PCOS Messages for February, 2002: Re: BCP (changed subject line)

Re: BCP (changed subject line)

From: Belle (anonymous@obgyn.net)
Mon, 4 Feb 2002 00:40:12 -0600 (CST)

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This is very convoluted! Is this how people who get the digest normally see the posts? I would go nuts trying to figure out what has been said. You have to read things backward and it is difficult to determine if someone else has asked the question or given a reply. I would highly recommend that if you are getting the automated listing and you are finding it to be a hassle, bookmark this page http://forums.obgyn.net/pcos/ . The subject line is very easy to see and you can easily pick and choose which posts you wish to veiw and which are of no interest. No wonder people come on here and are screaming for help to get off of the mailing list! No wonder the instructions tell us to cut out everything but the necessary parts when we are responding to a post!

Now, Victoria,

I am glad you said you changed the subject line or I would never have seen this post. I almost skipped over it tonight anyhow. The way this particular post came through is very confusing. The arrows and italics that differentiate between the original post and the new post are not correct. I may have missed something you have said.

You said:

>>> At the bottom of the first page for Ortho Cyclen and TriCyclen reference,
>"The information contained in this package insert is principally based on
>studies carried out in patients who used oral contraceptives with higher
>formulations of estrogens and progestogens than those in common use today. The
>effect of long term use of the oral contraceptives with lower formulations of
>both estrogens and progestogens remains to be determined."

That is true. All oral contraceptives are required to carry certain warnings that are based on the findings of the original testing. The only way around this rule is for the manufacturer to preform other studies and present them to the FDA proving their claim that the pill they make is exempt. If the FDA approves, the warning can be removed. A recent example of this is the removal of the cancer warning from saccarine.

You also said: (I am putting this in so it is easier to identify, just in case the post is odd again.)

I also didn't see >anything in the contraindictions list regarding insulin resistance.

It wouldn't have anything about insulin resistance. Decreased glucose metabolism is enough. That is the standard by which we currently measure insulin resistance. The real test for insulin resistance is very costly and only done in a research setting. Those of us who have had the Glucose Tolerance Test with insulin levels (I-GTT) have really only been tested for decreased glucose metabolism and hyperinsulinemia (high levels of insulin). When our body is unable to get rid of the glucose in our system, we pump out more insulin to compensate. While the I-GTT is the test we use, it is not very sensitive, but it is the best we have right now.

You wrote:

Under #8, it >said that "Oral contraceptives have been shown to cause a decrease in glucose
>tolerance in a significant percentage of users. (But this also said that this
>information is based on studies for different formulations that what we have
>now.) 17 This effect has been shown to be directly related to estrogen dose. ##
>(unable to read). Progestogens increase insulin secretion and create insulin
>resistance, this effect varying with different progestastional agents. 17, 85?
>However, in the non-diabetic woman, OC's appear to have no effect on fasting
>blood glucose. 57? Because of these demonostrated effects, prediabetic and
>diabetic women in particular should be carefully monitored while taking OC's. In
>clinical studies with oral
>contraceptives there were no clinically significant changes in fasting blood
>glucose levels. No statistically significant changes in mean fasting blood
>glucose levels were observed over 24 cycles of use. Glucose tolerance tests
>showed minimal, clinically
>insignificant changes from base to cycles 3, 12, and 24." (About the same is
>said for Ortho TriCyclen).

>>> On Diane 35, it said that "Although COCs may have an effect on peripheral
>insulin resistance and glucose tolerance, there is no evidence for a need to
>alter the therapeutic regimen in diabetics using COCs. However, diabetic women
>should be carefully
>observed while taking COCs."

The first number you were unable to read was 65. There is a magnifying glass in the tool bar of Acrobat that will make the text larger. :-) The second number was a 66. The third was 67. I do not see any place in that paragraph for #8 that indicates that this information was based on a different formulation indicating that it does not apply to this (or any other) pill. If we are non-diabetic women, we should consider ourselves pre-diabetic since is seems so clear that there is a link between PCOS and an insulin problem. Women with PCOS have a FAR greater likelyhood of becoming diabetic that the general population. By age 40, 40% of us will have diabetes. We do not have to be overweight in order to have this insulin problem. Some physicians who do research on PCOS have stated that probably *ALL* women with PCOS would test insulin resistant if the test were sensitive enough. We should be "carefully monitored when taking oral contraceptives". Any further decrease in our glucose metabolism could be significant. Again I will use the example of Glucophage: if you have poor liver function, you probably should not take Glucophage even if you have PCOS and think that it might help you.

>> If the studies were done on higher dosages, this could make a difference in
>the side effects also. There are references in here in regards to changes, but
>it does say that some of them are clinically insignificant. I didn't see
>anything on glucose tolerance on Yasmin. Maybe I am confusing the known side
>effect with the possible side effect. Can you explain this more indepth, please?

If you look at the Yasmin information just below table III the insert clearly states that "Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogen may create a state of hyperinsulinism." We as women with PCOS are already at risk for diabetes, hyperlipidemias, obesity and lower HDL. (By-the-way, did you see the circulatory disease mortality rates for Yasmin? I was so shocked by the rates, I had to show them to someone when I was doing some research. I was so glad that I had never been a smoker!)

A known side effect is simply a side effect that has been reported. Usually this is from the stage when the product is being researched and tested since doctors are required to send in information about the medication. Sometimes this can be a side effect that is reported after the med has been on the market. Doctors are not as quick to send information in at that point but it can happen.

>From a previous post, I wrote and you responded: (See how it appears
that your response came before my statement? It is usually so clear but this post must have hit the internet waves at a particularly strange second. Oh, well, I hope you can read my reply without any trouble.)

>Decreased glucose metabolism is a known side effect on *all* oral
>contraceptives that I have seen. I have linked the prescribing
>information for a couple of birth control pills for other people on this
>board. Here are some examples for you to see. Package insert for Ortho
>Cyclen and Ortho Tri-cyclen:
>http://www.ortho-mcneil.com/products/pi/pdfs/cycltri.pdf. The
>information for Diane-35 and Dianette:
>http://www.inhousepharmacy.com/bcp-hormones/diane-35-information.html.
>Yasmin: http://www.yasmin-us.com/home.html. Those are all of the BCPs
>that I can think of right off of the bat, but all of these mention
>decreased glucose metabolism as a possible side effect.
>
>Weight loss is a known side effect of metformin but not everyone gets
>it.
>
>If you have a syndrome or a disease process that already incorporates a
>decrease in glucose metabolism you would be wise not to take a
>medication that has a known side effect of making it worse. This is the
>same for women with liver dysfunction -- I would not recommend
>metformin.
>
>>> True. However, the studies in the previous OC's don't mention separating out
>PCOS women from other women either.

I am not sure what your point is here. You are correct in stating that the oral contraceptives (OC) did not separate out the women with PCOS. PCOS has just gained the attention of researchers in the last +/- 3 years. It has only been in these last couple of years that it has been known that we have a problem with insulin resistance. (O.K. there was that study in 1989 but it wasn't repeated of followed up on until 1999. One study is not significant. In order for a study to carry any weight, it must be repeated.) Since we must assume that the research was done on the general population, we must assume that out of every 100 women that were involved in the research for the pill, only 8 - 15 of them had PCOS. It is not a big stretch to assume that out of those 8 - 15 of them, approximately 20% dropped out of the study (as well as approx. 20% of the other women, this is the current drop out rate for medical studies in my area.) This leaves 6 - 12 women, a number that is potentially statistically insignificant. This is because many of us do not have a high fasting glucose level and a problem could easily be missed. By the time we have a high fasting glucose level, we are severely insulin resistant.

You wrote:

>(By the side title note of "Oral Contraceptives", "A recent uncontrolled study
>of 16 non-diabetic
>hyperandrogenic women treated with a combined oral contraceptive containing 150
>µg of desogestrel and 30 µg of ethinyloestradiol (my note: this should be
>Desogen) demonstrated a significant deterioration in glucose tolerance over six
>months, with two women developing frank diabetes.38 This raises doubts about the
>short and long term safety of ovarian
>suppression in polycystic ovary syndrome with oral contraceptives. The effects
>of individual oral contraceptives on glucose tolerance will now need to be
>studied specifically in polycystic ovary syndrome before their use can be
>advocated.
>

Wow! That is particularly telling. That is scary! The effects need to be studied before their use can be advocated in PCOS. Wow. You have just given me support for what I have been saying all along. We should NOT be taking the pill as a treatment for PCOS. It is for birth control only. Now, I am thinking that I should recommend other methods of birth control. The higher than average incidence of diabetes is awful. I would have to see this study repeated in a more controlled atmosphere but the preliminary results are discouraging.

You wrote:

>>> http://nicho_v.tripod.com/qbcp.html "You might want to check out or ask your
>doctor to read the Journal of Clinical Endocrinology and Metabolism's Vol. 80
>no. 11 article on pages 3327-34 about the 'Metabolic effects of oral
>contraceptives in women with polycystic ovary syndrome'. This article says that
>a reduction in insulin resistance happened. There is also a good article from S.
>Nader, M. Riad-Gabriel, and M. Saad on, 'The effect of a desogestrel-containing
>oral contraceptive on glucose tolerance and leptin concentrations in
>hyperandrogenic women' in the Journal of Clinical Endocrinology and Metabolism,
>Year 1997, issue 82, pages 3074-307"
>
>>> I might suggest looking at the archives or past postings on obgyn.net's birth
>control forum. The posts I have seen state a possible gain of 5 pounds, the rest
>are lifestyle changes that have nothing to do with OC's. Those are the responses
>that I've seen so far.

I have personal access to medical journals I have been involved in research at some level since 1987, but frankly, I probably will not be looking these articles up. I am not trying to prevent a pregnancy and I have many other things on my plate that I would rather do. There is no personal or professional reason why I would spend my time looking up these two articles. The evidence against women with PCOS using the BCP as a treatment is fairly overwhelming both in the testing of the pill and in incidental evidence. It seems surprising that a study would indicate that there was a reduction in insulin resistance with OCs when everything else has shown that there is a potential problem. I am ultimately more concerned with the insulin levels in non-diabetic women with PCOS than the glucose level. As I mentioned before, when we get to the point that our glucose levels are effected, we are not doing very well.

One thing did concern me greatly about the website, the reference was to women with PCO. We have PCOS. There is a difference. About one quarter of the women have polycystic ovaries and that is all. We are in a different group. We have PCOS, meaning that there is a specific group of related symptoms that we may or may not have. We may or may not have cysts on the ovaries, we may or may not have significant weight gain. We may or may not have facial hair, etc. PCOS is entirely different from PCO. We cannot afford to confuse the two different terms. There has been much discussion about finding a new name for what we have because of the confusion but so far nothing has changed. There have also been many women who come to this site frightened because they have been told that they have Poly-Cystic Ovaries and they are afraid that they are going to develop all of the symptoms that are listed on the PCOSupport homepage.

The women on the obgyn.net birth control page may or may not have PCOS. A good deal of women with PCOS have a difficult time getting pregnant and therefore would not be likely to visit the birth control page. We have a metabolic problem that other women do not share. The experiences of the women on the birth control page would have little relavance to the women on this page. I would always place more weight on the women that I have seen clinically and personally in the last 16 years. >
>Victoria
>

--
Belle

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