scholarly journals Antidepressant Effects of a Persian Medicine Remedy on Multiple Sclerosis Patients: A Double-Blinded Randomized Clinical Trial

2019 ◽  
Vol 8 ◽  
pp. e1212
Author(s):  
Maryam Adalat ◽  
Mohammad Khalili ◽  
Hormoz Ayromlou ◽  
Sajjad Haririan ◽  
Seyyed Mohammad Bagher Fazljou ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Placebo Group ◽  
Drug Group ◽  
Rate Of Change ◽  
Crocus Sativus ◽  
Depression Symptoms ◽  
Double Blind ◽  
Symptoms Of Depression ◽  
Persian Medicine ◽  
Multiple Sclerosis Patients

Background: Multiple sclerosis (MS), an inflammatory neurodegenerative disease of the central nervous system, is accompanied by some psychiatric disorders, one prominent example of which is depression. The aim of this study was to investigate the effects of a Persian herbal medicine treatment that contains Crocus sativus, Hypericum perforatum, Cinnamon verum, and Vitis vinifera on fatigue and sleep disorders in MS patients. Materials and Methods: A Persian medicine remedy containing C.sativus, H.perforatum, C.verum, and V.vinifera was tested for its ability to improve the symptoms of depression in MS patients. This randomized double-blind clinical study was performed among 52 patients with MS who were allocated to their respective research groups through blocked randomization. The patients were treated for 4 weeks with either the drug or the placebo. To quantify the symptoms of depression, Beck depression inventory (BDI) was used. Results: Forty-six patients completed the study. In the course of the study, as the primary outcome, BDI decreased in the drug group (p=0.000) and the placebo group (p=0.001) significantly, but the rate of change in the drug group was significantly higher than in the placebo group (-13.9 ± 8.6 vs. -3.9 ± 4.3, p=0.000). While analyzing time and treatment effect for BDI, significant decreases in BDI were observed for the drug group, but not in the placebo group (p= 0.001). Conclusion: The present study suggests that Persian medicine remedy treatment in combination with chemical drugs may improve depression symptoms in MS patients. More investigations are needed to discover the exact mechanisms and processes involved. [GMJ.2019;8:e1212]

Antidepressant Effects of a Persian Medicine Remedy On Multiple Sclerosis Patients: A Double-Blinded Randomized Clinical Trial

2019 ◽  
Vol 8 ◽  
pp. 1212
Author(s):  
Maryam Adalat ◽  
Mohammad Khalili ◽  
Hormoz Ayromlou ◽  
Sajjad Haririan ◽  
Seyyed Mohammad Bagher Fazljou ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Placebo Group ◽  
Drug Group ◽  
Rate Of Change ◽  
Crocus Sativus ◽  
Depression Symptoms ◽  
Double Blind ◽  
Symptoms Of Depression ◽  
Persian Medicine ◽  
Multiple Sclerosis Patients

Background: Multiple sclerosis (MS), an inflammatory neurodegenerative disease of the central nervous system, is accompanied by some psychiatric disorders, one prominent example of which is depression. The aim of this study was to investigate the effects of a Persian herbal medicine treatment that contains Crocus sativus, Hypericum perforatum, Cinnamon verum, and Vitis vinifera on fatigue and sleep disorders in MS patients.Materials and Methods: A Persian medicine remedy containing C.sativus, H.perforatum, C.verum, and V.vinifera was tested for its ability to improve the symptoms of depression in MS patients. This randomized double-blind clinical study was performed among 52 patients with MS who were allocated to their respective research groups through blocked randomization. The patients were treated for 4 weeks with either the drug or the placebo. To quantify the symptoms of depression, Beck depression inventory (BDI) was used.Result: Forty-six patients completed the study. In the course of the study, as the primary outcome, BDI decreased in the drug group (p=0.000) and the placebo group (p=0.001) significantly, but the rate of change in the drug group was significantly higher than in the placebo group (-13.9 ± 8.6 vs. -3.9 ± 4.3, p=0.000). While analyzing time and treatment effect for BDI, significant decreases in BDI were observed for the drug group, but not in the placebo group (p= 0.001).Conclusion: The present study suggests that Persian medicine remedy treatment in combination with chemical drugs may improve depression symptoms in MS patients. More investigations are needed to discover the exact mechanisms and processes involved. [GMJ.2019;ipress:e1212]

Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years

2000 ◽  
Vol 6 (4) ◽  
pp. 255-266 ◽  
Author(s):  
K P Johnson ◽  
B R Brooks ◽  
C C Ford ◽  
A Goodman ◽  
J Guarnaccia ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Relapse Rate ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Open Label Phase ◽  
Multiple Sclerosis Patients ◽  
To Receive

In a randomized, placebo-controlled, double-blind study, glatiramer acetate (Copaxone®) reduced the relapse rate and slowed accumulation of disability for patients with relapsing-remitting multiple sclerosis. Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in an open-label study with all patients receiving active drug. The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse. The data reported here are from approximately 6 years of organized evaluation, including the double-blind phase of up to 35 months and the open-label phase of over 36 months. Daily subcutaneous injections of 20 mg glatiramer acetate were well tolerated. The mean annual relapse rate of the patients who received glatiramer acetate since randomization and continued into the open-label study was 0.42 (95% confidence interval (CI), CI=0.34-0.51). The rate per year has continued to drop and for the sixth year is 0.23. Of the group who have received glatiramer acetate without interruption for 5 or more years, 69.3% were neurologically unchanged or have improved from baseline by at least one step on the Expanded Disability Status Scale (EDSS). Patients who left the open-label phase were surveyed by questionnaire. The majority responded, providing information about their current status and reasons for dropping out. This study demonstrates the sustained efficacy of glatiramer acetate in reducing the relapse rate and in slowing the accumulation of disability in patients with relapsing forms of multiple sclerosis.

The efficacy of multidisciplinary rehabilitation in stable multiple sclerosis patients

2006 ◽  
Vol 12 (2) ◽  
pp. 235-242 ◽  
Author(s):  
L K Storr ◽  
P S Sørensen ◽  
M Ravnborg
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Bodily Pain ◽  
Intervention Group ◽  
Inpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Multidisciplinary Rehabilitation ◽  
Upper Limb Function ◽  
Multiple Sclerosis Patients

Objective To evaluate the short-term efficacy of multidisciplinary, inpatient rehabilitation of multiple sclerosis (MS) patients. Methods A double-blind, randomized, parallel group design was used. The intervention group were offered comprehensive, multidisciplinary inpatient rehabilitation at the Haslev MS Hospital for an average of 35.5 days, while the control group received no treatment related to the study. All patients were examined in their homes twice with a 10-week interval. The rehabilitation of the intervention group started 2-3 weeks after the first examination and ended 2-3 weeks before the second examination. Impairment was assessed by the Multiple Sclerosis Impairment Scale and the Expanded Disability Status Scale. Disability was assessed by means of Guy’s Neurological Disability Scale. Two specific scales were used to assess upper limb function and ambulation: The Nine-Hole Peg Test and timed 10-metre walking. Patients’ own perception of bodily pain, bladder symptoms, spasticity, fatigue, impaired walking and transfers were recorded using visual analogue scales. Finally, quality of life was assessed using the Life Appreciation and Satisfaction Questionnaire and the Functional Assessment in Multiple Sclerosis. Patients Two hundred and thirty-three patients were screened and of those 38 were included for treatment and 52 as controls. Results We found no statistically significant differences between the two groups in any of the outcome measures. Conclusion Although the study was underpowered, the negative outcome exposes the difficulties in quantitative analyses of the efficacy of multidisciplinary rehabilitation, which is liable to confounding factors such as variation in the indication for treatment, in the placebo effect, and in the reliability and responsiveness of the outcome measures.

Depression symptoms in multiple sclerosis patients – The role of IL1B

2017 ◽  
Vol 381 ◽  
pp. 242 ◽  
Author(s):  
A. Bettencourt ◽  
B. Leal ◽  
M. Ferreira ◽  
C. Carvalho ◽  
I. Moreira ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Depression Symptoms ◽  
Multiple Sclerosis Patients

The Withdrawal of Benztropine Mesylate in Chronic Schizophrenic Patients

1983 ◽  
Vol 143 (6) ◽  
pp. 584-590 ◽  
Author(s):  
Linda A. Baker ◽  
L. Y. Cheng ◽  
I. B. Amara
Keyword(s):  
Placebo Group ◽  
Test Scores ◽  
Drug Group ◽  
Extrapyramidal Symptoms ◽  
Antiparkinsonian Drug ◽  
Double Blind ◽  
Neuroleptic Medication ◽  
Chronic Schizophrenic ◽  
Wechsler Memory Scale ◽  
Schizophrenic Patients

SummaryIn this double-blind, four-week study, 28 chronic schizophrenic patients receiving neuroleptic medication plus the antiparkinsonian drug, benztropine mesylate, were either switched to placebo or maintained on benztropine. Patients withdrawn from benztropine reliably increased their overall scores on the Wechsler Memory Scale in comparison with the drug group. Sub-test scores suggest that deficits in attention and concentration were induced by treatment with benztropine. Psychotio decompensation appeared to develop simultaneously with extrapyramidal symptoms (EPS) in some patients, but only 14.2 per cent of the placebo group experienced extrapyramidal symptoms severe enough to require resumption of benztropine therapy. It is suggested that antiparkinsonian agents should be prescribed only if and when EPS occur.

Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study

2021 ◽  
pp. 135245852110559
Author(s):  
Jun-ichi Kira ◽  
Jin Nakahara ◽  
Denis V Sazonov ◽  
Takayoshi Kurosawa ◽  
Isao Tsumiyama ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Opportunistic Infections ◽  
Open Label ◽  
Double Blind ◽  
Rate Versus ◽  
Open Label Extension ◽  
Clinical Benefits ◽  
Anti Cd20 ◽  
Multiple Sclerosis Patients ◽  
Relapsing Multiple Sclerosis

Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, has been developed as a treatment for relapsing multiple sclerosis (RMS) which can be self-administered at home. Objective: To investigate the efficacy and safety of ofatumumab in RMS patients from Japan and Russia. Methods: APOLITOS included a 24-week, double-blind, placebo-controlled core-part followed by an open-label extension-part. Patients were randomized (2:1) to subcutaneous ofatumumab 20 mg or placebo. Primary outcome was the number of gadolinium-enhancing (Gd+) T1 lesions per scan over 24 weeks. Results: Sixty-four patients were randomized (ofatumumab, n = 43; placebo, n = 21). Primary endpoint was met; ofatumumab reduced Gd + T1 lesions versus placebo by 93.6% ( p < 0.001) and the results were consistent across regions (Japan/Russia). Ofatumumab reduced annualized T2 lesion and relapse rate versus placebo by week 24. Both groups showed benefit from ofatumumab in the extension-part. Incidence of adverse events was lower with ofatumumab versus placebo (69.8% vs 81.0%); injection-related reactions were most common. No deaths, opportunistic infections, or malignancies were reported. Conclusion: Ofatumumab demonstrated superior efficacy versus placebo, with sustained effect through 48 weeks in RMS patients from Japan/Russia. Switching to ofatumumab after 24 weeks led to rapid radiological and clinical benefits. Safety findings were consistent with pivotal trials.

Efficacy of andrographolide in not active Progressive Multiple Sclerosis: A prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Ethel Ciampi ◽  
Reinaldo Uribe-San-Martin ◽  
Claudia Carcamo ◽  
Juan Pablo Cruz ◽  
Ana Reyes ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Placebo Group ◽  
Controlled Trial ◽  
Mean Difference ◽  
Relative Reduction ◽  
Disability Progression ◽  
Double Blind ◽  
The Mean ◽  
Anti Inflammatory

Abstract Background: Multiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been re-organized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS. Methods: A pilot clinical trial using 140mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change. Results: Forty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was -0.679% for the AP group and -1.069% for the placebo group (mean difference: -0.39; 95% CI [-0.836-0.055], p=0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200 – 1.777], p=0.06). The mean EDSS change was -0.025 in the AP group and +0.352 in the placebo group (mean difference: 0.63, p=0.042). Adverse events related to AP were mild rash and dysgeusia. Conclusions: AP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial. Trial registration: ClinicalTrials.gov NCT02273635

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