Effect of metildigoxin (beta-methyldigoxin) on congestive heart failure as evaluated by multiclinical double blind study.

The efficacy on congestive heart failure of metildigoxin (beta-methyldigoxin, MD), a derivative of digoxin (DX), which had a good absorption rate from digestive tract, was examined in a double blind study using a gorup comparison method. After achieving digitalization with oral MD or intravenous deslanoside in the non-blind manner, maintenance treatment was initiated and the effects of orally administered MD and DX were compared. MD was administered in 44 cases, DX in 42.

Statistical considerations on the parameters in drug evaluation.

Some fundamental considerations are described on the parameters in clinical drug evaluation, and on the combination of them into a judgement on the usefulness of the drug. Regardless of the types of study, informal exploratory or formal controlled study, we must recognize that we work in the clinical field where many pitfalls of variability and bias are ambushing us.

Comparison of efficacy of amoxapine and imipramine in a multi-clinic double-blind study using the WHO schedule for a standard assessment of patients with depressive disorders.

A multi-clinic double-blind controlled study on amoxapine in comparison with imipramine, using the WHO Schedule for a Standard Assessment of Patients with Depressive Disorders, was performed and the data were analyzed with 111 patients. The assessment of severity of illness and overall improvement indicated clearly the superiority of the antidepressive effect of amoxapine to that of imipramine. The onset of antidepressive effect of amoxapine was clearly more rapid than that of imipramine, and in more than half of the patients in the amoxapine group the improvement was seen within four days following the drug administration.

A multiclinic double-blind trial of pyridinolcarbamate and inositol niacinate in ischemic ulcer due to chronic arterial occlusion.

A double-blind multiclinic trial compared the efficacies of pyridinolcarbamate and inositol niacinate in the patients with the ischemic ulcer due to chronic arterial occlusion. A thrice-daily dose of 1.5 g of pyridinolcarbamate or 1.

Regulatory differences and similarities: systems in Japan.

The historic steps that led up to the present federal drug regulations in the United States are outlined as a background to the development of the current drug regulatory system in Japan, consisting of the procedures for approval of new drugs, of double-brand naming, by which the same drug under different names can be sold as ethical or over-the-counter (OTC). The more recent provisions for re-evaluation of drugs, the mechanism for monitoring adverse reactions, and the dissemination of the collected information are described. The prescription habits of physicians, the influence of the health insurance systems on these, and the strikingly high level of drug consumption in Japan, as compared with those in other industrial countries, are discussed and illustrated graphically.

Comparison of efficacy of lithium carbonate and chlorpromazine in mania. Report of collaborative study group on treatment of mania in Japan.

A multi-institutional cooperative study comparing lithium carbonate with chlorpromazine was conducted, using a controlled double-blind design in a series of 80 cases of endogenous manic psychosis, to evaluate the drugs' clinical utility and efficacy, characteristics of therapeutic effect, and side-effects. Dosages employed were consistently at an equipotent ratio of 4:1 (lithium carbonate:chlorpromazine). Physicians' overall ratings showed lithium carbonate as significantly superior to chlorpromazine in efficacy for manic psychosis.