Volker Pfaffenrath

Acupuncture in patients with tension-type headache: randomised controlled trial

Abstract Objective To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. Design Three armed randomised controlled multicentre trial. Setting 28 outpatient centres in Germany. Participants 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache. Interventions Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks. Main outcome measure Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries. Results The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. Conclusions The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache. Trial registration number ISRCTN9737659.

Efficacy and Safety of Sumatriptan Tablets (25 mg, 50 mg, and 100 mg) in the Acute Treatment of Migraine: Defining the Optimum Doses of Oral Sumatriptan

That sumatriptan tablets are effective and well tolerated in the acute treatment of migraine has been established, but the relationship between dose and efficacy has not been adequately defined to date in clinical trials. This multinational double‐blind trial (N=1003) in which patients treated up to three migraine attacks with sumatriptan 25 mg, 50 mg, 100 mg, or placebo, with a second independently randomized dose for headache recurrence, evaluated the efficacy and tolerability of three doses of sumatriptan. The results demonstrate that all doses of sumatriptan were superior (P<0.05) to placebo in reducing moderate or severe predose headache to mild or no headache 4 hours postdose for each of the three treated attacks; sumatriptan 50 mg and 100 mg were each superior (P<0.05) to sumatiptan 25 mg 4 hours postdose for two of three attacks. Sumatriptan (all doses) was similarly effective at relieving nausea and photophobia or phonophobia or both and at reducing clinical disability. Headache recurrence was experienced by similar proportions of patients across treatment groups (35% to 48% after placebo; 26% to 39% after sumatriptan). Relief of recurrent headache 2 hours after the second dose of study medication occurred in greater percentages of patients using any dose of sumatriptan compared with patients using placebo to treat recurrence. The incidence of adverse events with 25‐mg and 50‐mg sumatriptan tablets was similar to the incidence with placebo and lower than the incidence with 100‐mg sumatriptan tablets. These data provide the first demonstration from a large well‐controlled clinical trial that both the 50‐ and 100‐mg doses are more effective than the 25‐mg dose and that the 50‐mg dose is associated with a lower incidence of adverse events than the 100‐mg dose.

The Fixed Combination of Acetylsalicylic acid, Paracetamol and Caffeine is more Effective than Single Substances and Dual Combination for the Treatment of Headache: a Multicentre, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Parallel Group Study

We investigated efficacy, safety, and tolerability of two tablets of the fixed combination of 250 mg acetylsalicylic acid (ASA) + 200 mg paracetamol + 50 mg caffeine (Thomapyrin®) in comparison with two tablets of 250 mg ASA + 200 mg paracetamol, two tablets of 500 mg ASA, two tablets of 500 mg paracetamol, two tablets of 50 mg caffeine, and placebo in patients who were used to treating their episodic tension-type headache or migraine attacks with non-prescription analgesics. For the primary endpoint ‘time to 50% pain relief’ in the intention-to-treat dataset (n = 1743 patients), the fixed combination of ASA, paracetamol and caffeine was statistically significantly superior to the combination without caffeine (P = 0.0181), the mono-substances ASA (P = 0.0398), paracetamol (P = 0.0016), caffeine (P < 0.0001) and placebo (P < 0.0001). All active treatments except caffeine differed significantly (P < 0.0001) from placebo. The superior efficacy of the triple combination could also be shown for all secondary endpoints such as time until reduction of pain intensity to 10 mm, weighted sum of pain intensity difference (%SPIDweighted), extent of impairment of daily activities, global assessment of efficacy. All treatments were well tolerated. The incidence of adverse events observed was low.

Prevalence of chronic migraine and medication overuse headache in Germany—the German DMKG headache study

Population-based epidemiological studies about the prevalence of chronic migraine using the 2004 International Headache Society (IHS) classification definition are rare. We analysed the data of the Deutsche Migräne und Kopfschmerz Gesellschaft headache study, which included 7417 adults in three regions of Germany, with respect to their headache. Additionally, body mass index, alcohol consumption and smoking behaviour were recorded. Using the IHS definition from 2004, chronic migraine was diagnosed in 0.2% of the population. Half of these patients also fulfilled the criteria of medication overuse headache (MOH). The distribution of migraine attacks per subject was highly skewed, with only 14% of all migraine patients having more than six migraine attacks per month. Patients with chronic migraine or MOH seem more often to be active smokers than controls without headache. A body mass index of ≥ 30 was present significantly more often in patients with MOH than in controls or in patients with episodic migraine. The skewed distribution of the numbers of attacks per patient supports the recommendation to differentiate between episodic migraine with low and high attack frequency, as is done in the classification of tension-type headache. It further suggests that migraine with high attack frequency might be biologically different. The higher prevalence of smokers and of patients with a body mass index ≥ 30 in chronic migraine or MOH supports the idea of a frontal dysfunction in these patients.

Atypical facial pain–application of the IHS criteria in a clinical sample

Atypical facial pain is a residual category for otherwise unclassifiable pain syndromes in the facial region. In 35 patients (31F, 4M) with a mean age of 53.2 ± 14.9 years and a chronic facial pain syndrome we tested the new diagnostic criteria of the International Headache Society (IHS). There was a marked female preponderance, vague description of symptoms and a long history of incorrect diagnoses. A high number of invasive procedures (3.5 ± 3.0 (1–13)) were performed in this group. In agreement with the IHS criteria, an operaiion or injury to the face was a suspected cause in 43%. In contrast to the IHS criteria, our patient sample had dysaesthesiae (63%), bilateral occurrence (37%), remission periods (57%), pain attacks (23%) and superficial as well as deep pain. The IHS classification is insufficient to separate atypical facial pain from other primary headache and facial pain syndromes. We suggest a modified version of the IHS criteria for atypical facial pain.

Effectiveness and Tolerability of Acupuncture Compared With Metoprolol in Migraine Prophylaxis

Objectives.—In a randomized controlled multicenter trial extending over 24 weeks, we investigated whether acupuncture is as effective and safe as metoprolol in the prophylactic treatment of migraine under conditions similar to routine care.

Regional variations in the prevalence of migraine and tension-type headache applying the new IHS criteria: the German DMKG Headache Study.

The prevalence of migraine and tension-type headache (TTH) varies considerably with respect to gender, age group and geographic regions. Methodological differences in the assessment and classification of cases are a major cause of this variability across studies, limiting the ability to perform true regional comparisons. We conducted three population-based studies in different German regions and assessed headache prevalence and headache characteristics in face-to-face interviews, applying standardized methods. We analysed the 6-month prevalence of migraine, TTH and their probable subtypes based on the new criteria of the International Headache Society (IHS). Among the 7417 participants in all three regions, the pooled 6-month prevalence of migraine, probable migraine, TTH and probable TTH was 6.75, 4.40, 19.86 and 11.61%, respectively. Despite the application of standardized classification methods, regional variations between 4.39 and 8.00% for migraine and 15.44 and 23.64% for TTH were observed, indicating differences in the local headache burden. Application of the new IHS criteria yielded headache categories that were not mutually exclusive, indicating a need for further discussion about the value of probable headache types in epidemiological studies.

Altered Metabolism in Frontal Brain Circuits in Cluster Headache

Neuroimaging studies have explored cerebral activation patterns in patients with cluster headache (CH) during attacks and have revealed activation of multiple brain areas known to belong to the general pain-processing network. However, it is still unclear which changes in brain metabolism are inherent to the shift from the ‘in bout’ to the ‘out of bout’ period. We measured cerebral glucose metabolism in 11 episodic CH patients during the cluster and again during the remission period with 18F-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET) and compared these data with 11 healthy controls. ‘In bout’ compared with ‘out of bout’ scans were associated with increases of metabolism in the perigenual anterior cingulate cortex (ACC), posterior cingulate cortex, prefrontal cortex, insula, thalamus and temporal cortex. Decreases in metabolism were observed in the cerebellopontine area. Compared with healthy volunteers, hypometabolism in the patient group (‘in bout’ and ‘out of bout’) was found in the perigenual ACC, prefrontal and orbitofrontal cortex. Thus, FDG-PET in CH patients revealed ‘in bout’ activation of brain structures which are involved in descending pain control. Compared with controls, the regional brain metabolism was constitutively decreased in most of these structures, irrespective of the bout. This finding indicates a deficient top-down modulation of antinociceptive circuits in CH patients. We suggest that trigger mechanisms of CH are insufficiently controlled and thus promote the initiation of the bout period and acute attack.

Association between lifestyle factors and headache.

Modification of lifestyle habits is a key preventive strategy for many diseases. The role of lifestyle for the onset of headache in general and for specific headache types, such as migraine and tension-type headache (TTH), has been discussed for many years. Most results, however, were inconsistent and data on the association between lifestyle factors and probable headache forms are completely lacking. We evaluated the cross-sectional association between different lifestyle factors and headache subtypes using data from three different German cohorts. Information was assessed by standardized face-to-face interviews. Lifestyle factors included alcohol consumption, smoking status, physical activity and body mass index. According to the 2004 diagnostic criteria, we distinguished the following headache types: migraine, TTH and their probable forms. Regional variations of lifestyle factors were observed. In the age- and gender-adjusted logistic regression models, none of the lifestyle factors was statistically significant associated with migraine, TTH, and their probable headache forms. In addition, we found no association between headache subtypes and the health index representing the sum of individual lifestyle factors. The lifestyle factors such as alcohol consumption, smoking, physical activity and overweight seem to be unrelated to migraine and TTH prevalence. For a judgement on their role in the onset of new or first attacks of migraine or TTH (incident cases), prospective cohort studies are required.

Acupuncture Randomized Trials (ART) in Patients with Migraine or Tension-Type Headache – Design and Protocols

Background and Objective: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. Design: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.