ACOG update: Letrozole is the first line therapy for ovulation induction in PCOS

The American College of Obstetricians and Gynecologists (ACOG) now recommends Letrozole (aromatase inhibitor) as the first-line treatment for ovulation induction in women with Polycystic Ovarian Syndrome (PCOS) due to data demonstrating increased ovulation rates, clinical pregnancy rates and live-birth rate vs clomiphene citrate. The guidelines are published as Practice Bulletin No. 194 in the June issue of Journal Obstetrics and Gynecology.

This replaces the Practice Bulletin Number 108, published October 2009, which recommends letrozole as first-line therapy for ovulation induction only in women with PCOS and a BMI greater than 30.

It is estimated that polycystic ovary syndrome (PCOS) affects 1 in 10 women of childbearing age and it is the most common cause of ovulatory infertility. If lifestyle modifications and weight loss are unable to achieve conception, currently clomiphene citrate (CC) is usually prescribed as the first-line treatment for ovulation induction.

  

The gonadotropin-stimulating action of letrozole has been used off-label in the treatment of patients with ovulatory dysfunction, such as polycystic ovary syndrome.

The results of recent double-blind, multicenter trial show that letrozole was associated with higher live-birth (27.5% vs 10.1%) and ovulation rates (61.7% vs 48.3%) among infertile women with the polycystic ovary syndrome as compared to CC.

Women on letrozole also had a 40% higher clinical pregnancy rate (OR 1.40 95% CI, 1.18-1.65) and 64% increased live birth rate (OR 1.64 (95% CI, 1.32-2.04) as compared to CC.

If prescribing letrozole, the starting dose is 2.5 mg/day for 5 days typically starting on day 3, 4, or 5 after a spontaneous menses or progestin-induced bleed. If ovulation does not occur, the dose can be increased to 5 mg/day for 5 days with a maximum dose of 7.5 mg/day. Doses higher than 7.5 mg/day have been associated with thinning of the endometrium as seen with clomiphene citrate.

Lifestyle modification and weight loss are strongly encouraged along with letrozole therapy.

Several studies have also shown that letrozole is also the drug of choice in clomiphene non-responders with 50–80% women ovulating on letrozole.

Letrozole and clomiphene citrate are pregnancy category X drugs, and studies have demonstrated similar rates of congenital malformation in mothers who achieved pregnancy because of ovulation induction using these drugs.

When prescribing letrozole for ovulation induction, patients should be counseled that unlike clomiphene citrate, letrozole is not approved by the U.S. Food and Drug Administration for ovulation induction.

More recent papers on PCOS:

Fresh or frozen-embryo transfer results in similar pregnancy rates in women without PCOS

The therapeutic dilemma in PCOS patients not desiring pregnancy: A systematic review and meta-analysis

Clomiphene compared with other drugs in terms of ovulation, EMT, pregnancy and live births: systematic review and meta-analysis

Stair-step clomiphene protocols shorten time to ovulation in women with PCOS

Preconception IGT in PCOS results in adverse pregnancy outcome, independent of BMI

New study quantifies the risk of developing type 2 Diabetes in women with PCOS

Polycystic ovarian syndrome increases the risk of subsequent early ovarian aging later in life

PCOS is often underdiagnosed as the common cause of Abnormal Uterine Bleeding in Adolescents

Letrozole does not increase the risk of adverse pregnancy or neonatal outcomes and major congenital anomalies in patients conceived by ARTs

ACOG calls upon all obstetrician-gynecologists to screen PCOS patients for metabolic abnormalities.

Current options for ovulation induction in Polycystic Ovarian Syndrome (PCOS)

PCOS and Infertility: Pretreatment Weight loss hikes the live birth and ovulation rate in overweight and obese patients. 

PracticeBulletin No. 194

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Landmark cancer prevention report puts forth a blueprint to reduce the risk of cancers

The American Institute for Cancer Research (AICR) and the World Cancer Research Fund (WCRF) recently issued an evidence-based blueprint for healthy living that could prevent nearly half of all cancer cases.

This is the 3^rd report in the series of expert reports Diet, Nutrition, Physical Activity, and Cancer: A Global Perspective, and updates the two previous comprehensive reports, which were published in 1997 and 2007.

The report has distilled evidence of 30 years of research into 10 recommendations that could help prevent cancer by lifestyle modification. The report is based on a review of data from 51 million people, including 3.5 million cancer cases in 17 cancers.

The evidence shows that a modification in your diet, staying physically active, having a healthy body weight and other health-related choices can prevent 12 cancer diagnoses. These include breast, colorectal, pancreatic, endometrial, ovarian, prostate, liver, gallbladder, kidney, bladder, stomach and esophageal cancers.

In 2012, an estimated 14.1 million new cases of cancer occurred worldwide, with nearly 1 in 6 deaths due to cancer.

Biology Computes

“The evidence is clear that making changes to diet and exercise and maintaining a healthy weight cuts cancer risks, regardless of age. The message may not be glamorous, but these changes can save your life,” said Kelly Browning, Chief Executive Officer of AICR.

The ten recommendations are:

1) Maintaining a healthy weight is the most important thing you can do to reduce your risk of cancer. Aim to be in the lower end healthy Body Mass Index (BMI) range.

2) Be physically active-incorporate physical activity as a part of your daily life. Walk more and sit less, for maximum health benefits, aim for 150 minutes of moderate, or 75 minutes of vigorous, physical activity a week.

3) Eat a diet rich in vegetables, fruits, whole grains, and beans. AICR recommends a plant-based diet that forms at least two-thirds of your plate.

4) Limit the intake of fast food. There is strong evidence that consuming "fast-foods" and a "Western-type" diet are causes of weight gain, overweight and obesity, which are linked to 12 cancers. Glycemic load also increases the risk for endometrial cancer.

5) Limit red meat and avoiding processed meat - red meat includes beef, pork and lamb and processed meat includes ham, bacon, salami, hot dogs, sausages.

6) Limit consumption of sugar-sweetened beverages- Whenever you feel thirsty drink water or unsweetened beverages.

7) Limit alcohol consumption- alcohol in any form is a potent carcinogen. It's linked to 6 different cancers. The best advice for those concerned about cancer is not to drink.

8) Do not take the supplement for cancer prevention-Aim to obtain nutrition from diet instead of popping the supplements. The panel doesn’t discourage the use of multivitamins or specific supplements for those sub-sections of the population who stand to benefit from them, such as women of childbearing age and the elderly. But, dietary supplements will not avoid cancer.

9) Mothers, please breastfeed your baby- There is a strong evidence that breastfeeding your baby protects against breast cancer later in life.

10) If you are already diagnosed with cancer, you should follow the nutritional advice from an appropriately trained professional. For breast cancer survivors, there is persuasive evidence that nutritional factors and physical activity reliably predict important outcomes from breast cancer.

The report emphasizes the need for knowledge about the link between lifestyle and cancer. In a 2017 AICR Cancer Risk Awareness Survey more than 50% of the population who responded was not aware of the link between obesity and cancer.

The report provides robust evidence for healthcare professionals and government officials to advise the patients about healthy eating and making policies that make healthy eating more affordable.  

AICR today launched Cancer Health Check – an easy-to-use tool, which shows how your lifestyle stacks up against known cancer risks and outlines the changes you can make to follow AICR’s evidence-based Cancer Prevention Recommendations.

ACIR News Release

Cancer Health Check – an easy-to-use tool

Diet, Nutrition, Physical Activity, and Cancer: A Global Perspective, the Second Expert Report

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Here is a video about AICR 10 recommendations for cancer prevention.

Younger age at hysterectomy linked to increased risk of heart disease later in life

Ovarian conservation at hysterectomy does not reduce the risk of future cardiometabolic diseases reports the results of large prospective cohort study published in Menopause, the journal of The North American Menopause Society (NAMS).

This is one of the few studies that focuses on long term effect of hysterectomy with ovarian conservation. Earlier studies have documented strong evidence between increased incidence of cardiovascular diseases(CVD) and other chronic diseases after hysterectomy with bilateral oophorectomy.

The risk was especially increased if the hysterectomy was carried out before the age of 35.

Using Epidemiological project record, the researchers identified 2094 women who underwent hysterectomy with ovarian conservation between 1980 and 2002. Each woman was age matched with a control residing in the same county and who have neither undergone hysterectomy nor bilateral oophorectomy.

Cox proportional hazard models and Kaplan-Meier analysis was used to calculate hazards ratios and absolute risk after taking into consideration 20 risks factors and other potential confounders.

The two cohort were followed up for a period of 22 years, and women who have undergone hysterectomy were at increased risk of obesity, hyperlipidemia, hypertension, cardiac arrhythmias and coronary artery diseases.

Women who had hysterectomy under the age of 35 years were at nearly 5 times increased risk of congestive heart failure and 2.5 times increased risks of coronary artery disease.

Dr. JoAnn Pinkerton, NAMS executive director said in a NAMS press release, “These study results suggest that alternative uterine-preserving treatments may need to be considered more often in lieu of hysterectomies, especially in benign situations. For those women having hysterectomy, hormone therapy should be considered for added protection, because ovarian function appears to be impaired by the surgery.”

Abstract

NAMS press release

Media courtesy: Detroit Free Press

CDC links overweight and obesity to increased risk of 13 different cancers

CDC recently released ‘vital signs’ have reported that being obese or overweight puts you at increased risk of 13 different cancers. These cancers constitute about 40% of all burden of cancer incidence in US. In 2014, approximately 631,000 persons in the United States received a diagnosis of a cancer associated with overweight and obesity.

Endometrial, ovarian, and postmenopausal female breast cancers accounted for 42% of new cases of overweight-and obesity-related cancers in 2014.

A review of data from 2005-2014 revealed that incidence of many of these cancers have increased by 7% in last 10 years, except colorectal cancers. Nearly 30% of US adult weigh more than what’s recommended and 50% do not have any idea that being overweight puts them at risk for these cancers.

CDC fact sheet

The obesity related cancers are adenocarcinoma of the esophagus, cancers of the breast [in postmenopausal women], colon and rectum, endometrium, gallbladder, gastric cardia, kidney, liver, ovary, pancreas, and thyroid; meningioma; and multiple myeloma.

On the other hand, non-obesity related cancers are down by 13%.

These obesity related cancers constitute nearly half of all the cancers in women and quarter of all cancers in men.

This finding has important public health implications as the burden can be considerably reduced by making a change in lifestyle and behaviors.

Multiple level interventions into policy, systems, and environmental changes that promote physical activity and healthy food options in communities

The CDC’s National Comprehensive Cancer Control Program supports comprehensive cancer control efforts, including environmental approaches that promote physical activity and healthy food options in communities.

To start with everyone can:

Eat a healthy diet by following the 2015-2020 Dietary Guidelines for Americans.

Do at least 150 minutes of moderate intensity physical activity, such as brisk walking, every week.

Talk to your primary healthcare provider about losing weight.

Vital signs by CDC

CDC vital signs fact sheet PDF

Latest facts and figures about Breast Cancer from American Cancer Society

October is breast cancer awareness month. Here are some facts and figures to know from American Cancer Society (ACS).

Increasing awareness among women, increased screening and better techniques for early cancer detection has decreased a woman’s risk of dying from breast cancer by 38% between late 1980s and 2014, translating into 297,300 fewer cancer death during that period.

However, much is needed to be done as breast cancer is still second leading cause of cancer death in women, being exceeded by lung cancer which kills more women peryear.

A woman chances of dying from breast cancer is about 1 in 37 (about 2.7 percent).

ACS estimates for breast cancer for the year 2017 are:

Currently, there are more than 3.1 million people with breast cancer in USA, which includes persons undergoing treatment and also persons who have already completed the treatment.

It is expected that about 40,610 women will die from breast cancer in the year 2017.

About 63,410 new cases of carcinoma in situ (CIS) and 252,710 new cases of invasive breast cancer will be diagnosed in 2017

Although the incidence of breast cancer is nearly same in black and white women, black women are more likely to die from breast cancer.

Some latest research related to risk factors shows that:

Long term and heavy smoking increases a woman’s risk of breast cancer particularly if it started before her first pregnancy.

An obese postmenopausal woman faces 1.5 times increased risk of cancer, if she is overweight and 2 times the risk if she is obese women as compared to lean women.

Evidence is accumulating that regular physically activity lower your chances of breast cancer by 10-25%, more so in postmenopausal than premenopausal women.

Each alcoholic drink/day increases the chances of getting breast cancer by 7-10% on an average and women who regularly consume 2-3 drinks have 20% higher chances as compared to non-drinkers.

News from ACOG 2017: Obese Women face higher risks of Hormonal IUD expulsion.

http://www.healthtalktanzania.com

Women with a BMI of 40 or more have 3.06 times higher odds of expulsion of levonorgestrel IUD as compared with women who are overweight, obese or have a BMI less than 35 according to a study presented at the at the ACOG 2017.

Lynne Saito-Tom, MD and her colleague from University of Hawaii at Manoa, Honolulu, conducted this retrospective cohort study at Kaiser Permanente-Hawaii between January 2009 and December 2010.

The study was also published in May issue of Journal of Obstetrics and Gynecology.

The researchers recruited 1,071 eligible patients, of whom nearly one third were obese with nearly 8% had a BMI more than 35. The main independent variable was BMI at the time of insertion and the dependent variables include successful IUD insertion, difficult IUD insertion, 12-month continuation, and complications related to the LNG-IUD.

No differences were observed across different BMI groups for insertion (P = .59) or acceptance of IUD for 1 year (P = .69)

Patients with BMI 40 and more faced higher rates of complications (24%) as compared to obese (13%) , overweight or class 1 obesity counterparts (10%).

The study did not have sufficient women enrolled to explore the reasons of higher expulsion but the researchers did think that it may be related to difficult insertion in very obese women and also menorrhagia experienced by these women.

This is the first known study to evaluate LNG-IUD use by BMI in diverse Hawaiian population of Asian and Pacific Islander women. 

Larger studies are needed to stratify the expulsion and complications according to class of obesity.

Meanwhile, the researchers advocate that the study findings should not discourage physician from educating women about the benefits of IUDs.

“While the expulsion rate was higher than seen generally, it is still an effective method for most obese women. That’s much more beneficial than discouraging patients,” said the lead researcher Dr. Saito-Tom.  

Obesity linked strongly with 11 cancers including digestive, endometrial and breast cancer.

Results of a recent umbrella review published online in BMJ have provided strong evidence to support the association between excess body weight and 11 cancers that include G.I tract, endometrial and postmenopausal breast malignancies.

“The association is now clear; it’s time to get serious about prevention, “write Professors Yikyung Park and Graham A Colditz in an accompanying editorial.

An Umbrella review is the reviews of existing systematic reviews and only considers the highest level of evidence to be included, namely systematic reviews and meta-analysis.[1] Hence, the findings from this umbrella review is the strongest evidence put forth so far linking obesity and cancer.

The study by Kyrgiou et al. initially selected 204 individual meta-analyses from 49 papers and further narrowed it down to 95 meta-analysis based on validity and association provided by the studies. 76% of the meta-analyses provided varied level of evidence for association between obesity and cancer.

  

The literature search was performed for meta-analysis and reviews that investigated association between adiposity indices and risk of developing or dying from any cancer. Adiposity indices included in the study were body mass index, waist circumference, hip circumference, waist to hip ratio, weight, weight gain, and weight loss from bariatric surgery.  Obesity was defined as a body mass index (BMI) >30 kg/m2.

The nine obesity related cancers with strong evidence were endometrial cancer (premenopausal women), breast cancer (postmenopausal), kidney cancer, multiple myeloma, esophageal adenocarcinoma, colon and rectal cancer (in men), biliary tract system and pancreatic cancer. The risk of ovarian and stomach cancer increases as the weight increases with maximum risk in obese vs. normal weight individuals.

The BMI was measured as a continuous variable.

With every 5 units increase in BMI, the risk of developing rectal cancer increased by 9% in men and that of developing biliary tract cancers increased by 56%.

For each 5 kg of weight gain in adulthood the risk of postmenopausal breast cancer increased by 11% even if the women have never used HRT, similarly for .1 increases in waist to hip ratio the risk of endometrial cancer increased by 21%.

Obesity has become a major public health problem in last four decades with the incidence being doubled among women and tripled among men. And preventing adult weight gain can bring down the risk of these cancers.

The authors also stressed the importance of primary care physicians in medical practice because they are the primary point of contact with the patients. They said “Given the critical role of healthcare providers in obesity screening and prevention, clinicians, particularly those in primary care, can be a powerful force to lower the burden of obesity related cancers, as well as the many other chronic diseases linked to obesity such as diabetes, heart disease, and stroke.”

Although more prospective studies are needed to confirm the association, personalized primary preventive strategies could be designed in subjects at ‘ high risk’ for cancers.  

Link to  full article here.

Link to Editorial here

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[1] https://www.ncbi.nlm.nih.gov/pubmed/26360830 accessed March 2, 2017

PCOS is often underdiagnosed as the common cause of Abnormal Uterine Bleeding in Adolescents.

Image courtesy: University of Utah.

 Abnormal uterine bleeding(AUB) is very frequent in adolescents and generally lasts for 4-5 years after menarche. It is an important cause of visit to emergency room or healthcare provider in pediatric patients. Although DUB due to immaturity of hypothalamic pituitary ovarian (HPO) axis is a common cause of AUB in healthy adolescent, it is also important to rule out other pathological causes.

PCOS as a cause of AUB in adolescent’s patients is often underdiagnosed and poses a diagnostic dilemma as normal pubertal changes like acne, menstrual irregularities and hyperinsulinemia can mimic several features of PCOS.

Prompt diagnosis and treatment of PCOS is very important because of future reproductive and metabolic repercussions.[1] Evidence suggests that adolescents diagnosed with PCOS have elevated risk of Metabolic Syndrome (MetS) and premature cardiovascular dysfunction and cardiovascular disease.[2]

Adolescents with AUB are mostly managed as outpatients but some require hospitalization because of hemodynamic instability. A recent paper published in Journal of Pediatricand Adolescent Gynecology evaluated the most common etiology for AUB in hospital admitted adolescent patients with severe anemia.[3]

This retrospective study was conducted by Dr. Sofya Maslyanskaya, Assistant Professor of Pediatrics, Albert Einstein College of Medicine, Bronx, New York and her colleague at Children's Hospital at Montefiore in New York City.

The researchers identified 125 females aged 8 to 20 years admitted to the hospital for anemia with AUB from January 2000 to December 2014.

As per hospital protocols, all the subjects underwent hormonal testing for PCOS and other endocrinal disorders. Hence the data could be accessed and reviewed by the researchers for laboratory test results, treatment and final diagnosis.

The demographics of the study subjects were: mean age at the time of admission was 16 years, mean Hb 7gm/dl, nearly half were obese and 41% sexually active.

PCOS was diagnosed as the leading cause (33%) for hospital admissions for severe bleeding, followed by HPO axis immaturity in 31% of cases. Endometritis was responsible for 13% of admissions while bleeding disorder accounted for 10%.

Nearly three-fourth of teenagers diagnosed with PCOS were obese while subjects with HPO axis immaturity have the lowest Hb level as compared to other etiologies.

The lead author stressed the need for ruling out PCOS as the cause of AUB before any form of treatment is started, especially in adolescent girls admitted for anemia with AUB. Once hormonal treatment is started the diagnosis becomes more difficult.

The study results cannot be generalized to patients with less severe DUB. Also, the participants were mostly from Asian and Latino communities, so the results may not apply to other demographics.

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[1] http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/content/tags/adolescent-gynecology/pcos-adolescents-beyond-reproductive-implicati

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3703718/

[3] http://www.jpagonline.org/article/S1083-3188(16)30284-4/abstract

Sugar is as big a threat as tobacco: We need to treat it that way.

Courtesy: Fateclick 

This article is based on a speech by Dr. Aseem Malhotra, MBChB, MRCP at the UK parliamentary “Sugar Summit.” [1]The sugar summit was convened by a distressed mother Rend Platings, after learning that today’s generation of parents will be the first to bury their children because of increasing obesity. She launched ‘Sugarwise’ an organization for increasing attention, education, awareness and giving people options on sugar in their food and drink.[2]

Keith Vaz chaired the event which included number of representatives from high-profile UK retailers as Tesco, Caffè Nero, and the Jamie Oliver Group, as well as such influential stakeholders as the UK Department of Health, Public Health England, the British Soft Drinks Association, and the Food and Drink Federation. [3]

About 2 years back the WHO and Scientific Advisory Committee on Nutrition (SACN) made a recommendation to halve the amount of sugar in our diet. But, we are still far behind in meeting that mark.  Sugar continues to play a major role as an important cause of obesity for two-thirds of the U.K. population.

The U.K government has recently made an announcement of an introduction of a 20% tax on sugar-sweetened beverages in 2017,[4] similarly WHO also announced to tax sugary drink by 20% to check the global epidemics of obesity and type 2 diabetes. [5]

Scientists, researchers and public health personal has long raised voices against the hidden sugar found in daily food items and paralleled the addiction to tobacco. Legislative measures against tobacco use and smoking is the single most driving factor behind the drop in cardiovascular mortality since 3 decades.

Health Benefits:

Dr Assem Malhotra has included the following research data in his editorial. Oxford researchers have estimated that a 15% reduction in sugar consumption through such a tax would prevent 180,000 people in the UK from becoming obese within a year and a larger number from becoming overweight.[6] But the scientific evidence reveals that the positive health benefits for the whole population of such a tax goes beyond a mere reduction in calories:

• An econometric analysis of 175 countries (considered the highest quality of study with the exception of randomized controlled trials) revealed that for every additional 150 sugar calories available for consumption, there was an 11-fold increase in the prevalence of type 2 diabetes in the population. This is compared with 150 calories from another source such as fat or protein and independent of body mass index (BMI) and physical activity levels.
• The prevalence of type 2 diabetes in the US population between 1988 and 2012 increased by 25% in both obese and normal-weight populations, which goes to show that type 2 diabetes is not a condition related purely to obesity.
• A high-quality prospective cohort study revealed a trebling in cardiovascular mortality among US adults who consumed more than 25% of calories from added sugar versus those who consumed less than 10%, with consistent findings across physical activity levels and BMI.
• The positive health effects of reducing sugar intake appear to be quite rapid. In a study of 43 Latino and African-American children with metabolic syndrome, keeping total calories and calories from carbohydrate identical, a reduction from a mean of 28% of calories from added sugar to 10% significantly reduced triglycerides, LDL cholesterol, blood pressure, and fasting insulin within just 10 days.

Here is a video of Dr. Aseem Malhotra’s lecture at Cape Town Sugar Free Breakfast” Sugar is public enemy number one.”

 How much sugar is safe?

No amount of added sugar is needed by our body, as it does not have any nutritional value. Just a very little amount of free sugar, which includes sugar in fruit juices, honey and syrup has a very deleterious impact on most common global disease of tooth decay. It is the single most important cause of chronic pain and hospital admission in young children.

WHO recently recommended that no more than 3% of our daily calorie intake should come from sugar which amounts to three teaspoons. The average US and UK citizen consumes nearly 4-7 times the recommended amount. This is also because of much of the sugar is consumed unknowingly because it comes from foods that are normally not considered to have much added sugar like Tomato ketchup, salad dressings, and bread. The rest comes from sugary drinks and junk foods like cookies, ice-cream and chocolates.

He also further added that in US, there is no reference range of sugar printed on the food labels. In Europe and UK, food labels carry the range but does not differentiate between children and adults. A can of regular cola contains 9 teaspoons of added sugar which is triple the amount of daily recommendation made in 2009. The public lacks knowledge because of confusing food labels and nearly 80% of processed food contains sugar.[7]

It took nearly 50 years of research and lobbying before a link was established between tobacco and lung cancer. Dr. Cristin Kearns, University of California, San Francisco reveals in her recent paper published in JAMA internal medicine how sugar industry paid scientist and researcher to downplay its role in causation of coronary artery disease. [8]

Sugar Research Foundation paid two scientists, Mark Hegsted and his colleague Dr. Robert McGandy to write a review that countered the link between sucrose and   coronary artery disease. Both of them, overlooked the studies that implicated sugar as a culprit, instead  made only one recommendation of  changing fat and cholesterol intake to prevent coronary heart disease.[9] Similarly, Coca-Cola and candy makers have both tried to influence research practice in favor of their products.  

The message is very clear. There is nothing wrong in an occasional treat, but sugar cannot be a part of “healthy balanced diet”.

Dr. Aseem Malhotra's other articles can be read at his blog: http://doctoraseem.com/

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[1] http://www.thesugarreductionsummit.co.uk/

[2] http://sugarwise.org/

[3]http://blog.euromonitor.com/2016/10/sugar-summit-sugarwise-takeaways.html

[4] https://petition.parliament.uk/petitions/106651

[5] http://www.who.int/mediacentre/news/releases/2016/curtail-sugary-drinks/en/

[6] Briggs ADM, Mytton OT, Kehlbacher A, et al. Overall and income specific effect on prevalence of overweight and obesity of 20% sugar sweetened drink tax in UK: econometric and comparative risk assessment modelling study. BMJ. 2013;347:f6189.

[7] Aseem M. The dietary advice on added sugar needs emergency surgery. BMJ. 2013;346:f3199.

[8] http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2548255

[9] https://www.statnews.com/2016/09/12/sugar-industry-harvard-research/

New obesity treatment device AspireAssist approved by FDA

Image courtesy:Aspire Bariatrics

One more gadget added to the armamentarium of obesity treatment device as FDA approves  The AspireAssist device[1]. This device uses a surgically placed tube in the stomach to drain about 30% of the content after every meal. AspireAssist, is created by Segway inventor Dean Kamen and a team of bariatricians and was patented in 2013[2].

It is not a short term procedure and is not indicated in patients who are moderately obese. Its main indication is in patients aged 22 and older, with BMI between 35-55 and who have failed to achieve and maintain weight through non-surgical procedure.

The short OPD procedure consists of endoscopically placing a tube in the stomach through a small incision in the abdomen. A small disc shaped port valve is connected to the tube and it lies outside the abdominal skin flushed with the body. The patient is taught to drain the content of the stomach 20-30 minutes after a meal into toilet. For optimal weight loss the patients should drain the contents atleast 3 times daily[3].

AspireAssist is in use in parts of Europe since late 2011. In a trial of 111 study participants who received AspireAssist and lifestyle modification vs 60 control participants who only received lifestyle modification, AspireAssist patients lost 3 times the body weight by simple lifestyle modification only.

All the patients are monitored closely as it requires shortening of the tube as patients lose weight and abdominal girth. Frequent electrolyte checkup and nutritional supplement are required, along with dietary and life style modification. The patient is also taught the hygiene of the abdominal port.

Side effects of the tube include diarrhea, indigestion, nausea and vomiting.

The risks associated with AspireAssist include risk of the surgical procedure and risk associated with the abdominal port. Surgical risk includes sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the lining of the abdomen, sores on the inside of the stomach, pneumonia, unintended puncture of the stomach or intestinal wall and death. 

A number of complications associated with the abdominal port requires removal of the tube and closing the port. Patient may present with abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site where the tube is placed, leakage, bleeding and/or infection around the site where the tube is placed and device migration into the stomach wall.

Contraindication to AspireAssist includes diagnosed bulimia, diagnosed binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease or stomach ulcers. Certain systemic conditions like uncontrolled hypertension, serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain also places the patients at high risk for abdominal surgery.

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[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm506625.htm

[2] http://www.popsci.com/gadgets/article/2013-01/segway-inventor-patents-gadget-sucks-food-directly-out-stomach

[3] http://www.aspirebariatrics.com/about-the-aspireassist/