Intravenous ibuprofen for acute treatment of migraine: A double‐blind, randomized, placebo‐controlled pilot study

Hydroxocobalamin, A Nitric Oxide Scavenger, in the Prophylaxis of Migraine: an Open, Pilot Study

Cephalalgia ◽

10.1046/j.1468-2982.2002.00412.x ◽

2002 ◽

Vol 22 (7) ◽

pp. 513-519 ◽

Cited By ~ 40

Author(s):

P-HM van der Kuy ◽

FWHM Merkus ◽

JJHM Lohman ◽

JWM ter Berg ◽

PM Hooymans

Keyword(s):

Nitric Oxide ◽

Pilot Study ◽

Migraine Attack ◽

Acute Treatment ◽

Total Duration ◽

Double Blind Study ◽

Prophylactic Effect ◽

Attack Frequency ◽

Double Blind ◽

Total Study Population

Drugs which directly counteract nitric oxide (NO), such as endothelial receptor blockers, NO-synthase inhibitors, and NO-scavengers, may be effective in the acute treatment of migraine, but are also likely to be effective in migraine prophylaxis. In the underlying pilot study the prophylactic effect of the NO scavenger hydroxocobalamin after intranasal administration in migraine was evaluated. Twenty patients, with a history of migraine of <1 year and with two to eight migraine attacks per month, were included in an open trial. A baseline period was followed by an active treatment period of 3 months with 1 mg intranasal hydroxocobalamin daily. Patients were instructed to complete a diary in which details of each attack were described. A reduction in migraine attack frequency of ≥50% was seen in 10 of 19 patients, which corresponds to 53% of the patients (responders). A reduction of ≥30% was noted in 63% of the patients. The mean attack frequency in the total study population showed a reduction from 4.7 ± 1.7 attacks per month to 2.7 ± 1.6 ( P< 0.001). For the responders the migraine attack frequency was reduced from 5.2 ± 1.9 (baseline) to 1.9 ± 1.3 attacks per month ( P < 0.005), while for those who did not respond a non-significant reduction was found: 4.1 ± 1.4 to 3.7 ± 1.5 (P > 0.1). A reduction was also observed for the total duration of the migraine attacks per month, the total number of migraine days per month and the number of medication doses for acute treatment used per month. This is the first prospective, open study indicating that intranasal hydroxocobalamin may have a prophylactic effect in migraine. As a percentage of responders in prophylactic trials of > 35-40% is unlikely to be a placebo effect, a double-blind study is warranted.

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Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

American Journal of Perinatology ◽

10.1055/s-0038-1653946 ◽

2018 ◽

Vol 35 (13) ◽

pp. 1319-1325 ◽

Cited By ~ 5

Author(s):

Gur Mainzer ◽

Liron Borenstein-Levin ◽

Huda Jubran ◽

Gil Dinur ◽

Meirav Zucker ◽

...

Keyword(s):

Pilot Study ◽

Patent Ductus Arteriosus ◽

Preterm Infants ◽

Ductus Arteriosus ◽

Closure Rate ◽

Double Blind ◽

Positive Tendency ◽

Postmenstrual Age ◽

Intravenous Ibuprofen ◽

Patent Ductus

Objective The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 316/7 weeks postmenstrual age. Study Design This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol (n = 12) or ibuprofen + placebo (n = 12). Results There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol. Conclusion Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety.

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