Effect of parenteral cladribine on relapse rates in patients with relapsing forms of multiple sclerosis: results of a 2-year, double-blind, placebo-controlled, crossover study

2009 ◽  
Vol 15 (6) ◽  
pp. 767-770 ◽  
Author(s):  
Z Stelmasiak ◽  
J Solski ◽  
J Nowicki ◽  
B Jakubowska ◽  
M Ryba ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Crossover Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Sustained Reduction ◽  
Scale Scores ◽  
Group A ◽  
Group B ◽  
Favorable Safety ◽  
Relapse Rates

Objective This randomized, 2-year, double-blind, placebo-controlled, crossover study evaluated cladribine for relapsing forms of multiple sclerosis. Design Patients ( n = 84) received seven 5-day courses of subcutaneous cladribine at 5 mg/day (group A) or placebo (group B) in year 1; treatment was reversed in year 2. Results Cladribine was well tolerated and associated with a favorable safety profile. Mean Expanded Disability Status Scale scores remained stable. In group A, mean relapse rates were 0.15 in year 1 (cladribine) and 0.42 in year 2. In group B, relapse rates were 0.61 in year 1 and 0.50 in year 2 (cladribine). Patients required fewer steroid courses during cladribine periods. The therapeutic efficacy of cladribine was associated with a sustained reduction in lymphocyte count.

Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study

2004 ◽  
Vol 10 (4) ◽  
pp. 417-424 ◽  
Author(s):  
C Vaney ◽  
M Heinzel-Gutenbrunner ◽  
P Jobin ◽  
F Tschopp ◽  
B Gattlen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Crossover Study ◽  
Plant Extract ◽  
Active Treatment ◽  
Cannabis Sativa ◽  
Self Report ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group A ◽  
Cannabis Extract

Objective: Cannabis may alleviate some symptoms associated with multiple sclerosis (MS). This study investigated the effect of an orally administered standardized Cannabis sativa plant extract in MS patients with poorly controlled spasticity. Methods: During their inpatient rehabilitation programme, 57 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled crossover study of cannabis-extract capsules standardized to 2.5 mg tetrahydrocannabinol (THC) and 0.9 mg cannabidiol (CBD) each. Patients in group A started with a drug escalation phase from 15 to maximally 30 mg THC by 5 mg per day if well tolerated, being on active medication for 14 days before starting placebo. Patients in group B started with placebo for seven days, crossed to the active period (14 days) and closed with a three-day placebo period (active drug dose escalation and placebo sham escalation as in group A). Measures used included daily self-report of spasm frequency and symptoms, Ashworth Scale, Rivermead Mobility Index, 10-m timed walk, nine-hole peg test, paced auditory serial addition test (PASAT), and the digit span test. Results: In the 50 patients included into the intention-to-treat analysis set, there were no statistically significant differences associated with active treatment compared to placebo, but trends in favour of active treatment were seen for spasm frequency, mobility and getting to sleep. In the 37 patients (per-protocol set) who received at least 90% of their prescribed dose, improvements in spasm frequency (P- 0.013) and mobility after excluding a patient who fell and stopped walking were seen (P- 0.01). Minor adverse events were slightly more frequent and severe during active treatment, and toxicity symptoms, which were generally mild, were more pronounced in the active phase. Conclusion: A standardized Cannabis sativa plant extract might lower spasm frequency and increase mobility with tolerable side effects in MS patients with persistent spasticity not responding to other drugs.

scholarly journals Stopping Disease-Modifying Therapy in Nonrelapsing Multiple Sclerosis

2017 ◽  
Vol 19 (1) ◽  
pp. 11-14 ◽  
Author(s):  
Gary Birnbaum
Keyword(s):  
Multiple Sclerosis ◽  
Acute Disease ◽  
Published Data ◽  
Secondary Progressive ◽  
Disease Modifying Therapy ◽  
Scale Scores ◽  
Group A ◽  
Multiple Variables ◽  
Disease Modifying ◽  
Group B

Background: Current disease-modifying therapies (DMTs) are of benefit only in people with relapsing forms of multiple sclerosis (RMS). Thus, safely stopping DMTs in people with secondary progressive MS may be possible. Methods: Two groups of patients with MS were studied. Group A consisted of 77 patients with secondary progressive MS and no evidence of acute central nervous system inflammation for 2 to 20 years. These patients were advised to stop DMTs. Group B consisted of 17 individuals with RMS who stopped DMTs on their own. Both groups were evaluated at treatment cessation and for a minimum of 1 year thereafter. Multiple variables were assessed to determine those that predicted recurrent acute disease. Results: Nine patients in group A (11.7%) and ten patients in group B (58.8%) had recurrent acute disease, almost always within 1 to 2 years of stopping treatment. The only variable of significance in group A distinguishing stable and relapsing patients was age (P = .0003), with relapsing patients being younger. Group B patients were younger and had significantly lower Expanded Disability Status Scale scores than group A, with no significant differences in age between relapsed and stable patients. Conclusions: The DMTs can be stopped safely in older patients with MS (≥7 decades) with no evidence of acute disease for 2 years or longer, with an almost 90% probability of remaining free of acute recurrence. The high proportion of untreated patients with RMS experiencing recurrent acute disease is consistent with published data.

scholarly journals Chinese HerbAstragalus membranaceusEnhances Recovery of Hemorrhagic Stroke: Double-Blind, Placebo-Controlled, Randomized Study

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Chun-Chung Chen ◽  
Han-Chung Lee ◽  
Ju-Hsin Chang ◽  
Shuang-Shuang Chen ◽  
Tsai-Chung Li ◽  
...  
Keyword(s):  
Scale Score ◽  
Hemorrhagic Stroke ◽  
Randomized Study ◽  
Functional Independence Measure ◽  
Functional Independence ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group A ◽  
Group B ◽  
Acute Hemorrhagic Stroke

We tested the effect ofAstragalus membranaceus(AM) on acute hemorrhagic stroke. Seventy-eight patients were randomly assigned to Group A (3 g of AM three times/day for 14 days); or Group B (3 g of placebo herb). A total of 68 patients (Group A 36, Group B 32) completed the trial. The increase of functional independence measure scale score between baseline and week 4 was 24.53 ± 23.40, and between baseline and week 12 was 34.69 ± 28.89, in the Group A was greater than 11.97 ± 11.48 and 23.94 ± 14.8 in the Group B (bothP≦0.05). The increase of Glasgow outcome scale score between baseline and week 12 was 0.75 ± 0.77 in the Group A was greater than 0.41 ± 0.50 in the Group B (P<0.05). The results are preliminary and need a larger study to assess the efficacy of AM after stroke.

XP-828L in the Treatment of Mild to Moderate Psoriasis: Randomized, Double-Blind, Placebo-Controlled Study

2006 ◽  
Vol 10 (5) ◽  
pp. 241-248 ◽  
Author(s):  
Yves Poulin ◽  
Robert Bissonnette ◽  
Christina Juneau ◽  
Kim Cantin ◽  
Rejean Drouin ◽  
...  
Keyword(s):  
Severity Index ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Double Blind Placebo ◽  
Sweet Whey ◽  
Severity Index Score ◽  
Group A ◽  
Group B

Background: XP-828L, a protein extract obtained from sweet whey, has demonstrated potential benefit for the treatment of mild to moderate psoriasis in an open-label study. Objective: To study in a randomized, double-blind, placebo-controlled study the safety and efficacy of XP-828L in the treatment of mild to moderate psoriasis. Design: XP-828L 5 g/d (group A, n = 42) or placebo (group B, n = 42) was given orally for 56 days followed by XP-828L 5 g/d in group A and by XP-828L 10 g/d in group B for an additional 56 days. Results: Patients receiving XP-828L 5 g/d for 56 days had an improved Physician's Global Assessment (PGA) score compared with patients under placebo ( p < .05). Considering the data of group A only, the PGA score improved from day 1 to day 56 ( p < .01); the Psoriasis Area and Severity Index score improved as well, but to a lesser extent ( p < .05). Conclusion: Oral administration of 5 g/d XP-828L compared with a placebo significantly improved the PGA score of patients with mild to moderate psoriasis.

scholarly journals Efficacy of green jackfruit flour as a medical nutrition therapy replacing rice or wheat in patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
A. Gopal Rao ◽  
K. Sunil Naik ◽  
A. G. Unnikrishnan ◽  
James Joseph
Keyword(s):  
Diabetes Mellitus ◽  
Nutrition Therapy ◽  
Controlled Study ◽  
Medical Nutrition Therapy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group A ◽  
Group B ◽  
Medical Nutrition

Abstract Background/Objectives Medical nutrition therapy along with pharmacological interventions as a multidisciplinary approach is required to treat type 2 diabetes mellitus (T2DM). This study evaluated the efficacy of Jackfruit365™ green jackfruit flour as an integral part of daily meal in patients with T2DM. Subjects/Methods This was a randomized, double-blind, placebo-controlled study conducted between May 2019 and February 2020. Patients of either sex aged ≥18 to ≤60 years with a diagnosis of T2DM for >1 year receiving oral antihyperglycemic agents were randomized (1:1) to receive either jackfruit flour 30 g/day (Group A) or placebo flour (Group B) (breakfast and dinner) daily for 12 weeks replacing an equal volume of rice or wheat flour. The primary endpoint was a mean change in glycosylated hemoglobin (HbA1c). Other endpoints were mean changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), lipid profile, and body weight. The independent t-test was used to compare changes between the groups. Results A total of 40 patients were enrolled (n = 20 each). A significantly higher reduction in HbA1c was observed in Group A compared to Group B from baseline to week 12 [−2.73 mmol/mol (−0.25%) vs. 0.22 mmol/mol (0.02%), p = 0.006]. The mean change in FPG and PPG was significantly higher in Group A than that of Group B (p = 0.043 and p = 0.001). The continuous glucose monitoring showed decreasing mean blood glucose in 7 days of administration of jackfruit flour meal. Conclusion Patients from Group A had a significantly higher reduction in HbA1c, FPG, and PPG than Group B demonstrating the efficacy of jackfruit flour in glycemic control as medical nutrition therapy replacing an equal volume of rice or wheat flour in daily meal. Clinical trial registry CTRI/2019/05/019417.

scholarly journals Prophylactic use of Tranexamic Acid during Caesarean Section in Preventing Postpartum haemorrhage– a Prospective Randomised Double Blind Placebo Controlled Study

2020 ◽  
Vol 33 (2) ◽  
pp. 125-130
Author(s):  
Nazlima Nargis ◽  
Farhana Dewan
Keyword(s):  
Blood Loss ◽  
Cesarean Section ◽  
Tranexamic Acid ◽  
Postpartum Haemorrhage ◽  
Study Group ◽  
Reduce Blood Loss ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group A ◽  
Group B

Background: Postpartum haemorrhage (PPH) is a major cause of maternal mortality,accounting for one-quarter of all maternal deaths worldwide. Tranexamic acid (TXA), anantifibrinolytic agent, has therefore been investigated as a potentially useful complement toprevention and treatment of PPH. It has been proved to reduce blood loss in elective surgery,bleeding in trauma patients, and menstrual blood loss. Aims: To evaluate the effectiveness of TXA in reducing blood loss given just immediatelyafter delivery of baby in women undergoing cesarean section. Methods: This was a prospective, randomized, double blind, placebo controlled studyconducted in the Department of Gynaecology and Obstetrics unit of IBN SINA Medical CollegeDhaka, Bangladesh from June 2016 to May 2017. Participants were randomly assigned toTXA group or group A (n=60) and placebo group or group B (n=60). Randomization wasdone by residents using computer generated random numbers. Group A received 1 gram(10ml) of intravenous bolus dose of TXA just after delivery of the baby, Group B received 10ml of sterile distilled water for injection intravenously at the same time. Statistical analysishas been done by SPSS. Results: The subjective characteristics in the two groups were similar with respect to theirage, BMI, gestational age and gravidity. The duration of surgery was 40-50 minutes. Therewas no statistically significant difference in the heart rates (p>0.05) and blood pressuresbetween the two groups, after 2 hours of delivery. Blood losses from both placental deliveriesto the end of cesarean section and from end of CS to 2 hours postpartum were significantlylower in the study group (p<0.05). Change in hemoglobin concentration in study group wasalso significantly less than in the control group. Total amount of oxytocin required wassignificantly less in TXA group (p<0.05) also the number of women requiring other oxytocics(inj. Methyl ergometrine, inj carboprost and tab misoprostol per rectally) was significantlyless in TXA group (p< 0.05). The amount of intra-operative fluid required were significantlyless in TXA group (p<0.005); however post – operative fluid requirement and minor sideeffects in the form of nausea and vomiting were similar in both the groups. Conclusion: Tranexamic acid can effectively reduce blood loss in patients undergoing LSCSand its use was not associated with any side effects and or complications like thrombosis.The adoption of WHO guidelines for using uterotonic agents and prophylactically administeringTXA may significantly reduce the number of PPH incidents. Bangladesh J Obstet Gynaecol, 2018; Vol. 33(2) : 125-130

Randomized study of antibodies to IFN-g and TNF-a in secondary progressive multiple sclerosis

2001 ◽  
Vol 7 (5) ◽  
pp. 277-284 ◽  
Author(s):  
S Skurkovich ◽  
A Boiko ◽  
I Beliaeva ◽  
A Buglak ◽  
T Alekseeva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Randomized Study ◽  
Progressive Multiple Sclerosis ◽  
Double Blind ◽  
Secondary Progressive ◽  
Number Of Patients ◽  
Scale Scores ◽  
Term Administration ◽  
Group A

Studies of cytokines in multiple sclerosis (MS) have shown that immune mechanisms connected with disturbance of the synthesis of cytokines probably play critical roles in the initiation and prolongation of MS. In a double-blind, placebo-controlled trial, 45 patients with active secondary progressive MS were randomized to three groups of 15 patients, each receiving a short course of antibodies to IFN-g, to tumor necrosis factor (TNF)-a, or a placebo. After 12 months with analysis of disability (Expanded Disability Status Scale scores), accompanied by interval determinations of lymphocyte subpopulations, cytokine production levels, MRI, and evoked potentials, it was found that only patients who received antibodies to IFN-g showed statistically significant improvement compared to the placebo group-a significant increase in the number of patients without confirmed disability progression. This was supported by MRI data (a decrease in the number of active lesions) and systemic changes in cytokine status (a decrease in IL-1b, TNF-a, and IFN-g concentrations in supernatants of activated blood cells of these MS patients and an increase in TGF-b production). Neutralization of IFN-g could be a new approach to treating secondary progressive MS. Long-term administration of humanized monoclonal antibodies to IFN-g and simultaneous use of antibodies to IFN-g together with IFN-b products are planned.

Effect of human chorionic gonadotrophin (hCG)/follicle-stimulating hormone treatment versus hCG treatment alone on testicular descent: a double-blind placebo-controlled study

1994 ◽  
Vol 130 (1) ◽  
pp. 60-64 ◽  
Author(s):  
Jantine JG Hoorweg-Nijman ◽  
Hester M Havers ◽  
Henriette A Delemarre-van de Waal
Keyword(s):  
Follicle Stimulating Hormone ◽  
Chorionic Gonadotrophin ◽  
Human Chorionic Gonadotrophin ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Retentio Testis ◽  
Group A ◽  
Group B ◽  
Stimulating Hormone

Hoorweg-Nijman JJG, Havers HM, Delemarre-van de Waal HA. Effect of human chorionic gonadotrophin (hCG)/follicle-stimulating hormone treatment versus hCG treatment alone on testicular descent: a double-blind placebo-controlled study. Eur J Endocrinol 1994;1 30:60–4. ISSN 0804–4643 The medical treatment of retentio testis remains controversial because of ineffectiveness and/or adverse events. Follicle-stimulating hormone (FSH) seems to influence the spontaneous descent of the testis; furthermore, it induces luteinizing hormone (LH) receptors. Therefore, we performed a double-blind placebo-controlled study to investigate the effect of FSH with human chorionic gonadotrophin (hCG) versus hCG alone in retentio testis patients. Twenty-two boys with retentio testis were investigated, excluding retractile testis. Group A (N= 14: four with bilateral and 10 with unilateral retentio testis; mean age 3.1 5 years) was treated with 150 IU of FSH twice a week for 2 weeks followed by 1 50 IU of FSH and 250 IU of hCG (half the recommended World Health Organization dose) twice a week for another 4 weeks. Group B (N = 8: two with bilateral and six with unilateral retentio testis: mean age 3.3 years) was treated with 250 IU of hCG twice a week for 6 weeks. Testicular position, volume and consistency as well as the appearance of the scrotum and the penile length were determined at the start of the treatment as well as at weeks 2.4.6 and 12 by two independent investigators. Blood investigation consisted of measurements of LH, FSH, testosterone and sex hormone-binding globulin. Successful descent was considered when the testis reached a mid- or low scrotal position. In group A, 6/18 testes descended successfully. In group B, 6/10 testes descended. Of the unsuccessfully treated patients, six of group A and three of group B underwent surgery. Of these patients, 6/8 testes of group A and all testes of group B showed anatomical abnormalities, which could explain the lack of hormonal response. There were no significant differences in hormonal parameters between the two groups. In both groups no serious adverse events were mentioned or observed. In conclusion, half the recommended WHO dose of hCG is sufficient to reach successful descent in 43% of treated patients, with no serious adverse events; this response rate is in agreement with the literature. Follicle-stimulating hormone does not seem to have an additional effect on the success rate, and most of the unsuccessfully treated patients showed anatomical abnormalities at operation. JJG Hoorweg-Nijman, Department of Paediatrics, Free University Hospital. PO Box 7057, 1007 MB Amsterdam, The Netherlands

Flunarizine in Prophylaxis of Childhood Migraine: A Double-Blind, Placebo-Controlled, Crossover Study

Cephalalgia ◽  
1988 ◽  
Vol 8 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Fulvio Sorge ◽  
Roberto De Simone ◽  
Enrico Marano ◽  
Maria Nolano ◽  
Giuseppe Orefice ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Trial ◽  
Average Duration ◽  
Base Line ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Childhood Migraine ◽  
Group A ◽  
Group B ◽  
Line Observation

An 8-month, double-blind, placebo-controlled, crossover trial of flunarizine in the prophylaxis of migraine has been performed in 70 children. After 4 weeks of medication-free base-line observation, 35 children (group A) received flunarizine (5 mg/day) and 35 (group B) received placebo over a 12-week period. After a 4-week washout they crossed treatments for another 12 weeks. Sixty-three patients completed the trial. In both groups flunarizine significantly reduced the frequency and average duration of headache attacks. In group A efficacy was maintained after placebo crossover for the last 4 months of the study. Five subjects in group B stopped placebo because of ineffectiveness; two children in group A discontinued flunarizine treatment, one because of excessive daytime sedation and the other because therapy was ineffective. The main side effects were daytime sedation and weight gain. It is concluded that flunarizine is an effective drug for the treatment of childhood migraine. In a study of this length no serious side effects were discovered.

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