[Topical gel formulation of ibuprofen in the treatment of acute and chronic joint and soft tissue pain. Results of a non-interventional observational trial]. / Topisches Ibuprofen bei akuten und chronischen Gelenk- und Weichteilschmerzen. Ergebnisse einer nicht-interventionellen Studie.

BACKGROUND: Pain, inflammation or swelling of soft tissues orjoints is often treated with oral or topical formulation of lbuprofen. METHOD: Thetherapeutic effect of a topical gel formulation of Ibuprofen (doc Ibuprofen Schmerzgel) was investigated in an observational trial. A total of 170 patients suffering either from pain, inflammation or swelling of soft tissues or joints or having experienced a blunt trauma were enrolled into this study. Physicians and patients evaluated typical symptoms at study entry and after 1 week at the final visit. Further, the patients were asked and instructed to monitor their symptoms in a daily diary over this week. RESULTS: Patientssufferingfromacute trauma (group A (symptoms existent up to 48 hours) as well as patients with chronic symptoms (group B) experienced a fast and prominent improvement of symptoms. In group A total reduction of all symptoms after one week was recorded to amount to considerably more than 80%, in group B a reduction of more than 50% compared to the initial scores could be seen. Evaluation done by physicians and patients were extremely concordant with regard to timecourse and final outcome of the treatment. After first use on day one group A noted a reduction of pain symptoms after approximately 25 minutes, while in group B a considerable relief of pain was reported after approximately 37 minutes. During this one-week treatment period no adverse-effects were reported.Tolerability and applicability were classified as good to excellent. CONCLUSIONS: The results of this study confirm findings from existing clinical trials data. In acute traumata a faster symptom relief is found, in chronic conditions the product leads to symptom reduction in case seven where pretreatment has shown insufficient results. Thus this topical treatment provides a treatment option either alone or in combination with orally taken NSAIDS.

[Acetylsalicylic acid in self-medication of migraine. A pharmacy-based observational study]. / Acetylsalicylsäure bei der Selbstmedikation von Migränekopfschmerzen. Eine apothekenbasierte Analyse.

BACKGROUND: The aim of the study was to investigate the efficacy and tolerability of acetylsalicylic acid in the treatment of acute migraine attacks by self-medication under daily life conditions when bought in a pharmacy and also the ability of patients to self-diagnose correctly. METHODS: A total of 296 patients were recruited from 156 pharmacies and recorded up to 3 migraine attacks. Following an advisory discussion the pharmacists gave a questionnaire to persons who had purchased acetylsalicylic acid (Aspirin Migraine) in the pharmacy to treat migraine. A total of 578 questionnaires containing 36 questions about demographic details, headache phenotype, medical history, efficacy over 2 h and tolerability of the preparation were analyzed. RESULTS: The IHS criteria (1988) for migraine were identified correctly by 92.7% of the patients. In 66.3% of the attacks, the intensity of the headache was reported as severe. In 60% of the documented attacks, a decrease from severe or moderate to mild or no headache was recorded after medication, and freedom from headache was achieved in 35.8%. The effect was reproducible over 3 migraine attacks. Nausea, photophobia and phonophobia were reduced by 71-86% compared to the baseline level. Side-effects were reported twice as often by the participants in response to closed questions than to open questions (16.6 vs. 8.3%). CONCLUSION: A high percentage of migraine patients are capable of diagnosing their condition themselves when they seek advice in a pharmacy. The data on efficacy confirm the results from controlled clinical studies. The same parameters as those used in controlled clinical studies can also be recorded in pharmacy-based observational studies, therefore, the safety and tolerability of the medication can be recorded under real conditions.

[Double blind study of intravenous aspirin vs placebo in the treatment of acute migraine attacks.]. / Therapie des akuten Migräneanfalls mit intravenös applizierter Acetylsalicylsäure : Eine plazebokontrollierte Doppelblindstudie.

INTRODUCTION: The empirical use of oral acetylsalicylic acid (ASA) in the treatment of acute migraine attacks has led to the recommendation of ASA as a basic treatment of migraine. However, there are no controlled studies on the intravenous use of acetylsalicylic acid. METHODS: Forty patients with a 1- to 12-year history of migraine were included in this placebo-controlled trial. The sociodemographic data of patients receiving placebo or 500 mg ASA i.v. and migraine symptoms before treatment were identically distributed. Pain relief during attacks was documented by the Visual Analogue Scale (VAS) for 1 h at 5-min intervals. Furthermore, the change of concurrent non-pain symptoms was evaluated by self-rating (worse-unchanged-better-absent). RESULTS: The VAS showed a mean pain reduction of about 60% after 1 h versus placebo. Efficacy varied significantly between patients. We observed a small number of socalled non-responders as well as patients with complete pain relief. The most common concomitant symptoms were nausea, photophobia, vertigo, vomiting and sweating. During the time of observation these symptoms were significantly reduced compared to placebo. The study shows a maximum placebo effect of about 17% (mean value). Significant differences in pain ratings were measured 25-30 min after application (P=0.0008). CONCLUSIONS: In this study i.v. ASA showed a significant reduction in pain intensity during migraine attacks. In addition, most concomitant non-pain symptoms were equally reduced. The onset of pain relief did not correspond with the inhibition of platelet aggregation (after 2-4 min) or with peak plasma concentrations of ASA (immediately after application) or salicylic acid (after 2-3 h). More efficacy studies with higher doses and longer periods of observation are necessary to optimize the treatment of migraine attacks with intravenous ASA. Studies including neurophysiological and vascular parameters are recommended to confirm the results of this study.

The epidemiology of headache in Germany: a nationwide survey of a representative sample on the basis of the headache classification of the International Headache Society.

This study presents the first account of the prevalence of headache syndromes, defined according to the International Headache Society criteria, in a large representative sample of the German population; 5000 persons representative of the total population were selected from 30,000 households. Subjects were requested to answer a questionnaire about headache occurrence during their lifetime. The completion rate was 81.2%. Seventy-one point four percent (n = 2902) reported a history of headache. Twenty-seven point five percent fulfilled the criteria for migraine. Thirty-eight point three percent (n = 1557) met the criteria for tension-type headache and 5.6% (n = 229) did not fulfil criteria for either migraine or tension-type headache. Significant correlations were found between the prevalence of the different headache syndromes and sociodemographic variables such as sex, age and place of residence. The prevalence of headache did not exhibit any significant differences between the various länder (states or regions) of Germany. When extrapolated to the total population these results reveal that 54 million people in Germany suffer from headache at least occasionally or persistently. These findings suggest that the magnitude of the neurological disorders, migraine and tension-type headache, is seriously underestimated and thus constitutes a major contemporary health problem.

[Prevalence of headache syndromes in Germany.]. / Die Prävalenz von Kopfschmerzen in deutschland : Ein Untersuchung an einer repräsentativen Stichprobe auf der Basis der Kopfschmerzklassifikation der International Headache Society.

This study presents the first-ever account of the prevalence of headache syndromes in Germany and the frequency with which they occur in a large representative sample according to the International Headache Society criteria, as set out in the German translation approved by the Classification Committee. 5000 persons representative of the total population were selected from a panel of 30000 households and requested to answer a questionnaire about headache occurrence during their life to date (lifetime prevalence). Of the 5000 persons who were sent questionnaires, 81.2% (n=4061) completed and returned them: 71.4% (n=2902) said they suffered from headache at least occasionally. Of the base population (all respondents: 100% orn=4061), 27.5% (n=1116) fulfilled the criteria for the IHS classification ofmigraine, 38.3% (n=1557) displayed the criteria oftension headache and 5.6% (n=229) said they suffered from headaches, but did not fulfil the criteria for either migraine or tension headache and were therefore classified in the category other headache. Significant correlations were found between the prevalence of the different headache syndromes and sociodemographic variables such as sex, age and place of residence. Headache prevalence in the various "länder" (states or regions) of Germany did not exhibit any significant differences. Applying the results to the total population reveals that some 54 million people in Germany occasionally or persistently suffer from headaches. The importance of the neurological disorders migraine and tension headache is currently seriously underestimated. They are one of the major health problems of our time. There is an urgent need for much greater attention to them by the health system.