A double-blind clinical trial of hydroxyethylrutosides in Menière's disease.
A double-blind, placebo-controlled, cross-over trial was undertaken in 39 patients with well-defined Menière's disease. After a one-month placebo run-in period, the patients were assigned, on a randomized basis, to three months' treatment with O-(beta-hydroxyethyl)-rutosides (HR) (2 g./day) followed by three months on placebo, or vice-versa. In spite of a very pronounced placebo effect and a marked tendency to a 'carryover' effect from the first sequence with HR into the second placebo sequence, there appeared to be a clear trend to a greater symptomatic improvement with HR treatment than with placebo. The audiometric findings showed a very clear, uniform superiority under HR treatment, for both air and bone conduction and at all five frequencies studied (250, 500, 1,000, 2,000 and 5,000 Hz.) (p values between 0.002 and 0.05). Indeed, whereas there was a worsening of hearing-loss at each frequency under placebo during the first sequence, this was significantly diminished at each frequency under HR treatment. There were no significant changes in vestibulometry (caloric test) which showed wide variations already during the run-in period. Tolerance to HR treatment was excellent, the incidence of side-effects being similar to that in the placebo periods.