Sofi studies | on the science of people and plants

[Kaveh]

I thought to share a post here about an ambition that’s alway been at the heart of sofi - which is to push the frontier of our understanding and science of plants and their impact on human health forward. We want to learn from the great traditions of plants being used in human health but we also want to understand why. We want to see if we can find evidence to support our historic practices. And where we find evidence to the contrary try to understand what knowledge may be hiding in those boundaries of past traditions, and current effect. In the coming weeks, ahead of the S1 boxes being shipped to you we will invite all Pioneers (we are doing this too!) to participate in a few questionnaires which we will run as survey format to your emails. We will also repeat some of these at the end of the S1 program. We will then analyse each individual journey and see if we can make any observation or conclusions. We plan to share the results of all of our scientific discoveries with the community here. We will kick start this next week so keep an eye out for email communication from sofi. This would also be a good opportunity to check your spam or junk folders and see if any past communication got stuck there and to mark our sofi communications as safe.

The S1 program is a world first. It is the first time that 300 Pioneers from across the world have had their unique journeys with a plant captured in real-time looking for an effect in how we feel. We are extremely grateful to you for being on this journey with us and we really don’t know what we are going to find. For our thousands of years of practice across many cultures we are the first people to be able to do such a study. And we are going to do this as a caring and compassionate community. Absolutely thrilled guys. We will not only be making history together, but we are genuinely pushing forward the science of people and plants in a way we have never been able to before. More on this with the specifics of the studies shortly. In the meantime, hope you’ve had a restful night and wishing you a wonderful day and weekend ahead. Xo

[laurent.rossier]

@Kaveh; thank you very much for sharing this. It is interesting and I agree that it is an exciting journey. I have enjoyed to be part of this so far and look forward to the next steps and witnessing new milestones.

Could you expand a bit more on the following topics:
. What kind of data will you be looking to capture during initial trial period with the Pioneers?
. How will you allow for the unexpected? With that I mean that you might be expecting certain outcomes and be looking for evidence to proof certain hypothesis. How will you ensure that the unexpected won’t be missed and be lost? How will you be positioned to “find” the unexpected?
. Once data starts coming in, how will you analyze the data points? I.e into what areas will you be looking and what is it that you hope to be able to find?
. Once participation grows beyond the Pioneers, whatever had been collected up to that moment might be dwarfed by a new wealth of data - how will you be prepared for the flood of data - especially as it would come from a group that hasn’t had similar experiences to what the Pioneers where part of.

Again: thanks for the journey so far - I can’t wait for the next steps!
Sleep well

[Kaveh]

These are some excellent questions … and more will be coming shortly on this - we are just in the process of designing stuff memos these studies so stay tuned. But to give some further colour on this for you @laurent.rossier … as we are very close to the start of the S1 program these studies will have to ask their questions outside of the sofi app as we don’t have sufficient time to release them within the app. Also these studies will be specific to each pioneer program … the first and second studies are super interesting … to give you a preview - the first one is “on constitutional types” … there has been a long tradition in many methods of healing in categorising folks as a type and using that as a basis of expectation of response to plants … well we have a unique opportunity to test for the first time. The second study will look at “stress” … we know valerian as a plant can impact anxiety and stress levels so we will do a test for that before and after. We will send this as questionnaires using emails through our comms channels so super important that you have enabled our communication not to go into spam so you can participate in these additional studies and of course as soon as the S1 Pioneer Program is up we will run any exist surveys and see what we found. More to come on this in the coming days! Hope you’re managing to have an excellent weekend snd stay tuned!

[laurent.rossier]

Thank you as always @Kaveh
The weekend has been good so far. The cold spell over here is quite something - everyday at about minus 10 to minus 15 degrees C…
helps to stay active outside and to be tired in the evening

[stephendahmermd]

Love this @Kaveh and one KEY reason of MANY you find me here in this beautiful tree house.
Many of us don’t realize that most patients don’t benefit from many of the routine medications I prescribe as a physician. There’s a fancy term for this: numbers needed to treat (NNT). In the common tongue, for medications, this refers to the total numebr of patients I need to treat with a specific medication for ONE to repond in the way we hoped. A concrete example - I need to prescribe 104 patients without known heart diease (their cholesterol is elevated) a statin medication for 5 years for one of the to prevent a heart attack - Statins for Heart Disease Prevention (Without Prior Heart Disease) – TheNNTTheNNT. the NNT is a great website that looks closely at these numbers.
You can imagine that this can be frustrating for a physician. That’s a LOT of people taking a medication and risking potential harms (NNH or numbers needed to harm is another fascinating data point). How do you identify that one patient and save the other 103 the potential side effects of the medication??
The answer to this is : 1.) start with interventions that have lowest potential for side effects (highest NNH) 2.) personalize the therapy to the individual patient. Enter the idea of N-of-1 trials. Common sense for most of us - especially in more subjective/individualized issues like sleep - let each person decide what is best for them! Personalized medicine: Time for one-person trials | Nature.

VERY excited for each of the 300 pioneers to NOT to have their therapy unfallingly dictated by a study that may not pertain to them, NOR be directed by a therapy ONLY becuase it passed the necessary hurdles to be an approved pharmaceutical, but rather DECIDE themsleves if the therapy is helpful and/or contributes to their overall health.
Go Pioneers!

[Kaveh]

It’s always been a privilege to have you with us on this journey @stephendahmermd … we really believe we can do well and do good. Strongly believe in the principles you uphold and going to make sure our sofi puts them into practice. Wishing you an amazing Sunday.

[dcasarett]

Now that sofi is starting to gather data and learn, we’ve got a really interesting chance to think about some really basic, foundational definitions.
What does it mean, for instance, to say that a therapy ‘works’?
That seems like a really basic question. Almost silly. Either a therapy works or it doesn’t, right?
But there’s actually a lot of science, and social science, and even philosophy devoted to this question. How much of a benefit counts? How much evidence do we need that a therapy works? And–at the risk of getting meta–who gets to decide the answers to these questions?
Those are all really big, broad questions–because they’re so basic. The basic questions are always the hardest.
I can’t answer those questions, but I think it’s really neat that sofi is trying to.
Here’s an example: If you’re using a sofi stick to help you sleep, how do you know whether it’s working for you?
That’s sofi’s promise: that it gives the ability to look at your own data to see what effect you’re experiencing. And–more important–to decide for yourself how you would define benefit.
I think that’s really important, because you and I probably won’t define benefit in the same way. I might want to sleep longer, and you might want a better sleep quality, for instance.
And we might have very different definitions of how much of an improvement we want. If you look at the data that’s gotten various sleep medications approved for use, you’ll see pretty small evidence of benefit. One commonly-used prescription drug helps you fall asleep about 15 minutes faster. For me, that’s not enough of a benefit. But for you, it might be.
That’s what’s so cool about sofi–the ability for each of us to see how a therapy is helping us, so that we can make informed decisions for ourselves.
So we’d love to hear from you about what success looks like. How would you define it? What’s reasonable? What’s ideal?
Thanks!

[Kaveh]

That’s an amazing conversation @dcasarett and I would definitely love to hear thoughts from our awesome pioneers as well as @stephendahmermd and @pamelaspence on this. An over riding philosophy for sofi has always been that there is only one single source of truth - and that is the Pioneer. They are the ultimate observer in how they feel, and how they are. Any standard on a measure of effect at best may be an arbitrary consensus on the herd by a panel experts - and though I totally under the group utility of it … it’s hard to stomach that as you lie wide awake at night thinking - well - at least for every nine of us lying wide awake (or getting side effects), someone is sleeping!

[sonja.ekkers.77]

Sofi team had a look at my data. And observation number 3 made me go

Observation 3: Spraying Valerian improved sleep quality by 140% with 99.9% certainty

I knew I had improved much but 140%

Before sofi it would take me about two or three hours to fall asleep than two or three hours later I would wake up and feel alrightish but Its still night so the rest of the night i used to sleep on and off but mostly be awake. My brain would start to over think everything mostly not important stuff. Stuff than could definitely wait till the moment.
Than by the time my alarm goes I be so tired and feel horrible.
During the day I used to be short,tired, grumpy and I would overthink everything before, during and after everything I did.

Now on sofi

I’m on the refill spray and only spray 3 sprays just before I go to bed.
I have stopped overthinking everything what is great. I definitely be less short, tired and grumpy. And sleeping is now I lay down and maybe 10 minutes and I’m gone, than probably 5 or 6 hours later I wake up. Mostly half hour before my alarm and feel great so I get out of bed and start the day refreshed.
Valerian is definitely working for me

[Aaron]

Observation 1: Significant sleep pattern occurring every 1, 2 and 7 days

Observation 2: Sleep quality most impacted by valerian use 6 days ago (V-6)

Observation 3: Spraying Valerian improved sleep quality by 114% with 99.9% certainty

I rate all of these observations 10/10

It’s crazy on how well my sleep has improved and my mood, you don’t realise until you see the data, it’s incredible to see everyone’s journey is having such a impact!

[Aaron]

I am the same now using only 3 - 4 sprays and I find myself falling asleep so fast after the spray

[stephendahmermd]

What a great discussion. Thank you @dcasarett
Agree with @Kaveh: The Pioneer decides.

Long left out of the efficacy question in medicine is “patient preference”. Even as a physician - once a patient walks out the door - only they will decide whether or not to continue with a therapy as suggested/prescribed. No matter how much I believe in the the therapy - or how definitive the research to support it - or even how much I “convince” them - the decision on efficacy (which runs parallel in my head to the decision to continue with a therapy) is decided upon by the individual - and often on a “gut” level.

Also, in an age of polypharmacy and rampant adverse events, it is incredibly important to empower individuals to use safer interventions earlier in the course of chronic disease that have an impact not only on specific symptoms, but on their overall resiliency and response to stress (like Valerian).

Further supporting individuals with a supportive community, a trusted product, and then with data to make informed decisions not only if a therapy works, but when it does NOT not seem to be working will be the key to success (so we can avoid potential side effects, try a different therapy, or even another dose) . The potential harm of any given intervention also makes this decision even more imperative (ambien/benzos vs. valerian).

Even in the current reality, where many of us lack access to the important feedback Sofi affords - I find most people are good at deciding for themselves if a therapy is working. When in doubt, in my clinical practice, I may have a patient stop a therapy to truly know. Removing a therapy that is working can be VERY revealing (both subjectively, and as we have seen on an individual’s data).

I think that is why I get so excited about Sofi. I’m very excited to be on this incredible journey with everyone - finding new approaches to age-old questions. Clinical trials serve us well - but its high time we move beyond the extrapolation of others data to a personalized, precise, and data-driven individual approach to health (starting with those therapies that have least chance for harm)!

I truly wish that for every ambien and/or benzodiazapine I consider prescribing in the future, I can offer Sofi first to those patients interested/willing/ideally-suited. Personal preference based on data reflecting the total overall effect of the entire Sofi experience will help guide each one of us to make our own decisions on efficacy.

Dream Big!

[Kaveh]

What an awesome contribution @stephendahmermd ! The primacy of Pioneers is one of the central axioms of sofi (along with the purity of plants and the preservation of planet) - our assumption with sofi is that there is only one source of truth as we are developing sofi to tune into the individual frequency of our intrepid pioneers. Wishing you a wonderful and restful Sunday Stephen.

ps Just seen an amazing piece on the bbc about living a life of pain (BBC iPlayer - A Life of Pain) - it’s about living with chronic pain - and the challenge of chronic suffering and current tools we have to address them. Of course a different target state than chronic sleeplessness or anxiety, but certainly an area we can imagine that sofi can look to expand to in time and to introduce a range of natural solutions, a caring community, journalling, tracking, and of course personalised learning … I think sofi has a lot of work in front of her!

[laurent.rossier]

This is an incredibly interesting conversation. Some scary aspects (further up the comment trail on NNT: 104 patients treated for 5 years for medication to work in 1 patient…!!!)
It is crazy to see that some people on the forum here have had sleep issues for decades and despite having tried lots of remedies, tricks and received lots of advise, nothing has helped. Now they have been using Valerian for a few weeks and BOOM… 2-3 hours of sleep turn into 5-6 hours. This is most beautiful to read.

It would be interesting for laymen such as me to learn from people such as @stephendahmermd and @dcasarett how they “read” such firsthand accounts. What does it mean to you when some Pioneers are reporting significant improvements in length and depth of sleep (however the latter is measured…)

Thank you for sharing your insights.

[pamelaspence]

Sorry for the lag! Last week was a bit frantic travelling, now I’m playing catch up!

Thanks for patching me in to the discussion @Kaveh and for your thoughts @dcasarett and @stephendahmermd

I think the thing that has bowled me over here is that sofi has made it possible for everyone to have different experiences and to support each person through that experience. For some Pioneers it may be that valerian was a wonderful intervention - but we’ve seen that for others it wasn’t, some found that dosing all at once helped, some needed much less than 6 sprays.

So here’s the thing - this is the scenario I work with in my clinic with my patients every day. I adjust the dose, the delivery method, the herb for each person according to their experience and nothing else. I don’t have to abide by a protocol, I am allowed to make that call with each individual. And medical herbalists like me often say that if 10 people come to see us in clinic, each one will go out with a different medicine. So this is my normal.

I never thought a product, could ever allow for that kind of personalisation. But actually through the sofi-sphere of this community, the data and the herbs together this is as close as it may be possible to get. And as we move through the herbs that are in the pipeline (excited much??!!) we will be able to guide each one of you to the one that works best.

And the fact that, as @Kaveh likes to remind us, that you are seeing a group like us from such different areas of medicine discussing these important questions in an open way is not to be underestimated. It is a rare and wonderful thing.

[Kaveh]

Couldn’t agree more with you @pamelaspence … too often differences of perspectives are seen as incompatible truths … with sofi what we have discovered is that knowledge and discovery hides across those boundaries and perspectives. Thank you as always for sharing yours xx

[Yvonne]

Fantastic! Your ‘before’ scenario sounds just like mine…

[alexwalkerjones]

Hi @Yvonne! Welcome to the treehouse, thrilled you found us here

If you have any questions at all, feel free to post them here; our community is full of support!

[drmudlark]

I have found this a brilliant and fascinating thread and was very interested to read Stephen’s comments.
Im sure that many people have known or felt for a long time that the individual’s response to any type of drug can be vastly different from another’s, even if just talking to friends about (for e.g.) what painkillers work for them, or observing how different friends react to alcohol (some get just happy (me honest); others seem to have a big personality change and may even go batshit crazy!). And for sure the Medical profession must see it all the time. Not to mention the various allergies that only some people
have that can even be life threatening. We must all have varied brain- and body- chemistries.
It’s so good to see this type of study; Big Pharma justs wants to sell a generic product to the Masses.
I would like to add a couple of questions:

1. Given that all plants contain chemicals, often as a defence against being munched) and although many herbs have been used without harm (e.g. those in Sofi tests) for centuries, might it be a good idea to ask people for any side effects they may notice??
   Good or any observations, even mild side effects might be useful to know, there may be some common to many. Im convinced that antibiotics make me depressed ( and constipated … she whispered) but other people i have asked have never noticed that.
   In my case, I know that people find lavender relaxing but if i put just a tiny drop of oil in the bath my skin feels badly irritated and stings for ages.
   I had a colleague at work (plant ecologist) who, if she just touched the sticky Cleavers plant (Galium aparine) she would get terrible burn symptoms - skin blistering and coming off, flesh raw and weeping. No effect on most people. Ironically that herb can apparently be used internally to treat skin complaints like eczema and psoriasis!

I vaguely remember a while ago that i signed a petition against some ban against any herbal medicine, that was being considered by the Govt because no formal clinical testing was done. No doubt pressure by Big Pharma. Studies like this could add useful info about having confidence in the plants tested by Sofi?

2. Sorry this does go on … just out of personal curiosity- i imagine that you are now able to tackle more complex studies like this because of advances in statistical analysis of the data (methods and computer programs)?
   Thanks, Sue

[drmudlark]

And, off topic, does the heart mean you like a post? I have been pressing them on this thread with no idea if it is for that!!