Safety and efficacy assessment of a synthetic porcine recombinant corticotrophin for the ACTH stimulation test in healthy cats.

Porcine adrenocorticotrophic hormone (ACTH) has been considered valid for the ACTH stimulation test (ACTHST) in humans and dogs; however, its safety and efficacy for use in cats are unknown. Also, the equivalence between 5 µg/kg and 125 µg/cat dose of synthetic corticotropin (1-24 ACTH - cosyntropin/tetracosactide) is assumed for ACTHST in cats. This study evaluated the safety and effectiveness of different porcine recombinant ACTH doses for the ACTHST in healthy cats and its equivalence with tetracosactide. The study was divided into two arms. The first evaluated safety and equivalence of intravenous 1 µg/kg, 5 µg/kg, or 125 µg/cat porcine ACTH in seven healthy cats for the ACTHST evaluating basal and post-ACTH androstenedione, aldosterone, cortisol, and progesterone concentrations. In the second arm, the equivalence of the 125 µg/cat porcine ACTH dose was evaluated compared to results obtained using 125 µg/cat of tetracosactide in ten healthy cats regarding cortisol responses. In all tests, several cat-friendly strategies were adopted, and the ACTHST protocol involved basal and 60-minute post-ACTH blood sampling and intravenous ACTH injection. No adverse reactions were documented, and no tested cat showed any complications during the study. No porcine ACTH tested dose significantly increased androstenedione secretion. In contrast, all tested doses were able to increase progesterone concentration significantly (P < 0.05), and Δ-progesterone in response to 5 µg/kg or 125 µg/cat was considered equivalent (P > 0.99). The 125 µg/cat dose promoted greater responses for both cortisol and aldosterone, characterized by Δ-cortisol (P = 0.009) and Δ-aldosterone (P = 0.004). Despite equivalent Δ-cortisol results in response to 5 µg/kg or 125 µg/cat (P = 0.18); post-ACTH results of cortisol in response to 5 µg/kg only approximate statistical significance when compared with basal (P = 0.07). Porcine ACTH and tetracosactide significantly increased post-ACTH cortisol concentration (P < 0.0001) while the Δ-cortisol was slightly greater in response to the porcine ACTH (P = 0.006). These results suggest porcine ACTH could be an alternative source of corticotropin for the ACTHST in cats; however, maximum corticoadrenal stimulation seemed more reliable in response to a 125 µg/cat regarding cortisol and aldosterone.

Applying children's enuresis treatment with amitriptyline for canine post-spaying urinary incontinence: A pilot estriol-controlled randomized clinical trial.

Urinary incontinence due to urethral sphincter mechanism incompetence (USMI) affects up to 20% of bitches that undergo spaying surgery. Amitriptyline is a tricyclic antidepressant whose urinary retention is a reported side effect. This study aimed to assess the efficacy and safety of amitriptyline when compared to estriol orally. Fifteen bitches with a clinical diagnosis of post-spaying UI were evaluated during 60 days in a non-blinded randomized clinical trial. All patients were enrolled after clinical evaluation consisting of anamnesis, physical examination, and complementary exams (complete blood count, biochemical parameters, urinalysis, and abdominal ultrasound). The amitriptyline (AMT) group consisted of 8 bitches, which received the initial dose of 1 mg/kg every 12 h, whereas the estriol (EST) group consisted of 7 bitches which were initially treated with 1 mg/animal every 24 h. Patients underwent clinical evaluation at 7 days, and then at 21 and 60 days of treatment to assess safety and efficacy, as well as adjustments of dose when necessary. A urinary incontinence scale was used to assess the level of incontinence and therapeutic response to treatment. During the period of the study, estriol was fully effective in 71% of cases and amitriptyline in 62%. Both drugs proved safe in the medical treatment of USMI, with adverse effects such as somnolence (AMT, n = 5/8) and male attraction (EST, n = 1/7). The results support the amitriptyline recommendation as a substitute for estriol in USMI treatment.

Effect of a structured early mobilization protocol on the level of mobilization and muscle strength in critical care patients: A randomized clinical trial.

BACKGROUND: Few studies have evaluated the effects of structured early mobilization (EM) protocols on the level of mobilization in critical care patients. OBJECTIVE: To evaluate the impact of a structured EM protocol on the level of mobilization, muscle strength, and the level of activities of daily living (LADL) after intensive care unit (ICU) and hospital discharge. METHODS: This randomized clinical trial (U1111-1245-4840) included adults patients who were randomized into two groups: intervention (n = 40) and control (n = 45). The intervention group underwent conventional physiotherapy and structured EM protocols, and the control group underwent conventional physiotherapy. The level of mobilization from 0 (no mobilization) to 5 (walking), muscle strength (Medical Research Council scale), LADL (Katz Index), and incidence of complications were evaluated. RESULTS: The level of mobilization from day 1 to day 7 increased in the intervention group compared with the control group (p < .05). Muscle strength did not change during the protocol in the intervention and control groups {day 1 [effect size (r) = 0.15, p = .161], at ICU discharge [r = 0.16, p = .145], and after ICU discharge [r = 0.16, p = .191]}. The LADL did not differ between the intervention and control groups after ICU discharge [4 (1-6) vs. 3 (1-5), p = .702] or 30 days after hospital discharge [6 (5-6) vs. 6 (5-6), p = .945]. The structured EM protocol was safe, and no severe complications were observed during the protocol. CONCLUSION: A structured EM protocol increased the level of mobilization without improving muscle strength and the LADL compared with conventional physiotherapy.

Association between fear of falling and a history of falls in patients with end-stage renal disease on hemodialysis.

INTRODUCTION: Hemodialysis patients have complications that increase fear of falling (FOF). This study evaluated the association between FOF and a retrospective history of falls in hemodialysis patients and investigated the ability of the Fall Efficacy Scale-International (FES-I) to discriminate fallers from nonfallers. METHODS: A retrospective study was conducted with 183 patients to investigate the history of falls in the last 12 months and to evaluate FOF by the FES-I. RESULTS: The univariate linear regression model showed that the FES-I score was significantly associated with a history of falls (p = 0.01). After adjustment for potential confounders, this association remained significant (R2  = 0.19, p < 0.001). The FES-I score showed an area under the curve of 0.660 with a cutoff point of 25 (sensitivity-61.8%; specificity-62.2%). CONCLUSION: FOF was associated with a history of falls in the 12-month period in hemodialysis patients, and FOF assessed by the FES-I was able to discriminate fallers from nonfallers.

Spirituality and religiosity are associated with physical and psychological status in patients with chronic obstructive pulmonary disease.

BACKGROUND: Management strategies that incorporate spirituality and religiosity (S/R) have been associated with better health status in clinical populations. However, few data are available for patients with chronic obstructive pulmonary disease (COPD) to improve the traditional disease-model treatment. AIMS: The objectives of this study were to evaluate the association between S/R and physical and psychological status in patients with stable COPD. DESIGN: This is a cross-sectional study. METHODS: Religiosity, spiritual well-being and S/R Coping were measured. Physical status was evaluated with the activity of daily living, dyspnoea and the impact of the disease. Psychological status was assessed with anxiety and depression symptoms and quality of life. Spearman correlation coefficients were calculated, multivariate linear regression was applied in the analyses. This study is reported following the STROBE recommendations. RESULTS: Seventy-two patients with stable COPD (male 58%, aged 68 ± 9 years, forced expiratory volume in 1s (FEV1 ) of 49.2 ± 19.6% predicted) were included. There was no association between S/R and activity of daily living. However, higher spiritual well-being and lower Negative S/R Coping was associated with reduced dyspnoea and burden of the disease. Increased S/R and lower Negative S/R Coping was also associated with less anxiety, depression and better quality of life. Multivariate linear regression showed that S/R variables explained the physical and psychological health status in people with stable COPD. CONCLUSIONS: Higher spirituality and less negative S/R Coping are associated with reduced dyspnoea, the burden of the disease, anxiety and depression symptoms, and better quality of life in patients with stable COPD. RELEVANCE TO CLINICAL PRACTICE: Understanding how religiosity and spirituality are associated with physical and psychological features in patients with COPD may contribute to the long-term management of this patient population.

Social Participation and Associated Factors in Individuals with Chronic Obstructive Pulmonary Disease on Long-Term Oxygen Therapy.

Long-term oxygen therapy (LTOT) reduces hypoxaemia and mitigate systemic alterations in chronic obstructive pulmonary disease (COPD), however, it is related to inactivity and social isolation. Social participation and its related factors remain underexplored in individuals on LTOT. This study investigated social participation in individuals with COPD on LTOT and its association with dyspnoea, exercise capacity, muscle strength, symptoms of anxiety and depression, and quality of life. The Assessment of Life Habits (LIFE-H) assessed social participation. The modified Medical Research Council dyspnoea scale, the 6-Minute Step test (6MST) and handgrip dynamometry were used for assessments. In addition, participants responded to the Hospital Anxiety and Depression Scale (HADS) and the Chronic Respiratory Questionnaire (CRQ). Correlation coefficients and multivariate linear regression analyses were applied. Fifty-seven participants with moderate to very severe COPD on LTOT were included (71 ± 8 years, FEV1: 40 ± 17%predicted). Social participation was associated with dyspnoea (rs=-0.46, p < 0.01), exercise capacity (r = 0.32, p = 0.03) and muscle strength (r = 0.25, p = 0.05). Better participation was also associated with fewer depression symptoms (rs=-0.40, p < 0.01) and a better quality of life (r = 0.32, p = 0.01). Dyspnoea was an independent predictor of social participation (p < 0.01) on regression models. Restricted social participation is associated with increased dyspnoea, reduced muscle strength and exercise capacity. Better participation is associated with fewer depression symptoms and better quality of life in individuals with COPD on LTOT.

Factors associated with fear of falling in hemodialysis patients.

PURPOSE: Fear of falling (FOF) has important clinical and psychological consequences. This study evaluated the factors associated with FOF in hemodialysis patients and compared with the FOF reported by age-gender matched individuals without chronic kidney disease. METHODS: This cross sectional study included hemodialysis group (n = 60, 55.4 ± 7.6 years, 55.0% male) and control group (n = 40, 55.1 ± 7.5 years, 52.5% male). FOF was assessed by the Falls Efficacy Scale International (FES-I). Physical function was evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest), Timed Up and Go test, 4-m gait speed, isometric handgrip force and 10-repetition sit-to-stand test. The physical and mental components of quality of life was evaluated by 36-Item Short Form Health Survey. RESULTS: The FES-I score was higher in the hemodialysis group compared to the control group (28.2 ± 9.7 vs. 23.3 ± 5.1, p = 0.020). In addition, the prevalence of individuals with a higher concern about falling was greater in the hemodialysis group (41.7 vs. 17.5%, p = 0.033). Multiple linear regression showed that the FES-I score was associated with the Mini-BESTest score and the physical component summary of quality of life (coefficient of determination of 0.51 and an adjusted coefficient of determination of 0.46). CONCLUSION: FOF was associated with poor postural balance and reduced physical component of quality of life in patients on hemodialysis and these patients showed higher FOF compared to individuals without chronic kidney disease.

Comparison between intra-articular ozone and placebo in the treatment of knee osteoarthritis: A randomized, double-blinded, placebo-controlled study.

OBJECTIVE: The aim of the trial was to determine the effectiveness of oxygen-ozone injections on knee osteoarthritis concerning pain reduction, joint functional improvement, and quality of life. METHODS: In this randomized, double-blinded, placebo controlled clinical trial, 98 patients with symptomatic knee osteoarthritis (OA) were randomized into two groups receiving intra-articular 20 µg/ml of ozone (OZ) or placebo (PBO) for 8 weeks. The efficacy outcomes for knee OA were the Visual Analogue Scale (VAS), Lequesne Index, Timed Up and Go Test (TUG Test), SF-36, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Geriatric Pain Measure (GPM). RESULTS: After 8 weeks of treatment, ozone was more effective than the placebo: VAS [mean difference (MD) = 2.16, p < 0.003 (CI 95% 0.42-3.89)], GPM [MD = 18.94, p < 0.004 (CI 95% 3.43-34.44)], LEQ [MD = 4.05, p < 0.001 (CI 95% 1.10-7.00)], WOMAC (P) [median of diff = 9.999, p = 0.019 (CI 95% 0.000-15.000)], WOMAC (JS) [median of diff = 12.499, p < 0.001 (CI 95% 0.000-12.500)], WOMAC (PF) = [median of diff = 11.760, p = 0.003 (CI 95% 4.409-19.119)], TUG (no statistical difference) and SF-36 (FC) [(MD = -25.82, p < 0.001 (CI 95% 33.65-17.99)], SF-36 (PH) [MD = -40.82, p < 0.001 (CI 95% -54.48-27.17)], SF-36 (GSH) [MD = -3.38, p < 0.001 (CI 95% -4.83-1.93)], SF-36 (SA) [MD = 2.17, p < 0.001 (CI 95% -19.67-8.24), SF-36 (EA) [MD = -35.37, p < 0.001 (CI 95% -48.86-21.89)]. Adverse events occurred in 3 patients (2 in the placebo group and 1 in the ozone group) and included only puncture accidents. CONCLUSIONS: The study confirms the efficacy of ozone concerning pain relief, functional improvement, and quality of life in patients with knee osteoarthritis. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register ISRCTNR55861167.