This is a story about a new device coming to market for menstrual pain. The story is a great example of how the media should deal with claims made about new devices. With a dose of healthy skepticism, the story provides the reader with a complete discourse on the merits of the device and of TENS (transcutaneous electrical nerve stimulation) in general. We welcomed that skepticism across the board and appreciated the grounding comments of an independent source. Bravo.
Perimenstrual pain is a common problem affecting most premenopausal women. So, the availability of a device that is safe and effective in relieving symptoms would be welcomed.
We were pleased to see cost discussed in the story. The story points out that the projected retail cost of the Livia device ($149) and the pre-order price ($85) is more than similar devices (as low as $30 on Amazon).
The story provides quantified benefits via an unsubstantiated quote from the company’s CEO: “So far, Nachum said they have tested the device on 163 women in two different trials — and more than 80 percent experienced relief with the device. The company is currently working on another study, which will include about 60 women.” That normally would generate a Not Satisfactory rating, as we’d want to see a more specific description of the benefit than “experiencing relief.” But the story makes it clear that this was the only data available owing to the lack of published research. It also provides provides comments from an ob-gyn specialist with a good deal of experience with the use of TENS, who counters the CEO’s claims. For these reasons, we rule this one Satisfactory.
We would normally look for some statement about potential harms but in this case we don’t think the requirement is applicable: TENS, when used according to directions, have a low harm profile.
The story makes it clear that there is essentially no published information available on how the device manufacturer tested the device in women (eg, randomized/ blinded or not, what pain measures were used, etc). And it comments critically on this lack of published data.
The story does not overstate the problem.
The comments from an independent expert help ground the claims made by the company CEO. The outside source is the key to balance in this article.
The story notes that oral contraceptives and analgesics are also used, and that traditional TENS units are also widely available.
The story makes it clear that the device is not available at the present time, and it makes it clear that there are available TENS units now that are not as expensive.
The story makes it clear that the Livia device has as yet to be characterized fully by the company, but at face value appears to be equivalent to a TENS unit, which have been used for menstrual pain for many years.
The story clearly does not rely on a press release.