PurSleep Product Safety

This term has been used in several of the posts so far in a way that implies that it means safe. As I recall, GRAS, Generally Recognized as Safe, does NOT mean a substance has been shown to be safe. It means only that it was in commerce before testing was required and therefore was exempt from having to prove itself safe.

I guess the idea is that since these products were used for years we'd have noticed if everybody exposed immediately keeled over dead. That's true but long term effects can't be observed that way - the time between exposure and symptom prevents it. You need formal testing for that and GRAS substances may not have had it.

Could there be other tests showing safety? Sure. Could something be safe even tho it's never been tested for safety? Also sure. But GRAS doesn't necessarily mean safe. And as already noted, safe used one way doesn't mean all usages are safe.

Whoa, lotta great comments, information and observations yesterday. Most important being that -SWS is back on the Expressway to recovery (continuing the BQE theme)(although that's the BQE at 11:30 PM Saturday night, when the average speed is 127)(same as the average blood alcohol level).

Right on up there is LoQ's link about Vicks VapoRub sending an 18 month old to the ED. The original article from Chest:

Vicks VapoRub Induces Mucin Secretion, Decreases Ciliary Beat Frequency, and Increases Tracheal Mucus Transport in the Ferret Trachea

(Note to self: Add ferrets to list of animals adversely affected by EOs.)(Indirectly, anyway.)

In the ED, the child was not interactive with her grandparents or the medical staff. She had wheezing and intercostal retractions. Her initial pulse oximetry saturation was 0.66 while breathing ambient air. The patient was thought to have acute asthma and was treated with inhaled oxygen by nasal cannula, 360 μg of albuterol by pressurized metered-dose inhaler and holding chamber, and 2 mg/kg IV prednisolone without a clinical response. A chest radiograph showed mild peribronchial cuffing but no infiltrates or hyperinflation. With supplemental oxygen, pulse oximetry saturation increased to 0.93. On further questioning, the grandmother spontaneously stated that VVR had been placed under the child's nostrils and respiratory distress had quickly developed over a period of 30 to 45 min. The child was taking no other medications and had no clinical evidence of an allergic response. The patient was admitted to the hospital while receiving supplemental oxygen and was discharged to home the following day. We hypothesized that the application of VVR induced inflammation and mucociliary dysfunction, with mucus hypersecretion leading to severe dyspnea. The specific aims of this study were to evaluate the effect of VVR on tracheal mucus secretion and clearance, airway inflammation, and pulmonary vascular fluid leakage in the ferret airway, with and without initial exposure to bacterial endotoxin (ie, lipopolysaccharide [LPS]), to induce acute inflammation similar to that occurring during a respiratory tract infection.

We were prompted to conduct these studies in the ferret because of the infant described in the “Case Report” section as well as other young children we have seen in the ED since we began routinely asking about the use of VVR in young children with acute respiratory distress. Because of the limitations in conducting clinical studies, we do not know the extent to which the results in our ferret model adequately explain the clinical difficulties experienced by some, but certainly not all, infants with VVR placed directly in their nose. It is likely that there was a neurogenic response to the VVR, which could take the form of mucus secretion, pulmonary vascular leakage, or alterations in CBF, as well as things we did not measure, including the elaboration of inflammatory mediators and bronchial smooth muscle contraction. It is also possible that reflex inhibition of respiration could lead to hypoxemia, although it is unlikely that this would produce the significant respiratory distress that we documented in this infant.

This incident can be directly applied to the overall discussion of EO, for, as previously noted:

StillAnotherGuest wrote:

CorgiGirl wrote:The Merck article about environmental lung disease does not mention essential oils as a pollutant which can cause ELD.

Gas and chemical toxicity.

Rather than searching for the "politically correct" "Essential Oils", research the more scientifically-appropriate "Volatile Oils", as in

Materia Medica Pharmacy, Pharmacology And Therapeutics by W. Hale White

Group VI. Volatile Oils
These, when applied externally, stimulate the skin, and thus cause redness, sometimes even vesication, tingling, and subsequent numbness. Taken internally, they stimulate the gastro-inteslinal tract, increasing its vascularity, the flow of saliva, of gastric juice, and of succus entericus; and they excite its unstriped muscular fibres. Thus in moderate doses they are stomachics and carminatives; in large doses they are gastro-intestinal irritants. Their irritation of the stomach reflexly stimulates the heart and the central nervous system. They are absorbed and excreted by the skin, which they may thus irritate, and by the bronchial mucous membrane, while they consequently stimulate, increasing the amount of secretion from it, its vascularity, the expulsive power of its unstriped muscles, and reflexly this irritation leads to coughing; consequently they are expectorants, although they may later limit the amount of secretion formed.

The concern over long-term and inappropriate use of EO or VO is not because of a "side effect"-- this irritation is the effect by design. Looking at the chemical composition, which includes terpenes, alcohols, esters, aldehydes, ketones and phenols, at least 2 of them (phenols and terpenes) are significant mucous membrane irritants.

-SWS wrote:If PurSleep is "the" deciding compliance factor, then it probably makes sense to use PurSleep (or any other comparable essential oil(s) deemed "safe for consumption" by the FDA). Under those circumstances I believe the well-known health risks of CPAP non-compliance are likely far greater than the currently (empirically) unknown health risks of using PurSleep.

OK, if there's a guy who desats to 60 and absolutely won't comply with therapy unless he uses PurSleep Bubble Gum EO With Pressure-Injector Apparatus, then fine, you may have a point. But as previously noted, it's only GRAS now because nobody bothered to ask if it's not GRAS (until recently).

-SWS wrote:I tried only part of the PurSleep sampler pack. I discovered that one drop sitting anywhere on my night stand is too strong for at least two or three nights. I literally had to place the diffuser pad way over on my dresser until night three or four.

What you're describing is not the PurSleep delivery system (Bong Methodology, or "BM"), but the Sag 'n Sleep II delivery system (More Is Not Necessarily Better, And May Generate Additional Problems Down The Road, So Put It Someplace Else In The Room, or MINNBAMGAPDTRSPISEITR).

Y'know, what I'm starting to hear now is that there may not BE a study group with SAG criteria (high concentration, prolonged contact time, chronic utilization). I can see how that could be as well, given development of tolerance (as you noted, -SWS, you get "used to it" after a few days), failure to achieve results, stinking the house up, etc. and be a self-limiting process.

SAG

SAG wrote: given development of tolerance (as you noted, -SWS, you get "used to it" after a few days)

I think both aromatic tolerance and acclimation can factor in as distinctly unique variables across the population. I'm probably toward one far end of the tolerance spectrum. It would take me several nights to tolerate any one drop---whether I eventually found it pleasant smelling or not. A new drop of that same pleasant-smelling fragrance meant yet another couple or even few nights before I could place the diffuser pad on my nightstand. So in my case the concentration was initially too high, despite using very small drops.

Once I got the concentration down I found some of the PurSleep aromas made for an extremely pleasant wake-to-sleep transition. But I personally didn't perceive any benefits other than that initial sensory pleasure during the wake/sleep transition.

I'm still of the opinion that aromatic EO can literally be a compliance-making lifesaver for some CPAP users.

SAG wrote:What you're describing is not the PurSleep delivery system (Bong Methodology, or "BM"), but the Sag 'n Sleep II delivery system (More Is Not Necessarily Better, And May Generate Additional Problems Down The Road, So Put It Someplace Else In The Room

I think this is very good advice in some cases, such as my own. But I also think there can be a hitch for people who think they require a certain aromatic threshold to receive the sleep or relaxation benefits of EO.

First, let's underscore your implied point that the EO particle count or concentration in the ambient air will be considerably higher a few centimeters away from the diffuser pad than part way across the room. The essence of my having placed the diffuser pad on my dresser really had to do with my needing to get the aromatic EO particle count down to an acceptable level, based on sensitivity and subjective preference. I was literally titering or titrating the ambient air around the intake of my CPAP machine to achieve a subjectively preferred concentration or particle count---a diminished particle count in my case.

However, many people who enjoy the EO aromatic experience will probably try to achieve a higher particle count than I preferred. They will try to achieve whatever particle count corresponds to the aromatic concentration they subjectively think is right. And there are essentially two practical ways to titer that aromatic particle count presented at the intake of any CPAP machine: 1) more or less EO fluid on the diffuser pad, and/or 2) more or less distance between the diffuser pad and the CPAP intake.

So the caveat here is that moving the diffuser pad away from the CPAP intake may not get the particle count down, if the user compensates for that increased distance by adding more EO to the diffuser pad. If an aromatic EO user perceives that they don't have a high enough particle concentration in the air to satisfy their subjective preference, then they're probably going to offset the latter titering technique (distance) with that former technique (increasing the EO concentration at the pad).

So again, personal preference and common sense are going to have to apply IMO.

TXKajun wrote:Sheesh, give it a rest, will ya???

Sure, no problem!

-SWS wrote:I think both aromatic tolerance and acclimation can factor in as distinctly unique variables across the population.

We'll need to add sensitization in there at some point, but that'll be Episode #87.

-SWS wrote:I'm still of the opinion that aromatic EO can literally be a compliance-making lifesaver for some CPAP users.

As usual, I am in complete agreement with you there, -SWS. Also important to note that "essential oils" should not be linked exclusively to "aromatherapy" or "the aforementioned commercial product". Essential oils need not (and are not) limited to inhalation as point of entry but will pass through almost anything human (or avian, feline, ferretine, etc.):

How do essential oils enter the body? These volatile oils readily diffuse through protective skin layers because of their small size and lipophilic (fat-loving) nature. They may also penetrate hair follicles on the surface of the skin. Once essential oils penetrate the dermis they may bind with a number of lipids in the blood such as albumin or globulin lipoproteins. Essential oils may also enter the bloodstream via absorption through the respiratory system. Absorption by this means is more likely to occur with smaller and lighter essential oils constituents which adhere to the lipophilic surface of the lungs.

It's More Than Just Good Smellin'

This means that perhaps using an EO in a carrier oil and employing other techniques, like massage, foot bath or regular bath may be helpful.

Mas importante...

Now one must now ask, "Since this stuff can/will have some systemic effects, what will they be? Should that be a consideration in EO selection?" And if so, just WTF good does "Essence of Bubble Gum or Dark Chocolate" do?" Is getting the "Ultimate Box O' 16 Smells" (although I only count 15) simply the aromatic equivalent of "dial wingin' "? Is that science or a "Consumer Taste Test"? "IMHO", if I were doing a "Product Evaluation", I'd be looking for a little dinero in return for my opinion, especially since it's obvious that some of those "sleep helpers" are "sleep hinderers".

So again, some good EO choices that have sleep-enhancing properties include Lavender, Mandarin, Chamomile, and Sweet Marjoram. Nature's Gift has these and a blend of all four called SleepEase, and another good source is Anatolian Treasures.

Because if we are in agreement

-SWS wrote:that aromatic EO can literally be a compliance-making lifesaver for some CPAP users.

then we must also realize that the make or break point for CPAP acceptance for the great majority of new CPAP users is probably only a day or two. If you're gonna get the group that needs the most help some actual help, you got 48 hours to do it, and that's not the time to be doin' Dart Board Aromatics.

SAG

I dont know anything about PurSleep- but now I want to know more.
I am on CPAP now for 4 nights-and have developed bronchitis...CRAP.
My first instinct is to put some Thieves EO in it to clean it out...but my concerns are: 1.) then the plastics are going to be broken down and launched into my blood system with the EO molecules 2.) destroy my machine
---
Does anyone have hard evidence that the plastics machine doesn't get damaged from EO in humidifier?
Long time user of YL EO's- short-timer on CPAP- that plastic sure stinks....

Don't put anything in your humidifier.
The product is called Pur-Sleep and has an internet site with all the info you may want.
O.

-SWS wrote:So the caveat here is that moving the diffuser pad away from the CPAP intake may not get the particle count down, if the user compensates for that increased distance by adding more EO to the diffuser pad. If an aromatic EO user perceives that they don't have a high enough particle concentration in the air to satisfy their subjective preference, then they're probably going to offset the latter titering technique (distance) with that former technique (increasing the EO concentration at the pad).

And yet, what is being titrated (subjective preference to smell) may not have anything to do with what the goal is (achieve and/or maintain sleep).

I'd like to again use the case of lavender, probably the most studied of the essential oils and one that actually has some sleep-enhancing qualities. In the oft-quoted Goel Study, subjects had 2 minutes of contact time x4 with container held at chest level and demonstrated an increase in SWS sleep. This cannot be extrapolated to mean that increasing contact time 50-fold increases results 50-fold, for in fact, lavender is an adaptogen whose actions are dose-dependent:

Lavender is another adaptogen- small quantities are usually relaxing, while high concentrations are usually stimulating. With essential oils, balance is all, and when balanced, the body and mind can perform to their best. Bear all this in mind when you see a particular oil appearing on two lists of opposing conditions- the quantities of these oils can be all-important, as is the quality or nature of an individual person at any given time.

from The Fragrant Mind: Aromatherapy for Personality, Mind, Mood, and Emotion by Valerie Ann Worwood

That commercial product makes the absolutely unfounded implication that the other 14 or 15 essential oils have sleep-enhancing properties when they could just as easily have stimulating properties.

rooster wrote:Reading this blasted thread over and over made me think, "Don't just sit here, do something." I had a sample kit of PurSleep oils and had tried one many months ago for only one night. So last night I tried a drop of "Paradise" flavor on a diffuser pad placed near the CPAP intake. I woke up about 15 times last night!

Welcome to the [commercial link deleted] Proving Grounds.

Fact: Lavender is an essential oil, whose aroma some people find pleasing, and, in measured doses, may have sleep-enhancing properties.

Fantasy: Stuff that smells good automatically helps you sleep.

Another Insomnia-Specific Essential Oil: Insomnia and Sleeplessness Blend

Note that this product contains essential oils diluted in carrier oil, so can be used for massage or bath therapy.

oxtotl@yahoo.com wrote:Does anyone have hard evidence that the plastics machine doesn't get damaged from EO in humidifier?

No (Note to self: Find machine that has been subjected to high-use EO).

Is that your real e-mail address? Do you have a good spam-blocker?

oxtotl@yahoo.com wrote:Long time user of YL EO's

You're kidding, right? Is that you, Linda?

SAG

[quote="StillAnotherGuest]
Fact: Lavender is an essential oil, whose aroma some people find pleasing, and, in measured doses, may have sleep-enhancing properties.

Fantasy: Stuff that smells good automatically helps you sleep.
[/quote]


personally it helps me relax, which in turn helps me sleep.
i originally got pur-sleep because i was staying at a relatives house that had cats, wanted to cover that smell.
found it does help me relax, so for me it does help me sleep.

StillAnotherGuest wrote:

-SWS wrote:So the caveat here is that moving the diffuser pad away from the CPAP intake may not get the particle count down, if the user compensates for that increased distance by adding more EO to the diffuser pad. If an aromatic EO user perceives that they don't have a high enough particle concentration in the air to satisfy their subjective preference, then they're probably going to offset the latter titering technique (distance) with that former technique (increasing the EO concentration at the pad).

And yet, what is being titrated (subjective preference to smell) may not have anything to do with what the goal is (achieve and/or maintain sleep).

I think we would also have to question the extent to which any given EO's sleep enhancing properties may be comprised of effects that are psychological versus physiologic.

We probably shouldn't assume that all essential oils' potential effects on sleep are of purely biochemical origins. Some of the aromas you mentioned may very well contribute largely at the biochemical level---as they directly impact neural biochemistry. However, that Bubble Gum aroma you mentioned earlier in the thread, for instance, may not work primarily at the biochemical level. Surprisingly, I found that Bubble Gum aroma to be one of the more relaxing aromas, once I managed to get the concentration down. If I recall correctly, Bret introduced that Bubble Gum aroma and a few others when he was trying to find a way to reduce mask anxiety among children.

So I suppose we shouldn't neglect the fact that sensory input can impact human psychology-----and that human psychology, in turn, can factor into both sleep onset and the reduction/mitigation of anxiety. To complicate that side of this largely empirically unknown EO issue, psychological response to sensory stimuli can be be very unique from one person to the next. As an example, the smell of freshly-baked chocolate-chip cookies will probably be perceived as a pleasant aroma by some people, but as an offensive aroma or perhaps even as a psychological aversive to yet others. Some of those people who perceive the aroma offensive may do so simply because they find both the taste and smell of chocolate chip cookies offensive to the senses; while others just may find that aroma to be an aversive because it is associated with bad memories or experiences.

On the flip side of various possible human reactions to that chocolate chip cookie aroma: many people will undoubtedly perceive that fragrance in a more positive way. In some of those cases the aroma might be so pleasant and relaxing that it is conducive to sleep. Yet, in other cases the pleasant aroma might even produce a bit of a Pavlovian response that is actually counter-productive to sleep onset: I'd probably salivate and subconsciously fight the urge to go down to the kitchen, since I love freshly-baked chocolate chip cookies so much.

-------------------------------------------------------------------------------

So while we employ hypothetical examples, anecdotes, and syllogisms as we vaguely ponder to what extent certain aromas just might directly impact biochemistry, let's not forget the possibility that in some/many cases aromatic EO's may actually do their work based largely on psychology.

I think sound, independent research examining both the short-term effects of aromatic EOs on sleep as well as their long-term impact on health are warranted but unlikely. However, I think that statement stands true for many of the chemical substances that we are directly exposed to every day.

-SWS wrote: .......... If I recall correctly, Bret introduced that Bubble Gum aroma and a few others when he was trying to find a way to reduce mask anxiety among children.

...........

Silly me. I just assumed it was to address bruxism.

rooster wrote:

-SWS wrote: .......... If I recall correctly, Bret introduced that Bubble Gum aroma and a few others when he was trying to find a way to reduce mask anxiety among children.

...........

Silly me. I just assumed it was to address bruxism.

Well, if choclate chip cookies induce salivation, I'd expect Bubble Gum to induce bruxism...

O.

Bubblegum is one of my favorites.

While there may or may not be therapeutic effects from smells (lavender is the ony one that has been studied from a therapeutic standpoint), that is not what the product claims. The sense of smell is directly tied to the brain's emotional centers. A smell that is perceived to be pleasant results in pleasant emotions. That's about all that any "aromatherapy" product could ever claim based on existing evidence. So it's all about hedonism and I like Bubblegum. It makes me happy.

On top of that, some but not all people find that unpleasant CPAP smells are distracting or irritating. The same kinds of chemosensory irritants found in much CPAP equipment results in chemosensory irritation, even at very low levels, according to various studies in the areas of worker health exposures and "sick building" exposure claims. In any event, a pleasant smell introduced into the CPAP curcuit seems to help overcome this problem for many people.

Cognitive distraction is another aspect of human senses, including the sense of smell. Magicians use it all the time, distracting your conscious attention on one point while they pull another trick you don't notice. Athletes use head fakes, pump fakes and the like to distract their opponents and every baseball pitcher tries to create optical illusions with the ball. The point of all of this is that it's a fact: Our conscious attention can focus on only one thing at a time (which is why there's really no such thing as 'multi-tasking'). While that attention may quickly transition from input to input (as media makers have found out), the fact remains that conscious attention is still a linear, one-dimensional experience.

CPAP therapy has many distractions: air pressure, exhalation back pressure, noise, mask irritation, headgear, etc. You could try the "counting sheep" trick but that might not be of sufficient interest to capture your conscious attention enough to overcome these other sensory inputs. The PurSleep product provides a pleasant sensory input that many people find has enough power to capture their conscious attention and help them count sheep till they sleep. It's really not more complicated than that.

On one hand I feel bad that PurSleep is taking some pretty harsh scrutiny in this thread. Because I know for a fact that many people report how beneficial PurSleep is to their sleep. But I wish I knew the underlined part of this statement for a fact:

SleepGuy wrote:The PurSleep product provides a pleasant sensory input that many people find has enough power to capture their conscious attention and help them count sheep till they sleep. It's really not more complicated than that.

Because I think if the EO issue were as chemically simple as the above statement implies, that people wouldn't select certain EOs to clear their nasal passages, while selecting yet other very specific EOs to induce heightened relaxation benefits. No offense, Bret, but I think if EOs can have varying systemic effects based on varying chemical structures that nightly, intense aromatherapy may not be "as simple as that".

With that said I have to confess that I don't particularly enjoy the witch-hunt style rhetoric that PurSleep sometimes seems to draw. But I do appreciate the rational inquiry, which I think is necessary. My apologies if I have offended anyone.

-SWS wrote:Because I think if the EO issue were as chemically simple as the above statement implies, that people wouldn't select certain EOs to clear their nasal passages, while selecting yet other very specific EOs to induce heightened relaxation benefits. No offense, Bret, but I think if EOs can have varying systemic effects based on varying chemical structures that nightly, intense aromatherapy may not be "as simple as that".

SWS, I hope that we're not "talking past each" other on that point.

On a personal level I believe that there's a lot more going on behind the scenes when it comes to essential oils and our physiological responses to them. The sense of smell is a chemical sense, meaning that physical molecules we pereceive as having an aroma physically connect with our olfactory receptors, causing neurological signals to the brain. The human sense of smell has only been the subject of serious scientific inquiry for the last 20 years and as with most things, is far more complex than anyone had imagined. Humans can consciously distinguish some 10,000 different smells (which are actually combinations of thousands of different molecules that are perceived to impart odors). Smells have also been shown to have all kinds of impacts on subconscious levels. The retail industry is just now starting to discover the power of smell for retail purposes. They think of it as "legal" submiminal marketing. Casino slot machines emit imperceptible levels of aromatics because study after study has shown that people will spend significantly longer at those slot machines than at others. The leading researcher in this area has stated that the sense of smell has more potential to influence retail sales than everything else combined. I do not believe that's an overstatement based on the studies I've seen. And again, this is largely subliminal.

All of that said, it's one thing for an aromatic product to claim that this will help you relax and calm down and quite another to claim therapeutic benefits. A therapeutic claim that goes beyond generalized realaxation (as in, take this substance and it will bring about a given therapeutic effect) may start to look like a "medication." While there may well be therapeutic effects with essential oils in this sense, the evidence is lacking and even if it were available, such claims could be subject to regulation as a medication by the FDA. The days of miracle Snake Oil cures and Patent Medicine are gone.

Or are they? Take a look at the Young Living stuff and it might make you wonder. The Young Living Multi-Level-Marketing and distribution system lends itself well to a business where individuals make whatever medical claims they want while leaving the company with plausible deniability.

In marketing and promotion I have tried to stay on the generalized relaxation and cognitive distraction side of things although there may well be other things happening.

By the way I am happy to provide free product samples to anyone who sends me a request by email (bret@pursleep.com) and a mailing address (that will be used only for sending you the sample). I also ask that you give me some indication that it's a legitimate request because this offer was recently spammed on the internet (so some generic "inside" cpap detail will be fine so I know you're really a patient). I've had a lot of fun giving this stuff away and letting people take it for a test drive.

oxtotl@yahoo.com wrote:I dont know anything about PurSleep- but now I want to know more.
I am on CPAP now for 4 nights-and have developed bronchitis...CRAP.
My first instinct is to put some Thieves EO in it to clean it out...but my concerns are: 1.) then the plastics are going to be broken down and launched into my blood system with the EO molecules 2.) destroy my machine
---
Does anyone have hard evidence that the plastics machine doesn't get damaged from EO in humidifier?
Long time user of YL EO's- short-timer on CPAP- that plastic sure stinks....

Ditto Oz. Don't put ANYTHING in your humidifier, other than distilled water. And whatever you use to wash it. Have you washed it? Did you use Control III on it?

http://www.pur-sleep.com

IMHO is a far superior - and more cost friendly - product than any MLM product hawked by YL. And yes, my sister is a YL dealer.

Here's how you use it - put a 2-3 drops of EO on a cotton pad. Position cotton pad behind your machine, below the air intake filter. Do not put EO on filter or any other part of machine.

Good luck!
B.