Allergic rhinitis: The patient's perspective
`
`William Storms, MD," Eli 0. Meltzer, MO,b Robert A . Nathan, MD,• and
`John C. Selner, MD< Colorado Springs and Denver, Colo., and San Diego, Calif.
`
`A elf-administered screening questionnaire was scot to
`15,000 househo lds randomly elected from a nationwide
`panel of approximately 200,000 households. This question(cid:173)
`naire was used to select a balanced sa mple of 1450 persons
`with 2:7 days of nasal/ocular symptoms in the previous 12
`months. These persons received a second questionnaire that
`contained detailed questions regarding symptoms, triggers,
`patient attitudes, and medical treatment. or the 1065 people
`who responded to the second questionnaire, 481 were identi(cid:173)
`fied as having self-reported seasonal or perennial allergic
`rhinitis. Our major findings regarding the attitudes toward
`their disease expressed by these 481 respondents ore as fol(cid:173)
`lows. Although 53% or our study population regarded their
`symptoms as mild, 47% reported onset before age 17, sug(cid:173)
`gesting that many have become accustomed to their symp(cid:173)
`toms. The level of allergen avoidance was generally low; only
`38% took any allergen avoidance measures in the home. The
`level of self-medication was high; 92% reported self-medica(cid:173)
`tion with prescription and nonprescription drugs. Finally,
`26% believed that their symptoms were "well controlled" or
`"completely controlled," and 52% believed that effective treat(cid:173)
`ments were available. Our llndings suggest the need for a
`greater eft'ort on the part of health care providers to identify
`patients with allergic rh initis and to educate them about
`their disease. (J Allergy Clio lmmunol 1997;99:5825-8.)
`
`Key words: Allergic rhinitis, nasal symptoms, environmemal
`triggers, self-medication, nationwide survey
`
`The most common allergic condition, allergic rhinitis,
`presents several diagnostic challenges. Standardized di(cid:173)
`agnostic criteria are not available. The ymptoms (itch(cid:173)
`ing, sneezing, nasal discharge, or blockage) may prompt
`physicians and patients alike to think first of a viral cause
`(i.e., the common cold) and not an allergic reaction .
`Many patients have coexisting allergic and oonallergic
`factors that trigger their rhinitis. A careful history is
`critical, but who bas not had na al symptoms at some
`time? Patients with mild symptoms may not attribute
`tbem to allergies. lndeed, it ha been sugge ted that
`there is no clear boundary marking onset of the allergic
`response; rather, there may be a continuum, with pa(cid:173)
`tients experiencing occa ional symptoms of rhioiti at
`one end and, on the other, patients with evere, chronic
`disease. 1 Therefore, what a patient ays may not fully
`reflect the clinical reality.
`Management of this disorder is also less straightfor-
`
`From •Asthma and Allergy Associates, Colorado Springs; bthe Allergy
`and Aslhma Medical Group and Re earch Center, San Diego; and
`•the Allergy Respiratory Institute of Colorado, Denver.
`Reprint req uests: William Storms, MD, 2709 North Tejon Street.
`Colorado Springs, CO 80907.
`Copyright C 1997 by Mosby-Year Book, lnc.
`0091-6749/97 $5.00 + 0
`l/0/81434
`
`ward than it may appea r at the outset. First, there i the
`i ue of defining clinically relevant outcomes. Functional
`·tatu and weU-being arc increasingly recognized a
`important outcomes.2 A related issue concern the point
`at which the primary care physician should refer the
`patient for evaluation by a specialist. It is important for
`doctor and patient to arrive at an understanding of
`treatment expectation .
`This article is intended to help clinician address these
`diagnostic and management issues. It reports on a
`community-based, nationwide sample of people with
`self-reported allergic rhinitis with 7 days or more of
`symptoms in the previous 12 months. These patients
`were surveyed with regard to their perceptions of their
`yrnptoms their perceptions of the safety and effective(cid:173)
`ness of treatment, and how these perceptions affect their
`deci ion to eek medical advice.
`
`MATERIAL AND METHODS
`Sample
`
`Target household were elected from a nationwide panel of
`approximately 200,()()() households maintained by a market
`ational Family Opinion Inc. of Toledo, Ohio.
`research firm,
`Details regarding recruitment and updating of this database
`have been published elsewhere.~
`
`Survey
`In 1993, a elf-ad mini tered screening questionnaire was sent
`to 15,000 randomly selected household from the nationwide
`pane~ with the request that it be an wered by the hou ehold
`member who knew the most about the family' health tatus and
`history in the previous 12 month . A total of 9946 hou e holds
`(66.3% ) responded; 5273 of these households contained a total
`of 8394 persons with nasal/ocular sympto m (sneezing runny
`nose, stuffy nose or head, itchy eyes, or watery eyes). A bal(cid:173)
`anced sample of 1450 persons with 7 or more days (singly or
`con ecutively) of these symptom within the previous year were
`selected to receive a questionnaire containing detailed ques(cid:173)
`tions regarding symptom , triggers, patient attitudes, and med(cid:173)
`ical treatmenL A Iota! of 1065 people (73.4%) responded to this
`second que tionnaire. Among the questions asked was, "Which
`of the following best describe
`the group of symptoms you
`indicated?" Options provided were ( I) a common cold; (2) a
`easonal allergy (i .e., hay fever) ; (3) an allergy I have all the
`time; ( 4) an allergy only when expo cd to triggers (i.e., du t,
`p llution); (5) sinus problems; and (6) other (plea e . pecify).
`Subjects who answered items (2) or (3) were assumed to have
`seasonal or perennial allergic rhinitis, re pectively, and were
`included in our analysis.
`The detailed survey included a series of que tions designed to
`evaluate how allergic rhinitis sufferers perceive their symptoms
`and their expectations regarding medical care. Respondents
`were questioned about their level of satisfaction with -ymptom
`control and current reasons for seeking or not seeking medical
`
`S825
`
`PLAINTIFFS'
`TRIAL EXHIBIT
`
`PTX0042
`
`MEDA APTX03502663
`
`PTX0042-00001
`
`CIP2170
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`1
`
`

`

`SS26 Storms et al.
`
`J ALLERGY CUN IMMUNOL
`JUNE 1997
`
`TABLE I. Demographic characteristics of study
`population
`
`Characteristic
`
`Total
`Gender
`Male
`Female
`Age (yr)
`< 18
`18-34
`35-49
`50-64
`~65
`Region
`ortheast
`New England
`Middle Atlantic
`Midwest
`Ea t North cntral
`West orth Central
`South
`South Atlantic
`East South Central
`West South Central
`West
`Mountain
`Pacific
`Population density
`Rural
`< 100,000
`Urban
`100,000-499,999
`500,000-1 ,999,999
`~ 2 ,000,000
`Hou ehold income ($)
`< 12,500
`12,500-24,999
`25,000-39.999
`40,000-59,999
`~60,000
`
`Number (o/o)
`
`481 (100.0)
`
`206 (42.8)
`271 (56.3)
`
`57 (J i.9)
`99 (20.6)
`161 (33.5)
`92(19.1)
`52 (10.8)
`
`25 (5.2)
`77 ( 16.0)
`
`69 ( 14.3)
`36 (7.5)
`
`81 (16.8)
`23 (4.8)
`56 (l1.6)
`
`39 (8. t)
`75 (15.6}
`
`108 (22.5)
`
`73 (15.2)
`102 (21.2)
`J98 (41.2)
`
`43 (8.9)
`89 (18.5)
`109 (22.7)
`126 (26.2)
`114 (23.7)
`
`help. They were also asked to indicate whether during the past
`12 months their symptoms were "completely controlled," "well
`controlled," "somewhat controlled,'' " poorly controlled," or
`" not controlled." They also reported factOrs that affected their
`symptoms, including potential allergens. time of day, and
`cason. In addition, they were asked to indicate their level of
`agreement with a number of statements concerning symptoms.
`such as " My symptoms arc mild."
`Perceptions of physician interactions were indicated by re(cid:173)
`sponden ts' behavior in seeking treatment from a physician,
`including estimation of the length of time that elapsed after
`symptom onset before they consulted a physician. U e of
`self-medication (nonprescription, pre cription, or both) before
`consultation with a physician was also probed.
`
`RESULTS
`Population demographics
`A total of 481 subjects were included in the final analysis.
`Most of the respondents were white (93%), and there
`were slightly more fema les than males (56% ver us
`
`TABLE il. Response to survey question, "Which
`of the following best describes your behavior in
`seeking treatment from a doctor for your rhinitic
`symptoms?"
`
`Responses of 481 persons with
`self-reported allergic rhinitis
`
`I see a doctor about my symptom
`a soon a
`they begin
`I di cuss my symptoms with my
`doctor only when 1 am seeing
`him for another reason
`My symptoms have to be everc
`enough to limit normal daily
`activiric before I seek treat(cid:173)
`ment from a doctor
`
`Number
`(%)
`
`240 (49.9)
`
`7 (18.1)
`
`77 (16.0)
`
`77 (16.0)
`
`43%). The study population represented all geographic
`regions of the mainland United States with an equal
`distribution among rural and urban areas. Full details of
`the population demographic are given in Table I.
`
`Perception of symptoms
`Onset. The age at which patients first started experi(cid:173)
`encing nasaVocular symptoms was :::3 years in 9% of
`patients, between 4 and 10 years in 20%, between ll and
`17 year in 18%, and between 18 and 34 years in 31 %.
`After age 34, the likelihood of symptom onset dimin(cid:173)
`ished; only 13% reported ymptom onset after age 34.
`The age at symptom on et was
`imilar in males and in
`females.
`Patients were more likely to experience symptom in
`the pring and fail; 64% and 54% , respectively reported
`that their ymptoms were most evcre at these time . In
`contrast, on ly lO% and 25 % reported that their symp(cid:173)
`toms were wor t in winter or ·ummer. A circadian
`pattern wa ' also evident, with 42% reporting that their
`symptom were worst immcdjately after awakening and
`10% reporting that their symptoms were wor t during
`tudy group re(cid:173)
`the nighL Thirty-two percent of ur
`ported that their symptoms were wor ened only by
`expo ure to environmental triggers such a.~ pollen or air
`pollution.
`Description of symptoms. Subjects were asked to indi(cid:173)
`cate their level of agreement with statement about their
`symptoms. To the statement " My symptom are an
`inconvenience," 87% agreed. To the statement "My
`symptoms are mild, ' 53% agreed. To the tatement " l
`have learned to live with my symptoms," 80% agreed.
`
`Perception of physician interaction
`Extefll of physician consultation. Sixty-three percent of
`subjects had consu.lted a phy ician about their symptoms
`during the previous 12 month . Unless symptoms be(cid:173)
`came severe enough to limit daily activitic , study sub(cid:173)
`jects tended to discus
`their rhinitis during a visit that
`\Vas scheduled for some other rea on (Table II). Tho e
`
`MEDA APTX03502664
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`PTX0042-00002
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`2
`
`

`

`J ALLERGY CUN IMMUNOL
`VOLUME 99, NUMBER 6, PART 2
`
`Storms et al. S827
`
`60
`
`50
`
`- 40
`en - 30
`
`~ 0 .........
`c
`<l>
`-.;::
`ctl a.
`
`20
`
`10
`
`0
`
`Strongly/
`somewh at
`agree
`
`Neither
`agree
`nor disagree
`
`Strongly/
`somewhat
`disagree
`
`FIG. 1. Survey of 481 people with self-reported al lergic rhinitis. Responses to the statement "I don't believe
`treatment is avai lable that wil l help my rhinitic symptoms."
`
`who did consult a physician during lhe previou 12
`months waited a mean of 7.85 days after onset of their
`symptoms before doing so.
`Type oj' physician consulted. Fifty-six percent of
`subjects reported that a general or family practitioner
`first diagnosed their symptoms. Fifty-nine percent
`reported that a general or family practitioner was the
`type of physician seen most often for their symptoms.
`Although the initiaJ diagnosis was made by an allergist
`in only 17% of subjects, 52% reported that they bad at
`some time seen an allergist for their symptoms. When
`asked to specify reasons for seeing a specialist, 55%
`reported referral by another physician, 28% reported
`seeking specialist treatment on their own initiative,
`and J 1% were referred by a friend or family member.
`
`Perception of treatment
`
`Degree of satisfaclion. Of those subjects who had
`consulted a physician, 92% reported se lf-medicating
`before their visit; 46% bad tried only nonprescription
`medications, 17% bad tried on ly prescription medica(cid:173)
`tions, and 29% had tried both. Of the total study
`population, 26% believed that their symptoms were
`completely or well controlled during the past 12
`months, 52% reported that their symptoms were
`somewhat controlled, and 22% reported that their
`symptoms were poorly controlled or not controlled
`(Table HI). When a ked to indicate level of agree(cid:173)
`ment with the tatement " I don' t believe treatment is
`avai lable tha t will help my symptoms," 18% agreed
`(Fig. I), Of subjects who had stopped seeing a doctor
`
`TABLE Ill. Perceptions of symptom contro l and
`side effects in 481 persons w ith self-reported
`allergic rhinitis
`
`Degree of symptom control
`Complete or well controlled
`Somewha t controlled
`Poorly or not controlled
`
`from drug taken for ~-ymptoms
`Side effect
`Experiences symptoms
`Avoids some drug because of side effects
`Worrie · about side effects
`
`Number
`(%)
`
`125 (26.0)
`250 (52.0)
`106 (22.0)
`
`149 (31.0)
`313 (65.1)
`231 (48.0)
`
`for their symptom , 19% did o because they believed
`effective treatments were not available and 44% be(cid:173)
`cause they had found effective treatment.
`Side effects. When asked to ind icate level of agree(cid:173)
`ment with the statement -y experience ide effects from
`the medications I take for my symptom ,'' 31% agreed.
`Sixty-five percent agreed with the statement "Becau e of
`the ide effects, there are some drugs I would not take
`for my symptom ." Forty-eight percent agreed with the
`statement "I worry about side effects from the drugs I
`take for my symptoms."
`Compliance. The level of compliance reported by this
`population was high. When asked whether they took
`more medication than their physician recommended,
`
`MEDA APTX03502665
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`PTX0042-00003
`
`3
`
`

`

`S828 Storms et al.
`
`J ALLERGY CUN IMMUNOL
`JUNE 1997
`
`TABLE IV. Responses to survey question "Which
`of the following do you do to help control your
`symptoms? (Check all that apply)"
`
`Responses of 481 persons with self-reported
`allergic rhinitis
`
`Number
`(%)
`
`Avoid smoke-filled places (bars, restaurantS)
`Vacuum my hou e frequently
`Dust my house frequently
`Don't have pets inside my house
`Avoid outdoor activities
`Avoid wearing perfume
`Wash bedding in hot water
`Wrap mattresses in plastic cover
`Do not have carpeting (or rugs) in my bedroom
`Medication/see doctor
`Keep only fumiturc and necessities in my
`bedroom
`Air filter/cleaner
`Do not have carpeting (or rugs) in my house
`Treat carpets or furniture with acaricides or
`tannic acid
`Humidifier/vaporizer
`Wear dust/face mask
`AJI others
`one of the above
`
`219 (45.5)
`184 (38.3)
`164 (34.1)
`100 (20.8)
`90 (18.7)
`83 (17.3)
`72 (15.0)
`29 (6.0)
`20 (4.2)
`18 (3.7)
`14 (2.9)
`
`14 (2.9)
`10 (2.1)
`7 (1.5)
`
`2 (0.4)
`I (0.2)
`17 (3.5)
`122 (25.4)
`
`92% answered seldom or never. When asked whether
`they took less, 68% answered eldom or never.
`Nonpharmacologic meast1res. The most common al(cid:173)
`lergen avoidance measures were du ting and vacuuming
`in the home and avoiding smoke-filled locations uch a
`bars and restaurants (Table IV).
`
`DISCUSSION
`The portrait that emerges from this tudy i one of a
`somewhat stoic population of patients who consider
`consulting a physician only after they have been
`significantly troubled or inconvenienced by their con (cid:173)
`dition.
`Further. patients may not report their symptoms fulJy
`to a physician. Often, the subject of their rhiniti.
`is
`brought up only in passing, in the course of a visit for
`some other reason-hardly an optimal context for the
`physician to make an accurate diagno ·is or develop a
`management plan. The physician may also underesti(cid:173)
`mate the severity of disease because patient , when
`a ked about their symptoms, are likely to describe them
`as mild; 53% of the study population responded in this
`fashion. Yet the reality may be otherwi e. Data. uggest
`that allergic rhinitis can result in a measurable decline in
`general health status.•· 5 Patient may not be awar of
`this decline because they have been living with their
`condition their entire adult life (47% reported on et of
`allergic rhiniti before 17 years of age) and have become
`accustomed to their state of health. Often it i only
`when they notice an improvement after receiving treat-
`
`taru was
`ment that they realize their previous health
`lead us to su -
`less than optimal. These consideration
`pect that allergic rhiniti may be underdiagnosed.
`Allergen avoidance particularly
`in
`the bedroom
`(where patients may spend 8 hours or more daily), i an
`important step in management. Yet in our study popu(cid:173)
`lation there were few measures taken against dust mites,
`such as mattress encasement hot water wash of bedding,
`acaricide treatment of carpets, and removal of carpeting
`from the bedroom. This finding suggests a need for more
`patient education regarding effective allergen avoidance
`measures.
`is also
`it
`When selecting a management strategy
`important to keep in mind that mo t patient have had
`prior experience with medication that resulted in either
`an inadequate therapeutic response or adverse etrects.
`In our study, there was a high level of self-medication
`(92%) i.nvolving prescription and nonprescription drugs,
`without much hope of ·uccess: only 52% believed eJfec(cid:173)
`tivc treatments were avai lable; 31 % had experienced
`side effects; 48% were concerned about adverse effects.
`Dosing regimens should take into account our finding
`that symptoms are worse in the morning than in the
`evening.
`For patients who remain unre ponsive to apparently
`optimal pharmacologic therapy, referral should be con(cid:173)
`sidered. An allergist can help identify allergic triggers.
`This is particularly important when better environmental
`control measures are being considered; such measures
`can be implemented only after important allergens have
`been identified through a detailed history and skin
`testing. The allergist can also, if indicated, institute
`specific immunotherapy.
`In conclusion, there i · a need to educate patien
`about allergic rhinitis, its ymptoms, and the problem.
`they may cause. The health care provider shou ld listen
`carefully and be aware of what is left unsaid as well as
`what i actually . aid . Such attentiveness may take addi(cid:173)
`tional time, but our study suggests that it would be time
`well spent.
`
`REFERENCES
`
`3.
`
`1. Inte rnational Rhin i t~ Manageme nt Working Group. lnt~rnation:ll
`consensu
`report on the diagnosis ~nd mannge mem of rhinitis.
`Allergy l994;49(suppl): 1-34.
`2. Stew-Mt AL, Greenfie ld S. Hays RD. ct 31. Functional status and
`we ll·t>eing of patients with chronic condition : results from the
`Medical Outcomes Study. JAMA t989;2o2:907-13.
`tewart WF, Lipton RB. Celentano DD. Reed ML Prevalence of
`migraine headache in the United State : relation to age. income. race,
`and other sociodemographic factors. JAMA 1992;267:64-9.
`4. Bou quet J, Bullinger M. Fayol C, Marquis P, Valentin B. Burt in B.
`Assessm~nt of qu ality of life in patknts with perenni al allergic rhinitis
`wilh the French version of the SF-36 Health St atus Queslionnaire.
`J Allergy Clin lmmunol 1994;94:182·8.
`5. Melt1.er EO. Nalhan R. Selner JC, Storms W. Qunlity of life and
`rltinitic symptoms: results of a nationwide survey with the SF-36 and
`RQLQ queslionnaircs. J Allergy Clin lmmunol l997:99:S815-9.
`
`M EDA_APTX03502666
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`PTX0042-00004
`
`4
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