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- Wilson, I., et al.
(författare)
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Management of gastroduodenal ulcers and gastrointestinal symptoms associated with nonsteroidal anti-inflammatory drug therapy : A summary of four comparative trials with omeprazole, ranitidine, misoprostol, and placebo
- 2001
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Ingår i: Current Therapeutic Research. - 0011-393X .- 1879-0313. ; 62:12, s. 835-850
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Tidskriftsartikel (refereegranskat)abstract
- Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of systemic diseases such as rheumatoid arthritis but are associated with a range of adverse gastrointestinal (GI) side effects, including dyspepsia, peptic ulcer, and ulcer complications. Several studies have compared the relative efficacy and tolerability of omeprazole, ranitidine, and misoprostol in the management of NSAID-associated GI adverse events. Objective: The purpose of this paper is to summarize and evaluate the results of 4 clinical studies that compared the efficacy and tolerability of omeprazole, misoprostol, and ranitidine in the acute and maintenance treatment of NSAID-associated gastroduodenal ulcers and GI symptoms. Methods: The 4 trials, which included 1822 patients being treated continuously with NSAIDs, studied omeprazole (20 and 40 mg once daily) as acute treatment for healing gastroduodenal ulcers and erosions and as prophylaxis (20 mg once daily) over 3 to 6 months. Comparators were misoprostol 200 µg 4 times daily or ranitidine 150 mg twice daily in the acute phases and misoprostol 200 µg twice daily, ranitidine 150 mg twice daily, or placebo in the prophylactic phases. Results: Gastric and duodenal ulcer healing rates were higher with omeprazole than with either misoprostol (P = 0.004 for gastric ulcers, P < 0.001 for duodenal ulcers) or ranitidine (P < 0.001 for gastric ulcers, P = 0.032 for duodenal ulcers). A significantly larger percentage of patients taking misoprostol had the number of gastric or duodenal erosions reduced from >10 to <5 compared with patients taking omeprazole (P < 0.001), whereas a significantly larger percentage of patients taking omeprazole achieved the same reduction in number of erosions compared with patients taking ranitidine (P = 0.008). More patients taking omeprazole remained in remission than patients taking misoprostol (P = 0.001), ranitidine (P = 0.004), or placebo (P < 0.001). More patients taking misoprostol (16.9%) or ranitidine (14.1%) discontinued treatment because of adverse events, lack of efficacy, or other reasons compared with patients taking omeprazole (9.9% and 10.2% in 2 studies). Conclusions: Omeprazole was more effective in healing and prophylaxis of NSAID-associated gastroduodenal ulceration and symptoms than misoprostol and ranitidine in chronic NSAID users, and was better tolerated than misoprostol.
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| 2. |
- Yeomans, N, et al.
(författare)
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Quality of life in chronic NSAID users : a comparison of the effect of omeprazole and misoprostol
- 2001
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Ingår i: Scandinavian Journal of Rheumatology. - 0300-9742 .- 1502-7732. ; 30:6, s. 328-334
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To compare the impact on quality of life (QoL) of omeprazole and misoprostol during healing, and omeprazole, misoprostol, and placebo during maintenance treatment in chronic NSAID users with NSAID-associated gastroduodenal lesions. Methods: Validated baseline and follow-up QoL questionnaires were completed by 610 patients (healing: after 4.8 weeks: maintenance: after 6 months). Results: Patients with arthritis being treated with NSAIDs have a poor QoL. Rheumatoid arthritis causes more joint problem. and physical mobility limitations than osteoarthritis. Chronic NSAID use causes heartburn and dyspepsia. QoL improved on both treatments (about equally on two general QOL scales), but omeprazole relieved gastrointestinal symptoms more than misoprostol, particularly reflux. abdominal pain and indigestion symptoms, During maintenance, both treatments maintained QoL, but misoprostol induced diarrhoea, Conclusion: QoL in arthritis patient, on chronic NSAID treatment is destroyed. Omeprazole is superior to misoprostol for relief and prevention of NSAID-associated gastrointestinal symptoms allowing continued NSAID treatment without compromising the patients' QoL.
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| 5. |
- Danielsson, Aina, 1953, et al.
(författare)
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Health-related quality of life in patients with adolescent idiopathic scoliosis: a matched follow-up at least 20 years after treatment with brace or surgery.
- 2001
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Ingår i: European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. - 0940-6719. ; 10:4, s. 278-88
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Tidskriftsartikel (refereegranskat)abstract
- No results on long-term outcome in terms of health-related quality of life (HRQL) have previously been presented for patients treated for adolescent idiopathic scoliosis. A consecutive series of patients with adolescent idiopathic scoliosis, treated between 1968 and 1977 before the age of 21, either with distraction and fusion using Harrington rods [surgical treatment group (ST), n=156; 145 females and 11 males] or with a brace [brace treatment group (BT), n=127; 122 females and 5 males] were followed at least 20 years after completion of the treatment. Ninety-four percent of ST and 91% of BT patients filled in a questionnaire comprising the SF-36, Psychological General Well-Being Index (PGWB), Oswestry Disability Back Pain Questionnaire, parts of SRS/MODEM'S questionnaire and study-specific questions concerning the treatment, as a part of an unbiased personal follow-up examination including radiography and clinical examination. An age- and sex-matched control group of 100 persons was randomly selected and subjected to the same examinations. The results showed no differences in terms of sociodemographic data between the groups. Both ST and BT patients had a slightly, but significantly, reduced physical function using the SF-36 subscales, SF-36/Physical Component Summary (PCS) score as well as the Oswestry Disability Back Pain Questionnaire compared to the controls. Neither the mental subscales and the Mental Component Summary (MCS) score of SF-36 nor the PGWB index showed any significant difference between the groups. Forty-nine percent of ST, 34% of BT and 15% of controls admitted limitation of social activities due to their back [P<0.001 ST vs controls, P=0.0010 BT vs controls, and n.s. (P=0.024) ST vs BT], mostly due to difficulties with physical participation in activities or self-consciousness about appearance. Pain was a minor reason for limitation. No correlation was found between the outcome scores and curve size after treatment, curve type, total treatment time or age at completed treatment. Patients treated for adolescent idiopathic scoliosis were found to have approximately the same HRQL as the general population. A minority of the patients (4%) had a severely decreased psychological well-being, and a few (1.5%) were severely physically disabled due to the back.
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| 7. |
- Degl'Innocenti, A., et al.
(författare)
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Measuring treatment satisfaction. A review of randomized controlled drug trials.
- 2004
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Ingår i: Clinical Research and Regulatory Affairs. ; 21:1, s. 39-47
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Tidskriftsartikel (refereegranskat)abstract
- The development of new drugs calls for additional patient-reported endpoints to health-related quality of life and symptoms assessment. Among these, one of the ambition to evaluate treatment satisfaction in clinical trials, since it can be crucial for compliance and must be considered as an important factor when planning treatment. To measure this concept, a range of instruments may be used. The purpose of this study was to investigate which types of instruments for measuring treatment satisfaction are the most frequent in clinical trails. Specifically, we explored whether instruments are single item or questionnaires, and in the latter case, whether the instruments are psychometrically validated or not. We carried out a search of the literature published in English in the period July 1966 to December 2002, looking for controlled trials of treatment satisfaction. Using the Embase and Medline databases, 126 studies were included in this review. The main finding suggests that assessment of treatment satisfaction in clinical trials vary in quality. It is evident that the majority of the studies reviewed rely on single items when measuring treatment satisfaction. Moreover, in cases where questionnaires were applied, psychometric properties were rarely reported or documented. This study highlights the need for developing and improving psychometric documentation of instruments measuring treatment satisfaction, as well as the need for guidance documents.
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| 8. |
- Erling, Ann, 1963, et al.
(författare)
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Psychological functioning in boys of short stature: Effects of different levels of growth hormone secretion
- 2002
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Ingår i: Acta Paediatrica. - 0803-5253. ; 91:9, s. 966-971
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Tidskriftsartikel (refereegranskat)abstract
- Aim: To examine the relationship between growth hormone (GH) and psychological functioning, especially self-perception and well-being, in 60 prepubertal boys of short stature with a wide range of GH levels. Methods: A comparison was made of the well-being and self-perception of children with GH insufficiency, children with idiopathic short stature (ISS), a normative sample and healthy boys with normal stature. Results: Children with GH insufficiency had a more negative perception of their own physical appearance than the normative sample. They perceived themselves as more alert but also more inhibited than both the children with ISS and the healthy boys with normal stature. In comparison with the healthy boys with normal stature they perceived themselves as having more stability. The parents of the boys with GH insufficiency also perceived their children as being more stable compared with how the parents of boys with ISS perceived their children. To elucidate the effects of GH on psychological functioning a multiple regression analysis was performed. Conclusion: The lower the levels of GH the more inhibited were the boys of short stature, as perceived both by themselves and by their parents. The boys with GH insufficiency had a more negative perception of their physical appearance than the normative sample.
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| 9. |
- Glise, Hans, et al.
(författare)
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Health-related quality of life and gastrointestinal disease
- 2002
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Ingår i: Journal of Gastroenterology and Hepatology. - : Wiley. - 0815-9319 .- 1440-1746. ; 17:SUPPL. 1
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Society is changing rapidly, and new aspects need to be considered when evaluating treatment of disease. Health-related quality of life (HRQL) is a relatively new addition to the tools clinicians use to gain a better understanding of the impact of disease and its treatment. The questions 'What is it?', 'How it is measured?' and 'How can the information be used?' are now better understood than a few years ago. Generic instruments to capture HRQL enable a broad assessment of a range of aspects and can be used to make comparisons between different patient populations. Irrespective of the choice of instrument, they can classify the influence of different factors, such as gender, age, general health status and disease severity. Health-related quality of life assessments have been made in many areas of gastroenterology, such as reflux disease, inflammatory bowel disease and irritable bowel syndrome, to describe the burden of illness and the impact of treatment. Health-related quality of life as a prediction of treatment response is another interesting option. Its ability in the context of surgical intervention and outcomes is also emerging even though more work must be done in this area. Health-related quality of life evaluations, as an additional tool in the management of patients, are here to stay. © 2002 Blackwell Publishing Asia Pty Ltd.
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| 10. |
- Herlitz, Johan, 1949, et al.
(författare)
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Impact of a history of diabetes on the improvement of symptoms and quality of life during 5 years after coronary artery bypass grafting.
- 2000
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Ingår i: Journal of diabetes and its complications. - : Elsevier Inc.. - 1056-8727 .- 1873-460X. ; 14:6, s. 314-21
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Tidskriftsartikel (refereegranskat)abstract
- To describe the impact of a history of diabetes mellitus on the improvement of symptoms and various aspects of quality of life (QoL) during 5 years after coronary artery bypass grafting (CABG). Patients who underwent CABG between 1988 and 1991 in western Sweden were approached with an inquiry prior to surgery and 5 years after the operation. QoL was estimated with three different instruments: Physical Activity Score (PAS), Nottingham Health Profile (NHP) and Psychological General Well-Being (PGWB) index. 876 patients participated in the evaluation, of whom 87 (10%) had a history of diabetes. Symptoms of dyspnea and chest pain improved both in diabetic and non-diabetic patients. Diabetic patients scored worse than non-diabetic patients both prior to and 5 years after CABG, but without any major difference in improvement between the two groups with all three measures of QoL. PAS tended to improve more in non-diabetic than in diabetic patients, whereas improvement in NHP and PGWB was similar regardless of a history of diabetes. Diabetic patients differ from non-diabetic patients having an inferior QoL both prior to and 5 years after CABG. Both diabetic and non-diabetic patients improve in symptoms and QoL after the operation. In some aspects improvement tended to be less marked in the diabetic patients but on the whole improvement was similar compared to non-diabetic patients.
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