Current medical research and opinion
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and tolerability of diclofenac dispersible in elderly patients with osteoarthritis.
The efficacy and tolerability of a new dispersible formulation of diclofenac were evaluated in a randomized, double-blind, placebo-controlled, multi-centre study in patients aged 60 to 80 years suffering from osteoarthritis. A total of 314 elderly patients with a mean age of 68.9 years received either 50 mg diclofenac dispersible or placebo 3-times daily for a period of 4 weeks, with paracetamol being allowed as rescue analgesic for both treatment groups. The study consisted of a baseline evaluation and two follow-up visits after 14 and 28 days of treatment. ⋯ Thirty (14.4%) patients out of 208 assessed in the diclofenac group reported adverse events compared to 18 (17%) out of 106 who received placebo; therapy was discontinued prematurely due to poor tolerability in 4.8% and 5.7% of patients, respectively. The adverse events were predominantly related to the gastro-intestinal system and were mostly mild to moderate in severity. The results of this 4-week study thus demonstrate that diclofenac dispersible is not only effective in treating osteoarthritis in the elderly but also has an acceptable tolerability profile in a patient population which is especially vulnerable to adverse effects induced by non-steroidal anti-inflammatory drugs.
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Randomized Controlled Trial Clinical Trial
Etizolam in the treatment of generalized anxiety disorder: a double-blind study versus placebo.
A double-blind, placebo-controlled study was carried out in 36 patients diagnosed as suffering from Generalized Anxiety Disorder with associated depressive symptoms to assess the efficacy and tolerability of two unitary doses of etizolam. After a 1-week wash-out period on placebo, patients were assigned at random to receive 1 tablet twice daily of either 0.50 mg or 0.25 mg etizolam or placebo for 5 weeks. ⋯ Analysis of the results from the remaining 26 patients showed that, at the 0.50 mg dosage level, etizolam produced significant improvement in anxiety and depressive symptoms, particularly somatic manifestations, and was significantly more effective than placebo or the 0.25 dosage regimen. Etizolam was generally well tolerated and the few side-effects reported, mainly daytime drowsiness, were of mild to moderate severity.
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Randomized Controlled Trial Comparative Study Clinical Trial
Fluvoxamine and imipramine in the treatment of depressive patients: a double-blind controlled study.
A double-blind, controlled study was carried out in 20 patients diagnosed as suffering from depressive disorder according to DSM-III criteria to compare the effectiveness and tolerability of fluvoxamine, a serotonin re-uptake inhibitor, with that of imipramine. Patients were allocated at random to receive one or other drug for a period of 4 weeks, dosage starting at 50 mg for the first 3 days and increasing to 100 mg daily for a further 3 days. Dosage was continued at this level for the remainder of the trial but was increased, if necessary, to 150 mg daily in two divided doses. ⋯ Tolerability was assessed using the Dosage Record and Treatment Emergent Symptom Scale. The results showed that at the end of the trial there was a significant reduction in depressive symptoms severity in both groups and that fluvoxamine was significantly more effective than imipramine in reducing suicidal ideas and anxiety/somatic symptoms. Both drugs were relatively well tolerated but the side-effect profiles were different, being mainly of the anticholinergic type with the tricyclic and gastro-intestinal with fluvoxamine.
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Randomized Controlled Trial Clinical Trial
Double-blind, placebo-controlled clinical trial of a mixture of gangliosides ('Cronassial') in post-herpetic neuralgia.
A double-blind, parallel-group clinical trial was carried out in 25 patients with post-herpetic neuralgia to determine the efficacy and tolerability of a mixture of gangliosides ('Cronassial') compared with placebo. Patients were allocated at random to receive treatment with either 'Cronassial' (100 mg in 2 ml buffered solution) or placebo given by 11 subcutaneous injections over a period of 27 days, and their symptoms assessed on entry and after 2, 4 and 8 weeks. The four aspects of pain considered (overall pain, hyperaesthesia, stabbing pain and constant ache) all showed maintained reductions in severity with 'Cronassial' treatment, but not with placebo. ⋯ Two of these 5 patients were withdrawn from the study. There were no withdrawals in the placebo group. It is suggested that further studies employing greater numbers of patients should be carried out to confirm the efficacy of gangliosides in improving symptoms of patients with post-herpetic neuralgia.
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Randomized Controlled Trial Clinical Trial
Etizolam versus placebo in the treatment of panic disorder with agoraphobia: a double-blind study.
Thirty out-patients suffering from panic disorders associated with agoraphobia were enrolled in a double-blind, controlled trial to compare the effectiveness and tolerability of etizolam and placebo. After a 1-week washout period on placebo, patients were allocated at random to receive twice daily doses of either 0.5 mg etizolam or placebo over a period of 4 weeks. ⋯ The results showed that etizolam produced significant improvements in chronic anxiety, phobic ideas, associated depressive symptoms and episodic anxiety, and was significantly more effective than placebo. Etizolam treatment was generally well tolerated and was not significantly different from placebo in this respect.