Tuesday, October 7, 2014

Life cycles - from baseball to black cohosh



The 2014 Kansas City Royals baseball team closed the door on a 29 year cycle of unsatisfying baseball. After decades of not reaching the post season, the KC Royals finally made it. And they did it with style. Whatever happens next, the 2014 KC Royals re-set the clock. KC baseball fans will watch future seasons through eyes of hope and not obligation. My nephew (who is a huge baseball fan) will at least have this one season. 

When I think back on my formative years growing up in Kansas City, I remember three major regional events:
  • In 1981, two walkways collapsed at the new Hyatt Regency Hotel in KC. Over 100 people were killed and about 200 people were injured. This was tragic for the families and friends of those who died and were harmed as well as for the community. It was not a "war zone" by any means, but it was quite horrible. (KC public library website accessed October 6, 2014).

  • In 1983, Hollywood descended upon Lawrence, KS and turned the lovely city that houses the University of Kansas into a fictitious war zone. I never saw the 1983 TV movie drama The Day After, but I absolutely remember when it was made! Part of the movie was filmed in Lawrence and they used local actors whenever possible. It seemed like everyone I knew auditioned for it.


  • And, of course, I fondly remember the 1985 Kansas City Royals baseball team that featured the legendary George Brett. Prior to 1985, I rarely watched baseball, but these guys were so fun that even I was filled with Kansas City pride. I have been willing to watch and follow baseball ever since. I even enjoy it.


https://www.flickr.com/photos/chrism70/7570912402/

A lot has happened in the 29 years since the KC Royals baseball team made it to the post-season. For example, I graduated from high school, left the state of Kansas and moved all around. Over the past 29 years:
  • Babies were born.
  • Some of us were able to attend college and some of us graduated.
  • We made friends, lost friends, made other friends...but one way or another, we dealt with it.
  • The internet happened. 
  • We've dealt with the death of our family members, friends and other loved ones.
  • We've had all sorts of major "first" events in our lives. We've won, lost, succeeded and failed. We always move on from these experiences. Sometimes we learn from them, but not always.
  • We've gotten jobs, lost jobs, found new jobs, changed careers (or tried), some of us have gone back to school, and some of us never really left.
  • We've found short-term and long-term partners to share the ups and downs of our lives. We've made formal commitments to special people. Some of us have broken them. It's hard, but we deal with it.
  • Some of us have children and some of us don't. Whether they are our own children or those of our family and friends, we share in their joys, sorrows, successes and failures. Sometimes, when we pay attention, we get to see the world from their perspective. In a blink of an eye, these children move on from first words and walking to first dates and driving. Some of these children have children themselves.

We have the ability to live more youthful lives at older ages. Grandparents don't seem or look like grandparents anymore. Some of my friends are grandparents. Some of my friends have kids in diapers. We are all about the same age. We have the flexibility to move through life at an individualized pace and we have the luxury to set and follow unique goals and priorities. 

All this individuality leaves me yearning for certainties. Regardless of how the World Series turns out this year (and they will win), the Royals are an inspiration. As I said, they re-set the clock for me as a fan and I look forward to and can count on the return of regular season Royals baseball in the spring. 

I also count on science. I love biochemistry and biology. Based on posts I've recently encountered in social media news feeds, I think many of my friends can also count on biology whether they want to or not. 


Oh yes, it's menopause time. Pull out a fan, buy some lubricant and contemplate the pros and cons of things like black cohosh. 



What is black cohosh?

Black cohosh is part of the buttercup family of plants and is native to North America. There are two main forms of black cohosh - Cimicfuga racemosa and Actcea racemosa. Below is a picture of black cohosh growing wild.



"Cimicifuga racemosa 001". Licensed under Creative Commons Attribution-Share Alike 3.0 via Wikimedia "Cimicifuga racemosa 001". Wikimedia Commons http://commons.wikimedia.org/wiki/File:
Cimicifuga_racemosa_001.jpg#mediaviewer/
File:Cimicifuga_racemosa_001.jpg









Black cohosh can be and has been consumed as a tea, tincture, and a pill (usually a softgel capsule). The Cimicfuga racemosa form is native to North America and may have more bioactive potential. 

Different cultures have used black cohosh to regulate menstrual cycles and reduce the discomfort associated with many different ailments ranging from rheumatism to fatigue. Black cohosh has most commonly been used to alleviate menopausal discomforts such as mood swings and hot flashes. To date, black cohosh is not an officially recommended treatment for any condition. Despite this, women experiencing symptoms of menopause often turn to black cohosh.



Will black cohosh reduce symptoms of menopause?

What does the research say?

At this time, there is not enough research available to make a recommendation for or against the use of black cohosh as a treatment to alleviate symptoms associated with menopause. Some evidence suggests black cohosh supplements (mostly from Cimicfuga racemosa formmay be helpful in reducing menopausal symptoms such as hot flashes. The effect is mostly seen when the supplement is used for up to 6 months, although not all research supports this. Office of Dietary Supplement - Review of Black Cohosh

According to the Office of Dietary Supplements, part of the problem they face when evaluating the efficacy of black cohosh is that there is a lack of well-designed published research about it.

Here is what I've learned:
  • Different research studies use different preparations (formulations) and dosages of black cohosh.This makes comparing results across multiple studies virtually impossible.
    • The stems and roots of black cohosh contain what are believed to be the active component(s) of the plant. If other parts of the plant are used the active component(s) could be missing or diluted. Also, we need consistency with regard to what parts are being used across preparations (stems and roots, just stems, just roots). 
    • Using different extraction techniques may impact the active components of the final product. Sometimes it is unavoidable, but it may matter and should be minimized whenever possible. 
    • Different studies use different dosages and have people take the supplements for different periods of time. This makes comparing outcomes hard if not impossible.
  • Different studies measure different outcomes
    • It is important that researchers use validated assessment tools to measure survey data (self-reported data and interviewer-collected data). There needs to be consistency in what symptoms are measured and how they are measured. Symptoms that might be measured include frequency and intensity of hot flashes, insomnia and depression. Blood tests can be used to examine hormones. Tissue samples can be obtained to examine changes in the vaginal epithelium (these changes lead to vaginal dryness). 
  • Lack of rigorous control in clinical trials
    • There are not enough randomized, placebo-controlled clinical trials (RCT defined) that test the ability of black cohosh to alleviate menopausal symptoms. 
      • Studies are needed that focus on healthy women
      • There is a need for long term (longitudinal) studies that continue for at least 6 months and possibly extend as long as 12-24 months. 
      • It is important to investigate the effect of black cohosh when taken with and without hormone replacement therapy. 
      • Another factor to consider may be where in the menopausal cycle a woman is when black cohosh use begins (perimenopause, menopause, postmenopause). It may be that black cohosh is more effective during one phase of menopause than another.
    • All black cohosh preparations need to be prepared at the same time using the same methods.  
      • This is a challenge with any type of plant chemical (phytochemical) research. 
      • Many types of phytochemicals vary in response to environmental exposure. Climate impacts the phytochemical content of a plant. For example, plants coming out of a drought year may have a different phytochemical composition than plants during a normal year or a flood year. 
When I searched ClinicalTrials.gov for Black Cohosh + Menopause (October 3, 2014), I got 15 hits with one study in the "recruiting" phase, one listed as "terminated", two identified with "unknown" status, and the remainder listed as "completed." 



Are black cohosh supplements considered food or drug?

All dietary supplements sold in the United States fall under the category of "food" and therefore are not considered drugs. This means that they do not undergo the same monitoring as drugs do and are not held to the same standard. The Food and Drug Administration (the FDA) investigates  a dietary supplement when and only when there have been a large number of health and safety complaints about a specific supplement.

What does it mean that dietary supplements are not regulated by the FDA?

  • Manufacturers of dietary supplements are not required to provide documents to the FDA proving that their products are effective or safe.
  • Dietary supplement manufacturers are not required to test for consistency in their products. 
  • If you ever experience adverse effects in response to a supplement contact your healthcare provider right away and let them know what you have taken (always let your healthcare provider know what supplements you take). If your symptoms are serious, your healthcare provider will probably initiate contact with the FDA. You can as well. 
    • The FDA only gets involved once they have had a number of complaints about serious adverse health complications in response to a dietary supplement. 


Dietary Supplement Labels

If you purchase black cohosh, the label will indicate what you have purchased. The scientific name, common name, and what part of the plant was used to make the dietary supplement will be contained within the confines of the label. 





The front panel shows the common name of the product and what you will find in the bottle (a capsule). This particular label also tells you the scientific name.







It's hard to see here, but the back portion of this bottle contains what is called the Supplement Facts panel. This is the portion of the label that is like the Nutrition Facts panel on a food label. The serving size in the label pictured here is 1 capsule.

Manufacturers are required to provide specific pieces of information within the Supplement Facts panel:

  • Serving Size refers to the how much the manufacturer recommends that you take of the supplement at a given time.
    • This must be listed in units like tablet, capsule, teaspoon, etc.
    • This must also include directions about how much and often to take the supplement.
    • They must also include how much of the supplement is in a serving size
      • For example, the bottle of black cohosh pictured above provides 540 mg of black cohosh per serving. According to the label, a serving is defined as one capsule. 
  • Servings per Container reflects how many servings are in the unopened package. This information must be provided unless the servings per container is the same as the net quantity of contents in the container.
  • Manufacturers must provide the common name and scientific name of the dietary supplement. Manufacturers must also include the portion or portions of the plant used to make the product. 
  • If any total calories, calories from total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, or iron are present at measurable levels it must be reported.
  • An Ingredients List must be included just like on food labels. This list includes the names of dietary ingredients used to make the supplement. 
  • Manufacturers are required to provide the company name and contact information (address) on every label.

If a manufacturer decides it wants to make a structure/function claim (for example, they might say "Supports Positive Mood") the manufacturer must also include the following statement, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease."


FDA Food Labeling Guidelines (accessed on October 6, 2014)



Is black cohosh safe?

There have been reports of adverse reactions to black cohosh. Reports of stomach discomfort and headaches are the most common. There have been some reports of liver damage with black cohosh use, but these are rare. The most severe instance I am aware of occurred after a woman took the package-recommended dose for 3 weeks. She got very sick, had liver failure, and had to undergo a liver transplant. Doctors found no other cause for her liver failure other than black cohosh use. 

It is always important to discuss supplement use with your primary healthcare provider and pharmacist. If you ever experience abdominal pain, dark urine color, or jaundice when taking black cohosh it is recommended that you stop taking the supplement immediately and go see your primary healthcare provider right away.



The evidence may be inconclusive, but I'm going to try black cohosh. 


1. Talk to your healthcare provider. If you decide that you want to try black cohosh supplements, please talk to your healthcare professional to let them know about your decision. There are some underlying health conditions that may be incompatible with the use of black cohosh.

2. Be patient (always easy for someone experiencing hot flashes and/or mood wings!). Seriously though, be prepared to wait a bit. It is not uncommon for black cohosh to take time. Part of the reason we need more longitudinal studies to test the effectiveness of black cohosh is because it is believed that it takes time for it to work. It may take a few months of ingestion before there is any effect.

3. Set realistic expectations. We live in a society where we can be in our mid-40s and at a strong point in a successful career, or struggling to make ends meet, or starting to discover who we are (perhaps doing it again), or be at the beginning part of raising a child. Biology, however, is on a totally different time frame. Menopause may have arrived or may be lurking around the corner regardless of where we are in life. Menopause is natural and inevitable. 

The KC Royals reset the time clock for fan expectation and reversed 29 years of disappointment the moment they won the Wildcard game. Women cannot do that. We cannot reset our biological time clocks. Why would we want to? We are who we are, where we are and when we are. There is no herbal supplement in the world that can change that. We are only going to be disappointed if we expect more than any supplement can potentially give. Potentially give. The best black cohosh or any supplement can do under the best of circumstances is offer nutritional support through a process. It is up to us to embrace it.



Some resources about black cohosh and menopause

(all accessed October 1, 2014 and again on October 6, 2014)