Trial of long-term anticoagulant therapy in the treatment of small stroke associated with a normal carotid arteriogram.

Anticoagulant vs anti-platelet therapy as prophylactic against cerebral infarction in transient ischemic attacks.

Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study.

A randomized trial of anticoagulants versus aspirin after cerebral ischemia of presumed arterial origin. The Stroke Prevention in Reversible Ischemia Trial (SPIRIT) Study Group.

Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial.

Long-term follow-up after extracranial internal carotid artery dissection.

Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial.

Treatment with anticoagulants in cerebral events (TRACE).

The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators.

Abstract: The clinical features of 49 patients who had sustained small strokes in the internal carotid artery territory, who were normotensive, free from cardiac or other relevant disease, and who each had a normal appropriate single vessel angiogram are presented. These were randomized into two groups: group A, 25 patients, who received only supportive treatment; group B, 24 patients who were treated with anticoagulants for an average period of 18 months. There was a reduced incidence of neurological episodes during the administration of anticoagulant therapy but, after treatment was discontinued, there was no significant difference between the two groups. In view of the relatively benign prognosis for this syndrome, unless special facilities exist for the personal control of anticoagulant treatment, the dangers may outweigh the benefits.

Abstract: 156 patients with transient ischemic attacks (TIA) or reversible ischemic neurological deficit (RIND) were given prophylactic anticoagulant (AC) treatment against cerebral infarction in a prospective multicenter study from 5 hospitals in southern Sweden. After 2 months of AC treatment, 135 patients remained in the study and were randomized into 2 groups; one continued with AC treatment and one changed to anti-platelet therapy. The patients were followed for 12 months. No significant difference was seen between the 2 groups but 3 completed cerebral infarctions occurred during anti-platelet therapy against one during AC treatment. One cerebral hemorrhage was seen during AC treatment. All completed strokes occurred in men who initially had carotid symptoms. The number of patients with TIA/RIND was somewhat higher in the anti-platelet group whereas myocardial infarctions occurred more often during AC treatment. Compared to the natural history of untreated TIA/RIND both treatments were found to have a prophylactic effect against cerebral infarction.

Abstract:
This trial evaluated the efficacy and safety of the combination of antiplatelet and moderate-intensity anticoagulation therapy in patients with atrial fibrillation associated with recognized risk factors or mitral stenosis.
                Warfarin was more effective than aspirin in preventing stroke in these patients; combined therapy with low anticoagulant intensity was ineffective. Mitral stenosis patients were not investigated.
                We performed a multicenter randomized trial in 1,209 patients at risk. The intermediate-risk group included patients with risk factors or age >60 years: 242 received the cyclooxygenase inhibitor triflusal, 237 received acenocumarol, and 235 received a combination of both. The high-risk group included patients with prior embolism or mitral stenosis: 259 received anticoagulants and 236 received the combined therapy. Median follow-up was 2.76 years. Primary outcome was a composite of vascular death and nonfatal stroke or systemic embolism.
                Primary outcome was lower in the combined therapy than in the anticoagulant arm in both the intermediate- (hazard ratio [HR] 0.33 [95% confidence interval (CI)0.12 to 0.91]; p = 0.02) and the high-risk group (HR 0.51 [95% CI 0.27 to 0.96]; p = 0.03). Primary outcome plus severe bleeding was lower with combined therapy in the intermediate-risk group. Nonvalvular and mitral stenosis patients had similar embolic event rates during anticoagulant therapy.
                The combined antiplatelet plus moderate-intensity anticoagulation therapy significantly decreased the vascular events compared with anticoagulation alone and proved to be safe in atrial fibrillation patients.

Abstract: Aspirin is only modestly effective in the secondary prevention after cerebral ischemia. Studies in other vascular disorders suggest that anticoagulant drugs in patients with cerebral ischemia of presumed arterial (noncardiac) origin might be more effective. The aim of the Stroke Prevention in Reversible Ischemia Trial (SPIRIT) therefore was to compare the efficacy and safety of 30 mg aspirin daily and oral anticoagulation (international normalized ratio [INR] 3.0-4.5). Patients referred to a neurologist in one of 58 collaborating centers because of a transient ischemic attack or minor ischemic stroke (Rankin grade < or =3) were eligible. Randomization was concealed, treatment assignment was open, and assessment of outcome events was masked. The primary measure of outcome was the composite event "death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction, or nonfatal major bleeding complication." The trial was stopped at the first interim analysis. A total of 1,316 patients participated; their mean follow-up was 14 months. There was an excess of the primary outcome event in the anticoagulated group (81 of 651) versus 36 of 665 in the aspirin group (hazard ratio, 2.3; 95% confidence interval [CI], 1.6-3.5). This excess could be attributed to 53 major bleeding complications (27 intracranial; 17 fatal) during anticoagulant therapy versus 6 on aspirin (3 intracranial; 1 fatal). The bleeding incidence increased by a factor of 1.43 (95% CI, 0.96-2.13) for each 0.5 unit increase of the achieved INR. Anticoagulant therapy with an INR range of 3.0 to 4.5 in patients after cerebral ischemia of presumed arterial origin is not safe. The efficacy of a lower intensity anticoagulation regimen remains to be determined.

Abstract:
Too few patients with nonvalvular atrial fibrillation (NVAF) receive appropriate antithrombotic therapy. We tested the short-term (primary outcome) and long-term (secondary outcome) effect of a patient decision aid on the appropriateness of antithrombotic therapy among patients with NVAF.
                We conducted a cluster randomized trial with blinded outcome assessment involving 434 NVAF patients from 102 community-based primary care practices. Patients in the intervention group received a self-administered booklet and audiotape decision aid tailored to their personal stroke risk profile. Patients in the control group received usual care. The primary outcome measure was change in antithrombotic therapy at 3 months. Appropriateness of therapy was defined using the American College of Chest Physicians (ACCP) recommendations.
                The mean patient age was 72 years, and the median duration of NVAF was 5 years. In the control group, there was a 3% decrease over 3 months in the number of patients receiving therapy appropriate to their risk of stroke (40% [85/215] at baseline v. 37% [79/215] at 3 months). In the intervention group, the number of patients receiving therapy appropriate to their stroke risk increased by 9% (32% [69/219] at baseline v. 41% [89/219] at 3 months). Although the proportion of patients whose therapy met the ACCP treatment recommendations did not differ between study arms at baseline (p = 0.11) or 3 months (p = 0.44), there was a 12% absolute improvement in the number of patients receiving appropriate care in the intervention group compared with the control group at 3 months (p = 0.03). The beneficial effect of the decision aid did not persist (p = 0.44 for differences between study arms after 12 months).
                There was short-term improvement in the appropriateness of antithrombotic care among patients with NVAF who were exposed to a decision aid, but the improvement did not persist.

Abstract:
To evaluate long-term outcome after extracranial internal carotid artery dissection (eICAD) in consideration of the applied antithrombotic therapy.
                Among 33 consecutive eICAD patients initially treated either with anticoagulation (n = 25) or with antiplatelets (n = 8), a standardized interview was performed after 28 +/- 22.1 months to analyze risks and benefits of both agents. Ischemic and hemorrhagic complications, occurrence of seizure and rates of arterial recanalization were compared and long-term clinical outcome was assessed using the modified Rankin Scale (mRS) and Barthel Index (BI).
                Among anticoagulated patients, 1 died due to brain herniation. In 3 patients stroke (n = 2) or TIA (n = 1) recurred. In the antiplatelet group, none died and no subsequent ischemic events happened. Hemorrhagic complications were noted in neither treatment group. Functional outcome among anticoagulated patients was BI 92 +/- 21.6 and mRS 1.48 +/- 1.50, which did not differ from patients initially treated with antiplatelets (BI 89 +/- 18.9, mRS 1.50 +/- 1.41, p > 0.05). Four anticoagulated patients developed seizures, compared to 2 patients with antiplatelets (p > 0.05). Arterial recanalization occurred in 16 of 22 antico- agulated patients with ultrasound follow-up, compared to 6 of 6 patients with antiplatelets (p > 0.05).
                In the absence of iatrogenic side effects, both anticoagulation and antiplatelets seem to be safe for eICAD. The rates for death and stroke were low and outcome ratings did not differ between both agents. These findings may indicate that a controlled randomized trial comparing anticoagulation and antiplatelets is ethically justified.
                Copyright 2000 S. Karger AG, Basel

Abstract:
Oral anticoagulants are better than aspirin for secondary prevention after myocardial infarction and after cerebral ischaemia in combination with non-rheumatic atrial fibrillation. The European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) aimed to determine whether oral anticoagulation with medium intensity is more effective than aspirin in preventing future vascular events in patients with transient ischaemic attack or minor stroke of presumed arterial origin.
                In this international, multicentre trial, patients were randomly assigned within 6 months after a transient ischaemic attack or minor stroke of presumed arterial origin either anticoagulants (target INR range 2.0-3.0; n=536) or aspirin (30-325 mg daily; n=532). The primary outcome was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever occurred first. In a post hoc analysis anticoagulants were compared with the combination of aspirin and dipyridamole (200 mg twice daily). Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with ClinicalTrials.gov (NCT00161070).
                The anticoagulants versus aspirin comparison of ESPRIT was prematurely ended because ESPRIT reported previously that the combination of aspirin and dipyridamole was more effective than aspirin alone. Mean follow-up was 4.6 years (SD 2.2). The mean achieved INR was 2.57 (SD 0.86). A primary outcome event occurred in 99 (19%) patients on anticoagulants and in 98 (18%) patients on aspirin (hazard ratio [HR] 1.02, 95% CI 0.77-1.35). The HR for ischaemic events was 0.73 (0.52-1.01) and for major bleeding complications 2.56 (1.48-4.43). The HR for the primary outcome event comparing anticoagulants with the combination treatment of aspirin and dipyridamole was 1.31 (0.98-1.75).
                Oral anticoagulants (target INR range 2.0-3.0) are not more effective than aspirin for secondary prevention after transient ischaemic attack or minor stroke of arterial origin. A possible protective effect against ischaemic events is offset by increased bleeding complications.

Abstract: 90 patients with acute stroke and a concomitant cardiac embolism source or a symptomatic high-grade stenosis of an extra-or intracranial vessel received in a mulitcenter, randomized, controlled study either Enoxaparin 1 mg/kg BW s.c. b.i.d. or i.v. heparin aPTT-adjusted daily for 8 +/- 2 days as secondary prophylaxis. There were no significant differences between the two groups regarding cerebral and systemic embolic events, bleeding complications, length of hospital stay, number of diagnostic and therapeutic measures and outcome after three months. This suggests that Enoxaparin, which is easier to administer and monitor, is a safe drug in patients with acute cerebral events.

Abstract:
Nonrheumatic atrial fibrillation increases the risk of stroke, presumably from atrial thromboemboli. There is uncertainty about the efficacy and risks of long-term warfarin therapy to prevent stroke.
                We conducted an unblinded, randomized, controlled trial of long-term, low-dose warfarin therapy (target prothrombin-time ratio, 1.2 to 1.5) in patients with nonrheumatic atrial fibrillation. The control group was not given warfarin but could choose to take aspirin.
                A total of 420 patients entered the trial (212 in the warfarin group and 208 in the control group) and were followed for an average of 2.2 years. Prothrombin times in the warfarin group were in the target range 83 percent of the time. Only 10 percent of the patients assigned to receive warfarin discontinued the drug permanently. There were 2 strokes in the warfarin group (incidence, 0.41 percent per year) as compared with 13 strokes in the control group (incidence, 2.98 percent per year), for a reduction of 86 percent in the risk of stroke (warfarin:control incidence ratio = 0.14; 95 percent confidence interval, 0.04 to 0.49; P = 0.0022). There were 37 deaths altogether. The death rate was markedly lower in the warfarin group than in the control group: 2.25 percent as compared with 5.97 percent per year, for an incidence ratio of 0.38 (95 percent confidence interval, 0.17 to 0.82; P = 0.005). There was one fatal hemorrhage in each group. The frequency of bleeding events that led to hospitalization or transfusion was essentially the same in both groups. The warfarin group had a higher rate of minor hemorrhage than the control group (38 vs. 21 patients).
                Long-term low-dose warfarin therapy is highly effective in preventing stroke in patients with non-rheumatic atrial fibrillation, and can be quite safe with careful monitoring.

Compared with control, there was no evidence of benefit from long-term anticoagulant therapy in people with presumed non-cardioembolic ischaemic stroke or transient ischaemic attack, but there was a significant bleeding risk.


Neuropsychological counseling improves social behavior in cognitively-impaired multiple sclerosis patients.

An evaluation of cognitive-behaviour therapy for depression in patients with multiple sclerosis.

Telephone-administered cognitive-behavioral therapy for the treatment of depressive symptoms in multiple sclerosis.

Effects of neuropsychological treatment in patients with multiple sclerosis.

Professional and paraprofessional group treatments for depression: a comparison of cognitive-behavioral and mutual support interventions.

A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia.

Comparative outcomes for individual cognitive-behavior therapy, supportive-expressive group psychotherapy, and sertraline for the treatment of depression in multiple sclerosis.

A trial of two cognitive-behavioural methods of treating drug-resistant residual psychotic symptoms in schizophrenic patients: I. Outcome.

Evaluation of cognitive assessment and cognitive intervention for people with multiple sclerosis.

Abstract: We studied the effectiveness of a newly-developed cognitive-behavioral intervention in 15 patients with marked cognitive impairment and behavior disorder. The design was a single-blind test of a neuropsychological intervention, with pre- and post-treatment assessments of personality and social behavior. MS patients underwent neurological examination and neuropsychological testing at baseline. The patients were then randomly assigned to neuropsychological counseling or standard, non-specific supportive psychotherapy. The active 12-week treatment emphasized enhancement of insight through education, social skills training, and behavior modification. All patients were re-examined within 2 weeks of the termination of treatment. Neuropsychological technicians were blind to treatment condition. Both groups showed evidence of cognitive impairment and personality/behavior disorder prior to treatment and were well matched on demographic, disability, and cognitive measures. Patients who underwent neuropsychological counseling showed significant positive response on measures of social behavior (e.g. excessive ego-centric speech) compared to those who underwent standard counseling. We conclude that these data support the use of non-pharmacological, neuropsychological counseling in patients with acquired, MS-associated behavior disorder.

Abstract: Twenty depressed multiple sclerotic patients were randomly allocated either to cognitive-behaviour therapy or to a waiting list control condition. Assessment of depressive symptoms was conducted at pre-treatment, post-treatment, and a four-week follow-up. In comparison to the waiting list condition, cognitive-behaviour therapy was found to result in clinically and statistically significant improvement on most measures. Although the mechanism by which such treatment achieves its effects is unclear, these results clearly support the use of cognitive-behavioural treatments for depression in this population.

Abstract: This study examined the efficacy of an 8-week telephone-administered cognitive-behavioral therapy (CBT) for the treatment of depressive symptomatology in multiple sclerosis (MS) patients. The treatment, Coping with MS (CMS), included a patient workbook designed to structure the treatment, provide visual aids, and help with homework assignments. Thirty-two patients with MS, who scored at least 15 on the Profile of Mood States Depression-Dejection scale, were randomly assigned to either the telephone CMS or to a usual-care control (UCC) condition. Depressive symptomatology decreased significantly in the CMS condition compared with the UCC condition. Furthermore, adherence to interferon beta-1a, a disease-modifying medication for the treatment of MS, was significantly better at the 4-month follow-up among patients who received CMS as compared with those in the UCC condition.

Abstract: The chronic and progressive nature of multiple sclerosis (MS) often excludes patients from neuropsychological treatment. At the Multiple Sclerosis Rehabilitation Hospital, Haslev, 40 patients with mild to moderate cognitive and behavioral impairment associated with MS were randomized to either specific cognitive treatment (20 pts) by direct training, compensatory strategies and neuropsychotherapy, or to non-specific, deliberately diffuse mental stimulation (20 pts). Treatment was for a mean of 46 days. The effects of treatment were evaluated by neuropsychological tests before treatment, immediately after treatment (short-term effects) and 6 months later (long-term effects). After short-term treatment, effects on cognitive measures were not convincing, but on the Beck Depression Inventory (BDI) the specific cognitive treatment group reported significantly less depression. After 6 months only this group showed an effect, since the visuo-spatial memory was improved. However, the depression ratings (BDI) were almost maintained from the short-term level. Interestingly, the non-specific treatment group rated themselves as significantly more depressed. Conclusively, it is worth while to offer specific neuropsychological treatment to MS patients with cognitive and behavioral dysfunction.

Abstract: The relative efficacy of professional and paraprofessional therapists in providing group cognitive-behavioral therapy (CBT) and mutual support group therapy (MSG) was examined. Depressed outpatients (N = 98) were randomly assigned to CBT or MSG led by either 2 professional or 2 paraprofessional therapists. Results suggest that nonprofessionals were as effective as professionals in reducing depressive symptoms and that clients in the CBT and MSG conditions improved equally. Clinically significant improvement was demonstrated for both conditions. However, following treatment, more patients in the professionally led CBT groups were classified as nondepressed and alleviated than in the paraprofessionally led CBT groups. Additionally, therapist adherence to manual-based treatments was associated with greater improvement in clinician-rated depressive symptoms in both conditions and skills in cognitive restructuring were associated with greater improvement among clients in CBT.

Abstract:
To investigate short-term effects of Multi-Sensory Stimulation (MSS) on behaviour, mood and cognition of older adults with dementia, the generalization of effects to day hospital and home environments and the endurance of any effects over time.
                A randomized controlled trial comparing MSS with a credible control of one-to-one activities.
                Fifty patients with diagnoses of moderate to severe dementia were randomized to either MSS or Activity groups. Patients participated in eight 30-minute sessions over a 4-week period. Ratings of behaviour and mood were taken before, during and after sessions to investigate immediate effects. Pre, mid, post-trial, and follow-up assessments were taken to investigate any generalization of effects on cognition, behaviour at the day hospital and behaviour and mood at home and endurance of effects once sessions had ceased.
                Immediately after MSS and Activity sessions patients talked more spontaneously, related better to others, did more from their own initiative, were less bored/inactive, and were more happy, active or alert. Both groups were more attentive to their environment than before, with a significantly greater improvement from the MSS group. At the day hospital, patients in the Activity group improved on their 'speech skills' (amount of speech; initiation of speech), whereas the MSS group remained unchanged during the trial. The MSS group showed a significant improvement in mood and behaviour at home compared to the Activity group whose behaviour deteriorated. No longer-term benefits were shown; indeed, behaviour declined sharply during the month follow-up period.
                Both MSS and Activity sessions appear to be effective and appropriate therapies for people with dementia.

Abstract: This study compared the efficacy of 3 16-week treatments for depression in 63 patients with multiple sclerosis (MS) and major depressive disorder (MDD): individual cognitive-behavioral therapy (CBT), supportive-expressive group therapy (SEG). and the antidepressant sertraline. Significant reductions were seen from pre- to posttreatment in all measures of depression. Intent-to-treat and completers analyses using the Beck Depression Inventory (BDI; A. T. Beck, C. H. Ward. M. Medelson. J. Mock, & J. Erbaugh, 1961) and MDD diagnosis found that CBT and sertraline were more effective than SEG at reducing depression. These results were largely supported by the BDI-18, which eliminates BDI items confounded with MS. However, the Hamilton Rating Scale for Depression (M. Hamilton, 1960) did not show consistent differences between treatments. Reasons for this inconsistency are discussed. These findings suggest that CBT or sertraline is more likely to be effective in treating MDD in MS compared with supportive group treatments.

Abstract: Despite neuroleptic medication, many schizophrenic patients continue to experience residual positive psychotic symptoms. These residual symptoms cause distress and disability. We report a controlled trial of two cognitive-behavioural treatments to alleviate residual hallucinations and delusions. Forty-nine patients were recruited into the trial, of whom 27 entered the trial and completed post-treatment assessment, and 23 were reassessed at six-month follow-up. Patients were randomly allocated to either coping strategy enhancement (CSE) or problem solving (PS). Half the patients were allocated to a high-expectancy positive demand condition and half to a counter-demand condition to evaluate expectation of improvement. Patients receiving either cognitive-behavioural treatment showed significant reductions in psychotic symptoms compared with those in the waiting period, who showed no improvement. There was some evidence, although equivocal, that patients receiving CSE improved more than those receiving PS. There was no evidence that improvements generalised to negative symptoms or social functioning, nor was there evidence that expectancy of treatment benefit contributed to the treatment effect.

Abstract:
Cognitive problems in multiple sclerosis are common but any possible benefits of treatment remain uncertain. The aim of the study was to evaluate the benefits of providing a psychology service, including cognitive assessment and intervention, to patients with multiple sclerosis.
                The study was a single blind randomised controlled trial. A total of 240 patients with clinically definite, laboratory supported, or clinically probable multiple sclerosis were recruited from an multiple sclerosis management clinic and assessed on a brief screening battery. They were randomised into three groups. The control group received no further intervention. The assessment group received a detailed cognitive assessment, the result of which was fed back to staff involved in the patients' care. The treatment group received the same detailed cognitive assessment and a treatment programme designed to help reduce the impact of their cognitive problems. Patients were followed up 4 and 8 months later on the general health questionnaire (GHQ-28), extended activities of daily living scale, SF-36, everyday memory questionnaire, dysexecutive syndrome questionnaire, and memory aids questionnaire.
                The three groups were compared on the outcome measures at 4 and 8 months after recruitment. There were few significant differences between the groups and those that occurred favoured the control group. Overall, the results showed no effect of the interventions on mood, quality of life, subjective cognitive impairment or independence.
                The study failed to detect any significant effects of cognitive assessment or cognitive intervention in this cohort of people with multiple sclerosis.

The diversity of psychological interventions identified indicates the many ways in which they can potentially help people with MS. No definite conclusions can be made from this review. However there is reasonable evidence that cognitive behavioural approaches are beneficial in the treatment of depression, and in helping people adjust to, and cope with, having MS.


Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial.

Rofecoxib in the acute treatment of migraine: a randomized controlled clinical trial.

Effectiveness of ibuprofen-arginine in the treatment of acute migraine attacks.

Placebo-controlled comparison of effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the treatment of migraine attacks.

Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine: results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study.

The efficacy of metoclopramide in the treatment of migraine headache.

Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial.

Ibuprofen plus caffeine in the treatment of tension-type headache.

Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial.

Abstract:
To evaluate the efficacy and safety of ibuprofen, 200 mg and 400 mg, compared with placebo and each other for the treatment of pain of migraine headache.
                Migraine headache is a common illness with significant social and economic impact.
                Randomized, placebo-controlled, double-blind trial of 6 hours' treatment duration.
                Fifteen investigators at 17 private practice and referral centers in the United States participated in this study of 660 outpatient adults aged 18 to 84 years with migraine headache of moderate to severe intensity. Each patient was randomly assigned to a single dose of study medication: ibuprofen 200 mg (n = 216) or 400 mg (n = 223), or placebo (n = 221). The percentage of patients with a reduction in baseline headache intensity from severe or moderate to mild or none 2 hours after treatment and the headache pain intensity difference from baseline at 2 hours were the primary efficacy measures. Secondary outcomes included other measures of pain relief, severity differences from baseline for migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability, and percentage of patients with migraine-associated symptoms reduced to none.
                Significantly (P < or = .006) more patients treated with ibuprofen, 200 mg or 400 mg, reported mild to no pain after 2 hours (41.7% and 40.8%, respectively), compared with those treated with placebo (28.1%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P < or = .001) greater for patients treated with ibuprofen 200 mg or 400 mg (0.68 and 0.65, respectively), compared with those treated with placebo (0.39). Statistically significant differences in favor of both doses of ibuprofen over placebo were observed for mean pain intensity difference at 1 hour after treatment. In patients with severe baseline pain intensity, ibuprofen, 400 mg, was significantly (P < or = .048) superior to placebo for the primary efficacy end points, while ibuprofen, 200 mg, was not. Ibuprofen, 200 mg and 400 mg, were statistically significantly more effective than placebo for all clinically important secondary pain relief outcomes. Mean severity changes of migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability at 2 and 6 hours were significantly (P < or = .03) in favor of both doses of ibuprofen over placebo, and results for the percentage of patients with symptoms reduced to none consistently, although less often statistically significant, favored ibuprofen. No statistically significant differences in adverse events were found among treatment groups.
                Ibuprofen at doses of 200 mg and 400 mg is an efficacious, cost-effective, well-tolerated, single-ingredient nonprescription treatment for pain of migraine headache. In addition, while not always statistically significant, ibuprofen provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disability.

Abstract:
To investigate the efficacy, tolerability, and safety of rofecoxib and ibuprofen for acute migraine treatment.
                Rofecoxib was effective and well tolerated in a previous study of treatment of a single migraine attack. We sought to replicate these findings for a single attack and also study the clinical profile of rofecoxib in the acute treatment of multiple migraine attacks. Ibuprofen was included as a reference nonselective NSAID.
                Adult migraineurs (n = 783) treated one migraine attack with either rofecoxib (25 or 50 mg), ibuprofen 400 mg, or placebo in a randomized, double-blind study. Patients could elect to enroll in a 3-month double-blind extension phase.
                In the single-attack phase, headache relief at 2 hours postdose was reported by 59.4%, 62.2%, and 57.7% of patients who took rofecoxib 25 mg, rofecoxib 50 mg, and ibuprofen 400 mg, respectively, versus 30.5% for placebo (all P < .001 vs placebo). The active drugs were statistically superior to placebo on a variety of additional measures. In the extension phase, the mean percentage of patients' attacks with headache relief at 2 hours postdose was 61.8% for rofecoxib 25 mg, 65.4% for rofecoxib 50 mg, and 59.3% for ibuprofen 400 mg. The mean percentage of patients' attacks with 24-hour sustained headache relief was greater for rofecoxib 50 mg (52.0%) than for rofecoxib 25 mg (47.8%, P < .050) or ibuprofen (39.0%, P < .010). In the single-attack phase, the adverse event rate was higher for rofecoxib 50 mg (37.8%) than placebo (27.8%, P < .050); rates were similar to placebo for rofecoxib 25 mg (32.0%, n.s.) and ibuprofen 400 mg (28.1%, n.s.). In the extension phase, treatment groups had similar adverse event rates.
                Rofecoxib 25 and 50 mg and ibuprofen 400 mg were effective and generally well tolerated in the acute treatment of migraine.

Abstract: The purpose of this study was to evaluate the effectiveness of a new formulation of ibuprofen (ibuprofen-arginine [IA]) in the treatment of migraine attacks. This is a faster absorbed formulation as compared with ibuprofen alone. The rapidity of action is considered to be a crucial factor in the treatment of migraine attacks. Forty migraine patients participated in this multicenter, double-blind, crossover, randomized, placebo-controlled trial. Each patient was treated with a single oral dose of IA 400 mg or placebo during two consecutive migraine attacks. The results confirm the efficacy of IA, with a significant (p < 0.05) improvement in pain relief at 30 min after treatment. A statistically significant (p < 0.001) reduction in pain intensity was observed at 1, 2, 4 and 6 h after treatment with ibuprofen as compared with placebo. IA was well tolerated and our data indicate that this new formulation of ibuprofen is valuable in the treatment of acute migraine attacks.

Abstract: Acetylsalicylic acid (ASA) in combination with metoclopramide has been frequently used in clinical trials in the acute treatment of migraine attacks. Recently the efficacy of a new high buffered formulation of 1000 mg effervescent ASA without metoclopramide compared to placebo has been shown. To further confirm the efficacy of this new formulation in comparison with a triptan and a nonsteroidal anti-inflammatory drug (ibuprofen) a three-fold crossover, double-blind, randomized trial with 312 patients was conducted in Germany, Italy and Spain. Effervescent ASA (1000 mg) was compared to encapsulated sumatriptan (50 mg), ibuprofen (400 mg) and placebo. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (primary endpoint) was 52.5% for ASA, 60.2% for ibuprofen, 55.8% for sumatriptan and 30.6% for placebo. All active treatments were superior to placebo (P < 0.0001), whereas active treatments were not statistically different. The number of patients who were pain-free at 2 h was 27.1%, 33.2%, 37.1% and 12.6% for those treated with ASA, ibuprofen, sumatriptan or placebo, respectively. The difference between ASA and sumatriptan was statistically significant (P = 0.025). With respect to other secondary efficacy criteria and accompanying symptoms no statistically significant differences between ASA and ibuprofen or sumatriptan were found. Drug-related adverse events were reported in 4.1%, 5.7%, 6.6% and 4.5% of patients treated with ASA, ibuprofen sumatriptan or placebo. This study showed that 1000 mg effervescent ASA is as effective as 50 mg sumatriptan and 400 mg ibuprofen in the treatment of migraine attacks regarding headache relief from moderate/severe to mild/no pain at 2 h. Regarding pain-free at 2 h sumatriptan was most effective.

Abstract:
Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine.
                Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief.
                There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036).
                AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.

Abstract:
By evaluating the efficacy of metoclopramide alone and in combination with ibuprofen versus placebos, this study was designed to both evaluate the efficacy of metoclopramide and elucidate its mechanism of action in the treatment of migraine headache.
                The study was conducted over a two-year period and was a randomized, double-blind, placebo-controlled study.
                An urban teaching hospital.
                Patients enrolled were at least 18 years old and had recurring headaches with one or more of the following characteristics: unilateral, preceded by neurologic symptoms, significant nausea and vomiting, or mood changes and photophobia.
                Ten milligrams of metoclopramide or an equal volume of IV normal saline was given and 600 mg of ibuprofen or identical-appearing placebo was given orally at time 0. Patients rated their pain and nausea at time 0, 30 minutes, and 60 minutes using visual-analog scales.
                The differences in pain and nausea scores for the metoclopramide + placebos group versus the other three groups were tested using exact nonparametric (Mann-Whitney) statistical procedures. The metoclopramide + placebos group had significantly better relief of pain compared with the placebos + ibuprofen and placebos + placebos groups. The metoclopramide + placebos group had significantly better relief of nausea than the ibuprofen + placebos group; nausea scores for the placebos + placebos group could not be analyzed due to excessive variance from the other groups at baseline. The differences between the metoclopramide + placebos group and the metoclopramide + ibuprofen group were not statistically significant with regard to either pain or nausea.
                Metoclopramide is efficacious in the treatment of both the pain and nausea of migraine headache. This is a direct action that is not dependent on the concomitant administration of another agent.

Abstract:
Rofecoxib is a potent cyclo-oxygenase-2 inhibitor with a long duration of action. Its role in migraine has not been systematically evaluated.
                To study the efficacy of rofecoxib in migraine.
                In a randomised placebo controlled trial rofecoxib 25 mg, ibuprofen 400 mg, and placebo were compared regarding their efficacy in relieving acute migraine attack. Migraine patients with 2-6 attacks per month were recruited. Headache severity, functional disability, and severity of associated symptoms were graded on a 0-3 scale. The primary endpoint was pain relief at two hours. Relief of associated symptoms and sustained pain relief for 24 hours were also noted.
                One hundred and twenty four patients were randomised into rofecoxib (42), ibuprofen (40), and placebo (42) groups. One hundred and one patients were followed up: 33 on rofecoxib, 35 ibuprofen, and 33 placebo. Patients' ages ranged from 16-62 (mean 31.4) years, and 83 were females. Pain relief at two hours was noted in 45.5% on rofecoxib, 55.6% on ibuprofen, and 9.1% in the placebo group. The associated symptoms at two hours were reduced in 39.4% on rofecoxib, 50% on ibuprofen, and 9.1% in the placebo group. Sustained 24 hour pain relief was noted in 36.4% on rofecoxib, 41% on ibuprofen, and 6.1% in the placebo group. In the ibuprofen group, five patients had abdominal pain but there were no side effects in those on rofecoxib or in the control group. Both rofecoxib and ibuprofen were significantly effective in relieving pain, associated symptoms at two hours, and in sustained pain relief. There was no significant difference between rofecoxib and ibuprofen in aborting acute migraine attacks.
                Both ibuprofen and rofecoxib were superior to placebo in aborting an acute migraine attack, and there was no significant difference in their efficacy in an acute migraine attack.

Abstract:
The effectiveness of caffeine as an adjuvant to ibuprofen has been documented in investigations of acute pain. Our objectives were to assess this agent in the treatment of tension-type headache and to establish clinical trial methods capable of assessing this agent in comparison with various tension headache treatments. Stopwatch technology was used for measurement techniques.
                A randomized, double-blind, parallel, multicenter, single-dose, placebo- and active-controlled study included 301 subjects diagnosed with tension-type headache. Treatment groups included ibuprofen and caffeine, ibuprofen alone, caffeine alone, or placebo. Subjects measured onset of relief (both time to first perceptible relief and time to meaningful relief) after taking a single oral dose of their assigned medication. Pain intensity and pain relief were rated over a 6-hour study period. Overall evaluation was made on completion of all other ratings.
                Ibuprofen and caffeine administered together provided significantly greater analgesic activity than ibuprofen alone, caffeine alone, and placebo. Ibuprofen and caffeine administered together demonstrated significantly shorter times to meaningful improvement in headache relief than ibuprofen or placebo; significantly greater total analgesia than ibuprofen alone, caffeine alone, or placebo; and significantly greater peak relief than ibuprofen alone, caffeine alone, or placebo. Significantly more subjects obtained meaningful headache relief with ibuprofen and caffeine administered together than with ibuprofen alone or placebo. More patients reported complete headache relief with ibuprofen and caffeine administered together than with ibuprofen alone, caffeine alone, or placebo. Ibuprofen and caffeine administered together was rated significantly better by patients than either ibuprofen alone, caffeine alone, or placebo. No subjects ended participation in the study early because of adverse events.
                Sensitive methods have been introduced to assess differences in analgesia among over-the-counter analgesic agents in relieving tension-type headache pain. A double-blind study with this method suggests that ibuprofen and caffeine administered together provides greater analgesic effectiveness than either component alone.

Abstract: The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with <8 attacks/months were included. One hundred and fifty-five migraine patients were randomised to rizatriptan 10 mg (53), ibuprofen 400 mg (52) and placebo (50). Efficacy was assessed by headache relief, and headache freedom at 2 h and 24 h. Two-hour headache relief, was noted in 73% in rizatriptan, 53.8% in ibuprofen and 8% in placebo groups. Headache freedom was achieved in 37.7% in rizatriptan, 30.8% in ibuprofen and 2% in placebo groups. Rizatriptan was superior to ibuprofen and placebo in relieving headache at 2 h but not at 24 h. Side effects were noted in 9 patients in rizatriptan, 8 in ibuprofen and 3 in placebo, all of which were nonsignificant. Rizatriptan and ibuprofen are superior to placebo. Rizatriptan is superior to ibuprofen in relieving headache, associated symptoms and functional disability.

We found no new studies since the last version of this review. Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of sufferers, but complete relief from pain and associated symptoms for only a minority. NNTs for all efficacy outcomes were better with 400 mg than 200 mg in comparisons with placebo, and soluble formulations provided more rapid relief. Adverse events were mostly mild and transient, occurring at the same rate as with placebo.


Insulin lispro therapy in pregnancies complicated by type 1 diabetes mellitus.

Human insulin analogue [LYS(B28), PRO(B29)]: the ideal pump insulin?

[Comparison of intensified traditional insulin therapy and micropump therapy in pregnant women with type 1 diabetes mellitus].

Effect of the rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with Type 1 diabetes.

Evaluation of efficacy and safety of human insulin (Novo) in the treatment of insulin-dependent diabetes mellitus: a double-blind, multicenter clinical trial.

Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients.

Special management of insulin lispro in continuous subcutaneous insulin infusion in young diabetic children: a randomized cross-over study.

Effects of insulin pump vs. injection treatment on quality of life and impact of disease in children with type 1 diabetes mellitus in a randomized, prospective comparison.

Improved mealtime treatment of diabetes mellitus using an insulin analogue. Multicenter Insulin Lispro Study Group.

Abstract:
To compare the efficacy and safety of preprandial administration of rapid-acting lispro analogue with regular short-acting insulin to pregnant women with type 1 diabetes.
                Open randomised multicentre study. Women were treated with multiple insulin injections aiming at normoglycaemia. Blood glucose was determined six times daily, HbA(1c) every 4 weeks. Diurnal profiles of blood glucose were analysed at gestational week 14 and during the study period at weeks 21, 28 and 34.
                33 pregnant women with type 1 DM were randomised to treatment with lispro insulin (n=16) or regular insulin (n=17).
                Blood glucose was significantly lower (P<0.01) after breakfast in the lispro group, while there were no significant group differences in glycemic control during the rest of the day. Severe hypoglycaemia occurred in two patients in the regular group but biochemical hypoglycaemia (blood glucose <3.0 mmol/l) was more frequent in the lispro than in the regular group (5.5 vs. 3.9%, respectively). HbA(1c) values at inclusion were 6.5 and 6.6% in the lispro and regular group respectively. HbA(1c) values declined during the study period and were similar in both groups. There was no perinatal mortality. Complications during pregnancy, route of delivery and foetal outcome did not differ between the groups. Retinopathy progressed in both groups, one patient in the regular group developed proliferative retinopathy.
                The results suggest that it is possible to achieve at least as adequate glycemic control with lispro as with regular insulin therapy in type 1 diabetic pregnancies.

Abstract: The short-acting insulin analogue lispro ([LYS(B28), PRO(B29)] is absorbed from the subcutis more rapidly than soluble insulin (S). To compare the clinical effectiveness of lispro vs S, 11 Type 1 patients using continuous subcutaneous insulin infusion (CSII) therapy (6 F, 5 M, age 30 +/- 2.5 years, diabetes duration 14 +/- 1.0 years, BMI 24.0 +/- 0.8 kg m(-2), HbA1c 6.5 +/- 0.2%) were studied in an open, randomized, crossover study for 6 months (3 months lispro and 3 months S or vice versa). During lispro treatment mean fasting and 2 h postprandial blood glucose were lower compared to the S phase (fasting 6.5 +/- 0.4 vs 7.5 +/- 0.4 mmol l(-1) (NS), postprandial 6.8 +/- 0.3 vs 8.3 +/- 0.3 mmol l(-1), p = 0.03). In patients treated first with lispro HbA1c levels improved from 6.3 +/- 0.2% to 5.7 +/- 0.3%; On reversion to S HbA1c increased to 6.2 +/- 0.2%. In the group treated first with S, HbA1c fell (6.7 +/- 0.4% vs 6.5 +/- 0.3%) and then improved further to 6.3 +/- 0.3% with lispro. None of these changes were significant. There was no significant difference with respect to hypoglycaemic or other adverse events. It can be concluded that lispro in CSII therapy is safe and may improve postprandial glucose excursions.

Abstract: Ten pregnant women, affected by type I diabetes mellitus, observed for the first time during the II-III month of pregnancy, were examined. These patients were divided in two groups at random: group A underwent continuous subcutaneous insulin infusion with micropump CPI 9100 Lilly; group B underwent intensified insulin therapy with three daily doses of MC rapid insulin, two of which associated with MC intermediate insulin. All the patients were able to monitor their own blood glucose levels at home by means of reactive strips and reflectometer. In both the groups the mean glycemic values during fast and two hours after meals, and the eventual presence of urinary keton bodies and hypoglycemic crisis were evaluated during the course of pregnancy: these parameters turned out to be identical in the two groups. The increased need of insulin, the maternal body weight gain, the week and mode of delivery, the neonatal weight and the maternal and fetal complications also turned out to be identical in the two groups. To conclude, a good maternal metabolic control can be obtained either with the intensified conventional insulin therapy of with micropumps, if the patients, being properly instructed, are responsible for the monitoring of their own blood glucose levels at home.

Abstract:
To compare quality of life (QoL) and treatment satisfaction in patients with Type 1 diabetes receiving the rapid-acting insulin analogue, insulin aspart (IAsp), with that in patients receiving soluble human insulin (HI).
                In this 6-month, multinational, randomized, open-label trial, 424 patients from German-speaking countries were subjected to psychometric assessment before and after randomization (ratio 2 : 1) to basal-bolus treatment with either IAsp (n = 283) or HI (n = 141). Patients on HI were advised to keep an injection-meal interval of 30 min, whereas patients on IAsp were advised to inject immediately before meals. Treatment satisfaction and diabetes-related QoL were assessed using validated instruments to measure the domains of patients' individual treatment goals, physical complaints, worries about the future, social relations, leisure time flexibility, daily hassles, diet restrictions, burdens and fear of hypoglycaemia, blood glucose fluctuations, self-efficacy, and fear of insulin analogues.
                After 6 months, IAsp was associated with significantly greater improvement in treatment satisfaction than HI in two different scales (P < 0.01), and in QoL with respect to diet restrictions (P < 0.01). Improved satisfaction was mainly due to increased dietary and leisure time flexibility (P < 0.0001). Twenty-three percent of the IAsp group vs. 14% of the HI group achieved small but important improvements of total QoL (between-group difference, P < 0.06). The number needed to treat (NNT) with IAsp for an important increase in QoL was calculated to be 10. Regression analyses of potential predictors of improvement in QoL highlighted patients intensely striving for physical strength (P < 0.01; NNT = 7) and patients feeling less protected against hypoglycaemia (P < 0.005; NNT = 8) as being the most likely to benefit from IAsp.
                Under these study conditions, IAsp improved treatment satisfaction and quality of life regarding diet restrictions when compared with human insulin. The 'numbers needed to treat' for important quality of life benefits indicate that the effect of IAsp in this regard is not trivial.

Abstract: The safety and efficacy of human insulin (Novo) were evaluated in a double-blind, parallel, multicenter trial in which 47 insulin-dependent diabetic patients were randomly divided into two equal groups and treated with either purified pork or human insulin (Actrapid and Monotard, Novo) for 12 wk. Mean levels of fasting plasma glucose, glycohemoglobin, and daily insulin dosages showed no statistical differences between the two groups, and there was no significant difference in the incidence of hypoglycemic reactions. The results from this clinical trial indicate that human insulin, prepared by enzymatic transpeptidation of pork insulin, appears to be as safe and efficacious as purified pork insulin in the treatment of insulin-dependent diabetes mellitus.

Abstract:
Optimal insulin regimens for non-insulin-dependent diabetes mellitus (NIDDM) patients with secondary failure are controversial. We evaluated the efficacy, side effects, and quality of life of patients receiving insulin either alone or in combination with their previous oral hypoglycemic agents (OHAs).
                Fifty-three Chinese patients with NIDDM (mean age 53.9 +/- 12.6 years, duration of diabetes 9.0 +/- 4.9 years, body wt 60.4 +/- 13.3 kg with corresponding body mass index 24.2 +/- 4.3 kg/m2, receiving the maximum dose of sulfonylurea and/or metformin) were confirmed to have OHA failure. Twenty-seven patients were randomized to continue OHAs and were given additional bedtime insulin (combination group); 26 patients were randomized to insulin therapy alone with twice-daily insulin (insulin group). Insulin doses were increased incrementally, aiming at fasting plasma glucose (FPG) < 7.8 mmol/l during a stabilization period of up to 8 weeks. Insulin dosage, body weight, glycemic control, and quality of life were assessed before and at 3 and 6 months after stabilization.
                Both groups showed similar improvement of glycemic control. For the combination group, FPG decreased from 13.5 +/- 2.7 to 8.9 +/- 3.0 mmol/l at 3 months (P < 0.0001) and to 8.6 +/- 2.5 mmol/l at 6 months (P < 0.0001). For the insulin group, FPG decreased from 13.5 +/- 3.6 to 7.5 +/-3.0 mmol/l at 3 months (P < 0.0001) and to 9.8 +/- 3.5 mmol/l at 6 months (P < 0.0001). No significant differences were observed between the groups. Similarly, both groups had significant improvement of fructosamine and glycosylated hemoglobin (HbA1c). Fructosamine fell from a mean of 458 to 365 mumol/l at 3 months (P < 0.0001) and to 371 mumol/l at 6 months (P < 0.0001) and from 484 to 325 mumol/l at 3 months (P < 0.0001) and to 350 mumol/l at 6 months (P < 0.0001) for the combination and insulin groups, respectively. HbA1c decreased from 10.2 to 8.4% at 3 months (P < 0.0001) and to 8.7% at 6 months (P < 0.0001) in the combination group and from 10.7 to 7.8% at 3 months (P < 0.0001) and to 8.4% at 6 months (P < 0.0001) in the insulin group. Despite similar improvement of glycemia, insulin requirements were very different. At 3 months, the combination group was receiving a mean of 14.4 U/day compared with 57.5 U/day in the insulin group (P < 0.0001). Similar findings were observed at 6 months (15.0 vs 57.2 U/day, P < 0>0001). Both groups gained weight. However, for the combination group, weight gain was 1.6 +/- 1.8 kg at 3 months and 2.1 +/- 2.5% kg at 6 months (both P < 0.0001 vs baseline), whereas for the insulin group, weight gain was 3.5 +/- 4.3 and 5.2 +/- 4.1 kg, respectively (both P < 0.0001 vs baseline). Weight gain was significantly greater in the insulin group (P < 0.05 at 3 months, and P < 0.005 at 6 months). Fasting plasma triglyceride decreased in the insulin group (1.8 +/- 1.0 to 1.4 +/- 0.8 mmol/l at 3 months [P < 0.005] and to 1.4 +/ 0.7 mmol/l at 6 months [P < 0.02] but not in the combination group. No changes were observed in total and high-density lipoprotein cholesterol. No severe hypoglycemic reactions were recorded in either group. Mild reactions occurred with similar frequency in both groups. Well-being and quality of life improved significantly in both groups. The majority of patients (82.7%) wanted to continue insulin beyond 6 months, irrespective of the treatment group.
                In NIDDM patients with secondary OHA failure, therapy with a combination of OHAs and insulin and with insulin alone was equally effective and well tolerated. However, combination therapy was associated with a lower insulin dose and less weight gain. Combination treatment may be considered when OHA failure occurs as a potential intermediate stage before full insulin replacement.

Abstract:
To compare the safety, efficacy and management of insulin lispro (LP) with regular human insulin (RH) in young diabetic children treated with continuous subcutaneous insulin infusion (CSII).
                27 very young diabetic children (age 4.6 +/- 2.2 years) treated with CSII participated in an open-label, randomized cross-over multicenter study comparing 2 periods of 16 weeks of CSII with LP or RH.
                Mean daily basal rate was significantly higher during the LP period (p = 0.04). No differences were seen in changes in HbA1c levels, number of hypoglycemic events, cutaneous infections and catheter occlusions. There was no significant difference between the two treatments for preprandial and postprandial glucose values, although prandial glucose excursions tended to be lower with LP (significant at dinner, p = 0.01). Mean blood glucose levels were significantly higher at 0.00 and 3.00 a.m. during LP therapy (p < 0.05). No episode of ketoacidosis occurred during LP treatment. More parents indicated that LP made their own and the child's daily life easier (p = 0.02) and preferred LP (p = 0.01).
                LP in CSII therapy in children is safe, as effective as RH, improved postprandial excursions, met the needs of young children in their daily life well, and gained their parents' satisfaction and preference. However, a shorter duration of LP resulted in hyperglycemia during the first part of the night, which must be compensated for by increasing nocturnal basal rates during this time.

Abstract:
Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control.
                An open, parallel, randomized controlled prospective comparative study lasting 14 months was completed by 38 type 1 children with diabetes (age 4-16 yr) following a 3.5-months run-in phase. Standardized quality-of-life Pediatric Quality of life Inventory (PedsQL) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters. Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality.
                Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment. Treatment group comparisons did not show significant improvement. Pump treatment resulted in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22% after run in.
                Within-patient comparison suggests that metabolic control, frequency of severe hypoglycaemia (a threefold decrease), quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections.

Abstract: The absorption of regular human insulin from subcutaneous injection sites is delayed due to the self-association of insulin to multimeric forms. The insulin analogue insulin lispro has a weak self-association and a fast absorption rate. We examined the safety and efficacy of insulin lispro in the premeal treatment of patients with diabetes mellitus. A 12-month study was performed in 336 patients with insulin-dependent diabetes mellitus (IDDM) and 295 patients with non-insulin-dependent diabetes mellitus (NIDDM). The patients were randomized to inject either regular human insulin 30 to 45 minutes before eating, or insulin lispro immediately before each meal, in addition to basal insulin. The postprandial rise in serum glucose was lower in patients receiving insulin lispro than in those receiving regular human insulin therapy. At end point the increment was significantly lower at 1 hour (35%) and at 2 hours (64%) after the meal in IDDM patients; in NIDDM patients, the increment was nonsignificantly lower at 1 hour (19%) and significantly lower at 2 hours (48%). IDDM patients receiving insulin lispro achieved significantly lower glycated hemoglobin (HbA1c) levels in patients receiving regular human insulin (8.1% vs 8.3%). In NIDDM patients, HbA1c levels decreased equally in both treatment groups. Due to its fast absorption rate, insulin lispro improves postprandial control in diabetes. Insulin lispro can be considered one step toward optimal insulin therapy and improved patient convenience.

Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child.


The State Children's Health Insurance Program: a multicenter trial of outreach through the emergency department.

A randomized, controlled trial of the effectiveness of community-based case management in insuring uninsured Latino children.

The effect of outreach workers' educational efforts on disadvantaged preschool children's use of preventive services.

A randomized study of tracking with outreach and provider prompting to improve immunization coverage and primary care.

Increasing patient knowledge, satisfaction, and involvement: randomized trial of a communication intervention.

Monetary incentives in primary health care and effects on use and coverage of preventive health care interventions in rural Honduras: cluster randomised trial.

Improving the immunization coverage of children less than 7 years old in a family practice residency.

Maximizing immunization coverage through home visits: a controlled trial in an urban area of Ghana.

Training in complementary feeding counselling of healthcare workers and its influence on maternal behaviours and child growth: a cluster-randomized controlled trial in Lahore, Pakistan.

Abstract:
We evaluated emergency department (ED)-based outreach for the State Children's Health Insurance Program (SCHIP).
                We conducted a multicenter trial among uninsured children (< or = 18 years) who presented to 5 EDs in 2001 and 2002. On-site staff enrolled consecutive subjects for a control period followed by an intervention period during which staff handed out SCHIP applications to the uninsured. The primary outcome was state-level confirmation of insured status at 90 days.
                We followed 223 subjects (108 control, 115 intervention) by both phone interview and state records. Compared to control subjects, those receiving a SCHIP application were more likely to have state health insurance at 90 days (42% vs 28%; P<.05; odds ratio [OR]=3.8; 95% confidence interval [CI]=1.7, 8.6). Although the intervention effect was prominent among 118 African Americans (50% insured after intervention vs 31% of controls, P<.05), lack of family enrollment in other public assistance programs was the primary predictor of intervention success (OR=3.7; 95% CI=1.6, 8.4).
                Handing out insurance applications in the ED can be an effective SCHIP enrollment strategy, particularly among minority children without connections to the social welfare system. Adopted nationwide, this simple strategy could initiate insurance coverage for more than a quarter million additional children each year.

Abstract:
Lack of health insurance adversely affects children's health. Eight million US children are uninsured, with Latinos being the racial/ethnic group at greatest risk for being uninsured. A randomized, controlled trial comparing the effectiveness of various public insurance strategies for insuring uninsured children has never been conducted.
                To evaluate whether case managers are more effective than traditional methods in insuring uninsured Latino children.
                Randomized, controlled trial conducted from May 2002 to August 2004.
                A total of 275 uninsured Latino children and their parents were recruited from urban community sites in Boston.
                Uninsured children were assigned randomly to an intervention group with trained case managers or a control group that received traditional Medicaid and State Children's Health Insurance Program (SCHIP) outreach and enrollment. Case managers provided information on program eligibility, helped families complete insurance applications, acted as a family liaison with Medicaid/SCHIP, and assisted in maintaining coverage.
                Obtaining health insurance, coverage continuity, the time to obtain coverage, and parental satisfaction with the process of obtaining insurance for children were assessed. Subjects were contacted monthly for 1 year to monitor outcomes by a researcher blinded with respect to group assignment.
                One hundred thirty-nine subjects were assigned randomly to the intervention group and 136 to the control group. Intervention group children were significantly more likely to obtain health insurance (96% vs 57%) and had approximately 8 times the adjusted odds (odds ratio: 7.78; 95% confidence interval: 5.20-11.64) of obtaining insurance. Seventy-eight percent of intervention group children were insured continuously, compared with 30% of control group children. Intervention group children obtained insurance significantly faster (mean: 87.5 vs 134.8 days), and their parents were significantly more satisfied with the process of obtaining insurance.
                Community-based case managers are more effective than traditional Medicaid/SCHIP outreach and enrollment in insuring uninsured Latino children. Case management may be a useful mechanism to reduce the number of uninsured children, especially among high-risk populations.

Abstract: A special program of outreach services was implemented to assist a poverty population to appropriately use health services in the Kaiser-Permanente Medical Care Program. A study was conducted to determine the effect of outreach workers' intervention on the use of preventive services by this population. Intially, families were divided into two groups, one with and one without outreach workers. Outreach workers (neighborhood health coordinators) were trained in prevention and health education. They were then assigned to specific subgroups of the poverty population to teach the importance of preventive services and to motivate persons to use these services. This paper focuses on the effect of outreach workers' services on the use of selected preventive care services (immunizations and tine test) by preschool children from poverty families. Preschool children in families with coordinator services had higher use rates for preventive care. The sub-group for which outreach workers were specially trained to focus on preventive procedures for the pre-school group had markedly higher use rates for preventive care. The findings suggest that special intervention programs, using indigenous and nonprofessional outreach workers, can increase preventive service utilization by poverty groups.

Abstract:
To compare and measure the effects and cost-effectiveness of two interventions designed to raise immunization rates.
                Nine primary care sites serving impoverished and middle-class children.
                Complete birth cohorts (ages 0 to 12 months; n = 3015) from these sites.
                Two 18-month duration interventions: 1) tracking with outreach [tracking/outreach] to bring underimmunized children to their primary care provider office, and 2) a primary care provider office policy change to identify and reduce missed immunization opportunities (prompting).
                Randomized, controlled trial, randomizing within sites using a two-by-two factorial design. Subjects were allocated to one of four study groups: control, prompting only, tracking/outreach only, and combined prompting with tracking/outreach. Outcomes were obtained by blinded chart abstraction.
                Immunization status for age; number of days of delay in immunization; primary care utilization; and rates of screening for occult disease.
                Out of 3015 subjects, 274 subjects (9%) transferred out of the participating sites or had incomplete charts and were excluded. The 2741 (91%) remaining subjects were assessed. At baseline, study groups did not differ in age, gender, insurance type, or immunization status. Of the remaining subjects, 63% received Medicaid. Final series-complete immunization coverage levels were: control, 74%; prompting-only, 76%; tracking/outreach-only 95%; and combined tracking/outreach with prompting, 95%. Analysis of variance showed that: 1) tracking/outreach increased immunization rates 20 percentage points; 2) tracking/outreach decreased mean immunization delay 63 days; 3) tracking/outreach increased mean health supervision visits 0.44 visits per child; 4) tracking/outreach increased mean anemia screening 0.17 screenings per child and mean lead screenings 0.12 screenings per child; 5) impact of tracking/outreach was greatest for uninsured and impoverished patients; and 6) the prompting intervention had no impact on the studied outcomes, and its failure was caused by inconsistent use of prompts and failure to vaccinate ill children when prompted. Using tracking/outreach, the cost per additional child fully immunized was $474. Each $1000 spent on the tracking/outreach intervention resulted in: 2.1 additional fully vaccinated children and 668 fewer child-days of delayed immunization; 4.6 additional health supervision visits and 5.9 additional other visits to the primary care provider; and 1.8 additional anemia screenings and 1.3 additional lead screenings.
                Outreach directed toward children not up-to-date on immunizations improves not only immunization status, but also health supervision visit attendance and screening rates. The cost per additional child immunized was high, but should be interpreted in view of the spillover benefits that accompanied improved immunization. Effective means to improve coverage by reducing missed immunization opportunities still need to be identified.

Abstract: A brief educational intervention to promote effective communication between physicians, children, and parents during pediatric office visits was designed and tested. A randomized clinical trial involving 141 children (5- to 15-year-olds) tested the effectiveness of the intervention to improve the process and outcome of medical care. The intervention was contained in three brief videotapes (one each for parents, physicians, and patients) and in accompanying written materials. Materials were designed to build skills and motivation for increased child competence and participation during pediatric medical visits. Control subjects saw health education videotapes and received materials comparable in length with those of experimental subjects. Postintervention medical visit process was analyzed using videotapes of visits. Visit outcomes, assessed with standardized instruments and interviews, included children's rapport with physicians, children's anxiety, children's preference for an active health role, children's recall of information, parents' satisfaction with the medical visit, and physician satisfaction. Results indicated that physicians in the intervention group, compared with their counterparts in the control group, more often included children in discussions of medical recommendations (50% vs 29%, t = 2.39, P less than .05); that children in the intervention group, compared with control children, recalled more medication recommendations (77% vs 47%, P less than .01) and reported greater satisfaction and preference for an active health role; and that the intervention and control groups did not differ in parent satisfaction, physician satisfaction, or child anxiety. The results suggest that a brief educational intervention administered during waiting room time can positively impact physician-child rapport and children's preference for an active role in health and their acquisition of medical information.

Abstract:
Scaling-up of effective preventive interventions in child and maternal health is constrained in many developing countries by lack of demand. In Latin America, some governments have been trying to increase demand for health interventions by making direct payments to poor households contingent on them keeping up-to-date with preventive health services. We undertook a public health programme effectiveness trial in Honduras to assess this approach, contrasting it with a direct transfer of resources to local health teams.
                70 municipalities were selected because they had the country's highest prevalence of malnutrition. They were allocated at random to four groups: money to households; resources to local health teams combined with a community-based nutrition intervention; both packages; and neither. Evaluation surveys of about 5600 households were undertaken at baseline and roughly 2 years later. Pregnant women and mothers of children younger than 3 years old were asked about use of health services (primary outcome) and coverage of interventions such as immunisation and growth monitoring (secondary outcome). Reports were supplemented with data from children's health cards and government service utilisation data. Analysis was by mixed effects regression, accounting for the municipality-level randomisation.
                The household-level intervention had a large impact (15-20 percentage points; p<0.01) on the reported coverage of antenatal care and well-child check-ups. Childhood immunisation series could thus be started more opportunely, and the coverage of growth monitoring was markedly increased (15-21 percentage points; p<0.01. Measles and tetanus toxoid immunisation were not affected. The transfer of resources to local health teams could not be implemented properly because of legal complications.
                Conditional payments to households increase the use and coverage of preventive health care interventions.

Abstract:
This prospective cohort study was designed to evaluate the effectiveness of mail and telephone contact with parents as a means to improve the immunization coverage of children less than 7 years old in a family practice residency clinic.
                Immunization records for 519 children enrolled in an outpatient clinic were reviewed and updated. Children whose immunizations were current (55) were excluded, which left 464 children whose immunizations were more than 1 month behind for their age groups. A random sample of one-half of these children (231) were mailed a postcard listing the immunizations that they required to be up to date. The mailing was followed up with telephone contact, when necessary, to prompt compliance. The other one-half of the children were not contacted and served as the control group. Immunizations provided to the two groups were compared 6 months after the initial mailing.
                Before the initiation of the study, only 10.6 percent of the infants and children in the practice had their immunizations completed or were up to date. There were 124 immunizations given to 49 children in the intervention group compared with 84 immunizations to 33 children in the control (P < 0.047). Thirty-four children were brought up to date in the control group compared with 17 in the intervention cohort (P < 0.011).
                Direct mail reminders and telephone contact with parents of children who were behind in their immunizations were effective methods to encourage compliance. The increased number of immunizations received by the children in the intervention group was overshadowed by the poor coverage of the entire practice, a highly mobile and predominantly indigent group. Additional interventions are urgently needed to improve immunization levels in infants and children.

Abstract: A strategy of home visits to maximize children's immunization coverage was implemented in three towns in Ghana. The strategy was tested in town 1 in a controlled trial where clusters of children were allocated to the intervention and control groups. A total of 200 mothers in the intervention group were visited at home by non-health workers and their children were referred to a routine under-fives' clinic. Subsequent home visits targeted at those who failed to complete immunization schedules were made by nurses. After 6 months, coverage had risen from 60% to 85%, which was 20% higher than in the town 1 control group of 219 age-matched children (P < 0.005). A similar home-visiting strategy in a neighbouring town resulted in a rise in coverage from 38% to 91% (n = 55), mainly through home immunizations. Children were more likely to complete the schedule if their fathers were interviewed and participated in the decision to send them to the clinic. Countries with national service programmes can use a home-visiting strategy to supplement and strengthen their routine immunization programmes. A wide range of other community-based primary health care interventions could also be tested and implemented using this methodology.

Abstract: Malnutrition is common among children aged 6-24 months in developing countries. It increases the risk of mortality. Interventions to improve infant-feeding hold the promise of reducing malnutrition among these children. A study in Brazil has shown the success of training in communication and counselling skills among health workers in improving the nutritional status of young children. Questions were raised whether the method used in the study in Brazil would also be effective when applied in other countries. The aim of the present study was to reduce growth faltering in young children through proper nutrition-promotion techniques. The objective of the study was to determine the efficacy of training health workers in nutrition counselling in enhancing their communication skills and performance, improving feeding practices, and reducing growth faltering in children aged 6-24 months. A cluster-randomized controlled trial was carried out. The method used in this study was a replica of the method in a similar study in Pelotas, Brazil. Forty health centres were paired, and one centre of each pair was randomly allocated to the intervention group, and the other to the control group. The Integrated Management of Childhood Illness (IMCI) module-'Counsel the mother'-was used for training health workers in the health centres in the intervention group. Data from 36 paired health centres and 375 mothers and their children aged 6-24 months recruited from these health centres following consultation with health workers were included in analysis. Independent observers, masked to the intervention status, examined the performance of health workers within the first month after training. Mother-child pairs were visited at home within two weeks, 45 days, and 180 days after recruitment. Information was recorded on the feeding practices, recall of the recommendations of health workers, and sociodemographic variables at these home-visits. Weight and length of the child were measured at each contact. The communication skills and consultation performance of health workers were significantly better in the intervention group than in the control group. The mothers' recall of the recommendation of health workers and reported infant-feeding practices were also significantly better in the intervention group than in the control group, even 180 days after the recruitment consultation. Growth faltering was less in the intervention group, with the largest effect observed among children in the age-group of 12 + months. These results indicate that training in IMCI feeding counselling can enhance the communication skills and performance of health workers. Improved feeding practices of counselled mothers can, in turn, reduce growth faltering in their children.

The two studies included in this review provide evidence that in the US providing health insurance information and application assistance, and handing out application materials in hospital emergency departments can probably both improve insurance coverage of children. Further studies evaluating the effectiveness of different outreach strategies for expanding health insurance coverage of children in different countries are needed, with careful attention given to study design.


Low positioning of umbilical-artery catheters increases associated complications in newborn infants.

Randomized trial of umbilical arterial catheter position: clinical outcome.

Efficacy of thromboresistant umbilical artery catheters in reducing aortic thrombosis and related complications.

Umbilical artery catheters: high, low, or no.

Effect of heparin infusates in umbilical arterial catheters on frequency of thrombotic complications.

Prophylactic antibiotics in neonates with umbilical artery catheter placement: a prospective study of 137 patients.

Prevention of umbilical artery catheter clots with heparinized infusates.

Intravenous access in newborn infants: impact of extended umbilical venous catheter use on requirement for peripheral venous lines.

Umbilical artery catheterization in newborns. I. Thrombosis in relation to catheter type and position.

Abstract: We performed a randomized prospective study of the effect of placement position of umbilical-artery catheters on complication rates in high-risk newborn infants. A higher complication rate (31 of 40 vs. 13 of 33) (P less than 0.005) occurred in the group with the catheter tip at the third to fourth lumbar segment, as compared to those with the tip at the seventh to eighth thoracic segment, owing to more episodes of blanching and cyanosis of the extremities. There was no difference between groups in the rate of complications requiring catheter removal. Aortography revealed thrombosis in 21 of 23 patients studied, but there was no clinical evidence of impaired circulation. In retrospect, we found that, independently of catheter position, administration of antibiotics through the catheter was associated with an increased rate of complications (63 vs. 20 per cent). Umbilical-artery catheterization entails potential risks regardless of the position of the catheter; placement of the catheter with its tip at the seventh to eighth thoracic segment may be associated with fewer complications than at lower positions.

Abstract: In order to determine if umbilical arterial catheter position affects the incidence of necrotizing enterocolitis, clinical outcome was analysed in 308 infants whose umbilical arterial catheter had been randomly allocated to a high (n = 162) or a low (n = 146) position. Necrotizing enterocolitis was classified as suspected or confirmed; all renal, lower limb and local catheter complications were also recorded. High umbilical arterial catheters were in place for longer than low catheters, provided more samples and were removed as an emergency less often. Lower limb blanching and cyanosis were more common with low catheters. Eleven cases of confirmed necrotizing enterocolitis occurred in the "high" group and nine in the "low" group. One case of fatal aortic thrombosis was encountered in the high group. Positioning umbilical arterial catheters in a high position allowed longer functional use and did not increase the incidence of necrotizing enterocolitis.

Abstract: Previous in vitro and in vivo reports suggest that catheters constructed of polyurethane with heparin bonded to the surface (HB-PU) are less thrombogenic than catheters made of polyvinyl chloride (PVC). A randomized trial sufficiently large (power 80%) to detect a reduction in the incidence of umbilical artery (UA) catheter complications, including aortic thrombus formation, from 45% to 20% was conducted in 125 infants. The infants were monitored for complications possibly related to the use of a UA catheter, such as systemic hypertension and abnormalities of lower extremity perfusion. The presence of aortic thrombi was assessed by ultrasound study 3.5 +/- 1.2 (SD) days and 11.1 +/- 2.3 days after insertion of the catheter. The use of HB-PU umbilical catheters did not lead to a significant reduction in the incidence of complications and aortic thrombi compared with the use of PVC catheters. The lack of reduction may have been related to the prolonged duration of catheter use in both groups. A much larger study would have been required to detect a smaller, but perhaps clinically significant, reduction in catheter-associated complications.

Abstract: We studied 111 infants requiring an umbilical artery catheter, 59 with heparin and 52 without. Thirty-four thrombi were detected, 16 in the heparin group and 18 in the control group. The numbers of thrombi in the two groups was not significantly different, but the number of clotted or nonfunctioning umbilical artery catheters was greater in the control group (P less than 0.05), as was the incidence of hypertension (P less than 0.05). There were no other significant differences between the two groups. We conclude that the use of low doses of heparin may not change the incidence of umbilical artery catheter-related thrombi, but it does appear to lower the incidence of their sequelae.

Abstract: To analyze the risk of cannula sepsis from indwelling umbilical arterial catheters and the indication for prophylactic antibiotics, 137 catheterized neonates with respiratory distress were prospectively placed into either antibiotic-treated (penicillin 50,000U/kg/day and kanamycin 15 mg./kg./day) or non-treated groups. Although bacteria were frequently isolated from blood and catheter tip cultures obtained upon removal of the catheter, especially among non-antibiotic treated infants, these isolates were predominantly non-pathogens and probably skin flora. Corresponding peripheral blood cultures were usually sterile. No cases of cannula-associated sepsis occurred among treated and non-treated newborns. The risk of bacteriologically proven sepsis resulting from an indwelling umbilical artery catheter appears insufficient to justify prophylactic antibiotics.

Abstract: 49 neonates requiring umbilical artery catheters (UACs) were randomly assigned to receive standard or heparin-containing infusates. 3 of 23 (13%) of the patients receiving heparin had catheters removed because they became functionally occluded compared to 15 of 26 (58%) in the control group (p less than 0.005). 4 of 13 (31%) single injection aortograms obtained in control infants demonstrated thrombi, compared to none of 7 in the heparin group. 1 patient in the heparin group had an aortic clot demonstrated at post-mortum examination. There were neither clinical coagulopathies nor abnormalities of partial thromboplastin time attributable to the administration of heparinized fluids. Heparinization of UAC infusates appears to be a safe method of reducing the risk of catheter occlusion. Heparin effect on large vessel clot risk remains unproven.

Abstract: Central venous lines are used to care for critically ill neonates in cases of limited peripheral venous access. This prospective, randomized study evaluated the risks and benefits of the use of single- and double-lumen umbilical venous catheters for up to 14 days. Patients were randomized to one of three treatment arms: (1) single-lumen umbilical catheter, (2) double-lumen umbilical catheter, or (3) no umbilical catheter; peripheral intravenous lines only. Infants in the groups treated with an umbilical venous catheter had significantly fewer venipunctures and peripheral intravenous lines placed during their first 2 weeks of life than those in the peripheral line only group. Less time and money were spent obtaining peripheral line placement in the umbilical venous catheter groups. The incidence rates of sepsis and complications were not higher in treated patients than in control patients. The double-lumen catheter further reduced peripheral venipunctures and lines. We conclude that an umbilical venous catheter used during the first 2 weeks of life is a relatively safe, less stressful, cost-effective means of providing intravenous therapy to neonates.

Abstract: Seventy-one sick newborn infants, who had an umbilical artery catheterized, were randomized in one of four catheter groups: long end-hole-, short end-hole-, long side-hole- or short side-hole catheter. A long catheter means a high position of the catheter tip (Th6--11) and a short catheter a low position of the tip (L3--5). An angiography through the indwelling catheter in order to diagnose thrombosis was performed before the catheter was withdrawn. Dissection of the aorta and its brances was performed on infants who died. The total frequency of thromboses was 26%. There were no thromboses among infants with long end-hole catheters while infants with short end-hole catheters had thrombosis in 26%, long side-hole catheters in 33% and short side-hole catheters in 64%. Long end-hole catheters functioned better than the others. Only 6 of 16 infants with thrombosis had physical signs from the legs, while 12 infants without thrombosis had similar signs.

There appears to be no evidence to support the use of low placed umbilical artery catheters. High catheters should be used exclusively.


Q:

Avoid repetition of code during data conversion

I have some dummy data like below:
data: {
    first: {
        date_2019_01: 10,
        date_2019_02: 15,
        ....
    },
    second: {
        date_2019_01: 30,
        date_2019_02: 35,
        ....
    }
}

I have to convert this initial data into following format where date as key is to converted to month and its value as growth.

first: [
    {
        month: 1,
        growth: 10
    },
    {
        month: 2,
        growth: 15
    },
    ...
],
second: [
    {
        month: 1,
        growth: 30
    },
    {

    }
]

In my solution I get the keys and split it to get my desired month which is pushed to new array.

I am learning on quality of code which includes DRY concept as well.

Please anybody help me write this piece of code in better format.

let first = data["first"];

let firstMonth = [];
Object.keys(first).map(function(key) {
    firstMonth.push({
        month: key.split('_')[2],
        growth: first[key]
    });
});

let second = data["second"];

let secondMonth = [];
Object.keys(second).map(function(key) {
    secondMonth.push({
        month: key.split('_')[2],
        growth: second[key]
    });
});

let finalData = {
    first: firstMonth,
    second: secondMonth
}

A:

One option is a .map inside a .reduce.

You can use Object.entries instead of Object.keys to retrieve both the keys and values at once, which will cut down a bit on the amount of syntax needed:

const data = {
    first: {
        date_2019_01: 10,
        date_2019_02: 15,
    },
    second: {
        date_2019_01: 30,
        date_2019_02: 35,
    }
};
const newData = Object.entries(data).reduce((a, [key, obj]) => {
  a[key] = Object.entries(obj).map(([key, growth]) => ({
    month: Number(key.slice(10)),
    growth
  }));
  return a;
}, {});
console.log(newData);


My blog is about security and optimization of Windows system, it will be useful to beginners who needs informations to secure & optimize their system or more advanced users who need to know more about security softwares.

I want to precise that i cant test it against malwares since it creates
BSODs on my Virtual Box, so it will be a descriptive and usability
review.

One interesting thing, is when you install it , it ask you if you want it start with high or normal security after the reboot.

SSP sit on my system between 20-30mb WS of RAM, i don't feel any visible slowdown.

1- Protection Tab

Spyshelter is an Anti-Keylooger and also an HIPS, here we can see the
various protection modules, SSP, it share the common protection with
other products but where it is innovative is the "Anti-sound module"
that protect your system against VOIP sound trojan loggers and other
sound capture.

Note: the kernel module is only for x86 systems

2- Rules tab

Here is the place where the rules will be shown, you can
alow/deny/check/add/edit/remove them ,you can also impot/export some
rules, clean old ones (from uninstalled programs) and check all
component and details of them, i like the Virus Total integration, when a
process is allowed/denied, you can upload the file to it.

3- Log tab

Here is shown all the decision made by SSP or by you, nothing very exceptionnal there.

4- Restricted Apps tab

Here is an interesting feature of SSP, it is in fact a kind of
policy-based "Sandbox" (like OAP's Runsafer or Comodo's Auto-sandbox),
with the addition of selecting which folder/file access will be
allow/deny to be writed.

When an process is run restricted, its windows will got the "Restricted" tag (if selected in the settings)

5- Firewall

SpyShelter firewall module is designed to control
(permit or deny) network transmissions based upon a set of rules.

It's
commonly used to protect computer system networks from unauthorized access while
permitting trusted communications to pass.

SpyShelter Firewall supports IPv6
protocol

6- Keystroke Encryption

This feature (available for x64 system only) will encrypt any of your keystrokes (a la "Keyscrambler") so even if a keylogger successfully leaks datas to the attacker , he will not be able to read them.

6- Settings tab

There are the settings options

a- General : here nothing special except the auto-clean option of the rules, quite convenient.

b- Security: here you can allow
how SSp will react when confronted to a process, you can select one of
the 4 options, "Allow Microsoft" is the less intrusive, "Ask" the most
(means more popups)

c- Advanced: here you can increase the protection by terminating processes and their child

Use Hard Hook seems to be an option to enforce compatibility with other security apps.

d- List of Monitored Actions :
here you can decide what actions SSP will react from.

When a popup will
appears the number of the action will be shown so you can know what
happened.


xml version="1.0" encoding="UTF-8" standalone="no"?

DOCTYPE tiles-definitions PUBLIC "-//Apache Software Foundation//DTD Tiles Configuration 2.1//EN" "http://tiles.apache.org/dtds/tiles-config_2_1.dtd">
<tiles-definitions>
    <definition extends="default" name="regelsrtbers/list">
        <put-attribute name="body" value="/WEB-INF/views/regelsrtbers/list.jspx"/>
    </definition>
<definition extends="default" name="regelsrtbers/show">
        <put-attribute name="body" value="/WEB-INF/views/regelsrtbers/show.jspx"/>
    </definition>
<definition extends="default" name="regelsrtbers/create">
        <put-attribute name="body" value="/WEB-INF/views/regelsrtbers/create.jspx"/>
    </definition>
<definition extends="default" name="regelsrtbers/update">
        <put-attribute name="body" value="/WEB-INF/views/regelsrtbers/update.jspx"/>
    </definition>
</tiles-definitions>


Q:

Recover corrupted aspx file

My system crashed whilst I was in the middle of updating an .aspx page in visual studio 2010.

When I rebooted my PC and started visual studio again the .aspx file was still there, but when I clicked to open it in solution explorer notepad opened and a blank file was displayed.

Looking at the file in windows explorer the file still has it's size of 31Kb, My file content was replaced with some white space characters
Any suggestions to how I might recover this file?

I've spent a 4-5  days of work,  with no backup - arrh!

any help would be really appreciated

A:

Though Old post, sharing my experience :D
I faced the same problem with a file today and overcame it successfully.

:D
Felt freaking heavenly after getting my file back ... :D \m/ :D
Here is the solution.

Actually, there can be two types of solution of recovering corrupted files I found.

null or space everywhere in the file while the size is ok)
Solution #1: Using file recovery software.

File recovery softwares can recover a file when it is already deleted.

In our scenario, your file is not deleted but corrupted.

So how to use
  the software in this case!!!!

Just delete your file
Try to recover your deleted files with popular file recovery softwares

And voila ... it is recovered ... :D
The recovery software I used is Recuva.

Solution #2: If its a web content, like CSS/Javascript/html etc.

You can collect the last working copy of the file from browser cache,
  IF and ONLY IF you hadn't opened the corrupted webpage in that brower.

The thought that help me finding the first solution is from
Mark Twain - "Never argue with stupid people, they will drag you down to their level and then beat you with experience."

While I was thinking how to use this recovery software, I thought about this quote and said myself "LETS DRAG THE FILE DOWN TO THE LEVEL, WHERE RECOVERY SOFTWARE CAN RECOVER" ... :D