This news release from UCLA Health Sciences uses a story-telling approach to inform readers how scientists observed that women with relapsing-remitting multiple sclerosis (RRMS) experienced lower rates of relapses during their third trimester. The story told here is well-written, engaging, and effective. The researchers discovered that these intermission periods coincided with the periods when women had the highest levels of estriol in their blood.
Estriol is a relatively weaker and, it’s assumed, safer female sex hormone. When researchers gave estriol with conventional medication, or placebo and conventional drugs, to 164 MS patients they found a lower rate of relapses among those getting the estriol. The trial is published in the journal Lancet Neurology. It’s a Phase II, randomized and controlled trial that was first presented at a national neurological meeting in April 2014. The release offers important, interesting and substantial detail about the clinical observation that led researchers at UCLA to experiment with estriol but doesn’t explicitly state that it is still too soon for neurologists to recommend estriol therapy. The release also omits some key data concerning the reduction of relapse among the patient volunteers.
There are precious few treatments that have a significant impact on MS relapse rates and none that can reverse or improve cognitive, visual and physical disabilities that occur in most patients over time. The availability of a relatively safe, effective, and likely low-cost hormone therapy that, taken as a pill, can reduce relapses and nerve cell damage due to inflammation would be welcome news. If confirmed in a larger Phase lll trial, estriol might have potential value, as the release points out, for MS as well as other autoimmune disorders.
The release could have used some explicit indication of the potential cost of adding estriol to treatment with injectable glatiramer acetate. The text suggests that the hormone is widely available and thus likely to be simpler and less costly to take.
In the United States estriol is available only as a vaginal cream, not in tablet form. It is mostly used in “bioidentical” hormone replacement products obtained from compounding pharmacies.
The release does a pretty good job of noting the apparent benefits in its narrative, but hard data are notably missing or under-reported. Readers would benefit from knowing, for example:
How many of the women who took estriol along with their conventional medications showed reduced relapse rates, and to what degree, compared to women who took the placebo with conventional drugs? (Telling us that these women had “a third to a half as many relapses” is a relative comparison — we wanted to see absolute numbers.)
If there were extended breaks between relapses, how long were they?
What was the rate of inflammatory lesions in the brain and when did they occur? These numbers should be included for the current study, not the 2002 findings.
Finally, the release could have noted an important reduction-in-the-reduction of relapse rates over time. For example, a Medscape news report on the 2014 presentation noted a 47% reduction in confirmed relapses compared to placebo group in the first year and a 32% relapse rate reduction in the second year.
The release notes that the only significant adverse event for those on estriol was irregular menses. It could have gone into more detail, perhaps, but this passes muster. The point is that estriol is essentially a weak form of estrogen that has been shown in previous studies to be fairly safe, and whatever risks exist are likely outweighed by benefits in women with MS.
It’s noted in the release that the study is a randomized, placebo-controlled trial. This is important since randomized, controlled trials provide a higher quality source of evidence. The reader should come away with the idea that this is another good piece of evidence that estriol can, when combined with other medicines, safely decrease MS relapses. The release could have made clearer the limitations of the findings. Not all patients were helped and the effects decreased over time.
No fear mongering here.
The release goes into significant detail about the funders and their mission. Funders include the National Institutes of Health, the National Multiple Sclerosis Society, and a private foundation. The drugs and placebo used in the study were provided by Synthetic Biologics, the manufacturer. The release also notes, somewhat vaguely, that Synthetic Biologics has licensed some rights from UCLA.
This is a comparison study that measures the results of taking estriol and conventional medications compared to placebo with conventional medications to reduce relapses.
The release makes it clear that estriol is widely available now for other uses and that researchers have yet to complete Phase lll trials and apply for FDA approval for application in MS patients. However, it should be noted that estriol is far more commonly used in topical skin creams and not in tablet form as was the case with this study.
Although the release mentions previous studies by the UCLA investigator dating back to 2002, the timeline for the relevance of some findings is somewhat confusing, and it would have been useful to mention that the current data were substantially presented in 2014.
In the headline the release refers to estriol as a “safe” hormone. We think it would have been better to qualify the hormone as “safer” than others.