scholarly journals Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients.

2020 ◽  
Author(s):  
Flavio A. Cadegiani ◽  
Andy Goren ◽  
Carlos G. Wambier ◽  
John McCoy
Keyword(s):  
Safety Profile ◽  
Randomized Clinical Trials ◽  
Clinical Symptoms ◽  
Early Stage ◽  
Control Group ◽  
Placebo Control ◽  
Control Groups ◽  
Persistent Symptoms ◽  
Number Of Patients ◽  
Outpatient Settings

Abstract Background: While there was a lack of pharmacological interventions proven to be effective in early, outpatient settings for COVID-19, in a prospective, open-label observational study (pre-AndroCoV Trial) the use of nitazoxanide, ivermectin and hydroxychloroquine demonstrated similar effects, and apparent improvement of outcomes compared to untreated patients. The unexpected apparent positive results led to ethical questions on the employment of further full placebo-control studies in early stage COVID-19. The objective of the present study was to elucidate whether the conduction of a full placebo-control RCT was still ethically viable, through a comparative analysis with two control-groups.Materials and methods: Active group (AG) consisted of mild-to-moderate early stage COVID-19 patients enrolled in the Pre AndroCoV-Trial, treated with nitazoxanide ivermectin, or hydroxychloroquine in selected cases, in association with azithromycin. Vitamin D, vitamin C, zinc, glucocorticoids and anticoagulants, when clinically recommended. Control Group 1 (CG1) consisted of a retrospectively obtained group of untreated patients from the same population as those from the Pre-AndroCoV Trial, and Control Group 2 (CG2) resulted from a precise prediction of clinical outcomes, based on a thorough and structured review of articles indexed in PubMed and MEDLINE and statements by official government agencies and specific medical societies. For both CGs, patients were matched for proportion between sex, age, obesity and other comorbidities. Results: Compared to CG1 and CG2, AG showed a reduction of 31.5 to 36.5% in viral shedding (p < 0.0001), 70 to 85% and 70 to 73% in duration of COVID-19 clinical symptoms when including and not including anosmia and ageusia, respectively ((p < 0.0001 for both), and 100% in respiratory complications through the parameters of the Brescia COVID-19 Respiratory Scale (p < 0.0001). For every 1,000 confirmed cases for COVID-19, a minimum of 140 patients were prevented from hospitalization (p < 0.0001), 50 from mechanical ventilation, and five deaths, when comparing to age-, sex- and comorbidity-matched non-treated patients with similar initial disease severity at the moment of diagnosis.Conclusion: Apparent benefits of the combination between early detection and early pharmacological approaches for COVID-19 demonstrated to be consistent when when compared to different control groups of untreated patients. The potential benefits could allow a large number of patients prevented from hospitalizations, deaths and persistent symptoms after COVID-19 remission. The potential impact on COVID-19 disease course and numbers of negative outcomes and the well-established safety profile of the drugs proposed by the Pre-AndroCoV Trial led to ethical questions regarding the conduction of further placebo control randomized clinical trials (RCTs) for early COVID-19. Early pharmacological approaches including azithromycin in combination with any of the options between nitazoxanide, ivermectin or optionally hydroxychloroquine should be considered for those diagnosed with COVID-19 presenting less than seven days of symptoms. Of the three drugs, we opted for nitazoxanide, due to more extensive demonstration of in vitro and in vivoantiviral activity, proven efficacy against other viruses in humans, and steadier safety profile.

scholarly journals Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients

2020 ◽  
Author(s):  
Flavio A. Cadegiani ◽  
Andy Goren ◽  
Carlos G. Wambier ◽  
John McCoy
Keyword(s):  
Safety Profile ◽  
Randomized Clinical Trials ◽  
Clinical Symptoms ◽  
Early Stage ◽  
Control Group ◽  
Placebo Control ◽  
Control Groups ◽  
Persistent Symptoms ◽  
Number Of Patients ◽  
Outpatient Settings

AbstractBackgroundWhile there was a lack of pharmacological interventions proven to be effective in early, outpatient settings for COVID-19, in a prospective, open-label observational study (pre-AndroCoV Trial) the use of nitazoxanide, ivermectin and hydroxychloroquine demonstrated similar effects, and apparent improvement of outcomes compared to untreated patients. The unexpected apparent positive results led to ethical questions on the employment of further full placebo-control studies in early stage COVID-19. The objective of the present study was to elucidate whether the conduction of a full placebo-control RCT was still ethically viable, through a comparative analysis with two control-groups.Materials and methodsActive group (AG) consisted of mild-to-moderate early stage COVID-19 patients enrolled in the Pre AndroCoV-Trial, treated with nitazoxanide ivermectin, or hydroxychloroquine in selected cases, in association with azithromycin. Vitamin D, vitamin C, zinc, glucocorticoids and anticoagulants, when clinically recommended. Control Group 1 (CG1) consisted of a retrospectively obtained group of untreated patients from the same population as those from the Pre-AndroCoV Trial, and Control Group 2 (CG2) resulted from a precise prediction of clinical outcomes, based on a thorough and structured review of articles indexed in PubMed and MEDLINE and statements by official government agencies and specific medical societies. For both CGs, patients were matched for proportion between sex, age, obesity and other comorbidities. Results: Compared to CG1 and CG2, AG showed a reduction of 31.5 to 36.5% in viral shedding (p < 0.0001), 70 to 85% and 70 to 73% in duration of COVID-19 clinical symptoms when including and not including anosmia and ageusia, respectively ((p < 0.0001 for both), and 100% in respiratory complications through the parameters of the Brescia COVID-19 Respiratory Scale (p < 0.0001). For every 1,000 confirmed cases for COVID-19, a minimum of 140 patients were prevented from hospitalization (p < 0.0001), 50 from mechanical ventilation, and five deaths, when comparing to age-, sex- and comorbidity-matched non-treated patients with similar initial disease severity at the moment of diagnosis.ConclusionApparent benefits of the combination between early detection and early pharmacological approaches for COVID-19 demonstrated to be consistent when when compared to different control groups of untreated patients. The potential benefits could allow a large number of patients prevented from hospitalizations, deaths and persistent symptoms after COVID-19 remission. The potential impact on COVID-19 disease course and numbers of negative outcomes and the well-established safety profile of the drugs proposed by the Pre-AndroCoV Trial led to ethical questions regarding the conduction of further placebo control randomized clinical trials (RCTs) for early COVID-19. Early pharmacological approaches including azithromycin in combination with any of the options between nitazoxanide, ivermectin or optionally hydroxychloroquine should be considered for those diagnosed with COVID-19 presenting less than seven days of symptoms. Of the three drugs, we opted for nitazoxanide, due to more extensive demonstration of in vitro and in vivo antiviral activity, proven efficacy against other viruses in humans, and steadier safety profile.

Supplementation of c-type natriuretic peptide during in vitro growth period benefits the development of murine preantral follicles

Zygote ◽  
2020 ◽  
pp. 1-5
Author(s):  
Li Ang ◽  
Cao Haixia ◽  
Li Hongxia ◽  
Li Ruijiao ◽  
Guo Xingping ◽  
...  
Keyword(s):  
Natriuretic Peptide ◽  
Granulosa Cells ◽  
Culture System ◽  
Early Stage ◽  
Developmental Competence ◽  
Control Group ◽  
Follicle Development ◽  
Control Groups ◽  
Preantral Follicles

Summary The present study investigated the effects of c-type natriuretic peptide (CNP) on the development of murine preantral follicles during in vitro growth (IVG). Preantral follicles isolated from ovaries of Kunming mice were cultured in vitro. In the culture system, CNP was supplemented in the experimental groups and omitted in the control groups. In Experiment 1, CNP was only supplemented at the early stage and follicle development was evaluated. In Experiments 2 and 3, CNP was supplemented during the whole period of in vitro culture. In Experiment 2, follicle development and oocyte maturity were evaluated. In Experiment 3, follicle development and embryo cleavage after in vitro fertilization (IVF) were assessed. The results showed that in the control groups in all three experiments, granulosa cells migrated from within the follicle and the follicles could not reach the antral stage. In the experimental groups in all three experiments, no migration of granulosa cells was observed and follicle development was assessed as attaining the antral stage, which was significantly superior to that of the control group (P < 0.0001). Oocyte meiotic arrest was effectively maintained, hence giving good developmental competence. In conclusion, CNP supplementation in the culture system during IVG benefited the development of murine preantral follicles.

scholarly journals THERAPY OF ENDOCRINE DISEASE: T4 + T3 combination therapy: is there a true effect?

2017 ◽  
Vol 177 (6) ◽  
pp. R287-R296 ◽  
Author(s):  
Wilmar M Wiersinga
Keyword(s):  
Combination Therapy ◽  
Thyroid Function ◽  
Healthy Subjects ◽  
Randomized Clinical Trials ◽  
Peripheral Tissue ◽  
Thyroid Function Tests ◽  
Peripheral Tissues ◽  
Persistent Symptoms ◽  
Function Tests ◽  
Number Of Patients

About 5%–10% of hypothyroid patients on T4 replacement therapy have persistent symptoms, despite normal TSH levels. It was hoped that T4 + T3 combination therapy might provide better outcomes, but that was not observed according to a meta-analysis of 11 randomized clinical trials comparing T4 monotherapy with T4 + T3 combination therapy. However, the issue is still subject of much research because normal thyroid function tests in serum may not necessarily indicate an euthyroid state in all peripheral tissues. This review evaluates recent developments in the field of T4 + T3 combination therapy. T4 monotherapy is associated with higher serum FT4 levels than in healthy subjects, and subnormal serum FT3 and FT3/FT4 ratios are observed in about 15% and 30% respectively. T4 + T3 combination therapy may mimic more closely thyroid function tests of healthy subjects, but it has not been demonstrated that relatively low serum FT3 or FT3/FT4 ratios are linked to persistent symptoms. One study reports polymorphism Thr92Ala in DIO2 is related to lower serum FT3 levels after thyroidectomy, and that the D2-Ala mutant reduces T4 to T3 conversion in cell cultures. Peripheral tissue function tests such as serum cholesterol reflect thyroid hormone action in target tissues. Using such biochemical markers, patients who had a normal serum TSH during postoperative T4 monotherapy, were mildly hypothyroid, whereas those with a TSH 0.03–≤0.3 mU/L were closest to euthyroidism. Peripheral tissue function tests suggest euthyroidism more often in patients randomized to T4 + T3 rather than that to T4. Preference for T4 + T3 combination over T4 monotherapy was dose-dependently related to the presence of two polymorphisms in MCT10 and DIO2 in one small study. It is not known if persistent symptoms during T4 monotherapy disappear by switching to T4 + T3 combination therapy. The number of patients on T4 + T3 therapy has multiplied in the last decade, likely induced by indiscriminate statements on the internet. Patients are sometimes not just asking but rather demanding this treatment modality. It creates tensions between patients and physicians. Only continued research will answer the question whether or not T4 + T3 combination therapy has true benefits in some patients.

THE APPLICATION OF STATISTICAL METHODS IN EVALUATING THE RESULTS OF CLINICAL FINDINGS OF THE DRUG BOVHUALONIDASE AZOXIMER IN CATS WITH UROLOGICAL DISEASES

2020 ◽  
pp. 212-218
Author(s):  
А. V. Nazarova ◽  
◽  
B. S. Semenov ◽  
Т. Sh. Kuznetsova ◽  
◽  
...  
Keyword(s):  
Relative Risk ◽  
Side Effects ◽  
Risk Reduction ◽  
Absolute Risk ◽  
Control Group ◽  
Control Groups ◽  
Saint Petersburg ◽  
Number Of Patients ◽  
And Control ◽  
Experimental Group

In the period from November 2018 to August 2020, we conducted a randomized blind placebo-controlled confirmatory clinical trial in parallel groups on the basis of network of veterinary clinics in Saint Petersburg and Saint Petersburg state university of veterinary medicine. The purpose of the study: to evaluate the effectiveness of Bovhualonidaze azoximer(BA) in patients subjected to surgical intervention on the urethra and bladder, to prevent postoperative complications and relapses of the underlying disease. The frequency of complications was taken as an indicator of effectiveness. 80 cats were evaluated according to the criteria for inclusion in the study, after evaluation and randomization, 53 patients (24 and 29 cats in the experimental and control groups, respectively) who had indications for surgery on the urethra and/or bladder were included in the study. After the withdrawal of some patients, 38 cats were analyzed (17 and 23 cats in the experimental and control groups, respectively). Animals in the experimental group received BA drugs in addition to conventional therapy, and animals in the control group received placebo. The rate of complications in the experimental group was 11.8 %, in the control group-61.9 %. The relative risk was 19.0 %, and the relative risk reduction was 80.9 %. The chance of developing complications in the animals of the experimental group is 12.2 times lower than in animals of the control group.. Absolute risk reduction — 50.1 %, and the number of patients to be treated — 2 patients. The confidence interval for the risk of side effects of BA drugs in cats was 0.0-10.1 %. Based on the results of our clinical study, we proved that the use of BA drugs is effective for preventing complications during surgical interventions on the urethra and bladder, and the risk of side effects when using BA drugs in cats is insignificant

Impact of Medicaid expansion on pancreatic cancer care: A difference-in-difference analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18567-e18567
Author(s):  
Ahmad Hamad ◽  
Mariam Eskander ◽  
Yaming Li ◽  
Oindrila Bhattacharyya ◽  
James L Fisher ◽  
...  
Keyword(s):  
Low Income ◽  
Early Stage ◽  
Ductal Adenocarcinoma ◽  
Control Group ◽  
Medicaid Expansion ◽  
Difference In Difference ◽  
Post Surgery ◽  
Number Of Patients ◽  
The Impact ◽  
Expansion Period

e18567 Background: The Affordable Care Act (ACA) increased insurance coverage for low-income individuals, which should potentially lead to better access to care and improved oncological outcomes. This study seeks to evaluate the impact of Medicaid expansion (ME) on care for pancreatic ductal adenocarcinoma (PDAC). Methods: Patients who were uninsured or on Medicaid and diagnosed with PDAC between 2004 and 2017 were queried from the National Cancer Database (NCDB). Two different expansion cohorts were included: early expansion states and 2014 expansion states. For early expansion states, the time period of pre-expansion was 2004-2009 and post-expansion was 2010-2017. As for the 2014 expansion states, the pre-expansion period was from 2004-2013 and post-expansion period was from 2014-2017. Patients in non-expansion states formed the control group. A difference-in-difference (DID) analysis was used to assess the association of ME with stage of diagnosis, treatment and survival for each expansion cohort. Results: In both early and January 2014 expansion states, there was an increase in overall Medicaid coverage (Early: DID = 0.29, 2014: DID = 0.37; P < 0.001), in particular for non-Hispanic Black and Hispanic Black patients (Non-Hispanic Black: Early: DID = 0.11, 2014: DID = 0.11; P < 0.001, Hispanic-Black: 2014: DID = 0.20; P = 0.003). There were no differences in early stage diagnosis (Early: DID = 0.02, 2014: DID = -0.02; P > 0.05). There was an increase in the number of patients receiving surgery (Early: DID = 0.05; P = 0.001, 2014: DID = 0.03; P = 0.029) but no difference in time to surgery among patients receiving surgery upfront (Early: DID = 1.75, 2014: DID = 0.38; P > 0.05). There was no difference in 30-day readmission post-surgery (Early: DID = 0.003; 2014: DID = -0.00007; P > 0.05) or 90-day mortality (Early: DID = -0.007, 2014: DID = -0.035; P > 0.05). Moreover, there was no difference in receipt of chemotherapy (Early: DID = 0.01, 2014: DID = 0.005; P > 0.05) or time to chemotherapy for patients receiving neoadjuvant chemotherapy (Early: Early: DID = 9.62, 2014: DID = 0.01; P > 0.05). Finally, there was no difference in receipt of palliative care among stage IV patients in both cohorts (Early: DID = -0.004, 2014: DID = 0.004; P > 0.05). Conclusions: This study suggests that after ME, PDAC patients were more likely to be insured and had increased access to surgical care. Future, studies should evaluate the implications of improved surgical access on clinical outcomes such as mortality.

Implementation of a European Cohort to Follow Sickle Cell Children and Adults Treated with Hydroxycarbamide

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 564-564
Author(s):  
Mariane De Montalembert ◽  
Frédéric Galacteros ◽  
Jean Antoine Ribeil ◽  
Uwe Kordes ◽  
Jean Benoit Arlet ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Safety Profile ◽  
Conflicts Of Interest ◽  
Subcutaneous Tissue ◽  
Acute Chest Syndrome ◽  
Control Group ◽  
Cell Disease ◽  
Skin Reactions ◽  
Number Of Patients

Abstract Hydroxycarbamide (HU) is a myelosuppressive drug marketed since 1968 for the treatment of hematological cancer, and authorized since 2007 in Europe as orphan medicinal product for the prevention of recurrent vaso-occlusive crises including acute chest syndrome in adults and children older than 2 years with sickle cell disease (SCD). ESCORT-HU (European Sickle Cell Disease Cohort – Hydroxyurea) is a multicenter prospective non interventional study implemented in Europe to collect more information about the safety profile of HU and morbi-mortality in SCD patients treated with HU. The study responds to EMA (European Medicines Agency) request and has been approved by the Ethical of Necker Enfants Malades Hospital (Paris, France).The ongoing study involves the largest number so far of patients with SCD treated with HU. Primary endpoints of ESCORT HU are to determine frequency of adverse events, and possible consequent changes of HU treatment. Secondary endpoints are to evaluate morbi-mortality of the disease although in the absence of control group. From June 2008 to June 2014, 483 patients (255 females; 228 males) were enrolled from 3 European countries, Greece (24%), Germany (19%), and France (56%). 67% patients were adults, median aged 37.35 yrs (17-83.5) and 33% were children, median aged 11.06 yrs (2.6-16.9). genotypes were HbS/HbS in 71.4% cases, and compound heterozygotous HbS/β-thalassemia in 22.8 % (Table 1). 137 (28.4%) patients experienced 421 events (Table 2). 132 (32.2%) of these events may be attributed to HU. The safety profile is roughly similar in children and adults. As expected the most frequent side effects were firstly blood disorders (n=86 events, 42.4%) such as neutropenia or thrombocytopenia. In all cases, these cytopenias were rapidly resolved with the transitory stop of HU. 71 events related to skin and subcutaneous tissue disorders were observed, mostly cutaneous dryness, skin reactions, alopecia and nails or skin pigmentation; 4 patients had a leg ulcer (34.8%). Most of these events are ongoing or stabilized despit the decrease of HU. No secondary cancer has been reported until now. Even if HU is an old drug with a relatively well-known safety profile, some uncertainties remain in terms of long-term safety as well as tolerance in the youngest people. The main interest of ESCORT HU is to offer the possibility of safety surveillance of hydroxycarbamide in European sickle cell patients. Table 1 Demographic data Adults Children < 17 years old Total Number of patients 322 (67%) 161 (33%) 483 Females/Males 183/139 72/89 255/228 Median age (yrs) (range) 37.35 (17-83.5) 11.06 (2.6-16.9) 28.58 Genotype SS 206 (64%) 139 (86.3%) 345 (71.4%) SC 1 (0.3%) 3 (1.86%) 4 (0.8%) Sβ0 51 (15.8%) 11 (6.8%) 62 (12.8%) Sβ+ 46 (14.2%) 2 (1.2%) 48 (9.9%) Other 18 (5.5%) 6 (3.7%) 24 (4.9%) Treatment with HU before enrollment in ESCORT HU No of pts 232 83 315 (65%) Median duration (range) of HU treatment before ESCORT HU 8.2 yrs (0.5 ans-24 yrs) 3. 1 yrs ( 71 days – 8.9 yrs) 6.85 (71 days-24 years)] HU ESCORT Daily mean dose (mg/kg/d) 16.11 ± 4.79 19.63 ± 4.69 17.32 ± 4.94 Abstract 564. Table 2 The most frequent events of hydroxycarbamide in the two populations of SCD patients ADULTS CHILDREN No ofGerman(%) No of adults No ofEpisodes(%) No of children Total(% /411) Events Related to HU treatment (Siklos®)(%**) Blood and lymphatic system disorders (%) 32 (17.7) 22 54 (31.03) 28 86 (20.9) 56 (65.1) Skin and subcutaneous tissue disorders (%) 42 (23.2) 28 29 (16.7) 19 71 (17.3) 46 (64.8) Nervous system disorders Headache (24), Dizziness/vertigo (14), 32 (17.7) 23 12(6.9) 10 44 (10.7) 11 (25) Gastrointestinal disorders Nausea (14), diarrhea (8), other (14) 20 (11) 17 23 (13.2) 16 43 (10.4) 7 (16.3) Metabolic and nutrition disorders: vit D deficiency (17), weight gain (5) 13 (7) 11 18 (18.3) 18 36 (8.75) 4 (11.1) Fever 11 (6) 10 12(6.9) 7 23 (5.6) 1 (4.3) Cardiac disorders (hypertension, bradycardia, chest pain, cardiomegaly) 4 4 2 2 6 1 (16.6) General disorders : fatigue 5 5 0 0 5 0 Hepatobiliary disorders 2 2 0 0 2 0 Neoplasms benign, malignant and unspecified (incl. cysts and polyps) Harmatoma, benign vulvar sebaceous cyst 2 2 0 0 2 0 Renal & urinary disorders 2 2 0 0 2 0 Reproductive system and breast disorders 3 3 0 0 3 0 Other 13 13 21 14 34 6 (17.1%) 181 80 /181(24.8%) 174 57 / 174(35.4%) 411 132/411 (32.2%) ** compared to the total number of “system organ class” events Disclosures No relevant conflicts of interest to declare.

scholarly journals IVF outcomes after hysteroscopic metroplasty in patients with T- shaped uterus

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Esra Uyar ◽  
Deniz Usal ◽  
Belgin Selam ◽  
Mehmet Cincik ◽  
Tayfun Bagis
Keyword(s):  
Unexplained Infertility ◽  
Control Group ◽  
Reproductive Outcomes ◽  
Control Groups ◽  
Ivf Outcomes ◽  
Number Of Patients ◽  
Adverse Pregnancy ◽  
And Control ◽  
The Impact

Abstract Background T- shaped uterus may be associated with infertility and adverse pregnancy outcomes. Hysteroscopic metroplasty may improve the reproductivity for these cases. To our knowledge, there is no data in literature about the clinical consequences of in vitro fertilization (IVF) in patients undergoing hysteroscopic metroplasty for T-shaped uterus. The principal objective of the current study is to assess the impact of hysteroscopic metroplasty for T-shaped uterus on the reproductive outcomes of IVF. Methods IVF outcomes of 74 patients who underwent hysteroscopic metroplasty for T- shaped uterus and 148 patients without any uterine abnormalities and with diagnosis of unexplained infertility (control group) were retrospectively analyzed. Results Patients in metroplasty and control groups were comparable with respect to age, BMI, partner’s age and duration of infertility. Number of patients with a history of pregnancy beyond 20 weeks of gestation was significantly lower in the metroplasty group (4.1% vs 18.2%; p < 0.05). Number of previous unsuccessful cycles and percentage of patients with ≥3 unsuccessful IVF cycles (35.1% vs 17.6%; p < 0.05) were significantly higher in the metroplasty group. There were no significant differences in the reproductive outcomes such as the pregnancy rate, clinical pregnancy or live birth rate between the metroplasty and control groups. There were non-significant trends for higher rates of miscarriage (18.8% vs 8%, p > 0.05) and biochemical pregnancy (20.0% vs 10.7%, p > 0.05) in the metroplasty group compared to the control group. Conclusions Reproductive results of the IVF cycles after hysteroscopic correction of T-shaped uterus were comparable to those of the patients without any uterine abnormalities and with diagnosis of unexplained infertility. Hysteroscopic metroplasty may contribute to improved IVF outcomes in patients with T-shaped uterus.

Letter to the Editor

PEDIATRICS ◽  
1994 ◽  
Vol 93 (5) ◽  
pp. 871-871
Author(s):  
Mary C. Theroux ◽  
David West
Keyword(s):  
Heart Rate ◽  
Placebo Group ◽  
Multiple Comparisons ◽  
Control Group ◽  
Placebo Control ◽  
Maximum Heart Rate ◽  
Control Groups ◽  
Placebo Control Group ◽  
Objective Outcome ◽  
Mean Heart Rate

We thank Drs Lopez and Urbansky for their comments. Their observation that the placebo group may have sufficiently biased the combined placebo/control group to account for the significant findings noted is reasonable, despite no significant differences being found between the placebo group and the control group. Analysis of variance among the three groups was carried out for the objective outcome variables. Differences in mean heart rate changes and maximum heart rate changes remained significant, and differences between study versus control groups and study versus placebo groups were both found to be significant, accounting for multiple comparisons.

Abstract 102: Out-of-Hospital Cardiac Arrest Clinical Trial Control Groups: Time Capsules for Discovery of Secular Trends---Fraction of Patients with Good Neurological Outcomes, 1985 to Present

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Katelin M Engerer ◽  
James V Coleman ◽  
Luca F Valle ◽  
Matt Roginski ◽  
Norman A Paradis
Keyword(s):  
Cardiac Arrest ◽  
Neurological Outcome ◽  
Randomized Clinical Trials ◽  
Temperature Management ◽  
Control Group ◽  
Control Groups ◽  
Large Variability ◽  
Patterns Of Utilization ◽  
Resuscitated Patients ◽  
Hospital Cardiac Arrest

Introduction: Over time there have been changes in consensus therapy for out of hospital cardiac arrest (OOHCA), including changes in BLS-ACLS, and recently targeted temperature management. There has been only limited success, however, in determining the effect of specific interventions on neurological outcome using randomized clinical trials (RCT’s) and registries. Hypothesis: The control groups in OOHCA RCT’s can be utilized to identify the presence or absence of potential trends in neurological outcome related to secular changes in care. Methods: Comprehensive online search for RCT’s in OOHCA with n > 50 in control group, and reporting neurological outcome, 1960 to present. Extraction of demographic and outcome variables. Analysis, fraction of resuscitated patients with good neurological outcome (GNO), defined as CPC 1 or 2 as a function of year. Results: n=32 usable RCTS were identified, all since 1985. No significant trends in the fraction of patients with GNO were identified (Figure). There was relatively large variability. Outcomes in the epoch since the promulgation of hypothermia have not changed overall. However, since about 2012 there have been a handful of RCT’s with relatively high fraction of patients with GNO compared to historical norms. Limitations: Retrospective methodology and background regional differences limits significance and applicability, hypothesis generating only. Conclusion: Between 1985 and the present, there were no trends in GNO rates in the control groups of RCTs, possibly indicating lack of efficacy or toxicity with respect to therapies experiencing changing patterns of utilization, or an offsetting change in substrate.

scholarly journals Neuropsychological rehabilitation program and behavioral disturbances in early-stage Alzheimer patients

2008 ◽  
Vol 2 (2) ◽  
pp. 146-150
Author(s):  
Vera Lúcia Duarte Vieira ◽  
Sônia Maria Dozzi Brucki ◽  
Anna Luiza Costa Marques Martins ◽  
Fabíola Canali ◽  
Luciano Gois ◽  
...  
Keyword(s):  
Pharmacological Treatment ◽  
Cognitive Rehabilitation ◽  
Cholinesterase Inhibitors ◽  
Early Stage ◽  
Rehabilitation Program ◽  
Disease Assessment ◽  
Control Group ◽  
Behavioral Alteration ◽  
Neuropsychological Rehabilitation ◽  
Number Of Patients

Abstract Alzheimer's disease (AD) is the most frequent cause of dementia and cholinesterase inhibitors are the available treatment in the mild stage. However cognitive rehabilitation has shown satisfactory results when combined with pharmacological treatment. Behavioral alteration is common in AD patients, which burdens caregivers and raises the risk of institutionalization. Providing caregivers guidance may enable them to assure better quality of life for patient and caregiver and lower institutionalization rates. Objective: To evaluate the effects of a neuropsychological rehabilitation program (NRP) combined with pharmacological treatment in early stage AD patients. Methods: We studied 12 AD patients (6 women), average age 75.42 (6.22) with 9.58 (5.6) years education in use of stable doses of cholinesterase inhibitors. Cognitive performance was evaluated using Mini-Mental State Examination (MMSE) and Alzheimer´s Disease Assessment Scale-cognitive (ADAS-Cog). Caregivers responded to Neuropsychiatric Inventory (NPI) and Functional Activities Questionnaire (FAQ) at initial evaluation (T1), and after 8 months of rehabilitation program (T2). The program comprised two sessions every week and family guidance every fortnight. Results: MMSE (T1:23.25 (1.82)/T2:23.42 (2.81); ADAS-Cog (T1:17.11 (6.73)/T2:21.2 (8.59); NPI (T1:23.42 (23.38)/T2:19.83 (17.73); FAQ (T1:10.67 (7.24)/T2: 13.92 (6.92). Conclusions: These results show the importance of providing guidance and support for caretakers. Study limitations were the small number of patients and absence of a control group with only drug treatment to compare with combined pharmacological and rehabilitation treatments.

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