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Rates of Multiple Births from Fertility Treatment Still Unacceptably High In The United States

MD-FM Thursday December 5th, 2013 

 

 

SARAH:

MD FM: Medical News from around the world with Peter Goodwin.

 

Segment 1: Assisted Reproductive Conception: rates of multiple births still too high in the United States.

PETER:

Hello, and with me is Sarah Maxwell. In the United States fertility treatments are resulting in far too many multiple births and that’s despite guidelines aimed at limiting the number of embryos transferred during in-vitro fertilization procedures…

 

SARAH:

Yes, that’s according to an analysis, published in the New England Journal of Medicine, that shows while the rate of IVF-related triplets and higher order births have declined by more than 30 percent in the last decade, the rate of twin births are still on the rise. Multiple births are a threat to mothers’ and babies’ health, and they also cost a whole lot more to manage:

 

PETER BRAUDE:

In America, the ASRM (that’s the American Society for Reproductive Medicine), in 1998, suggested that clinicians should really consider very carefully how many embryos they put back and should by preference put back two rather than three. It reduced the triplet rate significantly, but what it didn’t change was the twin rate, which went up from 27 percent to 36 percent even, in 2011. So people were putting back two rather than three, but not putting back one! The question is what accounts for the reasons that there are multiple pregnancies… These are competition, financial and, most importantly, that the patients don’t really appreciate that twin outcome is not a good outcome. So it’s the responsibility of good clinicians to appreciate the fact that single embryos will produce good singleton pregnancy rates.

 

SARAH:

That was Professor Peter Braude, from King’s College in London, who did not participate in the study. And he reiterated that multiple births are dangerous for both the mothers and the children. The study data also showed that multiple births resulting from non-IVF fertility treatments, such as ovulation induction and ovarian stimulation, are also on the rise, and harder to control. Dr. Dmitry Kissin:

 

DMITRY KISSIN:

Consideration should be given to expanding current public reporting to include clinical outcomes of non-ART treatment because we don’t really know enough to recommend... There is no national registry on non-ART fertility treatments in the US at this time. So we are in a disadvantage compared to IVF.

 

SARAH:

Study co-author Dmitry Kissin, from the Centers for Disease Control and Prevention in Atlanta, Georgia, who added that starting with low doses of non-IVF treatment and monitoring the ovarian response, can help reduce rates of multiple births.



SEGMENT 2: First evidence confirming pelvic floor muscle exercises relieve symptoms in women with pelvic organ prolapse. 

 

PETER:

For women with pelvic organ prolapse, pelvic floor muscle exercises improved symptoms compared to controls, as shown for the first time in a randomized study published in The Lancet. Around 450 patients were randomised to either a 16 week training program spread over five visits or no muscle training. The intervention consisted of regular and repeated squeezing of the muscles, with both short and long holds. And women in the training group reported fewer prolapse symptoms at 12 months than those in the control group.



SEGMENT 3: Trial results posted on ClinicalTrial.gov are more transparent than in published articles. 

 

PETER:

Research data posted on the website ClinicalTrials.gov is much more transparent and comprehensive than corresponding publications in peer-reviewed journals, according to a new analysis published in PLoS Medicine. It showed that half of the trials posted on ClinicalTrials.gov didn’t have corresponding articles in journals…

 

SARAH:

And for those that did, data on: efficacy, safety, adverse events and patient flow were much more detailed on ClinicalTrials.gov. Study co-author Agnes Dechartres, said that this could be due to the website’s template. Results from studies with Food and Drug Administration approved agents must be posted on the website within one year of study completion and they have to be reported in a standardized fashion, with staff checking them systematically before the information is made public. But other reasons might also come into play:

 

AGNES DECHARTRES:

We cannot exclude that perhaps this under-reporting of trial results is related to the nature of the results. We know the tendency for trials with positive results to be more published that those with negative results, we also have the time lag bias: trials with positive results are more likely to be published more quickly than trials with negative results.

 

SARAH:

That was Agnes Dechartres, from INSERM in Paris, whose team analysed data on nearly 600 trials randomly selected on ClinicalTrials.gov. Dr. Dechartres encouraged all practitioners to get used to checking the site regularly:

 

AGNES DECHARTRES:

Having access to transparent and complete results is crucial for general practitioners and specialists to take well-informed decisions for their patients. So it is important for all types of physicians to know that at ClinicalTrials.gov trial results are more completely reported than in publications.

 

SARAH:

Agnes Dechartres, from France.


 

SEGMENT 4: BCG vaccine may also help prevent multiple sclerosis. 

 

PETER:

The BCG vaccine, primarily used to prevent tuberculosis, may also help prevent multiple sclerosis in people showing early signs of the disease. That’s according to a study, reported in Neurology, looking at 73 patients with clinically isolated syndrome…

 

SARAH:

Yes, those who received a single injection of the live attenuated BCG, had substantially fewer MRI brain lesions at six months than those who received a placebo shot. And five years after getting disease-modifying drugs, 58 percent of people vaccinated had not developed MS, compared to 30 per cent of those who had a placebo.

PETER:

Sounds encouraging, but are there any safety implications to be borne in mind here?

SARAH:

Side effects were apparently similar in both groups. But the authors of an editorial said one injection might not be enough to ward off a disease that lasts decades, but that the long-term safety of repeated injections is unknown. Lead study author, Giovanni Ristori from Rome, agreed that more studies are needed.

 

PETER:

So, do we have an idea at this stage what the possible mechanism is at work?

SARAH:

Well in the past we’ve heard of potential immune modulatory effects of BCG in other clinical settings, and in this one Dr. Ristori told MDFM he had some good ideas of what might be happening to combat the autoimmune mechanisms of MS:

 

GIOVANNI RISTORI:

 A hypothesis is that BCG is an inductor of TNF (tumor necrosis factor) that is considered a pro-inflammatory cytokine but several studies have demonstrated that tumor necrosis factor in the brain is neuroprotective, and this may, at least in part, explain why this approach may protect from tissue damage.

SARAH:

Giovanni Ristori from Sapienza University in Rome, who mentioned that the BCG has also proved effective at reducing autoimmunity in patients with type-1-diabetes.

 

SEGMENT 5: Opioids are effective in patients with restless legs syndrome refractory to first line therapy.

  

PETER:

For patients with severe restless legs syndrome, in whom dopamine-agonists have failed, a randomized study has now provided the first solid evidence that opioids can significantly relieve symptoms…

 

SARAH:

Yes, according to a study, published in The Lancet Neurology, 12 weeks of oxycodone-naloxone reduced symptoms by about eight points on the International RLS severity rating scale compared to placebo…

CLAUDIA TRENKWALDER:

To give you an idea, the dopamine-agonists have been licenced when there was only a change in the mean of 4 or 5 points and the best results ever until this study was 6 point different. So this was very surprising that even in the severely affected group, one could manage that patients are getting almost symptom free.

SARAH:

That was lead study author Professor Claudia Trenkwalder, from Paracelsus-Elena Hospital in Kassel, Germany, who noted that the benefits of opioids were sustained in patients who prolonged their treatment for a year. There were more adverse events in the opioid group, mainly fatigue, constipation and drowsiness, but these effects were expected.

 

PETER:

In fact doctors have in fact been prescribing opioids off label for RLS for at least a decade now haven’t they?

 

SARAH:

Yes, and Professor Trenkwalder told us she now had recommendations to guide practitioners:

CLAUDIA TRENKWALDER:

The message is now to say: if you use an opioid use it in a low dosage, 10 mg twice a day is absolutely effective, and use it twice a day to have a very stable plasma level of the opioid. But with this medication, one should be careful giving an opioid to restless leg syndrome patients who may previously had constipation.

SARAH:

Claudia Trenkwalder, who said the next step will be to investigate how to refine the selection of patients with RLS who might benefit best from having opioid therapy.  



IN BRIEF 1: Metal-on-metal hip resurfacing associated with reduced mortality compared with total hip replacement. 

 

PETER:

Finally, in brief: Patients with hip osteoarthritis who had metal-on-metal resurfacing had reduced mortality, in the long-term, compared to those underwent cemented or un-cemented total hip replacement. This is according to new data, published in the British Medical Journal. It follows last year’s controversy regarding local and systemic adverse effects, also reported in the BMJ, caused by debris of metal on metal hip resurfacing. The authors concluded that randomized studies are needed to further assess these apparently conflicting results.

 

IN BRIEF 2: Use of inhaled corticosteroids increased the risk of tuberculosis.

PETER:

The use of inhaled corticosteroids apparently increased the risk of tuberculosis in a dose-dependent manner, according to research led in South Korea. A cohort study, published in the journal Thorax, reached this conclusion after comparing over 4,000 users of inhaled respiratory medications diagnosed with tuberculosis, with around 20,000 uninfected controls taking inhaled corticosteroids.


PETER:

That's all from MDFM for now. Sarah Maxwell and I will be back with more next week, so until then from me Peter Goodwin, goodbye!

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