[Randomized, placebo-controlled, double blind clinical trial for the evaluation of the efficacy and safety of oral methantheliniumbromide (Vagantin) in the treatment of focal hyperhidrosis].

BACKGROUND Methanthelinium bromide is a quaternary ammonium derivate with anticholinergic activity. Since 1951 it has been used to treat patients with hyperhidrosis. However, all efficacy data has so far been limited to case reports and case series. We here report on the results of the first randomised clinical controlled trial on the efficacy and safety of methanthelinium bromide. PATIENTS AND METHODS A total of 41 patients with a mean age (+/- standard deviation) of 28 +/- 9.8 years (Range 18.7-54.8) were included, 31 (76%) of them were females. Main inclusion criteria were are focal hyperhidrosis of a one year or longer duration and a gravimetrically assessed sweat production of > or =50 mg/min. Patients were treated with 2 x 50 mg methanthelinium bromide or placebo orally daily for 4 weeks. The therapeutic effect was determined by repeated gravimetric measurement of sweat production and by recording the patients' degree of satisfaction. RESULTS The efficacy was most pronounced for patients with an axillary hyperhidrosis of > or =50 mg/min (p = 0.02, chi2-test, two-sided). For the total group the main axillary sweat production decreased in the verum-treated arm from a mean value of 89.2 +/- 73.4 mg/min prior to therapy to 53.3 +/- 48.7 mg/min during therapy (p = 0.02, Wilcoxon test, two-sided). In contrast, no difference was detected in the placebo arm with 60.7 +/- 42.8 mg/min prior to and 59.1 +/- 40.6 mg/min during therapy (p = 0.92, Wilcoxon test, two-sided). For the palmar sweat production no difference between the verum- and the placebo-treated group was found. No serious adverse events were reported. As expected, dryness of the mouth, a known adverse reaction of anticholinergics, was reported significantly more frequently in the verum-treated arm. CONCLUSIONS Methanthelinium bromide has been considered for many years as a therapeutic option for the treatment of focal hyperhidrosis. However, its efficacy and safety have not previously been investigated in controlled randomised studies. We demonstrated both a decline in axillary sweat production and good tolerance. Therefore, the treatment of axillary hyperhidrosis with methanthelinium bromide in a regimen of 50 mg twice daily can be recommended, especially in those cases which are refractory to topical treatment with for example aluminium chloride hexahydrate solution. In contrast, we found no evidence for a clinically relevant diminution of palmar sweating.