Preventive Treatment of Migraine Headache with a New Isoergolenyl Derivative

1978 ◽  
Vol 6 (6) ◽  
pp. 476-482 ◽  
Author(s):  
W M Herrmann ◽  
M Krištof ◽  
M Sastre y Hernandez
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Migraine Headache ◽  
Preventive Treatment ◽  
Double Blind ◽  
Good Tolerance ◽  
Dopaminergic Activity ◽  
Double Blind Clinical Trial ◽  
Term Administration

In the present double-blind clinical trial an isoergolenyl derivative with periphal antiserotonin, central dopaminergic activity and a-increasing effect on the human EEG, lisuride hydrogen maleate, was tested against placebo in a six-month trial involving 240 patients. Lisuride in long-term administration significantly reduces the frequency of migraine attacks in comparison to placebo. Its advantages are good tolerance and minimal side-effects. It is therefore concluded that lisuride is a suitable and effective drug for the prevention of migraine.

A Long Term Double-Blind Clinical Trial of Ibuprofen and Indomethacin in Rheumatoid Arthritis

1975 ◽  
Vol 3 (3) ◽  
pp. 158-171 ◽  
Author(s):  
G L Royer ◽  
T E Moxley ◽  
M S Hearron ◽  
A Miyara ◽  
B M Shenker
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Side Effects ◽  
Double Blind ◽  
Double Blind Clinical Trial

Two-hundred and eighteen individuals with rheumatoid arthritis were randomly assigned to six months treatment with ibuprofen (900-1800 mg/day) or indomethacin (75-150 mg/day). The drugs were equally effective in the treatment of rheumatoid arthritis while the incidence of indomethacin side-effects was 1·5 times greater than the incidence of ibuprofen side-effects.

scholarly journals Mig-RL: a Natural Preventive Treatment Against Migraine. Outcomes of a Randomized, Double-Blind Clinical Trial

2021 ◽  
Vol 8 (7) ◽  
pp. 01-09
Author(s):  
Rémi Shrivastava
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Plant Extracts ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Salix Alba ◽  
Double Blind ◽  
Tanacetum Parthenium ◽  
Double Blind Clinical Trial ◽  
The Mean

BACKGROUND The efficacy and safety of Mig-RL (Commercial name HERBA MIG), a synergistic association of two plant extracts, Tanacetum parthenium (150mg, 0.5% parthenolide) and Salix Alba (150mg, 25% salicin) were investigated as a preventive treatment for episodic migraine. Mig-RL was compared with a placebo in a randomized, double-blind clinical trial. MATERIALS AND METHODS This trial included 129 patients having episodic migraine and diagnosed with migraines without aura for over a year and meeting the migraine criteria, as defined in the International Classification of Headache Disorder (ICHD-3 :1.1). P). Baseline data was collected for 28 days before the start of the three-months treatment period. Patients were randomized in a 1:1 ratio to receive either Mig-RL (a single dose of 300mg per day, per os) or placebo (identical capsules containing 300 mg starch, 1 per day, per os) for a period of 12 consecutive weeks. The primary endpoint was the mean change in the average number of migraine days per month, comparing the baseline 28-days pre-intervention period with the weeks 9 to 12 after the first dose of the trial regimen. Secondary endpoints were the percentage of patients with a reduction of at least 30% in the average number of migraine days per month and days of use of any acute headache medication per month. The HIT-6 and MIDAS scores were also evaluated vs. baseline between the two groups. RESULTS Out of 172 patients enrolled, 129 were randomly assigned to the Mig-RL arm (n=65) or the placebo arm (n=64). The mean (±SD) number of baseline migraine days per month was 8.4±1.9 and 8.7±1.9, respectively. The mean reduction in the average number of migraine days per month was 2.5±0.4 (p<0.001) with Mig-RL and 1.9±0.4 (p<0.001) with placebo. A difference of 0.6±0.4 (p=0.01) between the two groups. The percentage of patients with at least 30% reduction in average number of migraine days per month was 49% in Mig-RL and 32% in placebo (p<0.05 vs. placebo). Only a few isolated and minor side effects were reported and overall Mig-RL was well tolerated by patients. CONCLUSIONS Mig-RL, a synergistic combination of two plant extracts, seems to have a moderate effect in the prevention of migraines. Without side effects, the combination of Tanacetum parthenium and Salix alba could be an additional help for some patients. However, further investigations and an improvement in the quality of the plants are still necessary.

scholarly journals Comparison the Efficacy of Intranasal Ketamine Versus Intravenous Ketorolac on Acute Non-Traumatic Headaches: A Randomized Double-Blind Clinical Trial

2020 ◽  
Author(s):  
Houman Rafiee Sarvari ◽  
Hamidreza Baigrezaii ◽  
Mohammad Nazarianpirdosti ◽  
Amirhossein Meysami ◽  
Roya Safari-Faramani
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Double Blind ◽  
Analgesic Effects ◽  
Headache Severity ◽  
Selective Approach ◽  
Double Blind Clinical Trial ◽  
Group B ◽  
Short Time ◽  
Intravenous Ketorolac

Abstract Introduction: Non - traumatic headaches are one of the most common causes of referral to hospital emergency. This study aimed to compare the efficacy of intranasal ketamine and intravenous ketorolac on acute non-traumatic headaches.Methods: This randomized and double-blind clinical trial in 2019 years. 140 people were randomly divided into intranasal ketamine (A) and intravenous ketorolac (B). Group (A) received ketamine intranasal (0.75 mg/kg, max 75mg), and group B received intravenous ketorolac (30 mg). Headache severity was measured on arrival, 30, 60, and 120 minutes after intervention with Visual Analogue Scale (VAS). The side effects were recorded an hour after the intervention.Result: The mean difference of pain intensity 30, 60, and 120 minutes after the intervention between the two groups were statistically significant (p<0.001). In the first 30 minutes, significant changes were observed in the VAS levels of the two groups. These changes were more and significant in the intranasal ketamine group (p <0.001). Side effects such as fatigue, dizziness, public discomfort, nausea, increased heart rate, and hypertension were significantly higher in the ketamine group (p <0.05).Conclusion: Intranasal ketamine and intravenous ketorolac both effectively reduced headaches. However, more analgesic effects of intranasal ketamine in a short time can be considered as a selective approach to reducing headaches.

scholarly journals Comparison the Efficacy of Intranasal Ketamine Versus Intravenous Ketorolac on Acute Non-traumatic Headaches: A Randomized Double-Blind Clinical Trial

2020 ◽  
Author(s):  
Houman Rafiee Sarvari ◽  
Hamidreza Baigrezaii ◽  
Mohammad Nazarianpirdosti ◽  
Amirhossein Meysami ◽  
Roya Safari-Faramani
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Double Blind ◽  
Analgesic Effects ◽  
Headache Severity ◽  
Selective Approach ◽  
Double Blind Clinical Trial ◽  
Group B ◽  
Short Time ◽  
Intravenous Ketorolac

Abstract Introduction: Non - traumatic headaches are one of the most common causes of referral to hospital emergency. This study aimed to compare the efficacy of intranasal ketamine and intravenous ketorolac on acute non-traumatic headaches.Methods: This randomized and double-blind clinical trial in 2019 years. 140 people were randomly divided into intranasal ketamine (A) and intravenous ketorolac (B). Group (A) received ketamine intranasal (0.75 mg/kg, max 75mg), and group B received intravenous ketorolac (30 mg). Headache severity was measured on arrival, 30, 60, and 120 minutes after intervention with Visual Analogue Scale (VAS). The side effects were recorded an hour after the intervention.Result: The mean difference of pain intensity 30, 60, and 120 minutes after the intervention between the two groups were statistically significant (p<0.001). In the first 30 minutes, significant changes were observed in the VAS levels of the two groups. These changes were more and significant in the intranasal ketamine group (p <0.001). Side effects such as fatigue, dizziness, public discomfort, nausea, increased heart rate, and hypertension were significantly higher in the ketamine group (p <0.05).Conclusion: Intranasal ketamine and intravenous ketorolac both effectively reduced headaches. However, more analgesic effects of intranasal ketamine in a short time can be considered as a selective approach to reducing headaches.Trial registration: IRCT20180108038276N3, Registered 29 September 2019.

scholarly journals Treatment of patients with Schistosomiasis mansoni: a double blind clinical trial comparing praziquantel with oxamniquine

1986 ◽  
Vol 28 (3) ◽  
pp. 174-180 ◽  
Author(s):  
Luiz Caetano da Silva ◽  
José Murilo R. Zeitune ◽  
Lucia Maria F. Rosa-Eid ◽  
Dirce Mary C. Lima ◽  
Rita H. Antonelli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Statistical Significance ◽  
Double Blind ◽  
Chemical Structures ◽  
Double Blind Clinical Trial ◽  
Negative Findings ◽  
Rectal Biopsies ◽  
Cure Rates

A double-blind clinical trial involving 120 patients with chronic schistosomiasis was carried out to compare the tolerability and efficacy of praziquantel and oxamniquine. The patients were randomly allocated into two groups. One was treated with praziquantel, 55 mg/kg of body weight CBWT), and the other one with oxamniquine, 15mg/kg bwt, administered in a single oral dose. The diagnosis and the parasitological follow-up was based on stool examinations by quantitative Kato-Katz method and on rectal biopsies. Side-effects — mainly dizziness, sleepness, abdominal distress, headache, nausea and diarrhea — were observed in 87% of the cases. Their incidence, intensity and duration were similar for both drugs but abdominal pain was significantly more frequent after praziquantel intake and severe dizziness was more commonly reported after oxamniquine. A significant increase of alanine-aminotransferase and y-glutamyltransferase was found with the latter drug and of total bilirubin with the former one. A total of 48 patients treated with praziquantel and 46 with oxamniquine completed with negative findings the required three post-treatment parasitological controls — three slides of each stool sample on the first, third and sixth month. The achieved cure rates were 79.2% and 84.8%, respectively, a difference without statistical significance. The non-cured cases showed a mean reduction in the number of eggs per gram of feces of 93.5% after praziquantel and of 84.1% after oxamniquine. This diference also was not significant. Five patients retreated with praziquantel were cured but only one out of three treated a second time with oxamniquine. These findings show that both drugs — despite their different chemical structures, pharmacological properties and mechanisms-of-action — induce similar side-effects as well as a comparable therapeutical efficacy, in agreement with the results reported from analogous investigations.

scholarly journals The comparison of the effect of flaxseed oil and vitamin E on mastalgia and nodularity of breast fibrocystic: a randomized double-blind clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gholamali Godazandeh ◽  
Shahram Ala ◽  
Tahereh Madani Motlaq ◽  
Adeleh Sahebnasagh ◽  
Aliyeh Bazi
Keyword(s):  
Clinical Trial ◽  
Vitamin E ◽  
Luteal Phase ◽  
Flaxseed Oil ◽  
Breast Pain ◽  
Double Blind ◽  
Benign Condition ◽  
Double Blind Clinical Trial ◽  
Significant Difference

Abstract Background Fibrocystic changes are a common benign condition in women aged 20–50. The medical intervention aims to stop fibrocystic disease progress and relieve the breast’s pain and tenderness. In the long-term, reversing the fibrocystic changes is also desirable. Methods In this randomized double-blind clinical trial, the effect of flaxseed oil on the severity of pain and breast nodularity was investigated against vitamin E. This study was conducted on 100 women with mastalgia. The intervention group received Flaxseed oil pearls and the control group received vitamin E pearl 200 IU twice a day for 2 months. The duration and severity of breast pain were evaluated by Cardiff chart and VAS (Visual Analogue Scale). The nodularity was assessed by Lucknow-Cardiff scale at baseline, then the first and second months of intervention. Results At baseline, there was no statistically significant difference between the two groups in characteristics. The breast pain improved in both groups during the first and second months of intervention (P-value within group< 0.001). However, the mean breast pain was not significantly different between the two groups at the end of the first and second month (P1= 0.54, P2= 0.73). Furthermore, the breast pain during four phases of the menstrual cycle showed no difference between vitamin E and flaxseed oil groups (menstruation phase= 0.76, follicular phase= 0.48, the first week of luteal phase= 0.86, the second week of luteal phase=0.30). The breast nodularity also decreased during the first and second months of intervention, yet no significant difference between the two groups was found (p= 0.9). Conclusions This study showed that flaxseed oil and vitamin E both could be effective in breast pain-relieving and decreasing nodularity with minimal side effects in contrast with the baseline. But there are no significant differences between these two agents. Larger scale prospective studies are needed to evaluate these effects in the long-term. Trial registration IRCT201612243014N18, Registration date: 2017-10-15.

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