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- Balldin, J, et al.
(författare)
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A 6-month controlled naltrexone study: Combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence
- 2003
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Ingår i: Alcoholism: Clinical and Experimental Research. - 0145-6008 .- 1530-0277. ; 11
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Tidskriftsartikel (refereegranskat)abstract
- Background: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed. Methods: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups—50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity). The supportive therapy was defined as "the treatment as usual." Alcohol consumption, craving, carbohydrate-deficient transferrin, medication compliance by tablet count, and adverse clinical events were assessed at all visits. Other liver enzymes and psychiatric symptoms were also determined. Results: Ninety-one (77%) patients completed the study, and 92 (78%) were 80% compliant with the medication regimen. A lower percentage of heavy-drinking days was shown in the naltrexone group (p = 0.045) compared with the placebo group, as was a lower craving score (p = 0.029). These results are supported by the lower levels of liver enzyme activities (p < 0.010 for aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltransferase), but not by the carbohydrate-deficient transferrin levels, in the naltrexone group. The mean time period before the first day of heavy drinking was longer for the group treated with CBT (p = 0.010), especially in combination with naltrexone (p = 0.007). Naltrexone was well tolerated, and no patients discontinued the study due to side effects. Conclusions: This study supports the effect of naltrexone in outpatient treatment of alcohol dependence and suggests that a beneficial interaction effect with CBT can be expected.
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| 2. |
- Gustafsson Stolt, Ulrica, 1965-
(författare)
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Aspects in bioethics : Theory and practice in a preventive screening for type 1 diabetes
- 2003
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- From a clinical perspective, as well as societal and global, the present rapid increase in the number of people diagnosed with diabetes is a cause of great concern. Simultaneously, our understanding of the aetiology and pathogenesis of type 1 diabetes (IDDM) remain limited. As of now there are two main approaches to predict the risk of diabetes development: either before by assessing the genetic factors presumably involved, or after by a combination of immunological (IAA, la-2, GAD) and genetic typing. The problems are for example that only 10% of those that develop diabetes have a first-degree relative, and that only a proportion of those with a genetic susceptibility will eventually develop type 1 diabetes Theoretically, prevention of type 1 diabetes can be done at three different levels: primary, secondary and tertiary intervention. However, it is argued that more basic research is needed before effective and safe prevention of type 1 can be introduced. More effort is also needed to identify the environmental factors and potential triggers.Screening for pre-diabetes belong to one of the two type of genetic testing and screening who are generally considered being ethically controversial: predictive, pre-symptomatic testing of children for disorders that do not usually (or where there are uncertainty in progression rate) manifest until adult life, and for which an effective intervention measure is not available. There are risks for creation of distress and anxiety, risks for false-positive results, risks of bypassing informed consent and stigmatisation in case of potential positive results. Discussed are also issues concerning the upholding of individual autonomy, confidentiality and integrity. Simultaneously, it has been argued that the ethical discussion is based on empirical premises that are not sufficiently studied, and that we furthermore lack empirical data.Thematically this thesis belongs to the discipline of descriptive ethics. Our aim was to empirically explore and describe the attitudes and opinions of to, on the basis of the empirical results, point at and discuss issues of bioethical relevance. Our case was ABIS (All Babies In Southeast Sweden) an ongoing prospective longitudinal cohort study for the prediction and prevention of type 1 diabetes (n=17,005). The research design included both qualitative studies: interviews with participating and non-participating mothers, as well as health professionals involved, and a quantitative study: consisting of a designed questionnaire exploring bioethical issues.The interview data indicate a positive attitude both to the ABIS aims and methods and there were less concern over research material, screening results, prevention than often assumed. However, there were concern expressed of issues concerning confidentiality, integrity and restrictions. The reasons for declining participation varied: not wanting their child put through frequent blood testing, fear of "experimentation". The interviews with the staff involved gave important data regarding information procedures and research design, for example the importance of identifying and informing all actors in research involving humans. The questionnaire data support at large earlier empirical findings: a benevolent attitude, less concern over biological samples and written material. Similar concerns were raised of confidentiality and integrity: material used to initial purposes, protection of identity, renewed consent. The majority wanted to know about high-risk status, even though no available intervention. Our interest in information and informed consent was renewed since participants showed a lack of knowledge/understanding regarding basic aims and methods. The problem of informed consent was discussed in the last two papers: the first focusing on the problem of obtaining informed consent, while the second explored potential alternatives of action if we have reason to believe the participants lack a sufficient understanding.
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