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OR I GI NAL AR T I C L EHealth-related quality of life and symptom severity in Chinesepatients with major depressive disorderYuping Cao1MD PhD, Wen Li2MD, Jingjin Shen1,3MD, Robert T. Malison4MD, Yalin Zhang1MD PhD &Xingguang Luo4MD1 Mental Health Institute, Second Xiangya Hospital, Central South University, Changsha, China2 Department of Psychosomatics, Hunan Mental Hospital, Changsha, China3 Department of Psychiatry, Shenzhen Sixth Hospital, Shenzhen, China4 Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USAKeywordsChinese, correlation, health-related quality oflife, major depressive disorder, symptomseverityCorrespondenceYalin Zhang MD PhD, Mental Health Institute,Second Xiangya Hospital, Central SouthUniversity, Changsha, Hunan 410011, China.Tel: +86 731 85292159Fax: +86 731 85362586Email: [email protected] 5 March 2012Accepted 4 December 2012DOI:10.1111/appy.12059AbstractIntroduction: Patients sufferingfrommajor depressivedisorder (MDD)have been reported to have substantial long-lasting limitations in multipledomains of health-related quality of life (HRQoL). The thoughtful assess-ment of HRQoLandtheimpact of treatment responseonHRQoLareemerging as important issues in the care of patients with major depressivedisorder.Methods: OnehundredandthreepatientsmeetingDiagnosticandSta-tisticalManualofMentalDisorders(DSM-IV)criteriaforMDDtooku-oxetine(20 mg/d)for6weeksandwereassessedbytheShortForm36Health Survey (SF-36), the 17-item Hamilton Depression Rating (HAMD-17) and the Clinical Global Impression (CGI) scales. Relationships betweenSF-36 scores and depressive symptom severity and early change of thesesymptoms were tested.Results: SF-36component scoresat week6werehigherthanthoseatbaseline (all P 0.0058). Scores for general healthwere signicantlyhigher in responders than non-responders (P = 0.0009). The overallHAMD-17andCGIscoresat2-and6-weekfollow-upweresignicantlylower thanthose at baseline (P 0.0001). Higher scores for anxiety/somatizationweresignicantlyassociatedwithpoorer SF-36scores atbaseline(P = 0.0001);role-physicalscoresatweek6werepositivelycor-relatedwithreductionrateofanxiety/somatizationin2-weekfollow-up(P = 0.0002).Discussion: DepressivesymptomseveritywasassociatedwithHRQoLinpatients with MDD. HRQoL may vary with severity of depression and/oranxiety-somatization at baseline.IntroductionDepressionis amongthemost prevalent of medicalillnesses, and has become the fourth leading cause ofglobal disabilityadjustedlifeyears(DALYs), andtheleading cause indeveloped countries (Murray andLopez, 1997a). Depression is also projected to becomethesecondleadingcauseofglobaldisabilityby2020accordingtotheWorldHealthOrganization(WHO)(Murray and Lopez, 1997b). Thus, many nations nowacknowledge the importance of recognizing andtreating depression both for the benet of patients andfor society.WHO dened health as a state of complete physi-cal, mental, and social well-being and not merely theabsenceof diseasein1948. Thisconcepthasresur-faced as an important touchstone for the evaluation ofbothmentalandphysicalhealthtreatmentoutcomes(Rapaportet al., 2005). Health-relatedqualityoflife,referring to the perceptions of daily function andwell-being in physical, social, and psychologicaldomains,canhelpdoctorsbetterunderstandhowanbs_bs_bannerOfcial j ournal of thePacicRim College of PsychiatristsAsia-Pacific Psychiatry ISSN 1758-5864276 Asia-Pacific Psychiatry 5 (2013) 276283Copyright 2013 Wiley Publishing Asia Pty Ltdillness or its treatment affects a persons life(Endicott et al., 1993).Patients suffering fromMDDhave beenreported tohavesubstantial long-lastinglimitations inmultipledomains of health-related quality of life (HRQoL),when compared to the general population (Pyne et al.,1997) or tothose whosuffer fromother commonchronic medical illnesses such as diabetes, arthritis orcardiovascular diseases (Wells et al., 1989; Ormel et al.,1994;Hayset al.,1995;WellsandSherbourne,1999;Saarijarvi et al., 2002). Thus, the thoughtful assessmentof HRQoLandtheimpact of treatment responseonHRQoL are emerging as important issues in the care ofdepressed patients. In fact, reports in the literature innon-Chinese populations have suggested that depres-sionseverity is associated withhealth-related quality oflife (Rapaport et al., 2005; Aydemir et al., 2009;Patten et al., 2009; ten Doesschate et al., 2010).To our knowledge (by searching English[lan-guage], (severity OR early improvement), health-related quality of life, Chinese, depression inPubMed), no literature inany international journal hasreported the relationship between the severity ofsymptomsortheirearlyimprovement(intherst2weeks (Quitkinet al., 1984; Bech, 2001) ) andtheHRQoL improvement in Chinese MDD patients.However, basedonprior workinthenon-Chinesepopulations (Quitkin et al., 1984; Bech, 2001;Rapaport et al., 2005; Aydemir et al., 2009; Patten et al.,2009; tenDoesschateet al., 2010), wehypothesizedthat such an association might also exist in the Chinesepopulation. The current study employed a xed, open-label trial of antidepressant medication (uoxetine) for6 weeks in Chinese MDD patients in order to explorethis hypothesis. We assessed health-related quality oflife (HRQoL) among Chinese patients with majordepressivedisorder (MDD) usingstandardizedmea-sures and investigated its correlations with depressivesymptomseverity and with early change of thesesymptoms after antidepressant intervention. These cor-relations were investigated within the same subjects; inother words, HRQoL and depressive symptom severitywere assessed under the same conditions. This study isimportant for us toknowif HRQoLcanserveas apotential supplemental outcome measurement inclini-cal treatment trials in Chinese MDD patients.MethodsSubjectsTheMental HealthInstituteofSecondXiangyaHos-pital andtheHunanMental HealthHospital aretwoprovince-runpsychiatricinstitutes/hospitalsinSouthChina.Theyaretwoofthetoppsychiatricinstitutes/hospitals in China. Consecutive outpatients fromthesetwoinstitutes/hospitalswereinvitedtopartici-patefromJanuarytoJuly2006.Theinclusioncrite-riawereasfollows: (i)all participantsagedbetween1865years;(ii)allparticipantsmetDSM-IVcriteriafor MDD; (iii) Hamilton Depression Rating forDepression17-item(HAMD-17)totalscoreswerenoless than 16; and (iv) all participants were free of anyantidepressant and antipsychotic within 1 monthbeforetrial.The exclusioncriteria included(i) a historyofdysthymia, mania, hypomania, bipolar disorder ordepression secondary to a known substance or generalmedicalcondition;(ii)adrugallergyorclinicallysig-nicant laboratory abnormality; (iii) active suicidalideation, comorbid mental disorders, catatonic fea-tures, and/or severe psychomotor retardation thatmadeinterviewdifcult; (iv)activesubstanceabuse;(v) historyof braininjuryor other severemedicalcomorbidity, such as stroke, diabetes or cardiovasculardisease;(vi)currentmedicationthatmightinuencemoodorthecentralnervoussystem;(vii)pregnancyor breastfeeding; or (viii) current use of other antide-pressants or electroconvulsive therapy.Subjectswerediagnosedbytwoseniorpsychia-trists. These psychiatrists were trained before study toassure they used the tools consistently. The inter-raterreliability of the assessment of the measurements was97% for assessing ten patients. Each patient was ratedby the same clinician each time. This study wasapproved by the Medical Ethics Committee of SecondXiangya Hospital of Central South University inChina. All patients provided written informed consentprior to their participation in the study.MeasurementsShort Form 36 Health Survey Questionnaire(SF-36) (Ware and Sherbourne, 1992)TheChineseversionofSF-36(FangandHao,2001),developedbytheMedical Outcomes Study(MOS),wasusedtoassesshealth-relatedqualityoflife. TheSF-36 is a self-rated instrument consisting of ninedomains: physical functioning, role-physical, bodilypain,generalhealth,vitality,socialfunctioning,role-emotional,mentalhealthandreportedhealthtransi-tion.SF-36hasbeenclaimedtohavegoodreliabilityand validity for assessment in major depressivepatients (Zhanget al., 2006). Ahigher scoreontheSF-36 represents a better health-related quality of life.Y. Cao et al. Quality of life and severity of symptoms277 Asia-Pacific Psychiatry 5 (2013) 276283Copyright 2013 Wiley Publishing Asia Pty Ltd17-Item Hamilton Depression Rating Scale(HAMD-17) (Hamilton, 1967)The Chinese version of the HAMD-17 (Zhu andZhang, 1998), whichis the most widelyemployedinstrumentforassessingMDD, wasappliedtoassessseverity of depressive symptoms. It consists of 17items that evaluate functioning inve areas (sub-scales): cognitive impairment, retardation, anxiety/somatization, sleepdisturbance, andweight change.Higher scores indicatemoreseveredepression. ThereliabilityoftheChineseversionoftheHAMD-17is0.880.99.Clinical global impression (CGI)The Chinese version of the CGI (Wu, 1998) was usedto assess severity of depressive symptoms. Higherscores represent more severe symptoms.ProceduresAll patients met DSM-IV criteria for major depressivedisorder. They were assessed by SF-36 at baseline andat the end of the 6th week after taking antidepressant.HAMDandCGIforthesepatientswereevaluatedatbaseline, 2-week and 6-week follow-up. Symptomseveritychangewas measuredbyachangeintotalHAMD-17 score. Responders were dened as patientswith a 75% or greater improvement in symptoms andnon-responders as those with less than 75% improve-ment in symptoms.One hundred and twenty-eight patients wereenrolled in this study. All patients were given a xeddosageof 20 mg/dof uoxetinehydrochloridefor6weeks. One hundredandthree patients completedboththe2-weekand6-weekfollow-upevaluations.Eighteen(14.1%)patientswithdrewfromthestudyduetotravel/inconvenience,lackoftime/availabilityorbeingunsatisedwithantidepressant response; 2(1.6%)patientswereunabletotolerateside-effects,such as severe nausea, vomiting, anxiety, insomnia orweakness; 5 (3.9%) patients were non-compliant withresearchprocedures. 15ofthe103(14.6%)patientshad ever taken estazolam or nitrodiazepam to alleviatesevere insomnia.Statistical analysisSPSS version 15.0 was used for analyses. Paired t-testswere usedfor withinsubject comparisons betweenbaseline and either 2-week or 6-week follow-upassessments. Two-sample (unpaired) t-tests were usedfor comparisons of responders andnon-responders.Pearsoncorrelationtest wasusedtoassesstherela-tionshipsbetweenHRQoLanddepressivesymptomsandbetweenHRQoLandsymptomseveritychange.Multiple testing was accounted for by Bonferronicorrection.ResultsDemographic characteristicsA total of 103 patients completed the 6-weekfollow-upandwereincludedforstatistical analyses,including45men(43.7%)and58women(56.3%).The mean age was (34.4 12.7) years (ranging from18 to 63 years). The duration of illness ranged from 2to77weeks, withanaverage of 12.0weeks. Theaverageeducationlevel was(11.1 3.1)years. Theresponse rate of antidepressant intervention was 34%(threshold for improvement: 75%).Comparisons of scores for the SF-36 at baselineand week 6As showninTable 1, scores for all domains of theSF-36 were nominally higher at week six as comparedTable 1. Six-week follow-up and baseline comparisons of scores of SF-36 (M SD)SF-36 Baseline 6-week follow-up t P-valuePhysical function 80.73 18.92 92.86 8.90 -7.226