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

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.

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 24-28 ◽  
Author(s):  
G. Harrer ◽  
W.-D. Hübner ◽  
H. Podzuweit

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.


1982 ◽  
Vol 12 (4) ◽  
pp. 741-751 ◽  
Author(s):  
Joan Thomson ◽  
H. Rankin ◽  
G. W. Ashcroft ◽  
Celia M. Yates ◽  
Judith K. McQueen ◽  
...  

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.


1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 19-23 ◽  
Author(s):  
E.-U. Vorbach ◽  
W.-D. Hübner ◽  
K.-H. Arnoldt

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.


1973 ◽  
Vol 18 (5) ◽  
pp. 403-408 ◽  
Author(s):  
D.J. Mcclure ◽  
G.L. Low ◽  
M. Gent

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.


1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 15-18 ◽  
Author(s):  
K.-D. Hänsgen ◽  
J. Vesper ◽  
M. Ploch

Seventy-two depressive patients of 11 physicians’ practices were treated in a double-blind study for a period of 6 weeks either with hypericum extract LI 160 or with placebo. Inclusion criterion was a major depression in accordance with DSM-III-R. The changes were assessed using four psychometric scales (HAMD, D-S, BEB, CGI). After 4 weeks of therapy, the statistical evaluation revealed a significant improvement in all four psychometric tests in the active group as compared to the placebo group. After switching the placebo group to active treatment (5th to 6th week of therapy), significant improvements were found in the original placebo group. No serious side effects were observed.


1989 ◽  
Vol 17 (1) ◽  
pp. 24-27 ◽  
Author(s):  
L. Ghys ◽  
J.-P. Rihoux

In a double-blind study performed in 81 healthy volunteers, 10 mg cetirizine and 60 mg terfenadine given orally in a single administration significantly inhibited skin reactivity to histamine. Astemizole (10 mg) was completely ineffective. The inhibitory effect of cetirizine was potent and regular whereas 6/28 (21%) volunteers did not respond to terfenadine. The difference observed beween cetirizine and terfenadine might be due to differences in the metabolism of the two drugs after administration: terfenadine is rapidly and extensively metabolized whereas cetirizine is directly active without the need for biotransformation and, indeed is poorly metabolized.


1994 ◽  
Vol 83 (04) ◽  
pp. 202-204 ◽  
Author(s):  
A. Rafferty ◽  
S. Kayne

AbstractIn a pilot double blind study carried out in Scotland, the effect of supplementing a conventional treatment plan with homoeopathic Arsenicum album was studied. In the management of neonatal calf scour it appeared that more animals recovered after one day in the group that had received active medicine, than in the placebo group. These results are encouraging.


1986 ◽  
Vol 95 (1) ◽  
pp. 32-35 ◽  
Author(s):  
Jens Thomsen ◽  
Mirko Tos ◽  
Poul Bretlau ◽  
Niels Jon Johnsen

The reason for the effectiveness of endolymphatic sac-mastoid shunt surgery in the treatment of patients with Meniere's disease is still open for debate. In a double-blind study, published in 1981, we could not demonstrate any difference between the effect of a simple mastoidectomy and a regular endolymphatic sac-mastoid Silastic sheet shunt. However, a significant reduction in symptoms could be demonstrated in both groups, and 70% of patients in both groups could be classified as successes. The patients were reexamined 3 years after surgery, and it was still not possible to demonstrate any differences between the sham and the active surgery. In this study, no significant differences between the two groups have been found at follow-up averaging 84 months, and success has been maintained in about 70% of patients. The only three failures, who have consistent vertiginous attacks, have been confined to the actual shunt group. Two patients in the active group have lost their hearing as compared with none in the sham group, and 35% of the patients have now developed bilateral disease. We believe that endolymphatic sac-mastoid shunt surgery is a nonspecific treatment modality, and we find no need for sac shunt surgery. The vast majority of the patients can be successfully treated by nonsurgical means, but we emphasize that above all the patient must be assured that in the event of persistent debilitating symptoms, a surgical solution to the problem is available.


2021 ◽  
Vol 12 ◽  
Author(s):  
Jiaojiao Zhou ◽  
Xu Chen ◽  
Le Xiao ◽  
Jingjing Zhou ◽  
Lei Feng ◽  
...  

Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the efficacy and safety of duloxetine with C. militaris in improving sleep symptoms in patients with depression.Methods: This study was a single-center, randomized, double-blind, placebo-controlled study that recruited outpatients admitted to Beijing Anding hospital from January 2018 to January 2019. Major depressive disorder (MDD) with insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and Mini-International Neuropsychiatric Interview (M.I.N.I.). Eligible subjects will be randomly assigned to two treatment groups in a 1:1 ratio, and receive treatment and follow-up of about 6 weeks of duloxetine plus Cordyceps militaris or placebo, respectively. The severity of depression and insomnia was evaluated at baseline and at 1, 2, 4, and 6 weeks using the 17-item Hamilton Depression Scale (HAMD-17) and Athens Insomnia Scale (AIS).Results: A total of 59 subjects were included in the study (31 in the placebo group and 28 in the C. militaris group). 11 (18.6%) participants withdrew during the study period, 5 (17.9%) in the C. militaris group, and 6 (19.3%) in the placebo group. Depressive and sleep symptoms in all patients reduced over time. We found that the total scores of AIS and its subscales decreased more in the placebo group compared to the C. militaris group (p &lt; 0.05). Secondary outcome revealed that there were no significant differences between the two groups in total HAMD-17 and its sleep factor scores (p &gt; 0.05) at 1, 2, 4, and 6 weeks after treatment initiation. The incidences of adverse events were not significantly different between the two groups (all p &gt; 0.05).Conclusion:C. militaris at the current dose and duration did not improve sleep symptoms in patients with depression, but it is safe with rare side effects.


1990 ◽  
Vol 73 (3) ◽  
pp. 383-386 ◽  
Author(s):  
Michel Djindjian ◽  
Elisabeth Lepresle ◽  
Jean-Bernard Homs

✓ The efficacy of oxacillin as a prophylaxis for infection was analyzed in a 27-month randomized double-blind study of 400 patients who had undergone clean neurosurgical interventions lasting longer than 2 hours. Four neurosurgeons took part in the study and 356 patients were eligible for final analysis. Among the 171 patients treated with oxacillin, there was one case of infection (0.6%), compared to nine (4.9%) of the 185 patients given a placebo. The difference between the two groups was statistically significant (p = 0.0398). This study, together with others (randomized or not), clearly demonstrates the efficacy of antibiotic prophylaxis in prolonged clean neurosurgery.


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