American journal of therapeutics
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Randomized Controlled Trial Multicenter Study
A double-blind controlled trial of a single dose naproxen and an amino acid medical food theramine for the treatment of low back pain.
To study the safety and efficacy of a new medical food (Theramine) in the treatment of low back pain, we performed a 28-day double-blind randomized controlled trial in 129 patients. Back pain was present for at least 6 weeks and was not mild. Patients were randomly assigned to receive medical food alone (n = 43), naproxen alone (250 mg/d, n = 42), or both medical food and naproxen (n = 44). ⋯ The naproxen-alone group showed significant elevations in CRP, alanine transaminase, and aspartate transaminase when compared with the other groups. Medical food alone or with naproxen showed no significant change in liver function tests or CRP, with medical food potentially mitigating the effects seen with naproxen alone. The medical food (Theramine) appeared to be effective in relieving back pain without causing any significant side effects and may provide a safe alternative to presently available therapies.
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Randomized Controlled Trial Comparative Study
Use of heptaminol hydrochloride for catecholamine weaning in septic shock.
We analyze in the current study the impact of heptaminol hydrochloride (Heptamyl) administration in patients with septic shock requiring adrenergic support on the duration of vasopressor infusion and on catecholamine delay weaning. In this prospective study were included 49 nonconsecutive patients with septic shock requiring vasopressor infusion and with stable hemodynamic parameters during more than 24 hours. All these patients were included in a random way to receive or not heptaminol hydrochloride. ⋯ By comparing the two groups, we found that the delay of catecholamine weaning was significantly faster for the dopamine (P = 0.008) and noradrenalin (P = 0.001) in the Heptamyl group. Finally, the intensive care unit mortality rate and the hospital mortality rate were significantly lower in the Heptamyl group. Our study shows a reduction in norepinephrine and dopamine weaning duration in septic patients enrolled in the heptaminol hydrochloride group.
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Randomized Controlled Trial Multicenter Study
Tramadol hydrochloride extended-release once-daily in the treatment of osteoarthritis of the knee and/or hip: a double-blind, randomized, dose-ranging trial.
This 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial evaluated tramadol ER (extended-release tramadol) in the management of osteoarthritis pain. Adults with knee and/or hip osteoarthritis and baseline pain intensity of ≥40 on a 100-mm visual analog scale (0 = no pain, 100 = extreme pain) received once-daily tramadol ER 100 mg (n = 201), 200 mg (n = 199), or 300 mg (n = 199), celecoxib 200 mg (n = 202; to test model sensitivity), or placebo (n = 200). Coprimary efficacy variables were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, WOMAC physical function subscale, and patient global assessment of disease activity. ⋯ Adverse events occurred more frequently with tramadol ER than placebo in the gastrointestinal (nausea, constipation, diarrhea) and central nervous (dizziness, headache) systems. In this study, tramadol ER 300 mg was effective in the management of moderate to severe painful osteoarthritis of the hip or knee. A large, increasing placebo response during the study may have contributed to the lack of statistical separation between tramadol ER 200 or 100 mg and placebo.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of E-OA-07 in moderate to severe symptoms of osteoarthritis: a double-blind randomized placebo-controlled study.
The efficacy and safety of a polyherbal preparation E-OA-07 was compared against placebo in patients with moderate to severe symptoms of osteoarthritis (OA) of the knee, in a double-blind, randomized, parallel groups study. Male or female subjects with American Rheumatism Association functional class II/III and Kellgren Lawrence grade 2 or 3 OA of the knee, who had moderate to severe OA symptoms as recorded by a score of at least 60 on the modified version of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, and an overall pain score of at least 70 mm on a 100 mm Visual analogue (VAS) scale were studied. Subjects received 2 capsules of E-OA-07 or placebo twice daily for 12 weeks and paracetamol up to 2 gm per day as rescue medication. ⋯ One E-OA-07 subject was hospitalized due to accidental fall and withdrawn from the study. No other serious adverse event occurred. The effect of E-OA-07 in relieving moderate to severe symptoms of OA of the knee is well tolerated, superior, and more persistent than placebo.
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Randomized Controlled Trial Comparative Study
A randomized, open-label pilot study comparing desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis: PREVENT-HIT Study.
Because of an extreme risk for thromboemboli, patients with suspected heparin-induced thrombocytopenia (HIT) require immediate initiation of an alternative anticoagulant. The only therapies approved by the Food and Drug Administration require intravenous infusion of expensive direct thrombin inhibitors. This prospective, randomized, open-label, exploratory study compared the clinical and economic utility of subcutaneous desirudin vs argatroban, the most frequently used agent for suspected or immunologically confirmed HIT, with or without thrombosis. ⋯ There was 1 minor bleed in each treatment group. The average medication cost per course of treatment was $1688 for desirudin and $8250 for argatroban. Desirudin warrants further study as a potentially cost-effective alternative to argatroban in patients with suspected HIT.