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Table 5 Summary of efficacy data of 11 randomized clinical studies (only drugs recommended as first or second choice)

From: Self-medication of migraine and tension-type headache: summary of the evidence-based recommendations of the Deutsche Migräne und Kopfschmerzgesellschaft (DMKG), the Deutsche Gesellschaft für Neurologie (DGN), the Österreichische Kopfschmerzgesellschaft (ÖKSG) and the Schweizerische Kopfwehgesellschaft (SKG)

Indication and drug

Active drug

Placebo

Therapeutic gain

Primary endpoint of the study

Literature reference

Migraine/ETTH

fixed-dose combination of 500 mg ASA + 400 mg paracetamol + 100 mg caffeine

Secondary endpoints:

PID at 2 h VAS: 44.7 mm ≥50% pain reduction at 2 h: 77% of patients

PID at 2 h VAS: 24.6 mm ≥50% pain reduction at 2 h: 47% of patients

Δ = 20.1 mm

Δ = 30%

Kaplan–Meier estimator of the proportion of patients with 50% pain relief during the first 4 h after drug intake

Diener et al. [39, 109]

Migraine

fixed-dose combination of 500 mg ASA + 500 mg paracetamol + 130 mg caffeine

Primary endpoint:

TOTPAR-2 at 2 h: 2.7

TOTPAR-2 at 2 h: 2.0

Δ = 0.7

TOTPAR-2 sum of pain relief scores at 2 h postdose (5-point VRS)

Goldstein et al. [44]

ETTH

fixed-dose combination of 1,000 mg paracetamol + 130 mg caffeine

Primary endpoint:

study 1: TOTPAR-4: 10.45 ± 0.20

study 2: TOTPAR-4: 10.54 ± 0.19

study 1: TOTPAR-4: 8.82 ± 0.30

study 2: TOTPAR-4: 7.86 ± 0.32

Δ = 1.63

Δ = 2.68

TOTPAR-4 sum of pain relief scores at 4 h postdose (5-point VRS)

Migliardi et al. [56]

Migraine

1,000 mg ASA

Primary endpoint: response rate at 2 h: 52.5% of patients

response rate at 2 h: 30.6% of patients

Δ = 21.9%

Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 2 h (4-point VRS)

Diener et al. [37]

Migraine

1,000 mg ASA

Primary endpoint:

response rate at 2 h: 52% of patients

response rate at 2 h: 34% of patients

Δ = 18%

Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 2 h (4-point VRS)

Lipton et al. [52]

ETTH

1,000 mg ASA

Primary endpoint:

response rate at 2 h: (7-point VRS): 75.7%

response rate at 2 h: (7-point VRS): 54.5%

Δ = 21.2%

Number of patients (in %) with headache relief to grade 1 or 0 at 2 h (7-point VRS)

Steiner et al. [63]

ETTH

12.5 mg diclofenac-K

Primary endpoint:

TOTPAR-3: 5.23 ± 2.71

secondary endpoint:

complete pain relief at 2 h: 18.1% of patients

TOTPAR-3: 3.49 ± 3.02

complete pain relief at 2 h: 7.8% of patients

Δ = 1.74

Δ = 10.3%

TOTPAR-3 (time-weighted sum of pain relief scores at 3 h)

Kubitzek et al. [49]

ETTH

25 mg diclofenac-K

Primary endpoint:

TOTPAR-3: 5.55 ± 2.95

secondary endpoint:

complete pain relief at 2 h: 22.6% of patients

TOTPAR-3: 3.49 ± 3.02

complete pain relief at 2 h: 7.8% of patients

Δ = 2.06

Δ = 14.8%

TOTPAR-3 (time-weighted sum of pain relief scores at 3 h)

Kubitzek et al. [49]

ETTH

400 mg ibuprofen

Primary endpoint:

TOTPAR-3: 5.37 ± 3.07

secondary endpoint:

complete pain relief at 2 h: 21.9% of patients

TOTPAR-3: 3.49 ± 3.02

complete pain relief at 2 h: 7.8% of patients

Δ = 1.88

Δ = 14.1%

TOTPAR-3 (time-weighted sum of pain relief scores at 3 h)

Kubitzek et al. [49]

Migraine

400 mg ibuprofen

Primary endpoint:

response rate at 2 h: 72.3% of patients

secondary endpoints:

PID at 2 h VAS: 1.23 ± 0.97 pain free (cumulative): 27.7% of patients

response rate at 2 h: 50% of patients

PID at 2 h VAS: 0.71 ± 0.87 pain free (cumulative): 13.4% of patients

Δ = 22.3%

Δ = 0.52

Δ = 14.3%

Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 2 h (4-point VRS)

Kellstein et al. [110]

Migraine

1,000 mg paracetamol

Primary endpoint:

response rate at 2 h: 57.8% of patients

secondary endpoint:

pain free (cumulative): 22.4% of patients

response rate at 2 h: 38.7% of patients

secondary endpoint:

pain free (cumulative): 11.3% of patients

Δ = 19.1%

Δ = 11.1%

Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 4 h (4-point VRS)

Lipton et al. [111]

ETTH

1,000 mg paracetamol

Secondary endpoint:

response rate at 2 h (7-point VRS): 71.2%

response rate at 2 h (7-point VRS): 54.5%

Δ = 16.7%

Number of patients (in %) with headache relief to grade 1 or 0 at 2 h (7-point VRS)

Steiner et al. [63]

Migraine

1,000 mg phenazone

Primary endpoint:

response rate at 2 h: 48.6% of patients

secondary endpoint:

pain free at 2 h postdose: 27.6% of patients

response rate at 2 h: 27.2% of patients

secondary endpoint:

pain free at 2 h postdose: 13.6% of patients

Δ = 21.4%

Δ = 14%

Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 4 h (4-point VRS)

Göbel et al. [42]

Migraine

2.5 mg nartriptan

Primary endpoint:

response rate at 4 h: 41% of patients

secondary endpoint:

response rate at 2 h: 25% of patients

response rate at 4 h: 19% of patients

response rate at 2 h: 10% of patients

Δ = 22%

Δ = 15%

Number of patients (in %) with headache relief from grade 3 or 2 to grade 1 or 0 at 4 h (4-point VRS)

Stark et al. [61]

  1. ASA acetylsalicylic acid, ETTH episodic tension-type headache, PID pain intensity differences, therapeutic gain: defined as response of the active drug minus placebo response, TOTPAR total pain relief, VAS visual analog scale (100 mm), VRS verbal rating scale