scholarly journals Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

2015 ◽  
Vol 2015 ◽  
pp. 1-14 ◽  
Author(s):  
Andrew J. Butler ◽  
Justiss Kallos ◽  
Stephen N. Housley ◽  
Michelle C. LaPlaca ◽  
Stephen F. Traynelis ◽  
...  

Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n=14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors.

2011 ◽  
Vol 24 (2) ◽  
pp. 327-335 ◽  
Author(s):  
Daniela D'Attilio Toledo ◽  
Anny Caroline Dedicação ◽  
Maria Elisabete Salina Saldanha ◽  
Miriam Haddad ◽  
Patricia Driusso

INTRODUCTION: Urinary incontinence affects more than 50 million people worldwide, it has a great impact on quality of life by affecting social, domestic, occupational and sex life, regardless of age. Objective: The objective of this study was to analyze the effectiveness of physical therapy treatment in women attending the Urogynecology service of Hospital and Maternity Leonor Mendes de Barros. METHOD: We retrospectively assessed 65 records of patients with diagnosis of urinary incontinence treated between November 2005 and November 2006. In order to have their data analyzed, patients were divided into two groups; group MF, which underwent medical treatment and physiotherapy, and group M, which had only medical treatment. In order to compare both groups' quantitative data, the analysis was performed in Statistica® software using Mann Whitney's non-parametric test. The analysis of association between the quantitative variables was performed through the Chi-Square test at 5% (p > 0.05) significance level. RESULTS: We observed that 60.6% of patients who underwent physical therapy treatment and medical treatment had the urinary incontinence symptoms decreased or completely cured, while 80% of women belonging to the medical treatmen only-group underwent surgery. CONCLUSION: Thus, we conclude that physical therapy is essential in treatment protocols of urinary incontinence outpatient clinics and to prevent surgery.


2016 ◽  
pp. 298-317
Author(s):  
Anna Abelló Pla ◽  
Anna Andreu Povar ◽  
Jordi Esquirol Caussa ◽  
Vanessa Bayo Tallón ◽  
Dolores Rexachs ◽  
...  

Stress Urinary Incontinence (SUI), defined as involuntary urine leakage caused by physical activity and/or efforts, is a frequently found pathology among women that significantly affects their quality of life. SUI treatments are often less effective than expected because they require a conscious effort by the patient to follow them correctly and usually have drawbacks, such as their high cost, time, and/or schedule requirements. ICT-mediated Physical Therapy treatment programs can be useful to improve Stress Urinary Incontinence symptoms and pelvic floor function in women while maintaining total confidentiality, with an at home treatment, accomplishing a higher adherence to the treatment, keeping a low budget for the patients, and saving the health systems' economic resources.


Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2027 ◽  
Author(s):  
Mariangela Rondanelli ◽  
Valentina Braschi ◽  
Clara Gasparri ◽  
Mara Nichetti ◽  
Milena Anna Faliva ◽  
...  

Osteoarthritis (OA) is the most common form of arthritis in the world and is characterized by pain, various disabilities and loss of quality of life. Chondroitin sulfate (CS) is recommended as first-line therapy. CS of non-animal origin is of great interest for safety and sustainability reasons. This study aims to investigate the anti-inflammatory effects, anti-pain and ability-enhancement of a short-term supplementation with non-animal CS in overweight subjects with OA. In a randomized, double-blind, placebo-controlled pilot study, 60 overweight adults with symptomatic OA were allocated to consume 600 mg of non-animal CS (n = 30) or a placebo (n = 30) daily for 12 consecutive weeks. The assessment of knee-pain, quality of life, related inflammation markers and body composition was performed at 0, 4 and 12 weeks. The Tegner Lysholm Knee Scoring (TLKS) scale of the experimental group showed a statistically significant increase (+10.64 points; confidence interval (95% confidence interval (CI) 5.57; 15.70; p < 0.01), while the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score decreased (−12.24 points; CI 95% −16.01; −8.38; p < 0.01). The results also showed a decrease in the C-reactive protein (CRP) level (−0.14 mg/dL, CI 95% −0.26; −0.04; p < 0.01) and erythrocyte sedimentation rate (ESR) level (−5.01 mm/h, CI 95% −9.18; −0.84, p < 0.01) as well as the visual analogue scale (VAS) score in both knees. In conclusion, this pilot study demonstrates the effectiveness of non-animal CS supplementation in overweight subjects with knee OA in improving knee function, pain and inflammation markers.


2011 ◽  
Vol 38 (7) ◽  
pp. 1403-1412 ◽  
Author(s):  
JAIME C. BRANCO ◽  
PATRICK CHERIN ◽  
AGNES MONTAGNE ◽  
ATHMANE BOUROUBI

Objective.This double-blind, 1-year extension study investigated the longterm efficacy and safety of milnacipran 100, 150, and 200 mg/day in the treatment of fibromyalgia (FM) in completers of a 3-month European double-blind lead-in study of milnacipran 200 mg/day versus placebo.Methods.A total of 468 patients with FM successfully completing the lead-in study were either blindly maintained on milnacipran 200 mg/day (MLN200:MLN200, n = 198) or (if previously receiving placebo) rerandomized to milnacipran 100 mg/day (PBO:MLN100, n = 91), 150 mg/day (PBO:MLN150, n = 92), or 200 mg/day (PBO:MLN200, n = 87) for an additional 12 months (including a 4-week dose escalation). The main efficacy endpoint was a 2-measure composite responder rate (relative to lead-in study baseline) incorporating the weekly-recall pain score recorded on a visual analog scale and the Patient Global Impression of Change score. A panel of other assessments including the Fibromyalgia Impact Questionnaire explored the multidimensional aspects of FM. Descriptive analyses using the last observation carried forward approach were performed.Results.At the 1-year endpoint, the proportion of composite responders (relative to the lead-in study baseline) ranged from 27.5% (PBO:MLN100) to 35.9% (MLN200:MLN200), and had increased from the extension study baseline by 15.2% (PBO:MLN150) to 20.7% (PBO:MLN200 and MLN200:MLN200). At endpoint, an improvement from both baselines was shown in all groups on pain, fatigue, sleep, and quality of life measures. Up to 1 year, all doses of milnacipran were safe and well tolerated. The most common drug-related adverse events were hyperhidrosis and nausea.Conclusion.Over 1 year, milnacipran 100, 150, and 200 mg/day exhibited sustained and safe therapeutic effects on predominant symptoms of FM. Registered as trial no.NCT00757731.


2014 ◽  
Vol 93 (1) ◽  
pp. 80-83 ◽  
Author(s):  
Mariana Tirolli Rett ◽  
Paulo César Giraldo ◽  
Ana Katherine da Silveira Gonçalves ◽  
José Eleutério Junior ◽  
Sirlei Siani Morais ◽  
...  

2002 ◽  
Vol 20 (1) ◽  
pp. 65-72 ◽  
Author(s):  
J. Bernhard ◽  
R. Maibach ◽  
B. Thürlimann ◽  
C. Sessa ◽  
M. S. Aapro

PURPOSE: We investigated the clinical validity of patients’ estimation of overall treatment burden. This measure was expected to be responsive to the wide spectrum of reactions on treatment and thus less precise for specific effects. PATIENTS AND METHODS: After the first chemotherapy within a randomized, double-blind trial of the prophylaxis for delayed emesis (SAKK 90/95), 249 patients documented nausea and vomiting daily for 6 days. Over the whole period, they estimated nausea/vomiting (N/V) burden and overall treatment burden by linear analog-self assessment (LASA) indicators and documented other side effects. RESULTS: At day 6, the two burden indicators were moderately correlated (r = 0.58) in accordance with their different concepts. No, partial, or total control of delayed emesis (days 2 to 6) was reflected in a consistent pattern by both indicators, with a stronger and more significant effect (P < .001) on changes in N/V burden than overall treatment burden. In contrast, toxicity other than N/V, assessed independently by patients and physicians, was mainly associated with overall treatment burden. Patients who indicated at least one other side effect rated their overall burden substantially higher than those with no indication of other toxicity (P < .0001). Physician-rated toxicity had a similar effect (P < .0001). CONCLUSION: A direct patient estimation of overall treatment burden by a LASA indicator may serve as an end point in clinical trials, particularly when treatments with different toxicity profiles are being compared. It is complementary to physicians’ ratings of specific toxicities and a major component of patient-rated symptom checklists and quality-of-life measures.


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