Tratamiento quirúrgico de la obesidad (Spanish Edition)
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All metformin trials were published between and apart from Freemark Orlistat trials were published between and , but one trial did not have any publications available and only posted results on a clinical trial website and in a conference abstract NCT The duration of interventions ranged from 12 weeks to 17 months, with a mean duration of 28 weeks.
None of the included trials were terminated before regular end; however, two trials that we identified from ClinicalTrials. All trials were performed in an outpatient setting apart from three trials which had both an inpatient and outpatient setting Freemark ; Maahs ; Yanovski The participating population consisted of the following: mainly obese children or adolescents Maahs also included overweight participants. The mean age of the participants in the trials ranged from Two studies required all participants to be postmenarchal Berkowitz ; Prado , while Yanovski only included children who were prepubertal or early pubertal.
Three trials reported glycosylated haemoglobin A1c HbA1c at baseline and the mean HbA1c ranged from 5. The mean BMI at baseline for the interventions groups ranged from The BMI at baseline for the comparator groups ranged from Criteria for entry into the individual trials are outlined in the Characteristics of included studies table. Major trial exclusion criteria were major illnesses such as type 1 or 2 diabetes mellitus or cardiovascular disease; pregnancy; major psychiatric disorders; taking or previously taken medication known to influence body composition or contradiction to the drug therapy; cigarette smoking or alcohol use; obesity associated with genetic disorders; and eating disorders such as bulimia.
All trials included participants who were defined as obese at baseline according to the growth reference they used, apart from one trial Maahs , which also included overweight children in their inclusion criteria. One trial used greater than 85th percentile to include also overweight participants Maahs , while Van Mil used the 97th percentile or greater but also further selected for triceps skinfold thickness 97th percentile or greater for age and sex. In two trials, it was unclear which growth reference charts they were referring to Ozkan ; Prado Participants were diagnosed with type 1 or 2 diabetes mellitus in none of our included trials.
All participants in Wiegand presented with comorbidities at baseline features of the metabolic syndrome ; however, this did not appear to be an inclusion criterion. Eleven trials used metformin as their pharmacological intervention Atabek ; Clarson ; Freemark ; Kendall ; Mauras ; Prado ; Rezvanian ; Srinivasan ; Wiegand ; Wilson ; Yanovski The intervention was administered orally and varied between one and four times per day.
Between trials, the daily dosage of metformin varied between mg and mg, with a mean daily dosage of mg. Seven trials had a titration period, consisting of increasing the number of tablets taken over a period of weeks until the maximum dosage was tolerated Clarson ; Kendall ; Mauras ; Rezvanian ; Srinivasan ; Wilson ; Yanovski In all six trials, the drug was administered orally once daily. The daily dosage of sibutramine varied between 5 mg and 15 mg, with a mean daily dose of 11 mg.
Two trials had a titration period Berkowitz ; Van Mil All trials had a matching placebo as the comparator intervention. The duration of treatment ranged from 12 weeks to 12 months, with a mean treatment duration of 6. The drug was administered orally three times per day and the daily dosage of orlistat was mg in all four trials. No trials gave participants any treatment before the trial. The duration of treatment ranged from six months to 12 months, with a mean treatment duration of 8. One trial also included two additional intervention arms: metformin plus fluoxetine and fluoxetine only Rezvanian The drugs were given by the oral route once daily.
Medical and surgical indications for treatment of morbid obesity
The daily dose of fluoxetine was 20 mg. Participants were also given lifestyle modification treatment before the start of the trial. They also had a titration period. The comparator group received a matching placebo. The duration of treatment was 12 weeks. NCT had no publication attached; however, the trial authors reported both a primary and secondary endpoint on the clinical trials website.
The most commonly defined primary outcomes in trial protocols were change in BMI from baseline and per cent change in BMI. All 21 trials measured raw BMI. All 21 trials reported on whether adverse events occurred. Of those trials which reported adverse events, some reported the total number of adverse events whilst others reported the total number of participants who experienced at least one adverse event. We asked all authors to provide further details on adverse events, such as how many participants experienced severe adverse events and if so, whether they were hospitalised.
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Seventeen trials reported that they measured body fat distribution. Two trials also measured body fat mass by bioelectrical impedance Maahs ; Wiegand Two trials measure changes in physical activity: Kendall used a physical activity questionnaire and Van Mil measured total energy expenditure which accounts for level of physical activity.
Only one trial investigated morbidity defined as illness or harm associated with the intervention Chanoine One trial reported a death from suicide Maahs Berkowitz reported two suicide attempts which did not result in death. No trials assessed participants' views or socioeconomic effects as outcomes.
For a summary of all outcomes assessed in each trial, see Appendix 5.
We excluded trials or trial records after careful evaluation of the full publication. For further details, see Characteristics of excluded studies table. For details on risk of bias of included trials see Characteristics of included studies table. For an overview of review authors' judgements about each risk of bias item for individual trials and across all trials, see Figure 2 and Figure 3.
We investigated performance bias, detection bias and attrition bias separately for objective and subjective outcome measures. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials. Risk of bias summary: review authors' judgements about each risk of bias item for each included trial. It was unclear whether four trials concealed allocation Atabek ; Berkowitz ; Rezvanian ; Wiegand Two trials reported random sequence generation was inadequate; hence, would have likely of introduced bias Maahs ; Ozkan All 21 trials reported both objective and subjective outcomes.
BMI, waist circumference. Ten trials explicitly stated that blinding of the participants, personnel and outcome assessors was undertaken Berkowitz ; Berkowitz ; Franco ; Maahs ; NCT ; Rezvanian ; Srinivasan ; Van Mil ; Wilson ; Yanovski No trials reported that single blinding was undertaken. Only nine trials provided a clinical trial identifier or reference to a protocol Berkowitz ; Berkowitz ; Kendall ; Mauras ; NCT ; Srinivasan ; Wiegand ; Wilson ; Yanovski ; however, we were unable to source the clinical trial entry of one trial Wiegand The remaining trials had unclear risk of reporting bias due to no protocol being available.
Seven trials were at high risk of other biases.
It is important to note that the trials which do not include a power calculation may not be powered to detect differences in their primary outcome. BMI or weight was the primary outcome in all but two trials Mauras ; Wiegand that included a power calculation. Mauras and Wiegand may not have been adequately powered to detect differences in BMI or weight.
With regards to adverse events and the review's secondary outcomes e. Hence, these results should be interpreted with caution.
See: Summary of findings for the main comparison Drug interventions for the treatment of obesity in children and adolescents. For details of baseline characteristics, see Appendix 3 and Appendix 4. We excluded two further trials because of substantial methodological concerns Ozkan ; Prado Most of the BMI data were from the publications, except for Chanoine and Freemark , where raw BMI, SDs or both were not available; hence, we obtained additional data from the trial authors.
Data were reported at six months from baseline apart from one trial Berkowitz , which reported the change in weight at 12 months from baseline. Only three trials had sufficiently long exposure times to evaluate adverse events possibly associated with drug interventions for obesity in children and adolescents: one trial with 39 participants randomised to metformin treatment for weeks Wilson , one trial with participants randomised to sibutramine treatment for 12 months Berkowitz , and one trial with participants randomised to orlistat treatment for 54 weeks Chanoine Adverse events were reported to have occurred in all 11 metformin trials except from Clarson , which reported that metformin was well tolerated, and the author clarified no adverse events occurred.
Gastrointestinal adverse events were most commonly reported with one metformin trial reporting that gastrointestinal adverse events were statistically more prevalent in the intervention group compared to the control group Yanovski However, Wiegand reported such events occurred more frequently in the placebo group. Kendall reported adverse events were more common in the metformin group and were mainly gastrointestinal.
Freemark also reported three participants experienced transient abdominal discomfort or diarrhoea, however so did one placebo participant.
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Wilson reported that the most common adverse events included headache, nausea, vomiting, upper respiratory tract infection and musculoskeletal complaints; however, none were statistically different between the metformin and placebo groups. Furthermore, Freemark reported one case of an exacerbation of migraine and one case of transient nausea in the metformin arm. Nausea was reported in the Srinivasan trial where two participants were unable to tolerate a higher dose of metformin 1 g ; however, they tolerated a lower dose and continued in the trial. Rezvanian reported two cases of headache, two cases of abdominal pain and three cases of loose stools in the metformin arm but they were all minor and tolerable.
Mauras reported metformin was well tolerated and safe, and the author added that the adverse effects between groups were comparable. Prado reported metformin was well tolerated by participants and both groups showed a significant increase in alanine transaminase ALT and aspartate transaminase AST , and a reduction in haemoglobin levels, but these were within the normal ranges. Three of six trials on sibutramine therapy reported on adverse events: one large trial showed tachycardia, dry mouth, constipation, dizziness, insomnia and hypertension were all reported more frequently by sibutramine participants than by placebo participants Berkowitz However, another trial reported that there was no statistically significant difference between changes in heart rate or blood pressure between the sibutramine and placebo groups, although abdominal cramps were significantly higher in the sibutramine group Van Mil All four orlistat trials reported on adverse events: gastrointestinal problems such as fatty stools, oily spotting and fecal urgency, along with headaches and upper respiratory tract infections, were the most common adverse effects.
Maahs also reported that the orlistat group had significantly increased gastrointestinal adverse events e. Symptomatic gallstones were also seen in six orlistat participants which were not seen at baseline five of these participants had lost large amounts of weight. In the trial which included a fluoxetine arm, there were five adverse events with regards to the drug which included three cases of dry mouth and two cases of loose stool; these were all considered as minor and tolerable, and reported as transient Rezvanian Only five trials reported that a serious or severe adverse event occurred Berkowitz ; Chanoine ; Maahs ; NCT ; Wilson ; the remaining 12 trials reported that there were no serious or severe adverse events.
Across all trials the RR for serious adverse events comparing drug interventions with comparators was 1.
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In the metformin trials, only one trial reported that there were serious adverse events and these included one case of appendectomy and one case of leg vein thrombosis in the metformin group, but these were both seen as unrelated to the drug Wilson One sibutramine trial reported that 2.
The placebo group had one case of suicide attempt and one case of depression. It was only the case of cholelithiasis in the orlistat participant which was seen to be possibly related to the trial medication potentially due to rapid weight loss. Another orlistat trial reported two serious adverse events in the placebo group and these were one case of hypoglycaemia and one case of left lower quadrant pain and vomiting NCT In the sibutramine trials, 32 participants 24 in the intervention groups and eight in the control groups left the trial because of adverse events.
Tratamiento quirúrgico de la obesidad patológica
Berkowitz reported that withdrawals due to tachycardia were similar in both groups but hypertension led to the withdrawal of five participants in the sibutramine group versus none in the placebo group. Two cases of attempted suicide one intervention and one placebo also led to discontinuation but were considered unlikely to be related to the trial drug; one case of excessive nausea and vomiting in the sibutramine group also led to withdrawal and may have been related to the drug.
Van Mil had one withdrawal from the sibutramine group due to symptoms of clinical depression and Berkowitz had one withdrawal from the placebo group. In the metformin trials, nine participants withdrew due to adverse events five in intervention group and four in placebo group.
Wilson reported one participant from the metformin group withdrew due to nausea which was probably related to the drug, and a further two metformin and one placebo participants dropped out of the trial due to elevated levels of ALT. In addition, Yanovski reported one participant dropped out of the metformin group due to medication intolerance. Across all trials the RR for discontinuing the trial because of adverse events comparing drug interventions with comparators was 1. All four orlistat trials had dropouts due to adverse events; 28 participants 23 in the intervention group and five in the placebo group.
Maahs reported two participants in the orlistat group discontinued due to adverse events assumed to be gastrointestinal and one participant in the orlistat group committed suicide. NCT reported one participant in the orlistat group and two participants in the placebo group dropped out of the trial due to medication intolerance. For further details, see Appendix 9 , Appendix 10 , and Appendix Eighteen trials reported outcomes which measured body fat distribution.