Effectiveness and Tolerance of the Hypericum Extract LI 160 Compared to Maprotiline: A Multicenter Double-Blind Study

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 24-28 ◽  
Author(s):  
G. Harrer ◽  
W.-D. Hübner ◽  
H. Podzuweit
Keyword(s):  
Depression Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Mean Values ◽  
Mouth Dryness ◽  
Treatment Groups ◽  
Icd 10 ◽  
Hypericum Extract

A randomized, double-blind study examining the effectiveness and tolerance of a standardized hypericum preparation when compared to maprotiline was performed in a group of 102 patients with depression, in accordance with ICD-10, F 32.1. The study was conducted in the offices of neurology and psychiatry specialists. The patients received, over a period of 4 weeks, either 3 x 300 mg of the hypericum extract or 3 x 25 mg maprotiline pills of identical appearance. Effectiveness was determined using the Hamilton Depression Scale (HAMD), the Depression Scale according to von Zerssen (D-S), and the Clinical Global Impression Scale (CGI). The total score of the HAMD scale dropped during the 4 weeks of therapy in both treatment groups by about 50%. The mean values of the D-S scale and the CGI scale showed similar results, and after 4 weeks of therapy, no significant differences in either treatment group were noticed. The onset of the effects occurred up to the second week of treatment, but were observed earlier with maprotiline than with the hypericum extract. On the other hand, maprotiline treatment resulted in more cases of tiredness, mouth dryness, and heart complaints.

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.

Clomipramine HCL — A Double-Blind Study of a New Antidepressant Drug

1973 ◽  
Vol 18 (5) ◽  
pp. 403-408 ◽  
Author(s):  
D.J. Mcclure ◽  
G.L. Low ◽  
M. Gent
Keyword(s):  
Antidepressant Drug ◽  
Depression Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Treatment Of Depression ◽  
Before And After ◽  
Anxiety Index

A double-blind study was carried out comparing the antidepressant and anxiolytic properties of clomipramine HCL (a new antidepressant) and imipramine on a group of 24 subjects suffering from psychotic depression. The patients were divided into two groups of twelve by random sampling. Clinical assessments were made by two independent psychiatrists using the Hamilton Depression Scale and the Beck Depression Inventory, and also by a psychologist using the Welsh Anxiety Index of the MMPI and IPAT scales. The assessments were carried out one day prior to treatment and on the 5th, 10th, 15th, 22nd and 44th day after treatment commenced. Clomipramine HCL was found to be as effective as imipramine in the treatment of depression, and it also showed similar anxiolytic properties. There were no significant changes in the laboratory tests carried out before and after the treatment program was completed in both treatment groups.

Placebo-Controlled Double-Blind Study Examining the Effectiveness of an Hypericum Preparation in 105 Mildly Depressed Patients

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 9-11 ◽  
Author(s):  
H. Sommer ◽  
G. Harrer
Keyword(s):  
Placebo Group ◽  
Depression Scale ◽  
Blind Study ◽  
Active Group ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Group 13 ◽  
The Difference ◽  
Hypericum Extract

One hundred and five outpatients with mild depressions of short duration were treated in a double-blind study with either 3 x 300 mg hypericum extract or placebo. The therapy phase was 4 weeks. The effectiveness was judged according to the Hamilton Depression Scale after 2 and 4 weeks. The values of the mean basic score in these periods fell from 15.8 to 9.6 or 7.2 in the active group, and in the placebo group, from 15.8 to 12.3 and 11.3. The difference between active and placebo groups were statistically significant with P < .05 and P < .01 achieved after 2 and 4 weeks, respectively. In the active group, 28 of 42 patients (67%) and, in the placebo group, 13 of 47 Patients (28%) responded to treatment. Notable side effects were not found.

The treatment of depression in general practice: a comparison of L-tryptophan, amitriptyline, and a combination of L-tryptophan and amitriptyline with placebo

1982 ◽  
Vol 12 (4) ◽  
pp. 741-751 ◽  
Author(s):  
Joan Thomson ◽  
H. Rankin ◽  
G. W. Ashcroft ◽  
Celia M. Yates ◽  
Judith K. McQueen ◽  
...  
Keyword(s):  
Depression Scale ◽  
Double Blind Study ◽  
Global Rating ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Plasma Tryptophan ◽  
Treatment Of Depression ◽  
Biochemical Profiles ◽  
The Difference

SynopsisOne hundred and fifteen patients from 5 general practices participated in a 12-week, double-blind study comparing L-tryptophan, amitriptyline, L-tryptophan–amitriptyline combination and placebo in the treatment of depression. Analysis of total score on the Hamilton Depression Scale and a global rating of depression showed that all 3 active treatments were more effective than placebo. Significantly more patients were withdrawn as treatment failures in the placebo group compared with the active treatment groups. Side-effects necessitated withdrawal of more patients from the amitriptyline group than from the other active tratment groups, but this difference was not significant. Plasma amitriptyline and nortriptyline levels were similar in the difference was not significant. Plasma amitriptyline and nortriptyline and biochemical profiles did not alter significantly in any group, but mean heart rate was significantly increased in patients receiving amitriptyline. There was no change in free or total plasma tryptophan concentration with treatment or on remission of symptoms.

A Comparative Clinical Trial of Diflunisal and Ibuprofen in the Control of Pain in Osteoarthritis

1979 ◽  
Vol 7 (4) ◽  
pp. 272-276 ◽  
Author(s):  
J G M Keet
Keyword(s):  
Clinical Trial ◽  
Blind Study ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Comparative Clinical Trial ◽  
Treatment Groups ◽  
Ambulatory Patients ◽  
Efficacy Parameters ◽  
Osteoarthritis Of Hip

A randomized double-blind study in ambulatory patients with osteoarthritis of hip and/or knee was conducted, comparing the efficacy and safety of diflunisal 500 mg daily with ibuprofen 1200 mg daily, over a period of 8 weeks. Thirty-five patients participated in the study. The results revealed no significant differences between the treatment groups with regard to the efficacy parameters.

Comparison of Diflorasone Diacetate and Betamethasone Dipropionate Ointment in the Treatment of Psoriasis

1982 ◽  
Vol 10 (1) ◽  
pp. 22-27 ◽  
Author(s):  
Eugene Leibsohn
Keyword(s):  
Betamethasone Dipropionate ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Clinical Evaluations ◽  
Lesion Severity

In this double-blind study, 100 patients with mild, moderate, or severe thick lesion psoriasis, characterized as acute, subacute, or chronic, were treated with either diflorasone diacetate ointment 0.05% or betamethasone dipropionate ointment 0.05% twice a day for 3 weeks. Clinical evaluations were based on overall improvement and improvement in signs or symptoms of erythema, oedema, lichenification, induration, scaliness, excoriations, pruritus, and soreness. Results showed that both medications were effective and when patients were categorized according to initial lesion severity, no statistically significant differences existed between treatment groups.

scholarly journals Ertapenem Once a Day Versus Piperacillin–Tazobactam Every 6 Hours for Treatment of Acute Pelvic Infections: A Prospective, Multicenter, Randomized, Double-Blind Study

2003 ◽  
Vol 11 (1) ◽  
pp. 27-37 ◽  
Author(s):  
Subir Roy ◽  
Iliana Higareda ◽  
Edith Angel-Muller ◽  
Mahmoud Ismail ◽  
Caren Hague ◽  
...  
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Primary Efficacy ◽  
Pelvic Infection ◽  
Double Blind ◽  
Treatment Groups ◽  
Duration Of Therapy ◽  
The Difference ◽  
Cure Rates ◽  
Post Therapy

Objective:To compare ertapenem therapy with piperacillin–tazobactam therapy for the management of acute pelvic infections.Methods:In a multicenter, double-blind study, 412 women with acute pelvic infection were assigned to one of two strata, namely obstetric/postpartum infection or gynecologic/postoperative infection, and were then randomized to ertapenem, 1 g once a day, or piperacillin–tazobactam, 3.375 g every 6 hours, both administered intravenously.Results:In total, 163 patients in the ertapenem group and 153 patients in the piperacillin–tazobactam group were clinically evaluable. The median duration of therapy was 4.0 days in both treatment groups. The most common single pathogen wasEscherichia coli. At the primary efficacy endpoint 2–4 weeks post therapy, 93.9% of patients who received ertapenem and 91.5% of those who received piperacillin–tazobactam were cured (95% confidence interval for the difference, adjusting for strata, –4% to 8.8%), indicating that cure rates for both treatment groups were equivalent. Cure rates for both treatment groups were also similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both groups.Conclusions:In this study, ertapenem was as effective as piperacillin–tazobactam for the treatment of acute pelvic infection, was generally well tolerated, and had an overall safety profile similar to that of piperacillin–tazobactam.

Effects of Hypericum Extract LI 160 Compared with Maprotiline on Resting EEG and Evoked Potentials in 24 Volunteers

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 44-46 ◽  
Author(s):  
D. Johnson ◽  
H. Ksciuk ◽  
H. Woelk ◽  
E. Sauerwein-Giese ◽  
A. Frauendorf
Keyword(s):  
Evoked Potentials ◽  
Healthy Volunteers ◽  
Cognitive Functions ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Acoustic Evoked Potentials ◽  
Hypericum Extract

In a randomized double-blind study, the effect of hypericum extract was compared to that of maprotiline in 24 healthy volunteers. The investigations included measurements of resting EEG as well as visual and acoustic evoked potentials. In resting EEGs, both medications revealed oppositely directed changes in the theta frequencies, and mainly similarly directed changes in alpha and beta frequencies. Measurements of evoked potentials in the theta and beta frequencies supported these results. The results indicate improved cognitive functions mainly with the treatment of hypericum extract.

Prevention and Therapy of Serous Otitis Media by Oral Decongestant: A Double-Blind Study in Pediatric Practice

PEDIATRICS ◽  
1978 ◽  
Vol 61 (5) ◽  
pp. 679-684 ◽  
Author(s):  
Ardis L. Olson ◽  
Suzanne W. Klein ◽  
Evan Charney ◽  
James B. MacWhinney ◽  
Thomas K. McInerny ◽  
...  
Keyword(s):  
Otitis Media ◽  
Clinical Evaluation ◽  
Acute Otitis Media ◽  
Blind Study ◽  
Double Blind Study ◽  
Pediatric Practice ◽  
Double Blind ◽  
Treatment Groups ◽  
Serous Otitis Media ◽  
Prevention And Therapy

We studied the efficacy of (1) preventing the development of serous otitis media (SOM) by using an oral decongestant in children with acute otitis media and (2) treating SOM with an oral decongestant. In a randomized double-blind study, 190 children were treated for acute otitis media with antibiotics and either pseudoephedrine hydrochloride (Sudafed) or placebo. They were evaluated two weeks later by tympanometry and (independently) by clinical evaluation and pneumotoscopy. There were no significant differences between the two groups, except that males developed SOM significantly more often than did females. Use of decongestant and placebo was continued in 78 patients with SOM for up to four more weeks. Again, there were no significant differences between the treatment groups except that patients with an allergic history did significantly worse using a decongestant. Overall there was no benefit from pseudoephedrine in either the prevention or treatment of SOM.

A Comparative Clinical Trial of Fenbufen and Indomethacin in Patients with Rheumatoid Arthritis

1976 ◽  
Vol 4 (6) ◽  
pp. 418-426 ◽  
Author(s):  
J M Vergara-Castro ◽  
L F Arias ◽  
B P Greenberg
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Crossover Trial ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Physical Measurements ◽  
Rheumatoid Arthritis Activity ◽  
Single Blind

A 12-week double-blind crossover trial compared fenbufen and indomethacin in 40 patients with rheumatoid arthritis. Fenbufen (600-800 mg/day) was significantly superior to indomethacin (75-100 mg/day) in improving the physical measurements of rheumatoid arthritis activity. Twenty-four patients who demonstrated marked or moderate improvement in the double-blind study participated in a 14-week single-blind study. After one week on placebo, patients received either fenbufen once a day at bedtime, fenbufen twice a day, or indomethacin three times a day for 12 weeks, followed by 2 weeks of placebo. All three treatment groups demonstrated significant improvement. The two fenbufen groups were significantly superior to indomethacin in improving the physical measurements of rheumatoid arthritis activity. No significant differences were found between the two fenbufen treatment groups. Drug-related side-effects reported during both studies were significantly ewer with fenbufen than with indomethacin.

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