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Caffeine intake & bone density..what’s the scoop?

Wednesday, November 11th, 2015

By Morgan Bailey, PharmD Student Cedarville University School of Pharmacy

In college and even in the workplace, caffeine has consumed our lives. Our generation turns to caffeine to give us the burst of energy that we need to make it through the day. According to Healthresearchfunding.org, almost 90% of people in the world consume at least one beverage with caffeine in it daily.1 These beverages would include coffee, energy drinks and soda or pop. Caffeine is considered to be a stimulant to the body, which is why whenever you drink a lot of caffeine you tend to feel more energized and awake. Even though we may get a great feeling from these drinks, are they really being beneficial to our bodies? Recent evidence debates whether consuming large amounts of caffeine can increase your risk for osteoporosis.

Image courtesy of samuiblue at FreeDigitalPhotos.net

Image courtesy of samuiblue at FreeDigitalPhotos.net

Osteoporosis is condition where your bones become brittle and can make you become more at risk of breaking or fracturing your bones. Research on this topic leads some to believe that the caffeine stops the absorption of calcium in the bones, therefore causing them to become thin. Studies have also shown that caffeine acts on the bone promoting an increase of calcium excretion, inhibition of osteoblast proliferation and delay in tissue repair process, raising the risk of fractures, osteoporosis, periodontal disease and affecting the success of bone reconstructive procedures.2, 3

In 2015, The European Journal of Clinical Nutrition published a study looking at the influence of dietary patterns on bone mineral density and osteoporosis. This was a cross-sectional study that looked at Brazilian women aged 45 and over. The five categories retained were; “healthy”, red meats and refined cereals”, “low-fat dairy”, “sweet foods, coffee and teas”, and “western”. After analyzing that data that they received, they found that excessive sweet foods and caffeinated beverages appeared to have a negative affect on the bone mineral density. Although the study did find a negative effect on the bone density, they could not make a direct link to increased risk of osteoporosis. This was also a cross-sectional study, which was only looking at a specific time period; other results may have been revealed with a longer follow up study.4 In addition, recall bias may have affected the results due to patients self-reporting diet. There was also not any specific type of caffeine separated out (ie is there a difference between coffee, tea, or soda).

Similar findings were found in a 2006 study that found women with high coffee consumption, more than four cups a day, had an increase risk of bone fractures.5 On the other hand, a 2012 systemic review of multiple trials, concluded coffee intake did not increase risk of bone fractures, however suggested more research is needed.6 In 2013, a study was conducted on the long-term effects of coffee consumption and how that relates to the risk of bone fractures. The researchers found that there was no increased risk when the women drank low amounts of coffee, but when they drank more than four cups per day then they found that there could be a reduction in density of the bones.7 This cannot be directly linked to osteoporosis, but is considered a possible risk factor.

While it is not completely clear whether or not caffeine intake (or which type of caffeine) can increase the risk of osteoporosis and bone fractures, there is a lot of promising research being done to answer these questions. It appears there is a trend that over 4 cups a day may be an issue. If you are someone that drinks a lot of caffeine throughout the day, you could discuss supplementing with calcium and/or vitamin D and also consider limiting the amount of caffeine that you consume in a day and increase exercise.8, 9

Even though you may not be seeing the results of your caffeine intake now, would you still drink the same amount of caffeine if you knew that it could potentially hurt you in the future?

References

  1. 25 Shocking Caffeine Addition Statistics. HRF website. http://healthresearchfunding.org/shocking-caffeine-addiction-statistics/. August 30, 2014. Accessed October 20, 2015.
  2. Hallstrom H. Coffee consumption in relation to osteoporosis and fractures: Observational studies in men and women. DiVA. 2013.
  3. Vanin, Carla, Harter ,Danielle, Ribeiro RV,Pinto, Kato ,Sergio, Dibi R,Papandreus, Stein ,Airton. Effects of caffeine intake on bone tissue in an animal model of osteoporosis. 2015. 10.1016/j.maturitas.2015.02.185
  4. De Franca N.A.G., Camargo M.B.R., Lazaretti-Castro M., Peters B.S.E., Martini L.A. Dietary patterns and bone mineral density in brazilian postmenopausal women with osteoporosis: A cross-sectional study. Eur J Clin Nutr. 2015; doi: 10.1038/ejcn.2015.27. [Epub ahead of print]
  5. Hallstrom H, Wolk A, Glynn A, Michaelsson K. Coffee, tea and caffeine consumption in relation to osteoporotic fracture risk in a cohort of swedish women. Osteoporos Int. 2006; 17(7):1055-1064.
  6. Huifang L, Ke Y, Wenjie Z, Jun Z, Taixiang W, Chengqi H. Systematic review/Meta-analysis
coffee consumption and risk of fractures: A meta-analysis. Arch Med Sci. 2012;8(5).
  7. Hallstrom H, Byberg L, Glynn A, Lemming EW, Wolk A, Michaelsson K. Long-term coffee consumption in relation to fracture risk and bone mineral density in women. Am J Epidemiol. 2013; 178(6):898-909.
  8. Sanders S, Geraci SA. Osteoporosis in postmenopausal women: Considerations in prevention and treatment: (women’s health series). South Med J. 2013; 106(12): 698-706.
  9. Suzanne Sanders, M.D., Stephen A. Geraci, M.D. Osteoporosis in postmenopausal women: Considerations in prevention and treatment (women’s health series).

Acetaminophen: Is it Really Your Safest Option?

Friday, November 6th, 2015

By Tori Bumgardner, PharmD Student Cedarville University

Acetaminophen has long been a popular over-the-counter product used to treat pain and fever in both adults and children (1). It is recommended to women as the preferred pain medication while pregnant. The FDA has been approved for dosing in individuals of all ages, from infants to adults, who may be suffering from pain or fevers (2). While it is known that acetaminophen causes liver damage to people who take it at high doses for an extended period of time, recent studies have investigated the possibility that it can lead to dangerous levels of toxins in the body, potentially increasing the risk of attention deficit hyperactive disorder (ADHD) and even autism (3,4). The buildup occurs when one of the metabolites of acetaminophen, N-acetyl-p-benzoquinone imine (NAPQI), inhibits the detoxification of reactive oxygen species (ROS) in the body (5). When ROS builds up, inflammation can occur, giving it the potential to cause ADHD or autism. Additionally, a meta-analysis was conducted looking at the correlation between use of acetaminophen during pregnancy and occurrence of asthma in offspring (6). The study found that mothers who used acetaminophen while pregnant increased the risk of their child developing asthma. This blog post will review the recent evidence on the dangers associated with pre-natal exposure to acetaminophen.

Image courtesy of David Castillo Dominici at FreeDigitalPhotos.net

Image courtesy of David Castillo Dominici at FreeDigitalPhotos.net

A study from 2014 examined the relationship between mothers who took acetaminophen during pregnancy and the subsequent occurrence of ADHD in their children (4). In this study, 1714 European children were followed for 11 years and their mothers were surveyed when the children were newborn, 1, 3.5, 7, and 11 years old. For the newborn interview, information on the mothers’ pregnancy was collected. The other interviews were focused on the child, paying special attention to cognitive development, behavior, and physical activity. In the final interview, at age 11, the children also completed and interview that asked about topics like behavior, emotions, and self-esteem. The investigators examined the relationships between different drugs that were taken during pregnancy with the results of the strengths and difficulties questionnaire that were completed throughout the study. Interestingly, it was found that the group who used acetaminophen showed higher difficulties and lower social scores. The findings of this study indicate that acetaminophen use during pregnancy is correlated with higher rates of ADHD in children. Limitations to the study included a low follow-up rate, lack of generalization since the study was specific to European women and their children, and a possibility of selection bias if both parents were already predisposed to ADHD. Authors concede that additional research should be done to determine the actual risks associated with exposing children to acetaminophen at young ages. Other data found that children whose mothers used acetaminophen while pregnant had a higher incidence of behavior problems and hyperkinetic disorders (HKDs) like ADHD during a follow up when the children were seven years old (7). Due to the safety concern in allowing pregnant women to continue taking acetaminophen, since research seems to suggest its harm, the FDA has begun looking into the issue (8).

Though research is not yet conclusive, they encourage women to talk to their healthcare providers before taking anything.While it is always a good recommendation to talk to a doctor first, what does that leave women to use when they are in pain, but don’t have time to see or call the doctor, and are left with no options to provide relief? There are certainly alternatives available that don’t include drugs and can help relieve pain caused by headaches and aching in other parts of the body. Sometimes headaches are caused by stress and can be helped by practicing relaxation through deep-breathing, yoga, or any other technique that is convenient and will divert their mind off stress-inducing stimulation (9). A regular sleeping schedule is also important and exercise can help to relieve headaches, so taking a nap or a walk are both ways to relieve stress and pain without taking medication. Pain in other parts of the body may be troublesome, but a gentle massage or an external, topical pain relief product can be used to help establish comfort.

The data is still uncertain on the magnitude of risk with acetaminophen use in pregnant women, it is best to err on the side of caution and avoid use if possible. At the end of the day, the question that is left is one of risk versus benefit. Since nothing is conclusive about the danger that acetaminophen may have on babies, is it ultimately worth the risk to use it as a quick fix for a couple of hours free of pain?

 

References:

  1. Medline Plus: Trusted Health Information for You Web site. https://www.nlm.nih.gov/medlineplus/druginfo/meds/a681004.html. Published 08-15-2014. Updated 2014. Accessed October 16, 2015.
  2. DailyMed (package inserts). National Institutes of Health; National Library of Medicine.  http://dailymed.nlm.nih.gov/dailymed/ (accessed October 26, 2015).
  3. Jennifer Margulis PD. Could A common painkiller cause brain inflammation — and even autism — in children? http://reset.me/story/could-a-common-painkiller-cause-brain-inflammation-and-even-autism-in-children/. Published 09-08-2015. Updated 2015. Accessed 10-16-2015.
  4. Thompson JMD, Waldie KE, Wall CR, Murphy R, Mitchell EA, the ABC study group. Associations between Acetaminophen Use during Pregnancy and ADHD Symptoms Measured at Ages 7 and 11 Years. Hashimoto K, ed. PLoS ONE. 2014;9(9):e108210. doi:10.1371/journal.pone.0108210.
  5. Shaw W. Evidence that increased acetaminophen use in genetically vulnerable children appears to be a major cause of the epidemics of autism, attention deficit with hyperactivity, and asthma. Journal of Restorative Medicine. 2013;2:1. Accessed October 26, 2015. doi: 10.14200/jrm.2013.2.0101.
  6. Cheelo M, Lodge CJ, Dharmage SC, et al. Paracetamol exposure in pregnancy and early childhood and development of childhood asthma: A systematic review and meta-analysis. Arch Dis Child. 2015;100(1):81.
  7. Liew Z, Ritz B, Rebordosa C, Lee P,Olsen J. Acetaminophen use during pregnancy, behavioral problems, and hyperkinetic disorders. JAMA Pediatrics. 2014;168(4):313-320.
  8. FDA drug safety communication: FDA has reviewed possible risks of pain medicine use during pregnancy. U.S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm429117.htm. Published 01-09-2015. Updated 2015. Accessed October 16, 2015.
  9. Krinsky D, Ferreri S, Hemstreet B, et al. Headache. In: Young L, ed. Handbook of nonprescription drugs: An interactive approach to self-care. 18th ed. Washington, DC: American Pharmacists Association; 2015:65-83-95. Accessed 10-16-2015.

A Natural Approach to Preventing Gestational Diabetes

Monday, October 26th, 2015
image courtesy of freedigitalphotos.net

By Katie Woodward, PharmD Student

You are having a new baby! Congratulations! You’ve probably already had several opportunities to answer that age-old question, “What gender are you hoping for?” And it is likely you responded with something like, “I don’t care as long as my baby is healthy!” Thanks to new scientific research, your chances of delivering a healthy baby are constantly improving.

We are going to play a quick game of “Bad News/Good News.” The bad news: gestational diabetes may cause complications in your pregnancy. Several factors may put you at risk of developing gestational diabetes. If diabetes runs in your family, if you are overweight, not very active, or over the age of 40 you are at risk of developing gestational diabetes.1 Gestational diabetes can cause jaundice, high birth weight, trauma during birth, increase necessity for C-section, and increase likelihood of obesity or diabetes in the child.1,2 Gestational diabetes also puts a new mother at risk of developing Type 2 Diabetes, which can require insulin injections and other treatments to control.

Now, for the good news: new research has demonstrated that myo-inositol is a supplement you can take which significantly decreases your chances of developing gestational diabetes, even if you are at high-risk.3 For those already diagnosed with gestational diabetes, taking a myo-inositol supplement can help decrease your need for insulin, make you more likely to carry the baby to term, and decrease your infant’s chances of developing hypoglycemia.3 Standard treatment for gestational diabetes requires the patient to check blood sugar levels in the morning and after meals, which can require several needle sticks per day as well as the purchase of a glucometer, test strips, and lancets.4 Insulin injections are also used to help control the blood sugar in up to 20% of women with gestational diabetes.4

A research study published in the Journal of Maternal-Fetal and Neonatal Medicine was designed as a prospective, double-blind, randomized controlled clinical trial which compared a placebo group to a group of mothers who supplemented with myo-inositol twice daily.3 The myo-inositol group had significantly better outcomes including lower maternal BMI, longer gestation at the time of delivery, and decreased abnormal oral glucose tolerance test results. The oral glucose tolerance test is the standard screening measure for gestational diabetes.  One limitation was that the study was relatively small. Some of the data may have been statistically significant if there had been more women involved in the study; for instance, the myo-inositol group had a lower incidence of neonatal hypoglycemia, but the data was not quite strong enough to be statistically significant. Another interesting statistic is that 21% of women in the placebo group required insulin therapy, while only 3% of women in the myo-inositol group required insulin therapy. While larger studies may be needed to validate this data, this study demonstrated that at least 50% of women who take myo-inositol may benefit from the treatment.3 Since the current standard of care for prevention of gestation diabetes is diet change and monitoring blood sugar, myo-inositol may be an easy and beneficial way to minimize complications from gestational diabetes.  It also has a promising potential to minimize the requirement of insulin injections.

Since it is a compound naturally found in both your body and your baby’s body, you can safely consume myo-inositol supplements.5 The product may be a little bit difficult to find in grocery stores, but it can be found in combination products or ordered online. According to research, the supplement is best if taken 2000 mg twice daily (make sure you separate the doses by at least six hours.)One product can be purchased from Fairhaven Health6 where you can get a 60-day supply for less than $20.* Myo-inositol is often combined with another compound called D-chiro inositol, which has also been demonstrated to assist with gestational diabetes.7 The combination product is called Ovasitol and it can be purchased online from Theralogix Nutritional Science Company, but it must be ordered online and can cost up to $1 per day ($90 for a 90 day supply.)8 Another product to consider is called Sensitol, and it contains D-chrio inositol, myo-inositol, and alpha lipoic acid. The product can be ordered online and a thirty day supply is $52.9

Gestational diabetes can have some scary consequences for you and your baby. Based on the evidence, I would recommend that any mother who has increased risk of gestational diabetes should discuss supplementation with myo-inositol with their medical provider.   It could help prevent or minimize problems associated with gestational diabetes. Myo-inositol may be expensive and may not be easily accessible to all; since it is commonly used as a preventative supplement, do you think that pregnant women at high risk for developing gestational diabetes should consider it as an option?

*The manufacturer suggests that the drug be taken four times daily, but in studies, the 2000 mg dose was only recommended twice daily.3 Also, this will help decrease the cost of the drug.

**Note: The Cochrane Collaboration is working on a new study to further describe the dosing and efficacy of myo-inositol as a treatment/ prevention method for gestational diabetes and it should be released soon.

References

  1. Available at: http://www.cdc.gov/diabetes/pdfs/library/diabetesreportcard2014. Accessed October 14, 2015.
  2. Brown J. Myo-inositol for preventing gestational diabetes. Cochrane Database Of Systematic Reviews [serial online]. February 2, 2015;(2)Available from: Cochrane Database of Systematic Reviews, Ipswich, MA. Accessed October 11, 2015.
  3. Matarrelli B, Vitacolonna E, Celentano C, et al. Effect of dietary myo-inositol supplementation in pregnancy on the incidence of maternal gestational diabetes mellitus and fetal outcomes: a randomized controlled trial. The Journal Of Maternal-Fetal & Neonatal Medicine: The Official Journal Of The European Association Of Perinatal Medicine, The Federation Of Asia And Oceania Perinatal Societies, The International Society Of Perinatal Obstetricians [serial online]. July 2013;26(10):967-972. Available from: MEDLINE with Full Text, Ipswich, MA. Accessed October 11, 2015
  4. Available at: http://www.mayoclinic.org/diseases-conditions/gestational-diabetes/basics/treatment/con-20014854. Accessed October 21, 2015.
  5. D’Anna R, Scilipoti A, Di Benedetto A, et al. myo-Inositol supplementation and onset of gestational diabetes mellitus in pregnant women with a family history of type 2 diabetes: a prospective, randomized, placebo-controlled study. Diabetes Care [serial online]. April 2013;36(4):854-857. Available from: MEDLINE, Ipswich, MA. Accessed October 11, 2015.
  6. Available at: http://www.fairhavenhealth.com/myo-inositol.html?cmp=bing&kw=myo-inositol&utm_source=BingShopping&utm_medium=CSE&utm_campaign=myo-inositol. Accessed October 14, 2015.
  7. Costantino D, Guaraldi C. [Role of D-chiro-inositol in glucidic metabolism alterations during pregnancy]. Minerva Ginecol. 2014;66(3):281-91.
  8. Available at: http://www.theralogix.com/index.cfm?fa=products.ovasitol.default&dvsn=reprohealth. Accessed October 14, 2015.
  9. Available at: http://catalog.designsforhealth.com/Sensitol?quantity=1. Accessed October 21, 2015.

Melting Away the Pounds: The Cold Facts

Monday, November 17th, 2014

By: Sara Hill, PharmD Student

As the holidays rapidly approach, more and more people start to think about losing weight for their family functions or maintaining their current weight throughout a food-laden season. However, despite the urge to snap up the first weight loss supplement that we hear advertised, we have to remember the importance of evaluating each product to decide if it is our best option. One supplement that fits that description is Garcinia cambogia, a growingly popular herbal supplement that Dr. Oz and others believe to be a good choice to help us lose weight.

In June, a journal called Phytotherapy Research published a study that researched Garcinia cambogia to determine how effective it truly is. (In case you are wondering, phytotherapy is the use of plants and plant products for medicinal purposes.) The researchers wanted to see if Garcinia cambogia made a difference in several health values, including weight, body mass index (BMI), waist-hip ratio, and percentage of fat mass in the body. The study involved two groups of women whose BMI values were greater than 25 (BMI >25 is considered obese). The first group of women was given Garcinia cambogia for 60 days and put on a diet that reduced their calorie intake. The second group of women was given a placebo and put on a diet that reduced their calorie intake in the same way as the first group of women. After 60 days, the researchers compared the health values of the women who had taken the supplement and those who hadn’t. Although the study identified that G. cambogia helped to lower the women’s triglycerides (a cholesterol marker), the weight, BMI, waist-hip ratio, and percentage of fat mass was not significantly different between the two groups of women.1 Although the study provided useful information, it did not account for ways that different groups of people gain and lose weight. Men and women gain weight differently, as do young people and elderly people. Furthermore, the study only accounts for the lifestyle and diet of a particular geographic location. The diet the researchers chose may not be reasonable for women (or men) in other parts of the world.

This study only contributes to a growing collection of studies examining Garcinia cambogia. Several studies have been conducted on the benefits of taking G. cambogia, but they do not always come to the same conclusion. Studies published in the late 90’s found that G. cambogia did not cause significant weight loss.2 However, studies from 2000 and 2004 shows that G. cambogia actually does lead to weight loss.2

Our decision to take or not to take Garcinia cambogia involves several things. First, we have to know that G. camgobia has not been proven save, although no studies have seen any harmful effects­­3. However, G. cambogia has been on the market before as a part of other weight loss supplements that caused safety concerns. It was one of the key ingredients in several versions of Hydroxycut that were removed from the market because of safety concerns. Furthermore, multiple cases of liver damage have led to concerns that G. cambogia is poisonous to the liver. Yet another case reported that G. cambogia interacts with some prescription medications (like antidepressants) and causes harmful levels of certain compounds in the body. Finally, we must remember that no one has conducted an extensive safety study on G. cambogia to identify the risks that go along with taking it. Without being fully aware how likely we are to be harmed, we cannot compare the risks and benefits and therefore make a fully educated decision.

Second, we have to know if G. cambogia is effective. As we have already discussed, the studies that tested how effective the supplement is do not agree with each other. One possible explanation suggests that some forms of G. cambogia work better because your body can absorb it better than the other forms. When more of the supplement makes it into your body, it can actually have its full effect. The scientists who proposed this reasoning recommend looking for bottles that list G. cambogia in the potassium and calcium salt forms instead of simply one or the other, or a completely different salt altogether. (Please note that the term “salt” here does not refer to standard table salt but to the chemical structure that allows the compound to get into your body. You should look for a product like this one that lists calcium and potassium as the salt forms.) The scientists who evaluated the calcium/potassium form of G. cambogia found positive results, indicating that G. cambogia does lead to significant weight loss.

Finally, our decision to take G. cambogia should include a comparison to standard weight loss methods. Our primary study compared women taking G. cambogia to women not taking it, but both groups of women decreased the number of calories in their diet, and both groups of women lost weight. The standard weight loss methods of diet and exercise should always be our first approach (although they are certainly difficult to accomplish during the holidays). By focusing on eating healthier foods (fewer fatty and fried foods, fewer carbs, and less sugar) in appropriate quantities and spending more time being physically active, you may find that additional weight loss techniques are no longer needed. Supplements like G. cambogia should only become an option once you’ve tried these other weight loss techniques and should be used carefully to meet your specific physical needs.

Because weight loss is often such a pressing concern, we are usually tempted to choose what seems to be the easiest, fastest option. However, due to the concerns presented above, G. cambogia does not seem like the best option. Until further tests examine the safety of the supplement as well as the effectiveness of the particular salt forms, you are probably better off staying away from it.

But what do you think? Would you feel comfortable taking Garcinia cambogia to supplement your weight loss efforts? Would you expect it to be effective?

Works Cited:

  1. Vasques, C.A.R.; Schneider, R.; Klein-Junior, L.C.; Falavigna, A.; Piazza, I.; Rossetto, S. Hypolipemic Effect of Garcinia cambogia in Obese Women. Phytotherapy Research. 2014;28(6):887-891.
  1. Downs, B.W.; Bagchi, M.; Subbaraju, G.V.; Shara, M.A.; Preuss, H.G.; Bagchi, D. Bioefficacy of a novel calcium-potassium salt of (-)-hydroxycitric acid. Mutat Res 2005;579: 149-162.
  1. Chuah, L.O.; Yeap, S.K.; Ho, W.Y; Beh, B.K.; Alitheen, N.B. In Vitro and In Vivo Toxicity of Garcinia or Hydroxycitric Acid: A Review. Evidence-Based Complementary and Alternative Medicine. 2012;1155(10) 12 pages.

Nicotine Patches Fail Most Pregnant Women

Friday, November 14th, 2014

By Kara Bobka, PharmD Student

In 2011, 10% of pregnant women reported smoking during the last trimester.1 Smoking during pregnancy can lead to miscarriages, premature births, placenta problems, birth defects, and infant death.1 The standard treatment for smoking cessation is behavioral therapy, like staying active or chewing gum, and support groups. Nicotine replacement therapy (NRT), such as over-the-counter nicotine patches, provides a way to help pregnant women achieve smoking cessation or stop smoking.2 Nicotine patches are applied directly to the skin, where they release a nicotine source that is then absorbed through the skin to decrease withdrawal symptoms for up to twenty-four hours.2,3 Yet, most recommend wearing the patch for sixteen-hours to give the body a break from nicotine and to decrease the potential for skin irritation.3

Patches fight symptoms of anxiety, cravings, irritability, restlessness, increased appetite, low mood, and poor concentration that are associated with smoking withdrawal. 3 However, two recent meta-analyses4,5 and one well-powered study6 showed that standard NRT doses (15 mg a day) are ineffective with pregnant women smokers when used for eight months or less. To address the effectiveness of NRT in pregnant smokers, a randomized, double blind, multicentre trial in the British Medical Journal (BMJ) confirms nicotine patches are no more effective than placebo at increasing either smoking cessation rates or birth weights even when nicotine doses are adjusted to individuals and given at higher doses. 7  

 What They Did

Berlin et al. randomized 402 pregnant women smokers (≥5 cigarettes per day) from 23 French maternity wards to receive either nicotine or placebo patches.7 All were ≥18 years of age and between 9 and 20 weeks gestation.7 All had to have health insurance. 7 More so, participants were motivated to stop smoking.7

Participants were given a two-week grace period between their initial and first follow-up visit for a chance to either stop smoking or to reduce cigarette consumption (<5 per day) on their own.7 This was necessary because people must be asked to quit smoking before using NRTs.7 Pregnant women can only be prescribed NRTs if they are unable to stop alone.7 Failing to either quit or reduce cigarette use, patients were eligible to continue, where they set a quit date and began the study.7 Smoking cessation was monitored via monthly measurements of saliva nicotine levels.7

Therapy lasted from quit date to the end of pregnancy, where women were either given 16-hour delivery nicotine patches (10-15 mg), similar to those produced in the US, or an identical placebo manufactured specifically for the study.7 For those who received active patches, daily doses ranged between 10-30 mg and were adjusted based on initial saliva nicotine levels.7 Behavioral support was provided at each visit.7

Primary outcomes were complete smoking cessation (self reported and confirmed via spirometry-confirmed carbon monoxide levels ≤8ppm) and birth weight.7 Secondary outcomes were self-reported smoking abstinence and birth characteristics.7

 What They Found

Results demonstrated that 11 of 96 (5.5%) and 10 of 76 (5.1%) women in the nicotine patch and placebo patch groups, respectively, achieved complete smoking cessation (P=0.87).7 42% in the nicotine patch group and 37% in the placebo patch group decreased their consumption of cigarettes by half.7 After two weeks, 62% had smoked again.7 More so, the nicotine patch did not decrease tobacco cravings or withdrawal symptoms or the number of cigarettes smoked.7 Average birth weights of groups did not differ significantly.7 Yet, newborns of mothers who were able to quit had a notably higher birth weight than those who were unable to stop smoking.7

Study limitations included that the subjects were women who smoked at least five cigarettes a day. So, results are hard to generalize to other expecting smokers. More so, the treatment began after the first trimester. It may be more effective to begin treatment earlier since smoking abstinence before 15 weeks gestation has yielded comparable birth outcomes to those of non-smokers.8 Another study conducted in England showed NRT combinations to be effective versus single or no NRT use.9 Despite other findings and its limitations, this study shows a lack of effectiveness of NRTs in pregnant women smokers and thereby a lack of birth characteristics’ improvements.

 What To Tell Patients

Although NRT has been shown to help others quit smoking, its effects on pregnant women remain unclear.   Earlier treatment with NRT during pregnancy may be more beneficial, although no evidence is to suggest that at this point. So, the best way to achieve smoking cessation is via behavioral therapy and support.7

To stop smoking, the Center for Disease Control and Prevention (CDC) recommends five great behavioral therapies. These include: asking family and friends for support; developing a quit plan or joining a quit program; staying busy (Get active. Chew gum. Drink water.); avoiding smoking triggers (Toss cigarettes, lighters, and ashtrays. Avoid caffeine.); and staying positive, yet vigilant.10 To successfully stop smoking, it takes time, but you can! So, reward yourself after the first 24 hours. You deserve it! Your baby will thank you!

If you smoked and wanted to quit, what actions would you take? Would you try a nicotine patch?

 

Bibliography and References Cited

 

  1. Tobacco use and pregnancy. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/reproductivehealth/tobaccousepregnancy/. Published August 5, 2014. Updated 2014. Accessed October 26, 2014.
  2. American Society of Health-System Pharmacists, Inc. Nicotine Transdermal Patch. MedlinePlus: Trusted Health Information for You. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601084.html. Published June 13, 2013. Updated September 24, 2014. Accessed October 26, 2014.
  3. Nicorette® 16hr Invisipatch. Nicorette. http://www.nicorette.com.au/products/16hr-patch. Updated September 29, 2014. Accessed October 26, 2014.
  4. Coleman T, Chamberlain C, Cooper S, Leonardi-Bee J. Efficacy and safety of nicotine replacement therapy for smoking cessation in pregnancy: systemic review and meta-analysis. 2011;106(1): 52-61.
  5. Coleman T, Chamberlain C, Davey MA, Cooper SE, Leonardi-Bee J. Pharmacological Interventions for promoting smoking cessation during pregnancy. Cochrane Database Syst Rev. 2012;9:CD010078.
  6. Coleman T, Cooper S, Thornton JG, Grainge MJ, Watts K, Britton J, Lewis S. A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy. N Engl J Med. 2012;336:808-18.
  7. Berlin I, Grangé G, Jacob, N, Tanguy ML. Nicotine patches in pregnant smokers: randomized, placebo controlled, multicentre trial of efficacy. BMJ. 2014;348(1622):1-16.
  8. McCowan LM, Dekker GA, Chan E, Stewart A, Chappell LC, Hunter M, et al; SCOPE consortium. Spontaneous preterm birth and small for gestational age infants in women who stop smoking early in pregnancy: prospective cohort study. 2009;338:b1081.
  9. Brose LS, McEwen A, West R. Association between nicotine replacement therapy use in pregnancy and smoking cessation. Drug Alcohol Depend. 2013;132:660-664.
  10. Tips From Former Smokers. Centers for Disease Control and Prevention. http://www.cdc.gov/tobacco/campaign/tips/quit-smoking/guide/steps-on-quit-day.html. Updated March 24, 2014. Accessed October 26, 2014.

 

An Aspirin a Day Keeps Breast Cancer Away?

Wednesday, November 5th, 2014

By Lauren Haines, Pharm.D. student

According to the American Cancer Society, one in eight U.S. women will develop breast cancer in their lifetime.1 Breast cancer involves cancer cells forming a tumor in the breast tissue. Risk factors include: women ages 65 and older, inherited genetic mutations, two or more close relatives diagnosed at an early age, postmenopausal obesity, use of combined estrogen and progestin menopausal hormones, cigarette smoking, alcohol consumption, and women who breastfed for a long time. Currently, breast cancer is treated with surgery, radiation therapy, systemic therapy, chemotherapy, hormone therapy, and targeted therapy. Treatment with surgery is the most common and involves removing cancer from the breast to determine the disease severity. However, other methods may also be used to kill the cancer cells such as chemotherapy and radiation. These methods have many side effects that women must choose to endure to treat their cancer, including increased risk of uterine cancer, pain, hair loss, nausea, vomiting, fatigue, increased risk of infections, and depression.1

A new method researchers are evaluating to help prevent death from breast cancer is the use of aspirin. In a recent article by Michelle Holmes and colleagues, researchers evaluated the relationship between aspirin use and breast cancer survival. Researchers identified women newly diagnosed with breast cancer and then assigned them one of three groups, which were either to not receive any daily dose (75mg to 160mg depending on where it was bought) of aspirin, receive less than one daily dose of aspirin, or receive one or more daily doses of aspirin. Patients were followed throughout the study, for up to five and a half years, to determine if they died from breast cancer. When the women taking at least one daily dose of aspirin were compared to those not taking any aspirin in the last six months of the study, there was about a 4% decreased risk of death from breast cancer in the women taking the aspirin. However, the women taking less than a daily dose compared to those not taking any aspirin had about a 3% increased risk of death from breast cancer. The limitations of this study included that aspirin could be bought over-the-counter, so anybody could buy it without pharmacy record; low dosages were only available through prescriptions; and researchers lacked additional clinical data on breast cancer characteristics and treatment.2

Although using aspirin is still being researched to determine its effect on breast cancer patients, it may be a good option for women aside from standard treatment options. Current methods involve aggressive strategies to destroy breast cancer and prevent future cases, which must be authorized by a doctor or surgeon.  Aspirin is available over-the-counter, which would provide easy access for patients who can’t receive other types of treatment. However, aspirin does have side effects of its own that patients should be aware of, including: nausea, vomiting, stomach pain, and heart burn. Aspirin can also cause decreased blood clotting, which may cause increased bleeding. Also, aspirin shouldn’t be used during pregnancy, and it has many drug interactions with blood pressure, water, and blood thinner medications.3

Although the previous article doesn’t provide clear evidence that aspirin decreases death from breast cancer, other articles support its conclusions. In another article, researchers tested the effect of aspirin used with tamoxifen, a prescription drug used to treat breast cancer, to determine if the combination of the medications helped with the treatment. Researchers found that aspirin helped balance blood protein levels when used with tamoxifen, which improved treatment. However, research showed an increased risk of bruising and upset stomach with aspirin and tamoxifen therapy.4 Other research evaluated the use of aspirin while also using beta-blockers and ACE inhibitors, common drugs used to promote breast cancer patient survival.5 Results showed the use of aspirin with these drugs helped promote the survival process versus the use of the drugs without aspirin by increasing survival rate by more than 50%.5 Evidence also showed the use of aspirin greatly reduced the risk of developing breast cancer in women.6 However, the use of ibuprofen (Advil) and acetaminophen (Tylenol) didn’t reduce breast cancer risk like aspirin did. Ibuprofen had a slight reduction in breast cancer risk, but acetaminophen had no relationship with it. Aspirin especially showed a reduction in postmenopausal women.6 Research on the frequency of aspirin use and potential breast cancer diagnosis concluded that women using aspirin more than six times a week had a 23% decreased risk of developing breast cancer and was not associated with altering hormones.7

Thus, aspirin may be an appropriate choice for women with a high risk of developing breast cancer and women who have been diagnosed with it previously. Aspirin doesn’t require a prescription, so patients can easily buy it usually at a lower cost than many prescription medications. However, patients should consult their primary care physicians before taking aspirin to ensure they are not taking other medications that would interact with it, and that aspirin has potential to help them. Patients should also receive additional advice from loved ones to ensure they support their decision to use aspirin.  With both a decreased risk in developing breast cancer and an increased promotion of breast cancer survival, aspirin may be a good option for women.

Would you recommend aspirin to a friend diagnosed with breast cancer or who may have a risk of developing breast cancer?

 

References

 

  1. American Cancer Society- Breast Cancer. http://www.cancer.org/breastcancer/index. Updated 2014. Accessed October 3, 2014.
  1. Holmes MD, Olsson H, Pawitan Y, et al. Aspirin intake and breast cancer survival – a nation-wide study using prospectively recorded data in sweden. BMC Cancer. 2014;14(1):1150-1165.
  1. Aspirin. Aspirin: MedlinePlus Drug Information Web site. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682878.html#side-effects. Updated 2014. Accessed October 3, 2014.
  1. Holmes CE, Jasielec J, Levis JE, Skelly J, Muss HB. Initiation of aspirin therapy modulates angiogenic protein levels in women with breast cancer receiving tamoxifen therapy. CTS: Clinical & Translational Science. 2013;6(5):386-390.
  1. Holmes MD, Hankinson SE, Feskanich D, Chen WY. Beta blockers and angiotensin-converting enzyme inhibitors’ purported benefit on breast cancer survival may be explained by aspirin use. Breast Cancer Res Treat. 2013;139(2):507-513.
  1. Chung CT. Association of frequency and duration of aspirin use and hormone receptor status with breast cancer risk. Women’s Oncology Review. 2004;4(4):279-281.
  1. Bardia A, Olson JE, Vachon CM, et al. Effect of aspirin and other NSAIDs on postmenopausal breast cancer incidence by hormone receptor status: Results from a prospective cohort study. Breast Cancer Res Treat. 2011;126(1):149-155.

New research finds acetaminophen use during pregnancy is associated with ADHD in offspring

Tuesday, November 4th, 2014

By: Jeremy Flikkema Cedarville University PharmD Student

Acetaminophen is a commonly recommended over the counter medication given to pregnant women for treating mild pain. Recently however, the safety of this medication was put under investigation after JAMA Pediatrics published a study that found links between acetaminophen use and attention deficit/hyperactivity disorder (ADHD).1 This is alarming because acetaminophen is preferred over other pain killers. Non-steroidal inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and aspirin are not recommended during pregnancy due to potential birth defects in the offspring.2

ADHD is characterized as a behavioral disorder affecting 5-10% of the school age population.1 Symptoms include inability to concentrate, impulsivity, and/or hyperactivity all of which can impact performance at work and school. Acetaminophen use during pregnancy led to an increase probability of their offspring taking ADHD medications and developing a hyperkinetic disorder.3 To clarify, hyperkinetic disorders are a more severe form of ADHD.

The recently published Danish prospective cohort interviewed 64,322 live-born children and mothers from 1996-2002.1 They did three telephone interviews during pregnancy followed by a fourth interview six months after giving birth. In this study, over half of the women had admitted to taking acetaminophen at some point during pregnancy. The characteristics of interest were hyperkinetic disorders, use of ADHD medications, and/or having ADHD-like behaviors at age 7. All three of these variables were found to be significantly increased due to acetaminophen use. Increased frequency of use and long duration (more than 1 trimester) both increase the associations that were observed. This study’s strength was the large sample size, prospective study design that eliminated recall bias by the mothers, and because it measured more than one variable. However, the limitation of this study was the design type.3 Cohort studies only infer association not causation. Therefore, results must be interpreted cautiously until further research is done.

Additional research has been done regarding this topic. A Norwegian prospective cohort found that acetaminophen use for more than 28 days or more correlated with reduced gross motor skills, delay in walking, increased activity, reduced communication skills, and attention-seeking behavior.4 This study supports the association between acetaminophen use and ADHD. Another study tested the effect of other drugs (aspirin, antacids, and antibiotics) and found no correlation in regards to behavioral difficulties at age 7.3 These strengthen the evidence that acetaminophen use increases the risk of ADHD.

Before this research, acetaminophen was considered safe to use throughout all trimesters of pregnancy for pain, fever, and colds and was used by 55 to 65% of pregnant women.5 These new research findings suggest potential changes to the standard of care, further prospective research is required to determine if acetaminophen is the true cause. Until then acetaminophen during pregnancy should be used with caution and only when necessary. There are many different ways to relieve pain in a non-pharmacological manner such as; sleeping with lots of pillows for support, drinking lots of water, gentle exercise, massages, and taking warm baths, music, and yoga can increase the health of your baby.6 There are many harmful effects that medications can have on our bodies that may still be unknown. If however, the medication is used, it is of uttermost importance to limit the duration and frequency.

Knowing the potential risk with Acetaminophen use and ADHD, do you think the risk outweighs the benefit?

 

Bibliography:

  1. Liew Z, Ritz B, Rebordosa C, Lee PC, Olsen J. Acetaminophen use during pregnancy, behavioral problems, and hyperkinetic disorders. JAMA Pediatr. 2014;168(4):313-320.
  2. CAZACU I, FARCAŞ A, MOGOŞAN C, BOJIŢĂ M. Safety of over-the-counter medication in pregnancy. sometimes a dilemma. Clujul Medical. 2011;84(3):348-354.
  3. Thompson JMD, Waldie KE, Wall CR, Murphy R, Mitchell EA. Associations between acetaminophen use during pregnancy and ADHD symptoms measured at ages 7 and 11 years. PLoS ONE. 2014;9(9):1-6.
  4. Brandlistuen RE, Ystrom E, Nulman I, Koren G, Nordeng H. Prenatal paracetamol exposure and child neurodevelopment: A sibling-controlled cohort study. Int J Epidemiol. 2013;42(6):1702-1713.
  5. Blaser JA, Allan GM. Acetaminophen in pregnancy and future risk of ADHD in offspring. Can Fam Physician. 2014;60(7):642-642.
  6. Pritham U, McKay L. Safe Management of Chronic Pain in Pregnancy in an Era of Opioid Misuse and Abuse. JOGNN: Journal Of Obstetric, Gynecologic & Neonatal Nursing [serial online]. September 2014;43(5):554-567. Available from: CINAHL Plus with Full Text, Ipswich, MA. Accessed November 3, 2014.

 

 

How can you help your baby if you are smoking and pregnant?

Tuesday, October 28th, 2014

By Samantha Smolinski, PharmD Student

Approximately 50% of women who smoke before pregnancy continue to smoke after pregnancy. Smoking during pregnancy has been shown to cause some adverse effects on the baby. These adverse effects include lifelong decreases in lung function, an increased risk for asthma, low birth weight, shortened pregnancy terms, miscarriage, and infant mortality.1,2 The standard of care for pregnant women who smoke is to suggest that they quit.3

Many women have difficulty quitting smoking. Research has shown that when women join smoking cessation programs like Freedom From Smoking through the American Lung Association or FreshStart from the American Cancer Society to help them quit smoking, they are more likely to quit due to social support and encouragement.4,5 Women have reported that when they were living with another person who smoked, it was much harder for them to quit smoking and remain a non-smoker. In addition to this, many women claim that they found quitting easier when their significant other was supportive of their decision.6 Another common option to aid the mother in her journey to quit smoking is nicotine replacement therapy. Nicotine replacement therapy involves substituting cigarettes with pure nicotine, so that the patient maintains the same level of nicotine in the blood to reduce withdrawal symptoms. The amount of nicotine the patient receives is gradually reduced overtime until the patient can comfortably quit smoking. The forms for this replacement therapy can come in patches, gums, lozenges (dissolved in mouth), inhalators, nasal sprays, and microtabs. Nicotine replacement therapy increases the chances for someone to quit smoking by approximately 80%.4 However, this therapy may cause some adverse pregnancy outcomes and potential malformations. Although malformations may occur, studies have shown that this side effect may be less harmful than those adverse effects that result from smoking during pregnancy.3 In addition to the potential side effects, nicotine is absorbed faster in pregnant women than in non-pregnant women, which means that standard uses of this therapy may not be applicable to pregnant women.4

Recently, a randomized, double-blind trial was conducted with one hundred fifty-nine newborns of pregnant smokers and seventy-six newborns of pregnant non-smokers. Smoking pregnant women were randomly placed in groups where sixty-three received vitamin C 500 mg and eighty-three received a placebo.1 Vitamin C was chosen for this study because there have been multiple studies that have shown that it has a protective effect on lung function.7 After the women had their babies, pulmonary function tests were performed on the babies within seventy-two hours after birth and again a year later. The tests that were conducted a year later were only for the babies of the smoking pregnant due to institutional review board regulations. The first outcome included the measured pulmonary function tests within seventy-two hours of birth and the second outcome included pulmonary function tests at one year as well as the incidence of wheezing. Results suggested that women who smoked while they were pregnant and taking vitamin C 500 mg improved their newborn pulmonary function and decreased the chance of wheezing within one year when compared to the offspring of women who were pregnant and smoking in the placebo group. This study was conducted because of a prior study that had been done on pregnant rhesus monkeys.1 This study had shown that the offspring of the pregnant monkeys with nicotine treatment and vitamin C supplementation had increased pulmonary functions when compared to the offspring of the pregnant monkeys who were only treated with nictotine.7 Thus, vitamin C can be an inexpensive and simple approach to decrease the adverse effects smoking has on pregnancy.4

Vitamin C supplementation can bring additional benefit to women who are smoking and pregnant. This can help the adverse effects that smoking has on the baby’s lung function after birth. Although quitting is still the best choice for pregnant women and their babies, vitamin C supplementation can be useful by helping the baby if the mother smokes intermittently (through part of the pregnancy or through the entire pregnancy.) My recommendation to patients would be to quit smoking as soon as possible and that the best way to do this is through the support of others. In addition to quitting, they should take a daily 500 mg vitamin C supplement which has shown benefits for the babies of women who smoke during pregnancy. Vitamin C can be found over the counter at a relatively low price.

What changes are you willing to make to help your baby?

 

References:

  1. McEvoy CT, Schilling D, Clay N,et al. Vitamin c supplementation for pregnant smoking women and pulmonary function in their newborn infants: A randomized clinical trial.JAMA. 2014;311(20):2074-2082.
  2. Pollack H, Lantz PM, Frohna JG. Maternal smoking and adverse birth outcomes among singletons and twins.Am J Public Health. 2000;90(3):395-400.
  3. Forinash AB, Pitlick JM, Clark K, Alstat V. Nicotine replacement therapy effect on pregnancy outcomes.Ann Pharmacother. 2010;44(11):1817-1821.
  4. Coleman T. Recommendations for the use of pharmacological smoking cessation strategies in pregnant women.CNS Drugs. 2007;21(12):983-993.
  5. Lando HA, McGovern PG, Barrios FX, Etringer BD. Comparative evaluation of american cancer society and american lung association smoking cessation clinics.Am J Public Health. 1990;80(5):554-559.
  6. Flemming K, Graham H, Heirs M, Fox D, Sowden A. Smoking in pregnancy: A systematic review of qualitative research of women who commence pregnancy as smokers.J Adv Nurs. 2013;69(5):1023-1036.
  7. Proskocil BJ, Sekhon HS, Clark JA, Lupo SL,

Plan B- No Age Limit?

Friday, October 18th, 2013

By Jacob Farran, PharmD Student at Cedarville University School of Pharmacy

 

The Plan B One-Step emergency contraceptive, commonly referred to as “the morning after pill,” has always been surrounded by controversy. As a behind the counter medication, the morning after pill used to only be able to be purchased by anyone who is 17 years or older without a prescription. Now, even more dispute is occurring because a new drug application was submitted to the FDA that allows Plan B to be sold without a prescription to anyone without age restrictions.1 The FDA approved of this and lifted the age restriction. This means that any person can now purchase Plan B without a prescription and without talking to her physician or pharmacist.  Plan B works by taking a large dose of the hormone levonorgestrel that can work in three possible ways including delaying ovulation, interfering with fertilization of the egg, or preventing the implantation of a fertilized in the uterus by altering its lining.3 The prevention of implantation is controversial, however it works by a similar mechanism to oral contraceptives.2 If Plan B does prevent implantation, it could act as a form of abortion if one considers life beginning at fertilization. There is great debate on where life begins since an egg is not viable without implantation. Plan B’s effectiveness was found to be between 52% and 94% in preventing pregnancy.4

This article reported that the age restriction on Plan B would be lifted and it was lifted shortly after this article was written, as there is no age restriction on Plan B now. The article also voiced opinions both for and against the decision to remove the age limit on Plan B. Annie Tummino, a coordinator of the National Women’s Liberation, said that women and girls should have “the absolute right to control our bodies without having to ask a doctor or a pharmacist for permission.” She went on to say, “It’s about time that the administration stopped opposing women having access to safe and effective birth control.”1 Cecil Richards, the president of Planned Parenthood Federation of America said the government’s decision to drop the appeal was “a huge breakthrough for access to birth control and a historic moment for women’s health and equity.”1 These two people and groups were obviously supporting the change to no age requirement. Others such as the anti-abortion group Family Research Council criticized the government by saying, “We’re very concerned and disappointed at the same time because what we see here is the government caving to political pressure instead of putting first the health and safety of women (and) parental rights.”1 President Obama is against the age change. He said, “As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.”1

I agree with the anti-abortion group and President Obama that there needs to be an age limit on the Plan B pill. A women under 17 at least needs to talk to her healthcare provider about the risks and benefits before making a decision that big. My recommendation would be for young women to consult their parents and healthcare provider before using Plan B.  This article was limited due to a limited scope of opinion. Only opinions of politicians and organization leaders were included.  There were not any pharmacists or health care providers that voiced their opinion in this article. There is not any scientific evidence saying that we should or should not have an age restriction on Plan B; however, the intentions of this medication are to prevent conception of a baby. Statistics show that Plan B is successful in preventing more than 50% of pregnancies and is associated with side effects.

Should there be an age limit or not?

References

 

1.) Obama administration says it will allow all girls to have morning-after pill access | Fox News. (2013, June 11). Fox News Politics. Retrieved October 2, 2013, from http://www.foxnews.com/politics/2013/06/11/federal-govermment-to-comply-with-new-york-morning-after-pill-ruling/

 

2.) How emergency contraceptives (the morning after pill) prevent pregnancy. (n.d.). Emergency Contraception. Retrieved October 16, 2013, from http://ec.princeton.edu/questions/ecwork.

 

3.) Plan B One-Step. (2012, August 5).WebMD Women’s Health. Retrieved October 2, 2013, from women.webmd.com/guide/plan-b

 

4.) Update on Emergency Contraception: Effectiveness . (2011, March 1).Association of Reproductive Health Professionals. Retrieved October 16, 2013, from http://www.arhp.org/Publications-and-Resources/Clinical-Proceedings/EC/Effectiveness