Posted by sdb on June 1, 2008, at 9:15:51
In reply to comparism of hypericum studies, posted by sdb on May 31, 2008, at 17:35:24
> > > hypericum update:
> > >
> > > li-160 (called Jarsin in Germany) and ws 5570 (called Neuroplant in Germany) are widely used in the US.
> > >
> > > ZE 117 (called Remotiv in Switzerland) is an exotic extract without hyperforin. not many studies are available but promising single results are evident . it has some metabolic benefits compared to other extracts.
> > >
> > > The newest extract is STW3-VI (called Laif in Germany) with its 900mg 1/d pill that gave good results in some studies.
> > >
> > > The German seem to be still very actively involved in alternative medicine business.
> >
> > there is some data comparing extracts in efficacy of previous studies (unfortunately in German)
> >
> > http://www.phytotherapie-komitee.de/Forschung/kfn_hyperic_281206.pdf
>
> the article
>
> http://www.phytotherapie-komitee.de/Forschung/kfn_hyperic_281206.pdf
>
> is very easy to understand and gives some valuable information about all these studies hypericum/placebo, hypericum/ssri
>
> you only need to understand the Forest-Plot, intervals, weighing and the picture is a llllittle bit clearer.
>
> warm regards
>
> sdb
>
> German understanding could be useful1: Pharmacopsychiatry. 2006 Mar;39(2):66-75.Click here to read Links
Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study.
Gastpar M, Singer A, Zeller K.General Psychiatric Hospital, Department of Psychiatry and Psychotherapy, University of Essen, Essen, Germany. m.gastpar@uni-essen.de
OBJECTIVE: The objective of this double-blind, randomised, placebo-controlled, multicentre clinical study was to demonstrate the non-inferiority and safety of the hypericum extract STW3-VI in a once-daily dosage regime in the treatment of moderate depression. During the 6-week treatment phase, the course of depression was documented by use of HAMD (items 1-17), the von Zerssen's Adjective Mood Scale (BfS) and the CGI scales. The primary objective of this 3-arm design study was to demonstrate the non-inferiority of hypericum extract STW3-VI (900 mg) to the SSRI citalopram (20 mg) and superiority of hypericum over placebo. METHODS: Outpatients (N = 388) suffering from moderate depression were enrolled. The safety and tolerability of hypericum extract in comparison to citalopram and placebo was investigated on the basis of CGI, the occurrence of adverse events and the investigation of laboratory parameters and vital signs. RESULTS: From almost identical baseline values of 21.9 +/- 1.2 points (hypericum extract), 21.8 +/- 1.2 points (citalopram) and 22.0 +/- 1.2 points (placebo), the HAMD score was reduced to 10.3 +/- 6.4 (hypericum extract), 10.3 +/- 6.4 (citalopram) and 13.0 +/- 6.9 (placebo), respectively. Based on this data, the statistical significant therapeutic equivalence of hypericum extract STW3-VI to citalopram (p < 0.0001) and the superiority of this hypericum extract over placebo (p < 0.0001) was demonstrated. At the end of treatment 54.2 % (hypericum extract), 55.9 % (citalopram) and 39.2 % (placebo) of the patients were assessed as therapy responders. The secondary efficacy parameters, change in BfS, CGI and amount of therapy responders showed that the hypericum group was not statistically different from the citalopram group, and significantly superior to the placebo group. Significantly more adverse events with "certain", "probable" or "possible" relation to study medication were documented in the citalopram group (hypericum: 17.2 %, citalopram: 53.2 %, placebo: 30 %). In most cases, the investigators assessed the tolerability of hypericum extract, citalopram and placebo as "good" or "very good". CONCLUSION: The non-inferiority of hypericum extract as compared to citalopram and the superiority of both active compounds to placebo were demonstrated, as well as a better safety and tolerability of hypericum extract in comparison to citalopram. These results revealed that hypericum extract STW3-VI is a good alternative to chemically defined antidepressants in the treatment of outpatients with moderate depression.
PMID: 16555167 [PubMed - indexed for MEDLINE]
Related Articles
* Efficacy and tolerability of hypericum extract STW3 in long-term treatment with a once-daily dosage in comparison with sertraline. [Pharmacopsychiatry. 2005]
* Efficacy and tolerability of Hypericum extract STW 3-VI in patients with moderate depression: a double-blind, randomized, placebo-controlled clinical trial. [Adv Ther. 2004]
* [Escitalopram is more effective than citalopram for the treatment of severe major depressive disorder] [Encephale. 2004]
* Effectiveness of low doses of paroxetine controlled release in the treatment of major depressive disorder. [J Clin Psychiatry. 2004]
* Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John's wort): randomised controlled double blind non-inferiority trial versus paroxetine. [BMJ. 2005]
* » See all Related Articles...Patient Drug Information
*
Escitalopram (Lexapro®) Escitalopram is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer). Escitalopram is in a class of antidepressants called...
» read more ...
*
Citalopram (Celexa®) Citalopram is used to treat depression. Citalopram is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain...
» read more ...2: Pharmacopsychiatry. 2005 Mar;38(2):78-86.Click here to read Links
Efficacy and tolerability of hypericum extract STW3 in long-term treatment with a once-daily dosage in comparison with sertraline.
Gastpar M, Singer A, Zeller K.General Psychiatric Hospital, Dept. of Psychiatry and Psychotherapy, University of Essen, Germany. m.gastpar@uni-essen.de
OBJECTIVE: The objective of this double-blind, multi-center clinical study was to demonstrate the non-inferiority of hypericum extract versus sertraline in the treatment of moderate depression. METHODS: A total of 241 patients with a diagnosis of moderate depressive disorder (according to ICD-10 criteria) were randomized with either 50 mg sertraline or 612 mg hypericum extract (hypericum group n = 123; sertraline group n = 118). According to the study protocol, 200 patients were treated for at least 12 weeks ( n = 102 hypericum extract; n = 98 sertraline); 81 patients in the hypericum group and 80 in the sertraline group were treated after week 12 for an additional 12 weeks. Thus, most patients were treated for a period of 6 months. The primary efficacy variable was the 17-item HAMD total score at the end of the first 12-week double-blind treatment period. RESULTS: After the first 12-week treatment period, the HAMD score decreased from almost identical initial values (22.0 +/- 1.1 for hypericum and 22.1 +/- 1.1 points for sertraline) to 8.3 +/- 5.5 points (hypericum) and 8.1 +/- 5.6 points (sertraline) (mean +/- SD) in the patients treated per-protocol (PP) population. The statistical test for non-inferiority (boundary delta = 3) revealed that hypericum extract is not inferior to sertraline ( P < 0.0001). The mean difference between the treatments was 0.1995 points, with a corresponding one-sided 97.5 % confidence interval (-infinity, 1.3772). In patients who continued treatment in the follow-up phase, the HAMD score at the end of the study was 5.7 +/- 4.8 points (hypericum group) and 7.1 +/- 6.3 points (sertraline group). Comparable improvement was also found for the von Zerssen's Adjective Mood Scale (BfS) and CGI during the first and second 12-week treatment period in both treatment groups. With 68.6 % of patients in the hypericum group and 70.4 % in the sertraline group, the percentage of patients rated as responders did not differ significantly between treatment groups (12 weeks). The adverse events of 12 patients in the hypericum group (9.8 %) and of 16 patients in the sertraline group (13.6 %) were possibly related to study medication. No basic differences in the treatment groups were observed and no interaction with concomitant medication was documented. In most cases , the investigators assessed the tolerability of hypericum extract and sertraline as "good" or "very good." CONCLUSIONS: The results indicate that hypericum extract STW 3 is not inferior to sertraline and that it is a well-tolerated drug for the treatment of moderate depression. These favorable effects were achieved with a once-daily dose of 612 mg of hypericum extract given for up to 24 weeks.
PMID: 15744631 [PubMed - indexed for MEDLINE]
Related Articles
* Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study. [Pharmacopsychiatry. 2006]
* Efficacy and tolerability of Hypericum extract STW 3-VI in patients with moderate depression: a double-blind, randomized, placebo-controlled clinical trial. [Adv Ther. 2004]
* Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John's wort): randomised controlled double blind non-inferiority trial versus paroxetine. [BMJ. 2005]
* Effectiveness of low doses of paroxetine controlled release in the treatment of major depressive disorder. [J Clin Psychiatry. 2004]
* Efficacy and tolerability of hypericum extract WS 5572 versus placebo in mildly to moderately depressed patients. A randomized double-blind multicenter clinical trial. [Pharmacopsychiatry. 2001]
* » See all Related Articles...Patient Drug Information
*
Sertraline (Zoloft®) Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme f...
» read more ...3: Adv Ther. 2004 Jul-Aug;21(4):265-75.Click here to read Links
Efficacy and tolerability of Hypericum extract STW 3-VI in patients with moderate depression: a double-blind, randomized, placebo-controlled clinical trial.
Uebelhack R, Gruenwald J, Graubaum HJ, Busch R.Charité, Humboldt University, Clinic of Psychiatry, Berlin, Germany.
In this double-blind, randomized, placebo-controlled, prospective study, the clinical efficacy and tolerability of oral Hypericum extract STW 3-VI (Laif) 900 mg once daily was compared with that of placebo. A total of 140 outpatients (94 women; 46 men) with moderate depressive disorders and a 17-item Hamilton Depression Scale (HAMD-17) score of 20 to 24 were enrolled in this study. Following a single-blind placebo run-in period of 7 days, the patients were randomized to Hypericum extract 900 mg or placebo for the 6-week treatment period. Nineteen patients have been excluded from the per protocol collective because of violations of protocol regarding the scheduling of study visits and intake of study medication. The primary endpoint for treatment efficacy was the change in total HAMD-17 score at the end of the 6-week treatment period. The HAMD-17 total score decreased significantly from baseline by approximately 11.1 +/- 4.5 points (from 22.8 +/- 1.1 to 11.8 +/- 4.4) in the Hypericum group and by approximately 3.4 +/- 3.9 points (from 22.6 +/- 1.2 to 19.2 +/- 3.8) in the placebo group (P < .001). Comparable group differences in favor of Hypericum were revealed by an additional responder analysis, the von Zerssen's Adjective Mood Scale, the Clinical Global Impressions scale, and a global efficacy assessment. Tolerability was very good in both groups; neither serious adverse events nor clinically relevant changes in safety parameters were observed, and only 2 cases demonstrated a possible connection between an adverse event and the study medication. The final safety assessment showed no differences between the Hypericum extract and placebo groups. The study provided evidence that Hypericum extract STW 3-VI in a once-daily dosing regimen may be an effective and well-tolerated option for patients with moderate depressive disorders.
PMID: 15605620 [PubMed - indexed for MEDLINE]
Related Articles
* Efficacy and tolerability of hypericum extract STW3 in long-term treatment with a once-daily dosage in comparison with sertraline. [Pharmacopsychiatry. 2005]
* Comparative efficacy and safety of a once-daily dosage of hypericum extract STW3-VI and citalopram in patients with moderate depression: a double-blind, randomised, multicentre, placebo-controlled study. [Pharmacopsychiatry. 2006]
* Efficacy and tolerability of hypericum extract WS 5572 versus placebo in mildly to moderately depressed patients. A randomized double-blind multicenter clinical trial. [Pharmacopsychiatry. 2001]
* Superior efficacy of St John's wort extract WS 5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial [ISRCTN77277298]. [BMC Med. 2006]
* Efficacy of St. John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial. [Am J Psychiatry. 2002]
* » See all Related Articles...Items 1 - 3 of 3
li 160 has many positive studies but unfortunately a tiny amount of them could be seen as valid.
warm regards
sdb
poster:sdb
thread:832177
URL: http://www.dr-bob.org/babble/alter/20080326/msgs/832337.html