scholarly journals Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

1999 ◽  
Vol 26 (4) ◽  
pp. 283-289 ◽  
Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Rating Scale ◽  
Effect Sizes ◽  
Active Therapy ◽  
Double Blind ◽  
Treatment Groups ◽  
Negative Effect ◽  
The Individual ◽  
Positive Effect

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

1998 ◽  
Vol 87 (02) ◽  
pp. 69-76 ◽  
Author(s):  
Rosemarie Papp ◽  
Gert Schuback ◽  
Elmar Beck ◽  
Georg Burkard ◽  
Jürgen Bengel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Rectal Temperature ◽  
Muscle Pain ◽  
Rating Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Number Of Patients ◽  
Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

scholarly journals A clinical efficacy of 30% ethenolic extract of Indian propolis and Recaldent TM in management of dentinal hypersensitivity: A comparative randomized clinical trial

2013 ◽  
Vol 07 (04) ◽  
pp. 461-468 ◽  
Author(s):  
Nilesh Arjun Torwane ◽  
Sudhir Hongal ◽  
Pankaj Goel ◽  
B. R. Chandrashekar ◽  
Manish Jain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Sterile Water ◽  
Double Blind ◽  
Treatment Groups ◽  
Casein Phosphopeptide ◽  
Group B ◽  
Dentinal Hypersensitivity

ABSTRACT Objective: The aim of this study is to evaluate the efficacy of 30% ethenolic extract of Indian propolis compared with Recaldent TM (casein phosphopeptide-amorphous calcium phosphate) in reduction of dentinals hypersensitivity, a randomized, double-blind, split mouth, controlled clinical trial was conducted among the patients residing in Central Jail. Materials and Methods: A sample of 73 teeth from 13 patients having at least three teeth with dentinal hypersensitivity (DH) were randomly allocated into three treatment groups: Group A: 30% ethenolic extract of Indian propolis, Group B: Recaldent TM , Group C: Sterile water. Verbal rating scale was used to record the degree of hypersensitivity based on patient′s response to tactile and air blast stimuli. The baseline scores were obtained. Each intervention group received applications of their respective agents consecutively on 1 st , 7 th , 14 th , and 21 st day. After each application the scores were recorded. Results: Both the 30% Indian propolis and Recaldent TM showed significant reduction in DH. Conclusions: Recaldent TM was found to be significantly better in reducing the DH compared to propolis and sterile water (P < 0.01).

Adjunctive Therapy to Manage Neuropsychiatric Symptoms in Moderate and Severe Dementia: Randomized Clinical Trial Using an Outpatient Version of Tailored Activity Program

2021 ◽  
pp. 1-12
Author(s):  
Alexandra Martini Oliveira ◽  
Marcia Radanovic ◽  
Patricia Cotting Homem de Mello ◽  
Patricia Cardoso Buchain ◽  
Adriana Dias Barbosa Vizzotto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Neuropsychiatric Symptoms ◽  
Caregiver Training ◽  
Controlled Clinical Trial ◽  
Post Intervention ◽  
Double Blind ◽  
Activity Program ◽  
Experimental Group

Background: Neuropsychiatric symptoms (NPS) such as aggression, apathy, agitation, and wandering may occur in up to 90%of dementia cases. International guidelines have suggested that non-pharmacological interventions are as effective as pharmacological treatments, however without the side effects and risks of medications. An occupational therapy method, called Tailored Activity Program (TAP), was developed with the objective to treat NPS in the elderly with dementia and has been shown to be effective. Objective: Evaluate the efficacy of the TAP method (outpatient version) in the treatment of NPS in individuals with dementia and in the burden reduction of their caregivers. Methods: This is a randomized, double-blind, controlled clinical trial for the treatment of NPS in dementia. Outcome measures consisted of assessing the NPS of individuals with dementia, through the Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and assessing the burden on their caregivers, using the Zarit Scale. All the participants were evaluated pre-and post-intervention. Results: 54 individuals with dementia and caregivers were allocated to the experimental (n = 28) and control (n = 26) groups. There was improvement of the following NPS in the experimental group: delusions, agitation, aggressiveness, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, and aberrant vocalization. No improvement was observed in hallucinations, sleep disturbances, and appetite disorders. The TAP method for outpatient settings was also clinically effective in reducing burden between caregivers of the experimental group. Conclusion: The use of personalized prescribed activities, coupled with the caregiver training, may be a clinically effective approach to reduce NPS and caregiver burden of individuals with dementia.

Ultrasound-Guided Injection of Dextrose Versus Corticosteroid in Chronic Plantar Fasciitis Management: A Randomized, Double-Blind Clinical Trial

2021 ◽  
pp. 193864002098092
Author(s):  
Gholamreza Raissi ◽  
Amin Arbabi ◽  
Maryam Rafiei ◽  
Bijan Forogh ◽  
Arash Babaei-Ghazani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Plantar Fasciitis ◽  
Rating Scale ◽  
Corticosteroid Injection ◽  
Treatment Options ◽  
Plantar Fascia ◽  
Numeric Rating Scale ◽  
Therapeutic Effects ◽  
Ultrasound Guided ◽  
Double Blind

Design Chronic plantar fasciitis (PF) is a common cause of chronic heel pain, with different conventional treatment options. In this randomized clinical trial, the effect of ultrasound-guided injection of dextrose versus corticosteroid in chronic PF was evaluated and compared. Methods A total of 44 patients suffering from chronic PF who visited the physical medicine and rehabilitation clinic were enrolled in the study. Two table-randomized groups were formed. They received an ultrasonography-guided, single injection of either 40 mg methylprednisolone or 20% dextrose. Numeric Rating Scale (NRS), Foot and Ankle Ability Measure questionnaire with 2 subscales, Activities of Daily Living (FAAM-A) and Sports (FAAM-S), along with ultrasonographic parameters were evaluated before and at 2 and 12 weeks after the injection. Results. A total of 40 participants completed the study. Both interventions significantly improved pain and function at 2 and 12 weeks postinjection. After 2 weeks, compared with the dextrose prolotherapy, the corticosteroid group had significantly lower daytime and morning NRS scores (2.55 vs 4.1, P = .012, and 2.75 vs 4.65, P = .004), higher FAAM-S (66.84 vs 54.19; P = .047), and lower plantar fascia thickness at insertion and 1 cm distal to the insertion zone (3.89 vs 4.29 mm, P = .004, and 3.13 vs 3.48 mm, P = .002), whereas FAAM-A was similar in both groups ( P = .219). After 12 weeks, all study variables were statistically similar between corticosteroid and dextrose prolotherapy groups. No injection-related side effects were recorded in either group. Conclusion Both methods are effective. Compared with dextrose prolotherapy, our results show that corticosteroid injection may have superior therapeutic effects early after injection, accompanied by a similar outcome at 12 weeks postinjection. Levels of Evidence: Level II

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

Comparative Efficacy and Safety of Sertraline Versus Nortriptyline in Major Depression in Patients 70 and Older

1999 ◽  
Vol 11 (1) ◽  
pp. 85-99 ◽  
Author(s):  
Sanford I. Finkel ◽  
Ellen M. Richter ◽  
Cathryn M. Clary
Keyword(s):  
Major Depression ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Change Score ◽  
Attrition Rate ◽  
Double Blind ◽  
Almost All ◽  
Positive Effect ◽  
Population Segment

Background. Few randomized, double-blind studies that examine antidepressant treatment in patients 70 years and older are available. To provide additional data on the safety and efficacy of antidepressants in this rapidly growing population segment, a subgroup analysis of a larger sertraline vs. nortriptyline elderly depression treatment study was performed. Methods. Outpatients (N = 76) who met DSM-III-R criteria for major depression with a minimum Hamilton Depression Rating Scale (HAM-D) severity score of 18 were randomized to 12 weeks of flexible dose treatment with sertraline (50–150 mg) or nortriptyline (25–100 mg). Results. Both treatments significantly improved depression as measured by the HAM-D and Clinical Global Impression scales. At Weeks 10, 12, and endpoint, sertraline demonstrated a significantly greater reduction in depression severity compared to nortriptyline as measured by improvement on the 24-item HAM-D (mean adjusted change score of 14.8 vs. 7.6, respectively, at Week 12; p = .001). Sixty-five percent of sertraline-treated patients were responders by Week 12 (50% or greater reduction from baseline in 24-item HAM-D score) compared to 26% of nortriptyline-treated patients (p < .05). Sertraline treatment had a significantly more positive effect, when compared to nortriptyline, across almost all associated measures of cognitive function, energy, anxiety, and quality of life and was better tolerated than nortriptyline, with a lower attrition rate/side effect burden. Conclusion. The efficacy advantage of sertraline appeared to be even greater in this subgroup of older patients drawn from a larger treatment study of depression that included elderly individuals over the age of 60.

Depressive symptoms in a treated multiple sclerosis cohort

2003 ◽  
Vol 9 (6) ◽  
pp. 616-620 ◽  
Author(s):  
Scott B Patten ◽  
Shanika Fridhandler ◽  
Cynthia A Beck ◽  
Luanne M Metz
Keyword(s):  
Multiple Sclerosis ◽  
Depressive Symptoms ◽  
Interferon Beta ◽  
Rating Scale ◽  
Epidemiological Studies ◽  
Treatment Groups ◽  
Increased Risk ◽  
The University ◽  
Depression Ratings

Background: Recent side effect data from clinical trials of interferon beta in multiple sclerosis (MS) have failed to confirm that these medications are associated with an increased risk of depression. However, these studies have used highly selected samples and the results may not be generalizable to real world settings. Methods: C linical data on subjects from southern A lberta who have applied for, or are receiving, public reimbursement for MS treatment are maintained in a database at the University of C algary Multiple Sclerosis C linic. Depression ratings obtained using the C enter for Epidemiological Studies Depression Rating Scale (C ES-D) are included in this database. In the current analysis, these longitudinal data were used to determine whether depressive symptoms were associated with disease-modifying treatments. Results: A t baseline, ratings were available for 163 subjects. Those choosing interferon beta resembled those choosing glatiramer acetate in most respects. During follow-up, no differences were observed in the prevalence or incidence of depression and C ES-D scores were not found to differ between the treatment groups. Conclusions: The failure to identify higher rates of depression both in previous intervention studies and in the current observational study provides confirmation that these drugs are not substantially associated with the occurrence of depression.

A Comparative Trial of Opipramol and Chlordiazepoxide in the Treatment of Anxiety

1973 ◽  
Vol 1 (3) ◽  
pp. 145-150 ◽  
Author(s):  
K Jepson ◽  
G Beaumont
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Rating Scale ◽  
Comparative Trial ◽  
Anxiety Score ◽  
Double Blind ◽  
Somatic Anxiety ◽  
Daily Dose ◽  
The Difference

A daily dose of 200 mg of opipramol (Insidon, Geigy) and 30 mg of chlordiazepoxide (Librium, Roche) were compared in a clinical trial in general practice. The trial was double blind and a stratified randomisation technique was employed. Twenty four patients received opipramol and twenty six chlordiazepoxide for four weeks. A total anxiety score and separate ‘psychic’ anxiety and ‘somatic’ anxiety scores were recorded, using a rating scale initially and after two and four weeks treatment. No overall difference in efficacy was found between the two drugs—opipramol producing a 76% improvement and chlordiazepoxide 64% by the end of the study. There was no difference in the relief of psychic anxiety. Although opipramol appeared to give more relief of somatic anxiety, the difference was not statistically significant. Again although opipramol relieved more individual symptoms than chlordiazepoxide, none of the differences were significant. 70% of patients on opipramol and 74% of those on chlordiazepoxide were classified ‘better’ globally by both doctor and patient by the end of the trial. The total number of side effects recorded was similar on both drugs although drowsiness occurred twice as frequently on chlordiazepoxide as it did on opipramol.

scholarly journals Consistent control of disease activity with fingolimod versus IFN β-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS

2019 ◽  
pp. jnnp-2019-321124 ◽  
Author(s):  
Kumaran Deiva ◽  
Peter Huppke ◽  
Brenda Banwell ◽  
Tanuja Chitnis ◽  
Jutta Gärtner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Phase Iii ◽  
Disability Progression ◽  
Double Blind ◽  
Younger Patients ◽  
Treatment Groups ◽  
Registration Number ◽  
Treatment Naïve ◽  
Post Hoc

BackgroundIn PARADIGMS, a double-blind phase III trial in 215 paediatric patients with multiple sclerosis (MS) (10 to <18 years), fingolimod administered for up to 2 years significantly reduced the annualised relapse rate (ARR) and rate of new/newly enlarged T2 (n/neT2) lesions compared with interferon (IFN) β-1a.ObjectivesTo investigate (1) differences between treatment groups across subpopulations (treatment-naïve, younger/prepubertal patients); (2) disability progression.MethodsARRs at 10, 11 and 12 years were estimated based on predefined modelling extrapolations. Changes in Expanded Disability Status Scale (EDSS), and in 3 month (3M) and 6 month (6M) confirmed disability progression (CDP) were evaluated post hoc.ResultsIn the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population. Model-based ARR reductions in younger patients (≤12 years) were 91.9%–94.6%. Twice as many IFN β-1a-treated than fingolimod-treated patients had worse EDSS scores at study end (20.6% vs 10.5%, p=0.043). Risk reductions in 3M-CDP and 6M-CDP were 77.2% (p=0.007) and 80.2% (p=0.040), respectively.ConclusionsFingolimod in paediatric MS was associated with consistent control of disease activity versus IFN β-1a (including treatment-naïve and younger patients) and resulted in less disability progression for up to 2 years.Trial registration numberNCT01892722.

scholarly journals Proteostasis and ALS: protocol for a phase II, randomised, double-blind, placebo-controlled, multicentre clinical trial for colchicine in ALS (Co-ALS)

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028486 ◽  
Author(s):  
Jessica Mandrioli ◽  
Valeria Crippa ◽  
Cristina Cereda ◽  
Valentina Bonetto ◽  
Elisabetta Zucchi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Amyotrophic Lateral Sclerosis ◽  
Disease Progression ◽  
Phase Ii ◽  
Mononuclear Cells ◽  
Rating Scale ◽  
Double Blind ◽  
Peripheral Blood Mononuclear ◽  
Double Blind Placebo ◽  
Lateral Sclerosis

IntroductionDisruptions of proteasome and autophagy systems are central events in amyotrophic lateral sclerosis (ALS) and support the urgent need to find therapeutic compounds targeting these processes. The heat shock protein B8 (HSPB8) recognises and promotes the autophagy-mediated removal of misfolded mutant SOD1 and TDP-43 fragments from ALS motor neurons (MNs), as well as aggregating species of dipeptides produced in C9ORF72-related diseases. In ALS-SOD1 mice and in human ALS autopsy specimens, HSPB8 is highly expressed in spinal cord MNs that survive at the end stage of disease. Moreover, the HSPB8–BAG3–HSP70 complex maintains granulostasis, which avoids conversion of dynamic stress granules (SGs) into aggregation-prone assemblies. We will perform a randomised clinical trial (RCT) with colchicine, which enhances the expression of HSPB8 and of several autophagy players, blocking TDP-43 accumulation and exerting crucial activities for MNs function.Methods and analysisColchicine in amyotrophic lateral sclerosis (Co-ALS) is a double-blind, placebo-controlled, multicentre, phase II RCT. ALS patients will be enrolled in three groups (placebo, colchicine 0.01 mg/day and colchicine 0.005 mg/day) of 18 subjects treated with riluzole; treatment will last 30 weeks, and follow-up will last 24 weeks. The primary aim is to assess whether colchicine decreases disease progression as measured by ALS Functional Rating Scale - Revised (ALSFRS-R) at baseline and at treatment end. Secondary aims include assessment of (1) safety and tolerability of Colchicine in patiets with ALS; (2) changes in cellular activity (autophagy, protein aggregation, and SG and exosome secretion) and in biomarkers of disease progression (neurofilaments); (3) survival and respiratory function and (4) quality of life. Preclinical studies with a full assessment of autophagy and neuroinflammation biomarkers in fibroblasts, peripheral blood mononuclear cells and lymphoblasts will be conducted in parallel with clinic assessment to optimise time and resources.Ethics and disseminationThe study protocol was approved by the Ethics Committee of Area Vasta Emilia Nord and by Agenzia Italiana del Farmaco (EUDRACT N.2017-004459-21) based on the Declaration of Helsinki. This research protocol was written without patient involvement. Patients’ association will be involved in disseminating the study design and results. Results will be presented during scientific symposia or published in scientific journals.Trial registration numberEUDRACT 2017-004459-21;NCT03693781; Pre-results.

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