Randomized, double-blinded, placebo-controlled pilot study: efficacy of faecal microbiota transplantation on chronic fatigue syndrome.

BACKGROUND: Chronic fatigue syndrome (CFS) is a disabling illness of unknown aetiology. Disruption of gut microbiota may play a role in several neurological disorders. In this study, the effect of faecal microbiota transplantation (FMT) on fatigue severity and health-related quality of life (HRQOL) in patients with CFS was evaluated. METHODS: Randomized, placebo-controlled pilot trial. Patients and researchers were blinded to treatment assignment. 11 patients with CFS (10 female and 1 male, mean age 42.2 years and mean duration of CFS 6.3 years) were randomly assigned to receive either FMT from a universal donor (n = 5) or autologous FMT (n = 6) via colonoscopy. Patients' HRQOL was assessed by using visual analog scale (VAS) and self-reporting questionnaires Modified Fatigue Impact Scale (MFIS), 15D and EQ-5D-3L. Patients' HRQOL was evaluated at baseline, and 1 and 6 months after the FMT. RESULTS: The baseline VAS scores in the FMT and placebo groups were 62.4 and 76.0 (p = 0.29). 1-month scores were 60.0 and 73.7 and 6-months scores 72.8 and 69.5, respectively. Total MFIS scores in the FMT and placebo groups were 59.6 and 61.0 at the baseline (p = 0.80), 53.5 and 62.0 at 1 month and 58.6 and 56.2 at 6 months. Compared to the baseline scores, differences at 1 and 6 months were statistically insignificant both in VAS and in MFIS. The 15D and EQ-5D-3L profiles did not change after the FMT or placebo. FMT-related adverse events were not reported. CONCLUSION: FMT was safe but did not relieve symptoms or improve the HRQOL of patients with CFS. Small number of study subjects limits the generalizability of these results. Trial Registration ClinicalTrials.gov Identifier NCT04158427, https://register. CLINICALTRIALS: gov , date of registration 08/08/2019.

Major Amputation Profoundly Increases Mortality in Patients With Diabetic Foot Infection.

Introduction: An acute diabetic foot infection (DFI) is a serious condition and a leading cause of hospitalization and major amputation in patients with diabetes. Aim of this study was to evaluate the long term survival and risk factors for death and amputation after the DFI requiring hospital treatment. Materials and Methods: A retrospective study included all adult patients hospitalized for DFI treatments during 2010-2014. Overall survival (OS) and amputation free survival (AFS) (without major amputation) was calculated. We performed a Cox regression analysis of several clinical parameters to evaluate the effects of clinical parameters on overall and amputation-free survival. Results: Total of 324 patients with mean age of 66.8 (SD 12.8) years were included. The one- and five-year OS after DFI 81.2% (95%CI 77.5-84.9%) and 49.7% (95%CI 44.8-54.6%), respectively. Major amputation, wound ischemia, older age, and a low glomerular filtration rate reduced the OS after DFI. After a major amputation, the one- and five-year OS was 41.7% (95%CI 13.9-69.5) and 8.3% (95%CI 0.0-24.0%), respectively. Wound ischemia, older age, and elevated C-reactive protein reduced AFS. In contrast, hypertensive medication use was identified as a protective factor. Conclusion: Mortality after a DFI remains high and is significantly increased after a major amputation. Findings highlight the importance of early wound and ischemia management for DFI prevention.

Structured outpatient peritoneal dialysis catheter insertion is safe and cost-saving.

BACKGROUND: Data about outcomes and costs for peritoneal catheter insertion on an outpatient basis are scarce. METHODS: Using patient files, all peritoneal dialysis (PD) catheter insertions performed between 2004 and 2009 in a single-center tertiary care institution for adult patients were located. Patient demographics, complications, hospitalizations, survival, and treatment modality changes were recorded. Procedure-related expenses were valued as actual production costs. RESULTS: During the study period, 106 PD catheters were inserted. In 46 cases, the patients were admitted electively for catheter insertion; 19 catheters were placed during admission for other medical reasons; and 41 catheters were placed on an outpatient basis. Among the study patients (54.7 ± 16.0 years of age), 45% were diabetic. Early (<30 days) catheter-related complications occurred in 22% of patients. The incidences of technique failure and any complication within 90 days were 10% and 38% respectively. The occurrence of complications was not statistically significantly different for outpatients and electively admitted patients. Average costs for catheter insertion were higher in electively hospitalized patients than in outpatients (€2320 ± €960 vs €1346 ± €208, p < 0.000). CONCLUSIONS: Compared with an inpatient procedure, outpatient insertion of a PD catheter results in similar outcomes at a lower cost.

Cerebral small vessel disease and kidney function predict long-term survival in patients with acute stroke.

BACKGROUND AND PURPOSE: Cerebral small vessel disease reflected by white matter lesions (WMLs) in MRI and kidney function reflected by estimated glomerular filtration rate (eGFR) is closely associated in patients without stroke. We studied whether eGFR and WMLs predict long-term survival in patients with acute stroke. METHODS: After exclusion of patients with low eGFR (N=5 [1.3%]; <30 mL/min/1.73 m(2)), consecutive patients with acute stroke (N=378) subjected to MRI and serum creatinine determination were included in the study and prospectively followed-up up to 12 years. RESULTS: Of the patients, 71.2% had died during the follow-up, 152 (40.2%) had moderate (eGFR <60 mL/min/1.73 m(2)), and 226 (59.8%) had normal or mildly impaired eGFR (>or=60 mL/min/1.73 m(2)). Of the patients, 108 (28.6%) had mild, 68 (18.0%) had moderate, and 202 (53.4%) had severe WMLs. In logistic regression analysis adjusted with age and sex, eGFR <60 mL/min/1.73 m(2) was associated with severe WMLs (relative risk 2.77, 95% CI 1.10 to 6.98, P=0.030). In Cox regression survival analysis adjusted with significant covariates, eGFR <60 mL/min/1.73 m(2) (1.30, 95% CI 1.00 to 1.68, P=0.047) and severe WMLs (hazard ratio 1.32, 95% CI 1.02 to 1.71, P=0.033) were associated with poor survival, whereas they were not independent from each other. In further analyses, presence of either eGFR >or=60 mL/min/1.73 m(2) or only mild to moderate WMLs, or both, was associated with improved survival compared with all other combinations. CONCLUSIONS: Cerebral small vessel disease is closely associated with kidney function in patients with acute stroke. Cerebral small vessel disease and kidney function are closely associated predictors of poor poststroke survival.

Alternative strategies to evaluate the cost-effectiveness of peritoneal dialysis and hemodialysis.

BACKGROUND: Dialysis treatment requires considerable resources and it is important to improve the efficiency of care. METHODS: Files of all adult end-stage renal disease (ESRD) patients who entered dialysis therapy between 1991 and 1996, were studied and all use of health care resources was recorded. A total of 138 patients started with in-center hemodialysis (HD) and 76 patients with continuous ambulatory peritoneal dialysis (CAPD). Four alternative perspectives were applied to assess effectiveness. An additional analysis of 68 matched CAPD-HD pairs with similar characteristics was completed. RESULTS: Cost-effectiveness ratios (CER; cost per life-year gained) were different in alternative observation strategies. If modality changes and cadaveric transplantations were ignored, annual first three years' CERs varied between $41220-61465 on CAPD and $44540-85688 on HD. If CAPD-failure was considered as death, CERs were $34466-81197 on CAPD. When follow-up censored at transplantation but dialysis modality changes were ignored, CERs were $59409-95858 on CAPD and $70042-85546 on HD. If observation censored at any change of primarily selected modality, figures were $57731-66710 on CAPD and $74671-91942 on HD. There was a trend of lower costs and better survival on CAPD, the only exception was the strategy in which technical failure of modality was considered as death. Figures of the matched CAPD-HD pairs were very close to the figures of the entire study population. CONCLUSIONS: Compared to HD, CERs were slightly lower on CAPD.

Implications of levels of serum mineral metabolism markers, albumin and C-reactive protein for treatment costs of patients on maintenance dialysis.

BACKGROUND: Secondary hyperparathyroidism, malnutrition and inflammation have been reported to associate with adverse outcomes in dialysis patients. However, little is known about the implications of these conditions for treatment costs. METHODS: The cost data of all adult patients who had entered dialysis therapy at Tampere University Hospital between 1991 and 1996 and had remained on dialysis for at least 1 year were collected. results of measurements of parathyroid hormone (PTH), calcium, phosphorus, albumin and C-reactive protein (CRP) were obtained from the database of the hospital. RESULTS: Patients (n = 109), aged 57.0 +/- 14.9 years, included 57% men and 37% diabetics; 62% started on hemodialysis and 38% on peritoneal dialysis. Average daily costs were USD 161 (range 95-360). After controlling for patients' age, body mass index, gender, dialysis modality and primary renal disease, there was a positive correlation between average CRP and average costs and a negative correlation between albumin and costs. Correlations between mineral metabolism markers and costs were not found, but there was a trend towards lower cost among patients who achieved the Kidney Disease Outcomes Quality Initiative targets of calcium, phosphorus and PTH (USD 145 +/- 31) compared with those with nonoptimal levels (USD 165 +/- 48; p = 0.095). Costs of patients with at least one in-target PTH measurement were lower than costs of patients with constantly low PTH (USD 148 +/- 31 vs. 170 +/- 48; p = 0.01). CONCLUSION: Serum levels of albumin and CRP correlated with dialysis patients' treatment costs. Achieving the Kidney Disease Outcomes Quality Initiative targets may be associated with lower costs.

Cost analysis of renal replacement therapies in Finland.

BACKGROUND: Costs for treating patients with end-stage renal disease (ESRD) have grown noticeably. However, most of the cost estimates to date have taken the perspective of the payers. Hence, direct costs of treating ESRD are not accurately known. METHODS: Files of all adult patients with ESRD who entered dialysis therapy between January 1, 1991, and December 31, 1996, were studied retrospectively, and all use of health care resources and services was recorded. Follow-up continued until December 31, 1996. RESULTS: Two hundred fourteen patients fulfilled the study criteria, 138 patients started with in-center hemodialysis (HD) therapy, and 76 patients started with continuous ambulatory peritoneal dialysis (CAPD) therapy. Patients were followed up until death (72 patients) or treatment modality changed for more than 1 month. Fifty-five patients received a cadaveric transplant, and after transplantation (TX), they were examined as a separate group of TX patients. Direct health care costs for the first 6 months in the HD, CAPD, and TX groups were 32,566 US dollars, 25,504 dollars, and 38,265 dollars, and for the next 6 months, 26,272 dollars, 24,218 dollars, and 7,420 dollars, respectively. During subsequent years, annual costs were 54,140 US dollars and 54,490 dollars in the HD group, 45,262 dollars and 49,299 dollars in the CAPD group, and 11,446 dollars and 9,989 dollars in the TX group. Regression analyses showed 4 variables significantly associated with greater daily costs in dialysis patients: age, ischemic heart disease, nonprimary renal disease, and HD treatment. CONCLUSION: Compared with HD, CAPD may be associated with lower costs, yet the absolute difference is not striking. After the TX procedure is performed once, annual costs decline remarkably, and cadaveric TX is less costly than both dialysis modalities.