Current medical research and opinion
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Objectives: Subcutaneous injection of botulinum toxin-A (sBONT-A) is a novel treatment for peripheral neuropathic pain. While its analgesic effects are well documented, this treatment is often not comfortable and fails in patients who show signs of sensory loss but rarely allodynia. There are some case reports about perineural BONT-A injection (pBONT-A) which could be an alternative approach. ⋯ Based on these results, we suggest that future parallel design trials on pBONT-A need to include at least 84 patients. Discussion: Ultrasound-guided pBONT-A injection seems to be a safe treatment leading to a sufficient pain relief for some months without sensory changes. Surprisingly, pBONT-A showed a pronounced analgesic effect also in patients without signs of hyperalgesia.
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Objectives: Pathological stage III melanoma patients have variable clinical presentation and outcome when divided by substages, and the number of metastatic lymph nodes is the most significant independent factor. We aimed to determine the clinical features and natural course of node positive melanoma, such as first relapse and final outcome, and other factors influencing them. Methods: A total of 362 node positive melanoma patients were included in the study and reviewed retrospectively. ⋯ Five- and 10 year overall survival (OS) rates were 49% and 40%, respectively. Older age, nodular histopathology, higher mitotic rates and relapse of disease (p = .001) were the independent variables that were inversely correlated with OS for all patients. Conclusion: Comparative analyses of node positive melanoma suggested that there was not only a remarkable heterogeneity in the recurrence and survival rates but also a distinctive pattern among independent prognostic indicators in accordance with the severity of nodal involvement.
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Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) plus the probiotic Lactobacillus rhamnosus GG (eHCF plus LGG; Nutramigen* LGG®) compared to an eHCF alone as first-line dietary management for Immunoglobulin E (IgE)-mediated cow's milk protein allergy (CMPA) in the UK. Methods: Decision modelling was undertaken to estimate the probability of IgE-mediated cow's milk allergic infants being symptom free (i.e. not experiencing urticaria, eczema, asthma or rhinoconjunctivitis) and developing tolerance to cow's milk by 5 years. The model also estimated the cost (at 2016/2017 prices) of healthcare resource use funded by the UK's National Health Service (NHS) over 5 years after starting a formula, as well as the relative cost-effectiveness of the two dietary formulae. ⋯ Additionally, the probability of acquiring tolerance to cow's milk was estimated to be 0.94 and 0.66 among infants who were originally fed eHCF plus LGG and an eHCF alone, respectively. The estimated total healthcare cost over 5 years of initially feeding infants with eHCF plus LGG was less than that of feeding infants with an eHCF alone (£4229 versus £5136 per patient). Conclusions: First-line management of newly diagnosed infants with IgE-mediated CMPA with eHCF plus LGG instead of an eHCF alone improves outcome, releases healthcare resources for alternative use, reduces the NHS cost of patient management and thereby affords a cost-effective dietetic strategy to the NHS.
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Multicenter Study Observational Study
VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand.
Objective: VITALITY, a 6-month, multicenter, prospective, observational study, assessed the effects of originator adalimumab (HUMIRA) on health and disability outcomes in patients with Crohn's disease (CD), rheumatoid arthritis (RA), or psoriasis treated in routine clinical practice in New Zealand (NZ). Methods: Biologic-naïve adults initiating adalimumab in accordance with NZ funding requirements were recruited. The primary endpoint was 6-month change from baseline in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score in all participants completing the study (full analysis set). ⋯ No new adalimumab safety signals were observed. Conclusions: Health and disability outcomes improved significantly after 6 months of adalimumab use in NZ patients with severe CD, RA, or psoriasis. Clinicaltrials.gov: NCT02451839.
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Comparative Study
Safety of naproxen compared with placebo, ibuprofen and acetaminophen: a pooled analysis of eight multiple-dose, short-term, randomized controlled studies.
Objective: To quantify the rate of adverse events reported with naproxen compared with placebo, ibuprofen and acetaminophen at non-prescription doses in multiple-dose, multi-day (7-10 days) duration clinical trials and further contribute towards current knowledge regarding the safety profile of naproxen. Methods: Safety data were retrospectively collected from eight randomized, controlled trials that included subjects exposed to a fixed dosing regimen of 220-750 mg naproxen per day over 7-10 days. All data on adverse events and their duration, severity and possible relationship to the study drug were taken from the clinical study reports. ⋯ Most events were mild to moderate. The most frequently reported adverse events in all groups were related to the gastrointestinal system (most commonly dyspepsia with naproxen), with no differences between groups. Conclusions: Our pooled analysis did not find an increased risk of adverse events with short-term use of non-prescription doses of naproxen compared with placebo, or compared to other common analgesics.