Period prevalence of self-reported headache in the general population in Germany from 1995-2005 and 2009: results from annual nationwide population-based cross-sectional surveys.

Background: Although primary headache is the most frequent neurological disorder and there is some evidence that the prevalence rates have increased in recent years, no long-term data on the annual prevalence of headache are available for Germany. The objective of the study was therefore to obtain long-term data on the period prevalence of headache in the general population in Germany by means of population-based cross-sectional annual surveys (1995-2005 and 2009).

Methods: These surveys were conducted as face-to-face paper-and-pencil interviews from 1995 through 2004, and from 2005 onwards as computer-aided personal interviews.

Responsiveness of efficacy endpoints in clinical trials with over the counter analgesics for headache.

Aim: To quantify and compare the responsiveness within the meaning of clinical relevance of efficacy endpoints in a clinical trial with over the counter (OTC) analgesics for headache. Efficacy endpoints and observed differences in clinical trials need to be clinically meaningful and mirror the change in the clinical status of a patient. This must be demonstrated for the specific disease indication and the particular patient population based on the application of treatments with proven efficacy.

Combined analgesics in (headache) pain therapy: shotgun approach or precise multi-target therapeutics?

Background: Pain in general and headache in particular are characterized by a change in activity in brain areas involved in pain processing. The therapeutic challenge is to identify drugs with molecular targets that restore the healthy state, resulting in meaningful pain relief or even freedom from pain. Different aspects of pain perception, i.

Clinical relevance of efficacy endpoints in OTC headache trials.

Objective: This analysis evaluates and ranks efficacy endpoints often used in headache trials concerning their clinical relevance in relation to the patient-related criterion "global assessment of overall efficacy" based on data gained in a large trial investigating different over-the-counter drugs in the treatment of headache.

Background: The original study showed a significant superiority of the fixed combination of acetylsalicylic acid+paracetamol+caffeine over the combination without caffeine, the single preparations, and placebo in the treatment of headache.

Methods: For 1734 patients included in the efficacy analysis we investigated the correlation of patient's global efficacy assessment with the endpoints "time to 50% pain relief" (primary endpoint), "time to be pain-free," pain intensity difference, sum of pain intensity difference, and extent of impairment of daily activities.

OTC analgesics in headache treatment: open-label phase vs randomized double-blind phase of a large clinical trial.

Objective: To compare the superior efficacy of the fixed combination of acetylsalicylic acid, paracetamol, and caffeine over the single substances, which was observed in the randomized, double-blind phase of the clinical trial, with the efficacy of the respective usual nonprescription medication taken by the patients in the open-label pre-phase of the same study.

Background: The "Thomapyrin Study" showed significant superiority of the fixed combination containing acetylsalicylic acid, paracetamol, and caffeine over the combination without caffeine, the single preparations, and placebo in the treatment of headache.

Methods: Prior to the randomized treatment phase, a headache episode treated with the patient's usual nonprescription medication was recorded (open-label pre-phase).

Modulation of catecholamine release from rat striatal slices by the fixed combination of aspirin, paracetamol and caffeine.

The fixed combination of aspirin, paracetamol (acetaminophen) and caffeine has been used successfully to treat different kinds of pain including migraine attacks. Even when this formulation has been marketed for a long time, the exact molecular mechanisms underlying its therapeutic effectiveness have not been completely elucidated. In the present investigation, we have studied the effects of the fixed combination of aspirin, paracetamol and caffeine (APC) on the release of dopamine and noradrenaline from rat striatal slices in an attempt to find potential new mechanisms of action of this widely used analgesic combination.

Efficacy and tolerability of ambroxol hydrochloride lozenges in sore throat. Randomised, double-blind, placebo-controlled trials regarding the local anaesthetic properties.

Unlabelled: Two confirmatory clinical trials were performed to investigate the efficacy and tolerability of ambroxol lozenges at doses of 20 mg and 30 mg relative to placebo in relieving the symptoms of sore throat of at least moderately severe intensity in patients suffering from oro-pharyngeal catarrh accompanied by pain on swallowing, feeling of scratchiness, burning and urge to cough.

Objective: Description and comparison of the efficacy and tolerability of lozenges containing 20 mg or 30 mg ambroxol hydrochloride (trans-4-[(2-amino-3,5-dibrom-benzyl)amino]cyclohexano hydrochloride, CAS 18683-91-5) in relieving acute sore throat, in comparison to placebo.

Design: Two similar, multi-centre, prospective, placebo-controlled, randomised, double-blind trials involving three days of treatment with up to 6 lozenges containing 20 or 30 mg ambroxol hydrochloride per day.

Local anaesthetic properties of ambroxol hydrochloride lozenges in view of sore throat. Clinical proof of concept.

Unlabelled: Acute oro-pharyngeal catarrh is characterised by mild to severe sore throat, such as pain on swallowing, feeling of scratchiness, burning and urge to cough. The present study was conducted to explore whether the test compound is going to show clinical relevance and is a suitable medication for the relief of these symptoms.

Objective: Description and comparison of the efficacy and tolerability of lozenges containing 20 mg ambroxol hydrochloride (trans-4-[(2-amino-3,5-dibrombenzyl)amino]cyclohexano hydrochloride, CAS 18683-91-5) in relieving acute sore throat, in comparison to placebo.