If my patients wish to experiment through trial and error on the utility of alternative, non-prescription agents, I would usually encourage them to do so, even though I rarely recommend a specific agent. My overall personal and professional experiences with these agents are quite limited, because most patients who visit our sleep center either want to eliminate sleep medications or have absolutely no interest in changing their medications.
Indeed, among troubled sleepers, it seems as if you could divide the world into those who eagerly embrace PAP therapy, cognitive-behavioral therapy, and other non-pharmacologic treatments for insomnia, and those who will always desire some type of sleep aid no matter how much benefit they receive from their non-pharmacological treatments.
For those in the latter category, I am comfortable with their pursuit of trial and error approaches for myriad reasons, which evoke a much broader and deeper discussion about crucial societal factors including but not limited to free markets, entrepreneurial endeavors, patients’ self-efficacy, government regulation, and medical research. If the ensuing discourse bores you, hopefully, it will put you to sleep.
Although my start in sleep research began in 1988, I followed medical research during the prior decade once I entered medical school in 1979. In all that time to the present, it remains a source of puzzlement that so many medical professionals put so little stock in anecdotal findings or only embrace evidence developed through randomized controlled trials (RCT). In my opinion and that of many others, there is enormous value in both types of studies, but based on the resources of the researchers, it may not be feasible to conduct therapeutic studies at the highest level of evidence (RCTs).
The impact of anecdotal studies is exemplified by our 30 peer-reviewed papers (published since 1999) describing the relationship between sleep-disordered breathing and insomnia, and culminating in our recent effort in the Mayo Clinic Proceedings. We demonstrated a 91% prevalence rate of OSA or UARS among patients presenting to a sleep center with a chief complaint of insomnia of which 75% were regular users of sleep aids, prescription or otherwise. Remarkably, every individual using a sleep aid was failing that treatment, that is, their residual insomnia was obvious and often severe. As will be discussed shortly, the failure of prescription drugs to solve insomnia problems favorably influences such patients to seek alternative medicines.
Why these patients were not tested for OSA/UARS before receiving drugs is its own story. To learn more about common delays in assessing for SDB in insomniacs, watch our 7-min video at https://www.youtube.com/watch?v=vdm1kTFJCK4&feature=youtu.be. It was published along with the paper.
Nearly all our 30 published papers were case series and therefore a lower level of evidence. Yet, the research field examining comorbid insomnia and sleep apnea has finally begun to blossom, including a few RCTs demonstrating that OSA or UARS treatment (PAP, dental devices, or throat surgery) decreases insomnia severity. Over the long-haul, however, it was the advent of anecdotal studies from our team and others that spawned greater interest in these types of patients and ultimately the initiation of RCTs to better understand the pathophysiology. In fact, we are fortunate to be in the planning stages with RESMED to conduct an RCT to test different PAP therapy devices for insomnia patients with sleep-disordered breathing.
Back to alternative medicine approaches for sleep, we see lots of sleep aid offerings such as herbs, supplements, homeopathic remedies, and others, most of which could be understood as large scale population-based, anecdotal “studies.” What roils some medical professionals is the view that these insomniacs believe they are in some way benefiting from these different products when in reality they must all be deceiving themselves. Few healthcare professionals would state it so bluntly, but many think of alternative medicine as a placebo-driven enterprise. No doubt the name of the game in alternative medicine is marketing, and no doubt some marketing can overcome the business prospects of a mediocre product. On the other hand, over time some knowledge is eventually transferred into the populace as well as into healthcare systems about the utility of these non-prescription agents, because it is grossly apparent that sufficient individuals continue to purchase them due to perceived and sustained benefits.
In a related matter, I would argue placebo is an extremely valuable “drug.” Indeed, really good placebo (or what I call “placebomycin”) ought to bring a high market value. Yet in teasing apart placebo effects, critics of alternative medicine may assume placebo effects last a long time and thus patients waste their money for months or years. While such experiences may be possible, most drugs that are not working usually manifest their failure in short order, thus I have rarely observed patients who maintain use of such agents for more than one to four weeks once it is clear the initial response was unsustainable. I have probably met a thousand patients in my career that started melatonin supplements and ceased use within a very short time frame, which informs me that many individuals are fairly honest about the self-appraisal of their trial and error efforts. I think the same goes for placebo, because I rarely see the effects last very long.
In the worst case scenario, the main danger of placebos is to the individual who normalizes the response to the supplement and imagines everything is just fine when in fact another more serious illness needs to be addressed. I do not know what data speak to this scenario, but it may prove deadly and is a cause for a concern. Yet, the trade-off is to take away the consumer’s right to make his or her own health decisions, allegedly to insure the safety of those individuals who make the wrong decision. Of course, that’s why the labeling on virtually all these products offer no curative declarations, and many are forthright in noting their products list no FDA attestations.
In the context of the over the counter market, there are probably hundreds of thousands or millions of people who would affirm without reservation their positive experiences with melatonin. I’m aware that many of my colleagues recommend melatonin to their patients. There is even a small amount of research supporting the use of melatonin specific to insomnia, and one meta-analysis describes how it produces modest effects, just a little bit better than placebo.(1) But, if you take melatonin and the response for you is greater than “just a little bit,” and you used the drug for several months or longer, achieving the same results and no side-effects, it is difficult to imagine why you would discontinue this supplement unless there is reason to believe you are missing something else that might underlie your insomnia.
In the above situation, the patient is acting as his or her own advocate for developing a personal system of self-efficacy, and perhaps the results were achieved through a lengthy trial and error period in which various brands and dosages of melatonin were tested. Again, even though I would usually not recommend this approach for long-term management of insomnia in the vast majority of patients encountered at our sleep center, there are far more insomniacs in the community who never visit a sleep center, and this alternative medicine approach may work well for them.
Because we live in a country (USA) that still shows some life for free markets (albeit many of us believe “being on life support” might be a more apt description), it is interesting how alternative medicine remains a shining example of how this economic system can work without the necessity of excessive government regulation. Tens of millions of individuals—patients or wellness seekers—have experienced tremendous frustrations, dissatisfactions, and adverse effects in their dealings with the healthcare system and its emphasis on prescription pharmaceutical treatments.
I am not suggesting that most people have an ax to grind against the pharmaceutical industry. Rather, I assume many people have had experiences like my own in which various prescription drugs for various ailments have either saved me from a serious illness or even a hospitalization. To be sure, I and many of my friends, family, colleagues, and patients are decidedly pro-Pharma, given the personal and wondrous benefits we have received from select medications. But, when a drug does not work or works only a bit and causes side effects, a market is bound to develop to address the frustration of a large enough cohort of patients (millions of insomniacs), who seek a product with fewer side effects. The alternative medicine community readily developed a larger footprint in the markets for sleep aids once the production of over the counter agents became financially feasible for smaller companies.
There has always been an alternative medicine community, and I worked in that area 40 years ago before I entered medical school, so I was exposed to many sincere and well-intentioned individuals in the field as well as a fair number of quacks and snake-oil salesmen. Back then, I was also impressed with the vigor in which individuals chose to investigate their health problems and attempted to gain satisfaction through alternative medications or supplements or other remedies.
While there are many in the healthcare system that wish to throw the baby out with the bathwater, I remain a strong supporter for the free market, alternative medicine community for the reasons described above, which to summarize create opportunities for entrepreneurs to develop individualized therapies to be tested in relatively safe ways and which over time may lead to sufficient information both for that individual and the community at-large to learn valuable insights regarding new ways to treat insomnia.
It cannot go without saying, however, there are charlatans and quick-buck artists in any field, but I have not reached that level of cynicism in my life to imagine the majority of alternative medicine proponents suffer from a lack of integrity. Just the opposite, I have met many good-willed, industrious, well-intentioned, and passionate advocates for their products, for which they have labored long and hard to find what they believed to be the right ingredients. Nearly all these companies test their products in various ways, although the number of randomized controlled studies on alternative medicines pales in comparison to that seen for standard pharmaceuticals.
At this point, someone would be chiming in about “quality control” and “serious side-effects” and how the alternative medicine market is under-regulated. I would disagree on the general premise that I prefer to “keep the government out of our bedrooms.” Thus, if you want to find an alternative medicine agent of your choice and are comfortable with your own personal “N of 1” trial to find that product, I believe you should have the right in a free society. Are there companies that are not as careful as they could or should be in making their products? Are there dastardly companies that knowingly engage in deceptive practices about the ingredients in their products? Yes and yes. However, the notion that government regulators could eradicate all these problems from alternative medications without dramatically raising prices on this industry is highly unlikely. Some people are of a mind that government regulation is the only answer to this problem in part because they think in a way that leads them to believe that government is the answer to just about every problem. My sense of history is that government regulation almost always produces unintended consequences that lead to many adverse effects, often causing more harm than the supposed good to be gained from excessive regulations. Just my opinion, but certainly I respect the concerns of those who have more experience and have seen first-hand some of the problems with side-effects in over-the-counter products.
There is a reason for the expression Caveat Emptor (“buyer beware”). One would like to think the vast majority of sellers understand that if their products are of good quality and produce good results, then their long-term prospects are more sustainable than if they take the low road in their production efforts. It is unquestionably an area of great political discussion, which is particularly timely to this current age of expanding government interference into the world of commerce. As above, I appreciate and acknowledge some people are quite happy with “more government,” and I understand their rationale for the regulation of just about everything under the sun, including apparently the regulation of speech (cf. political correctness policies). Frankly, I am disturbed by this extreme position, but the current state of politics in this country seems to favor a “more is more” approach to government.
My view is our sleep patients have the right to explore alternative medications as they deem appropriate to their individualized care, but I always encourage them to weigh their risks and benefits in the process.
1. Ferracioli-Oda E, Qawasmi A, Bloch MH. Meta-analysis: melatonin for the treatment of primary sleep disorders. PLoS One. 2013 May 17;8(5):e63773