Aims/hypothesis Our aim was to evaluate the safety and efficacy of a planned therapeutic withdrawal of all antihypertensive and diuretic medications, on commencing a formula low-energy diet replacement, targeting remission of type 2 diabetes. Methods Post hoc analysis of changes in BP, antihypertensive medication prescriptions and symptoms during the initial total diet replacement phase was performed in the intervention arm of the Diabetes Remission Clinical Trial (n = 143) and in the subset (n = 69) who discontinued antihypertensive medications at the start of total diet replacement. The Counterweight-Plus total diet replacement provided about 3470 kJ/day (830 kcal) with automatic reductions in all nutrients, including sodium, to achieve marked negative energy balance and rapid weight loss over 12–20 weeks, with regular BP monitoring and an antihypertensive reintroduction protocol based on current clinical guidelines. Results Of 143 intervention group participants who commenced total diet replacement, 78 (55%) were on treatment for hypertension at baseline. The overall mean BP fell significantly from the start of total diet replacement (week 1) and was significantly lower at week 20, after total diet replacement finished, and also at 12 and 24 months. Of the 78 participants previously on treatment for hypertension, 65 (83%) stopped all antihypertensive and diuretic medications as per protocol, and four (5%) stopped some drugs. These 69 participants experienced no immediate (within the first week) change in BP, but their mean BP fell significantly from 9 weeks. No excessive rises in BP were recorded in individuals, but antihypertensive medications were reintroduced during total diet replacement to manage raised BP for 19/69 (27.5%) participants, mostly within the first 3–7 weeks, despite some weight loss. Reintroduction of antihypertensive medications was necessary for 5/19 participants previously on one drug, and for 14/19 previously on two or more drugs. Of the 69 who stopped antihypertensives, 19 (28%) remained off medications at 24 months. Among the 53 participants who achieved sustained remissions of diabetes at 24 months (with a mean weight loss of 11.4 kg), 31 had been previously treated for hypertension. Twenty-seven stopped medication at baseline, and 15/27 required reintroduction of antihypertensive medications. Mild to moderate dizziness, suggesting some postural hypotension, was reported during total diet replacement by 51 participants, 15 of whom had recorded dizziness at baseline prior to starting total diet replacement, with nine of these on antihypertensive or diuretic medications. Conclusions/interpretation Replacing antihypertensive medications with a 3470 kJ/day (830 kcal) diet to induce weight loss reduces BP substantially and may increase mild dizziness. It is safe to stop antihypertensives, but BP should be monitored regularly, particularly for those taking two or more antihypertensives, as over two-thirds will require reintroduction of some medications. Long-term support to maintain weight loss is vital. Trial registration ISRCTN registry, number 03267836. Graphical abstract
Purpose: The aim of this randomized controlled clinical trial was the evaluation of alveolar ridge preservation using a composite of bioactive glass and platelet rich fibrin either alone or combined with melatonin in chronic periodontitis patients. This aim was fulfilled through: Clinical assessment and radiographic assessment. Subjects and Methods: A total of thirty extraction sockets in 29 patients were randomly divided into three groups; control group treated by atraumatic extraction alone, test1 group (application of bioactive glass mixed with PRF) and test 2 group (application of bioactive glass mixed with PRF and melatonin gel). The clinical parameters recorded at baseline, 3 months and 6 months after treatment. Cone beam tomography radiographs used to measure width of socket at base line and 6months post operatively. Results: By clinical assessment both group II and group III showed significant increase in length and width of alveolar ridge with significant difference between the two groups in the whole study period. Radiographically; both group II and group III showed a significant increase in all parameters by time, while control group, there was a significant decrease at the end of the study period. Conclusion: Within the limits of this study: The composite use of bioglass, Prf & melatonin in group III reflected the best clinical, and radiographic results.
To evaluate the safety and efficacy of surgeon-tailored polypropylene mesh (STM) through a needle-less single incision mini-slings (SIMS) vs. standard trans-obturator tape (TOT) in the treatment of female stress urinary incontinence (SUI). Methods: We conducted an open-label randomized controlled trial that included women with SUI. Eligible women were randomized in a 1:1 ratio to receive either standard TOT or SIMS techniques. All procedures were performed using a surgeon-tailored polypropylene mesh and monofilament tape. Results: A total of 60 women were included. The mean operative time was significantly longer in the standard TOT group. The mean bleeding rate was significantly higher in the standard TOT group (87.6 ± 10.6 cc) compared to the SIMS group (60.0 ± 8.1 cc). There was no urethral injury in both groups. Transient thigh pain occurs in 12 cases (40 %) of the standard TOT and no cases in the SIMS group (p < 0.001). After three months, there was no significant statistical difference between the result of the two groups as regard to cure or improvement rate. No failed cases were reported in both groups (p = 0.64). Likewise, there was no significant difference between the two groups regarding patients' satisfaction rate. Conclusions: SIMS was not inferior to standard TOT. STM SIMS is a mini-invasive, relatively safe, reproducible, easy to perform in a short time, with excellent patient tolerability and minimal pain, allowing early return to work and economically effective surgical procedure for the treatment of female stress urinary incontinence.
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