A randomized equivalence trial comparing the efficacy and safety of Luffa comp.-Heel nasal spray with cromolyn sodium spray in the treatment of seasonal allergic rhinitis.

BACKGROUND: The objective of the clinical study was to investigate the efficacy and tolerance of a homeopathic nasal spray in cases of hay fever (seasonal allergic rhinitis) in comparison with the conventional intranasal cromolyn sodium therapy. PATIENTS AND METHODS: In total, 146 outpatients with symptoms of hay fever were enrolled into the clinical study (randomized, double-blind, equivalence trial) (time of treatment: 42 days). The homeopathic remedy (Luffa comp.-Heel trade mark Nasal Spray, dosage: 0.14 ml per application, 4 times per a day / naris) consisted of a fixed combination made up of Luffa operculata, Galphimia glauca, histamine, and sulfur. The main outcome measure of the efficacy was the quality of life as measured by means of the Rhinoconjunctivitis Quality of Life-Questionnaire (RQLQ). The tolerance of the trial medication was registered by means of global assessment, rhinoscopy, recording of adverse events and with the aid of vital and laboratory parameters. RESULTS: The results of the study demonstrate a quick and lasting effect of the treatment. This effect was independent from the medication applied and produced a nearly complete remission of the hay fever symptoms. The RQLQ global score changed significantly in the course of the treatment, indicating therapeutic equivalence between the two forms of treatment. Adverse systemic effects did not occur. Local adverse events appeared in 3 patients. CONCLUSIONS: The study proved that, for the treatment of hay fever, the homeopathic nasal spray is as efficient and well tolerable as the conventional therapy with cromolyn sodium.

A new method for the determination of the bioavailability of thyroid hormone preparations.

Levothyroxine and levotriiodothyronine are vital hormones that are produced and stored in the thyroid gland. Due to endogenic hormone production and regulation, it is impossible to determine the bioavailability of exogenic hormone using conventional trial designs since exogenic hormone cannot be distinguished from endogenic hormone in serum unless radiolabelled. Bioavailability, however, is an essential quality attribute of thyroid hormone preparations. A new trial design was developed that allows the bioavailability of thyroid hormone preparations to be determined without the use of radiolabelled substances. The trial subjects were volunteers (athyreotic patients) who, after thyroidectomy and postoperative radioiodine therapy, do not produce endogenic thyroid hormone and have to be supplied with exogenic levothyroxine on a permanent basis (replacement therapy). An oral solution of levothyroxine was used as a reference. Such a solution can be prepared with the same biopharmaceutical quality on a reproducible basis and is suitable for comparing preparations with one another that are used in different trials with the same design. The orally given reference solution is well tolerated and can therefore be administered over the required periods of time (e.g., 3 x 4 weeks). In a randomized, 3-way Latin-square design, the volunteers were given either L-Thyroxin Henning, another tablet preparation, or the reference solution, each for 28 days running during each period. On days 26, 27 and 28 of each period, the serum concentrations of levothyroxine and levotriiodothyroine were determined in order to verify the steady state.(ABSTRACT TRUNCATED AT 250 WORDS)

Dialysability of dimethindene maleate (Fenistil) from blood after intravenous injection.

Dimethindene, an antihistaminic drug, is the treatment of choice in dialysis patients suffering from skin itching. During hemodialysis procedures not only toxic metabolites, but also drugs are extracted from plasma. To answer the question if dimethindene is dialyzable from plasma, three healthy male volunteers received 4 mg of dimethindene solution intravenously. Ten minutes later 100 ml cubital vein blood was taken and 25,000 I.E. Liquemine was added. Plasma was separated and pumped through a cuprophan hollow fiber dialyzing module with an effective surface of 35 cm2. In periods of ten minutes samples of plasma and dialysate were taken to analyze their dimetindene concentrations. A mean clearance of 38 ml/min*m2, SD 10.2 and coefficient of variation [%] 26.8 was found. This is comparable to the well known clearance of theophylline, so it can be considered that dimethindene is eliminated from plasma during hemodialysis procedures.