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Title: Evaluation of fluoxetin treatment effectiveness on vasomotor symptoms and body weight reduction among woman of menopausal age
Abstract:
Vasomotor symptoms can constitute serious problems which affect a great number of women in menopausal age. More than 80% of women complain about such problems existing for the period of more than one year. 25% of them assessed the problems as severe and therefore began looking for treatment. Hormonal therapy (HT) is usually applied in such cases. HT alleviates vasomotor symptoms up to 80%. Some women who are weary of HT or have contraindications against using it are looking for non-hormonal treatment. Women who have a history of breast cancer or are in a high risk population are the main group of patients in need of other options. Many alternative treatments have been investigated. The data have demonstrated that SSRI therapy can be effective and relieves vasomotor symptoms more effectively than placebo. Weight gain constitutes another problem of women in menopausal age. Obesity is a growing worldwide problem. There are a lot of health consequences of obesity. Pharmacologic therapy is recommended to obese patients who have failed to achieve their weight loss goals through diet and exercises alone. Menopausal women try to find successful therapy, which would help them decrease weight and maintain the effects. In our study we try to find out whether fluoxetine constitutes efficient treatment of both vasomotor symptoms and obesity. These problems have not been analyzed as end p ; oints together. We designed a randomized, double-blinded 12-week trial. All participants were randomly assigned to receive either fluoxetine (treatment) or placebo (control). Out of 100 patients enrolled in the study, 48 were randomized to control and 52 to treatment group. 79 patients have completed the study (treatment, n=45; control, n=34). After randomization and before medication, each woman was asked to complete the Green Climacteric Scale and MRS scale as well as undergo anthropometric measurements such as circumferences of hips and waist, weight and one blood test. Identical questionnaires and measurements were conducted during follow-up visits 4, 8 and 12 weeks after initiating treatment. The women were asked to write down potential adverse effects. The subjects were asked not to change their lifestyle, or take on new excessive exercise programs or diet. Diet was not an intended co-intervention during this examination. The results has undergone statistical analysis. Comparison of both groups regarding the influence of fluoxetine and placebo on body mass in the course of the study In case of patients’ body mass the variables of time (p<0,001) and interaction with method of treatment (p<0,001) have proved to be statistically significant. In case of the group treated with fluoxetine significant body mass loss occurred already in the beginning of treatment (p<0,00 ; 1; measurement No. 1 after beginning of treatment vs. measurement No. 0 before beginning treatment). This was followed by further body mass loss (p<0,01; measurement 2 vs. 1). Lower body mass was stable after the following measurement, however the difference between 3rd and 2nd measurements was not statistically significant (p=0,28). The group of patients taking placebo also displayed a small but significant loss of body mass. The observed difference was visible in measurements 0 and 3 (p<0,01). Comparison of both groups regarding the influence of fluoxetine and placebo on menopausal symptoms using the Greene’s Climacteric Scale, overall results Similarly to the results received from the Greene’s Climacteric Scale, both time and type of used treatment (fluoxetine vs. placebo) were significant as far as the received results are concerned . In the group of patients treated with fluoxetine a significant drop of results occurred immediately after initiation of treatment (p<0,001) compared to results from before treatment. This was followed by stabilization and the result of the following measurements were not significantly different (p=0,30 to p=0,95). Never the less, they were still lower than the results from before the treatment began (p<0,001). In case of patients taking placebo there were no significant differences between the results in individual measurements (p=0.90 to p ; =1,00). The results of women treated with fluoxetine were significantly lower (p<0,05) in the 2nd and 3rd measurement after treatment when compared to the results of the placebo group measured at the same periods of time The results obtained in the subgroup of symptoms A of the Green’s Climacteric Scale became significantly lower as the study progressed (p<0,001), and the drop was significantly faster in the group taking fluoxetine than placebo (p<0,001) . The group of women treated with fluoxetine already in the first measurement after the drug was introduced displayed a significant (p<0,001) drop of results in the said scale. On the other hand, in case of women taking placebo a significant (p<0,05) drop of result took place only after the second measurement. The objective of the study was to evaluate the effectiveness of fluoxetine for treatment of vasomotor symptoms and weight reduction. In the present study we focused on healthy women, who suffer from obesity. The aetiology of vasomotor symptoms (hot flashes and night sweating) is not clear. H. H. G. Berendsen’s hypothesis established the role of serotonin in initiating hot flash events. Berendsen suggested the potential role of SSRI in diminishing the severity of vasomotor symptoms. Available studies on the SSRI referred mostly to women with breast cancer history or in high risk group. The meta-analysis from 2006 ev ; aluates only 6 studies on newer antidepressants, indicating their potential efficacy. Only 2 studies evaluated the influence of fluoxetine on vasomotor symptoms, and only one of them assessed healthy women. The study was designed for 12 weeks. The fastest decrease of menopausal symptoms severity was observed in the first 4 weeks (p<0,001). Within the next few weeks the symptoms were further reduced however the results between 2nd and 3rd measurements were not statistically significant (p=0,3 to p=0,95). Therefore it seems plausible that this therapeutic option might be particularly useful in short term therapy. Additionally, studies of long-term (52 weeks) use of fluoxetine prove that after some time anorectic effect of the drug is no longer noticeable and patients begin gaining weight. This may be related to changes in receptors and neurotransmitters in the satiety and hunger centre. Admittedly fluoxetine influences appetite. The relation between 5-HT and satiety control has been well documented on animal models. Destroyed serotoninergic neurons in the central nervous system or blocked neuronal synthesis of 5-HT cause increased food consumption. Administration of 5-HT or its precursor cause diminished size and quantity of eaten meals. Throughout the study patients in both groups lost weight. Patients in treatment group lost significantly more weight and the differences betw ; een individual measurements have reached statistical significance. Body loss ratio in the placebo group was clearly slower, however after 12 weeks it also proved to be statistically significant compared to the first measurement in the placebo group (p<0.01). This may suggest that patients did attempt additional intervention. Despite the fact that diet was not intended as patients’ co-intervention, it cannot be definitely excluded that patients, satisfied with initial success, did attempt some form of additional intervention such as diet or physical exercise. This constitutes a limitation of our study. Nonetheless, the tendency noticeable throughout the study indicates that fluoxetine is an efficient drug which lowers the appetite by stimulating the central nervous system. It is intriguing how some patients especially in the fluoxetine group significantly lost weight, whereas others in the same group gained weight. Perhaps it is connected with the relatively low dose of the drug (20mg). Other studies of the influence of fluoxetine on body mass used larger doses (up to 80mg). Discontinuation level of 21% mainly referred to patients from the placebo group perhaps they were discouraged by the lack of expected results. A considerably short observation period can be a limitation, the tendency regarding weight loss and decreased menopausal symptoms is significant, however the result w ; as gradually lower as the therapy progressed. The problem regarding weight loss to a great extent involves lack of sufficiently strong motivation in patients. Many a time, during various types of treatments which fail to bring about desired results, patients lose what in a sense motivates them to further efforts. Nothing motivates our actions as strongly as success achieved in the process, regardless how it is measured. Therefore the form of therapy introduced by this study has become an impulse for many patients to continue implementing changes for the better. Lower body weight and waist circumference should translate into decreased potential risk of cardio-vascular disease and their consequences for the health.
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Last modified:
Mar 15, 2023
In our library since:
Jun 22, 2022
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http://dl.cm-uj.krakow.pl:8080/publication/4746
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| Edition name | Date |
|---|---|
| ZB-113521 | Mar 15, 2023 |
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