Skeletal pain in postmenopausal women with osteoporosis: prevalence and course during raloxifene treatment in a prospective observational study of 6 months duration

ABSTRACT

Objective: To assess the prevalence of skeletal pain in postmenopausal women before the onset of raloxifene treatment and the further course of pain during treatment in a naturalistic setting.

Research design and methods: Prospective, uncontrolled, multicentre, 6‐month, observational study in Germany. Clinical, diagnostic and pain data were collected at baseline, 6 weeks and 6 months of raloxifene treatment from 3299 female outpatients with postmenopausal osteoporosis. Physicians assessed the presence or absence of back pain, joint pain and diffuse bone pain at each visit, perceived sleep quality and the use of analgesics. Patients assessed intensity and frequency of pain using a 100?mm visual analogue scale (VAS) and a 5‐point scale (from ‘rarely’ to ‘permanently’), respectively.

Results: At baseline, patients had mean (SD) age 67.6 (9.3) years, 89.4% were reported to have reduced bone mineral density, 39.8% had pre-existing fractures and 93.4% had skeletal pain (physician assessment): 85.1% had back pain, 41.8% joint pain and 32.5% diffuse bone pain. Median pain intensity on VAS was 66.0?mm. After 6 months of raloxifene treatment, the frequency and intensity of pain and use of analgesics for skeletal pain decreased consistently by approximately 50%. Pain frequency decreased in 58.2% and increased in 2.3% of patients. The median decrease in pain intensity from baseline to 6 months was 27.0?mm (46%). Patients’ subjective quality of sleep improved: the proportion of patients who were reported to sleep well increased from 21.3% at baseline to 46.7% at 6 months. The decrease in relative pain frequency was greatest with diffuse pain (67.6%) followed by joint pain (36.9%) and back pain (32.5%).

Conclusion: Raloxifene treatment in postmenopausal women with osteoporosis was associated with a marked reduction of skeletal pain and analgesic consumption and an improvement in subjective sleep quality. Further investigation in a randomised, placebo-controlled trial is warranted.     

六味地黄丸联合唑来膦酸治疗妇女绝经后骨质疏松的临床研究

目的探讨六味地黄丸联合唑来膦酸治疗妇女绝经后骨质疏松的临床效果。方法选取2015年6月—2017年1月广东医科大学附属医院收治的86例绝经后骨质疏松患者,随机分为对照组和治疗组,每组各43例。对照组静脉滴注唑来膦酸注射液,5 mg/次,1次/年。治疗组在此基础上口服六味地黄丸,8丸/次,3次/d。所有患者均连续治疗12个月。观察两组的临床疗效,比较两组治疗前后视觉模拟(VAS)评分、简明健康状况调查量表(SF-36)评分、腰椎1~4骨质密度(BMD)、全髋关节骨BMD、左侧股骨颈BMD、Ⅰ型原胶原氨基端前肽(PINP)、β-胶原降解产物(β-CTX)、碱性磷酸酶(ALP)、骨钙素(BGP)的变化情况。结果治疗后,对照组和治疗组的总有效率分别为79.07%、95.35%,两组比较差异有统计学意义(P0.05)。治疗后,两组VAS评分、血清PINP、β-CTX、ALP及BGP水平显著降低,SF-36评分、腰椎1~4 BMD值、全髋关节骨BMD值、左侧股骨颈BMD值显著升高,同组治疗前后比较差异有统计学意义(P0.05);治疗后,治疗组VAS评分、血清PINP、β-CTX、ALP及BGP水平低于对照组,SF-36评分、腰椎1~4 BMD值、全髋关节骨BMD值、左侧股骨颈BMD值高于对照组,两组比较差异有统计学意义(P0.05)。结论六味地黄丸联合唑来膦酸治疗妇女绝经后骨质疏松具有较好的临床疗效,可有效缓解患者疼痛症状,增加骨密度,提高生活质量,具有一定的临床推广应用价值。     

Evaluation of health status in epilepsy using the EQ-5D questionnaire: a prospective,observational, 6-month study of adjunctive therapy with anti-epileptic drugs

ABSTRACT

Aims: The aims of this project were to evaluate the impact of adjunctive treatment with an anti-epileptic drug (AED) on the health status of people with epilepsy and to investigate how seizure frequency affects their health status.

Methods: Adult epilepsy patients, refractory to current treatment, were included in this prospective observational study. Patients commencing adjunctive therapy with one of five AEDs (topiramate, lamotrigine, gabapentin, clobazam, vigabatrin) were eligible for inclusion. The study took place at the outpatient clinics of the National Hospital for Neurology and Neurosurgery, Queen Square, London. Patients completed the EQ-5D, a generic health status measure, at baseline and again after 3 and 6 months. Information was also collected on medications and seizure frequency.

Results: In total, 125 patients entered the study and were followed up for 6 months. Patients treated with topiramate had a significant increase (?p < 0.05) in EQ-5D score from baseline, indicating an improvement in their health status whereas scores for lamotrigine, clobazam and gabapentin all showed a non-significant decline. When the data were analysed according to seizure frequency, only patients who became seizure-free on adjunctive treatment had a significant increase in their health status. The group who had a 50% reduction in seizure frequency did not have increased health status.

Conclusions: In summary, adjunctive treatment with topiramate significantly increased health status as measured by the EQ-5D. These data also suggest that achievement of seizure-freedom is the key to improving health status in this patient group.     

阿法骨化醇软胶囊联合雷洛昔芬治疗绝经后骨质疏松症的临床研究

目的观察阿法骨化醇软胶囊联合雷洛昔芬治疗绝经后骨质疏松症的临床疗效。方法选取2015年1月—2016年1月南阳市骨科医院收治的绝经后妇女骨质疏松症患者102例,随机分为对照组和治疗组,每组各51例。对照组患者口服盐酸雷洛昔芬片,1片/次,1次/d。治疗组在对照组的基础上口服阿法骨化醇软胶囊,1粒/次,1次/d。两组患者均治疗6个月。评价治疗后两组患者临床疗效,同时比较治疗前后两组骨强度、骨代谢标记物含量和不良反应差异。结果治疗后,对照组和治疗组临床总有效率分别为82.35%、96.08%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者骨密度和骨矿含量均明显升高(P0.05);且治疗后治疗组骨强度指标明显高于对照组(P0.05)。治疗后,两组患者I型胶原交联氨基端肽(NTXI)、I型胶原交联羧基端肽(CTXI)、抗酒石酸酸性磷酸酶5b(TRACP5b)和血骨钙素(BGP)含量均明显降低(P0.05);且治疗组患者的骨代谢标记物含量明显低于对照组(P0.05)。结论阿法骨化醇软胶囊联合雷洛昔芬治疗绝经后骨质疏松症疗效较好,具有一定的临床推广应用价值。     

Physical performance and life quality in postmenopausal women supplemented with vitamin D: a two-year prospective study

Aim:

To investigate the effects of calcium and vitamin D supplementation on bone turnover marker levels, muscle strength and quality of life in postmenopausal Chinese women.

Methods:

A total of 485 healthy postmenopausal Chinese women (63.44±5.04 years) were enrolled in this open-label, 2-year, prospective, community-based trial. The participants were divided into group A, B, C, which were treated with calcium (600 mg/d) alone, calcium (600 mg/d) and cholecalciferol (800 IU/d) or calcium (600 mg/d) and calcitriol (0.25 μg/d), respectively, for 2 years. Serum levels of 25-hydroxyvitamin D, parathyroid hormone, β-CTX and P1NP were measured, and the muscle strength and quality of life were assessed at baseline and at 12- and 24-month follow-ups.

Results:

Four hundred and sixty one participants completed this study. Serum levels of 25-hydroxyvitamin D were significantly increased in group C, but not changed in groups A and B at 24-month follow-up. Serum levels of parathyroid hormone, bone turnover marker β-CTX and bone formation marker P1NP were significantly decreased in group C, while serum levels of β-CTX were increased in group A at 24-month follow-up. The participants in group C maintained the grip strength, while those in groups A and B exhibited decreased grip strength at 24-month follow-up. The quality of life for the participants in groups B and C remained consistent, but that in group A was deteriorated at 24-month follow-up.

Conclusion:

Supplementation with calcitriol and calcium modifies the bone turnover marker levels, and maintains muscle strength and quality of life in postmenopausal Chinese women, whereas supplementation with cholecalciferol and calcium prevents aging-mediated deterioration in quality of life.     

Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting

ABSTRACT

Objective: The European Forsteo^* Observational Study (EFOS) study was primarily designed to assess fracture incidence, degree of pain, health-related quality of life (HRQoL) and compliance in women prescribed teriparatide in a community setting. This report describes the design of the study and characteristics of the patients at entry.

Methods: At entry, 1645 postmenopausal women with a diagnosis of osteoporosis and about to initiate teriparatide treatment were enrolled in eight European countries. Baseline data were collected on demographic characteristics, medical and osteoporosis history, disease status, prior use of medications and HRQoL.

Results: The mean (standard deviation [SD]) age of patients was 71.5 (8.4) years, lumbar spine bone mineral density (BMD) T?score was –3.3 (1.2), the mean number of previous fractures reported after 40 years of age was 2.9 (2.0), 70% had two or more vertebral deformities and 91.7% were pre-treated with bisphosphonates. HRQoL, evaluated by the health state value (HSV) (median: 0.59, Q1; Q3: 0.08; 0.71) and visual analogue scale (VAS) (median 50.0, Q1; Q3: 35.0; 69.0) status of the European quality of life questionnaire (EQ?5D) was poor. Extreme problems were reported by 31% of patients for the pain/discomfort dimension, mobility was limited in 69% and anxiety/depression was reported by 57% of patients. Chronic or intermittent back pain was reported by 91% of patients, which occurred every day or almost every day within the last month in 66% of patients.

Conclusions: The post-menopausal women prescribed teriparatide were severely osteoporotic, with a high fracture risk and poor HRQoL, despite previous therapy for osteoporosis. Moderate to severe back pain was very common.     

抗骨增生胶囊联合戊酸雌二醇治疗绝经后骨质疏松症的临床研究

目的探讨抗骨增生胶囊联合戊酸雌二醇片治疗绝经后骨质疏松症的临床疗效。方法选取2016年4月—2017年9月信阳市中心医院收治的绝经后骨质疏松症患者96例为研究对象,按照随机数字表法分为对照组和治疗组,每组各48例。对照组口服戊酸雌二醇片,1片/次,1次/d。治疗组在对照组治疗的基础上口服抗骨增生胶囊,5粒/次,3次/d。两组患者均连续治疗6个月。观察两组的临床疗效,比较两组的骨密度、骨代谢、VAS评分。结果治疗后,对照组和治疗组的总有效率分别为77.08%、91.67%,两组比较差异有统计学意义(P0.05)。治疗后,两组股骨颈、腰椎侧位、wards三角区、尺桡骨远端的骨密度显著升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗组骨密度明显高于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组骨钙素(BGP)水平显著升高,碱性磷酸酶(ALP)、Ⅰ型前胶原氨基末端肽(PINP)、Ⅰ型胶原羧基末端肽(CTX)水平显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组骨代谢指标明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组VAS评分明显降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组VAS评分明显低于对照组,两组比较差异具有统计学意义(P0.05)。结论抗骨增生胶囊联合戊酸雌二醇片治疗绝经后骨质疏松症具有较好的临床疗效,可改善骨代谢水平,提高骨密度,缓解疼痛,具有一定的临床推广应用价值。     

Economic burden and quality of life of vulvodynia in the United States

Abstract

Objective:

To explore the economic burden and quality of life of vulvodynia in the United States.     

骨愈灵胶囊联合唑来膦酸治疗绝经后骨质疏松症的临床研究

目的 观察骨愈灵胶囊联合唑来膦酸注射液治疗绝经后骨质疏松症的临床疗效.方法 选取2018年3月—2020年9月郑州市骨科医院接收的60例绝经后骨质疏松症患者,根据奇偶顺序将所有患者分为对照组和治疗组,每组各30例.对照组静脉滴注唑来膦酸注射液,将5 mg唑来膦酸注射液溶入100 mL生理盐水中,每3～4周给药1次.治疗...     

唑来磷酸盐对绝经后骨质疏松女性硫酸脱氢表雄酮的影响分析

目的：观察分析唑来磷酸盐对绝经后骨质疏松女性硫酸脱氢表雄酮的影响。方法选取收治的绝经后骨质疏松女性80例,患者随机分为观察组（ n =40）和对照组（ n =40）。对照组患者给予骨化三醇胶丸治疗,观察组患者在此基础上给予唑来磷酸盐治疗。比较2组疗效、硫酸脱氢表雄酮含量、骨痛症状、不良反应情况。结果治疗后,观察组总有效率为92烫．50%高于对照组的72．50%,差异有统计学意义（ P <0．05）。入组时,2组患者硫酸脱氢表雄酮含量比较无统计学意义（ P >0．05）;治疗60 d时,观察组硫酸脱氢表雄酮含量上升幅度较对照组大;治疗90 d时,观察组患者硫酸脱氢表雄酮含量上升幅度明显高于对照组患者,差异有统计学意义（ P <0．05）。治疗后,观察组骨痛症状缓解率为92．50%,明显高于对照组的75．00%,差异有统计学意义（ P <0．05）。观察组不良反应发生率为7．50%明显低于对照组57．50%,差异有统计学意义（ P <0．05）。治疗后,观察组患者骨密度增加比对照组患者明显,差异有统计学意义（ P <0．05）。结论应用唑来磷酸盐治疗绝经后骨质疏松女性疗效显著,能有效增加硫酸脱氢表雄酮含量,减少不良反应发生,安全性高。     

伴与不伴鼻息肉的慢性鼻-鼻窦炎患者生存质量比较

目的 探讨伴鼻息肉的慢性鼻-鼻窦炎（CRSwNP）和不伴鼻息肉的慢性鼻-鼻窦炎（CRSsNP）患者生存质量的差异。方法 选取2017年1月至2017年6月安徽省立医院的慢性鼻-鼻窦炎患者100例,依据欧洲鼻-鼻窦炎鼻息肉诊疗指南,分为CRSwNP组50例,CRSsNP组50例,运用Lund-Mackay CT评分及Lund-Kennedy鼻内镜评分对客观病情进行评估,采用汉化版生存质量评定量表（SF-36）及视觉模拟评分量表（VAS）对主观生存质量进行评估,分析两组患者生存质量差异。结果 ①CRSwNP组的Lund-Mackay CT评分（13.71±6.60）分及Lund-Kennedy鼻内镜评分（8.38±2.81）分均高于CRSsNP组的Lund-Mackay CT评分（8.11±6.45）分及Lund-Kennedy鼻内镜评分（4.78±2.08）分,差异均有统计学意义（P<0.05）;②CRSwNP组的VAS总体评分（19.55±8.02）分与CRSsNP组（19.21±9.65）分相比,差异无统计学意义（P>0.05）,但CRSsNP组的头痛、面部胀痛症状[（3.70±3.10）分、（3.72±3.01）分]高于CRSwNP组[（0.98±1.83）分、（0.55±1.18）分],鼻塞、嗅障碍症状评分[（4.19±3.28）分、（2.72±3.51）分]低于CRSwNP组[（6.65±3.24）分、（7.23±3.36）分],差异均有统计学意义（P<0.05）;③CRSwNP组SF-36量表躯体健康总分（PCS）（319.21±54.34）分与CRSsNP组（295.22±70.52）分相比,差异无统计学意义（P>0.05）,但CRSsNP组的生理职能（RF）（64.27±39.04）分低于CRSwNP组（79.42±28.54）分,差异有统计学意义（P<0.05）;④CRSwNP组SF-36量表精神健康总分（MCS）（306.79±67.52）分与CRSsNP组（286.24±86.02）分相比,差异无统计学意义（P>0.05）,但CRSsNP组活力（VI）、精神健康（MH）[（66.39±23.32）分、（66.98±21.14）分]低于CRSwNP组[（76.51±16.49）分、（76.65±17.48）分],差异均有统计学意义（P<0.05）。结论 客观病情方面,CRSwNP患者较CRSsNP患者更为严重,但生理职能、活力及精神健康方面,CRSsNP患者较CRSwNP患者下降更为显著,应注意提高客观病情轻但主观生活质量差的患者生活质量。     

健康教育对绝经后骨质疏松患者生活质量的影响

目的：探讨健康教育对绝经后骨质疏松症患者生活质量的影响。方法将160例绝经后骨质疏松患者随机分为实验组和对照组各80例,实验组进行系统健康教育并于出院后随访,对照组只进行常规的健康教育指导,应用SF-36生活质量量表分别对两组干预前及干预6个月后的生活质量进行评分。结果实验组干预后的各维度（总体健康、生理职能、社会功能、情感职能等）评分均明显升高,与干预前及对照组比较,差异有统计学意义（P＜0.05）。对照组干预前后的各维度评分比较,差异无统计学意义（P＞0.05）。结论对绝经后骨质疏松症患者实施系统的健康教育,可以提高患者的生活质量。     

Health-related quality of life in type 1 diabetes mellitus pediatric patients and their caregivers in Spain: an observational cross-sectional study

Objectives: This study assessed the health-related quality of life (HRQOL) of pediatric patients with type 1 diabetes mellitus (T1DM) and their caregivers.

Methods: CHRYSTAL was an observational cross-sectional study conducted in Spain in 2014 on 275 patients under 18?years old diagnosed with T1DM. Patient/caregiver pairs were stratified by patients’ HbA1c level (≥7.5% versus <7.5%) and by presence or absence of T1DM complications and/or comorbidities. EQ-5D and PedsQL questionnaires were administered to patients and caregivers.

Results: On the EQ-5D, according to caregivers’ perception, 17.7% of children experienced moderate pain or discomfort, 9.7% suffered problems performing usual activities, and 13.2% demonstrated moderate anxiety or depression. Mean EQ-5D index score was 0.95 and mean visual analog scale (VAS) score was 86.1. By HbA1c level (≥7.5% versus <7.5%), mean index scores were 0.94 and 0.95, and mean VAS scores were 82.8 and 89.2, respectively. Mean index scores were 0.91 for children with complications and/or comorbidities and 0.96 for children without. Mean VAS scores were 83.7 and 87.2, respectively. HRQOL per the PedsQL tool ranged from 68.1 (ages 2–4) to 73.1 (ages 13–18). EQ-5D index and VAS scores were significantly correlated (rho = 0.29–0.43) with several age groups of the PedsQL. EQ-5D scales showed significant moderate correlation between EQ-5D-Y and EQ-5D-3L proxy VAS score (rho = 0.45; p?<?.001).

Conclusions: Patients with few complications and controlled HbA1c reported a relatively high HRQOL. The results suggest that parent-proxy EQ-5D ratings are valid for use as part of an overall health outcomes assessment in clinical studies of T1DM in pediatric patients.     

女性尖锐湿疣118例生活质量分析

目的 探索女性尖锐湿疣患者的生活质量.方法 对118例女性尖锐湿疣患者使用含中文版SF-36量表问卷进行面对面询问式调查,采用t检验和x2检验等统计方法比较女性尖锐湿疣患者及健康对照人群SF-36量表各维度评分.结果 有效问卷101份,尖锐湿疣患者以躯体功能(PF)和躯体疼痛(BP)两个维度最高,分别为(92.9±10.5)分和(75.0±11.2)分;情感所致功能限制(RE)维度最低,为(50.8±13.7)分.两组比较,除PF无统计学意义外,各维度评分均为尖锐湿疣患者显著低于对照组(均P＜0.01).结论 女性尖锐湿疣患者生活质量显著低于对照人群,尤其是在心理功能上.     

唑来膦酸对绝经后骨质疏松患者骨密度、骨代谢指标、生活质量及疗效的影响

目的 探讨唑来膦酸对绝经后骨质疏松患者骨密度、骨代谢指标、生活质量及疗效的影响.方法 114例绝经后骨质疏松症患者依据随机数字表法随机分为观察组与对照组,每组57例.对照组采用常规治疗,观察组在对照组基础上结合唑来膦酸治疗.2组疗程均为12个月.比较2组患者骨密度、骨代谢指标、生活质量、疗效及不良反应情况.结果 2组腰椎和Ward三角区骨密度治疗后增加(P＜0.05);观察组腰椎和Ward三角区骨密度治疗后高于对照组(P＜0.05);2组S-Ca、S-P治疗前后比较差异均无统计学意义(P＞0.05);2组ALP治疗后下降(P＜0.05);观察组ALP低于对照组(P＜0.05);观察组SF-36量表中躯体疼痛、精神健康、生理功能、生理职能、情感职能、社会功能、生命活力、总体健康治疗后高于对照组(P＜0.05);观察组总有效率高于对照组(P＜0.05);2组均未见严重用药不良反应.结论 唑来膦酸可明显改善患者骨密度,降低ALP水平,提高患者生活质量,疗效显著,安全可靠,具有重要研究价值.     

特立帕肽联合阿仑膦酸钠治疗绝经后骨质疏松症的临床研究

目的探讨特立帕肽联合阿仑膦酸钠治疗绝经后骨质疏松症的临床疗效。方法选取2014年1月—2015年6月天津中医药大学第一附属医院收治的绝经后骨质疏松症患者140例,随机分为对照组和治疗组,每组各70例。对照组患者口服阿仑膦酸钠片,1片/次,1次/d。治疗组在对照组治疗基础上皮下注射特立帕肽注射液,20μg/次,1次/d。两组患者均连续治疗6个月。观察两组患者治疗前后骨密度和骨代谢指标的变化情况。结果治疗组治疗3个月时腰椎骨密度相对于治疗前有明显上升,全髋与股骨颈骨密度则无明显变化,治疗组治疗6个月时腰椎、全髋、股骨颈骨密度均明显上升,同组治疗前后差异具有统计学意义(P0.05);对照组治疗3个月各部位骨密度均未出现明显上升,治疗6个月腰椎骨密度较治疗前有明显上升(P0.05)。治疗组治疗6个月时腰椎、全髋、股骨颈骨密度改善情况明显优于对照组,两组比较差异有统计学意义(P0.05)。治疗组治疗3、6个月血清骨钙素(OC)水平逐渐上升,均明显高于治疗前,同组治疗前后差异具有统计学意义(P0.05);对照组则逐渐下降,均明显低于治疗前(P0.05);治疗组治疗3、6个月血清Ⅰ型胶原羧基端肽交联(β-CTX)水平逐渐下降,对照组也逐渐下降,对照组下降幅度则明显大于治疗组(P0.05)。结论特立帕肽联合阿仑膦酸钠治疗绝经后骨质疏松症具有较好的临床疗效,可增加患者的骨密度,可有效改善骨代谢,具有一定的临床推广应用价值。     

利塞膦酸治疗绝经后骨质疏松症的随机双盲对照临床研究

目的:探讨利塞膦酸治疗绝经后骨质疏松症的有效性和安全性。方法:采用随机双盲安慰剂对照平行临床比较研究,共入选病例48例。利塞膦酸组给予利塞膦酸钠片5 mg,qd;安慰剂组给予安慰剂1片,qd;每组均同时给予钙维D,咀嚼片1片,qd;疗程均为12 mo。结果:完成病例共46例,每组各23例。用药后腰椎和髋骨总骨密度,利塞膦酸组增加了(0．04±s 0．04)g·cm-2和(0．03±0．05)g·cm-2,与治疗前比较差异非常显著(P<0．01);安慰剂组无明显变化,2组间比较,差异有非常显著意义(P< 0．01)。利塞膦酸组用药后血骨钙素和I型胶原交联C端多肽分别下降(4±7)μg·L-1和(0．6±0．4)nmol·L-1,与治疗前比较差异非常显著(P<0．01)。不良事件2组各发生1例,组间无显著差异(P>0．05)。结论:利塞膦酸是一种疗效和安全性均良好的治疗绝经后骨质疏松症的药物。     

Psychometric validation of a generic health-related quality of life measure (EQ-5D) in a sample of schizophrenic patients

SUMMARY

Objective: The aim of this study was to evaluate the construct validity of a generic health related quality of life (HRQOL) instrument – the EQ-5D – in a sample of schizophrenic patients receiving antipsychotic treatment.

Research design and methods: A total of 2128 schizophrenic patients treated with olanzapine, 417 treated with risperidone, and 112 with haloperidol responded to the EQ-5D. The study also assessed the effect of patient age, gender, and co-morbidity variables on patient's HRQOL

Main outcomes measures: EQ-5D scores at the start of treatment and after 3 and 6?months of therapy were compared with results from the Clinical Global Impression (CGI) severity of illness scale and the (GAF) scale. The effect of antipsychotics and sociodemographic variables on patient's HRQOL over time was tested through a three-factor doubly multivariate repeated measures MANCOVA.

Results: High scores in the GAF scale and low scores in the CGI were linked with high scores on the EQ-5D scale. The correlational effects observed between the EQ-5D and the clinical indices ranged from 0.33 to 0.54. A significant effect of ‘visit time’ as well as an interaction of ‘visit time’ x drug, ‘visit time’ x gender, and ‘visit time’ x co-morbidity was observed.

Conclusions: Results suggest the EQ-5D is a valid instrument capable of detecting HRQOL differences between schizophrenic patients with different degrees of severity of illness.