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Chinese Medicine for Endometriosis PDF Print E-mail
Swift
Written by Christina Stephens   

Media outlets are reporting that Chinese herbs may relieve symptoms of endometriosis, using a Cochrane review of 2 research articles. Headlines read "Chinese herbs show early promise for endometriosis" and  "Chinese Herbs May Relieve Endometriosis Symptoms, Review Finds".

Endometriosis is a medical condition in which some of the endometrial cells (typically found in the uterus under the fluctuating influence of female hormones) are found outside of the uterine cavity. Symptoms include many nonspecific complaints such as pelvic pain, infertility, nausea, unusual menstruation, chronic fatigue, mood swings, back pain, ovarian cysts, constipation, urinary tract infections, diarrhea, anemia, etc. Appropriate diagnosis is by laparoscopic biopsy - a doctor will use a laparoscopic instrument to remove suspected extrauterine endometrial cells and examine them.  Treatments vary and can include hormonal treatments or surgery to remove the cells. In China, treatment of this disorder with Chinese herbal medicine (CHM) is routine.

Both of the media reports linked to above say that the Cochrane reviewers found some evidence that CHM has comparable benefits to conventional drug therapy after laparoscopic surgery for people with endometriosis but that the review has limitations. Andrew Flower, the primary author of the study is quoted as saying "I think the positive message is that Chinese herbal medicine may offer equivalent benefits to conventional medicine but with fewer side effects."

I found the Cochrane review [1] and noted that reviewers collected 110 studies for review and graded them based on methodological criteria. They dropped all but two of the 110 studies due to excluding trials with poor methodology, unconfirmed randomization procedures or ones diagnosing endometriosis without an appropriate laparoscopic biopsy.

Did the two retained articles feature research with superior methodology? First, let's look at what those two articles were, and what the author concluded from this review:

The first article [2] had two treatment arms: women treated with CHM orally (2x/day) and via enema (1x/day) after laparoscopic surgery versus women treated with gestrinone (2x/wk) after laparoscopic surgery for 3 months. The results showed no difference between rates of symptom relief or pregnancy in either group.

The second article [3] had three treatment arms: women treated with CHM orally(2x/day), women who treated with CHM orally and via enema(1x/day), and women treated with danazol(1x/day) for 3 months. These women did not undergo laparoscopic surgery, but instead were only biopsied for diagnostic purposes.  Women obtained greater symptomatic relief with oral and oral plus enema CHM versus danazol, oral plus enema CHM shower a greater reduction in dysmenorrhoea pain scores than danazol and shrinkage of adenexal masses. There were no differences for other factors (lumbrosacral pain, rectal discomfort, vaginal nodules).

The author concluded that post-surgical administration of CHM may have comparable benefits to gestrinone but with fewer side effects, that oral CHM may be better for treatment than danazol and may be more effective at relieving dysmenorrheal and shrinking adnexal masses when used with a CHM enema.

So, what are our weaknesses?

1.    No placebo control: There was no arm of the first study which looked at women receiving laparoscopic surgery alone without CHM or danazol, and no arm of the second study which looked at women receiving no treatment or a placebo pill treatment.

2.    Poor blinding: I should not have to point out that if you enroll in a study that has a pill treatment arm and an enema treatment arm, it is impossible for the participants to be blinded to which treatment group they are in. And enema, as you probably know, is a procedure in which liquids are forced into the rectum through the anus. It might be possible to blind participants to whether or not they are getting CHM versus the other medications, but I bet most people can tell the difference between a Chinese medicine pill and the other pills in the study. The researchers were also not blinded as to which treatment group women were in, though the paper indicates the assessors were blinded to which treatment group the women were in.

3.    Inadequate comparison treatments: Danazol is no longer commonly used as a treatment for endometriosis, and gestrinone is not available in the USA. These studies would have been much more robust had they compared it to typical drug treatments for endometriosis. In the world of conventional treatments for endometriosis, these two drugs can hardly be called conventional.

4.    Poor outcome measures: In both of the studies, a clinical outcome of "no effect" was recorded if there were no change in symptoms or if the symptoms became worse. Recording worsening symptoms as "no effect" biases the data toward a positive outcome.

I think that the most appropriate take home message or finding of the study is this: the massive stockpile of clinical trials that explore CHM for treating endometriosis have serious methodological shortcomings.

The author's main conclusion (and the conclusion parroted by the press), that CHM may work to alleviate symptoms of endometriosis, seems spurious in light of this.

Additionally, it appears that researchers used a specific mixture of herbs (Nei Yi) in the two studies, which raises the question: why the author did not title his paper "Nei Yi for endometriosis"?  Perhaps he wanted his readers to focus on the fact that this was a Chinese herbal medicine versus a "conventional" medicine. While I applaud the authors for making the weaknesses of the studies they looked at apparent, I do not applaud the way they framed their conclusions.

Lastly, it is worth noting that although the authors of the review state that there is no conflict of interest in the publication of this review, the primary author is an acupuncture and Chinese medicine practitioner at a center for Chinese medicine in the UK.

References:

[1] Flower A, Liu JP, Chen S, Lewith G, Little P. Chinese herbal medicine for endometriosis. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD006568. DOI: 10.1002/14651858.CD006568.pub2.

[2] Wu SZ,Chen XL,Chen WZ, Li SY.Clinical analysis of the treatment of endometriosis using Nei Yi pills and Nei Yi enema. Journal of Liaoning University of TCM 2006;8(7):5-6.

[3] Wu SZ, Chen XL, Chen WZ. Clinical observation of Nei Yi pills combined with Nei Yi enema in the treatment of endometriosis. Chinese Archives of TCM 2006;24(3):431-3.

Christina Stephens, OTD/s blogs at www.ziztur.com

 

 


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Placebos in CHM
written by mikeeslea, July 24, 2009
Hmmm. It's pretty common to have no placebo control where there are existing treatments. It would not be ethical to deprive patients of painkillers, say, in order to test a new one. But the study may be even worse than you think! You mention a "Chinese medicine pill" but most Chinese herbalism uses foul-smelling teas, not pills, making it even harder to blind the participants. Plus, Andrew Flower is not the only woo-meister among the authors: George Lewith is also a long-time CAM enthusiast who has previously been caught out making extravagant claims for homeopathy in fibromyalgia (http://www.dcscience.net/?p=131).
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written by MadScientist, July 24, 2009
Gee, when will they learn bullshit in, bullshit out? You won't find a pearl in a mountain of manure (unless someone put it there).
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Oh Dear...
written by Michael K Gray, July 24, 2009
George Lewith?
The rabid pro-homeopathy advocate?
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written by Otara, July 25, 2009
Ethicswise, if the alternative is 3 months of enema's, I think I could live with being in the placebo group.
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written by LovleAnjel, July 25, 2009
They might have said "Chinese herbs" because they were not compounding the pills, and thus could not be sure they contained what they were supposed to contain.
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written by Kuroyume, July 25, 2009
Excellent article and read. Shows how agenda meets media and alternative medicines keep on the charts.

Not being a medical student to any degree, do they have more objective means to measure pain relief besides subjective ratings by the participants? At least with claims of remissions or cures, you have objective means to measure efficacy. With pain it must be more difficult - and that's probably good for the alternative medicines.
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written by NewCoaster, July 25, 2009
Excellent review, and very timely from my point of view. I'm going to be doing an M&M rounds (that's morbidity and mortality for the non-medical folks) next month on Chinese herbs. I had a patient develop acute hepatitis while taking them to treat vitilogo...the skin condition Michael Jackson claimed to have. She recovered, but she got very sick first
I'm going to use my case to expand on a talk about Traditional Chinese Medicine in general, so this is more useful information. I live in a an area where "woo" is very popular, and a significant number of my medical colleagues use or endorse sCAM.
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Answers
written by ziztur, July 25, 2009
Hi, I'm the author of this Swift article.

@mike - True, it may not be ethical to use a placebo in these study. I did a quick journal search and found many studies comparing these two treatments to a placebo. I didn't look at the results and this is not an argument that having a placebo arm is ethical, but an observation that placbo arms have been used for these treatments.

The two medications used in the control arms (gestrinone and danazol) are both steroid treatments. I am not sure how common these treatments are outside of the UK and the US, but I know danazol is an uncommon treatment and gestrinone is banned in the US (I do not know why). It would have been better if these studies used common (possibly more effective) treatments. I did not do a literature review to see how effective gestrinone and danazol are.


@LovleAnjel - Both of the studies describe the Chinese herbal medicine treatment as "Nei Yi pills". The pills both were listed as having the same ingredients. It is quite likely they were the same pills, given that both studies in the review were conducted by the same group of people. The author acknowledges the issues in blinding with herbal products, stating, "The nature of CHM and herbal products make blinding problematic and CHM clinical trials may have to be more pragmatic."

This is what the Nei Yi pills were said to consist of: Dan Shen (Salviae multiorrhizae Radix), Xue Jie (Draconis Sanguis), San Leng (Sparganii Rhizoma), E Zhu (Curcumae Rhizoma), Tao Ren (Persicae Semen), San Qi (Notoginseng Radix), Dang Gui (Angelica sinensis), Gui Zhi (Cinnamomi Ramulus), Xiang Fu (Cyperi Rhizoma), Niu Xi (Achyranthis bidentate Radix)

@Kuroyume - Pain relief was measured subjectively. Pain relief is hard to measure objectively but can be done. You can measure it quantitatively with measures of things such as increased participation in activities or a reduced need for analgesics.

In the paper, "Chinese herbal medicine" was clearly pitted against "conventional medicine". For example, the weaknesses of current therapies are summarized as, "The short-term benefits of conventional medical treatment have to be balanced against the unpleasant and sometimes dangerous side effects resulting from these therapies." Chinese herbal medicine is introduced as "Chinese herbal medicine (CHM) is a system of medicine with
an unbroken written tradition stretching back over two thousand years."
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written by Willy K, July 25, 2009
So tell me.... WTF is "CHM" made from?

Oh yeah.. I know...

It's "Stuff Harvested In Taiwan" colloquially know as S**T. smilies/wink.gif
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chinese med
written by yo saxman, July 25, 2009
The two medical professions, Chinese and western, function on opposite principles, where one does empirical studies and shares information, the other does not(actually can not). If a Chinese practitioner knows a certain cure, he keeps his mouth shut and passes it on to his son. There is no JCMA published monthly. Whereas JAMA keeps every doctor on the golf course up to date.
However, let's not throw the tea out with the leaves. I had hep C, incurable. After 2 yrs, 1000's of dollars, and feeling like a a pin cushion from shooting up recombinant DNA from Ireland, the only result was my friends couldn't stand bein around me(that shit makes one irritable as hell). I was told to get my affairs in order and hope for a cure within 6 months.
By freak luck I ran into one of China's leading practitioners. I later learned he was well known in China. He cured me in 30 days with gawd awful tasting tea. He also cured 6 other people from a support group I was in.
Since he was in the states, technically he was practicing med without a license, so I had to keep quiet about it. My doctor took the credit, I made the JAMA as an interferon treatment success, and JAMA still dosen't know that they unwittingly approved a Chinese cure for an incurable disease that cost me $6.
However, NO! Generally I would not recommend Chinese medicine. It's got more quacks than a duck pond. But if you have a specific problem, especially liver, and a RELIABLE recommendation, it's worth looking into.
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@ yo saxman
written by Human Person Jr, July 25, 2009
Your comment, including your story about being cured of an incurable disease, is not credible. Your casual, yet hip and knowing tone only adds to my embarrassment for you. I seriously doubt you're finely attuned to the protocols amongst Chinese medical "professionals." (Well, y'see, the way it works is...)

If Chinese medicine could cure hepatitis C (let's call it hep C, sorry), I'm pretty sure we'd have heard. There are so few (some would say no) accomplishments for that crowd to crow about, they would be all over this like ugly on a Baldwin brother (not original with me, but funny as hell to me, for some reason). Nice try, bro, but your subjective opinion as to what made you better doesn't constitute evidence. Remember the thrust of this article? It's away from anecdotal evidence (which isn't evidentiary) and toward solidly-administered testing to obtain statistical evidence.
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written by cdion321, July 25, 2009
I see a lot of testimonials.. always a bad sign.

In fact one of the testimonials indicates that they treat psoriasis as an "auto-immune disorder". Hogwash! It's a genetic protein deficiency.
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written by Paul Murray, July 26, 2009
Of course, there's every possibility that these chinese herbs are in fact pharmaceutically active. Like digitalis. Or willow bark. The problem is "hey, these herbs work, so therefore chinese traditional medicine is valid, and chi and acupuncture are all sensible".
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Again -- @ yo saxman
written by Human Person Jr, July 26, 2009
yo saxman, you don't say WHEN your sCAM healing took place, but the latest ACTUAL treatments for hepatitis C are producing amazing results. From an overall cure rate of 6% 1n 1994, to a whopping 63% overall cure rate in 2004, the progress has been dramatic. Some forms of the disease are tougher to treat than others. However, in 2004, even the form most difficult to treat had a 50% cure rate. This is small comfort to those who cannot be helped, but I certainly hope that no sufferers will heed your ill-advised rhetoric and go on a mad quest for a Chinese sCAM practitioner (but only with a RELIABLE recommendation, as you so wisely advised).

If Chinese sCAM artists use botanicals that are pharmacologically active, and the botanicals prove to be of value, the drug companies will test, produce and market the resulting medications, without regard for any potential "boost" in public acceptance of sCAM practitioners. We should, if our doctors prescribe that product, take the medicine with the same attitude.

No sane person would want to return to ancient Greek medicine, just because the use of willow bark as a pain reliever was eventually shown to have a basis in fact. The same would, I think, would hold true for new pharmaceuticals, regardless of the source.
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Psul's got it.
written by ziztur, July 26, 2009
@Paul - yep, that was exactly my point!
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written by Mark P, July 26, 2009
Chinese herbal medicine (CHM) is a system of medicine with an unbroken written tradition stretching back over two thousand years


But at no stage in the last 2,000 years have people forgotten how to read and write in the West!
Western medicine has an unbroken written tradition for 2,000 years too. We still have some of the actual books written from back then. And it's not called the Hippocratic Oath for nothing!

Moreover China has several times descended into anarchism and darkness for long periods, so it's no like that's any different. It's ridiculous to pretend that their scholarship has always been fully active for 2,000+ years.

Of course since Hippocrates and Galen the West has collectively realised that its unbroken tradition was largely rubbish. So it has moved on.

The fact that Chinese traditional medicine has largely not moved on is a badge of shame, not honour. (Imagine saying Chinese chemistry is superior to Western chemistry because it is still based largely on ideas 2,000 years old, rather than atoms and energy levels.)
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written by cdion321, July 27, 2009
@NewCoaster: Are there any areas where woo isn't popular? If so, I'm moving there tomorrow..
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written by anthro, August 01, 2009
Hey, NewCoaster: I think we live in the same town (or area)! Part of the year, though, I live in the midwest and you know what? It's the same here, just a bit more low key. The coop magazine is nothing but woo, a clerk at Whole Foods was enthusiastically recommending a "cleansing" enema kit to an equally enthusiastic customer (I told them both off to no avail); evening classes offer tons of courses in all kinds of woo and Costco has a huge section devoted to all sorts of vitamin and herbal "treatments". Woo is everywhere and people I meet are astonished that anyone questions it. After I make my speech about evidence, all I ever get is, "well, that's your opinion". I can't even get past the the difference between "opinion" and "evidence"! The clerk at WF just smiled at me the way you would to a child who has just said something stupid but quaint. It's a religion and we all know that you can't even question religion in the US, so I despair, frankly.
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