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

Cephalalgia ◽  
2002 ◽  
Vol 22 (7) ◽  
pp. 513-519 ◽  
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.

Inhaled nitric oxide and prevention of pulmonary hypertension after congenital heart surgery: a randomised double-blind study

The Lancet ◽  
2000 ◽  
Vol 356 (9240) ◽  
pp. 1464-1469 ◽  
Author(s):  
Owen I Miller ◽  
Swee Fong Tang ◽  
Anthony Keech ◽  
Nicholas B Pigott ◽  
Elaine Beller ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Pulmonary Hypertension ◽  
Congenital Heart ◽  
Heart Surgery ◽  
Congenital Heart Surgery ◽  
Inhaled Nitric Oxide ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind

Treatment of Acute Migraine Attack With Diclofenac Sodium: A Double-Blind Study

1992 ◽  
Vol 32 (2) ◽  
pp. 98-100 ◽  
Author(s):  
George N. Karachalios ◽  
Adroniki Fotiadou ◽  
Nickolaos Chrisikos ◽  
Alexandros Karabetsos ◽  
Kyriakos Kehagioglou
Keyword(s):  
Migraine Attack ◽  
Diclofenac Sodium ◽  
Blind Study ◽  
Double Blind Study ◽  
Acute Migraine ◽  
Double Blind ◽  
Acute Migraine Attack

scholarly journals Intravenous chlorpromazine in the acute treatment of episodic tension-type headache: a randomized, placebo controlled, double-blind study

2002 ◽  
Vol 60 (3A) ◽  
pp. 537-541 ◽  
Author(s):  
Marcelo Eduardo Bigal ◽  
Carlos Alberto Bordini ◽  
José Geraldo Speciali
Keyword(s):  
Acute Treatment ◽  
Tension Type Headache ◽  
Blind Study ◽  
Number Needed To Treat ◽  
Double Blind Study ◽  
Emergency Rooms ◽  
Double Blind ◽  
Therapeutic Gain ◽  
Type Headache ◽  
To Receive

Acute headache is a very frequent symptom, responsible for a significant percentage of caseload at primary care units and emergency rooms. Chlorpromazine is easily available in such settings. The aim of this study is to conduct a randomized, placebo-controlled, double-blind study to assess the efficacy of chlorpromazine on the acute treatment of episodic tension-type headache. We randomized 30 patients to receive placebo (10 ml of saline intravenous injections) and 30 patients to receive 0.1 mg/Kg chlorpromazine intravenously. We used 7 parameters of analgesic evaluation. Patients receiving chlorpromazine showed a statistically significant improvement (p < 0.05 and p < 0.01) of pain compared to placebo, far up to 30 minutes after the drug administration. The therapeutic gain was 36.7% in 30 minutes and 56.6 % in 60 minutes. The number needed to treat (NNT, the reciprocal or the therapeutic gain) was 2.7 in 30 minutes and 1.8 in 60 minutes. There were reductions in the recurrence and in the use of rescue medication in the chlorpromazine group. We can conclude that intravenous chlorpromazine is an effective drug to relief the pain in tension-type headache.

scholarly journals Comparison of Effect of Intrathecal Fentanyl-bupivacaine and Tramadol-bupivacaine Combination on Postoperative Analgesia in Lower Abdominal Surgeries

2016 ◽  
Vol 1 (2) ◽  
pp. 35-40 ◽  
Author(s):  
Naina P Dalvi ◽  
Narendra Patil
Keyword(s):  
Blood Pressure ◽  
Postoperative Analgesia ◽  
Total Duration ◽  
Double Blind Study ◽  
Motor Blockade ◽  
Hyperbaric Bupivacaine ◽  
Double Blind ◽  
Sensory Blockade ◽  
Prolonged Duration ◽  
American Society

ABSTRACT Introduction This single-center, prospective, randomized, double-blind study compares the effect of intrathecal fentanylbupivacaine and tramadol-bupivacaine on the onset and duration of sensory and motor blockade, as well as postoperative analgesia in lower abdominal surgeries. Materials and methods Patients of either sex, aged 18 to 60 years, American Society of Anesthesiologists (ASA) grade I/II undergoing lower abdominal surgeries like appendicectomy, inguinal hernia repair surgery, and hydrocele surgery were administered either 2.5 mL of 0.5% bupivacaine + 0.5 mL (25 μg) of fentanyl citrate (group F) or 2.5 mL of 0.5% bupivacaine + 0.5 mL (25 mg) of tramadol (group T) intrathecally. Monitoring of the vital parameters, onset and duration of sensory and motor block, duration of postoperative analgesia, visual analog scale (VAS) score, sedation score, and any adverse drug reactions was done at predetermined intervals. Results Sixty patients were randomized to the group F (n = 30) and group T (n = 30). The duration of sensory blockade was significantly prolonged in group F (314.66 ± 49.25 minutes) as compared to group T (261.66 ± 27.92 minutes). Similarly, duration of motor blockade was longer in group F (263.66 ± 40.97 minutes) compared to group T (214.66 ± 26.61 minutes). The total duration of analgesia was significantly prolonged (p < 0.001) in group F (412 ± 97.888 minutes) compared to group T (301 ± 38.75 minutes). Hemodynamic parameters, such as pulse, systolic blood pressure, diastolic blood pressure and oxygen saturation were comparable in both the groups. Visual analog scores were significantly lower in the group F patients as compared to the group T patients. The group F patients had got significantly higher sedation scores as compared to Group T patients. Discussion Fentanyl 25 μg, when added to 2.5 mL of 0.5% hyperbaric bupivacaine, confers prolonged duration of sensory and motor blockade than 25 mg tramadol added to 2.5 mL of 0.5% hyperbaric bupivacaine. The bupivacaine-fentanyl combination prolonged duration of sensory and motor blockade, improved analgesia, as manifested by lower pain scores, and prolonged duration of postoperative analgesia. How to cite this article Dalvi NP, Patil N. Comparison of Effect of Intrathecal Fentanyl-bupivacaine and Tramadol-bupivacaine Combination on Postoperative Analgesia in Lower Abdominal Surgeries. Res Inno in Anesth 2016;1(2):35-40.

scholarly journals A.07 Efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine: a single-attack phase 3 study, ACHIEVE I

2019 ◽  
Vol 46 (s1) ◽  
pp. S9-S10 ◽  
Author(s):  
DW Dodick ◽  
RB Lipton ◽  
J Ailani ◽  
K Lu ◽  
H Lakkis ◽  
...  
Keyword(s):  
Migraine Attack ◽  
Initial Dose ◽  
Acute Treatment ◽  
Phase 3 ◽  
Double Blind ◽  
Safety Population ◽  
Parallel Group ◽  
Attack Phase ◽  
Headache Pain ◽  
Cgrp Receptor Antagonist

Background: To evaluate efficacy, safety, and tolerability of ubrogepant, an oral CGRP receptor antagonist, for acute treatment of a single migraine attack. Methods: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, single-attack, phase 3 study (NCT02828020). Patients randomized 1:1:1 to placebo, ubrogepant 50mg, or ubrogepant 100mg had 60 days to treat one migraine attack (moderate/severe pain intensity). Co-primary efficacy endpoints: pain freedom 2 hours post initial dose and absence of most bothersome migraine-associated symptom (MBS). Results: 1672 patients were randomized (safety population: n=1436; mITT population: n=1327). Mean age: 40.7 years; white (82.4%); female (87.5%). A significantly greater percentage of ubrogepant- than placebo-treated patients achieved pain freedom 2 hours post initial dose (50mg: 19.2%, adjusted P=0.0023; 100mg: 21.2%, adjusted P=0.0003; placebo: 11.8%). A significantly greater percentage of ubrogepant patients achieved absence of MBS (50mg: 38.6%, adjusted P=0.0023, 100mg: 37.7%, adjusted P=0.0023; placebo: 27.8%). The adverse event (AE) profile of ubrogepant was similar to placebo. The most common AEs (incidence ≥2% in any treatment group) within 48 hours of initial or optional second dose were nausea, somnolence, and dry mouth (all with incidence &lt;5%). Conclusions: Both co-primary endpoints were met, with clinically meaningful effects on migraine headache pain and MBS. Ubrogepant was well tolerated, with no identified safety concerns.

Sumatriptan nasal spray for the acute treatment of migraine

Neurology ◽  
1997 ◽  
Vol 49 (5) ◽  
pp. 1225-1230 ◽  
Author(s):  
R. Ryan ◽  
A. Elkind ◽  
C. C. Baker ◽  
W. Mullican ◽  
S. DeBussey ◽  
...  
Keyword(s):  
Adverse Events ◽  
Migraine Attack ◽  
Nasal Spray ◽  
Acute Treatment ◽  
International Headache Society ◽  
Migraine Treatment ◽  
Multicenter Studies ◽  
Double Blind ◽  
Treatment Groups ◽  
Migraine Medication

Background: Sumatriptan nasal spray may be particularly useful for patients whose nausea and vomiting preclude them from using oral migraine medication or for patients who prefer not to use an injectable migraine medication. The objective of this study was to evaluate in two clinical studies the efficacy and tolerability of the intranasal form of sumatriptan in the acute treatment of a single migraine attack. International Headache Society-diagnosed adult migraineurs in two randomized, double-blind, parallel-group, multicenter studies (n = 409 and 436) used sumatriptan nasal spray 20 mg, 10 mg, or placebo (2:1:1) for the acute treatment of a single migraine attack at home. Predose and at predetermined postdose intervals, patients recorded headache severity (none, mild, moderate, severe); time to meaningful relief; clinical disability (none, mildly impaired, severely impaired, bed rest required); presence/absence of nausea, photophobia, and phonophobia; and the occurrence of adverse events. Two hours postdose in the two studies, moderate or severe baseline pain was reduced to mild or none in 62 to 63% of patients treated with sumatriptan 20 mg, 43 to 54% of patients treated with sumatriptan 10 mg, and 29 to 35% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies and 10 mg versus placebo for study 1). Onset of relief relative to placebo began as early as 15 minutes postdose(sumatriptan 20 mg, study 2). Clinical disability at 2 hours postdose was reported as mildly impaired or normal in 72 to 74% of patients treated with sumatriptan 20 mg, 56 to 68% of patients treated with sumatriptan 10 mg, and 47 to 58% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies). Similar efficacy rates were observed for nausea, photophobia, and phonophobia. The most common adverse event in the active treatment groups was disturbance of taste (bad, bitter, or unpleasant taste). Aside from this event, the pattern and incidence of adverse events did not differ among treatment groups. From these results we determined that sumatriptan nasal spray is a rapidly effective, well-tolerated migraine treatment. The 20-mg dose was effective in treating the entire migraine symptom complex, and the 10-mg dose was less consistently effective.

Intranasal Civamide for the Acute Treatment of Migraine Headache

Cephalalgia ◽  
2000 ◽  
Vol 20 (6) ◽  
pp. 597-602 ◽  
Author(s):  
S Diamond ◽  
F Freitag ◽  
SB Phillips ◽  
JE Bernstein ◽  
JR Saper
Keyword(s):  
Migraine Headache ◽  
Acute Treatment ◽  
Serotonin Release ◽  
Pain Severity ◽  
Double Blind Study ◽  
Plasma Extravasation ◽  
Post Dose ◽  
Double Blind ◽  
Excitatory Neurotransmitters ◽  
Headache Pain

The objective of this study was to investigate the safety and efficacy of intranasal civamide for the acute treatment of migraine headache with or without aura. Civamide is a vanilloid receptor agonist and neuronal calcium channel blocker that inhibits the neuronal release of excitatory neurotransmitters (e.g. calcitonin gene-related peptide (CGRP) and substance P (SP)) and depletes the neurones of the trigeminal plexus of their neurotransmitter content. Applied intranasally, the release of neurotransmitters to meningeal and dural blood vessels should be decreased, along with the resultant vasodilatation, plasma extravasation, and histamine/serotonin release. Subsequent migraine headache pain may also be diminished. Thirty-four patients were enrolled into a double-blind study of intranasal civamide, and randomized to receive a single dose of either 20 μg or 150 μg of civamide, for the treatment of a single migraine headache, with or without aura, of moderate to severe pain. At 2 h post-dose, 55.6% of patients treated with either dose had a decrease in pain severity, with 22.2% of patients being pain-free. At 4 h post-dose, 72.7% of patients treated with either dose had a decrease in pain severity, with 33.0% of patients being pain-free. Adverse events were similar for both dosages, with 91.2% of patients experiencing nasal burning and 44.1% of patients experiencing lacrimation. No systemic side-effects were observed. Based upon the results of this study, intranasal civamide may be effective in the acute treatment of migraine headache. Given civamide's proposed mechanism of action, intranasal civamide should be substantially more effective for prophylaxis than acute treatment of migraine. A study evaluating its efficacy in prophylaxis of migraine is currently planned.

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