Family psychoeducation andmulti-family groups havedemonstrated remarkableeffects on relapse rates andrehabilitation outcomes forschizophrenia. Thecomponents of this approachindude techniques for1) establishing an empathiccollaboration with familymembers, 2) providinginformation about the illnessand spedffic guidelines forongoing management,3) problem solving to enhancecoping skills, and4) expanding the patient'sand family's social network.

La psycho-education familialeet les groupes multifamilriuxont demontre des effetsremorquables sur les taux derecidive et le pronostic derehabilitation dans laschizophrenie. Lescomposontes de cetteapproche induent lestechniques pour 1) etablir unecollaboration empathique avecles membres de la famille, 2)offrir des informations sur lamaladie et des lignesdirectrices specifiques pour laligne de conduite a longterme, 3) la solution deprobleme pour favoriserl'adaptation, et 4) etendre lereseau social du patient et dela famille.Gin hm Pliyskkn 1991;37:2457-2465.

Schizophrenia and

Psychoeducation

Modelfor interontion infamiy practice

WILLIAM R. McFARLANE, MD)

URING THE PAST DECADE FAM-

ily therapy in schizophreniahas undergone a dramaticshift of strategy, to the ex-tent that it is no longer valid

to use the term to describe what manyclinicians are now practising. Present prac-tice has become biologically based; thework with families is now described as fami-ly management or psychoeducation. Al-though this shift has been accompanied bycontroversy, studies of outcome in thesenewer strategies have provided the mostconsistent evidence to date for the efficacyof a family treatment.'

These approaches have all proceededfrom empirical studies of how family inter-action influences chronic psychiatric illness.Because these approaches have been devel-oped within an outcome research context,the family models for treating schizophre-nia resemble medical treatments and reha-bilitation more than other psychotherapies.They are based on a relatively simple bioso-cial paradigm: course and outcome are theresult of known, though circumscribed, in-

Dr McFarlane is Director of the Fellowship inPublic Pychiatiy, is Chief of the Biosocial TreamentResearch Division at the New York State PsychiatrcInstitute. and is an Associate Clinical Professor in theDepartment of P4ychiatgy, Colege ofPhysicans andSurgeons, Columbia Universiy, New rorki T

teractions between aspects of the patient'senvironment and specific biological pro-cesses. This new definition has significantparallels with many chronic medical dis-orders that are often treated in a familypractice. For that reason, family psycho-education could have relevance and utilityfor other chronic disorders.

This article describes 1) the current un-derstanding ofthe biological and social fac-tors associated with schizophrenia; 2) therationale for, and the key elements of, thepsychoeducational model of treatment forthis disorder; and 3) ways in which psy-choeducation can apply to family practice.The psychoeducational multi-family groupmodel is presented because it seems to holdgreat promise as a template for the designof family treatments for medical illnesses.New family-based treatments for medicaldisorders might be constructed in a mannersimilar to those for schizophrenia.

Current concepts of schizophreniaSchizophrenia is now viewed as a complexphenomenon, in which onset and courseare determined by factors at several levels:biochemical, physiological, psychological,family, and social network. Like manychronic medical illnesses, it is disabling; hasa poorly understood etiology; is incurable;has treatments that are only partially cor-rective; is complex, confusing, and stressful

Canadian Family Physician VOL 37: November 1991 2457

to family members; and requires their con-cern and assistance. Further, it has becomeclear that the disorder is heavily influencedby specific social factors, most of whichseem to be the result of the illness and itsdisabilities.

Psychobiological factorsSchizophrenia is best defined as a disorderof central nervous system functioning, withrelated defects in ventral tegmental arousalcenters, dorsolateral prefrontal cortical as-sociation areas, hippocampal attention ar-eas, and limbic affective areas. Weinberger2has proposed a comprehensive model thatinvolves deficient dopaminergic activationof the dorsolateral prefrontal cortex. Heproposes that, in response to stress, the lim-bic and possibly the hippocampal cortexbecome hyperactive, leading to deteriora-tion of attention and to more primitive af-fective and behavioral responses. This is anattractive model because it is consistentwith a large body of existing neurophysio-logic and neuroanatomic findings. It alsoplaces the brain in context, seeing it as re-sponding aberrantly to certain forms ofstressful input, generating cognitive, affec-tive, and behavioral symptoms, which inturn disrupt the immediate social environ-ment. The cause of the tegmental-frontaldisruption is unclear, but could lie in inher-ited chromosomal defects, perinatal trau-ma, or early viral infection.

This pervasive dysfunction of cerebralfunctioning leaves the individual sufferer vul-nerable to a variety of stimuli, all of whichtend to increase uncontrollably the level ofphysiologic arousal, leading to widespreaddeterioration in mental functioning. Disab-ling stimuli include 1) high rates of changein the environment,34 2) intense social inter-action,; 3) negative personal interaction,"4) high levels of complexity in communica-tion and task demand,6 and 5) physical andchemical influences.7 Stated another way,these patients have a lowered threshold forcognitive disorganization in response to a va-riety of commonly encountered stimuli.

How social environmentinfluences courseSome influences on the course of schizo-phrenia arise from the family and the socialnetwork of the patient; several are known

to be sources of disabling stimuli. I have di-vided the stimuli into problems within thesocial network and problems within thefamily.

Social networkfactorsStgrMa: In view of the public rejection of

patients, it is remarkable that most familiesdo not report feeling stigmatized by theemergence of schizophrenia in one of theirmembers.8 On the other hand, many familymembers act as if they have been stigma-tized. They attempt to conceal the illnessfrom friends and more distant relatives and,in many cases, drop friends after the initialepisode." Lamb and Oliphant"' reportedthat many parents find it difficult to talk toother parents about their children's achieve-ments - the contrast is too painful - andgradually see less of them. In contrast to oth-er kinds of crises, schizophrenia does notgenerally induce a rallying of support andempathy in the patient's social network.

Network size and structure: The social net-works of patients with schizophrenia andtheir families have been studied extensively,with a singularly consistent finding: patientsand, to a lesser extent, families are moteisolated than their peers, even those withother psychiatric disorders. Pattison et al,"Hammer,'2 and Garrison documentedsmaller network sizes in schizophreniccases, as did Brown et al.'4 Patient socialnetworks are constricted and more domi-nated by kin at first admission,) while theentire network decreases in size as the ill-ness becomes chronic.'"1'7

The explanation for these findings in-cludes withdrawal of contact and supportby friends and extended kin and reducedsocial initiative by family members second-ary to shame and preoccupation with thepatient. Attenuated social support leads tothe loss of adaptive resources coming fromoutside the family (eg, information, con-crete assistance, relief, and advice) and de-pletion of caretakers' emotional reserves.

Life events: Although there is some dis-agreement in the literature, life events seemto provoke symptoms of schizophrenia.Specifically, events that require a sizeableincrease in information processing andadaptation or that are perceived as subjec-tively unpleasant seem to trigger decom-pensation. Steinberg and Durell4 found

2458 Canadian Famity Physician VOI, 37: November 1991

that most first episodes were immediatelypreceded by entry into military service orcollege, events that also disrupt social net-works. Life events appear to be a primaryfactor in precipitating relapse in stable andmedicated outpatients.'8

Family factors. Families attempting tocope with a mental illness in their midst arefaced with an overwhelming set of chal-lenges. The resources that a given familycan bring to bear on this most chronic ofillnesses vary widely but seem to be criticalto the patient's later condition. Four factorsthat have been useful for predicting courseare reviewed briefly: lack of information,burden, inadequate coping skills, and ex-pressed emotion.

Lack ofinformatio Schizophrenia, like oth-er serious illnesses, appears to family mem-bers as threatening, confusing, and unpre-dictable. Because it varies widely over time,it does not even appear to be a single entity,let alone an identifiable illness, but rather aset of alternating states and vacillating, un-stable phenomena. Vaughn and LefP foundthat those relatives who were most critical ofthe patient tended to ascribe more subdesymptoms, unknowingly, to personality de-fects or character traits. Many family mem-bers are completely unaware of the extentand causes of the mental disruptions and ab-errations that are besieging their ill relative.Diagnosis and treatment often appear mys-terious and sometimes arbitrary or erratic.It is not surprising that one of the primarycomplaints of families in surveys is that theyhave been left uninformed and unguided byclinicians. 19

Burdnk The difficulties patients pose fortheir families are multiple.20 Remarkably,few translate their complaints into outrightrejection and abandonment. Nevertheless,relatives commonly report economic drain,sleep disruption, interferences with dailyroutine, exacerbations ofmedical conditions,depression, tension from fear of unpredict-able behavior, difficulties in communication,and strained family and marital relation-ships.2' Parents, especially, appear to resenthaving become captives of the situation butare also beset by feelings of guilt, inadequa-cy, and anger.

Inadequate coping skills: As experience hasaccumulated, it has become apparent that

much ofwhat previously was seen as familydisorders are actually misguided attemptsto help the patient. What looks like overin-volvement can be seen more usefully as vig-ilance, protectiveness, and anxiety in theface ofthe unknown; a reasonable responseto dangerous behavior; or a result of unin-formed guilt. The stress of caring for a per-son with chronic mental illness can lead todepression, high levels ofanxiety, and exac-erbation of existing chronic medical disor-ders. The result is that many family mem-bers find themselves with a markedlydiminished capacity to manage the illnesssuccessfully, especially when unsupportedby the professional treatment system.22 Tomake matters worse, many preferable ill-ness-management techniques are largelycounter-intuitive and would not appear tobe helpful or even reasonable to most ofthepopulation.

Expressed emotion: The factor that hasbeen researched most is termed expressedemotion (EE), a construct originally devel-oped by Brown and his colleagues,'4 whohypothesized that environmental affectivefactors might account for relapse. It con-sisted ofan attitudinal aspect (highly criticalviews of the patient) and a behavioral com-ponent (a tendency to be overinvolved, ie,highly protective of or attentive and reac-tive to the patient). Having assessed its levelin key relatives, they found that when EEwas higher, relapse occurred much morefrequently, at rates from 54% to 92% with-in 9 months, with and without medication,respectively. In low EE homes, the compa-rable rates were 12% and 15%. That is,some families seemed as protective againstrelapse as medication.

Leff and Vaughn23 documented the cen-tral role played by misunderstanding in thegenesis of high EE interaction: nearly 75%of family members' critical comments con-cerned functional disabilities that they at-tributed to character defects. Thus, a viewhas emerged that sees family interaction asa powerful influence, promoting either re-covery or relapse and disability. Further,some evidence suggests that levels ofEE arehigher in more isolated families.24

Key components of familypsychoeducationA number of investigators have developed

l

Canadian Family Physician VOL 37: November 1991 2459

Table 1. RELAPSE OUTCOME IN FAMILY INTERVENTCION TR1ALSl

AUTHOR N TEST TREATMENT COMEPARISON TRE^TMENT TEST INTERVAL (MIONTHS)

leff et 0132 24 RGT 8% IST 50% 12

Hoprty et u134 SO FPE 19% IST 41% 1 2l

MdoarloneV 41 PEMFG 50% FPE 72% 48

AVERAGE RATES/YEAR FAMLYllINTERVENTION 11.5% IST 47.5%|

FCT-family crisis therapy, IST- individual supportive therapy; RGT- relatives' group therapy; BFM- behavioralfamily management; l|FPE -family psychoeducation, PEMFG - psychoeducational multi-family groupl

clinical intervention models that attempt toameliorate the effects of these network andfamily factors on the course of the illnessand on the status of the patient. These ap-proaches can be grouped together as thepsychoeducational intervention models.Put simply, family psychoeducational treat-ment is a set of well described and struc-tured interventions having the factors de-scribed above as their targets.

The family management,25 psychoeduca-tional,26 and multi-family group approaches27to treating schizophrenia have been devel-oped using a common strategy: influencingclinical outcome by providing families withthe information, coping, and interaction skilisand social supports that appear to be lackingin most cases. We tum now to a short reviewof the components of the psychoeducationalapproach and their intended effects on theproblems outlined above.

Engaging thefamily andpatient. In allfamily treatments, creation of a treatmentsystem is the first necessity.28 The engage-ment process includes several crucial ele-ments. These include 1) delineating thefamily's existing coping methods, especiallythose that work; 2) eliciting each familymember's reactions to the illness and thetreatment system; 3) exploring each mem-ber's understanding of the disorder and itscauses; and 4) making a brief evaluation ofthe family as family. In addition, the stressesleading to relapse and early prodromal

signs are explored and clarified. It is crucialto describe explicitly what the family's rolewill be in treatment and that of the profes-sionals. If a given family member needs toshare unacceptable or suppressed feelings,there is value in allowing that, without thepatient present.

The goal is to establish a collaborative al-liance with all family members, alleviatingguilt, anxiety, and implicit blame. Thesestructured sessions are useful to normalizethe family's experience, comparing it to oth-ers in the same situation or to well-knownsocial support models, like Al-Anon, crimevictims' support groups, or organizations offamilies of the mentally retarded.

Educating families. Sharing informa-tion and illness management techniqueswith families has proved to be an enor-mously helpful and therapeutic strategy inschizophrenia and mental retardation.Education can be defined along a continu-um from simple suggestions and the distri-bution ofpamphlets to comprehensive edu-cational workshops lasting several hours.Psychoeducational models cluster along themore ambitious end of the spectrum, pri-marily because schizophrenia is so complexand poorly understood.

Education in the psychiatric disordersincludes clarifying 1) behaviors that are ac-tually symptoms of illness, 2) the inner sub-jective experience of the ill individual,3) the biological rationale for medication

2460 Canadian Family Physician VOL 37: November 1991

and social interventions, 4) the expectedoutcomes of treatment, and 5) the beststrategies for day-to-day management andinteraction at home. The desired effect isto create a shared frame ofreference withinthe patient-family-clinician network.

Enhancing coping skills. Experiencewith family approaches in schizophreniahas emphatically confirmed the impor-tance of assisting families to improve cop-ing skills. This has been necessary becauseintuitive approaches - providing protec-tion, reasoning with the patient about delu-sions, pressuring the patient to work as anantidote to the deterioration, etc - tend toexacerbate the condition.

In practice, enhancing coping skills hastaken several forms. The psychoeduca-tional model provides families with man-agement guidelines that are quite specificbut that require individualizing for eachfamily. The guidelines themselves arederived from a well validated psychophy-siologic model of schizophrenia29'30 thatsuggests the need for a calm, affectivelywarm, and low pressure social environ-ment, for increases in expectations whendone carefully and gradually, and for bet-ter role functioning. These guidelines areused to develop suggestions for new strate-gies that are practised at home and refinedas necessary. The procedure involves on-going, biweekly sessions, preferably inmulti-family groups, in which goals areavoiding psychotic relapse, buffering theeffects of life events, and gradually pro-moting functional recovery.

The family management approach ofFalloon and Liberman25 uses in-sessionproblem-solving methodology and struc-tured training in communication skills.Here, the goal is to deal with more generalfamily phenomena, especially distorted,overintense, or negative communication;overinvolvement by a family member; andconflicts precipitated by the illness. Falloonand Liberman25 have developed behavioralinterventions in which the clinician makesa careful assessment of interaction patternsand works with family members, using re-peated practice and problem-solving pro-cedures, to change key behavior patternsused by the patient and interactions be-tween family members.

Expanding the social network andmulti-family groups. Because familyisolation seems to be so common and sopernicious in its effects on the family andthe illness, a number ofintervention modelshave included means for expanding andstrengthening the family's social networks.The most ambitious of these is the mul-ti-family group, in which the clinical teamattempts to create a new, prosthetic socialnetwork among similarly afflicted families.My colleagues and I have developed apsychoeducational multi-family model thatstresses lively, positive social interactionamong participants, group-based problemsolving, and the gradual conversion of thegroup into a natural social network. Fami-lies and clinicians consistently describethese groups as more useful, enjoyable, andmeaningful than single family work.

In a study comparing multi-family andsingle family models, we found superioroutcomes in the multi-family group for-mat.27 The parsimonious conclusion is thatthe difference results from the additionalsupport, resilience, and problem-solvingcapacity inherent in the larger network.

Treatment effects of familypsychoeducationA distinguishing feature ofthe developmentofthe psychoeducational approaches is thatthey have been based on empirical re-search. The basic designs have attemptedto capitalize on previous studies of effectsof various factors on outcome, and theyhave been rigorously tested in experimentalstudies.

The results in these studies have been re-markable in the size of the main effects.Table 127,31-36 presents outcome, measuredby relapse rates, from seven studies under-taken during the past decade. While the in-tervention strategies and relapse criteriavary, there is sufficient similarity among thestudies that the summation of rates, com-paring family to no family treatment, ismeaningful. It is also telling. The averagerate for family-based treatment is roughly12%, compared with 48% for individu-al-based treatment, in seven studies withsamples totalling 271 cases.

There are altogether eight studies re-ported; all but one strongly replicate eachother. The eighth, which found no differ-

______________

Canadian Family Physician VOL 37: November 1991 2461

ence in a comparably designed experiment,is widely regarded as irrelevant, becausethe intervention involved a psychodynami-cally oriented family therapy that providesalmost none of the crucial elements de-tailed previously.37 The present record rep-resents one of the most successful and con-sistent clinical research efforts in the historyof the field.

Potential applications tofamily practiceThe extension of the experience with familyintervention in schizophrenia to medicalconditions with both biological and socialdetermninants seems natural and promising.It also faces a number of problems. Manymedical conditions seem amenable to one oranother of the treatment elements describedabove. However, we generally lack the basicstudies of family or network course predic-tors, like expressed emotion, that have beenso useful in designing treatments for schizo-phrenia. Further, in schizophrenia the pa-tient is assumed to be a somewhat passiverecipient of intervention. In medical disor-ders, this is rarely the case; the patient couldmore actively collaborate in developing newcoping solutions or, on the other hand, couldbe more capable ofsabotaging interventions.This difference has been taken into accountin existing treatment models in ways thatseem promising.38

It is likely that the family factors re-viewed above (lack of information, socialisolation, expressed emotion, stigma, andespecially insufficient coping skills) play arole in many medical disorders. Becausethe components ofthe family psychoeduca-tional approach have been designed to spe-cifically address these illness-induced prob-lems, applying them, in appropriatecombinations, seems likely to yield superioroutcomes. A small number of studies havetested this proposition and have generallyfound positive effects. The targeted disor-ders have included sexual dysfunction,39 at-tention deficit disorders of childhood,40 bu-limia,4' rheumatoid arthritis,42 myocardialinfarction,43 breast cancer,"4 senile demen-tia,45 childhood asthma,46 essential hyper-tension,47 seizure disorders,48 cystic fibro-sis,49 and juvenile diabetes.50 Note that inall such conditions, the common denomi-nators are 1) major, chronic biological dys-

function, which induces changes in socialand family interaction; and 2) some evi-dence that focused intervention to alter thatsocial interaction positively influences bio-logical and behavioral processes and sec-ondarily influences the course of illness.

Clinician-family coUaboration. Theexperience with schizophrenia has providedat least three general guidelines for applica-tion of psychoeducation in family practice.First, in the psychoeducational approach asmuch concentrated effort is expended on de-veloping an empathic and collaborative al-liance with family members as with the pa-tient. Simply including family members, ifonly as adjunctive clinical supports, in dis-cussions of treatment recommendations andongoing management appointments ap-pears essential to maximizing outcome inmany chronic disorders, especially those thatinduce depression, anxiety, or persistent dis-ability in the patient and exasperation, de-moralization, or exhaustion in the family.Because anxiety and depression arising fromdisability are often contagious within fami-lies, including family members in theface-to-face contacts between the physicianand patient acts to focus their energy on sup-porting treatment, enhances their sense ofef-ficacy, and serves to mobilize hope and mo-rale. That alone makes it worth the extraeffort, without necessarily making this inter-vention family therapy.

Education and training in illnessmanagement. Another lesson that can begeneralized is that social interventions toreduce the arousal and anxiety level in thepatient have proved invaluable in prevent-ing relapse in the psychotic disorders; thesame could be true in many chronic medi-cal illnesses. The educational component inpsychoeducation has been critical to thissuccess. Most families demonstrate signifi-cant alterations in their attitude toward thepatient, reductions in the tendency to criti-cize and reject, and enhanced interest andability in collaborating in the treatment andrehabilitation effort. Reductions in EE im-mediately after comprehensive educationalworkshops for the family are usually dra-matic. Given the common role of arousaland anxiety in mediating outcome in a varn-ety of medical disorders, negative family

2462 Canadian Family PhysiCian VOL 37: November 1991

reactions to these disorders could be alle-viated by the same sort of educationalprograms.

Problem solving in multi-familygroups. The third treatment element thatcan be generalized is well organized prob-lem solving in multi-family groups. Studiesof family educational and management ap-proaches suggest that enhanced copingskills is the variable that most powerfullypredicts improved clinical outcome.33 Thecapacity of several families, patients, andwell trained clinicians to jointly develophighly refined and individualized solutionsfor problems related to management ortreatment of a given disorder has beenimpressive. Combined with empirical gen-eral strategies for management, it is possi-ble to create nearly optimal social environ-ments for recuperation, recovery, andmaintenance of remission.

This format also allows for careful con-struction ofcomprehensive treatment plansthat take into account the contributionsand limitations of the patient's family andsocial network. For instance, in schizophre-nia, it is clear that patients need much morephysical and psychological space than un-affected family members. This has beentranslated into a guideline for families thatencourages reduced personal intensity,pressure, and frequency of contact, as wellas allowing withdrawal when social stimu-lation has become excessive. The goal is tokeep physiologic arousal at a manageablelevel.

In a multi-family problem-solving ses-sion, the entire group will make and evalu-ate many suggestions for means of imple-menting the general parameters of theguideline, in ways that are specific, useful,and feasible for a given family and patient.These solutions often are surprising to clini-cians and family alike, because they arisefrom a broad pool of human experienceand the creative influences of large-groupbrainstorming. Given the often complex ef-fects on family functioning in a variety ofcommon medical disorders and the re-quirements for unpleasant and unac-customed lifestyle modifications, the needsfor innovative, individualized ideas forfamily management can be as great as inschizophrenia.

Practical considerations. The issuesthat have been left out of consideration un-til now are those ofefficiency and feasibility.One of the strongest arguments for devel-oping variations on the psychoeducationalmulti-family group is that it is so efficient:families can be educated in larger numbers;management strategies can be developedand shared collectively; and brainstormingabout methods is more effective with moreparticipants. Also, the value of the newerfamily strategies is that they lend them-selves to "dose packaging"; that is, compo-nents can be assembled based on a reason-able estimate of what is relevant andfeasible, with a fairly clear idea of what theoutcome, and its limitations, will be.

ConclusionExperience with psychoeducation in treat-ing schizophrenia has demonstrated the ef-ficacy of including the family in ongoingpsychiatric management and of providingcomprehensive education and problemsolving in multi-family groups. These ele-ments could constitute the starting point indesigning family-oriented interventions forthe family practice setting, in whateverways appear feasible for given disordersand the specific circumstances of the prac-tice setting. The other lesson from theschizophrenia work is that interventionsshould be empirically tested and continual-ly refined on the basis of that evaluation.XVhat remains is to undertake trials of thesemethods in the family practice setting to de-termine their efficacy and feasibility. U

Requests for reprints to: Dr William R.McFarlane, Box 117, 722 [West 168th St, Newrork, Nr 10032 USA

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GRADUATEPOSTGRADUATE

As a professional, you know that theessence of professionalism is a recog-nized high standard of qualification.The Council for APMR was establishedto develop and maintain professionalstandards for pharmaceutical represen-tatives to serve you more effectivelyThe academic programs developed bythe Council set a high standard. Yourrecognition and support, when you seethe APMR lapel pin worn by a highlymotivated professional representative,are important to the achievement ofthe Council's objectives.The Blue Badge of Professionalism

The Council for the Accreditationof Pharmaceutical Manufacturers

Representatives of Canada

5Anaprox® DS 550 mg2Anaprox® 275 mg(naproxen sodium)Indications:Relief of mild to moderately severe pain, accompanied byinflammation such as musculoskeletal trauma, post-dental extraction, relief of post-partum cramping anddysmenorrhea.Contraindications:Anaprox and Anaprox DS (naproxen sodium) are contrain-dicated in patients, with active ulcers or active inflam-matory diseases of the gastrointestinal tract. They arealso contraindicated in patients who have shown hyper-sensitivity to it or to naproxen. Since cross-sensitivityhas been demonstrated, Anaprox or Anaprox DS shouldnot be given to patients in whom ASA or other non-steroidal anti-inflammatory drugs induce the syndromeof asthma, rhinitis, or uticaria. Sometimes severe andoccasionally fatal anaphylactic reactions have occurredin such individuals.Warnings:Peptic ulceration, perforation and gastrointestinal bleed-ing, sometimes severe and occasionally fatal, have beenreported during therapy with non-steroidal anti-inflam-matory drugs (NSAID's) including Anaprox and AnaproxDS. Anaprox and Anaprox DS should be given underclose medical supervision to patients prone to gastroin-testinal tract irritation particularly those with a history ofpeptic ulcer, diverticulosis or other inflammatory dis-eases of the gastrointestinal tract.

Patients taking any NSAID including this drug shouldbe instructed to contact a physician immediately if theyexperience symptoms or signs suggestive of peptic ulcer-ation or gastrointestinal bleeding. These reactions canoccur without warning at any time during the treatment.Elderly, frail and debilitated patients appear to be athigher risk from a variety of adverse reactions fromNSAIDs. For such patients, consideration should be

given to a starting dose lower than usual. The safetyof Anaprox and Anaprox DS in pregnancy and lactationhas not been established and its use is therefore notrecommended.

Precautions:Anaprox or Anaprox DS (naproxen sodium) should notbe used concomitantly with the related drug Naprosyng(naproxen) since they circulate in plasma as thenaproxen anion.

G.I. system: If peptic ulceration is suspected or con-firmed, or if gastrointestinal bleeding or perforation occursAnaprox or Anaprox DS should be discontinued, andappropriate treatment instituted. Renal effects: Patientswith impaired renal function, extracellular volume deple-tion, sodium restrictions, heart failure, liver dysfunction,those taking diuretics, and the elderly, are at greater riskof developing overt renal decompensation. Assessmentof renal function in these patients before and duringtherapy is recommended. Naproxen sodium and its metab-olites are eliminated primarily by the kidneys, and there-fore, a reduction in daily dosage should be anticipated toavoid the possibility of drug accumulation in patientswith significantly impaired renal function. Naproxensodium should not be used chronically in patients havingbaseline creatinine clearance less than 20 ml/minute.

Peripheral edema has been observed, consequently,patients with compromised cardiac function should bekept under observation when taking Anaprox or AnaproxDS. Each Anaprox tablet contains approximately 25mgof sodium and each Anaprox DS tablet contains approxi-mately 50mg of sodium. This should be considered inpatients whose overall intake of sodium must be mark-edly restricted. As with other drugs used in the elderly orthose with impaired liver function it is prudent to use thelowest effective dose. Severe hepatic reactions includ-ing jaundice and cases of fatal hepatitis have beenreported with NSAIDs. The prescriber should be alert tothe fact that the anti-inflammatory, analgesic and antipy-retic effects of Anaprox or Anaprox DS (naproxen sodium)may mask the usual signs of infection. Periodic liverfunction tests and ophthalmic studies are recommended

for patients on chronic therapy. Caution should be exer-cised by patients whose activities require alertness ifthey experience drowsiness, dizziness, vertigo or depres-sion during therapy with the drug. The naproxen anionmay displace other albumin-bound drugs from their bind-ing sites and may lead to drug interactions or interferewith certain laboratory tests. See product monograph forspecific examples. The safety and efficacy of this drug inchildren has not been established and its use in childrenis therefore not recommended.Adverse reactions:Adverse reactions which occur in >1% of patientsinclude:

G.I.: heartburn, constipation, abdominal pain, nausea,diarrhea, dyspepsia, stomatitis and diverticulitis.

CNS: headache, dizziness, drowsiness,.light-headed-ness, vertigo, depression and fatigue.

Skin: pruritus, ecchymoses, skin eruptions, sweatingand purpura.

CVS: dyspnea, peripheral edema and palpitations.Special Senses: tinnitus and hearing disturbances.Others: thirst.For additional adverse reactions please refer to the

product monograph.Availability:Anaprox® is available in OVAL-SHAPED, BLUE film-coated tablets of 275mg in bottles of 100, 500 and1000 tablets.

Anaproxg DS is available in OVAL-SHAPED, BLUEfilm-coated tablets of 550mg in bottles of 100 tablets.Dosage:Anaproxg 275mg: Two tablets (550mg) followed byone tablet (275 mg) every 6 - 8 hours as required.Anaprox® DS: One tablet (550 mg) twice daily.Maximum daily dose: 1375mg.Product monograph available on request.

SYNTEXISyntex Inc* Mississauga, Ont./Montreal, Que. Ip-A-I*Reg. user of all ® trademarks. LIEJ

Canadian Family Physician VOl. 37: November 1991 2465