    struction, rhinorrhea, sneezing, and nasal and ophthalmo-

    logical pruritus decreased significantly with time, from

    before surgery to 1 year after surgery (Scheffe test,   P

    .0001).

     Additional Effects and Follow-UpIn two male patients who had both allergic rhinitisand habitual snoring, RF turbinoplasty in combination

    with RF palatoplasty was carried out by using an SP 1010

    RF palate handpiece. They had improvement not only in

    the symptoms of allergic rhinitis but also in the severity of 

    snoring.

     Additional postoperative improvements of the other

    symptoms including headache, lumpy throat, night cough,

    and tinnitus were also reported by patients. Twenty-one

    patients have been followed up for more than 2 years. All

    patients reported that they would consider repeating this

    procedure if necessary, and would recommend the new

    method to their friends with the same disorder.

    DISCUSSION Although RF energy has been widely used in various

    medical fields for years, it was first used in the otolaryn-

    gological field by Powell et al. in 1997.21 To date, RF tissue

     volume reduction has been extensively applied to the tar-

    gets of upper airway disorders, including the nasal turbi-

    nates, soft palate, base of the tongue, and tonsils. With

    respect to RF turbinate surgery, most of the previous

    studies focused their attention only on the problems of 

    nasal patency resulting from inferior turbinate hypertro-

    phy.14–18,20 In the current study, we investigated the ef-

    ficacy of RF turbinate surgery emphasizing the common

    symptoms of allergic rhinitis.

    The investigation of the histological changes caused

    by RF surgery revealed that a well-circumscribed submu-

    cosal scar lesion with normal healing progression in the

    target site is stably formed at 3 weeks postoperatively.21

    Our results are compatible with the histological study.

    The effect of RF turbinoplasty for allergic rhinitis may

     vary at the end of 1 or 2 weeks postoperatively, but it

    achieved a relatively obvious and stable improved status

    in relation to the symptoms of allergic rhinitis 1 month

    later. One month after treatment, 96.7% of these patients

    obtained significant improvement of nasal obstruction,

    Fig. 3. Endoscopic views of inferior turbinate (no topical vasocon-

    striction agents were applied before obtaining the images). (  A 

     ) Pre-operative view. ( B ) Postoperative view. No superficial mucosal dam-age was noted. ( C ) One month postoperatively. The patency of theanterior nasal cavity obviously increases. S, septum; T, inferiorturbinate.

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    with the VAS score (mean    SD) changing from 6.84  

    2.09 to 2.64    1.79, an improvement of 61.4%. The VAS

    score for rhinorrhea changed from 5.74    2.75 to 2.90  

    2.19, an improvement of 49.5%. The VAS score for sneez-

    ing changed from 5.30 2.80 to 2.85 2.15, an improve-

    ment of 46.2%. The VAS score for itchy nose changed from

    3.74 3.16 to 1.59 2.05, an improvement of 57.5%. The

     VAS score for itchy eyes changed from 3.17 3.09 to 1.29  2.00, an improvement of 59.3%. During the follow-up

    period (Fig. 4) the symptoms of nasal obstruction, rhinor-

    rhea, and sneezing improved stably with time, with the

    average degrees of reduction of severity of nasal obstruc-

    tion, rhinorrhea, and sneezing at 1 year postoperatively

    being 63.9%, 55.2%, and 51.1%, respectively. Although the

    RF effects on the symptoms of itchy nose and eyes seemed

    to be less obvious and had a mildly decreasing tendency,

    the differences were still considered to be statistically

    significant when compared with the preoperative status.

    Regarding the sustainable effect of RF surgery on

    allergic rhinitis, 21 patients have been followed up for

    more than 2 years. In most of them, the treatment out-

    comes showed no obvious subsidence with the additional

    follow-up time. Among these patients, the VAS scores for

    nasal obstruction, rhinorrhea, sneezing, itchy nose, and

    itchy eyes changed from 6.43 2.27, 6.29 2.41, 6.05

    2.56, 2.81 3.25, and 2.00 2.66 preoperatively to 1.90

    1.84, 2.62 2.24, 3.00 2.32, 1.43 2.36, and 0.81 1.83

    at 2 years after RF surgery. Two years after the RF treat-

    ment, the average degrees of reduction of severity of nasal

    obstruction, rhinorrhea, sneezing, itchy nose, and itchy

    eyes were 70.5%, 58.3%, 50.4%, 49.1%, and 59.5%,

    respectively.

    Two of our patients had both allergic rhinitis and

    habitual snoring preoperatively. We used the RF SP 1010

    palate handpiece to perform the turbinate surgery first,

    then bent the electrode to carry out RF palatoplasty. The

    result revealed an improvement in allergic symptoms,

    snoring, and quality of sleep. Radiofrequency turbinate

    surgery combined with RF palatoplasty could be an effec-

    tive method for patients with nasal allergy with mild

    sleep-disordered breathing. This combined surgery would

    be more cost-effective than performing the two proceduresseparately. We also found that RF surgery had additional

    postoperative effects on the concomitant symptoms in the

    patients with allergic rhinitis as well. Some allergic pa-

    tients, who also had headaches, lumpy throat, night

    cough, posterior nasal dripping, and tinnitus preopera-

    tively, had improvement not only in the allergic symptoms

    but also in these additional discomforts after RF surgery.

    Haight and Cole22 reported that the resistance of the

    nasal airway significantly increased over the anterior

    ends of the inferior turbinates and nasal valve region. The

    mechanism of RF turbinate surgery in relieving the symp-

    tom of nasal obstruction was mainly based on the tissue

     volume reduction of the anterior portion of the inferiorturbinate by RF energy. Because the superficial submu-

    cosal layer of the inferior turbinate was thought to be the

    site where the allergic reaction occurred,7 we assumed

    that the superficial surface area for allergen contact would

    decrease after RF turbinate surgery. The consequence of 

    RF energy in the submucosa of the inferior turbinate, such

    as circumferential scar formation, obliteration of the sub-

    mucosal small vessels, and destruction of the submucosal

    glands, is thought to be a major factor for the RF effects on

    allergic rhinitis. In addition, there might also be a reaction

    to inhibit the local immune response and the passage of 

    histochemical mediators. Further investigations are

    needed.We performed the RF turbinoplasty (one procedure

    with four punctures) for each of our patients. The inser-

    tion sites limited to the anterior portion of the inferior

    turbinate were sufficient to obtain a satisfactory result.

    None of our positively responding patients underwent a

    revision RF surgery in the follow-up period. The current

    study revealed that RF turbinoplasty is a minimally inva-

    sive and well-tolerated surgery, and the middle-term re-

    sults of this procedure for allergic rhinitis were

    encouraging.

    TABLE I.

    The VAS Records (mean SD) of the Symptoms of Allergic Rhinitis at Each Follow-up Time.

    Pretreatment 1W 2W 1M 3M 6M 1Y   P*

    Nasal obstruction 6.84 2.09 4.24 2.45 3.32 2.06 2.64 1.79 2.46 1.61 2.45 1.62 2.47 1.60   .0001

    Rhinorrhea 5.74 2.75 4.03 2.69 3.46 2.38 2.90 2.19 2.66 2.25 2.60 2.34 2.57 2.31   .0001

    Sneezing 5.30 2.80 3.38 2.41 3.13 2.29 2.85 2.15 2.55 2.13 2.52 2.17 2.59 2.13   .0001

    Itchy nose 3.74 3.16 1.82 2.37 1.73 2.29 1.59 2.05 1.61 2.04 1.67 2.00 1.82 2.27   .0001

    Itchy eyes 3.17 3.09 1.78 2.60 1.60 2.35 1.29 2.00 1.47 2.18 1.32 2.00 1.68 2.38   .0001

    *Overall significance by repeated measures of ANOVA. VAS standard 0–10 visual analog scale.

    Fig. 4. The average degree of improvement of nasal allergic symp-toms at each follow-up time postoperatively (derived from thechange in visual analogue scale (VAS) score (range, 0 –10) afterradiofrequency turbinate surgery).

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    CONCLUSIONThe study suggests that RF is an effective and safe

    tool for treating allergic rhinitis refractory to medical

    therapy. Radiofrequency turbinate surgery can signifi-

    cantly improve the symptoms of allergic rhinitis. If the

    further long-term studies confirm these results, radiofre-

    quency may have the potential to be a surgical modality of 

    choice for allergic rhinitis refractory to medical therapy.

     Acknowledgments

    The authors thank Mei-Ling Kao for her assistance in

    the preparation of the manuscript and Jui-Hsin Chen for

    his assistance in drawing the illustrations.

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