Propolis increases Foxp3 expression and lymphocyte proliferation in HIV-infected people: A randomized, double blind, parallel-group and placebo-controlled study

Objectives: To assess the longitudinal effects of acetyl-L-carnitine (ALC) on patients diagnosed with Alzheimer's disease. Design: Longitudinal, double-blind, parallel-group, placebocontrolled. Setting: Twenty-four outpatient sites across the United States. Participants: A total of 334 subjects diagnosed with probable Alzheimer's disease by NINCDS-ADRDA criteria. These data were originally reported by Thal and colleagues (1996). Measurements: Cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS) given every 3 months for 1 year. Results: The average rate of change was estimated using the trilinear approach, which allows for periods of both change and stability. Both the ALC group and the placebo group exhibited the same mean rate of change on the ADAS (0.68 points/month). However, a multiple regression analysis revealed a statistically significant Age × Drug interaction characterized by younger subjects benefiting more from ALC treatment than older subjects. Further analyses suggested that the optimal, though not statistically significant, cutpoint for ALC benefit was 61 years of age. Conclusions: ALC slows the progression of Alzheimer's disease in younger subjects, and the use of the trilinear approach to estimate the average rate of change may prove valuable in pharmacological trials.

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Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

International Journal of Molecular Sciences ◽

10.3390/ijms20040856 ◽

2019 ◽

Vol 20 (4) ◽

pp. 856 ◽

Cited By ~ 9

Author(s):

Rafal Kaminski ◽

Marta Maksymowicz-Wleklik ◽

Krzysztof Kulinski ◽

Katarzyna Kozar-Kaminska ◽

Agnieszka Dabrowska-Thing ◽

...

Keyword(s):

Platelet Rich Plasma ◽

Meniscal Tear ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Non Union ◽

Parallel Group ◽

Significant Difference ◽

Clinically Significant ◽

Patient Related Outcome

Meniscal tears are the most common orthopaedic injuries, with chronic lesions comprising up to 56% of cases. In these situations, no benefit with surgical treatment is observed. Thus, the purpose of this study was to investigate the effectiveness and safety of percutaneous intrameniscal platelet rich plasma (PRP) application to complement repair of a chronic meniscal lesion. This single centre, prospective, randomized, double-blind, placebo-controlled study included 72 patients. All subjects underwent meniscal trephination with or without concomitant PRP injection. Meniscal non-union observed in magnetic resonance arthrography or arthroscopy were considered as failures. Patient related outcome measures (PROMs) were assessed. The failure rate was significantly higher in the control group than in the PRP augmented group (70% vs. 48%, P = 0.04). Kaplan-Meyer analysis for arthroscopy-free survival showed significant reduction in the number of performed arthroscopies in the PRP augmented group. A notably higher percentage of patients treated with PRP achieved minimal clinically significant difference in visual analogue scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) symptom scores. Our trial indicates that percutaneous meniscal trephination augmented with PRP results in a significant improvement in the rate of chronic meniscal tear healing and this procedure decreases the necessity for arthroscopy in the future (8% vs. 28%, P = 0.032).

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Oral laquinimod in patients with relapsing-remitting multiple sclerosis: 36-week double-blind active extension of the multi-centre, randomized, double-blind, parallel-group placebo-controlled study

Multiple Sclerosis Journal ◽

10.1177/1352458510378127 ◽

2010 ◽

Vol 16 (11) ◽

pp. 1360-1366 ◽

Cited By ~ 42

Author(s):

G. Comi ◽

O Abramsky ◽

T Arbizu ◽

A Boyko ◽

R Gold ◽

...

Keyword(s):

Liver Enzymes ◽

Extension Phase ◽

Controlled Study ◽

Safety Signal ◽

Double Blind ◽

Clinical Assessments ◽

Parallel Group ◽

Relapsing Remitting ◽

Relapsing Remitting Multiple Sclerosis ◽

Efficacy Profile

Background: Laquinimod, an oral novel immunomodulator, was shown to reduce MRI-measured disease activity in relapsing—remitting MS (RRMS) patients. Objectives: To determine whether the safety and efficacy profile of laquinimod, as shown in a placebo-controlled 36-week trial (LAQ/5062), is sustained and reproducible. Methods: Two hundred and fifty seven patients entered the extension phase in which MRI was performed at the beginning and at the end of the active extension phase. Clinical assessments were performed at weeks 4, 12 and every 12 weeks thereafter. Results: Two hundred and thirty nine (93%) patients completed the extension phase and 222 (86.3%) had a final scan available. Gadolinium-enhanced (GdE) T1 lesions were significantly reduced for patients switching from placebo to 0.3/ 0.6 mg doses (52%, p = 0.0006). In patients initially randomized to 0.6 mg in LAQ/5062 the reduction of MRI activity observed in the placebo-controlled phase was maintained in the extension. The proportion of GdE-free patients for those who switched from placebo increased from a baseline of 31% to 47% at the end of the extension phase ( p = 0.01). The most prominent safety signal was elevations of liver enzymes, reversible in all cases. Conclusions: The good efficacy and the excellent safety and tolerability profiles of laquinimod 0.6 mg/day are confirmed in this extension study.

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A multicentre, multinational, double blind, randomised, parallel group, placebo-controlled study of ethyl-eicosapentaenoate (EPA) in patients with Huntington's disease (HD)

http://isrctn.org/> ◽

10.1186/isrctn79170611 ◽

2013 ◽

Author(s):

Harald Murck

Keyword(s):

Huntington's Disease ◽

Huntington’S Disease ◽

Controlled Study ◽

Double Blind ◽

Parallel Group

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Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine

The British Journal of Psychiatry ◽

10.1192/bjp.bp.110.081513 ◽

2011 ◽

Vol 198 (1) ◽

pp. 51-58 ◽

Cited By ~ 92

Author(s):

Michael D. Lesem ◽

Tram K. Tran-Johnson ◽

Robert A. Riesenberg ◽

David Feifel ◽

Michael H. Allen ◽

...

Keyword(s):

Acute Treatment ◽

Phase Iii ◽

Controlled Study ◽

Primary Efficacy ◽

Double Blind ◽

End Point ◽

Syndrome Scale ◽

Parallel Group ◽

Negative Syndrome ◽

Clinical Global Impression Improvement

BackgroundThere is a need for a rapid-acting, non-injection, acute treatment for agitation.AimsTo evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.MethodThis phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov number NCT00628589) enrolled 344 individuals who received one, two or three doses of inhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression–Improvement scale (CGI–I) score 2 h after dose one.ResultsInhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS–EC score was evident 10 min after dose one with both 5 and 10mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications.ConclusionsInhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.

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