Tanacetum parthenium and Salix alba (Mig-RL) Combination in Migraine Prophylaxis

R. Shrivastava; J.C. Pechadre; G.W. John

Disclosures

Clin Drug Invest. 2006;26(5):287-296. 

In This Article

Patients and Methods

The primary efficacy criterion was migraine attack frequency, the secondary efficacy criteria were intensity and duration of migraine attacks, and other criteria were quality of life, tolerability and adverse effects.

The study was carried out at the Department of Neurology, Centre Hospitalier Universitaire, Clermont-Ferrand, France, in accordance with the Declaration of Helsinki. Ethics committee approval was obtained from the hospital and signed informed consent was obtained from each patient prior to inclusion in the study.

Inclusion criteria were: (a) patients diagnosed with migraine without aura according to International Headache Society (IHS) criteria,[27] as defined by The Headache Classification Subcommittee of the IHS (2004), ICH D-II code 1.1; ICD-IONA code [G43.0]; (b) males or females aged >18 years; and (c) no migraine prophylactic treatment employed for at least a month prior to the study.

Exclusion criteria were: (a) mental deficit, language barrier or incapacity to understand the study protocol or the investigators; (b) lactating or pregnant women or women able to become pregnant, i.e. premenopausal and not using adequate contraception; (c) patients with evolving neurological disorders, known previous cerebral trauma, diagnosed psychotic disorders, renal or hepatic insufficiency, or any other serious pathology; and (d) patients taking migraine prophylactic medication, corticosteroids, antidepressants or antipsychotics.

Otherwise healthy men (n = 5) and women (n = 7) aged 18–55 years were enrolled after an initial consultation that comprised a medical examination and establishment of their migraine attack history. Each patient was requested to provide detailed information in a headache diary on: (a) pain perception using a visual analogue scale (VAS) rated from 0 (pain-free) to 10 (unbearable); (b) attack frequency; (c) attack duration; (d) attack intensity; (e) use of symptomatic drugs; and (f) quality-of-life-associated parameters. The patients were required to complete this diary over a 6-week baseline period and then throughout the study. Attack (pain) intensity was recorded by each patient during consultations on days 0, 42 and 84 (overall attack intensity) and 3 hours after the onset of each attack (individual attack intensity). Quality-of-life-associated parameters were self-assessed on a 0 (very poor) to 10 (excellent) VAS, and included physical and intellectual performance, dynamism, memory, capacity to relax, concentration, sociability, emotionality, irritability, anxiety, mood, sleep, interictal 'heavy head' sensation, and social and professional satisfaction. Two subsequent consultations were planned at days 42 and 84 of treatment.

Two Mig-RL® capsules (size 1) containing standardised powdered extracts of S. alba 150mg and T. parthenium 150mg with 0.2mg copper gluconate stabiliser were administered twice daily. Hydroalcoholic freeze-dried extracts were obtained from a commercial source (Laboratoir Biosphere-99, Les Martres de Veyre, France). S. alba extract was standardised for salicilin (≥1.5%) and T. parthenium for parthenolide (≥0.2%). Both plant extracts are listed in the European Pharmacopoeia and are authorised for oral administration to human beings by the European Union Regulatory Authorities. Symptomatic medication was authorised and comprised NSAIDs, paracetamol (acetaminophen), Cafergot® (ergotamine/caffeine), metoclopramide and dihydroergotamine (DHE) spray.

In view of the small group size, data were compared on days 0, 42 and 84 by one-way ANOVA followed by a post-hoc Student's paired t-test, provided variance was homogeneous.

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