Transgender Teen Care 'Needs Urgent Regulation'

Young transgender people are being let down by the "terrible" quality of evidence underpinning their treatment and care, a leading researcher warns.

Prof Carl Heneghan, from Oxford University, said there was an "urgent" need for a new regulator in the field.

He said much more "rigorous" and "robust" research was needed into the effects of drugs given to young transgender people.

But the Department of Health says it has no plans to create a new regulator.

Prof Heneghan, director of the Centre of Evidence Based Medicine at Oxford University, along with Prof Tom Jefferson, who is also a clinical epidemiologist carried out an independent analysis of the most recent international research on medical interventions for the BBC's Panorama programme.

Prof Heneghan said "One of the key issues is to be able to say to parents and children in making a decision... 'Here's an informed decision based on the evidence.'

"The quality of evidence in this area is terrible."

One of the key elements of treatment is puberty blockers, which may be prescribed to young people with gender dysphoria.

They prevent the development of characteristics such as breasts or facial hair.

Puberty blockers have long been used to treat young children who start puberty too early but less is known about their long-term safety in transgender adolescents.

'Huge distress'

Prof Heneghan said: "What can you tell from the evidence? You can tell very little apart from they give you the intended effects of suppressing and blocking puberty."

Dr Polly Carmichael, a consultant clinical psychologist and director of the NHS Gender Identity Development Service, at the Tavistock Centre, said: "There are questions around risk.

"What you have is a phenomenon and that phenomenon is young people who are hugely distressed around their gender identity.

"I think that it is important that young people and families who have gone forward for treatment are exceedingly positive about it."

'It helps to take time'

Now 18, Jade, was referred to child mental health services for depression in her early teens. Realising that she was conflicted about her gender identity, they referred her on to the Tavistock Centre.

She spent a year on the waiting list, before starting counselling when she was 16-years-old.

"I took a lot of time playing with my identity, which I think is an important thing to do, especially for young people, because it gave me that time to realise that I lived my life as a feminine guy but that wasn't it. There was something more to it," she says.

"When people see me on the street, I want to be perceived as a woman."

Jade, like most under-18s referred to the Tavistock, didn't take puberty blockers or cross-sex hormones while she was a patient there.

"There's just so much thinking that needs to be done, especially to making life changes to go down the line like hormone blockers, when there are so many changes happening in your body," she says.

"It just helps to take time."

Jade says she's still struggling with gender dysphoria but is now ready for the next stage in her transition.

When children have been on puberty blockers for a year, and are about 16, they can be offered cross-sex hormones by the NHS - testosterone and oestrogen, the effects of which can be irreversible.

'Emotive' Area

Prof Heneghan said the way the research studies had collected and analysed evidence "prevented definitive conclusions" to be made on young people's outcomes with cross-sex hormones.

He said the number of patients in the research groups was small and many patients were "lost" from the studies, so their outcomes were not followed up.

The Tavistock Centre has undertaken its own research into patients but he said they had not done enough.

"They haven't produced systematic data on the outcomes based on all children," Prof Heneghan said.

"In the absence of evidence, I just do not understand how they can inform children, adolescents and parents and families in a way that helps them make an informed decision."

However, Dr Carmichael said the centre had recently been given a research grant "to follow young people who come to the service through and forward, whatever their outcomes, and that is going to be really important information".

The Tavistock Centre also said it engaged in research and published regularly.

But Prof Heneghan said a new regulator was urgently needed to provide oversight of the care and treatment offered by both the NHS and private providers.

He likened the "emotive" area of care for transgender children to that for fertility and called for a new regulator to oversee research and treatment, similar to the Human Fertilisation and Embryology Authority (HFEA), which would be independent to those providing the care.

The Department of Health said it had no plans to introduce an independent regulator but added: "We are committed to ensuring thorough accountability and oversight... and will review any arrangements when appropriate."

Panorama: Trans Kids - Why Medicine Matters is available on BBC iPlayer. Dr Faye Kirkland is also a GP.

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Type-2 Diabetes: 'Weight Loss Arrests Disease for Years'

Consuming 850 calories a day for three months and then keeping the weight off can arrest type-2 diabetes for at least two years, a study suggests.

The GP-led programme worked for more than a third of participating patients.

The study report builds on earlier work suggesting weight loss is one key solution and offers more time off medication than previously thought.

Experts say it challenges the view that type-2 diabetes is always a life-long, progressive condition.

Type-2 diabetes affects one in 16 adults in the UK.

It causes uncontrolled sugar levels that can lead to serious complications such as amputations, visual problems and heart disease.

'I Lost 17kg in 12 Weeks'

Joe McSorley, 58, who lives near Glasgow, was diagnosed with type-2 diabetes six years ago and though he was given two types of medication, found it hard to keep his blood sugars under control.

He told BBC news: "All I could see for the future was continuing to take these pills forever."

When he started the trial diet - consuming only low-calorie shakes every day - he found it very difficult.

But he saw rapid results, dropping from 90kg (14st 2lb) to 73 kg in just 12 weeks.

And, Mr McSorley said, the hardest part came when he had begun to eat solid food again.

"Using the shakes is only the start of the journey," he said.

"It gets you to the point where you can take destiny in your own hands."

Two years later, his weight is stable at 77kg.

He exercises regularly and hopes to become a lifestyle coach when he retires.

Mr McSorley was one of 149 people in Scotland and Tyneside put on a 12-30-week low-calorie diet of shakes and drinks to help trigger weight loss.

They were then reintroduced to solid meals over the next few weeks.

After one year, 69 of them (46%) had gone into remission, compared with just 4% of people given standard treatment including pills.

And after two years, 53 of them (36%) remained off medication and in remission.

Participants were encouraged to keep healthy through monthly meetings and had the option of a "rescue" plan including using the liquid diet again, if they gained weight.

'Not All About Weight'

Prof Roy Taylor, an investigator on the trial at Newcastle University, said: "These results are a significant development and finally pull down the curtain on the era of type-2 diabetes as an inevitably progressive disease."

Researchers said most of the weight-loss group whose diabetes had gone into remission had lost 10kg or more and maintained this weight loss during the trial.

But Dr Nicola Guess, at King's College London, said weight loss was not the whole story.

"Type-2 diabetes returned in a minority of people (16%) who kept off 15kg or more for two years," she said.

"Further research is needed to help us understand why this is.

"It is possible that these people had type-2 diabetes for longer before losing weight or perhaps there might be dietary or genetic factors which contributed."

The NHS in England is planning on piloting the programme and NHS Scotland has begun rolling out similar schemes. But NHS experts caution that this type of calorie restriction is not be suitable for everyone and should be done under medical supervision only.

The charity Diabetes UK, which funded the study, said the findings were exciting but added: "We know type-2 diabetes is a complex condition and this approach will not work for everyone."

The trial is published in the Lancet Diabetes and Endocrinology.

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Canada Appeals Court Orders Tobacco Firms to Pay Billions in Damages

A Canadian court has upheld the bulk of a decision that ordered three tobacco companies to pay billions in damages.

The judgment involves class action suits that were consolidated against Imperial Tobacco Canada, Rothmans Benson & Hedges and JTI-MacDonald.

The companies had appealed a 2015 ruling in favour that ordered them to pay over C$15bn (£8.5bn; $11bn).

The plaintiffs were Quebec smokers who said the firms failed to warn them of health risks associated with smoking.

Rothmans, Benson & Hedges said on Friday it will seek leave to appeal to the Supreme Court of Canada.

JTI-Macdonald Corp said it "fundamentally disagrees" with the decision and is considering all options, including an appeal.

Plaintiffs said the firms knew since the 1950s that their product was causing cancer and other illnesses and failed to warn consumers.

The companies had argued that Canadians have had a "high awareness" of smoking health risks for over half a century and say they have been strictly regulated.

The Quebec Court of Appeal sided on Friday with a lower court decision that concluded the companies had failed to provide adequate information about the "safety defect" in their tobacco products.

This is the largest award for damages in the country's history and will include interest on those damages.

The two class-action lawsuits were originally filed in 1998 before they were consolidated.

Smoking rates have reduced steadily in Canada over the years and in 2017 just under 17% of Canadians smoked at least occasionally.

In recent years, US courts have ordered tobacco companies to pay large awards.

But those payouts are often reduced upon appeal.

A $28 bn (£18.3 bn) ruling against Philip Morris was reduced to $28m on appeal in 2011.

American tobacco firms agreed in 1998 to pay US states over $200 bn (£131 bn) in fines in what is the largest civil litigation suit in US history. US states have been criticised for not spending enough of the compensation on anti-smoking programmes.

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Quick Pregnancy is Safe After Stillbirth, Study Finds

There is no reason to delay having another baby after a stillbirth, research in the Lancet suggests.

Although women are often told to wait for a year before getting pregnant again, there is little evidence to back up this advice.

This international study of 14,000 births found no increased risk of problems if conception happened earlier.

A UK stillbirth expert said the findings were important and reassuring.

About one in every 225 births in the UK ends in stillbirth, which is defined as the death of a baby after 24 weeks of pregnancy in the UK. However, in this study, a stillbirth is defined as a baby's death after 22 weeks' pregnancy.

Stillbirth rates have been gradually reducing in the UK since 2000, and more sharply since 2015, but compared with many other European countries, improvements in the UK have been slow.

In many countries there is limited guidance available on planning future pregnancies after stillbirth, the study says.

Manchester University's Prof Alex Heazell, spokesman for Tommy's stillbirth charity and the Royal College of Obstetrics and Gynaecology, said his message to women was "not to worry".

"As long as they get all the information about why their baby died, then the choice of when to have another baby is down to when they are psychologically ready."

He said there was no physiological reason to wait more than a year before trying for another baby.

"Stress may exacerbate things and so waiting until that goes may be a reason for some to hold off," Prof Heazell said.

To Wait or Not

The researchers looked at the birth records of 14,452 women who had previously had a stillbirth in Western Australia, Finland and Norway over 37 years.

A total of 2% of those subsequent pregnancies ended in stillbirth, 18% were preterm births and 9% were babies born small for their age.

The study found that those who conceived within 12 months of stillbirth were no more likely to have another stillbirth, or a preterm birth, than women who left two or more years between pregnancies.

Out of the births studied, 9,109 or 63% were conceived within 12 months of the stillbirth.

The study, led by Dr Annette Regan, from Curtin University in Australia, said the findings were useful for clinicians who give counselling after stillbirths.

She said women who did not leave enough time to recover after a previous pregnancy could be at risk of "poor nutritional status, which has been linked to increased risk of foetal growth restriction and birth defects".

But she said this may be less likely to occur after a pregnancy loss, such as stillbirth or miscarriage.

Commenting on the research, Mark A Klebanoff, from the Research Institute at Nationwide Children's Hospital in the US, said there were other factors to consider.

"Rather than adhering to hard and fast rules, clinical recommendations should consider a woman's current health status, her current age in conjunction with her desires regarding child spacing and ultimate family size, and particularly following a loss, her emotional readiness to become pregnant again."

What is stillbirth?

A stillbirth is when a baby is born dead after 24 completed weeks of pregnancy

If the baby dies before 24 completed weeks, it is known as a miscarriage or late foetal loss.

Some stillbirths are linked to complications with the placenta, a birth defect or with the mother's health. For others, no cause is found.

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Experimental Treatment Offers Hope to Restore Cells Damaged in Parkinson's Disease

A pioneering clinical trials program that delivered an experimental treatment directly to the brain offers hope that it may be possible to restore the cells damaged in Parkinson's disease. The study investigated whether boosting the levels of a naturally-occurring growth factor, Glial Cell Line Derived Neurotrophic Factor (GDNF), can regenerate dying dopamine brain cells in patients with Parkinson's and reverse their condition, something no existing treatment can do. Potentially promising results of the third arm of the trials, an open-label extension study, are reported in the Journal of Parkinson's Disease.

The three-part multimillion-pound GDNF study was funded by Parkinson's UK with support from The Cure Parkinson's Trust and in association with the North Bristol NHS Trust.

Six patients took part in the initial pilot study to assess the safety of the treatment approach. A further 35 individuals then participated in the nine-month double blind trial, in which half were randomly assigned to receive monthly infusions of GDNF and the other half placebo infusions. After the initial nine months on GDNF or placebo, the open-label extension study took place, which explored the effects and safety of continued exposure to GDNF for another 40 weeks in the patients previously receiving GDNF (80 weeks in total) and the effects of 40 weeks of open label GDNF in those subjects who had previously received placebo for the first 40 weeks. All 41 patients randomized and treated in the parent study (prior GDNF and placebo patients) were enrolled and completed the open label extension study.

A specially designed delivery system was implanted using robot-assisted neurosurgery. This delivery system allowed high flow rate infusions to be administered every four weeks and enabled so called Convection Enhanced Delivery (CED) of the study drug. Four tubes were carefully placed into each patient's brain, which allowed GDNF to be infused directly to the affected areas with pinpoint accuracy via a skull-mounted transcutaneous port behind the ear. After implantation and over the following several years the trial team administered, more than 1000 brain infusions, once every four weeks over 18 months to study participants. The high compliance rate (99.1%) in participants recruited from throughout the UK has potentially demonstrated that this new administration process for repeated brain infusion is clinically feasible and tolerable.

After nine months, there was no change in the PET scans of those who received placebo, whereas the group who received GDNF showed an improvement of 100% in a key area of the brain affected in the condition, offering hope that the treatment was starting to reawaken and restore damaged brain cells.

"The spatial and relative magnitude of the improvement in the brain scans is beyond anything seen previously in trials of surgically delivered growth-factor treatments for Parkinson's," explained principal investigator Alan L. Whone, PhD, FRCP, Translational Health Sciences, Bristol Medical School, University of Bristol, and Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, UK. "This represents some of the most compelling evidence yet that we may have a means to possibly reawaken and restore the dopamine brain cells that are gradually destroyed in Parkinson's."

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By 18 months, when all participants had received GDNF, both groups showed moderate to large improvements in symptoms compared to before they started the study and that GDNF was safe when administered over this length of time. However, no significant differences between the groups (placebo followed by GDNF versus GDNF for the entire study period) in the primary and secondary clinical endpoints were seen.

The question of whether clinical benefits lag behind biological changes seen in PET scans during disease reversal or need a longer period of repeated exposure to the drug to develop cannot be answered definitively on the basis of the extension study results. However, the integrated results of the two studies suggest that:

* Attending on an out-patient basis over 18 months, to receive infusions every four weeks via a skull-mounted port, is feasible.

* This treatment regimen and novel method of drug administration are well tolerated.

* Further testing of GDNF in a larger-scale study and including the use of higher doses are required to definitively determine whether GDNF has a future role as a neurorestorative treatment for Parkinson's.

According to Steven Gill, MB, MS(Lond.), FRCS, lead neurosurgeon and designer of the CED device, of the Neurological and Musculoskeletal Sciences Division, North Bristol NHS Trust, Bristol, and Renishaw plc, New Mills, Wotton-under-Edge, Gloucestershire, UK, "This trial has shown that we can safely and repeatedly infuse drugs directly into patients' brains over months or years. This is a significant breakthrough in our ability to treat neurological conditions, such as Parkinson's, because most drugs that might work cannot cross from the blood stream into the brain due to a natural protective barrier."

"It's essential to continue research exploring this treatment further - GDNF continues to hold potential to improve the lives of people with Parkinson's," commented Dr. Whone.

I believe that this approach could be the first neuro-restorative treatment for people living with Parkinson's, which is, of course, an extremely exciting prospect," added Dr. Gill.

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Almost Half of All Childhood Cancer Cases Go Undiagnosed

A new study published in The Lancet Oncology estimates that almost half of all children in the world who have cancer are not diagnosed or treated, leaving them to "die at home."

The study found that around 400,000 new cases of childhood cancer arise every year, but only 200,000 of these are diagnosed and therefore recorded.

The study authors say this can occur due to a lack of access to primary care, with children ending up dying undiagnosed at home.

The new "Global Childhood Cancer" model showed that under-diagnosis of childhood cancer is a particular problem in South Asia and Western Africa, where rates were high as 49% and 57%, respectively.

In North America and Europe, only 3% of childhood cancers were left undiagnosed. Study author Zachary Ward (Harvard TH Chan School of Public Health) and colleagues estimate that 3 million cases will be undiagnosed by 2030 if improvements are not made.

Previous estimates have been based on records from cancer registries, but 60% of countries do not have these registries, meaning the estimates only cover a small proportion of the global population.

The new model incorporates cancer registry data but also includes information from the World Health Organisation's Global Health Observatory, demographic health surveys and household surveys developed by UNICEF.

Accurate estimates of childhood cancer incidence are critical for policymakers to help them set healthcare priorities and to plan for effective diagnosis and treatment of all children with cancer. While under-diagnosis has been acknowledged as a problem, this model provides specific estimates that have been lacking."

Zachary Ward, First Author

The most common childhood cancer in 2015 was found to be acute lymphoblastic leukaemia, with 75,000 new cases identified worldwide, including almost 700 in Northern Europe, more than 1,500 in West Africa, over 3,500 in East Africa and almost 30,000 in South Central Asia.

Ward says the positive news is that many countries are committing to universal health coverage, which will help improve children's access to healthcare, although investment in cancer registries is still needed so that progress can be monitored.

Only real-world data can give us the true picture in a given country or region of the world. Cancer registries must be given the legislative, political and financial stability to collect complete and high-quality data in a timely fashion." - Dr. Claudia Allemani, Cancer Epidemiologist at LSHTM.

Ward, Z. J. et al. 2019. Estimating the total incidence of global childhood cancer: a simulation-based analysis. The Lancet Oncology.

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Morning Walks Could Be Better Than Drugs At Lowering Blood Pressure

According to a new study published in the journal Hypertension, just half-an-hour of walking in the morning could be as effective as medication at lowering blood pressure.

Researchers at the University of Western Australia found that 30 minutes of walking on a treadmill in the morning improved participants' blood pressure readings for the rest of the day. They say that for some individuals, the morning walking could replace the need for medication.

According to the charity Blood Pressure UK, about one-third of adults have high blood pressure, which is defined as a reading of more than 140/90 mmHg and, in Britain, about 12 million people take medication for the condition.

For the study, Michael Wheeler and colleagues assessed 67 overweight and obese men and women (aged 55 to 80) who engaged in three different 8-hour daily routines.

The first routine involved sitting continuously for eight hours. The second involved sitting for one hour before walking for 30 minutes at moderate intensity on a treadmill, followed by sitting for a further 6.5 hours.

The third routine involved sitting for one hour before 30-minute treadmill walking and then sitting for 6.5 hours, but with this interrupted every 30 minutes with 3 minutes of light intensity walking.

The results showed that blood pressure was significantly lower when participants engaged in the routines that involved walking, compared with the sitting-only routine.

Wheeler says that the magnitude of the blood pressure reduction approached that of what may be expected when this population group take anti-hypertensive medication.

Commenting on the study, the British Heart Foundation added that half-an-hour of morning exercise is also good for people's mental health.

Cardiac nurse at the British Heart Foundation, Chris Allen, says the findings add to a huge body of evidence showing that regular exercise can help to lower blood pressure and reduce the risk of heart attacks and strokes: "It can also give both your body and mind a boost, which is why 30 minutes of activity in the morning is a great way to set yourself up for the day."

As the proportion of those who are overweight with higher blood pressure increases with age, adopting a strategy of combining exercise with breaks in sitting may be important to control and prevent the development of high blood pressure." - Professor Michael Wheeler, Lead Author.

Wheeler, M., J., et al. 2019 Effect of Morning Exercise With or Without Breaks in Prolonged Sitting on Blood Pressure in Older Overweight/Obese Adults. Hypertension.

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