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.

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.

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.

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.

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.

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.

Trimethoprim/Sulfamethoxazole and Ampicillin in the Treatment of Acute Urinary Tract Infections in Children: A Double-Blind Study

PEDIATRICS ◽  
1977 ◽  
Vol 60 (2) ◽  
pp. 245-247
Author(s):  
N. S. Ellerstein ◽  
T. D. Sullivan ◽  
T. Baliah ◽  
E. Neter
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Side Effects ◽  
Tract Infection ◽  
Urinary Tract Infections ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Tract Infections ◽  
Acute Urinary Tract Infection

Trimethoprim/sulfamethoxazole and ampicillin therapy in children with acute urinary tract infection, whose microorganisms were susceptible to both drugs, proved to be of similar effectiveness. Side effects did not differ significantly between the two treatment groups.

scholarly journals Comparative efficacy of placebos in short-term antidepressant trials for major depression: a secondary meta-analysis of placebo-controlled trials

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lisa Holper ◽  
Michael P. Hengartner
Keyword(s):  
Side Effects ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Antidepressant Drugs ◽  
Depression Scale ◽  
Drug Efficacy ◽  
Controlled Trials ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Insignificant Correlation

Abstract Background The issue of unblinded outcome-assessors and patients has repeatedly been stressed as a flaw in allegedly double-blind antidepressant trials. Unblinding bias can for example result from a drug‘s marked side effects. If such unblinding bias is present for a given drug, then it might be expected that the placebos of that drug are rated significantly less effective than that of other antidepressants. Methods To test this hypothesis, the present exploratory analysis conducted a Bayesian network meta-analysis (NMA) comparing the efficacy of 19 different placebos in placebo-controlled trials provided in the dataset by Cipriani et al. (Lancet 2018; 391: 1357–66). Primary outcome was efficacy (continuous) estimated on the standardized mean difference (SMD) scale and defined as the pre-post change on the Hamilton Depression scale (HAMD-17), on which information was available in N = 258 trials. Results Comparative placebo ranking suggested mirtazapine-placebo (SMD -2.0 [− 5.0–1.0 95% CrI]) to be the most, and amitriptyline- (SMD 1.2 [− 1.6–3.9 95% CrI]) and trazodone- (SMD 2.1 [− 0.9–5.2 95% CrI]) placebos to be the least effective placebos. Other placebos suggested to be more effective than amitriptyline- and trazodone-placebos (based on 95% CrIs excluding zero) were citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, and venlafaxine placebos. These NMA results were corroborated by the observation that the relative efficacy between drug and placebo was considerably larger for amitriptyline and trazodone than for instance mirtazapine, duloxetine, and venlafaxine, supported by a small and insignificant correlation between drug-efficacy and placebo-efficacy (r = − 0.202, p = 0.408). Discussion The present exploratory NMA indicates that distinguishable side effects of older drugs may unblind outcome-assessors thus resulting in overestimation of the average drug-placebo difference and underrating bias in placebo-arms, particularly for the older antidepressant drugs amitriptyline and trazodone. If confirmed in prospective studies, these findings suggest that efficacy rankings for antidepressants are susceptible to bias and should be considered unreliable or misleading. The analysis is limited by the focus on the single-comparison placebos (76%, i.e., placebos assessed in two-arm trials), since double-comparison placebos (25%, i.e., placebos assessed in three-arm trials) are hard to interpret and therefore not included in the present interpretation. Another limitation is the problem of multiplicity, which was only approximately accounted for in the Bayesian NMA by modelling treatment effects as exchangeable.

Moclobemide in Elderly Patients with Cognitive Decline and Depression: An International Double-blind, Placebo-controlled Trial

1996 ◽  
Vol 168 (2) ◽  
pp. 149-157 ◽  
Author(s):  
M. Roth ◽  
C. Q. Mountjoy ◽  
R. Amrein ◽  
Keyword(s):  
Cognitive Function ◽  
Major Depression ◽  
Elderly Patients ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Depression Scale ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Diagnosis Of Dementia

BackgroundThe new reversible MAOI moclobemide was compared with placebo in the treatment of elderly patients with DSM–III diagnosis of dementia and/or of major depression.MethodSix hundred and ninety-four elderly patients with symptoms of depression and cognitive decline entered an international, multi-centre, double blind trial in which they were randomly allocated to treatment with either moclobemide 400 mg daily or placebo for 42 days. Five hundred and eleven patients met DSM–III criteria for dementia and were also depressed (DEM+D); 183 did not meet DSM–III criteria for dementia but met the criteria for DSM–III major depressive episode and also suffered from cognitive decline (MDE+CD).ResultsAnalysis of the 17 and 24-item Hamilton Depression Scale scores showed that moclobemide, compared with placebo, produced significantly greater improvement in both the demented and depressed groups (P= 0.001 both diagnostic groups). There was an improvement in cognitive function as measured by the SCAG Factor 1 in moclobemide treated patients (P= 0.005 DEM+D;P= 0.02 MDE+CD). There was no evidence of decline in cognitive function as the result of treatment Clinical global assessment of tolerance was ‘excellent’ and ‘good’ in 88% of the moclobemide and in 92% of the placebo treated patients. The proportion of patients discontinuing treatment prematurely was similar in both treatment groups. There were no significant differences in side-effects between treatment groups. There were no significant changes in vital signs, ECG or laboratory findings in either treatment group. There were no dietary restrictions and no report of any tyramine reaction.ConclusionsMoclobemide was shown to be a safe, well tolerated and effective antidepressant, which did not cause impairment of cognitive function in elderly patients with a DSM–III diagnosis of dementia and/or DSM–III major depression.

Hypericum Treatment of Mild Depressions with Somatic Symptoms

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 12-14 ◽  
Author(s):  
W.-D. Hübner ◽  
S. Lande ◽  
H. Podzuweit
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Active Treatment ◽  
Somatic Symptoms ◽  
Active Treatment Group ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Disturbed Sleep ◽  
Hypericum Extract

In a randomized, placebo-controlled, double-blind study, 39 patients with depression with somatic symptoms were treated with hypericum extract LI 160. The therapy lasted for 4 weeks; the dosage was 300 mg three times daily. At the onset of the study as well as after 2 and 4 weeks, the following criteria were analyzed: HAMD, B-L, CGI, and vegetative symptoms. The results show a significant improvement in the active treatment group at the 5% level as compared to placebo. Seventy percent of the patients treated with LI 160 were free of symptoms after 4 weeks. Typical symptoms of the depression such as lack of activity, tiredness, fatigue, and disturbed sleep, were especially responsive. In no case were any undesirable side effects observed.

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