scholarly journals Prolonged-release fampridine as adjunct therapy to active enabled motor training in multiple sclerosis patients: a pilot, double-blind, placebo-controlled study

2015 ◽  
Vol 42 (S1) ◽  
pp. S32-S33
Author(s):  
FH Jacques ◽  
A Schembri ◽  
A Nativ ◽  
C Paquette ◽  
P Kalinowski
Keyword(s):  
Statistical Significance ◽  
Treated Group ◽  
Controlled Study ◽  
Motor Training ◽  
Prolonged Release ◽  
Double Blind ◽  
Sit To Stand ◽  
Percent Improvement ◽  
The Difference ◽  
Multiple Sclerosis Patients

Objectives: To investigate if MS subjects treated with PRF 10mg BID will show a greater benefit from active enabled motor training compared with placebo. Methods: Single center, phase 4, pilot, placebo-controlled, double-blind 18 weeks study. Fifteen patients were randomized to receive PRF 10 mg BID and fifteen to received placebo BID. All patients participated in active enabled motor training of 3 sessions of 1 hour/week for 6 weeks. Patients were evaluated at -4, 0, 6 and 14 weeks using the timed 8 meters walk (8 MW), the 6 minute walk (6 MW) and the timed sit to stand (STS). Results: The PRF treated group achieved a higher mean percent improvement from baseline in all tasks at both 6 and 14 week time points. The difference reached statistical significance (mean difference of 14.29, p=0.046) for the 8MW at the 14 week time point. A higher incidence of responders (>20% improvement from baseline) was seen in the PRF treated group at 6 weeks on the 8MW (odds ratio [OR] of 2.31) and the 6MW (OR of 1.63), and at 14 weeks on the 8MW and the STS (OR of 2.0). Conclusions: PRF in MS patients appears to enhance the benefit of active enabled motor training and to better sustain it over the following 8 weeks.

scholarly journals Prolonged-Release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: A Pilot, Double-Blind, Randomized, Placebo-Controlled Study

2018 ◽  
Vol 4 (1) ◽  
pp. 205521731876116 ◽  
Author(s):  
François Jacques ◽  
Adrian Schembri ◽  
Avi Nativ ◽  
Chantal Paquette ◽  
Pawel Kalinowski
Keyword(s):  
Statistical Significance ◽  
Treated Group ◽  
Rehabilitation Program ◽  
Controlled Study ◽  
Motor Training ◽  
Prolonged Release ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Registration Number ◽  
Active Motor

Background Both prolonged-release fampridine (PRF) and enabling active motor training (EAMT) are beneficial in multiple sclerosis (MS) patients. Their combined effect is, however, understudied. Objective The objective of this paper is to determine if PRF augments the beneficial effect of EAMT in MS patients as opposed to placebo. Method This is a pilot, randomized, placebo-controlled, double-blind 14-week study. Participants were randomly assigned to receive PRF 10 mg BID ( n = 21) or placebo ( n = 20). All patients underwent EAMT during the first six weeks. Patients were assessed at –4, 0, 6 and 14 weeks. Results Both groups remained stable between –4 to 0 weeks and showed statistically significant improvements for the six-minute walk and the five-times-sit-to-stand test at weeks 6 and 14. The PRF-treated group achieved a greater mean percentage improvement and a higher incidence of responders in all three tasks at both time points. The study was, however, underpowered to reach statistical significance. Conclusion Our results confirm previous studies demonstrating that MS patients, despite significant disability, do benefit from a rehabilitation program. Our study is the first to show a trend suggesting that PRF in MS patients appears to enhance the benefit of EAMT. Further studies are required to confirm this. Clinical trial registration number with Clinicaltrial.gov: NCT02146534

scholarly journals Effect of GutGard in the Management ofHelicobacter pylori: A Randomized Double Blind Placebo Controlled Study

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Sreenivasulu Puram ◽  
Hyung Chae Suh ◽  
Seung Un Kim ◽  
Bharathi Bethapudi ◽  
Joshua Allan Joseph ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Treated Group ◽  
Controlled Study ◽  
Root Extract ◽  
Double Blind ◽  
Exact Probability ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
The Difference ◽  
H Pylori

A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract ofGlycyrrhiza glabra) in the management ofHelicobacter pylori(H. pylori) gastric load. Participants diagnosed withH. pyloriinfection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55) or placebo (n=52) once daily for 60 days.H. pyloriinfection was assessed using13C-urea breath test (13C-UBT) at days 0, 30, and 60. Stool Antigen test (HpSA) was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA), chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00) and significant difference in mean Delta Over Baseline (DOB) values between GutGard (n=50) and placebo (n=50) treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56%) in GutGard treated group whereas in placebo treated group only 2 subjects (4%) showed negative response; the difference between the groups was statistically significant. On day 60, the results of13C-UBT were negative in 24 (48%) in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management ofH. pylori.

Clinical Study of Qingpeng Ointment Treatment of Shoulder-Hand Syndrome After Cerebral Hemorrhage During the Rehabilitation Period

2020 ◽  
Vol 23 ◽  
Author(s):  
Ruihuan Pan ◽  
Shanshan Ling ◽  
Haodong Yang ◽  
Yan Huang ◽  
Lechang Zhan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Cerebral Hemorrhage ◽  
Clinical Medicine ◽  
External Rotation ◽  
Statistical Significance ◽  
Hand Function ◽  
Tibetan Medicine ◽  
Controlled Study ◽  
Control Group ◽  
The Difference

Background: Shoulder-hand syndrome (SHS) refers to a syndrome causing sudden edema, shoulder pain and limited hand function. Qingpeng ointment, a kind of Tibetan medicine, can reduce swelling, relieve pain, tonify stagnation and clear the meridians, which is consistent with the pathological mechanism of SHS after stroke. Therefore, if clinical trials can be used to explore the effectiveness of Qingpeng ointment for treatment of poststroke SHS and promote its application in clinical medicine, this is of specific significance for the treatment of poststroke SHS. Objective: To investigate the clinical efficacy and safety of Qingpeng ointment in the treatment of poststroke SHS. To provide an objective basis for a better therapeutic treatment for poststroke SHS． Method: A prospective, randomized, controlled study was conducted. This study recruited 120 patients with poststroke SHS who met the inclusion criteria. They were randomized into the treatment group and the control group, with 60 patients allocated to each group. The treatment group received routine medical treatment and rehabilitative care after using the Qingpeng ointment, while the patients in the control group received only routine treatment without the ointment. All patients received clinical assessment with the Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI) before and after the whole treatment. Results: After 4 weeks of treatment, the VAS scores of both groups were decreased significantly (P＜0.05), and the difference between the two groups was statistically significant (P < 0.05). There is no statistical significance for the difference between the treatment group and control group in terms of the FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles after treatment. The increases in the values of VAS, FMA-M and MBI in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). The increases in the values of the forward bend, outreach and external rotation angles in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). Conclusion: The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage. Qingpeng ointment is effective and safe in treating poststroke SHS.

A randomized clinical efficacy study targeting mPGES1 or EP4 in dogs with spontaneous osteoarthritis

2019 ◽  
Vol 11 (516) ◽  
pp. eaaw9993
Author(s):  
Carol Robertson-Plouch ◽  
John R. Stille ◽  
Peng Liu ◽  
Claire Smith ◽  
Dorothy Brown ◽  
...  
Keyword(s):  
Posterior Probability ◽  
Brief Pain Inventory ◽  
Repeated Measure ◽  
Controlled Study ◽  
Prostaglandin E ◽  
Double Blind ◽  
Mixed Effect ◽  
Secondary Endpoints ◽  
Efficacy Measures ◽  
The Difference

Canine studies of spontaneous osteoarthritis (OA) pain add valuable data supporting drug treatment mechanisms that may translate to humans. A multicenter, randomized, double-blind, placebo- and active-controlled study was conducted in client-owned dogs with moderate OA pain to evaluate efficacy of LYA, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES1), an EP4 antagonist (LYB), and carprofen, versus placebo. Of 255 dogs screened, 163 were randomized (placebo/LYA/LYB/carprofen: n = 43/39/42/39) and 158 completed treatment. Efficacy versus placebo was assessed using Bayesian mixed-effect model for repeated measure analyses of the Canine Brief Pain Inventory (CBPI) pain interference score (PIS; primary endpoint), pain severity score, and overall impression, as well as the Liverpool Osteoarthritis in Dogs (LOAD) mobility score. The posterior probability that the difference to placebo was <0 at week 2 was 80% for LYA and 54% for LYB for CBPI PIS (both <95% predefined threshold). For secondary endpoints, the posterior probability that the difference to placebo was <0 at week 2 ranged from 89 to 96% for LYA and from 56 to 89% for LYB. The posterior probabilities comparing carprofen to placebo groups were ≥90% for all efficacy endpoints. The proportion of dogs with one or more adverse event was not significantly different from placebo (32.6%) for LYA (35.9%) or carprofen (25.6%), but the rate for LYB (59.5%) was higher versus placebo (P = 0.017). LYA treatment demonstrated consistent improvement in all efficacy measures, suggesting that inhibition of mPGES1 may be an effective treatment for chronic pain associated with OA.

scholarly journals Beta alanine supplementation effects on metabolic contribution and swimming performance

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Matheus Silva Norberto ◽  
Ricardo Augusto Barbieri ◽  
Danilo Rodrigues Bertucci ◽  
Ronaldo Bucken Gobbi ◽  
Eduardo Zapaterra Campos ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Energy Demand ◽  
Swimming Performance ◽  
Controlled Study ◽  
Double Blind ◽  
Repeated Measures Anova ◽  
Beta Alanine ◽  
Before And After ◽  
The Difference ◽  
And Performance

Abstract Background Investigations of β-alanine supplementation shows effects on metabolic (aerobic and anaerobic) participation and performance on swimming by a possible blood acidosis buffering. Considering this background, the objective of the present study was to analyze the effects of β-alanine supplementation on metabolic contribution and performance during 400-m swim. Methods Thirteen competitive swimmers underwent a 6-week, double-blind placebo-controlled study, ingesting 4.8 g.day− 1 of β-alanine or placebo. Before and after the supplementation period, the total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS) were assessed. Anaerobic alactic (AnAl) and lactic energy (AnLa) was assumed as the fast component of excess post-exercise oxygen consumption and net blood lactate accumulation during exercise (∆[La−]), respectively. Aerobic contribution (Aer) was determined by the difference between total energy demand and TAn. In addition to conventional statistical analysis (Repeated measures ANOVA; p > 0.05), a Bayesian repeated measures ANOVA was used to evidence the effect probability (BFincl). Results No differences and effects were found between groups, indicating no supplementation effects. Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BFincl: 25.02); absolute AnLa (p: 0.002; BFincl: 12.61), fatigue index (p > 0.001; BFincl: 63.25) and total anaerobic participation (p: 0.008; BFincl: 4.89). Conclusions Thus, the results demonstrated that all changes presented were evidenced as a result of exposure to the training period and β-alanine supplementation doesn’t affect metabolic contribution and performance during 400-m freestyle.

Pc.6 Acupressure for Dental Nausea: A Preliminary Report of a Prospective Randomised Double Blind Clinical Trial, Part 1

1997 ◽  
Vol 15 (1) ◽  
pp. 6-9 ◽  
Author(s):  
RAC Chate
Keyword(s):  
First Trimester ◽  
Small Sample ◽  
Cytotoxic Agents ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
First Trimester Of Pregnancy ◽  
The Difference ◽  
Prior Application ◽  
Randomised Controlled

Acupressure effectively reduces the amount of nausea experienced, both in the first trimester of pregnancy, and after either opiates or cytotoxic agents. The aim of this randomised, controlled study was to establish whether it could also reduce any sensation of nausea related to the taking of maxillary dental impressions. The sample comprised 8 males and 14 females, with a mean age of 14.64 years and whose self-registration of nausea following an impression was greater than 33% of a 100mm visual analogue. The test involved a second impression with prior application of pressure on either PC.6, the sixth point on the Chinese pericardial meridian, or a placebo point on the forearm of the patient's dominant limb. A random mental choice as to which point to press was made by each patient, and double blind conditions prevailed. After the withdrawal of the impression, another visual analogue was marked. Of the 9 patients who had used the placebo point during the test impression, there had been a mean reduction of 29% in the scale of nausea experienced. Of the 13 who had used the PC.6 acupressure point, the mean reduction was 30%. The difference was not significant. Three and a half minutes of acupressure on PC.6 did not reduce the sensation of nausea induced by tactile stimulation of the soft palate in this small sample of susceptible patients.

scholarly journals Efficacy of an Oral Rehydration Solution Enriched with Lactobacillus reuteri DSM 17938 and Zinc in the Management of Acute Diarrhoea in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1189 ◽  
Author(s):  
Maria Maragkoudaki ◽  
George Chouliaras ◽  
Antonia Moutafi ◽  
Athanasios Thomas ◽  
Archodoula Orfanakou ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Lactobacillus Reuteri ◽  
Oral Rehydration Solution ◽  
Statistical Significance ◽  
Acute Diarrhoea ◽  
Controlled Study ◽  
Double Blind ◽  
Oral Rehydration ◽  
Number Of Patients ◽  
Rehydration Solution

The efficacy of oral rehydration solution (ORS) enriched with Lactobacillus reuteri DSM 17938 and zinc in infants with acute gastroenteritis, is poorly defined. The aim of this double-blind, randomized, placebo-controlled study, was to assess the efficacy of an ORS enriched with Lactobacillus reuteri DSM 17938 and zinc (ORS+Lr&Z) in well-nourished, non-hospitalized infants with acute diarrhoea. Fifty one infants with acute diarrhoea were randomly assigned to receive either ORS+Lr&Z (28 infants, mean ± SD age 1.7 ± 0.7 years, 21 males), or standard ORS (ORS−Lr&Z; 23 infants, mean ± SD age 1.8 ± 0.7 years, 16 males). Stools volume and consistency were recorded pre- and posttreatment using the Amsterdam Infant Stool Scale and were compared between the two groups, as well as lost work/day care days, drug administration and need for hospitalization. Both groups showed reduction in the severity of diarrhoea on day two (p < 0.001) while, all outcomes showed a trend to be better in the ORS+Lr&Z group, without reaching statistical significance, probably due to the relatively small number of patients. No adverse effects were recorded. In conclusion, both ORS were effective in managing acute diarrhoea in well-nourished, non-hospitalized infants. ORS enriched with L. reuteri DSM 17938 and zinc was well tolerated with no adverse effects.

The lack of sustained effect of bright light in non-seasonal major depression

2006 ◽  
Vol 36 (9) ◽  
pp. 1247-1252 ◽  
Author(s):  
KLAUS MARTINY ◽  
MARIANNE LUNDE ◽  
MOGENS UNDÉN ◽  
HENRIK DAM ◽  
PER BECH
Keyword(s):  
Major Depression ◽  
Randomized Study ◽  
Bright Light ◽  
Light Therapy ◽  
Treated Group ◽  
Bright Light Therapy ◽  
Double Blind ◽  
Sustained Effect ◽  
The Difference

Background. Recently accumulated evidence has demonstrated that bright-light therapy in combination with antidepressants is effective in patients with non-seasonal major depression. Whether bright light has a sustained effect after discontinuation is, however, poorly investigated.Method. In this double-blind randomized study we report the results from a 4-week follow-up period in patients with major non-seasonal depression who had been treated for 5 weeks with sertraline combined with bright-light therapy or sertraline combined with dim-light therapy. At the beginning of the follow-up period the light therapy was stopped while sertraline treatment continued for 4 weeks.Results. Depression scores decreased substantially in both groups, resulting in high response and remission rates in both groups after 9 weeks of treatment. The difference in depression scores at week 5, favouring the bright-light-treated group, disappeared gradually in the 4-week follow-up period, resulting in similar end-point scores.Conclusions. Bright light did not have a sustained effect after discontinuation. The offset of effect was complete after 4 weeks.

Cyclandelate in the Prophylaxis of Migraine

Cephalalgia ◽  
1996 ◽  
Vol 16 (6) ◽  
pp. 441-447 ◽  
Author(s):  
HC Diener ◽  
M F”h ◽  
C laccarino ◽  
P Wessely ◽  
H Isler ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Platelet Activating Factor ◽  
Baseline Period ◽  
Comparable Efficacy ◽  
Double Blind ◽  
Treatment Groups ◽  
Adverse Experiences ◽  
First Choice ◽  
The Difference ◽  
Better Than

Cyclandelate inhibits calcium-induced contraction of vascular smooth muscle cells, platelet aggregation induced by thrombin, platelet-activating-factor and adenosine, and also suppresses a provoked 5HT release from platelets. This pharmacological profile suggests that cyclandelate may have a potential prophylactic effect in migraine. To test this hypothesis, a double-blind multicentre study was performed in 214 patients to investigate the efficacy and tolerability of cyclandelate compared to placebo and propranolol. After a 4-week baseline period, eligible patients (randomization 3:2:3) were treated for 12 weeks with daily doses of 1.200 mg cyclandelate ( n=81), placebo ( n=55) or 120 mg propranolol ( n=78). The number of migraine attacks (350% responders) and the migraine duration/month were compared based on the difference between baseline and the last 4 weeks of prophylactic treatment. The percentage of patients with a reduction in migraine attacks of 350% treated with cyclancelate (37.0%) or propranolol (42.3%) was not significantly superior to placebo (30.9%; P>0.025). The mean duration of migraine in hours (h) per month decreased in both active treatment groups (cyclandelate: 36.8h, p=0.046; propranolol: 34.4 h, p=0.039) compared to placebo (13.7 h) without reaching statistical significance (alpha/2=0.025). The clinical efficacy of cyclandelate and propranolol was comparable. Adverse experiences were reported by 13 patients (16.0%) treated with cyclandelate, by 5 patients (9.1%) treated with placebo and by 19 patients (24.4%) treated with propranolol. These were drug-related in 7.1% ( n=6) of patients treated with cyclandelate and in 9% ( n=7) of patients treated with propranolol. In summary, cyclandelate has a comparable efficacy to that of propranolol an established drug of first choice in the prophylaxis of migraine. Both drugs were better than placebo, but not significantly so. Both active treatments were well tolerated. ÿ box

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