Current Issue : April-June Volume : 2025 Issue Number : 2 Articles : 5 Articles
Objective: To investigate the long-term effects of intravenous neridronate treatment in patients with complex regional pain syndrome type 1 (CRPS) in a real-life setting. Methods: We conducted a retrospective study on consecutive CRPS patients treated at our hospital from February 2018 to July 2023. All were treated within three months of the onset of CRPS symptoms. The Patient-Reported Outcomes Measurement Information System 29-Item Health Profile (PROMIS-29) version 2.1 was administered. The main outcome of interest was the evolution of the PROMIS-29 scores from baseline to the last follow-up visit. Patients were categorized as “complete responders” or “non-complete responders”. The association of clinical and demographic variables with a complete response was analyzed using chi-square tests and univariate logistic regression. Results: Thirty-six patients were included, with a median follow-up time of 4.8 years. A significant improvement was noted in the mean numerical pain rating scale (from 6.4 ± 1.9 to 3.1 ± 2.4, p < 0.001), as well as across all PROMIS-29 domains. Physical function improved from 34.2 ± 4.9 to 49.2 ± 9.9, p < 0.001; anxiety from 58.0 ± 6.7 to 49.6 ± 6.9, p < 0.001; depression from 55.3 ± 6.3 to 47.7 ± 6.6, p < 0.001; fatigue from 55.7 ± 7.7 to 50.9 ± 8.7, p < 0.001; sleep disturbance from 53.8 ± 6.8 to 51.3 ± 6.6, p = 0.034; social roles and activities from 41.8 ± 5.2 to 51.8 ± 8.9, p < 0.001; and pain interference from 64.1 ± 5.9 to 52.4 ± 9.9, p < 0.001. The likelihood of achieving a complete response was associated with the male sex, foot or ankle injuries (compared to hand and wrist injuries), and a younger age. No association was found with the type of inciting event or with the body mass index. Conclusions: Our real-life data indicate that early treatment with neridronate leads to substantial benefits in patients affected by CRPS type 1. The strongest responses are seen in young patients, males, and those with lower limb involvement....
Background/Objectives: Bempedoic acid (BA) is a novel cholesterol-lowering agent with proven positive effects on cardiovascular endpoints. Because it is an inhibitor of the hepatic transporters OATP1B1 and OATP1B3, two uptake transporters regulating the intrahepatic availability of statins, it increases the systemic exposure of co-administered statins. This interaction could raise the risk of myopathy. We hypothesized that the drug interaction between BA and statins could be mitigated by staggered administration. Methods: This was a single-centre, open-label, randomized, two-arm, cross-over, phase I drug interaction trial in healthy volunteers (EudraCT-No: 2022-001096-13). The primary objective was to evaluate the OATP1B1 inhibitory effect of BA on exposure to pravastatin after simultaneous administration versus different schedules of staggered administration. A secondary objective was to evaluate the impact of SLCO1B1 genotypes (*1, *5, *15, *37) on pravastatin exposure. Pravastatin was administered in single oral doses of 40 mg at six visits. After a baseline visit with pravastatin alone, BA was dosed to steady state at the approved oral dose of 180 mg. Outcome measures were the area under the plasma concentration–time curve, extrapolated to infinity (AUC∞) and Cmax of pravastatin, 3α- hydroxy-pravastatin (pravastatin 3-iso), and pravastatin lactone, and their geometric mean ratios (GMRs) of different schedules of administration. Log-transformed AUC∞ and Cmax were compared with one-way ANOVA with a 90% confidence interval (CI). Results: Fourteen participants completed all visits. At BA steady state, the GMRs of pravastatin AUC∞ and Cmax were 1.80 (90% CI 1.31–2.46) and 1.95 (90% CI 1.40–2.72), respectively, compared to baseline. There was no significant difference in pravastatin exposure between simultaneous vs. staggered administration. There was no statistically significant difference in pravastatin 3-iso or pravastatin lactone between different administration modes. For the AUC∞ of pravastatin and pravastatin 3-iso, haplotype was a significant source of variation (63% and 20%, respectively), while the type of administration (simultaneous vs. staggered) had no significant impact. Conclusions: The increase in pravastatin exposure with concomitant intake of BA was larger than expected. There was no significant difference between simultaneous vs. staggered administration of pravastatin and BA, possibly due to a population that was heterogenous in SLCO1B1 haplotypes....
Background/Objectives: The present work aimed to compare the effects of the standardized dry extract from the leaves of Monteverdia ilicifolia, popularly known as “espinheira-santa”, with omeprazole in the management of dyspepsia related to gastroesophageal reflux disease (GERD). Methods: A double-blind, randomized, non-inferiority and double-dummy clinical trial was conducted. In total, 86 patients with GERD symptoms were randomized into three groups: Omeprazol (20 mg), M. ilicifolia (400 mg), or M. ilicifolia (860 mg). Capsules were provided by SUSTENTEC®, Pato Bragato, Brazil. It was requested that the participants take three capsules before breakfast and dinner for 4 weeks. Clinical outcomes were obtained at the beginning and end of the study, with GERD symptoms (QS-GERD), the impact of heartburn symptoms on quality of life (HBQOL), and medical records. Results: Overall, 75.6% of the participants showed adherence without any differences among the experimental groups. All groups had significant reductions in both QS-GERD and HBQOL scores. Omeprazole and 400 and 860 mg of M. ilicifolia decreased the QS-GERD total scores at the endpoint compared to the baseline (Chi-square = 129.808; p < 0.0001), as well as individual item scores, such as heartburn intensity (Chi-square = 93.568, p < 0.0001) and heartburn after meals (Chi-square = 126.426, p < 0.0001). There were no differences among the experimental groups after the intervention. Conclusions: Our results suggest that capsules with a standardized dry extract from the leaves of M. ilicifolia at a dosage of 400 or 860 mg are non-inferior to omeprazole, a proton pump inhibitor....
Background/Objectives: Treating chronic wounds incurs substantial costs for Brazil’s Unified Health System. Natural compounds, particularly propolis, are increasingly explored as low-cost alternatives due to their healing properties. Brazilian green propolis, distinct in its chemical composition, has garnered scientific interest. This study aimed to assess the healing effects of green propolis ointment on lower-limb ulcers from leprosy. Methods: A blinded, randomized clinical trial included 18 wounds in two groups: propolis ointment (G1) and control (G2), with evaluations conducted weekly for 61 days. Wound progress was monitored using morphometry and the Pressure Ulcer Scale for Healing (PUSH). Results: No participants exhibited sensitivity to the propolis. G1 showed significant initial healing: average wound area reduction (%) for G1 vs. G2 included 56.38 vs. 6.13–p < 0.001 (week 1); 79.51 vs. 24.16–p = 0.022 (week 4); and 84.33 vs. 39.73–p = 0.051 (week 7). In G1, the PUSH scores decreased from the beginning, whereas in G2, reductions were observed after three weeks. By week 5, 71.4% of G1 wounds scored below eight points, versus 33.3% in G2. G1 wounds exhibited a reduced area and exudate, as well as revitalized granulation tissue without adverse effects. Conclusions: The findings suggest that green propolis ointment is safe, supports tissue repair and may offer cost-effective treatment benefits. Standard wound dressings are selected to support all healing stages, with an emphasis on antimicrobial action, hemostasis to reduce exudate, and pain-reducing and non-irritant properties. Green propolis ointment meets these criteria, offering a cost-effective treatment that accelerates lesion reduction and encouraging leprosy patients to follow the therapeutic regimen....
A double-blind, randomized, and controlled clinical trial with therapeutic intervention was performed at a university hospital in Rio de Janeiro to evaluate whether the addition of Copaifera multijuga Hayne oleoresin to a carboxypolymethylene hydrogel is more effective in skin tear healing than standard treatment. The sample consisted of 84 patients, predominantly men, with a mean age of 67.37 years. These participants were divided into three groups (29 in the intervention group, which received 10% Copaifera oleoresin; 28 in the intervention group, which received 2% Copaifera oleoresin; and 27 in the control group, which received carboxypolymethylene hydrogel). Data were tabulated and analyzed according to the relevant protocols and included only patients who had completed the treatment, while losses were excluded. Weekly follow-ups were conducted to monitor progress. The average healing time differed among the three groups (p > 0.05). There was also a significant difference in healing time between the two intervention groups. Ultimately, CopaibaPolyHy-2 led to significantly faster wound healing than CopaibaPolyHy-10 (p < 0.05). A high increase in granulation and epithelial tissue and a decrease in exudate quantity were observed in the CopaibaPolyHy-2 group. It was not possible to infer whether the wound size reduction differed between the treatments (p > 0.05). At the end of the study, 100% of wounds were healed, with 47,6% healing in week 2 (n = 40). No participants experienced local or serious adverse effects throughout the study period. The current study shows that CopaibaPolyHy-2 is effective, offering a statistically significantly faster healing time, better-quality tissue, and safe treatment for skin tears....
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