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Tension-type headache is the most frequent form of headache. The local topical treatment with peppermint oil (oleum menthae piperitae) has proven to be significantly more effective than placebo in controlled studies. Peppermint oil targets headache pathophysiology in multiple ways. The efficacy is comparable to that of acetylsalicylic acid or paracetamol. Solutions of 10 % peppermint oil in ethanol are licensed for the treatment of tension-type headache in adults and children above 6 years. It is included in treatment recommendations and guidelines by the respective professional societies and is regarded as a standard treatment for the acute therapy of tension-type headaches.

223 patients with non-ulcer dyspepsia (dysmotility type dyspepsia or essential/idiopathic dyspepsia, also in combination with irritable bowel syndrome) were included in a prospective, randomised, reference- and double-blind controlled multicentre trial to compare two different preparations of a fixed combination of peppermint oil and caraway oil. The aim of the trial was to evaluate the equivalence of the efficacy and tolerability of these two preparations. The test formulation consisted of the drug combination in an enteric coated capsule containing 90 mg peppermint oil and 50 mg caraway oil, while an enteric soluble formulation containing 36 mg peppermint oil and 20 mg caraway oil was used as the reference. The main target item defined was the "difference in pain intensity between the beginning and the end of therapy", measured by the patient on a visual analogue scale (0 = no pain, 10 = extremely strong pain). In 213 patients (n = 108 on the test preparation, n = 105 on the reference preparation) with mean pain intensity baseline measurements of 6.1 points in the test preparation group and 5.9 points in the reference group a statistically significant decline in pain intensity was observed in the two groups (-3.6 resP. -3.3 points; p < 0.001; two-sided one-sample t-test). Equivalent efficacy of both preparations was demonstrated (p < 0.001; one-sided t-test for equivalence). With respect to concomitant variables, the results in both groups were also similar. Regarding "pain frequency", the efficacy of the test preparation was significantly better (p = 0.04; two-sided t-test for difference). Both preparations were well tolerated. Despite the higher dose, the adverse event "eructation with peppermint taste" was less frequent in the group treated with the test formulation, due to the enteric coated capsule preparation.

The effect of a locally applied peppermint oil preparation on tension-type headache was examined in the design of a randomized, placebo-controlled double-blind crossover study for the first time. The preparation was tested against both the reference substance acetaminophen and to the corresponding placebo. The liquid test preparation contained 10 g of peppermint oil and ethanol (90%) ad 100 (test preparation LI 170, Lichtwer Pharma, Berlin); the placebo was a 90% ethanol solution to which traces of peppermint oil were added for blinding purposes. The reference preparation contained 500 mg acetaminophen; the placebo tablet was identical to the verum in size and appearance. The study included the analysis of 164 headache attacks of 41 patients of both sexes ranging between 18 and 65 years of age, suffering from tension-type headache in accordance with the IHS classification. Four headache episodes per patient were treated in a double-blind, randomized crossover design. Each headache attack was treated by the application of 2 capsules of the oral medication (1,000 mg of acetaminophen or placebo) and the cutaneous application of the oil preparation (peppermint oil or placebo solution). The oil was spread largely across forehead and temples which was repeated after 15 and 30 minutes. Using a headache diary, the headache parameters were assessed after 15, 30, 45 and 60 minutes. Compared to the application of placebo, a 10% peppermint oil in ethanol solution significantly reduced the clinical headache intensity already after 15 minutes (p < 0.01). This significant clinical reduction of the pain intensity continued over the one hour observation period. Acetaminophen, too, proved to be efficient compared to placebo (p < 0.01). There was no significant difference between the efficacy of 1,000 mg of acetaminophen and 10% peppermint oil in ethanol solution. Simultaneous application of 1,000 mg of acetaminophen and 10% peppermint oil in ethanol solution leads to an additive effect which remains below the significance threshold, however. The patients reported no adverse events. This controlled study showed for the first time that a 10% peppermint oil in ethanol solution efficiently alleviates tension-type headache. Peppermint oil thus proves to be a well-tolerated and cost-effective alternative to usual therapies.