Are Brand-Name and Generic Warfarin Interchangeable? Multiple N-of-1 Randomized, Crossover Trials

2005 ◽  
Vol 39 (7-8) ◽  
pp. 1188-1193 ◽  
Author(s):  
Jennifer A Pereira ◽  
Anne M Holbrook ◽  
Lisa Dolovich ◽  
Charles Goldsmith ◽  
Lehana Thabane ◽  
...  
Keyword(s):  
North America ◽  
International Normalized Ratio ◽  
Warfarin Interaction ◽  
Study Patient ◽  
Control Group ◽  
Brand Name ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Crossover Trials

BACKGROUND Warfarin is a commonly used anticoagulant in North America. Several generic formulations have been approved, raising concern over the safety and efficacy of these products compared with brand-name Coumadin. OBJECTIVE To ensure that generic warfarin products can be safely interchanged with Coumadin. METHODS Multiple n-of-1 randomized, double-blind, crossover trials switched outpatients (N = 7) between a generic warfarin formulation (Apo-warfarin) and Coumadin over 30 weeks. Study patients took each drug for five 3-week periods, with international normalized ratio (INR) measurements taken twice per period. Inter- and intrapatient differences between generic warfarin and Coumadin were compared, and overall study patient results were compared with those of a Coumadin control group. RESULTS There were no differences between warfarin products in terms of mean INR results or number of dosage adjustments required. There also was no difference in INR variation based on warfarin formulation (p > 0.69), nor was a patient and warfarin interaction found (p > 0.81). The INR results were not influenced by whether patients were maintained on Coumadin only (control group) or interchanged between Coumadin and generic warfarin (p = 0.98). CONCLUSIONS It appears that patients can safely and effectively switch between generic warfarin and Coumadin.

scholarly journals The safety and efficacy of transcranial direct current stimulation as add-on therapy to fluoxetine in obsessive-compulsive disorder: a randomized, double-blind, sham-controlled, clinical trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Sadegh Yoosefee ◽  
Man Amanat ◽  
Mona Salehi ◽  
Seyed Vahid Mousavi ◽  
Jamshid Behzadmanesh ◽  
...  
Keyword(s):  
Adverse Events ◽  
Direct Current ◽  
Adjunctive Therapy ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Compulsive Disorder ◽  
The Mean ◽  
Experimental Group

Abstract Background Obsessive-compulsive disorder (OCD) is an anxiety disorder that causes impairment in daily activities. This study aimed to assess the safety and efficacy of transcranial direct current stimulation (tDCS) as adjunctive therapy with fluoxetine in individuals diagnosed with moderate to severe OCD. Methods This is a randomized, double-blind sham-controlled trial. Individuals with OCD who had baseline Yale-Brown obsessive-compulsive scale (Y-BOCS) of > 15 were enrolled. Eligible cases were randomly assigned in 1:1 ratio to receive either 20-min-period of stimulation with tDCS and fluoxetine (experimental arm) or fluoxetine only (sham control arm). The anodal electrode of tDCS was placed over the left dorsolateral prefrontal cortex (Fp3) and the cathodal electrode was placed over the right orbitofrontal cortex (F8). Two mA electrical stimulation with the tDCS was used for 20 min in individuals of experimental group. In the control group, electrodes were placed and stimulation was administered for 30 s to induce the same skin sensation as in experimental group. This procedure was performed three times per week for 8 weeks. Y-BOCS test was assessed at baseline, week 4 (after 12th stimulation), week 8 (after 24th stimulation), and 1 month after the last stimulation. The primary endpoints were the mean changes in Y-BOCS total score from baseline to the last visit. The secondary endpoints were the mean changes in obsession and compulsion sub-scores from baseline to the last visit. Adverse events were also assessed. Mixed design repeated measures analysis of variance assessed the endpoints. Results Sixty individuals (30 in each group) were participated. All individuals in control group and 28 cases in experimental arm completed the trial. The mean Y-BOCS (F(1.85) = 30.83; P < 0.001), OCD obsession (F(2.23) = 25.01; P < 0.001), and compulsion (F(2.06) = 10.81; P < 0.001) scores decreased significantly during the study. No statistical differences were, however, detected between experimental and control groups (P > 0.05). The tDCS was well tolerated and no major adverse events were reported. Conclusion This study showed that among individuals with moderate to severe OCD, there was no significant difference regarding OC symptoms between cases used tDCS as adjunctive therapy with fluoxetine and individuals used fluoxetine only. Trial registration IRCT2017030632904N1. Registered 14 July 2017, http://irct.ir/user/trial/44193/view

Simultaneous Administration of Measles-Mumps-Rubella Vaccine With Booster Doses of Diphtheria-Tetanus-Pertussis and Poliovirus Vaccines

PEDIATRICS ◽  
1988 ◽  
Vol 81 (2) ◽  
pp. 237-246
Author(s):  
Adamadia Deforest ◽  
Sarah S. Long ◽  
Harold W. Lischner ◽  
Joseph A. C. Girone ◽  
Janet L. Clark ◽  
...  
Keyword(s):  
Geometric Mean ◽  
Test Group ◽  
Control Group ◽  
Simultaneous Administration ◽  
Rubella Vaccine ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Sequential Administration ◽  
Reaction Data ◽  
Second Year

The safety and efficacy of simultaneous administration of measles-mumps-rubella (MMR), diphtheria-tetanus-pertussis (DTP), and trivalent oral poliovirus (OPV) vaccines in a test group of 405 children were compared with the safety and efficacy of sequential administration of the same vaccines in a control group of 410 children given MMR followed by booster doses of DTP and OPV 2 months later. The study was double blind and placebo controlled with respect to DTP and OPV. Seroconversion rates to measles, mumps, and rubella exceeded 96% in both groups. Geometric mean titers to measles (P = .05) and rubella (P = .004) were higher in the test group, and titers of antibodies to the other seven antigens were similar in both groups. Clinical reaction data were analyzed in 248 of 405 test children and 249 of 410 control children. The rates of serious vaccine-associated reactions were low and similar in the two groups. Some minor side effects were reported more frequently in the test group, but these differences were judged to be related to study design rather than to differences in the safety of the two vaccine schedules. The results indicate that the safety and serologic efficacy of administering MMR simultaneously with reinforcing doses of DTP and OPV in the second year of life is equivalent to the safety and efficacy observed after administering these antigens separately.

scholarly journals Efficacy of Mudan Granule (Combined With Methylcobalamin) on Type 2 Diabetic Peripheral Neuropathy: Study Protocol for a Double-Blind, Randomized, Placebo-Controlled, Parallel-Arm, Multi-Center Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Yuehong Zhang ◽  
De Jin ◽  
Yingying Duan ◽  
Rui Hao ◽  
Keyu Chen ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Diabetic Peripheral Neuropathy ◽  
Intervention Group ◽  
Trial Registration ◽  
Nerve Tissue ◽  
Control Group ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Type 2 Diabetic

Background: Diabetic peripheral neuropathy (DPN) characterized by nerve damage is a common and disabling chronic microvascular complication in patients with type 2 diabetic mellitus (T2DM), affecting at least half of patients diagnosed with T2DM. Unfortunately, the current treatment for DPN is not ideal. Traditional Chinese medicine (TCM), with a unique theoretical system, has made outstanding contributions in the treatment of T2DM and related complications. Mudan granule, a Chinese patent medicine, has been previously validated that could ameliorate the symptoms, promote nerve tissue repair, increase nerve conduction velocity (NCV) in patients with DPN. However, the previous studies are of variable quality, which limits the clinical application of Mudan granule. Therefore, we designed a double-blind, randomized, placebo-controlled, parallel-arm, multi-center trial to estimate the safety and efficacy of Mudan granule in conjunction with methylcobalamin in individuals suffering from type 2 diabetic peripheral neuropathy.Methods: This work is conducted as a 14-center, double-blind, randomized, placebo-controlled, parallel-arm trial. In all, 402 subjects (aged 30–70 years) will be recruited and randomized in a 1:1 ratio to an intervention group (n = 201; Mudan granule + methylcobalamin) and a control group (n = 201; placebo + methylcobalamin). Treatment is administered in 24 weeks cycles without any treatment interruption between cycles. Michigan Diabetic Neuropathy Score (MDNS) as the primary outcome will be evaluated at baseline, 12 weeks during the intervention period, and after 24 weeks of the intervention. Adverse events and safety assessments will be also documented. The analysis of all data will be carried out based on a predefined statistical analysis plan.Discussion: The outcomes from this study will offer important evidence regarding the safety and efficacy that Mudan granule can be used as an alternative and complementary therapeutic intervention in patients with type 2 diabetic peripheral neuropathy.Clinical trial registration: Registered at https://clinicaltrials.gov/. Trial registration number: NCT04711980. Registered January 2021.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

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