Psycho-Babble Medication Thread 102603

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St. John's Wort No Better Than Placebo

Posted by djmmm on April 10, 2002, at 7:23:18

St. John's Wort No Better Than Placebo for Depression


Laurie Barclay, MD


NEW YORK (MedscapeWire) Apr 10 — In an 8-week, randomized trial reported in the April 10 issue of The Journal of the American Medical Association, St. John's wort was no better than placebo in the treatment of major depression, and sertraline was better only on a secondary outcome measure. A second study and an editorial in the same issue of the journal stress the importance of placebo controls in trials of antidepressants.
"Major depression is treatable, but this research suggests that major depression of at least moderate severity should not be treated with St. John's wort," principal investigator Jonathan R. T. Davidson, MD, from Duke University in Durham, North Carolina, says in a news release. "It is vitally important to conduct well-designed studies to examine herbal supplements and other drugs for the treatment of depression."

In this double-blind, parallel group study conducted at 12 academic or community clinics, 340 outpatients received St. John's wort 900 mg to 1500 mg daily, sertraline 50 mg to 100 mg daily, or placebo for 8 weeks, followed by up to 18 weeks of double-blind continuation treatment in responders. All subjects had a diagnosis of major depression, a score 20 or higher on the Hamilton Depression (HAM-D) scale, and a score 60 or lower on the Global Assessment of Functioning scale at baseline.

Neither St. John's wort nor sertraline proved to be more effective than placebo on primary measures of effectiveness including change on HAM-D score from baseline to 8 weeks and rate of full response on the Clinical Global Impressions scale (CGI) or HAM-D. Full response occurred in 31.9% of patients receiving placebo, 23.9% of those receiving St. John's wort, and 24.8% of patients receiving sertraline. Although sertraline was better than placebo on the CGI improvement scale (P=.02), a secondary outcome measure, St. John's wort showed no effectiveness on any measure.

The extract of St. John's wort used in this study (LI-160) was standardized to between 0.12% and 0.28% hypericin and was selected for the body of literature supporting its possible efficacy in depression.

Study coauthor Robert Califf, MD, from Duke Clinical Research Institute, emphasized possible interactions of St. John's wort and other herbal remedies with prescription medications, including antiretroviral therapy, certain cardiovascular drugs, and immunosuppressants. "Just because St. John's wort was found to be ineffective for this type of depression does not mean it is harmless to the body," Califf said. "As long as these types of products remain available to the public without the protection of adequate, controlled and unbiased studies, taking them is like playing Russian roulette with your health."

Pfizer provided sertraline and its matching placebo for this study and has financial relationships with some of the authors.

A meta-analysis in the same issue of JAMA notes that placebo response in published trials of antidepressants is highly variable, often substantial, and has increased significantly in recent years.

"Taken together, the two reports in this issue of The Journal return full circle to the placebo response and understanding its mechanisms of action and highlight the perplexing complexity of the placebo and its ability to cause 'mischief' in scientific inquiry," David J. Kupfer, MD, and Ellen Frank, PhD, from the University of Pittsburgh Medical School, write in an accompanying editorial. "This may be nature's way of providing clues to fundamental aspects of the healing process, even as advances in medicine and the discovery of new therapies take place. It is important to learn from, rather than dismiss, the variability of the therapeutic response."

A National Depressive and Manic-Depressive Association Consensus Statement on the use of placebo in clinical trials of mood disorders, published in the March issue of the Archives of General Psychiatry, concluded that findings of equivalence between a new drug and standard treatment are not evidence of efficacy unless the new drug is also significantly more effective than placebo.

JAMA. 2002;287(14):1807-1814, 1840-1847, 1853-1854

Reviewed by Gary D. Vogin, MD


from
http://www.medscape.com/px/mscpsearch?QueryText=st+johns+wort&searchfor=Clinical

 

Re: St. John's Wort No Better Than Placebo

Posted by JohnX2 on April 10, 2002, at 15:21:40

In reply to St. John's Wort No Better Than Placebo , posted by djmmm on April 10, 2002, at 7:23:18


My experience (kira brand)

900 mg/day - nada
1800 mg/day - response

John

> St. John's Wort No Better Than Placebo for Depression
>
>
> Laurie Barclay, MD
>
>
> NEW YORK (MedscapeWire) Apr 10 — In an 8-week, randomized trial reported in the April 10 issue of The Journal of the American Medical Association, St. John's wort was no better than placebo in the treatment of major depression, and sertraline was better only on a secondary outcome measure. A second study and an editorial in the same issue of the journal stress the importance of placebo controls in trials of antidepressants.
> "Major depression is treatable, but this research suggests that major depression of at least moderate severity should not be treated with St. John's wort," principal investigator Jonathan R. T. Davidson, MD, from Duke University in Durham, North Carolina, says in a news release. "It is vitally important to conduct well-designed studies to examine herbal supplements and other drugs for the treatment of depression."
>
> In this double-blind, parallel group study conducted at 12 academic or community clinics, 340 outpatients received St. John's wort 900 mg to 1500 mg daily, sertraline 50 mg to 100 mg daily, or placebo for 8 weeks, followed by up to 18 weeks of double-blind continuation treatment in responders. All subjects had a diagnosis of major depression, a score 20 or higher on the Hamilton Depression (HAM-D) scale, and a score 60 or lower on the Global Assessment of Functioning scale at baseline.
>
> Neither St. John's wort nor sertraline proved to be more effective than placebo on primary measures of effectiveness including change on HAM-D score from baseline to 8 weeks and rate of full response on the Clinical Global Impressions scale (CGI) or HAM-D. Full response occurred in 31.9% of patients receiving placebo, 23.9% of those receiving St. John's wort, and 24.8% of patients receiving sertraline. Although sertraline was better than placebo on the CGI improvement scale (P=.02), a secondary outcome measure, St. John's wort showed no effectiveness on any measure.
>
> The extract of St. John's wort used in this study (LI-160) was standardized to between 0.12% and 0.28% hypericin and was selected for the body of literature supporting its possible efficacy in depression.
>
> Study coauthor Robert Califf, MD, from Duke Clinical Research Institute, emphasized possible interactions of St. John's wort and other herbal remedies with prescription medications, including antiretroviral therapy, certain cardiovascular drugs, and immunosuppressants. "Just because St. John's wort was found to be ineffective for this type of depression does not mean it is harmless to the body," Califf said. "As long as these types of products remain available to the public without the protection of adequate, controlled and unbiased studies, taking them is like playing Russian roulette with your health."
>
> Pfizer provided sertraline and its matching placebo for this study and has financial relationships with some of the authors.
>
> A meta-analysis in the same issue of JAMA notes that placebo response in published trials of antidepressants is highly variable, often substantial, and has increased significantly in recent years.
>
> "Taken together, the two reports in this issue of The Journal return full circle to the placebo response and understanding its mechanisms of action and highlight the perplexing complexity of the placebo and its ability to cause 'mischief' in scientific inquiry," David J. Kupfer, MD, and Ellen Frank, PhD, from the University of Pittsburgh Medical School, write in an accompanying editorial. "This may be nature's way of providing clues to fundamental aspects of the healing process, even as advances in medicine and the discovery of new therapies take place. It is important to learn from, rather than dismiss, the variability of the therapeutic response."
>
> A National Depressive and Manic-Depressive Association Consensus Statement on the use of placebo in clinical trials of mood disorders, published in the March issue of the Archives of General Psychiatry, concluded that findings of equivalence between a new drug and standard treatment are not evidence of efficacy unless the new drug is also significantly more effective than placebo.
>
> JAMA. 2002;287(14):1807-1814, 1840-1847, 1853-1854
>
> Reviewed by Gary D. Vogin, MD
>
>
> from
> http://www.medscape.com/px/mscpsearch?QueryText=st+johns+wort&searchfor=Clinical

 

Re: St. John's Wort No Better Than Placebo

Posted by misty99 on April 13, 2002, at 7:23:40

In reply to Re: St. John's Wort No Better Than Placebo , posted by JohnX2 on April 10, 2002, at 15:21:40

John,

Obviously, I may be coming at this from a biased point of view since I feel St. John's Wort has helped me more than many of the antidepressants I have taken. Anyway, in reading the results of the study, it said participants were required to have a minimum of 20 on the Hamilton Score of Depression but I didn't see what the maximum requirement was if there was any. The reason why I am asking is if 14-17 is considered mild to moderate, it would just seem to me if the participants have a score much higher than 20, then essentially, participants don't really have true moderate depression. Therefore, I would think that would invalidate the results of the study, since the aim is to figure out if SJW works for moderate depression. Perhaps, I am not looking at that correctly and that's why I was glad to see this thread because I hoped someone could enlighten me.

Also, I truly question how any study can really be fair and accurate if all the major researchers involved had ties to drug companies. Please understand, I am not accusing anyone of unethical behavior but even the appearance of a conflict of ethics does not contribute to a good research study.

I did look to see if anyone had ties to any herbal company or to the folks who made the brand of St. Johns Wort that was used in the study but I didn't see anybody listed. So if I have overlooked anybody, my apologies.

Anyway, when I have more time, I intend to thorougly read the article on the American Medical Association website to see what went on. I don't have the link but go to http://www.google.com and plug in American Medical Association into the search box and when you go to the AMA Site, the article is on the home page.

I look forward to hearing what other people think.

Misty99

 

Re: Zoloft no better than placebo

Posted by Mitchell on April 13, 2002, at 10:07:43

In reply to Re: St. John's Wort No Better Than Placebo , posted by misty99 on April 13, 2002, at 7:23:40

The following excerpts from the study might be informative. Zoloft (made by Pfizer) proved no more effective than the herb or than placebo. The author disclosed financial ties to Pfizer. The link will take you to the full text of the JAMA article.

Results: On the 2 primary outcome measures, neither sertraline nor H perforatum was significantly different from placebo.

Dr Johnathon Davidson holds stock in Pfizer, American Home Products, GlaxoSmithKline, Procter and Gamble, and Triangle Pharmaceuticals; has received speaker fees from Solvay, Pfizer, GlaxoSmithKline, Wyeth-Ayerst, Lichtwer, and the American Psychiatric Association; has been a scientific advisor to Allergan, Solvay, Pfizer, GlaxoSmithKline, Forest Pharmaceuticals Inc, Eli Lilly, Ancile, Roche, Novartis, and Organon; has received research support from the National Institute of Mental Health (NIMH), Pfizer, Solvay, Eli Lilly, GlaxoSmithKline, Wyeth-Ayerst, Organon, Forest Pharmaceuticals Inc, PureWorld, Allergan, and Nutrition 21; has received drugs for studies from Eli Lilly, Schwabe, Nutrition 21, PureWorld Botanicals, and Pfizer; and has received royalties from MultiHealth Systems Inc, Guilford Publications, and the American Psychiatric Association

http://jama.ama-assn.org/issues/v287n14/rfull/joc11936.html

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

If anyone has questions about the effectiveness of St. John's Wort in treating mild to moderate depression, the following excerpt from McLean Hospital Psychiatric Update might be helpful:

St. John’s wort as an antidepressant

McLean Hospital Psychiatric Update, June 1998

Contributed by Dr. Scott E. Ewing, Director of McLean Hospital’s Depression & Anxiety Disorders Outpatient Service and an Instructor of Psychiatry at Harvard Medical School

McLean is the largest psychiatric teaching facility of Harvard Medical School, an affiliate of Massachusetts General Hospital.

Evidence of Efficacy: Extracts of hypericum are more efficacious than placebo in treating mild to moderately severe depressive disorders. At least 23 randomized trials with more than 1,750 outpatients support this conclusion. Fifteen studies were placebo controlled and eight compared hypericum with other drug treatments. In 13 trials comparing a single hypericum preparation with placebo, 22.3% responded to placebo versus 55.1% in the hypericum groups. In trials comparing single preparations of hypericum with standard antidepressants, 63.9% of the patients receiving hypericum responded versus 58.5% of those taking standard antidepressants.

Summary: Based on currently available evidence, St. John’s wort is probably effective in treating outpatients with mild to moderate depression. Its efficacy in treating severely depressed inpatients and its safety for long-term administration have not been systematically evaluated. St. John’s wort appears to be better tolerated than older cyclic antidepressants and may be useful in patients who are unable to take synthetic antidepressants. No controlled studies support combining St. John’s wort with prescription antidepressants and the safety of such combinations has not been evaluated.

http://www.mcleanhospital.org/psychupdate/psyup1998_06.htm

 

St Johns Wort Question - Anybody

Posted by oona on April 13, 2002, at 22:37:13

In reply to Re: Zoloft no better than placebo , posted by Mitchell on April 13, 2002, at 10:07:43

I have just gotten off Zoloft after 7 years and am in my first month of Welbutrin.

I have been growing St. Johns Wort in my garden with the expectations that "someday" I will be able to just rely on it.

Does anyone have any information on whether you take the flowers or the leaves (or both)?

Do you dry it or make tincture from plant?

I have been reading a little about it but most texts do not get into specifics.
Thanks
oona

 

Re: St Johns Wort Question - Anybody » oona

Posted by IsoM on April 14, 2002, at 1:18:56

In reply to St Johns Wort Question - Anybody, posted by oona on April 13, 2002, at 22:37:13

Oona, I have tried St. John's wort but even at high concentrations, didn't notice anything, but I had been interested in growing it myself if it did work.

First, the ornamental variety of St. John's wort that people grow in their garden as a small flowering shrub is NOT the same variety that's used to treat depression. I'm not sure where you live, but St. John's wort grows wild around here, but many people have no idea that the ornamental small shrubby plant they grow is St. John's too. The cultivated variety has large flowers & larger, leathery leaves. The wild looks weedy, with small yellow flowers & soft small leaves on an erect plant 2'-3' high.

To get the highest potency in the wild variety, they need LOTS of sun & no fertilizer. Fetilized, lush plants who low potency. Pick the growing tips of the flowering ends - buds, flowers & small leaves (they all contain hypercium) in the early morning before the sun gets hot.

It's not necessary to make a tincture immediately. Dry the pickings everyday till crumbly & then to keep potency up, I'd store the dried herb in bottles & keep them in the freezer, just taking out what you need each day. Good luck - I hope it works for you.

 

Can I take St. John's Wort with anti-depressants?

Posted by wcfrench on November 16, 2002, at 16:22:56

In reply to St. John's Wort No Better Than Placebo , posted by djmmm on April 10, 2002, at 7:23:18

I've heard of people trying this, and possibly some adverse reactions. Is it save to try just one tablet while taking an anti-depressant? Would it help? Any help thx. Take care,

-Charlie

 

Re: Can I take St. John's Wort with anti-depressants? » wcfrench

Posted by Mr Beev on November 16, 2002, at 18:06:55

In reply to Can I take St. John's Wort with anti-depressants?, posted by wcfrench on November 16, 2002, at 16:22:56

I took it for some time whilst on 50mg Luvox (fluvoxamine) as well as megadoses of assorted vitamins and minerals. I could discern no ill effects, could discern in fact no effects whatsoever. In my case, at least, StJW was indeed no better than placebo...

Regards,
Mr Beev

 

Re: Can I take St. John's Wort with anti-depressants?

Posted by wcfrench on November 16, 2002, at 22:58:46

In reply to Re: Can I take St. John's Wort with anti-depressants? » wcfrench, posted by Mr Beev on November 16, 2002, at 18:06:55

Thanks for your input

-Charlie

 

Re: Can I take St. John's Wort with anti-depressants?

Posted by fairnymph on November 19, 2002, at 15:41:10

In reply to Can I take St. John's Wort with anti-depressants?, posted by wcfrench on November 16, 2002, at 16:22:56

Theoretically, it's a very bad idea to combine SJW with a serotonergic antidepressants (like an SSRI, Effexor, trazadone, nefazadone, remeron, etc), just as it is not a good idea to combine 5-htp and serotonergic antidepressant.

I wouldn't risk it, personally. Plus I don't think SJW is very effective for depression, personally.


-fairnymph


> I've heard of people trying this, and possibly some adverse reactions. Is it save to try just one tablet while taking an anti-depressant? Would it help? Any help thx. Take care,
>
> -Charlie

 

Re: Can I take St. John's Wort with anti-depressants?

Posted by wcfrench on November 19, 2002, at 15:50:40

In reply to Re: Can I take St. John's Wort with anti-depressants?, posted by fairnymph on November 19, 2002, at 15:41:10

Thanks.

I tried SJW a couple of tablets, for a couple of days. Also before this tried 5HTP. Neither seemed to have any effect, or if any, made me feel worse. I feel better after stopping all of this (including fish oil). I wish there were something that helped!

I can tell you what does help, you know that cognitive behavioral therapy self-course that that lady came up with 14 years ago? I heard it advertised on the radio, and it's an 11-week course I believe. A friend of mine bought it (not sure how much) and I copied the first tape and the relaxation tape, and it really seems worthwhile. A LOT of people who had limited/no success with medications responded amazingly to this therapy. The relaxation tape is such an effective tool. I find it (so far) to be great for anxiety, but still haven't done it for long enough to judge how it deals with depression. Many people swear by it. If I do it, I'll keep you posted.

Thanks for your input. Good luck to everyone.

Take care,
Charlie

 

Name of the taped course? » wcfrench

Posted by dougie on January 6, 2003, at 21:44:40

In reply to Re: Can I take St. John's Wort with anti-depressants?, posted by wcfrench on November 19, 2002, at 15:50:40

What is that set of tapes called if you know?
>
> I can tell you what does help, you know that cognitive behavioral therapy self-course that that lady came up with 14 years ago? I heard it advertised on the radio, and it's an 11-week course I believe. A friend of mine bought it (not sure how much) and I copied the first tape and the relaxation tape, and it really seems worthwhile. A LOT of people who had limited/no success with medications responded amazingly to this therapy. The relaxation tape is such an effective tool. I find it (so far) to be great for anxiety, but still haven't done it for long enough to judge how it deals with depression. Many people swear by it. If I do it, I'll keep you posted.
>
> Thanks for your input. Good luck to everyone.
>
> Take care,
> Charlie

 

Re: Can I take St. John's Wort with anti-depressants? » wcfrench

Posted by wcfrench on January 7, 2003, at 0:06:18

In reply to Re: Can I take St. John's Wort with anti-depressants?, posted by wcfrench on November 19, 2002, at 15:50:40

Hey dougie

It's called Attacking Anxiety and Depression and it's from The Midwest Center for Stress and Anxiety. I haven't copied anymore of the tapes yet but I think I will at some point. I went through some ups and downs with alcohol, and I realized that when I drink alcohol regularly, my meds wear completely off and I go downhill, so I'm not close to stopping the meds anytime soon. BUT these tools offered in therapy can help no matter what, and it gives me hope that one day I won't needs meds.
Good luck.

-Charlie

 

Re: St. John's Wort No Better Than Placebo » djmmm

Posted by dougie on February 25, 2003, at 20:00:41

In reply to St. John's Wort No Better Than Placebo , posted by djmmm on April 10, 2002, at 7:23:18

I would take that study with a large grain of salt. The lack of inclusion of a "proven" antidepressant then led to the next large study which also purported to show that SJW does not work, BUT FAILED to mention that it worked as well as ZOLOFT, just no betterthan placebo. HMMM,, whats going on here? Is therapuetic response placebo response? Does the emperor have any clothing?

 

Re: St. John's Wort No Better Than Placebo

Posted by american woman on February 7, 2004, at 9:32:08

In reply to Re: St. John's Wort No Better Than Placebo » djmmm, posted by dougie on February 25, 2003, at 20:00:41

funny, it's helped me better than many of the anti-depressant drugs I've tried, including: zoloft, effexor, celexa, prozac. No allergic reaction, and no terrible side effects. The only anti-depressant that seemed to work better at alleviating depressive symptoms was Paxil. I'd still be on Paxil today if it hadn't pooped out and stopped working altogether. Go figure.

 

Redirect: St. John's Wort

Posted by Dr. Bob on February 7, 2004, at 14:51:45

In reply to Re: St. John's Wort No Better Than Placebo, posted by american woman on February 7, 2004, at 9:32:08

> funny, it's helped me better than many of the anti-depressant drugs I've tried...

Sorry if it's confusing, but there's now a separate board, Psycho-Babble Alternative, for alternative treatments, so I'd like to redirect this thread there. Here's a link:

http://www.dr-bob.org/babble/alter/20040110/msgs/310573.html

Thanks,

Bob


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