Prostate Cancer: Effects of Hormone Therapy on Cognitive Function Addressed in Large Study

MedicalResearch.com Interview with:

Ravi Jayadevappa, PhD, MS Department of Medicine Perelman School of Medicine University of Pennsylvania Philadelphia, PA 19104-2676 

Dr. Jayadevappa

Ravi Jayadevappa, PhD, MS
Department of Medicine
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA 19104-2676 

MedicalResearch.com: What is the background for this study?

Response: In the US, prostate cancer is the most commonly diagnosed non-skin cancer and the second leading cause of cancer death among men. Research shows that hormone therapy or ADT reduces the levels of male hormones in the body, called androgens, to stop them from stimulating cancer cells to grow., and thus is effective in reducing the spread and progression of prostate cancer.

At the same time, some research has suggested that decreasing androgen levels may increase the risk factors for Alzheimer’s and dementia, including loss of lean body mass, diabetes, cardiovascular disease, and depression. The ADT therapy may lead to impaired neuron growth and the regeneration of axons, thus affecting the cognitive function. Thus there is growing interest in the possible association between exposure to ADT and cognitive dysfunction.

Our study investigates the association between exposure to ADT and subsequent diagnosis of Alzheimer’s or dementia in elderly, fee-for-service Medicare enrollees using SEER-Medicare linked databases.

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Brain Aging in Women Linked to Obesity and Lower Estradiol Levels

MedicalResearch.com Interview with:

Rachel Zsido PhD student Department of Neurology  International Max Planck 

Rachel Zsido

Rachel Zsido
PhD student
Department of Neurology
International Max Planck

MedicalResearch.com: What is the background for this study?

Response: We integrated measures of brain network structure, visceral adipose tissue (VAT), serum estradiol levels, and cognitive performance from 974 participants in order to shed light on potential mechanisms underlying cognitive health. We believe it is imperative to assess sex-specific risk trajectories in brain aging and cognitive decline, especially given the known sex differences in both VAT accumulation patterns and estradiol fluctuations across the lifespan.

Thus, we aimed to answer three questions in men and in women:

1) Does visceral adipose tissue exacerbate the association between age and brain network structure,
2) Does estradiol mitigate the negative association between VAT and brain network structure, and
3) What does this imply for healthy cognitive aging in men and women?  Continue reading

Vaginal Progesterone May Reduce Miscarriages in Women with Bleeding in Early Pregnancy

MedicalResearch.com Interview with:

Prof. Arri Coomarasamy MBChB, MD, FRCOGInstitute of Metabolism and Systems ResearchProfessor of GynaecologyDirector of Tommy's National Centre for Miscarriage ResearchUniversity of Birmingham

Prof. Coomarasamy

Prof. Arri Coomarasamy MBChB, MD, FRCOG
Institute of Metabolism and Systems Research
Professor of Gynaecology
Director of Tommy’s National Centre for Miscarriage Research
University of Birmingham

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Progesterone hormone is known to be essential to maintain a pregnancy. Researchers and clinicians have debated for over 50 years whether progesterone supplementation in women with early pregnancy bleeding could rescue a pregnancy from miscarrying. There were some clinical studies suggesting progesterone could be useful, but the studies were of poor quality and small, so we could not be certain.

So the current study, called the PRISM trial, was conducted using very sound methods and on a large population of women, in fact over 4000 women in the UK, to produce a definitive answer to this question. Overall, there were more babies in the group of women given progesterone compared with the group of women given the dummy placebo tablets, but there was statistical uncertainty in this finding.

However, when we looked at the sub-population of women who were at high risk of miscarriage because of not only bleeding in early pregnancy but also having a history of previous miscarriage, we found progesterone was shown to have clear benefit. This is a hugely important finding as there is now a treatment option to women with early pregnancy bleeding and a history of previous miscarriages.

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Ying and Yang of Empathy and Aggression Differ for Boys and Girls

MedicalResearch.com Interview with:
Dr. Eider Pascual-Sagastizabal, PhD

Professor of Evolutionary Psychology and Education
University School of Education of Bilbao (Leioa)
University of the Basque Country 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The search for markers of aggression during childhood is a particularly relevant area of research, since the results of intervention and prevention during this developmental stage are more promising than those obtained during later stages. The psychobiological approach to aggressive behavior is of particular importance, as it analyzes the joint, interactive influence of both psychological and biological variables.

We have found that there are different interactions on a biological and psychological level that could account for aggressive behavior in children. More deeply, empathy and hormones could together account for aggressive behavior. In fact, the interactions were different for boys and for girls.  Continue reading

A Modifying Autoantigen in Graves’ Disease

MedicalResearch.com Interview with:

Terry Davies, MD, ProfessorMedicine, Endocrinology, Diabetes and Bone DiseaseIcahn School of Medicine at Mount SinaiCo-Director, The Thyroid Center, Mount Sinai Union Square

Dr. Davies

Terry Davies, MD, Professor
Medicine, Endocrinology, Diabetes and Bone Disease
Icahn School of Medicine at Mount Sinai
Co-Director, The Thyroid Center, Mount Sinai Union Square

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The receptor for thyroid stimulating hormone (TSH) is the major antigen for Graves’ disease and patients have unique antibodies to the TSHR which stimulate excessive thyroid hormone secretion.

We have characterized a variant TSHR called v1.3 which is a splicing variant which we find expressed in thyroid, bone marrow, thymus and adipose tissue and incorporates an intronic sequence which is fully translated.  Continue reading

Oxytocin Reduces Activation of Brain Areas Linked to Stimulation by High Calorie Food Images

MedicalResearch.com Interview with:

Liya Kerem, MDFellow, Pediatric Endocrine UnitMassachusetts General Hospital for ChildrenHarvard Medical School

Dr. Kerem

Liya Kerem, MD
Fellow, Pediatric Endocrine Unit
Massachusetts General Hospital for Children
Harvard Medical School

MedicalResearch.com: What is the background for this study?  

Response: The hypothalamic neurohormone Oxytocin (OXT), shown to decrease food intake in animals and humans, is a promising novel treatment for obesity. We previously showed that in men with overweight/obesity, intranasal (IN)OXT reduced the fMRI activation in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs non-food visual stimuli.

Here, we employed fMRI functional connectivity analysis, which better characterizes the exchange in information between neural systems in a context-dependent manner. We hypothesized that Oxytocin would reduce the functional connectivity of the VTA with food motivation brain areas in response to high-calorie foods.  Continue reading

Chemicals in Household Dust May Promote Fat-Cell Development

MedicalResearch.com Interview with:

Christopher D. Kassotis, Ph.D.NRSA Postdoctoral Research ScholarStapleton LabDuke UniversityNicholas School of the EnvironmentDurham, NC 27708 

Dr. Kassotis

Christopher D. Kassotis, Ph.D.
NRSA Postdoctoral Research Scholar
Stapleton Lab
Duke University
Nicholas School of the Environment
Durham, NC 27708 

MedicalResearch.com: What is the background for this study? What are the main findings?

  • So this was something that Heather Stapleton had been curious about for years, as she’s been one of several researchers characterizing the hundreds of chemicals that have been measured in indoor house dust. Before I came to Duke, one of her PhD students had measured the ability of many common indoor contaminants to activate the peroxisome proliferator activated receptor gamma (PPARg). The majority of these chemicals did, often quite well, which led to them testing indoor house dust extracts, also finding that the majority of dust extracts were also able to do so at very low levels. As PPARg is often considered the master regulator of fat cell development, the next obvious question was whether these common contaminants (and house dust) could promote fat cell development in cell models. My first work at Duke evaluated a suite of common indoor contaminants, finding that many of these chemicals could promote fat cell development, and that low levels of house dust extracts did as well.
  • We next explored this more systematically in a group of adults involved in a thyroid cancer cohort (this was just recently published in Science of the Total Environment:
    https://www.sciencedirect.com/science/article/pii/S0048969719307715?dgcid=author
  • In this study we evaluated the extent to which house dust extracts could promote fat cell development in a common cell model, and associated this with the metabolic health of adults living in these homes. We found that the greater extent of fat cell development was associated with significantly greater thyroid stimulating hormone concentrations (control residents only, with no evidence of thyroid dysfunction) and lower free triiodothyronine (T3) and thyroxine (T4). We further found a significant and positive association between extent of fat cell development and the body mass index (BMI) of all adults in the study. So this suggested that the indoor environment might play a role in the BMI and metabolic health of residents, and we next wondered if this would be more pronounced in children, who may be exposed to these contaminants during a critical window of development.
  • The next step, for our current work, was to substantiate these effects in a larger group of households, each with children.
  • Our major conclusions thus far have been that ~80% of house dust extracts promote significant fat cell development in a cell model – either via development from precursor cells into mature fat cells, measured via accumulation of lipids into the cells, or via the proliferation of those precursor fat cells. We also reported positive correlations of fat cell development with the concentrations of 70 different contaminants in the dust from these homes, suggesting that mixtures of contaminants are likely all acting weakly to produce these effects in combination. We’ve also begun to assess the other chemicals present in dust – chemistry can be either targeted (measuring concentrations of specific known chemicals in a sample), or non-targeted, where you try and determine the identity of the other chemicals in a sample. This has greater utility for identifying many more chemicals, though you will often not get chemical concentrations from this, nor absolute confirmed identification – just varying degrees of certainty based on evidence.

    Thus far we report approximately 35,000 chemicals in house dust samples across this study, and differential analyses have begun to pick out the few (less than 10 in each case) chemicals most differentially expressed between samples that exhibit high degrees of fat cell development in the lab vs inactive samples, for example, or which are differentially present in the homes of children categorized as obese or overweight. We are now working to confirm identity of these select contaminants that are more likely to be causative factors in the results we have observed.

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Trans Women May Require Higher Doses of Estrogens

MedicalResearch.com Interview with:

Joshua Safer, MD, Executive DirectorCenter for Transgender Medicine and SurgeryMount Sinai Health SystemSenior Faculty, Medicine, Endocrinology, Diabetes and Bone DiseaseIcahn School of Medicine at Mount Sinai

Dr. Safer

Joshua Safer, MD, Executive Director
Center for Transgender Medicine and Surgery
Mount Sinai Health System
Senior Faculty, Medicine, Endocrinology, Diabetes and Bone Disease
Icahn School of Medicine at Mount Sinai

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The standard trans feminizing hormone regimen includes estrogen both to suppress testosterone and so that the individual has sufficient circulating sex hormone in the body for good bone health. After orchiectomy, there is no need to suppress testosterone because the levels are very low and it is common to cut the estrogen dose in half.  Cis women with premature ovarian failure often take about 2 mg of estradiol daily so that dose has seemed reasonable for trans women without testes.  However, when my co-author Sira Korpaisarn and I checked estradiol levels and gonadotropins (pituitary hormones, LH and FSH) as a guide to dosing, we found that based on that testing, trans women may require higher doses of estrogens than the 2 mg that we expected.

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Pathogenic RET Variants Occur at Higher Prevalence Than Previously Recognized

MedicalResearch.com Interview with:

Emily J. Gallagher, MDAssistant Professor of MedicineEndocrinology, Diabetes and Bone DiseaseIcahn School of Medicine at Mount Sinai 

Dr. Gallagher

Emily J. Gallagher, MD
Assistant Professor of Medicine
Endocrinology, Diabetes and Bone Disease
Icahn School of Medicine at Mount Sinai 

MedicalResearch.com: What is the background for this study?

Response: Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2) is an inherited endocrine disorder characterized by the development of pheochromocytoma, medullary thyroid carcinoma (MTC) and parathyroid tumors. It occurs due to activating missense variants in the RET gene.

The estimated prevalence of MEN2 is 1 per 30,000 in the general population. Through a collaboration between The Center for Genomic Health, the Charles Bronfman Institute for Personalized Medicine, and the Division of Endocrinology at Mount Sinai, our aim was to investigate the prevalence and clinical manifestations of pathogenic RET variants in the multi-ethnic BioMe Biobank.

The BioMe Biobank is an electronic health record-linked biobank with exome sequencing data available for more than 30,000 patients recruited across The Mount Sinai Health System.

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Long Term Hormone Use May Raise Risk of Alzheimer’s Disease

MedicalResearch.com Interview with:

Tomi Mikkola MDAssociate ProfessorHelsinki University HospitalDepartment of Obstetrics and GynecologyHelsinki, Finland

Dr. Mikkola

Tomi Mikkola MD
Associate Professor
Helsinki University Hospital
Department of Obstetrics and Gynecology
Helsinki, Finland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In Finland we have perhaps the most comprehensive and reliable medical registers in the world. Thus, with my research group I have conducted various large studies evaluating association of postmenopausal hormone therapy use and various major diseases (see e.g. the references in the B;MJ paper). There has been various smaller studies indicating that hormone therapy might be protective for all kinds of dementias, also Alzheimer’s disease.

However, we have quite recently shown that hormone therapy seems to lower the mortality risk of vascular dementia but not Alzheimer’s disease (Mikkola TS et al. J Clin Endocrinol Metab 2017;102:870-7). Now in this upcoming BMJ-paper we report in a very large case-control study (83 688 women with Alzheimer’s disease and same number of control women without the disease) that systemic hormone therapy was associated with a 9-17% increased risk of Alzheimer’s disease.

Furthermore, this risk increase is particularly in women using hormone therapy long, for more than 10 years. This was somewhat surprising finding, but it underlines the fact that mechanisms behind Alzheimer’s disease are likely quite different than in vascular dementia, where the risk factors are similar as in cardiovascular disease. We have also shown how hormone therapy protects against cardiovascular disease, particularly in women who initiate hormone therapy soon after menopause. Continue reading

Childhood Onset of Puberty and Parental Height Linked

MedicalResearch.com Interview with:

Yehuda Limony, MD, MScPediatric Endocrinology UnitFaculty of Health SciencesBen-Gurion University of the NegevClalit Health ServicesBeer-Sheva, Israel 

Dr. Limony

Yehuda Limony, MD, MSc
Pediatric Endocrinology Unit
Faculty of Health Sciences
Ben-Gurion University of the Negev
Clalit Health Services
Beer-Sheva, Israel 

MedicalResearch.com: What is the background for this study?

Response: The variability of the onset age of puberty is the subject of many studies in numerous disciplines; nonetheless, the timing of puberty remains an enigma. The conventional paradigm is that the time of onset of puberty is genetically determined even though genome-wide association studies explain only a very low percentage of the physiologic variability. It is commonly believed, therefore, that many environmental factors interfere with the genetics of timing of puberty.

On the other hand, children grow toward an adult height that is the standardized average of parents’ height called “target height”. That is why children are usually similar in height to parents. This targeted growth process is evident especially in children whose height percentile in childhood is different from their target height percentile (we called this difference the “height gap”). It is known that the timing of puberty is associated with adult height: earlier puberty causes shorter adult height and vice versa. We hypothesized that the targeted process of growth involves adaptation of the age of onset of puberty in accordance with the height gap. Continue reading

Study Evaluates Thyroid Hormone Suppression For High Risk Thyroid Cancer

MedicalResearch.com Interview with:

Joanna Klubo-Gwiezdzinska, M.D., Ph.D., M.H.Sc. Assistant Clinical Investigator/Assistant Professor Metabolic Disease Branch/NIDDK/NIH Bethesda, MD

Dr. Klubo-Gwiezdzinska

Joanna Klubo-Gwiezdzinska, M.D., Ph.D., M.H.Sc.
Assistant Clinical Investigator/Assistant Professor
Metabolic Disease Branch/NIDDK/NIH
Bethesda, MD

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: People with intermediate- and high-risk differentiated thyroid cancer (DTC) are treated with surgical removal of the thyroid gland and radioactive iodine therapy.  After surgery and initial treatment, the thyroid hormone levothyroxine is used for long-term management not only to replace appropriate physiologic thyroid hormones post-surgery, but also to suppress thyrotropin (TSH) release from the pituitary gland at supraphysiologic doses.

The current recommended American Thyroid Association TSH suppression goal in patients with a high-risk differentiated thyroid cancer presenting with distant metastases is less than 0.1mIU/ml, and between 0.1-0.5 mIU/ml for patients with intermediate-risk DTC presenting with local metastases to the neck lymph nodes. This TSH goal is much lower than physiologic TSH level, which ranges between 0.4-4.1 mIU/ml, depending on the measurement method and person’s age.

TSH suppression is used because some preclinical evidence suggests that TSH can stimulate growth of cancer cells.  However, several preclinical studies show that thyroid hormones may also stimulate cancer growth. In addition, too much levothyroxine, leading to TSH suppression, may cause side effects such as abnormal heart rhythms and decreased bone mass.

In this study, based on a large multicenter database analysis, we found that continuous TSH suppression with levothyroxine was not associated with better progression-free survival and overall survival in patients with either intermediate- and high-risk differentiated thyroid cancer. The patients were followed for an average of 7 years after surgical thyroid cancer removal and radioactive iodine therapy.  Continue reading

Link Between Thyroid Function Genetics and Atrial Fibrillation Grows

MedicalResearch.com Interview with:

Joe-Elie Salem, MD, PhD Associate Professor - MCU-PH, Sorbonne Université - INSERM - CIC, Clinical Pharmacology, Cardio-oncology, APHP, La Pitié-Salpêtrière, Paris, France Adjunct Associate Professor, Vanderbilt University Medical Center, Cardio-oncology Clinical Pharmacology, Nashville, TN

Dr. Salem

Joe-Elie Salem, MD, PhD
Associate Professor – MCU-PH, Sorbonne Université – INSERM – CIC, Clinical Pharmacology, Cardio-oncology, APHP, La Pitié-Salpêtrière, Paris, France
Adjunct Associate Professor, Vanderbilt University Medical Center, Cardio-oncology
Clinical Pharmacology, Nashville, TN

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A study by researchers at Vanderbilt University Medical Center has strengthened the link between thyroid function and atrial fibrillation (AF), an irregular heart rhythm that increases the risk of stroke and other heart-related complications.

They phenome-wide association study scanned the medical records of more than 37,000 people for an association between genetically determined variation in thyroid stimulating hormone levels (a measure of thyroid function) and AF risk.

Previous observational studies have found that subclinical hyperthyroidism, an overactive thyroid which does not meet the clinical threshold for diagnosis or treatment, nevertheless can increase the risk of atrial fibrillation.  But whether to treat subclinical hypo- or hyperthyroidism to reduce AF risk remains a matter of debate in the medical community.  Continue reading

Blood Clots Linked to Oral Hormone Replacement for Menopause Symptoms

MedicalResearch.com Interview with:

Yana Vinogradova, PhD Research Fellow Department of Primary Care School of Medicine University of Nottingham University Park, Nottingham

Dr. Vinogradova

Yana Vinogradova, PhD
Research Fellow
Department of Primary Care
School of Medicine
University of Nottingham
University Park, Nottingham

MedicalResearch.com: What is the background for this study?  

Response: The study targeted middle age women going through menopause.  This is the stage of life when women naturally reach the end of their reproductive life and their hormones gradually decrease.  Some women experience unpleasant effects such as hot flushes, night sweats, mood swings, memory and concentration loss, headaches.  Quality of life may be severely affected.  Hormone replacement therapy uses a class of drugs, which, like all drugs, have side effects.   VTE is a serious side effect which can have a lethal outcome.

There are different preparations of hormones available for such women.  Some of them were extensively studied in a large American Trial Women’s Health Initiative and showed the risk of VTE to be twice as high for women who took them.  However, these well-studied drugs are mostly prescribed in America.  The more popular drugs in Europe and the UK have been much less studied, so it was unclear how they compared.  Continue reading

Testosterone Treatment May Reduce Depression in Men

MedicalResearch.com Interview with:

Dr. Andreas Walther

Dr. Walther

Dr. Andreas Walther PhD
Department of Biological Psychology, Technische Universität Dresden, Dresden, Germany
Department of Clinical Psychology and Psychotherapy, University of Zurich,
Zurich, Switzerland
Task Force on Men’s Mental Health of the World Federation of the Societies of Biological Psychiatry


MedicalResearch.com: What is the background for this study?

Response: The study situation with regard to endogenous testosterone level and depressive symptoms in men is currently very mixed. There are studies that show no association, but other studies show that low testosterone levels are associated with increased depressive symptoms. That is why several studies have tried to administer testosterone in men to treat depressive symptomatology among other conditions (e.g. erectile dysfunction, cognitive decline).

However, no clear conclusions could be drawn from the studies to date, as some studies reported positive results, while others did not show any effects. Likewise, some studies showed better results in certain subgroups of men such as dysthymic men, treatment resistant, men with low testosterone, which raised the question of relevant moderators.

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Advanced Prostate Cancer: Androgen-Receptor Testing May Guide Selection of Treatment

MedicalResearch.com Interview with:

Diagram_showing_prostate_cancer_that_has_spread_to_the_bones_CRUK_183.svg.png

Prostate cancer that has metastasized to the bone: Wikipedia Image

Vincenza Conteduca, MD, PhD
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl – IRCCS
Meldola , Italy

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In our previous publications, we showed that the study of plasma cell-free DNA holds promise for improving treatment choice in metastatic castration-resistant prostate cancer (mCRPC). Specifically, we demonstrated that the detection in plasma of aberrations (copy number alterations and/or point somatic mutations) of androgen receptor (AR), using an easy and robust multiplex droplet digital PCR method, predicted an adverse outcome in mCRPC patients treated with second-generation AR-directed therapies (abiraterone or enzalutamide) in both settings: chemotherapy-naïve and post-docetaxel.

This current multi-institution work builds on our previous discoveries. We investigated the association of androgen receptor status and survival in men treated with docetaxel. Moreover, we performed an exploratory analysis in patients treated with docetaxel or AR-directed therapies as first-line therapy.

Interestingly, we observed that plasma AR-gained patients do not have a worse outcome compared to AR-normal patients when treated with docetaxel as first-line therapy. This introduces the opportunity to use plasma to select for docetaxel in preference to androgen receptor-directed therapies in AR gained mCRPC patients.

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Endometriosis: Biomarker May Allow Personalized Approach to Treatment

MedicalResearch.com Interview with:

Valerie A. Flores, MD Clinical Instructor Division of Reproductive Endocrinology & Infertility Department of Obstetrics, Gynecology & Reproductive Sciences Yale School of Medicine - Yale New Haven Hospital

Dr. Flores

Valerie A. Flores, MD
Clinical Instructor
Division of Reproductive Endocrinology & Infertility
Department of Obstetrics, Gynecology & Reproductive Sciences
Yale School of Medicine – Yale New Haven Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Endometriosis is a debilitating gynecologic disease that affects 1 in 10 reproductive-aged women, causing pain and infertility.  It is a hormonally dependent disorder— estrogens promote growth of endometriosis, while progesterone inhibits estrogen-dependent proliferation. Although progestin-based therapies (including combined oral contraceptives) are first-line therapy in the management of endometriosis-associated pain, response to progestins is variable and currently unpredictable.

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Maternal Smoking Linked to Early Puberty in Offspring

MedicalResearch.com Interview with:

Nis Brix M.D., PhD Student Department of Public Health Department of Epidemiology Aarhus University Hospital Nis Brix M.D., PhD Student
Department of Public Health
Department of Epidemiology
Aarhus University Hospital 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Several studies have indicated a secular trend towards earlier puberty. This is a potential concern as early puberty has been linked to an increased risk of a number of diseases, such as obesity, diabetes, cardiovascular diseases and certain types of cancer. For this reason, our research team are interested in identifying potential modifiable causes of early puberty.

Smoking during pregnancy may be such a modifiable cause of early puberty in the children. Former studies have already linked smoking during pregnancy to earlier age at the daughters’ first menstrual period, a relatively late marker of pubertal development, but other markers of puberty are less studied, especially in the sons.

We studied 15,819 sons and daughters. The mothers gave detailed information on smoking during their pregnancies, and the children gave information on a number of pubertal milestones half-yearly from the age of 11 years. The milestones for the sons were age at voice break, first ejaculation of semen, pubic hair and testicular growth, armpit hair growth and onset of acne. For the daughters the milestones were age at their first menstrual period, pubic hair growth, breast development, armpit hair growth and onset of acne.

Our results suggested that the more cigarettes the mother smoked during her pregnancy the earlier her children, both sons and daughters, went through puberty. If the mother smoked more than ten cigarettes a day during pregnancy, the children appeared to go through puberty, on average, three to six months earlier than the children of non-smoking mothers. Continue reading

Nolasiban Phase 3 IMPLANT 2 Trial: IVF Live Birth Rate Increased Up to 35%

MedicalResearch.com Interview with:
Dr. Ernest Loumaye, MD, PhD
Co-Founder and CEO
ObsEva SA  

MedicalResearch.com: What is the background for this announcement? How does Nolasiban work to decrease contractions and improve uterine blood flow?

Response: The WHO has recognized infertility as a global health issue, and many couples undergo IVF treatment: there are more than 700,000 annual IVF treatment cycles in Europe and more than 200,000 in the U.S. However, more than 50% of IVF procedures do not result in pregnancy, and failure has tremendous emotional and financial costs to patients.  ObsEva is dedicated to improving fertility outcomes in IVF while also supporting the use of single embryo transfer to minimize multiple births that are associated with significant health risks to mother and baby, as well as significant health costs from premature delivery.

Nolasiban works by blocking the hormone oxytocin, which is known to induce uterine contractions.  Nolasiban reduces uterine contractions and could improve uterine blood flow, both effects being favourable for the embryo to properly implant. Continue reading

Most Patients With Subclinical Hypothyroidism May Not Require Thyroid Medication

MedicalResearch.com Interview with:
thyroid-gland-wikipediaDr. med. Martin Feller, MSc Epidemiology (LSHTM)
FMH Allgemeine Innere Medizin & Prävention und Gesundheitswesen
Scientific Research Coordinator
INSELSPITAL, Universitätsspital Bern
Universitätsklinik und Poliklinik für Allgemeine Innere Medizin (RodondiResearch)

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: SUBCLINICAL HYPOTHYROIDISM IS VERY COMMON, WITH AN ESTIMATED 13 MILLION AMERICANS AFFECTED. SUBCLINICAL HYPOTHYROIDISM IS OFTEN TREATED WITH LEVOTHYROXINE, PARTICULARLY WHEN IT CO-OCCURS WITH SYMPTOMS POTENTIALLY ATTRIBUTABLE TO HYPOTHYROIDISM SUCH AS TIREDNESS, CONSTIPATION, AND UNEXPLAINED WEIGHT GAIN. THIS PRACTICE MAY CONTRIBUTE TO LEVOTHYROXINE BEING THE MOST PRESCRIBED DRUG FROM 2014 ONWARDS IN THE US.

HOWEVER, IN OUR META-ANALYSIS OF 21 RANDOMIZED CLINICAL TRIALS, WE OBSERVED NO BENEFIT OF LEVOTHYROXINE THERAPY (COMPARED TO PLACEBO) REGARDING GENERAL QUALITY OF LIFE, THYROID-RELATED SYMPTOMS, DEPPRESSIVE SYMPTOMS, FATIGUE, COGNITIVE FUNCTION, BLOOD PRESSURE OR BODY-MASS INDEX.  Continue reading

Stress-Induced Cortisol During Pregnancy Linked to Smaller Male Babies

MedicalResearch.com Interview with:

Julie Flom, MD MPH Clinical Fellow Division of Allergy & Immunology Icahn School of Medicine at Mount Sinai

Dr. Flom

Julie Flom, MD MPH
Clinical Fellow
Division of Allergy & Immunology
Icahn School of Medicine at Mount Sinai

MedicalResearch.com: What is the background for this study?  

Response: Women who are minorities and of lower socioeconomic have particularly high rates of exposure to chronic ongoing adversity such as poverty as well as traumatic stressors in their lifetime and are also more likely to have low birthweight infants.  Not all women exposed to chronic adversity or trauma transfer this risk to the next generation – it is primarily when the trauma results in changes in her bodies’ ability to handle ongoing stress that the developing child can be impacted.

Our group undertook a study to investigate whether women with increased exposure to traumatic stressors over her lifetime were at higher risk of having low birthweight infants and also whether effects of trauma would only be evident among women who produced higher levels of cortisol, the major stress response hormone, while pregnant.

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High-Risk Gleason 5 Prostate Cancers Not Resistant to Androgen Deprivation Therapy

MedicalResearch.com Interview with:

Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles

Dr. Kishan

Amar U. Kishan, MD
Assistant Professor
Department of Radiation Oncology
University of California, Los Angeles

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Three large randomized trials demonstrated an overall survival (OS) benefit when androgen deprivation therapy (ADT) is combined with radiotherapy (RT) for high-risk prostate cancer (PCa). The duration of ADT in these seminal studies ranged from six months to lifelong. Because ADT has multiple attendant adverse effects–including bone loss, altered metabolism, diminished muscle mass, gynecomastia, hot flashes, and possibly increased cardiovascular events–shortening the duration of ADT without compromising oncologic effectiveness has been an area of active study. Five trials have compared various durations of ADT, reaching conflicting conclusions with respect to overall survival outcomes, with some suggesting an improvement with longer durations of ADT and others failing to show a uniform survival benefit.

Most of these trials have amalgamated Gleason grade group 4 (Gleason score 8) PCa with Gleason grade group (GG) 5 (Gleason score 9-10) PCa. Emerging data indicate that GS 9-10 PCa constitutes a distinct subset of high-risk PCa with inferior outcomes and earlier progression than GS 8 disease. With the knowledge that GS 9-10 PCas constitute a distinct, more aggressive form of PCa, one might hypothesize that longer durations of ADT may be more advantageous in both augmenting local control and controlling potential micrometastatic disease. Alternatively, as GS 9-10 lesions by definition contain highly de-differentiated Gleason pattern 5 disease foci and may proceed to a castrate-resistant state more rapidly, one may also hypothesize that GS 9-10 lesions are less responsive to ADT, and longer durations may be counter-productive.

In order to identify differences in the impact of ADT duration on clinical outcomes of patients with GG 4 and GG 5 PCa, we performed an individual patient-level meta-analysis of six randomized trials. Our working hypothesis was that longer durations of ADT would offer significant survival benefits in both groups.

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Prenatal Exposure to Air Pollution May Affect Newborn’s Thyroid Function

MedicalResearch.com Interview with:

Carrie Breton ScD Associate Professor and Director of the MADRES Center  Division of Environmental Health Los Angeles, CA 90032

Dr. Breton

Carrie Breton ScD
Associate Professor and Director of the MADRES Center
Division of Environmental Health
Los Angeles, CA 90032

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: I am interested in how the environment can influence our very early development, starting in the womb. I have studied the health effects of air pollutants on children for several years and wanted to focus now on the earliest windows of susceptibility.  Thyroid hormones play a critical role in fetal growth and development. We knew we could get information on newborn thyroid levels from the California Department of Public Health’s newborn screening program therefore look at this question in our study population.

We found that exposure to high levels of PM2.5 and PM10 throughout most of pregnancy affected TT4 levels in newborns. Continue reading

No Premature Menopause Found in Adolescents Who Receive HPV Vaccine

MedicalResearch.com Interview with:

Allison L. Naleway, PhD Senior Investigator Associate Director, Science Programs Center for Health Research Kaiser Permanente

Dr. Naleway

Allison L. Naleway, PhD
Senior Investigator
Associate Director, Science Programs
Center for Health Research
Kaiser Permanente

MedicalResearch.com: What is the background for this study?

Response: Reports of premature menopause after human papillomavirus (HPV) vaccination have received a lot of media attention, including on social media, but these reports were based on a small number of isolated cases. Large studies have demonstrated the safety of HPV vaccination, but parental safety concerns—including potential impact on future fertility—are often cited as one reason for lower HPV coverage.

Rates of HPV vaccination have lagged behind coverage rates for other recommended adolescent vaccinations, such as tetanus-diphtheria-acellular pertussis and meningococcal conjugate. (Based on national coverage estimates from 2016, 65% of 13–17 year-old females received at least one HPV vaccination and only 49.5% were up to date with the series, compared to about 88% of adolescents who received Tdap.)

We conducted a study of nearly 200,000 young women to determine whether there was any elevated risk of primary ovarian insufficiency (POI) after HPV or other recommended vaccinations.  Continue reading

Testosterone May Be Link Between PCOS and Autism

MedicalResearch.com Interview with:

Adriana Cherskov Autism Research Centre Department of Psychiatry University of Cambridge Cambridge

Ms. Cherskov

Adriana Cherskov
Autism Research Centre
Department of Psychiatry
University of Cambridge
Cambridge

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Autism is a condition that affects social interaction, communication, and may be accompanied by unusually narrow interests or difficulties adjusting to unexpected change. Signs of autism are usually present in childhood and the condition affects about 1-2% of the population. At the Autism Research Centre at the University of Cambridge, our research team is interested in understanding some of the environmental triggers of autism. Previously, our research group has shown that autistic children have elevated levels of “sex steroid” hormones (including testosterone) before they are born.

Polycystic ovary syndrome (PCOS) is a relatively common condition, affecting about one in ten women, which is primarily characterized by increased levels of the sex-steroid hormone testosterone and its precursors. These mothers may also have higher testosterone levels than usual during pregnancy, which may exposure their unborn baby to more of this hormone. Additionally, they may have genetic factors increasing sex steroid hormones that can be passed down to their children. Our research team sought to examine whether women with PCOS therefore may have an increased chance of having a child with autism.

We used anonymized health records from a large database of GP records in the UK and included 8,588 women with PCOS and their first-born children in the study as well as 41,127 women without PCOS as controls. We found that after adjusting for factors such as maternal mental health conditions or metabolic conditions, women with PCOS had a 2.3% change of having an autistic child, compared with 1.7% change for mothers without PCOS. We would like to stress, however, that the increased risk for women with PCOS is still very small, and the likelihood of having an autistic child is still very low.

As part of this research, we have also conducted two other studies, where we found that women with PCOS themselves were twice as likely to have autism and that women with autism were also twice as likely to have PCOS. These findings suggest a common pathway between autism and PCOS which will be important to explore in future research.

MedicalResearch.com: What should readers take away from your report?

Response: As mentioned earlier, our findings indicate women with PCOS have an increased chance of having a child with autism, but this increase is still very small, and the chance of having a child with autism is still very low even in this population (2.3% compared with 1.7%). As a result, the main take-away from our research is that we have found further evidence for the role of prenatal testosterone as one of many players in the development of autism and a potentially common pathway between autism and PCOS.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: This link will help us in the future to understand the cause of both conditions. In this study we were not able to measure testosterone or sex steroid levels in women or their children, and this will be an important step in determining whether it is the sex-steroid hormones themselves, another downstream factor (such as insulin levels which are affected in PCOS), or genetics at the root of this association. Ultimately, both autism and PCOS are very complex conditions with many causative factors. The association we find here is likely just one of these players for both conditions, but it paves the path for future research.

In the future, this research may also help doctors and patients make decisions about treatment, as women with autism at high risk of developing PCOS may be able to start treatment or lifestyle changes early, which can improve PCOS management and quality of life. Alternatively, we underline again that the small increased likelihood of women with PCOS having a child with autism should not cause additional stress or worry in this population, since there are many factors involved in developing autism which will require further research to understand fully. 

Citation: Adriana Cherskov, Alexa Pohl, Carrie Allison, Heping Zhang, Rupert A. Payne, Simon Baron-Cohen. Polycystic ovary syndrome and autism: A test of the prenatal sex steroid theory. Translational Psychiatry, 2018; 8 (1) DOI: 10.1038/s41398-018-0186-7

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Harmless or Hormone disorder?  New Test Enables Quick Diagnosis For Drinking by the Liter

MedicalResearch.com Interview with:

Prof. Dr. Mirjam Christ-Crain Professor of endocrinology, diabetes and metabolism Heads the Department of Clinical Research University and University Hospital of Basel 

Prof. Christ-Crain

Prof. Dr. Mirjam Christ-Crain
Professor of endocrinology, diabetes and metabolism
Heads the Department of Clinical Research
University and University Hospital of Basel  

MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Diabetes Insipidus?

Response: Drinking more than three litres per day with the equivalent increase in urination is regarded as too much. This drinking by the liter – known as “polyuria polydipsia syndrome” – usually develops over time through habit, or can be a side effect of a mental illness.

In rare cases, however, it may be caused by diabetes insipidus. This is when the pituitary gland lacks the hormone vasopressin, which regulates the water and salt content in our body. Patients have a decreased ability to concentrate the urine, therefore lose a lot of fluid and have to increase their fluid intake accordingly to prevent dehydration (= Diabetes insipidus).

The distinction between what is considered a “harmless” primary polydipsia and a diabetes insipidus is crucial, as their therapy is fundamentally different. Diabetes insipidus must be treated with the hormone vasopressin, while patients with primary polydipsia require behavioural therapy to reduce their habitual drinking. A wrong therapy can have life-threatening consequences as treatment with vasopressin without indication can lead to water intoxication.

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Testosterone Improved Body Mass and QoL in Male and Female Cancer Patients

MedicalResearch.com Interview with:

Traver Wright, Ph.D. Research Assistant Professor Department of Health and Kinesiology Texas A&M University College Station, TX

Dr. Wright

Traver Wright, Ph.D.
Research Assistant Professor
Department of Health and Kinesiology
Texas A&M University
College Station, TX

MedicalResearch.com: What is the background for this study?  

Response: Many cancer patients suffer from a loss of body mass known as cachexia which results in not only a loss of fat, but a debilitating loss of muscle mass and function. This cachexia negatively impacts patient mobility and quality of life, and can also reduce their eligibility to undergo treatments such as radiation and chemotherapy.  Despite the profound negative consequences of cachexia, there are no established therapies to directly address this debilitating loss of body mass during treatment.

In this National Cancer Institute funded double-blind, placebo-controlled study we examined the effectiveness of 7 weeks of treatment with the muscle-building hormone testosterone to preserve the body condition of men and women with cervical or head and neck cancer.  Twenty-one patients received weekly injections of either placebo or testosterone.  Over the 7 weeks of treatment, patients were monitored for changes in body composition, activity level, physical ability, and questionnaires regarding quality of life and well-being.

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Cardiovascular Risks of Hormone Therapy in Transgender Individuals

MedicalResearch.com Interview with:

Michael Goodman, MD, MPH Professor of Epidemiology Director, MD/MPH program Emory University School of Public Health Atlanta, GA  30322

Dr. Goodman

Michael Goodman, MD, MPH
Professor of Epidemiology
Director, MD/MPH program
Emory University School of Public Health
Atlanta, GA  30322

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: There is a concern that hormone therapy may be associated with higher risk of certain cardiovascular problems such as heart attacks, stroke and formation of blood clots (“venous thromboembolism”).

To study this concern we examined data on 4,960 transgender and gender non-conforming people enrolled in Kaiser Permanente health systems in Georgia, Northern California, and Southern California. They were matched to 48,686 cisgender men and 48,775 cisgender women.  Below are the main findings

  • Rates of venous thromboembolism in all transwomen were approximately twice as high as the rates among cisgender men or cisgender women. The data for stroke and myocardial infarction demonstrated little difference between transwomen and cisgender men, but 80% to 90% higher rates among transwomen compared to cisgender women.
  • When the analyses focused specifically on transwomen who started therapy with female hormone estrogen at Kaiser Permanente, the incidence of both venous thromboembolism and stroke was more clearly elevated relative to either reference group.  There was evidence that incidence of both of these conditions among transwomen was particularly increased two to six years after estrogen initiation. By contrast, the association between estrogen therapy and myocardial infarction was less evident due to relatively few observed events.
  • Transmen did not appear to have significantly higher rates of venous thromboembolism, ischemic stroke, or myocardial infarction than their non-transgender counterparts, but this group was rather young and included a relatively small proportion of participants who initiated their hormone therapy during the study.

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Young Survivors of Cancer at Increased Risk of Endocrine Disease

MedicalResearch.com Interview with:
“Cancer awareness” by Susan Roberts is licensed under CC BY 2.0Mette Vestergaard Jensen, MD

Danish Cancer Society Research Center

MedicalResearch.com: What is the background for this study?

Response: Cancer survival rates have improved and it is necessary to explore the long-term consequences of cancer treatment. Adolescents and young adults with cancer are at risk for several therapy-related late effects; however, these have not been studied extensively. We investigatet the lifetime risks of endocrine late effects of cancer and cancer treatment in adolescent and young adult cancer s

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Risky Drinking By Either Sex Can Affect Future Offspring

MedicalResearch.com Interview with:

Toni Pak, Ph.D. Professor and Department Chair Department of Cell and Molecular Physiology Loyola University Chicago Maywood, Ill 

Dr. Pak

Toni Pak, Ph.D.
Professor and Department Chair
Department of Cell and Molecular Physiology
Loyola University Chicago
Maywood, Ill 

MedicalResearch.com: What is the background for this study?

Response: We have known for many years that drinking alcohol during pregnancy can lead to developmental delays and birth defects in offspring. However, our data demonstrate that drinking large quantities of alcohol in a “binge” fashion before pregnancy can also impact future offspring and importantly, this is true for drinking behaviors of both parents, not just the mother.

Our previous data support the idea that alcohol is affecting the parental sperm and eggs to induce these modifications in the offspring, but this most recent work shows the extent of those effects on social behavior, pubertal maturation, and stress hormones as the offspring grow to adulthood.

This means that the risky behaviors of young people, such as the extremely popular practice of binge drinking, have potentially far-reaching consequences for generations to come.

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