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PubMed2003

Gender differences in shame in patients with binge-eating disorder.

OBJECTIVE: To examine the relationship between shame and the behavioral and attitudinal features of eating disorders in men and women diagnosed with binge-eating disorder (BED). RESEARCH METHODS AND PROCEDURES: Participants were 188 consecutively evaluated adults (38 men and 150 women) who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for BED. Participants were interviewed and completed a battery of measures assessing shame, behavioral and attitudinal features of eating disorders, and general psychological functioning. RESULTS: Shame did not differ significantly by gender and was not associated with BMI or binge-eating frequency. Shame was significantly associated with the attitudinal features of eating disorders, even after controlling for levels of depression and self-esteem. When considered separately by gender and controlling for depression and self-esteem, shame was associated with body dissatisfaction in men and with weight concern in women. DISCUSSION: Men and women with BED, who presented for treatment, reported similar levels of shame. Overall, while shame was related to attitudinal features, the specific associations differed by gender. For men, shame was related to how dissatisfied they felt with their bodies, whereas for women, shame was associated with concerns about weight. Interestingly, shame was not related to BMI or binge-eating frequency in men or women. These results provide preliminary support for self-conscious emotions playing different roles in men and women with BED.

Adult↗
PubMed2004

A randomised comparison of UK genetic risk counselling services for familial cancer: psychosocial outcomes.

The aim of the study was to compare psychosocial outcomes for 50 new clinic attendees, referred for cancer genetic counselling to five UK centres. The centres represented England, Scotland and Wales, and were randomly selected from groups ranked by different levels of clinical activity in cancer genetics practice. Questionnaires assessed demographic data, risk perception, mental health and use of health services pre-consultation and at 1 and 12 months follow-up. Satisfaction was measured for attendees and referring doctors at follow-up. A total of 256 unaffected adults fulfilled the study criteria. The five centres varied widely with respect to service organisation and activity, but all had a greater proportion of unaffected attendees with a breast cancer risk (61-91%) than either a bowel cancer risk (0-33%) or ovarian cancer risk (3-25%). There were no significant differences in the psychosocial data between centres pre-counselling. No significant change over time occurred for any of the centres for risk perception or general psychological distress. There were significant differences between centres in reduction of cancer worry from baseline to 12 months and with the number of women who were recommended to have mammographic surveillance who had not received this. Overall, one-third of women for whom mammography had been recommended had not been screened within 1 year of follow-up. Subsequent attendance at the GP, but not at a hospital, was associated with risk level, but differences between centres could not be analysed. Satisfaction differed significantly between centres for 4 : 14 aspects of service provision and with 3 : 17 items concerning communication; satisfaction was high overall. Over 90% of referring doctors were moderately/very satisfied with the service, but 23% were dissatisfied with waiting times and 19% with access to preventive treatment. Results differed significantly between centres for doctor's satisfaction with the provision of referral criteria and prescribing information. In conclusion, there were relatively few significant differences in psychosocial outcomes between centres, considering the wide variation in service organisation and activity. These significant differences were not consistent across the centres, therefore, differences could not be linked to specific aspects of service provision.

Adult↗
PubMed2001

Comparison of quality of life and cough on eprosartan and enalapril in people with moderate hypertension.

The objective of this study was to compare quality of life and incidence of dry persistent cough among patients treated with eprosartan and enalapril for mild-moderate hypertension. This was a randomised 26-week double-blind controlled trial carried out in clinics in nine countries of North America, Europe and South Africa. A total of 529 patients aged 18 and over with diastolic blood pressure between 95 mm Hg and 114 mm Hg were studied. Treatment comprised of eprosartan or enalapril monotherapy for 12 weeks with the option of hydrochlorothiazide addition for the remaining 14 weeks. The primary outcome measures were cough and the Psychological General Wellbeing Index (PGWB) total and subscales (anxiety, self-control, depression, general health, positive wellbeing and vitality). The results were that 17.8% of enalapril patients and 13.2% of eprosartan patients withdrew from randomised treatment. Those on enalapril were twice as likely to have gained a definite or possible cough by study end point as those on eprosartan (7.6% vs 3.2%) P = 0.099. At monotherapy end point the differences were greater (9.9% vs 2.1%) and of statistical significance, P = 0.001. Patients treated with enalapril, however, had small but significant improvements in measures of self-control and total PGWB compared with those on eprosartan. The effect sizes of 0.2 or less indicated that there were small differences. In conclusion eprosartan was associated with fewer coughs than enalapril but it performed less well on some aspects of quality of life.

Acrylates↗
PubMed2001

Quality of life and cough on antihypertensive treatment: a randomised trial of eprosartan, enalapril and placebo.

The objective of this study was to compare the quality of life and incidence of dry cough with the angiotensin II antagonist eprosartan, the ACE-inhibitor enalapril, and placebo, in hypertensive patients with a history of ACE-inhibitor cough. The study was a multicentre, randomised, double-blind, parallel group controlled trial. A total of 136 patients judged to have ACE-inhibitor cough during single-blind enalapril treatment which was lost during a subsequent placebo washout phase, were randomised to receive either eprosartan 300 mg twice daily, or enalapril 20 mg once daily, or placebo for 6 weeks. Self-completion questionnaires assessing quality of life and cough were examined at baseline and end of study. At study end point 23% of patients in the enalapril group and 5% in the eprosartan and placebo groups reported cough (which included definite, probable and possible coughs) (P = 0.02). After adjusting for multiple comparisons, the eprosartan group was not significantly different from either placebo or enalapril. There were no significant differences in the Psychological General Wellbeing Index (PGWB). In conclusion the incidence of self-reported cough on eprosartan was similar to that on placebo, and lower than on enalapril but this difference was not significant when adjustments were made for multiple comparisons. There were no differences in quality of life.

Acrylates↗
PubMed2004

Health-related quality of life during treatment of elderly patients with hypertension: results from the Study on COgnition and Prognosis in the Elderly (SCOPE).

The Study on COgnition and Prognosis in the Elderly (SCOPE) was a multinational, randomised, double-blind study to assess the effects of candesartan 8-16 mg daily on cardiovascular events and cognitive function in elderly patients (aged 70-89 years) with mild to moderate hypertension. A total of 4937 patients were randomised to candesartan or placebo with other antihypertensive drugs (mostly diuretics, beta-blockers, and calcium antagonists) added as needed to control blood pressure. Only 16% of the patients in the control group received placebo alone. The mean follow-up was 3.7 years. The aim of this health-related quality of life (HRQL) substudy analysis was to investigate changes in HRQL during antihypertensive treatment, and possible differences in patients receiving candesartan-based or other antihypertensive treatment. Three validated HRQL instruments were used: the Psychological General Well-being (PGWB) Index, the Subjective Symptoms Assessment Profile (SSA-P), and the EuroQoL Health Utility Index (EuroQoL). The HRQL was generally good at baseline and well preserved during follow-up in the presence of substantial blood pressure reductions in both treatment groups. Several of the observed changes in score from baseline to last visit favoured candesartan-based compared to control treatment, particularly the changes in PGWB Anxiety (-0.5 vs -1.0, P=0.01), PGWB Positive well-being (-0.8 vs -1.1, P=0.04), SSA-P Cardiac symptoms (0.03 vs 0.10, P=0.03), and EuroQoL Current health (-3.1 vs -5.3, P=0.008). This favourable result may be related to the somewhat lower blood pressure associated with candesartan-based treatment. In conclusion, there should be no reason to withhold modern antihypertensive therapy in elderly patients due to concerns for a negative effect on HRQL.

Aged↗
PubMed2000

Quality of life in patients with spinal cord injury receiving Viagra (sildenafil citrate) for the treatment of erectile dysfunction.

STUDY DESIGN: A multicenter, randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover study conducted June 1996 through January 1997. OBJECTIVES: To evaluate the effect of sildenafil citrate (VIAGRA(R)) on the quality of life (QoL) of men with erectile dysfunction (ED) caused by spinal cord injury (SCI). SETTING: Study centers in Australia, Belgium, France, Germany, Norway, Sweden and the United Kingdom. METHODS: Questions 13 and 14 of the 15-item International Index of Erectile Function (IIEF) addressed QoL issues directly related to ED in 178 men with SCI. A 5-item questionnaire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Several commonly used psychometric instruments, including the Medical Outcomes Survey (MOS) Short Form-12, Psychological General Well-Being Index, and MOS Family Survey, assessed general QoL issues. RESULTS: Significant improvements were seen for overall satisfaction with sex life (IIEF Q13), sexual relationship with partner (IIEF Q14), and concerns about erectile problems (P<0.0001). Improvements were reported in scores for the generic QoL parameters of mental health, well-being, depression, and anxiety (P<0.05 sildenafil versus placebo). CONCLUSION: Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI. SPONSORSHIP: This study was funded by Pfizer Inc. Spinal Cord (2000) 38, 363 - 370.

Adult↗
PubMed1989

Training and generalization of agrammatic aphasic adults' wh-interrogative productions.

The stimulus and response generalization effects of training wh-interrogative production were examined in 4 agrammatic Broca's aphasic subjects using a multiple baseline design across behaviors and subjects. Throughout treatment, response generalization to untrained questions and stimulus generalization to several nontraining conditions were assessed. Variable response generalization to untrained exemplars of trained wh-interrogative forms and little generalization to grammatically different wh constructions occurred. Stimulus generalization to only one of three conditions was noted. However, generalization treatment involving sequential modification of training across conditions was found to be effective in facilitating generalization to an additional stimulus condition for 2 of the 4 subjects.

Aged↗
PubMed2003

The health-related quality of life effects of once-daily cetirizine HCl in patients with seasonal allergic rhinitis: a randomized double-blind, placebo-controlled trial.

BACKGROUND: Seasonal allergic rhinitis (SAR) is characterized by subjectively irritating symptoms that can have a substantial impact on the patient's health-related quality of life (HRQL), adversely affecting physical and social or work activity, interpersonal relationships, and general psychological well-being. The objective of this study was to test the effect of cetirizine HCl 10 mg once daily on the HRQL of adult patients 18-65 years of age with SAR, concurrently assessing safety and efficacy. METHODS: Randomized double-blind, placebo-controlled, parallel group trial conducted during the 1999 spring SAR season at 19 centers in the US. Following a 1-week placebo run-in period, qualified patients were randomized to cetirizine 10 mg, or placebo once daily for a 2-week treatment period. Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Total Symptom Severity Complex (TSSC) scores from baseline were the primary outcomes of interest. RESULTS: Of the 611 patients enrolled, 403 (66%) were randomized. Cetirizine-treated patients reported significantly greater improvement in overall HRQL (P < 0.001) and in each of the seven domains of the RQLQ at all time-points (P < 0.05 to < 0.001) than the placebo group. They also experienced significantly greater symptom relief (P < 0.001) and were more satisfied with treatment (65% vs. 44%) compared to the placebo group. Correlations between symptomatic relief and overall HRQL improvement were moderate to strong and statistically significant (r = 0.49-0.68, P < 0.01). CONCLUSIONS: Results of this study are consistent with previous investigations, suggesting cetirizine HCl 10 mg taken once daily in the morning offers symptomatic relief that improves the HRQL of adults suffering from SAR.

Adolescent↗
PubMed1998

Beneficial effects of long-term GH replacement therapy on quality of life in adults with GH deficiency.

OBJECTIVE: Quality of life tends to be adversely affected in adults with GH deficiency. The aim of this study was to examine changes in quality of life in a large group of GH-deficient adults receiving long-term GH replacement therapy. DESIGN: The study was conducted in two stages. The first stage was a prospective, open trial of GH replacement therapy in 71 GH-deficient adults, during which GH was administered for 20-50 months. For the second stage, a further 90 patients were recruited to create a population of 161 GH-deficient adults, all of whom had received GH replacement therapy for more than 12 months. This population was investigated retrospectively, using a questionnaire designed specifically for this study. PATIENTS: All patients were GH deficient and showed a peak GH response of less than 3.0 micrograms/l during an insulin tolerance test in which blood glucose levels dropped to 2.2 mmol/l or below. MEASUREMENTS: The quality of life of patients in the prospective stage was assessed using the Nottingham Health Profile (NHP) parts I and II, and the Psychological General Well-Being (PGWB) index. In the retrospective study patients completed a specially developed questionnaire, designed to determine whether changes in quality of life were sudden or gradual, and whether quality of life continued to change after GH had been administered for more than 12 months. RESULTS: In the prospective stage, mean overall score on the NHP I improved significantly during the first 6 months of GH therapy, and remained at its new level thereafter. Scores in all areas of the NHP II improved significantly between baseline and 20-50 months, as did the total score and five of six area scores on the PGWB index. The total PGWB score and three area scores improved significantly between 6 or 12 months and 20-50 months. In the retrospective stage, 92.7% of the patients reported that they had experienced positive effects of GH therapy. In 30.3% of patients, however, such effects did not become apparent until GH had been administered for more than 6 months. Almost 60% of patients felt that their condition was still improving. CONCLUSIONS: These results indicate that the previously reported beneficial effects of GH therapy on quality of life in GH-deficient adults are sustained during long-term therapy. In addition, they suggest that, once started, GH therapy should be continued for at least 6 months before judgements are made regarding its efficacy in improving quality of life.

Adult↗
PubMed1999

Dose titration and patient selection increases the efficacy of GH replacement in severely GH deficient adults.

OBJECTIVE: Previous studies of GH replacement in adults have used unselected cohorts of GH deficient (GHD) adults and weight-based dosing regimens resulting in supraphysiological serum IGF-I levels and a high frequency of side-effects and withdrawal from these studies. By choosing patients with a high level of morbidity at baseline and using a low dose GH titration regimen we aimed to avoid over-replacement and increase the efficacy of treatment. DESIGN: An open study of GH replacement, initiating treatment with a dose of 0. 8 U/day and titrating the dose by 0.4 U increments to normalize the IGF-I SDS between - 2.0 and + 2.0 SD of the age-related normal range. PATIENTS: 65 severely GHD patients (peak GH < 9 mU/l to provocative testing), 25 males, of mixed adult and childhood-onset and mean age 38.7 (range 17-72) years. Inclusion criterion was that of subjectively poor quality of life on clinical interview. MEASUREMENTS: Height, weight, waist and hip circumference were measured to allow calculation of body mass index (BMI) and waist-hip ratio (WHR). Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DEXA). Serum haemoglobin A1C (HbA1C), lipid profile and insulin like growth factor 1 (IGF-I) were measured. The Psychological General Well-Being Schedule (PGWB) and Adult Growth Hormone Deficiency Assessment (AGHDA) self-rating questionnaires (SRQ) were used to assess quality of life. RESULTS: Baseline characteristics were consistent with those previously described in severely GHD adults; mean IGF-I SDS - 2.4 (+/- 2.7), BMI 28.8 (+/- 5. 4) kg/m2, total cholesterol 6.17 (+/- 1.2) mmol/l, reduced BMD z-scores at the lumbar spine (- 0.8 +/- 1.2) and femoral neck (- 0. 44 +/- 1.4), and SRQ scores considerably lower than reported in previous studies of GH deficient adults and normal controls. Following initiation of GH serum IGF-I SDS was increased significantly from baseline to a mean level of 0.15 +/- 2.7 (P < 0. 001) and 0.31 +/- 2.0 (P < 0.001) at three and eight months, respectively. The mean PGWB score increased from 59.7 +/- 19.9 to 75. 8 +/- 15.0 (P < 0.001) and 73.7 +/- 19.5 (P = 0.001) at three and eight months, respectively. An increase of 14 points represents the largest improvement in quality of life, using this index, that has been reported in GHD adults. The mean AGHDA score also demonstrated considerable improvement, falling from 15.3 +/- 6.0 to 10.4 +/- 6.2 (P < 0.001) and 9.8 +/- 6.5 (P < 0.001) at three and eight months, respectively. The changes observed in both the PGWB and AGHDA scores between baseline and at both three and eight months were shown to correlate significantly with the respective baseline score. A significantly greater improvement was observed in the PGWB following GH replacement in those with a baseline PGWB score of < 60 than in those with a score > 60. This observation was significant at both three (27.1 vs 6.7, P = 0.0001) and eight (25.6 vs 3.3, P = 0.0003) months. All PGWB subscales showed significant improvement though that of vitality was of greatest magnitude. A strong correlation was observed between the generic and disease-specific SRQ (r = - 0.73, P < 0.001). CONCLUSIONS: The observed improvement in quality of life in GH deficient adults is proportional to the degree of impairment before commencing therapy. The use of low-dose titration and selection of a population with greater morbidity reduces the occurrence of over-replacement and increases the efficacy of treatment. This allows direction of resources to those in greatest need.

Adolescent↗
PubMed1999

Influences on quality of life in GH deficient adults and their effect on response to treatment.

OBJECTIVE: Studies of the effect of GH on quality of life (QOL) in growth hormone deficient (GHD) adults have reported conflicting results. Recently, however, we have demonstrated that by selecting only those patients with impaired QOL the efficacy of GH replacement on QOL can be greatly improved. The improvement in QOL was observed to correlate significantly with that recorded before commencing GH therapy. This study aims to assess if demographic variables affect QOL in untreated GHD adults or the improvement in QOL following GH therapy. DESIGN: An open study of GH replacement, initiating treatment with a dose of 0.8 IU/day and titrating the dose by 0.4 IU increments to normalize the IGF-I SDS between - 2.0 and + 2.0 SD of the age related normal range. PATIENTS: 65 severely GHD patients (peak GH < 9 mU/l to provocative testing), mean age 38.7 (range 17-72) years. Inclusion criterion was that of subjectively poor quality of life on clinical interview. MEASUREMENTS: Blood was taken for insulin-like growth factor 1 (IGF-I). The Psychological General Well-Being Schedule (PGWB) and Adult Growth Hormone Deficiency Assessment (AGHDA) self-rating questionnaires were used to assess quality of life at baseline, three and eight months after commencing GH. RESULTS: The patients were subgrouped on the basis of gender, age of onset of GHD, pathology and presence of additional pituitary hormone deficits. The cohort consisted of 40 females and 25 males, 45 of adult-onset (AO) and 20 of childhood-onset (CO). GH deficiency resulted from a hypothalamo-pituitary pathology, or treatment thereof, in 36 patients and as a result of cranial irradiation for a primary brain tumour or prophylaxis in acute lymphoblastic leukaemia in 29 patients. Isolated GH deficiency (IGHD) was present in 25 patients, and 32 patients were demonstrated to have at least two additional pituitary hormone deficits (MPHD). No significant difference was detected between baseline PGWB scores of the subgroups. Multiple linear regression analysis revealed the age of onset of GHD to be a significant determinant of both the baseline PGWB (P = 0.05) and AGHDA (P = 0.025) scores, AO patients perceiving the greater distress. A significant improvement, from baseline, in both QOL scores was observed in all subgroups at three months, and in all subgroups at eight months except IGHD, where a trend towards improvement in the AGHDA score was observed but failed to reach significance. The mean improvement in the PGWB following GH therapy was not significantly different between subgroups. Multiple linear regression analysis confirmed baseline PGWB and AGHDA scores to be the most important variable in prediction of the level of improvement in respective scores following GH therapy. Age of onset was also observed to be a significant determinant of the PGWB scores following GH therapy (P = 0.02), the CO cohort experiencing the greater improvement. A similar relationship between age of onset and AGHDA scores was not observed (P = 0.22). CONCLUSIONS: Baseline QOL as assessed by self-rating questionnaires is influenced by the age of onset of the GH deficiency, adult onset patients expressing the greater distress. Improvements in QOL scores are influenced by both baseline score and to a lesser extent the age of onset of GHD, the greater improvement being observed in childhood onset patients. The degree of improvement was observed to be independent of gender, pathology and number of pituitary hormone deficits. In a cohort selected by subjectively impaired QOL, we have demonstrated childhood onset GHD patients perceive themselves to have less impairment of QOL pretreatment. In contrast to previous data in unselected cohorts, however, we have shown that those childhood onset GHD patients in whom QOL is significantly reduced, show a capacity for improvement that is equal to, if not greater, than that seen in adult onset-GHD patients.

Adolescent↗
PubMed2002

The effect of long-term untreated growth hormone deficiency (GHD) and 9 years of GH replacement on the quality of life (QoL) of GH-deficient adults.

BACKGROUND: Quality of life (QoL) is reduced in GH-deficient adults compared with the normal population. Further support for the role of GH in the maintenance of QoL is derived from short-term studies of GH replacement in severely GH-deficient adults; these have predominantly reported beneficial effects, although the degree of improvement has often been modest. To date, however, there are few data to demonstrate whether this beneficial effect on QoL is maintained in the long term. PATIENTS AND METHODS: This study consisted of the follow-up of 85 GH-deficient adults who completed the Nottingham Health Profile (NHP) and the Psychological General Well-Being Schedule (PGWB) self-rating questionnaires in 1992, as part of a 12-month double-blind randomized study of GH replacement. In 2001 we attempted to contact all 85 patients and asked them to complete the two questionnaires again. Follow-up data were obtained in 61 patients. The findings were analysed according to whether the individual had received GH continuously since completion of the initial study, received no further GH replacement, or received GH replacement for only part of the intervening time. Both the NHP and the PGWB give a total score and subsection scores for six specific areas of QoL. A high score correlates with increased morbidity in the NHP, and with reduced morbidity in the PGWB. RESULTS: Fifty-nine patients completed the NHP at both time points. The patients who continued GH (n = 17) had significantly greater morbidity at baseline than patients who opted to discontinue therapy (n = 27), as reflected by the higher scores overall (5.7 +/- 4.0 vs. 2.8 +/- 3.5; P = 0.01) and in the energy subsection (47.0 +/- 34.7 vs. 13.2 +/- 28.6; P < 0.001). Over the study period energy levels improved in the patients who remained on GH therapy (47.0 +/- 34.7 vs. 25.7 +/- 31.0; P = 0.04). By contrast, a deterioration in the physical mobility subsection (2.4 +/- 5.4 vs. 8.2 +/- 16.7; P = 0.04) occurred in the patients who did not continue GH therapy, and no change occurred in the energy subsection. In the 36 patients who completed the PGWB significant differences were observed at baseline between patients who received GH replacement continuously (n = 10) and those who discontinued therapy (n = 21) in the overall score (67.2 +/- 14.1 vs. 86.8 +/- 14.7; P = 0.001); and in the subsections for anxiety (P = 0.04), depression (P = 0.04), well-being (P = 0.001), self-control (P = 0.04) and vitality (P < 0.001); the greater morbidity at baseline being observed in the patients who continued GH replacement. In the patients receiving GH continuously for 9 years the vitality subsection score improved significantly (7.7 +/- 2.4 vs. 12.5 +/- 3.2; P = 0.003), whereas no change in vitality score occurred in patients who did not continue GH therapy. The change in the energy subsection of the NHP and vitality subsection of the PGWB over the 9 years of the study were significantly different between the patients who opted to continue GH replacement and those who discontinued therapy (P = 0.008 and P < 0.001, respectively). CONCLUSION: During this 9-year study, small but significant declines in health were observed in GH-deficient adults who remained untreated. By contrast, the patients who received GH continuously experienced improvements in energy levels while all other areas of QoL were maintained. The beneficial effects of GH on QoL are therefore maintained with long-term GH replacement and obviate the reduction in QoL seen over time in untreated GH-deficient adults.

Adult↗