Browsing by Subject "CONTROLLED-TRIAL"

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  • Vandenplas, O.; Vinnikov, D.; Blanc, P. D.; Agache, I.; Bachert, C.; Bewick, M.; Cardell, L. O.; Cullinan, P.; Demoly, P.; Descatha, A.; Fonseca, J.; Haahtela, T.; Hellings, P.W.; Jamart, J.; Jantunen, J.; Kalayci, Ö.; Price, D.; Samolinski, B.; Sastre, J.; Tian, L.; Valero, A. L.; Zhang, X.; Bousquet, J. (2018)
    BACKGROUND: Allergic rhinitis (AR) is increasingly acknowledged as having a substantial socioeconomic impact associated with impaired work productivity, although available information remains fragmented. OBJECTIVE: This systematic review summarizes recently available information to provide a quantitative estimate of the burden of AR on work productivity including lost work time (ie, absenteeism) and reduced performance while working (ie, presenteeism). METHODS: A Medline search retrieved original studies from 2005 to 2015 pertaining to the impact of AR on work productivity. A pooled analysis of results was carried out with studies reporting data collected through the validated Work Productivity and Activity Impairment (WPAI) questionnaire. RESULTS: The search identified 19 observational surveys and 9 interventional studies. Six studies reported economic evaluations. Pooled analysis of WPAI-based studies found an estimated 3.6% (95% confidence interval [CI], 2.4; 4.8%) missed work time and 35.9% (95% CI, 29.7; 42.1%) had impairment in at-work performance due to AR. Economic evaluations indicated that indirect costs associated with lost work productivity are the principal contributor to the total AR costs and result mainly from impaired presenteeism. The severity of AR symptoms was the most consistent disease-related factor associated with a greater impact of AR on work productivity, although ocular symptoms and sleep disturbances may independently affect work productivity. Overall, the pharmacologic treatment of AR showed a beneficial effect on work productivity. CONCLUSIONS: This systematic review provides summary estimates of the magnitude of work productivity impairment due to AR and identifies its main determinant factors. This information may help guide both clinicians and health policy makers. (C) 2017 American Academy of Allergy, Asthma & Immunology
  • Tanno, Luciana K.; Haahtela, Tari; Calderon, Moises A.; Cruz, Alvaro; Demoly, Pascal; Joint Allergy Academies (2017)
    Asthma and allergic diseases can start in childhood and persist throughout life, but could also be manifested later, at any time for still misunderstood reasons. They are major chronic multifactorial respiratory diseases, for which prevention, early diagnosis and treatment is recognized as a priority for the Europe's public health policy and the United Nations. Given that allergy triggers (including infections, rapid urbanization leading to loss in biodiversity, pollution and climate changes) are not expected to change in a foreseeable future, it is imperative that steps are taken to develop, strengthen and optimize preventive and treatment strategies. Currently there are good treatments for asthma, several risk factors are known (e.g., allergies, rhinitis, tobacco smoke) and tools to control the disease have been developed. However, we are still uncertain how to prevent patients from developing asthma and allergic diseases. In this paper, we list the positive and negative experiences in this field as well as analyze the missing links in the process. This critical analysis will be the basis of setting-up an effective program for prevention and making, a process labeled as "implementation gaps". (C) 2017 Elsevier Ltd. All rights reserved.
  • Vakkala, Merja; Jarvimaki, Voitto; Kautiainen, Hannu; Haanpaa, Maija; Alahuhta, Seppo (2017)
    Introduction: Spinal cord stimulation (SCS) is recommended for the treatment of postsurgical chronic back and leg pain refractory to other treatments. We wanted to estimate the incidence and predictive factors of SCS treatment in our lumbar surgery cohort. Patients and methods: Three questionnaires (a self-made questionnaire, the Oswestry Low Back Pain Disability Questionnaire, and the Beck Depression Inventory) were sent to patients aged 18-65 years with no contraindications for the use of SCS, and who had undergone non-traumatic lumbar spine surgery in the Oulu University Hospital between June 2005 and May 2008. Patients who had a daily pain intensity of >= 5/10 with predominant radicular component were interviewed by telephone. Results: After exclusions, 814 patients remained in this cohort. Of those, 21 patients had received SCS by the end of June 2015. Fifteen (71%) of these received benefit and continued with the treatment. Complications were rare. The number of patients who replied to the postal survey were 537 (66%). Eleven of them had undergone SCS treatment after their reply. Features predicting SCS implantation were daily or continuous pain, higher intensities of pain with predominant radicular pain, more severe pain-related functional disability, a higher prevalence of depressive symptoms, and reduced benefit from pain medication. The mean waiting time was 65 months (26-93 months). One hundred patients were interviewed by telephone. Fourteen seemed to be potential SCS candidates. From the eleven patients who underwent SCS after responding to the survey, two were classified as potential candidates in the phone interview, while nine were other patients. Twelve patients are still waiting for treatment to commence. Conclusion: In our region, the SCS treatment is used only for very serious pain conditions. Waiting time is too long and it may be the reason why this treatment option is not offered to all candidates.
  • Bonnet, Damien; Berger, Felix; Jokinen, Eero; Kantor, Paul F.; Daubeney, Piers E. F. (2017)
    BACKGROUND Heart rate reduction as a therapeutic target has been investigated in adults with heart failure (HF). Ivabradine has shown promising efficacy, but has not been evaluated in children. Currently, treatment recommendations for chronic pediatric HF are based mainly on chronic HF guidelines for adults. OBJECTIVES The authors explored the dose-response relationship of ivabradine in children with dilated cardiomyopathy and symptomatic chronic HF. The primary endpoint was >= 20% reduction in heart rate from baseline without inducing bradycardia or symptoms. METHODS This was a randomized, double-blind, placebo-controlled, phase II/III study with 12 months of follow-up. Children (n = 116) receiving stable HF therapy were randomized to either ivabradine or placebo. After an initial titration period, the dose was adjusted to attain the primary endpoint. Left ventricular function (echocardiography), clinical status (New York Heart Association functional class or Ross class), N-terminal pro-B-type natriuretic peptide, and quality of life (QOL) were assessed. RESULTS The primary endpoint was reached by 51 of 73 children taking ivabradine (70%) versus 5 of 41 taking placebo (12%) at varying doses (odds ratio: 17.24; p <0.0001). Between baseline and 12 months, there was a greater increase in left ventricular ejection fraction in patients taking ivabradine than placebo (13.5% vs. 6.9%; p = 0.024). New York Heart Association functional class or Ross class improved more with ivabradine at 12 months than placebo (38% vs. 25%; p = 0.24). There was a trend toward improvement in QOL for ivabradine versus placebo (p = 0.053). N-terminal pro-B-type natriuretic peptide levels decreased similarly in both groups. Adverse events were reported at similar frequencies for ivabradine and placebo. CONCLUSIONS Ivabradine safely reduced the resting heart rate of children with chronic HF and dilated cardiomyopathy. Ivabradine's effect on heart rate was variable, highlighting the importance of dose titration. Ivabradine treatment improved left ventricular ejection fraction, and clinical status and QOL showed favorable trends. (Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure from ages 6 months to 18 years; ISRCTN60567801) (C) 2017 by the American College of Cardiology Foundation.
  • Koskinen, Anni; Myller, Jyri; Mattila, Petri; Penttila, Matti; Silvola, Juha; Alastalo, Ismo; Huhtala, Heini; Hytonen, Maija; Toppila-Salmi, Sanna (2016)
    Conclusion This is the first controlled study of balloon sinuplasty's long-term efficacy with the follow-up time over 5 years. The results are in accordance with a previous 2-year-follow-up study. Both techniques retained the efficacy and patient satisfaction on average 6 years after the surgery. Background Endoscopic sinus surgery (ESS) and balloon sinuplasty are considered as a treatment for chronic rhinosinusitis (CRS) after a failure of conservative therapy. High cost and lack of long-term follow-up studies restrain the use of balloon sinuplasty. Objective The aim of this study was to compare long-term efficacy and satisfaction in CRS patients who had undergone maxillary sinus operation with either balloon sinuplasty or ESS technique. Previous or additional sinonasal operations were exclusion criteria. Materials and methods Study patients were recruited from 208 CRS-patients who underwent either ESS or balloon sinuplasty. Patients with nasal polyposis (gradus >= 2), previous sinonasal surgery, unilateral disease, or immune deficiency were excluded. Altogether 45 patients in the ESS group and 40 patients in the balloon group were included. Of these, 30 and 28, respectively, answered to a phone interview held on average 6 years after primary surgery. Symptom reduction and long-term satisfaction were evaluated by using symptom scores of 19 parameters altogether. Results Both groups experienced improvement in symptoms and were equally satisfied with the operation. The number of patient-reported acute exacerbations was higher among the balloon dilated patients. Also, the reduction of thick nasal discharge was less evident in the balloon sinuplasty group. Four patients in the balloon sinuplasty group underwent revision surgery. There were no revisions in the ESS group.
  • Järvinen, Tommi; Ilonen, Ilkka; Kauppi, Juha; Volmonen, Kirsi; Salo, Jarmo; Räsänen, Jari (2018)
    Background Methods In esophageal cancer, nutritional challenges are extremely common. Malignant obstruction resulting from esophageal cancer (EC) is often treated by the insertion of expandable stents, but little is known as to the role and evolution of sarcopenia in this patient population. The aim of this article was to determine the effects of body mass parameters on survival of advanced EC patients who received a stent for palliation of malignant obstruction. This was a retrospective observational study of 238 EC patients who had a stent inserted for palliation of malignant obstruction between 2005 and 2013. Skeletal muscle mass was calculated from abdominal computed tomography scans, and the patients were divided into sarcopenic and non-sarcopenic groups. A follow-up computed tomography scan was available in 118 patients. The primary outcome was survival, and complication rates and the need for an alternative enteral feeding route were secondary outcomes. Results Conclusions Sarcopenia occurred in 199 (85%) patients. Median survival was 146 (range: 76-226) days in the sarcopenia group and 152 (range: 71-249) days in the non-sarcopenic group (P = 0.61). Complication rates between the groups were not significantly different (P = 0.85). In Cox regression analysis, the skeletal muscle index was inversely correlated with overall survival (hazard ratio 0.98, 95% confidence interval 0.97-0.99; P = 0.033). Sarcopenia, defined by consensus thresholds, at the time of stent insertion cannot effectively predict poor survival in this patient cohort, but a lower skeletal muscle index correlates with poor prognosis as a continuous variable.
  • Fickert, Peter; Hirschfield, Gideon M.; Denk, Gerald; Marschall, Hanns-Ulrich; Altorjay, Istvan; Farkkila, Martti; Schramm, Christoph; Spengler, Ulrich; Chapman, Roger; Bergquist, Annika; Schrumpf, Erik; Nevens, Frederik; Trivedi, Palak; Reiter, Florian P.; Tornai, Istvan; Halilbasic, Emina; Greinwald, Roland; Pröls, Markus; Manns, Michael P.; Trauner, Michael; European PSC norUDCA Study Grp (2017)
    Background & Aim: Primary sclerosing cholangitis (PSC) represents a devastating bile duct disease, currently lacking effective medical therapy. 24-norursodeoxycholic acid (norUDCA) is a side chain-shortened C-23 homologue of UDCA and has shown potent anti-cholestatic, anti-inflammatory and anti-fibrotic properties in a preclinical PSC mouse model. A randomized controlled trial, including 38 centers from 12 European countries, evaluated the safety and efficacy of three doses of oral norUDCA (500 mg/d, 1,000 mg/d or 1,500 mg/d) compared with placebo in patients with PSC. Methods: One hundred sixty-one PSC patients without concomitant UDCA therapy and with elevated serum alkaline phosphatase (ALP) levels were randomized for a 12-week treatment followed by a 4-week follow-up. The primary efficacy endpoint was the mean relative change in ALP levels between baseline and end of treatment visit. Results: norUDCA reduced ALP levels by -12.3%, -17.3%, and -26.0% in the 500, 1,000, and 1,500 mg/d groups (p = 0.029, tively, while a +1.2% increase was observed in the placebo group. Similar dose-dependent results were found for secondary end-points, such as ALT, AST, gamma-GT, or the rate of patients achieving ALP levels <1.5 x ULN. Serious adverse events occurred in seven patients in the 500 mg/d, five patients in the 1,000 mg/d, two patients in the 1500 mg/d group, and three in the placebo group. There was no difference in reported pruritus between treatment and placebo groups. Conclusions: norUDCA significantly reduced ALP values dose-dependently in all treatment arms. The safety profile of norUDCA was excellent and comparable to placebo. Consequently, these results justify a phase III trial of norUDCA in PSC patients. Lay summary: Effective medical therapy for primary sclerosing cholangitis (PSC) is urgently needed. In this phase II clinical study in PSC patients, a side chain-shortened derivative of ursodeoxycholic acid, norursodeoxycholic acid (norUDCA), significantly reduced serum alkaline phosphatase levels in a dose-dependent manner during a 12-week treatment. Importantly, norUDCA showed a favorable safety profile, which was similar to placebo. The use of norUDCA in PSC patients is promising and will be further evaluated in a phase III clinical study. (C) 2017 European Association for the Study of the Liver. Published by Elsevier B.V.
  • Laine, M.; Siren, J.; Koskenpato, J.; Punkkinen, J.; Rantanen, T.; Typpö, I.; Kokkola, A.; Sallinen, V. (2018)
    Background and Aims: Severe, medically uncontrollable gastroparesis is a rare entity, which can be treated using a high-frequency gastric electric stimulator implanted surgically. Previous follow-ups have proven positive outcomes with gastric electric stimulator in patients with gastroparesis. The aim of this study was to evaluate the efficacy and safety of gastric electric stimulator in patients, in whom gastroparesis could not be controlled by conservative means in our country. Materials and Methods: This is a retrospective multi-center cohort comprising all patients who had been implanted gastric electric stimulator for severe, medically refractory gastroparesis during 2007-2015 in Finland. Results: Fourteen patients underwent implantation of gastric electrical stimulator without any postoperative complications. Laparoscopic approach was used in 13 patients (93%). Prior implantation, all patients needed frequent hospitalization for parenteral feeding, 13 had severe nausea, 11 had severe vomiting, 10 had notable weight loss, and 6 had frequent abdominal pain. After operation, none of the patients required parenteral feeding, 11 patients (79%) gained median of 5.1 kg in weight (P <0.01), and symptoms were relieved markedly in 8 and partially in 3 patients (79%). Of partial responders, two continued to experience occasional vomiting and one mild nausea. Five patients needed medication for gastroparesis after the operation. One patient did not get any relief of symptoms, but gained 6 kg in weight. No major late complications occurred. Conclusion: Gastric electrical stimulator seems to improve the nutritional status and give clear relief of the symptoms of severe, medically uncontrollable gastroparesis. Given the low number of operations, gastric electrical stimulator seems to be underused in Finland.
  • Peltola, Heikki; Pelkonen, Tuula; Roine, Irmeli; Cruzeiro, Manuel Leite; Bernardino, Luis; Latin Amer Meningitis Study Grp (2016)
    Introduction: C-reactive protein (CRP), a marker of inflammation, shows high serum levels in invasive bacterial infections. We investigated the potential of a single CRP measurement at different phases of acute childhood bacterial meningitis to predict outcomes. Methods: Using whole-blood finger-prick samples with no centrifugation, CRP was measured quantitatively on arrival and on day 3 or 4 in children participating in 2 prospective, randomized, double-blind treatment studies conducted in Latin America or Angola. The results were compared with patient outcomes. Results: Although initial CRP values from 669 children gave useful prognostic information, the 3rd or 4th day measurements taken from 275 children associated significantly with seizures, slow recovery and low scores on the Glasgow Outcome Scale, with odds ratios for CRP values above the median (62 mg/L) ranging from 2 to 6, 2 to 5, and 3 to 5 (Latin America-Angola), respectively. Hearing impairment, although not full deafness, was 3 to 7 times more likely if CRP was above the median soon after hospitalization. Conclusions: Especially in resource-poor settings, clinicians have few simple-enough tools to identify the child with meningitis who requires maximum attention. CRP is a worthy addition.
  • Korpela, Katri; Salonen, Anne; Vepsäläinen, Outi; Suomalainen, Marjo; Kolmeder, Carolin; Varjosalo, Markku; Miettinen, Sini; Kukkonen, Kaarina; Savilahti, Erkki; Kuitunen, Mikael; de Vos, Willem M. (2018)
    BackgroundInfants born by caesarean section or receiving antibiotics are at increased risk of developing metabolic, inflammatory and immunological diseases, potentially due to disruption of normal gut microbiota at a critical developmental time window. We investigated whether probiotic supplementation could ameliorate the effects of antibiotic use or caesarean birth on infant microbiota in a double blind, placebo-controlled randomized clinical trial. Mothers were given a multispecies probiotic, consisting of Bifidobacterium breve Bb99 (Bp99 2x10(8) cfu) Propionibacterium freundenreichii subsp. shermanii JS (2x10(9)cfu), Lactobacillus rhamnosus Lc705 (5x10(9) cfu) and Lactobacillus rhamnosus GG (5x10(9) cfu) (N=168 breastfed and 31 formula-fed), or placebo supplement (N=201 breastfed and 22 formula-fed) during pregnancy, and the infants were given the same supplement. Faecal samples of the infants were collected at 3months and analyzed using taxonomic, metagenomic and metaproteomic approaches.ResultsThe probiotic supplement had a strong overall impact on the microbiota composition, but the effect depended on the infant's diet. Only breastfed infants showed the expected increase in bifidobacteria and reduction in Proteobacteria and Clostridia. In the placebo group, both birth mode and antibiotic use were significantly associated with altered microbiota composition and function, particularly reduced Bifidobacterium abundance. In the probiotic group, the effects of antibiotics and birth mode were either completely eliminated or reduced.ConclusionsThe results indicate that it is possible to correct undesired changes in microbiota composition and function caused by antibiotic treatments or caesarean birth by supplementing infants with a probiotic mixture together with at least partial breastfeeding.Trial NCT00298337. Registered March 2, 2006.
  • Multanen, Juhani; Hakkinen, Arja; Heikkinen, Pauli; Kautiainen, Hannu; Mustalampi, Sirpa; Ylinen, Jari (2018)
    Low-energy pulsed electromagnetic field (PEMF) therapy has been suggested as a promising therapy to increase microcirculation, which is of great concern in patients with fibromyalgia. This study evaluated the effectiveness of PEMF therapy on the treatment of fibromyalgia. A group of 108 women with fibromyalgia were allocated to a 12-week treatment period with an active Bio-Electro-Magnetic-Energy-Regulation (BEMER) device and a similar treatment period with an inactive device. Each patient received active and sham treatments in a random order. Pain and stiffness were assessed on a visual analog scale (VAS, scale 0-100mm), and functional status was assessed by the Fibromyalgia Impact Questionnaire (FIQ). Mean VAS pain scores before the active and sham treatment periods were 66 (SD22) and 63 (SD22), respectively. After treatment periods, mean VAS pain scores had decreased significantly in active treatment, -12, 95% CI [-18, -6], and in sham treatment, -11, 95% CI [-17, -5]. Similarly, the decrease in stiffness and FIQ index after both treatments was statistically significant. However, per-protocol analysis showed no differences between active and sham treatments at any of the outcomes. This study demonstrated that low-energy PEMF therapy was not efficient in reducing pain and stiffness or in improving functioning in women with fibromyalgia. Bioelectromagnetics. 39:405-413, 2018. (c) 2018 Wiley Periodicals, Inc.
  • Rahe-Meyer, N.; Levy, J. H.; Mazer, C. D.; Schramko, A.; Klein, A. A.; Brat, R.; Okita, Y.; Ueda, Y.; Schmidt, D. S.; Ranganath, R.; Gill, R. (2016)
    Background: Single-dose human fibrinogen concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery. Methods: Patients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60-250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication. Results: 519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76-138) and 91 (71-112) g in the FCH and placebo groups, respectively (P=0.13). More allogeneic blood product units were administered during the first 24 h after FCH, 5.0 (2.0-11.0), when compared with placebo, 3.0 (0.0-7.0), P=0.026. Fewer patients avoided transfusion in the FCH group (15.4%) compared with placebo (28.4%), P=0.047. The FCH immediately increased plasma fibrinogen concentration and fibrin-based clot strength. Adverse event rates were comparable in each group. Conclusions: Human fibrinogen concentrate was associated with increased allogeneic blood product transfusion, an unexpected finding contrary to previous studies. Human fibrinogen concentrate may not be effective in this setting when administered according to 5-minute bleeding mass. Low bleeding rates and normal-range plasma fibrinogen concentrations before study medication, and variability in adherence to the complex transfusion algorithm, may have contributed to these results.
  • EFSA Panel Dietetic Prod Nutr (2017)
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on alginate-konjac- xanthan polysaccharide complex (PGX) as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The NF is an off-white granular powder composed of three non- starch polysaccharides: konjac glucomannan, xanthan gum and sodium alginate. The information provided on the composition, the specifications, the batch-to-batch variability and the stability of the NF is sufficient and does not raise safety concerns. The production process is sufficiently described and does not raise concerns about the safety of the NF. The applicant intends to add the NF to a variety of foods as well as to market the NF in capsules. The recommended maximum daily intake of the NF from fortified foods and food supplements is 15 g. The target population proposed by the applicant is adults from 18 to 64 years of age. Considering the no observed adverse effect level of 1.8 g/kg body weight (bw) per day in a subchronic toxicity study with PGX and the highest mean and 95th percentile anticipated daily intake of NF from fortified foods, the margin of exposure (MoE) is 12 and 6, respectively, whereas the MoE for the NF from food supplements is 9. The Panel concludes that the safety of the novel food, PGX, for the intended uses and use levels as proposed by the applicant, has not been established. (C) 2017 European Food Safety Authority.
  • Viikila, Juho; Nieminen, Tuomo; Tierala, Ilkka; Laine, Mika (2016)
    Backround: The optimal antithrombotic treatment during a primary percutaneous coronary intervention (pPCI) is not known. This single center registry study aims to assess the safety of a novel antithrombotic regimen combining enoxaparine and prasugrel at presentation, followed by bivalirudin at the catheterisation laboratory. Methods: All consecutive patients who underwent a pPCI were collected prospectively. The primary endpoint was major bleeding within 30 days. The secondary endpoints were a composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, a new target vessel revascularisation and all-cause mortality at 30 days. Results: Ninety-nine out of the total of 390 patients were treated according to the new regimen (protocol-treated group). The rest received other antithrombotic treatment (non-protocol-treated group). The protocol-treated group had a lower risk than the non-protocol-treated group according to the GRACE ischaemic (112 vs. 124, p = 0.002) and CRUSADE bleeding scores (21 vs. 28, p <0.0001). The incidences of bleeding were similar: severe GUSTO or TIMI bleeding occurred in 0 % of the protocol-treated group and in 1.0 and 0.3 %, respectively, of the other group (p = 0.311 for GUSTO and p = 0.559 for TIMI). The incidence of MACE in the groups was 6.1 and 10.7 %, respectively (p = 0.178). The respective incidences of all-cause mortality were 5.1 and 9.6 % (p = 0.158). Conclusions: Administration of the novel antithrombotic regimen seems to be safe.
  • Kuusimäki, Tomi; Kurki, Samu; Sipilä, Jussi O. T.; Salminen-Mankonen, Heli; Carpen, Olli; Kaasinen, Valtteri (2020)
    Background Advances in the treatment of Parkinson's disease (PD) and changes in general life expectancy may have improved survival in patients with PD. Objective The objective of this study was to investigate recent trends in PD mortality. Methods In total, 1521 patients with PD in local and national registries were followed for 11 years (2006-2016) from diagnosis until exit date or death, and the causes of death were recorded. Results The survival of men with PD improved during the follow-up period, but no change was observed in women (2-year postdiagnosis survival in men, 79.0%-86.3%, P = 0.03; 2-year postdiagnosis survival in women, 82.8%-87.5%, P = 0.42). Pneumonia was the most common immediate cause of death. Discussion The survival of men with PD has improved in Finland without a similar change in women. Because changes in treatment likely affect both sexes similarly, the results may reflect the decreasing sex gap in life expectancy. This phenomenon will likely increase the already high male-to-female prevalence ratio of PD.
  • Lavikainen, Piia; Helin-Salmivaara, Arja; Eerola, Mervi; Fang, Gang; Hartikainen, Juha; Huupponen, Risto; Korhonen, Maarit Jaana (2016)
    Objectives Previous studies on the effect of statin adherence on cardiovascular events in the primary prevention of cardiovascular disease have adjusted for time-dependent confounding, but potentially introduced bias into their estimates as adherence and confounders were measured simultaneously. We aimed to evaluate the effect when accounting for time-dependent confounding affected by previous adherence as well as time sequence between factors. Design Retrospective cohort study. Setting Finnish healthcare registers. Participants Women aged 45-64years initiating statin use for primary prevention of cardiovascular disease in 2001-2004 (n=42807). Outcomes Acute cardiovascular event defined as a composite of acute coronary syndrome and acute ischaemic stroke was our primary outcome. Low-energy fractures were used as a negative control outcome to evaluate the healthy-adherer effect. Results During the 3-year follow-up, 474 women experienced the primary outcome event and 557 suffered a low-energy fracture. The causal HR estimated with marginal structural model for acute cardiovascular events for all the women who remained adherent (proportion of days covered 80%) to statin therapy during the previous adherence assessment year was 0.78 (95% CI: 0.65 to 0.94) when compared with everybody remaining non-adherent (proportion of days covered Conclusions Our study, which took into account the time dependence of adherence and confounders, as well as temporal order between these factors, is support for the concept that adherence to statins in women in primary prevention decreases the risk of acute cardiovascular events by about one-fifth in comparison to non-adherence. However, part of the observed effect of statin adherence on acute cardiovascular events may be due to the healthy-adherer effect.
  • Cruccu, G.; Nurmikko, T. J.; Ernault, E.; Riaz, F. K.; McBride, W. T.; Haanpää, M. (2018)
    BackgroundDynamic Mechanical Allodynia (DMA) is a typical symptom of neuropathic pain (NP). In a recent study, the capsaicin 8% patch was noninferior to pregabalin in overall peripheral NP relief. In this study, we report the comparison of the two treatments in relieving DMA. MethodsIn a randomized, open-label, head-to-head, 8-week study, 488 patients with peripheral NP were treated with the capsaicin 8% patch (one application) or an optimized dose of pregabalin. Assessments included the area and intensity of DMA, and the number of patients achieving complete resolution of DMA. ResultsAt baseline, 253 patients in the capsaicin 8% patch group and 235 patients in the pregabalin group had DMA. From baseline to end of study, the change in DMA intensity was significantly in favour of the capsaicin 8% patch versus pregabalin [-0.63 (95% CI: -1.04, -0.23; p=0.002)]. Similarly, the capsaicin 8% patch was superior to pregabalin in reducing the area of DMA [-39.5cm(2) (95% CI: -69.1, -10.0; p=0.009)] from baseline to end of study. Overall, a greater proportion of patients had a complete resolution of allodynia with capsaicin 8% patch treatment compared with pregabalin treatment (24.1% vs. 12.3%; p=0.001) at end of study. ConclusionCapsaicin 8% treatment was superior to pregabalin in reducing the intensity and area of DMA, and in the number of patients with complete resolution of DMA. SignificanceThe superiority of a topical treatment over pregabalin in relieving DMA supports the view that both peripheral and central sensitization can mediate allodynia.
  • Brinck, Tuomas; Handolin, Lauri; Lefering, R. (2016)
    Background and Aims: Fluid resuscitation of severely injured patients has shifted over the last decade toward less crystalloids and more blood products. Helsinki University trauma center implemented the massive transfusion protocol in the end of 2009. The aim of the study was to review the changes in fluid resuscitation and its influence on outcome of severely injured patients with hemodynamic compromise treated at the single tertiary trauma center. Material and Methods: Data on severely injured patients (New Injury Severity Score>15) from Helsinki University Hospital trauma center's trauma registry was reviewed over 2006-2013. The isolated head-injury patients, patients without hemodynamic compromise on admission (systolic blood pressure>90 or base excess>-5.0), and those transferred in from another hospital were excluded. The primary outcome measure was 30-day in-hospital mortality. The study period was divided into three phases: 2006-2008 (pre-protocol, 146 patients), 2009-2010 (the implementation of massive transfusion protocol, 85 patients), and 2011-2013 (post massive transfusion protocol, 121 patients). Expected mortality was calculated using the Revised Injury Severity Classification score II. The Standardized Mortality Ratio, as well as the amounts of crystalloids, colloids, and blood products (red blood cells, fresh frozen plasma, platelets) administered prehospital and in the emergency room were compared. Results: Of the 354 patients that were included, Standardized Mortality Ratio values decreased (indicating better survival) during the study period from 0.97 (pre-protocol), 0.87 (the implementation of massive transfusion protocol), to 0.79 (post massive transfusion protocol). The amount of crystalloids used in the emergency room decreased from 3870mL (pre-protocol), 2390mL (the implementation of massive transfusion protocol), to 2340mL (post massive transfusion protocol). In these patients, the blood products' (red blood cells, fresh frozen plasma, and platelets together) relation to crystalloids increased from 0.36, 0.70, to 0.74, respectively, in three phases. Conclusion: During the study period, no other major changes in the protocols on treatment of severely injured patients were implemented. The overall awareness of damage control fluid resuscitation and introduction of massive transfusion protocol in a trauma center has a significant positive effect on the outcome of severely injured patients.
  • Stevenson, Nathan J.; Lauronen, Leena; Vanhatalo, Sampsa (2018)
    Objectives: To measure changes in the visual interpretation of the EEG by the human expert for neonatal seizure detection when reducing the number of recording electrodes. Methods: EEGs were recorded from 45 infants admitted to the neonatal intensive care unit (NICU). Three experts annotated seizures in EEG montages derived from 19, 8 and 4 electrodes. Differences between annotations were assessed by comparing intra-montage with inter-montage agreement (K). Results: Three experts annotated 4464 seizures across all infants and montages. The inter-expert agreement was not significantly altered by the number of electrodes in the montage (p = 0.685, n = 43). Reducing the number of EEG electrodes altered the seizure annotation for all experts. Agreement between the 19-electrode montage (K-19,K-19 = 0.832) was significantly higher than the agreement between 19 and 8-electrode montages (dK = 0.114; p <0.001, n = 42) or 19 and 4-electrode montages (dK = 0.113, p <0.001, n = 43). Seizure burden and number were significantly underestimated by the 4 and 8-electrode montage (p <0.001). No significant difference in agreement was found between 8 and 4-electrode montages (dK = 0.002; p = 0.07, n = 42). Conclusions: Reducing the number of EEG electrodes from 19 electrodes resulted in slight but significant changes in seizure detection. (C) 2017 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.
  • Salo, S. J.; Flykt, M.; Mäkelä, Jukka; Biringen, Z.; Kalland, M.; Pajulo, Marjukka; Punamaki, R. L. (2019)
    Aim: This randomised control trial (RCT) study examined the effectiveness of a mentalisation-based perinatal group intervention, Nurture and Play (NaP), in improving mother–infant interaction quality and maternal reflective functioning and in decreasing depressive symptoms. Background: Few preventive prenatal interventions have been developed for primary health care settings for mothers with depressive symptoms. Furthermore, previous prenatal intervention studies have only concentrated on reducing depressive symptoms and have not directly addressed enhancing optimal parenting qualities. Methods: The participants were 45 pregnant women with depressive symptoms. Women in the randomly assigned intervention group (n = 24) participated in the manualised, short-term NaP intervention group from pregnancy until the baby’s age of seven months, whereas control group women received treatment as usual (TAU). Maternal emotional availability (EA), reflective functioning (RF) and depressive symptoms were measured before the intervention and at the infants’ 12 months of age, and changes were evaluated using repeated measure analyses of variances (ANOVAs). Findings: The results showed that the intervention group displayed higher maternal sensitivity and RF and more reduction in depressive symptoms than the control group when babies were 12 months old. These findings provide preliminary support for the effectiveness of the NaP intervention.