Experimental mobile app helps manage migraines

[ad_1]

(Reuters Health) - A smartphone-based relaxation app could help migraine sufferers reduce the number of headaches they get each month, a small study suggests.

Using the app twice a week was associated with an average of four fewer headache days per month, according to the report in Nature Digital Medicine.

“Migraine is now the second most disabling condition in terms of disability-adjusted years lost,” said lead author Dr. Mia Minen of NYU Langone Health in New York City.

Migraines affect about 1 in 6 adults in the U.S., with women most at risk.

“Previous research has shown that the best treatment for preventing migraine is a combination of migraine medication and behavioral therapy,” Minen told Reuters Health by email. However, “patients have significant difficulty accessing these safe, top evidence-based treatments.”

Minen and colleagues created RELAXaHEAD, an app based on the technique of progressive muscle relaxation, a proven method of migraine prevention, the authors note. The study team analyzed whether patients recruited from a neurology clinic would use the app regularly and whether they’d have fewer headache days.

During the study, 51 patients in their 30s and 40s who typically had 13 or more headache days per month were asked to complete a daily headache diary and to do progressive muscle relaxation with the app for 20 minutes a day for 90 days. Nearly one third of the participants were considered to have severe migraine disability when they enrolled, meaning they had missed considerable amounts of work, school and family activities due to the headaches.

On average, participants used the app on 22 days per month, for about 11 minutes per day. Roughly half used it once per week and a third used it two or more times per week. Overall, those who used the app twice per week had four fewer headache days the following month, and those who used it once per week had two fewer headaches days. Use of the app tended to drop over time.

Patients with higher depression scores were less likely to use the daily headache diary, and those with higher anxiety scores were more likely to use it.

“The number of mobile health apps available in the iOS and Google Play stores has ballooned, and recent studies show that most people download an app but then rarely use it,” Minen said. “Importantly, we were able to get a considerable number of study participants to use the app.”

The researchers have received inquiries about the app from patients with migraines outside the NYU Langone system, she noted. Although it was created as a research tool, Minen’s team is exploring ways to expand access to the app or include it in office visits. They’re also studying whether the app can help healthcare providers who don’t know where to refer patients with migraines who want behavioral therapy.

“I would encourage people who live with migraines to consider a behavioral treatment,” said Alice Pressman of Sutter Health in Walnut Creek, California, who wasn’t involved in the study.

“The great thing about starting a (behavioral therapy) BT is that you don’t have to stop your other treatments if you feel they are effective,” Pressman said by email. “BTs can be used as add-ons with no added side effects.”

However, an in-person a mindfulness-based stress reduction program targeting migraines that was offered at her center was difficult for some patients to attend due to time and location, Pressman said, so an online program may help. At the same time, patients should know that apps are still new and not fully studied.

“Research here is important to enable therapeutically effective and safe smartphone apps. Lots of apps are offered that are not based on any scientific evidence,” said Thomas Dresler of the University of Tuebingen in Germany, who wasn’t involved in the study.

“There are a lot of migraine apps out there, but customers need to know that the availability of an app per se does not guarantee effectiveness, safety or the developers’ adherence to specific quality standards,” Dresler said by email.

SOURCE: bit.ly/2X9Iwa1 Nature Digital Medicine, online June 4, 2019.

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

Mesh implants work for bladder leakage, long-term safety unclear

[ad_1]

(Reuters Health) - Several different types of mesh implant surgery may be effective for treating bladder leaks, but the long-term safety and effectiveness of the procedures isn’t yet clear, a new analysis suggests.

Researchers examined data from 175 clinical trials that randomly assigned a total of 21,598 women with stress urinary incontinence to receive different types of surgical treatments.

Over the short-term, three types of surgeries appeared most effective at curing the incontinence. Two newer procedures using slings to support the bladder had cure rates of about 89% and an older abdominal surgery to suture the bladder had a cure rate of about 77%.

“With regard to surgical treatments, there is limited evidence to suggest that there is one ‘best’ option for the treatment of stress urinary incontinence. Rather there are several trade-offs and risks that women need to be aware of and consider alongside their clinician when making their treatment choice,” said study co-author Dawn Craig of Newcastle University in the UK.

“Based on our findings, the jury is still out on the long-term risks of vaginal mesh for stress urinary incontinence,” Craig said by email.

Up to half of adult women experience stress urinary incontinence, when the pelvic floor muscles are too weak to support the bladder. As a result, urine leaks during coughing, sneezing or exercise. Childbirth is a common reason for weak pelvic muscles, and obesity worsens the problem.

Surgical treatment for stress urinary incontinence has evolved over the past two decades from open abdominal operations to support the bladder with sutures to less invasive procedures that insert mesh slings instead. Recently, however, the safety of mesh implants for stress incontinence has come under scrutiny due to reports of severe complications, litigation and product withdrawals, researchers note in The BMJ.

One of the more effective mesh sling options in the study was a traditional suburethral sling, which involves placing a sling under the urethra and using one of a variety of techniques to secure it in place.

The other mesh sling option with similar effectiveness was the midurethral sling, a newer minimally-invasive procedure that enables surgeons to insert a narrow strip of synthetic mesh without the need to secure it in place.

In contrast, the older type of surgery known as an open coloposuspension requires cutting through the abdomen to reach the bladder and then using sutures to support the neck of the bladder, the group of muscles that connect the bladder to the urethra. These muscles tighten to hold urine in the bladder and relax to release urine.

Most of the available safety data was for the newer mesh sling procedures.

Mesh procedures done with one vaginal incision and two groin or thigh incisions - known as transobturator midurethral sling surgery - had more repeat surgeries and groin pain but fewer vascular complications, bladder or urethral perforations, or voiding difficulties than so-called retropubic midurethral surgery done with one vaginal incision and two abdominal incisions.

“We do not have good long-term follow up data for any of these surgeries as the trials analyzed lasted up to five years at most and mesh can cause problems many years after insertion,” said Rufus Cartwright of Oxford University Hospitals NHS Trust in the UK, who co-authored an accompanying editorial.

Some women might be able to address stress urinary incontinence without surgery, previous research has found. Lifestyle changes like avoiding caffeine, drinking small amounts of fluid, using the bathroom at scheduled times throughout the day and doing exercises that target the pelvic floor muscles can improve bladder control.

“Women should consider surgery for incontinence if their symptoms are severely affecting their quality of life, and they haven’t responded to conservative treatment (pelvic floor exercises),” Cartwright said by email. “The choice between the different procedures should be based on a process of shared decision making with the surgeon.”

SOURCE: bit.ly/31w78Jv and bit.ly/2KeSIIt The BMJ, online June 5, 2019.

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

IBM, Walmart, Merck in blockchain collaboration with FDA

[ad_1]

FILE PHOTO: The Walmart logo in New York, U.S., May 1, 2018. REUTERS/Brendan McDermid/File Photo

(Reuters) - IBM, Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution.

The companies said they would work with consultancy KPMG to create a shared blockchain network that will allow real-time monitoring of products in the pharmaceutical supply chain.

The project has been authorized under the U.S. Drug Supply Chain Security Act (DSCSA) that was set up to increase regulatory oversight of counterfeit, stolen, contaminated or otherwise harmful drugs.

The FDA has previously used the DSCSA to issue a warning letter to drug distributor McKesson Corp for violations involving opioid medications.

Opioids have been tied to thousands of overdose deaths and state and local governments across the United States have filed lawsuits seeking to hold pharmaceutical companies responsible for the epidemic of abuse.

The new project is aimed at reducing the time needed to track and trace prescription drugs, improving access to reliable distribution information and ensuring products are handled appropriately and stored at the right temperature while being distributed, the companies said in a statement.

Blockchain technology, originally conceived a decade ago as the basis for the cryptocurrency bitcoin, will help stakeholders establish a permanent record and can be integrated with existing systems used to trace products while they are distributed.

The project is scheduled to be completed in the fourth quarter of 2019 and results will be published in a report, the companies said.

Reporting by Tamara Mathias in Bengaluru; Editing by Shinjini Ganguli

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link

GSK signs up gene-editing pioneers in drug discovery alliance

[ad_1]

(Reuters) - British drugmaker GSK said it has struck a research deal with the early pioneers of a prominent gene-editing technology at the University of California, in a boost to its prospects for developing new drugs.

GlaxoSmithKline, Britain’s largest drugmaker, will pay up to $67 million over a five-year period for the new Laboratory for Genomics Research, which will be jointly run with the University of California and led by researchers such as Jennifer Doudna, a co-inventor of the CRISPR gene-editing technology.

New gene editing tools - with CRISPR/Cas9 as the most prominent example - have thrown the door wide open for rearranging the genetic code much more precisely and at lower costs than previously possible.

The technology made headlines last year when a Chinese scientist caused outrage with a claim to have “gene-edited” babies, but CRISPR/Cas9 can also be used in medical and agricultural research without interfering with the human germline.

CRISPR works as a molecular scissors that can trim away unwanted pieces of genetic material and replace them with new ones. Easier to use than older techniques, it has quickly become a preferred method of gene editing in research labs.

The new GSK lab will run tests on various irregularities in the human genome and track the malfunctions they trigger in cells, hoping to gain a clearer understanding of the causes of cancer as well as neurological and immunological diseases.

“Once we understand how that changes its function, we can think about how to mitigate that functional impairment and normalize the cell, and normalize, hopefully, the patient by just developing a drug that could prevent them from developing the disease,” said GSK’s Chief Scientific Officer Hal Barron.

GSK, which had hired Barron from Alphabet-backed biotech firm Calico in 2017, will become more dependent on its drug development fortunes as it prepares to fold its consumer health business into a joint venture with Pfizer that will be separately listed.

Automation and heavy-duty computing will allow researchers to analyze hundreds of millions of genetic combinations per experiment at the new lab, Barron added.

The University of California in February scored a victory in a drawn-out legal battle with the Cambridge, Massachusetts-based Broad Institute over the CRISPR patent application that Doudna filed together with Emmanuelle Charpentier of the University of Vienna in 2012.

The new lab in San Francisco will include facilities for 24 full-time university employees funded by GSK plus up to 14 full-time GSK staff.

Other pharma companies are investing in the new method. Bayer and Vertex Pharmaceuticals have independently established collaborations with CRISPR Therapeutics, a biotech firm working on gene therapies.

For GSK, the California lab project ties in with existing data-driven alliances in genetic research with Alphabet-funded gene testing company 23andMe, or with the UK Biobank, a genetic database project.

Additional reporting by Michael Erman in New York, editing by Deepa Babington

Our Standards:The Thomson Reuters Trust Principles.

[ad_2]

Source link