Flunarizine vs. Propranolol in the Prophylaxis of Migraine: Two Double-Blind Comparative Studies in More than 400 Patients

Cephalalgia ◽  
1988 ◽  
Vol 8 (8_suppl) ◽  
pp. 21-26 ◽  
Author(s):  
Carl Hermann Lucking ◽  
Wolfgang Oestreich ◽  
Rainer Schmidt ◽  
Dieter Soyka
Keyword(s):  
Side Effects ◽  
Comparative Studies ◽  
Prophylactic Treatment ◽  
Double Blind ◽  
Medical Practices ◽  
Treatment Groups ◽  
Highly Effective ◽  
Overall Evaluation ◽  
Outpatient Departments ◽  
Hospital Study

In the course of a 16 weeks' interval treatment of migraine in connection with two multicenter double-blind studies, flunarizine was compared with propranolol in patients suffering predominantly from “classical migraine”. Eighty-seven patients from 12 outpatient departments were admitted to the first study, while 434 patients from 99 medical practices participated in the second study. After each month of treatment, the patients were clinically evaluated, and the number, duration, and severity of attacks were documented. Concerning the frequency and intensity of attacks, additional analgesics consumption and overall evaluation, both drugs proved to be highly effective in the practice as well as in the hospital study. The percentage and severity of side-effects were comparable in the two treatment groups. Summarizing, it may be stated that the studies proved the efficacy of flunarizine to be rather similar to that of propranolol in the prophylactic treatment of migraine.

A Double-Blind Study Comparing the Effectiveness of Cromolyn Sodium and Sustained-Release Theophylline in Childhood Asthma

PEDIATRICS ◽  
1984 ◽  
Vol 74 (4) ◽  
pp. 453-459
Author(s):  
Clifton T. Furukawa ◽  
Gail G. Shapiro ◽  
C. Warren Bierman ◽  
Michael J. Kraemer ◽  
Daniel J. Ward ◽  
...  
Keyword(s):  
Side Effects ◽  
Challenge Test ◽  
Serum Levels ◽  
Cromolyn Sodium ◽  
Base Line ◽  
Double Blind Study ◽  
Office Visits ◽  
Double Blind ◽  
Treatment Groups ◽  
Asthma In Children

The effectiveness of cromolyn sodium and theophylline on asthma in children was compared during a 3-month trial. Forty-six children (aged 5 to 15 years) with asthma were assigned at random to cromolyn or theophylline (Theo-Dur) treatment groups. Each subject received theophylline placebo or cromolyn placebo in addition to the active drugs. A methacholine challenge test was done at the start of the study to document asthma and was repeated during the third month. The theophylline dosage was regulated to obtain serum levels of 10 to 15 µg/mL by a physician not involved directly with patient care. Forty patients completed the study. Both theophylline and cromolyn treatment groups showed improvement from base-line status in terms of symptom scores, pulmonary function, and decreased use of inhaled albuterol. Patients treated with theophylline had more side effects and required more frequent office visits than those treated with cromolyn. Both groups had decreased sensitivity to methacholine, and for one statistical test patients treated with cromolyn improved significantly. These results indicate that cromolyn is as effective as theophylline in treating mild to moderate asthma in children; additional benefits were fewer side effects and a possible decrease in bronchial hyperactivity.

The Initiation of Long-Term Pharmacotherapy in Schizophrenia: Dosage and Side Effect Comparisons Between Oral and Depot Fluphenazine*

1976 ◽  
Vol 09 (04) ◽  
pp. 159-169 ◽  
Author(s):  
Nina R. Schooler ◽  
J. Levine ◽  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Dosage Forms ◽  
The Other ◽  
Oral Drug ◽  
Double Blind ◽  
Moderate Severity ◽  
Treatment Groups ◽  
The Relationship

SummaryThis report focuses on two comparisons between oral and depot fluphenazine specifically FPZ decanoate: 1) can equivalent dosages for the two drugs be established and do these equivalencies change over six months of treatment; 2) what are the side effects seen with the two drugs during the early weeks of administration.Patients in the study receive either oral or depot FPZ as the active treatment but in order to preserve double blind conditions, they are also given the other treatment in placebo form. No dosage equivalence is established by the protocol, however, if dosage is adjusted, both forms must be changed and in the same direction. During the first weeks of treatment there is a linear relationship between the two dosage forms but a range of relatively low dosages of the oral compound (5-20 mg) is associated with a single dose (25 mg/q 3 weeks) of FPZ decanoate. At higher dosages of the oral drug the relationship is linear. Side effects of some kind are noted in over 60 percent of patients in both treatment groups after four weeks of treatment, while symptoms of at least moderate severity occur in almost 40 percent. Only symptoms involving the extrapyramidal system and sleep disturbance are observed in more than 20 percent of the patients. Benztropine was prescribed only if needed and was administered to 65 percent of patients. In general, those receiving benztropine had more side effects than those who did not. These differences reached significance for extrapyramidal symptoms and depression.Based on these data, we conclude that at the dosages used in this study there are no side effect differences between these two forms of fluphenazine in the early weeks of administration. Dosage equivalence between the two drugs can be set within the range of 5- 60 mg/day oral and 12.5-100 mg/three weeks depot.

Metoprolol and Pizotifen in The Prophylactic Treatment of Classical and Common Migraine. A Double-Blind Investigation

Cephalalgia ◽  
1985 ◽  
Vol 5 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Steinar Vilming ◽  
Brit Standnes ◽  
Christer Hedman
Keyword(s):  
Weight Gain ◽  
Side Effects ◽  
Prophylactic Treatment ◽  
Double Blind ◽  
Major Drawback ◽  
Serotonin Antagonist ◽  
Beta Adrenoceptor ◽  
Adrenoceptor Antagonist ◽  
Significant Difference

The prophylactic anti-migraine effect of the serotonin antagonist pizotifen and the beta1-selective beta-adrenoceptor antagonist metoprolol was compared in a double-blind cross-over study. The dosage of pizotifen was 0.5 mg t.i.d. and that of metoprolol 50 mg b.i.d. Thirty-five patients with classical or common migraine were included in the investigation. Five patients withdrew during the course of the study; four because of side effects (three on pizotifen, one on metoprolol) and one because of unassociated illness. The results show that there was no statistically significant difference in efficacy between metoprolol and pizotifen. The tolerance, especially regarding weight gain, was the major drawback with pizotifen, while metoprolol was generally well tolerated.

scholarly journals Rhodomyrtone as a New Natural Antibiotic Isolated from Rhodomyrtus tomentosa Leaf Extract: A Clinical Application in the Management of Acne Vulgaris

Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 108
Author(s):  
Suttiwan Wunnoo ◽  
Siwaporn Bilhman ◽  
Thanaporn Amnuaikit ◽  
Julalak C. Ontong ◽  
Sudarshan Singh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Clinical Assessment ◽  
Leaf Extract ◽  
Acne Vulgaris ◽  
Treated Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Rhodomyrtus Tomentosa

Rhodomyrtone, a plant-derived principal compound isolated from Rhodomyrtus tomentosa (Myrtaceae) leaf extract, was assessed as a potential natural alternative for the treatment of acne vulgaris. The clinical efficacy of a 1% liposomal encapsulated rhodomyrtone serum was compared with a marketed 1% clindamycin gel. In a randomized and double-blind controlled clinical trial, 60 volunteers with mild to moderate acne severity were assigned to two groups: rhodomyrtone serum and clindamycin gel. The volunteers were instructed to apply the samples to acne lesions on their faces twice daily. A significant reduction in the total numbers of acne lesions was demonstrated in both treatment groups between week 2 and 8 (p < 0.05). Significant differences in acne numbers compared with the baseline were evidenced at week 2 onwards (p < 0.05). At the end of the clinical trial, the total inflamed acne counts in the 1% rhodomyrtone serum group were significantly reduced by 36.36%, comparable to 34.70% in the clindamycin-treated group (p < 0.05). Furthermore, a commercial prototype was developed, and a clinical assessment of 45 volunteers was performed. After application of the commercial prototype for 1 week, 68.89% and 28.89% of volunteers demonstrated complete and improved inflammatory acne, respectively. All of the subjects presented no signs of irritation or side effects during the treatment. Most of the volunteers (71.11%) indicated that they were very satisfied. Rhodomyrtone serum was demonstrated to be effective and safe for the treatment of inflammatory acne lesions.

A Double-Blind, Multicentre Study of Paroxetine and Maprotiline in Major Depression

1996 ◽  
Vol 41 (4) ◽  
pp. 239-244 ◽  
Author(s):  
Ulrich Schnyder ◽  
Annemarie Koller-Leiser
Keyword(s):  
Side Effects ◽  
Major Depression ◽  
Rating Scale ◽  
Similar Efficacy ◽  
Nonsignificant Trend ◽  
Double Blind ◽  
Treatment Groups ◽  
Hopkins Symptom Checklist ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

Objective: This study was performed to compare the clinical efficacy, side effects, and safety of paroxetine and maprotiline, the latter being the most frequently prescribed antidepressant in Switzerland. Method: Seventy-one patients (in and outpatients) with major depression were randomly allocated to treatment with paroxetine (20 to 40 mg daily) or with maprotiline (50 to 150 mg daily). Efficacy was measured by means of the Hamilton Psychiatric Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale, the Clinical Global Impression, and the Hopkins Symptom Checklist. Results: The 2 components showed a similar efficacy. The adverse effect profile was comparable in the 2 treatment groups, although the findings showed a nonsignificant trend pointing in the direction of lower side effects with paroxetine. Conclusion: In the moderate dose regimens tested, the 2 components seemed to be of similar efficacy, with comparable profiles of side effects and safety.

Diftalone: A New Non-Steroidal Anti-Inflammatory Agent: Comparative Study with Phenylbutazone in the Treatment of Rheumatoid Arthritis

1977 ◽  
Vol 5 (1) ◽  
pp. 18-25 ◽  
Author(s):  
F Chalem ◽  
P Farias ◽  
H Lizarazo ◽  
P Peña
Keyword(s):  
Rheumatoid Arthritis ◽  
Side Effects ◽  
Comparative Study ◽  
Clinical Improvement ◽  
Laboratory Tests ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Inflammatory Agent ◽  
Anti Inflammatory

A double-blind study was carried out to compare the effectiveness and tolerability of diftalone and phenylbutazone in thirty patients with classical or definite rheumatoid arthritis, randomly distributed between the two treatment groups. Both drugs were administered according to a progressively decreasing daily dosage schedule: 1,000 mg during the 1st week; 750 mg the 2nd week and 500 mg from the 3rd week on for diftalone; 400 mg, 300 mg, and 200 mg daily for the 1st, 2nd and from the 3rd week on respectively for phenylbutazone. The study lasted twelve weeks. The clinical controls and laboratory tests were performed weekly up to the 8th week, while the final evaluation was made at the end of the 3rd month. Twelve patients in the group receiving diftalone and fourteen in the phenylbutazone group completed the trial. Clinical improvement was observed in both groups. Effectiveness was somewhat more evident in the diftalone group. Tolerability was acceptable for both drugs, although the diftalone patients showed less frequent and intense side-effects than those treated with phyenylbutazone. No significant differences were found as regards the laboratory parameters, except a significant fall of the E.S.R. (p < 0·05) in the diftalone group. Diftalone seems to be an effective and safe anti-inflammatory agent in the treatment of rheumatoid arthritis.

Metoprolol v. Clonidine in The Prophylactic Treatment of Migraine

Cephalalgia ◽  
1985 ◽  
Vol 5 (3) ◽  
pp. 159-165 ◽  
Author(s):  
P Louis ◽  
J Schoenen ◽  
C Hedman
Keyword(s):  
Side Effects ◽  
Prophylactic Treatment ◽  
Prophylactic Effect ◽  
Attack Frequency ◽  
Double Blind ◽  
Entire Study ◽  
Adrenoceptor Antagonist ◽  
Intensity Score

In a double-blind, cross-over trial, the migraine prophylactic effect of the b1-adrenoceptor antagonist metoprolol was compared with that of clonidine. The dosage of metoprolol was 50 mg b.i.d. and of clonidine 50 üg b.i.d. Thirty-one patients were included; twenty-three completed the entire study. Six patients withdrew during clonidine treatment, one during metoprolol treatment and one during the wash-out period (placebo). Metoprolol had a significantly better migraine prophylactic effect than clonidine regarding such parameters as the attack frequency, the number of migraine days and the sum of intensity score. Compared to baseline (placebo), metoprolol decreased these parameters, while clonidine did not. Metoprolol, but not clonidine, also. reduced the acute consumption of analgesics. No differences were found as regards side effects.

Oral naltrexone to enhance analgesia in patients receiving continuous intrathecal morphine for chronic pain: A randomized, double-blind, prospective pilot study

2007 ◽  
Vol 3 (3) ◽  
pp. 137 ◽  
Author(s):  
Scott Hamann, PhD, MD ◽  
Paul Sloan, MD
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Pain Intensity ◽  
Intrathecal Morphine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment Groups ◽  
Pain Scores ◽  
Oral Naltrexone ◽  
Group A

Background: Years’ worth of observations suggest that morphine has both inhibitory and excitatory actions, and that selective blockade of excitatory effects by low doses of opioid antagonists (e.g., naltrexone) may paradoxically enhance morphine analgesia. The purpose of this pilot study was to evaluate and compare the analgesic efficacy and safety of two different low doses of oral naltrexone given in addition to chronic intrathecal morphine infusions in patients with chronic nonmalignant pain (CNMP).Methods: After institutional review board approval, 15patients with CNMP receiving continuous intrathecal morphine were admitted into a prospective, randomized, double-blind, placebo-controlled, seven-day pilot study. Patients were randomized into three treatment groups based on oral naltrexone dose: 100 gg (Group A, n = 3), 10 gg (Group B, n = 7), or placebo (Group C, n = 5). All patients continued with their constant intrathecal morphine infusion, and in addition they received one capsule of study medication every 12 hours for seven days. Other analgesics or coanalgesics were kept at a constant dose level throughout the study. Patients rated pain scores (visual analogue score [VAS]; 0 = no pain, 10 = worst pain imaginable) and side effects three times daily throughout the study period. Efficacy measures included pain intensity difference (PID) scores, constructed so that positive scores indicate a reduction in pain intensity and negative scores indicate a worsening of pain.Results: Fifteen patients (six male, nine female) with a mean (SD) age of 55 (10) years and weight of 81 (21) kg completed the study. The mean (SD) baseline VAS pain intensity rating was similar in all three groups (6.8 [1.5]). Baseline pain VAS score minus the lowest daily pain VAS score yielded the peak PID score. The peak PID score from Day 1 was statistically (p < 0.05) highest (median PID score: 5.9) in Group A compared with Group C. There was a trend in PID scores across Days 2 through 7, with median PID scores higher (i.e., greater pain relief; p = 0.07) in Group A. In the daily global pain assessments, the pain scores across Days 2 through 7 approached significance (leastpain) in Group A compared to Group C (p = 0.07) or B (p = 0.08). Side effects were common (93 percent of patients), minor (headache, nausea, sedation, dry mouth), and similar across treatment groups. No serious adverse events were observed, and no evidence of opioid withdrawal was seen.Conclusions: 1) Patients with chronic pain who received oral naltrexone 100 gg BID in addition to their chronic intrathecal morphine infusions demonstrated the greatest improvement (p = 0.07) in their daily pain scores. Because of the small sample size, the results did not reach traditional levels of significance. 2) Side effects were common, minor, and similar across treatment groups. 3) No serious adverse events were recorded. 4) No evidence of opioid antagonist toxicity or opioid withdrawal was observed.

A Comparative Study Of Oral Acetylsalicyclic Acid and Metoprolol for the Prophylactic Treatment of Migraine. A Randomized, Controlled, Double-Blind, Parallel Group Phase III Study

Cephalalgia ◽  
2001 ◽  
Vol 21 (2) ◽  
pp. 120-128 ◽  
Author(s):  
HC Diener ◽  
E Hartung ◽  
J Chrubasik ◽  
S Evers ◽  
J Schoenen ◽  
...  
Keyword(s):  
Prophylactic Treatment ◽  
Phase Iii ◽  
Median Frequency ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Phase Iii Study ◽  
Responder Criterion

This study was a multinational, multicentre, double-blind, active controlled phase III trial designed to investigate efficacy and safety of 300 mg acetylsalicyclic acid (ASA) ( n = 135) vs. 200 mg metoprolol ( n = 135) in the prophylaxis of migraine. In total 270 (51 male and 219 female) patients, aged 18–65 years, suffering between two and six migraine attacks per month were recruited. The main objective was to show equivalence with respect to efficacy, defined as a 50% reduction in the rate of migraine attacks. A run-in phase was carried out with placebo for 4 weeks, followed by a 16-week drug phase. In both treatment groups the median frequency of migraine attacks improved during the study period, from three to two in the ASA group and from three to one in the metoprolol group; 45.2% of all metoprolol patients were responders compared with 29.6% with ASA. Medication-related adverse events were less frequent in the ASA group (37) than in the metoprolol group (73). The findings from this trial show that metoprolol is superior to ASA for migraine prophylaxis but has more side-effects. Acetylsalicylic acid is better tolerated than metoprolol. Using a strict responder criterion ASA showed a responder rate comparable with the placebo rate in the literature.

Effectiveness and Tolerance of the Hypericum Extract LI 160 in Comparison with Imipramine: Randomized Double-Blind Study with 135 Outpatients

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 19-23 ◽  
Author(s):  
E.-U. Vorbach ◽  
W.-D. Hübner ◽  
K.-H. Arnoldt
Keyword(s):  
Side Effects ◽  
Depression Scale ◽  
Adjustment Disorder ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Single Episode ◽  
Treatment Groups ◽  
Safety Parameters ◽  
Hypericum Extract

In a double-blind comparative study, 135 depressed patients were treated in 20 centers. Inclusion diagnoses were typical depressions with single episode (296.2), several episodes (296.3), depressive neurosis (300.4), and adjustment disorder with depressed mood (309.0) in accordance with DSM-III-R. The dosage was 3 x 300 mg hypericum extract LI 160 or 3 x 25 mg imipramine daily. The treatment lasted for 6 weeks. Main assessment criteria were the Hamilton Depression Scale (HAMD), the Depression Scale according to von Zerssen (D-S) and the Clinical Global Impressions (CGI). In both treatment groups, a parallel reduction of the Hamilton score from 20.2 to 8.8 (LI 160, n = 67) or from 19.4 to 10.7 (imipramine, n = 68), and the transformed D-S point values from 39.6 to 27.2 (LI 160) and 39.0 to 29.2 (imipramine) were found. The analysis of CGI revealed comparable results in both treatment groups. Clinically relevant changes of the safety parameters were not found. In the LI 160 group fewer and milder side effects were found as compared to imipramine.

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