Chlormezanone in the Treatment of Migraine Attacks: A Double Blind Comparison with Diazepam and Placebo

Cephalalgia ◽  
1982 ◽  
Vol 2 (4) ◽  
pp. 205-210 ◽  
Author(s):  
Peer Tfelt-Hansen ◽  
Kai Jensen ◽  
Per Vendsborg ◽  
Martin Lauritzen ◽  
Jes Olesen

One hundred and fifty patients treated for an acute migraine attack all received a standard regimen consisting of metoclopramide 10 mg i.m. and—20 min later—paracetamol 1 g orally. Simultaneous trial medication was given. This consisted of placebo, diazepam 5 mg as tablets, or chlormezanone 400 mg as capsules given in a double dummy fashion. A successful treatment result was defined as a decrease of two or three steps on a four-point verbal pain report scale, and no need for further treatment. Patients with severe pain (all three treatment groups together) showed significantly better treatment results ( p < 0.001) than patients with pain of medium severity. In the group with severe pain there was no significant difference between diazepam, chlormezanone or placebo. In the group with pain of medium severity there was a significant ( p < 0.01) effect of chlormezanone, but no significant effect of diazepam. Chlormezanone may possibly be a valuable addition to antiemetic and analgesic therapy of migraine attacks.

Cephalalgia ◽  
1994 ◽  
Vol 14 (2) ◽  
pp. 156-161 ◽  
Author(s):  
F Boureau ◽  
JM Joubert ◽  
V Lasserre ◽  
B Prum ◽  
G Delecoeuillerie

The purpose of this study was to compare the efficacy and tolerance of a single dose of the acetaminophen 400 mg-codeine 25 mg combination (ACC) aspirin 1000 mg (A) and a placebo (P) for the treatment of acute migraine attack. The study design was randomized, multicentre, double-blind and double dummy with cross-over on three periods. Of the 198 patients who had three attacks 29.8%, 52.3% and 49.7% had recorded the complete or almost complete disappearance of the pain at 2 h after P, A and ACC respectively. When compared with the placebo, the difference was significant for the A and ACC. When complete disappearance of pain at 2 h was used as a criterion, no significant difference was observed. These results enabled the sensitivity of the evaluation criteria suggested for clinical trials of migraine attack to be discussed.


1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).


Cephalalgia ◽  
1985 ◽  
Vol 5 (2) ◽  
pp. 115-119 ◽  
Author(s):  
Knut Nestvold ◽  
Reidar Kloster ◽  
Markku Partinen ◽  
Raimo Sulkava

A double-blind, cross-over, randomized study of acute migraine attack compared treatment results of naproxen with that of placebo. Each treatment period continued for either three months or six migraine attacks, whichever occurred first. The initial dose of naproxen was 750 mg, with additional 250–500 mg doses taken if and when required, to a maximum of five 250 mg tablets within a period of 24 h in each migraine attack. Forty-one patients were enrolled in the study; they had all experienced at least two but not more than eight migraine attacks a month during the preceding year. Thirty-two patients completed the two treatment periods. Naproxen was statistically significantly superior to placebo in reducing the severity of head pain, nausea, and photophobia; in shortening the duration of head pain, nausea, vomiting, photophobia, and lightheadedness; in diminishing the frequency of vomiting; and in decreasing the need for escape medication. Both patient and physician treatment preferences significantly favoured naproxen. Nine side effects were experienced by seven patients while receiving placebo and seven by five patients during naproxen treatment. Mild gastrointestinal discomfort was the main complaint. Only one patient withdrew from treatment because of a side effect, which occurred while receiving placebo.


1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.


1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.


1992 ◽  
Vol 32 (2) ◽  
pp. 98-100 ◽  
Author(s):  
George N. Karachalios ◽  
Adroniki Fotiadou ◽  
Nickolaos Chrisikos ◽  
Alexandros Karabetsos ◽  
Kyriakos Kehagioglou

1994 ◽  
Vol 22 (4) ◽  
pp. 202-217 ◽  
Author(s):  
P H Gebuhr ◽  
M Soelberg ◽  
W Strauss

In this multiple-dose, double-blind study 100 patients with moderate, severe or very severe pain following orthopaedic surgery were randomly assigned to receive ketorolac, a nonsteroidal anti-inflammatory drug with potent analgesic properties (10 mg), or the standard regimen of Ketogan® (a combination product containing the narcotic analgesic, ketobemidone, plus a spasmolytic agent) by intramuscular injection every 1 – 6 h as needed for pain. When patients were able to tolerate an oral diet and were expected to respond to oral analgesic medication, based on overall pain sensitivity, they were switched to oral doses of the same medication every 4 – 6 h as needed. A maximum of four daily doses of medication was allowed for up to 10 days. The severity of pain was scored on a five-point scale and was recorded before the first intramuscular dose, at fixed time points therafter for up to 6 h and at the end of each day. Both treatments were effective immediately after the first dose and during the subsequent multiple-dose phase. There were no statistically significant differences between ketorolac and Ketogan®. The results show that 10-mg doses of ketorolac in intramuscular injections followed by 10-mg doses of oral ketorolac are as effective as Ketogan® for the treatment of pain following orthopaedic surgery. Ketorolac appears to be better tolerated than Ketogan® since significantly fewer patients reported adverse events ( P = 0.004) when taking ketorolac.


1993 ◽  
Vol 27 (6) ◽  
pp. 700-703 ◽  
Author(s):  
Paul W. Jungnickel ◽  
Mark S. Shaefer ◽  
Pierre A. Maloley ◽  
James R. Campbell ◽  
Gregory G. Shawaryn ◽  
...  

OBJECTIVE: To compare the sensory and mixability characteristics of Flavored Colestid Granules (a new colestipol formulation) with Questran Light (the most recent cholestyramine formulation). METHODOLOGY: Seventy-two nonsmoking adults between the ages of 25 and 64 years were enrolled in the study. Subjects assessed the sensory and mixability characteristics of each product in chilled bottled water and orange juice after at least a one-hour fast. Products were administered in a double-blind, randomized fashion. The sensory characteristics that were rated included overall rating, aftertaste, appearance, aroma, color, consistency, flavor, sweetness, mouthfeel, and thickness. Each characteristic was rated with a nine-point hedonic scale. Mixability of the products was assessed on a five-point scale. Subjects also were asked to choose which product they preferred as to sensory and mixability characteristics in each vehicle. RESULTS: Fifty-three of the 72 subjects preferred the sensory characteristics of Flavored Colestid Granules in water (p<0.001). Questran Light was preferred by 61 subjects when mixed in orange juice (p<0.001). The sensory characteristic rating scores also supported subject preferences for Flavored Colestid Granules in water and Questran Light in orange juice. Mixability of Flavored Colestid Granules was rated significantly better (p<0.001) than Questran Light in water. There was no significant difference for mixability between the products in orange juice. CONCLUSIONS: Questran Light was significantly preferred on a sensory basis when mixed in orange juice. Flavored Colestid Granules was significantly preferred over Questran Light for both sensory and mixability characteristics with water as the vehicle.


Pharmacology ◽  
2019 ◽  
Vol 104 (1-2) ◽  
pp. 1-6
Author(s):  
Alfredo Costa ◽  
Daniele Bosone ◽  
Matteo Cotta Ramusino ◽  
Giulia Perini ◽  
Natascia Ghiotto ◽  
...  

Aim: To assess the effects of chronic evening oral administration of bromazepam alone or in combination with propranolol on ambulatory blood pressure (BP) and heart rate (HR) in mild hypertensive subjects. Methods: Thirty-seven mild hypertensive patients after a 2-week placebo period were randomized to bromazepam 3 mg, propranolol 40 mg, bromazepam 3 mg plus propranolol 40 mg or placebo for 2 weeks according to a double-blind, double dummy, cross-over design. After each treatment period, 24-h BP and HR ambulatory monitoring was performed by using a non-invasive device. Results: Ambulatory monitoring showed that during night-time SBP and DBP values were unaffected by bromazepam as compared to placebo, whereas SBP was significantly reduced by propranolol both when taken alone and in combination with bromazepam. HR nocturnal values were significantly reduced by propranolol, whereas they were significantly increased by bromazepan both when taken alone (+11.5%, p < 0.05 vs. placebo) and in combination with propranolol (+12.8%, p < 0.05 vs. propranolol). No significant difference in day-time values of SBP, DBP and HR was observed among the 4 treatment groups. Conclusions: In mild hypertensive patients, evening consumption of bromazepam for a 2-week period did not affect BP, while it increased nocturnal HR. Such an increase was observed both when bromazepam was taken alone and in combination with propranolol, which suggests that it depends on a bromazepam mediated decrease in vagal tone. Whatever the mechanism, the HR nocturnal increase might be of clinical relevance, due to the role of high HR as cardiovascular risk factor, particularly in already at risk hypertensive subjects.


1972 ◽  
Vol 1 (1) ◽  
pp. 26-29 ◽  
Author(s):  
S G Flavell Matts

In a double-blind cross-over comparison of two mild analgesic compound tablets patients in moderate or severe pain showed a significant preference for the pentazocine-paracetamol compound tablet. Side effects were of a minor nature only and no patient dropped out of the trial because of them. It is concluded that significantly more patients (p <0.01) prefer the pentazocine-paracetamol compound to the dextropropoxyphene-paracetamol compound.


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