St. John's wort ineffective??

[Guest guest]

Here is updated information on the St. John's wort study. Apparently the

SJW user group did have more remissions than the placebo group, just not

more than the cutoff criteria. The placebo rate OTOH was so low that

patient selection for the entire study has been called into question.

The herb quality is equivalent to that used in the European studies but

was applied to major depression instead of mild to moderate depression.

And most interesting is that 50% of all pharmaceutical studies of drugs

and depression show no significant effect.

 

Karen Vaughan

CreationsGarden

***************************************

Email advice is not a substitute for medical treatment.

In a dark time, the eye begins to see. "   -- Theodore Roethke

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Here is a more detailed reply that can be sent to the list:

 

On April 18, the Journal of the American Medical Association (JAMA)

published a study reporting that St. John's wort (SJW) was

ineffective for the treatment of serious depression. The study has

been picked up by every major news media stating that SJW is

ineffective for depression. Here are some important points that call

into question the validity of the findings of the study.

 

1. The study design was somewhat flawed. The study was partially

sponsored by Pfizer, the makers of the conventional antidepressant

Zoloft. At the end of the article it is stated that representatives

of the company were involved in the design and preparation of the

study. The investigators are considered to have a high degree of

scientific integrity, though several have received funding from

Pfizer. Having compeny representatives help design the study may be

the primary inherent flaw in this regard. Perhaps the primary

technical flaw was the lack of an active control, ie the inclusion of

a approved conventional antidepressant. This would have provided a

theoretical baseline of efficacy with which to compare both SJW and

the placebo. Perhaps, the approved antidepressant would have been

equally " ineffective " .

 

2. The primary focus of the study was for major depression and all

indications suggest that SJW is most appropriate for mild-to-moderate

depression. A sub-group of patients with less severe depression were

assessed with the same determination of inefficacy.

 

3. This study had the lowest placebo response rates (18.6%) of

depression studies for 20 years. This automatically calls into

question the study's validity. In all studies of depression using

measurements that are largely subjective, there is a very high

(30-50%) positive response to placebo. A number of pharmacologists

are asking why the placebo rate was so low. In questioning the

validity of previous studies, the authors state that the low placebo

response of another " well controlled study " calls into question its

validity. However, the authors do not address the reason for the

small placebo response in their own study.

 

4. In an interview, the primary investigator, Richard Shelton, stated

" ...the study by some statistical fluke may have included patients

that would not have responded to any medication... "

 

5. An overview of depression studies with approved antidepressant

medications show that the findings are 50/50 between positive and

negative findings meaning that half of the studies say that approved

anti-depressant medications are ineffective while the other half say

they are effective. So one study does not a conclusion make.

 

6. While the researchers reported that SJW was ineffective according

to the parameters they were studying, the conclusions of the study

clearly state that the number of patients whose symptoms completely

subsided ( " remission " ) was significantly higher in those using SJW

than placebo.

 

>Roy-

>

>can I forward your information on the test to the Traditional Chinese Herbal Medicine

>email list?

>

>Karen Vaughan

>CreationsGarden

>***************************************

>

>On Wed, 18 Apr 2001 10:40:45 -0700 Roy Upton <herbal writes:

>>Herbal Hall: The Professional Herbalists' Discussion List

>>Roy Upton

>>

>>The SJW used in the study was from Lichtwer Pharma, the primary

>>product used in German SJW studies. There are a few basic concerns.

>>1. the study was for major depression and all indications suggest

>>that SJW is most approproiate for mild-to-moderate depression.; 2.

>>This study had the lowest placebo response rates of depression

>>studies for 20 years. This automatically calls into question the

>>study's validity. 3. in an interview, the PI, Richard Shelton, stated

>> " ...the

>>Vanderbilt study by some statistical fluke may have included patients

>>that would not have responded to any medication... " ; 4. No positive

>>control was used. If there had been a positive control, perhaps that

> >would have also shown up to be ineffective again questioning the

>>validity of the findings. 5. An overview of depression studies with

>>approved antidepressant medications show that the findings are 50/50

>>between positive and negative findings so one study does not a

>>conclusion make.

>>--

>>Roy Upton, Herbalist

>>Executive Director, American Herbal Pharmacopoeia

>>Member, Standards Committee, American Herbal Products Association

>>Vice-president, American Herbalists Guild

>>Board of Directors, Botanical Medicine Academy

 

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