scholarly journals CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

2015 ◽  
Vol 39 (5-6) ◽  
pp. 309-318 ◽  
Author(s):  
Narayanaswamy Venketasubramanian ◽  
Sherry H. Young ◽  
San San Tay ◽  
Thirugnanam Umapathi ◽  
Annabelle Y. Lao ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Functional Independence ◽  
Stroke Recovery ◽  
Double Blind ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Time Points

Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.

scholarly journals Prognostic Factors and Pattern of Long-Term Recovery with MLC601 (NeuroAiD™) in the Chinese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study

2016 ◽  
Vol 43 (1-2) ◽  
pp. 36-42 ◽  
Author(s):  
Narayanaswamy Venketasubramanian ◽  
Chun Fan Lee ◽  
Sherry H. Young ◽  
San San Tay ◽  
Thirugnanam Umapathi ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Chinese Medicine ◽  
Treatment Effect ◽  
Treatment Time ◽  
Functional Independence ◽  
Stroke Recovery ◽  
Long Term Outcome ◽  
Nihss Score

Background: The Chinese Medicine NeuroAiD Efficacy on Stroke recovery - Extension (CHIMES-E) study is among the few acute stroke trials with long-term outcome data. We aimed to evaluate the recovery pattern and the influence of prognostic factors on treatment effect of MLC601 over 2 years. Methods: The CHIMES-E study evaluated the 2 years outcome of subjects aged ≥18 years with acute ischemic stroke, National Institutes of Health Stroke Scale (NIHSS) score 6-14, pre-stroke modified Rankin Scale (mRS) score ≤1 included in a multicenter, randomized, double-blind, placebo-controlled trial of MLC601 for 3 months. Standard stroke care and rehabilitation were allowed during follow-up with mRS score being assessed in-person at month (M) 3 and by telephone at M1, M6, M12, M18 and M24. Results: Data from 880 subjects were analyzed. There was no difference in baseline characteristics between treatment groups. The proportion of subjects with mRS score 0-1 increased over time in favor of MLC601 most notably from M3 to M6, thereafter remaining stable up to M24, while the proportion deteriorating to mRS score ≥2 remained low at all time points. Older age (p < 0.01), female sex (p = 0.06), higher baseline NIHSS score (p < 0.01) and longer onset to treatment time (OTT; p < 0.01) were found to be predictors of poorer outcome at M3. Greater treatment effect, with more subjects improving on MLC601 than placebo, was seen among subjects with 2 or more prognostic factors (OR 1.65 at M3, 1.78 at M6, 1.90 at M12, 1.65 at M18, 1.39 at M24), especially in subjects with more severe stroke or longer OTT. Conclusions: The sustained benefits of MLC601 over 2 years were due to more subjects improving to functional independence at M6 and beyond compared to placebo. Selection of subjects with poorer prognosis, particularly those with more severe NIHSS score and longer OTT delay, as well as a long follow-up period, may improve the power of future trials investigating the treatment effect of neuroprotective or neurorestorative therapies.

A double-blind, placebo-controlled trial of triheptanoin in adult polyglucosan body disease and open-label, long-term outcome

2017 ◽  
Vol 41 (5) ◽  
pp. 877-883 ◽  
Author(s):  
Raphael Schiffmann ◽  
Mary E. Wallace ◽  
Daisy Rinaldi ◽  
Isabelle Ledoux ◽  
Marie-Pierre Luton ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Open Label ◽  
Double Blind ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Double Blind Placebo ◽  
Polyglucosan Body ◽  
Adult Polyglucosan Body Disease

scholarly journals Long term outcome of functional independence and quality of life after traumatic SCI in Germany

Spinal Cord ◽  
2021 ◽  
Author(s):  
Florian Möller ◽  
Rüdiger Rupp ◽  
Norbert Weidner ◽  
Christoph Gutenbrunner ◽  
Yorck B. Kalke ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Functional Independence ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Cord Injury ◽  
Over Time

Abstract Study design Multicenter observational study. Objective To describe the long-term outcome of functional independence and quality of life (QoL) for individuals with traumatic and ischemic SCI beyond the first year after injury. Setting A multicenter study in Germany. Methods Participants of the European multicenter study about spinal cord injury (EMSCI) of three German SCI centers were included and followed over time by the German spinal cord injury cohort study (GerSCI). Individuals’ most recent spinal cord independence measure (SCIM) scores assessed by a clinician were followed up by a self-report (SCIM-SR) and correlated to selected items of the WHO short survey of quality of life (WHO-QoL-BREF). Results Data for 359 individuals were obtained. The average time passed the last clinical SCIM examination was 81.47 (SD 51.70) months. In total, 187 of the 359 received questionnaires contained a completely evaluable SCIM-SR. SCIM scores remained stable with the exception of reported management of bladder and bowel resulting in a slight decrease of SCIM-SR of −2.45 points (SD 16.81). SCIM-SR scores showed a significant correlation with the selected items of the WHO-QoL-BREF (p < 0.01) with moderate to strong influence. Conclusion SCIM score stability over time suggests a successful transfer of acquired independence skills obtained during primary rehabilitation into the community setting paralleled by positively related QoL measurements but bladder and bowel management may need special attention.

scholarly journals Thirty-year outcome of anxiety and depressive disorders and personality status: comprehensive evaluation of mixed symptoms and the general neurotic syndrome in the follow-up of a randomised controlled trial

2021 ◽  
pp. 1-10
Author(s):  
Peter Tyrer ◽  
Helen Tyrer ◽  
Tony Johnson ◽  
Min Yang
Keyword(s):  
Randomised Controlled Trial ◽  
Panic Disorder ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Personality Dysfunction ◽  
Randomised Controlled ◽  
Anxiety Depression

Abstract Background Cohort studies of the long-term outcome of anxiety, depression and personality status rarely join together. Methods Two hundred and ten patients recruited with anxiety and depression to a randomised controlled trial between 1983 and 1987 (Nottingham Study of Neurotic Disorder) were followed up over 30 years. At trial entry personality status was assessed, together with the general neurotic syndrome, a combined diagnosis of mixed anxiety–depression (cothymia) linked to neurotic personality traits. Personality assessment used a procedure allowing conversion of data to the ICD-11 severity classification of personality disorder. After the original trial, seven further assessments were made. Observer and self-ratings of psychopathology and global outcome were also made. The primary outcome at 30 years was the proportion of those with no Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis. Data were analysed using multilevel repeated measures models that adjusted for age and gender. Missing data were assumed to be missing at random, and the models allowed all subjects to be included in the analysis with missing data automatically handled in the model estimation. Results At 30 years, 69% of those with a baseline diagnosis of panic disorder had no DSM diagnosis compared to 37–47% of those with generalised anxiety disorder, dysthymia or mixed symptoms (cothymia) (p = 0.027). Apart from those with no personality dysfunction at entry all patients had worse outcomes after 30 years with regard to total psychopathology, anxiety and depression, social function and global outcome. Conclusions The long-term outcome of disorders formerly called ‘neurotic’ is poor with the exception of panic disorder. Personality dysfunction accentuates poor recovery.

scholarly journals Two-component surface replacement implants compared with perichondrium transplantation for restoration of Metacarpophalangeal and proximal Interphalangeal joints: a retrospective cohort study with a mean follow-up time of 6 respectively 26 years

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daniel Muder ◽  
Nils P. Hailer ◽  
Torbjörn Vedung
Keyword(s):  
Primary Outcome ◽  
Statistical Significance ◽  
Surface Replacement ◽  
Level Of Evidence ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Two Component ◽  
Pip Joint

Abstract Background The aim of our study was to compare the long-term outcome after perichondrium transplantation and two-component surface replacement (SR) implants to the metacarpophalangeal (MCP) and the proximal interphalangeal (PIP) joints. Methods We evaluated 163 joints in 124 patients, divided into 138 SR implants in 102 patients and 25 perichondrium transplantations in 22 patients. Our primary outcome was any revision surgery of the index joint. Results The median follow-up time was 6 years (0–21) for the SR implants and 26 years (1–37) for the perichondrium transplants. Median age at index surgery was 64 years (24–82) for SR implants and 45 years (18–61) for perichondium transplants. MCP joint survival was slightly better in the perichondrium group (86.7%; 95% confidence interval [CI]: 69.4–100.0) than in the SR implant group (75%; CI 53.8–96.1), but not statistically significantly so (p = 0.4). PIP joint survival was also slightly better in the perichondrium group (80%; CI 55–100) than in the SR implant group (74.7%; CI 66.6–82.7), but below the threshold of statistical significance (p = 0.8). Conclusion In conclusion, resurfacing of finger joints using transplanted perichondrium is a technique worth considering since the method has low revision rates in the medium term and compares favorable to SR implants. Level of evidence III (Therapeutic).

scholarly journals Long-term outcome of two forms of randomised benzodiazepine discontinuation

2006 ◽  
Vol 188 (2) ◽  
pp. 188-189 ◽  
Author(s):  
R. C. Oude Voshaar ◽  
W. J. M. J. Gorgels ◽  
A. J. J. Mol ◽  
A. J. L. M. Van Balkom ◽  
J. Mulder ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

scholarly journals Hyperglycemia in the Posttransplant Period: NODAT vs Posttransplant Diabetes Mellitus

2018 ◽  
Vol 2 (11) ◽  
pp. 1314-1319 ◽  
Author(s):  
Suruchi Gupta ◽  
Teresa Pollack ◽  
Candice Fulkerson ◽  
Kathleen Schmidt ◽  
Diana Johnson Oakes ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Liver Transplant ◽  
Controlled Trial ◽  
Organ Transplant ◽  
Long Term Outcomes ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Persistent Hyperglycemia

Abstract Objective To characterize the types of hyperglycemia that occur up to 1 year following liver transplant and to clarify the nomenclature for posttransplant hyperglycemia. Design We analyzed 1-year glycemic follow-up data in 164 patients who underwent liver transplant and who had been enrolled in a randomized controlled trial comparing moderate to intensive insulin therapy to determine if patients had preexisting known diabetes, transient hyperglycemia, persistent hyperglycemia, or new-onset diabetes after transplantation (NODAT). Results Of 119 patients with posttransplant hyperglycemia following hospital discharge, 49 had preexisting diabetes, 5 had insufficient data for analysis, 48 had transient hyperglycemia (16 resolved within 30 days and 32 resolved between 30 days and 1 year), 13 remained persistently hyperglycemic out to 1 year and most likely had preexisting diabetes that had not been diagnosed or insulin resistance/insulinopenia prior to transplant, and 4 had NODAT (i.e., patients with transient hyperglycemia after transplant that resolved but then later truly developed sustained hyperglycemia, meeting criteria for diabetes). Conclusions Distinct categories of patients with hyperglycemia following organ transplant include known preexisting diabetes, persistent hyperglycemia (most likely unknown preexisting diabetes or insulin resistance/insulinopenia), transient hyperglycemia, and NODAT. Those with preexisting diabetes for many years prior to transplant may well have very different long-term outcomes compared with those with true NODAT. Therefore, it would be prudent to classify patients more carefully. Long-term outcome studies are needed to determine if patients with true NODAT have the same poor prognosis as patients with preexisting diabetes (diagnosed and undiagnosed) undergoing transplant.

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