Evidence Table 4Efficacy of DHE nasal spray

REPORTDOSAGE# OF PATIENTS IMPROVED/NEFFICACY MEASURES
Active treatmentControl/comparisonActive treatmentControl/comparisonOdds Ratio (95% CI)Effect Size (95% CI)p-value
ACUTE TREATMENT: DHE vs. PLACEBO
Bousser and Loria 1985
#46010
0.9 – 1.8 mg-----p<0.01 (DHE)
Decrease in HA severity; timepoint N/S
---0.9 – 1.8 mg-----p<0.01 (DHE)
Complete relief at 2 hrs
DHE Nasal Spray Multicenter Investigators 1995
#50830
(Study 1)
2 mg----0.30 (−0.08 to 0.68)
HA relief at 2 hrs
-
Gallagher 1996
#56170
2 mg-74/105 (70%)27/98 (28%)6.3 (3.4 to 12)
HA relief at 4 hrs
-p<0.001 (DHE)
Complete relief at 4 hrs
---3 mg-56/97 (58%)27/98 (28%)3.6 (2.0 to 6.5)
HA relief at 4 hrs
--
Krause and Bleicher 1985
#45990
0.5 – 1 mg------
---1–2 mg-----p<0.01 (DHE)
Effect of treatment on HA severity; timepoint N/S
Massiou 1987
#45820
(Study 2)
1–2 mg-26/76* (34%)16/76* (21%)1.9 (0.94 to 4.0)
Complete relief at 2 hrs
--
Paiva, Esperanca, Marcelino, et al. 1985
#46020
0.5 – 2 mg----0 (−0.78 to 0.78)
HA relief; timepoint N/S
-
---1–4 mg----0.09 (−0.70 to 0.87)
HA relief; timepoint N/S
-
Rohr and Dufresne 1985
#46000
1–2 mg-----p<0.05 (DHE)
Effect of treatment on HA severity; timepoint N/S
Tulunay, Karan, Aydin, et al. 1987
#3280
1–2 mg----0.11 (−0.40 to 0.63)
Effect of treatment on HA pain; after each attack
-
Ziegler, Ford, Kriegler, et al. 1994
#2160
2 mg----0.53 (0.13 to 0.92)
HA relief at 2 hrs
-
Combined effect size
(DHE Nasal Spray Multicenter Investigators, 1995 [Study 1];
Paiva, Esperanca, Marcelino, et al., 1985 [1–4 mg dose]; Tulunay, Karan, Aydin, et al., 1987; Ziegler, Ford, Kriegler, et al., 1994):
-0.34 (0.10 to 0.57)
HA relief (various timepoints)
-
Tests for homogeneity (same four studies):-χ2= 0.257, d.f.=3, p=0.46-
ACUTE TREATMENT: DOSE COMPARISONS
Gallagher 1996
#56170
3 mg2 mg56/97 (58%)74/105 (70%)0.57 (0.32 to 1.02)
HA relief at 4 hrs
--
Krause and Bleicher 1985
#45990
1–2 mg0.5 – 1 mg-----
Paiva, Esperanca, Marcelino, et al. 1985
#46020
1–4 mg0.5 – 2 mg---0.09 (−0.71 to 0.89)
HA relief; timepoint N/S
-
ACUTE TREATMENT: DHE vs. ERGOTAMINE + CAFFEINE (CAFERGOT®)
Hirt, Lataste, and Taylor 1989
#45840
1–2 mg2 + 200 mg to 3 + 300 mg----n.s.
HA relief; timepoint N/S
ACUTE TREATMENT: DHE vs. SUMATRIPTAN (sc)
Touchon, Bertin, Pilgrim, et al. 1996
#56180
1–2 mg6 mg138/266 (52%) (estimated)216/266 (81%) (estimated)0.25 (0.17 to 0.37) HA relief at 2 hrs--
---1–2 mg6 mg86/266 (32%) (estimated)180/266 (68%) (estimated)0.23 (0.16 to 0.33) Complete relief at 2 hrs--
SHORT-TERM PREVENTION: DHE vs. PLACEBO
Massiou 1987
#45820
(Study 1)
2 mg-----p<0.05 (DHE)
Prevention of attack
*

indicates cross-over trial

Abbreviations used in this table:

CI is confidence interval. HA is headache. mg is milligram. n.s. is not significant. N/S is not specified. sc is subcutaneous.

From: Evidence Tables

Cover of Self-Administered Drug Treatments for Acute Migraine Headache
Self-Administered Drug Treatments for Acute Migraine Headache.
Technical Reviews, No. 2.4.
Gray RN, McCrory DC, Eberlein K, et al.

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