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

Results

Patient details, migraine history, attack frequency and the symptomatic drugs used for acute pain relief during the 6-week baseline period are shown in Table I . Migraine history ranged from 3 to 36 years in nine patients, with recent histories of >6 months recorded for the remaining three patients ( Table I ). Mean patient age was 35.8 years ( Table I ). Of the 12 patients enrolled, one (no. 10) was excluded from the study because of almost continuous headache and underwent further neurological examination for non-migrainous causes. Patient no. 11 was also excluded from the study for refusing to attend the planned consultancy, despite treatment continuation. Patient no. 2 had very frequent migraine attacks (average of 15 in the 6 weeks before the study), and began treatment for another illness during the 6- to 12-week study period; data for this patient are included only up to day 42. No patients stopped taking Mig-RL® because of adverse events or intolerance.

Primary Efficacy Criterion: Effects on Attack Frequency. Prior to starting Mig-RL® therapy, attack frequency ranged from 3 to 15 attacks over the baseline 6-week period (average 7.3 ± 4.4, n = 10; figure 1 and Table I ). After 6 weeks of Mig-RL® therapy, attack frequency diminished in eight patients, remained unchanged in one patient (no. 5 with a frequency of 3), and increased in one patient (no. 5 from 7.5 to 11). It was subsequently found that this patient had omitted to indicate that antidepressant treatment was stopped shortly before the study. The mean attack frequency at day 42 was 3.1 ± 3.0, corresponding to a 57.2% reduction (p < 0.029; figure 1). Over the following 6-week period, the mean attack frequency remained reduced at 2.8 ± 2.3, corresponding to a 61.7% reduction compared with day 0 (p < 0.02) and a further 10.4% reduction (p = 0.80) compared with day 42. Seventy percent of patients had a reduction in frequency of attacks of at least 50% after 12 weeks' treatment. Patient no. 7 had an attack frequency of 5 at day 84 compared with 7.5 at day 0 and 11 at day 42. Patient no. 8 had an attack frequency of 6 at day 0 and 0 at days 42 and 84. By day 84 of Mig-RL® treatment, improvements in attack frequency were seen in nine of ten patients (figure 1).

Effect of treatment with Tanacetum parthenium plus Salix alba (Mig-RL®) on attack frequency (primary efficacy criterion) in ten patients with migraine without aura. Data are means (± SEM) of the number of attacks recorded by the patient over a 6-week period. p-Values are shown for comparisons with data at day 0. No statistically significant differences were noted between days 42 and 84. * p < 0.029, ** p < 0.025.

Secondary Efficacy Criteria. Effect on Pain Intensity. Mean overall pain intensity appreciation during a migraine attack was 8.5 ± 1.3 on day 0, 5.2 ± 2.7 at day 42 (corresponding to a 38.7% decrease [p < 0.005]) and 3.2 ± 3.4 at day 84 (corresponding to decreases of 62.6% [p < 0.004] compared with day 0, and 39.0% [p < 0.22]) compared with day 42 (figure 2). Overall attack pain intensity was decreased in all patients at days 42 and 84 (figure 2). Seventy percent of patients had a reduction of at least 50% in overall pain intensity after 12 weeks' treatment.

Effect of Tanacetum parthenium plus Salix alba (Mig-RL®) treatment on overall attack intensity (secondary efficacy criterion) in ten patients with migraine without aura. Data are means (± SEM) of the number of the overall attack intensity on a 0–10 visual analogue scale (VAS) recorded by the patient on days 0, 42 and 84. p-Values are shown for comparisons with data at day 0. No statistically significant differences were noted between days 42 and 84. * p < 0.005, ** p < 0.004.

Mean individual attack intensity appreciation was 8.5 ± 1.3 on day 0, 5.2 ± 2.9 on day 42 (corresponding to a 39.0% decrease [p < 0.002]) and 4.0 ± 3.5 on day 84 (corresponding to reductions of 53.4% [p < 0.004]) compared with day 0, and 9.6% (p = 0.53) compared with day 42. Individual attack intensity was decreased in all patients at days 42 and 84. The individual attack intensity data can practically be superimposed on those of overall attack intensity (figure 2).

Effect on Attack Duration. Mean attack duration (figure 3) was 33.3 ± 14.7h at day 0, 10.9h at day 42 (corresponding to a 67.2% reduction [p < 0.001]) and 7.9h at day 84 (corresponding to a 76.2% decrease compared with day 0 [p < 0.001]) and 27.5% compared with day 42 [p < 0.21]). Attack duration was reduced in all patients at days 42 and 84 (figure 3).

Effect of Tanacetum parthenium plus Salix alba (Mig-RL®) treatment on attack duration (secondary efficacy criterion) in ten patients with migraine without aura. Data are means (± SEM) of the duration of attacks recorded by the patient over 6-week periods before (day 0) and after 6 and 12 weeks of treatment. p-Values are shown for comparisons with data at day 0. No statistically significant differences were noted between days 42 and 84. * p < 0.001.

Other Criteria. Quality of Life. Improvements in quality-of-life-associated parameters were apparent in patients' self-assessment of general health, physical performance, memory and anxiety by the end of the study ( Table II ). Although a propensity towards improvement in these parameters was apparent on day 42, statistically significant differences were not seen until day 84 ( Table II ).

Adverse Events and Tolerability. Mig-RL® was well tolerated in all patients and no notable adverse effects or adverse events were recorded.

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