Join Josh and Adam as they delve into a captivating study on the Ayurvedic remedy Shilajit, uncovering its potential in addressing osteopenia among postmenopausal women. Our discussion explores a carefully crafted 48-week trial, analyzing its design, methodology, and compelling outcomes. Navigating the intersection of evidence-based medicine and holistic practices, we uncover a promising link between Shilajit and bone mineral density. This sparks a thoughtful conversation on its integration with modern osteoporosis treatments
We invite you, our listeners, to join us in this ongoing exploration. Share your thoughts, questions, and experiences on our social media platforms—DrJournalClub on Twitter, Facebook, and LinkedIn. Together, let's nurture a dialogue that celebrates the intersection of tradition and innovation, enriching our understanding of health and healing.
Learn more and become a member at www.DrJournalClub.com
Check out our complete offerings of NANCEAC-approved Continuing Education Courses.
Join Josh and Adam as they delve into a captivating study on the Ayurvedic remedy Shilajit, uncovering its potential in addressing osteopenia among postmenopausal women. Our discussion explores a carefully crafted 48-week trial, analyzing its design, methodology, and compelling outcomes. Navigating the intersection of evidence-based medicine and holistic practices, we uncover a promising link between Shilajit and bone mineral density. This sparks a thoughtful conversation on its integration with modern osteoporosis treatments
We invite you, our listeners, to join us in this ongoing exploration. Share your thoughts, questions, and experiences on our social media platforms—DrJournalClub on Twitter, Facebook, and LinkedIn. Together, let's nurture a dialogue that celebrates the intersection of tradition and innovation, enriching our understanding of health and healing.
Learn more and become a member at www.DrJournalClub.com
Check out our complete offerings of NANCEAC-approved Continuing Education Courses.
Welcome to the Dr Journal Club podcast, the show that goes under the hood of evidence-based integrative medicine. We review recent research articles, interview evidence-based medicine thought leaders and discuss the challenges and opportunities of integrating evidence-based and integrative medicine. Continue your learning after the show at www. drjournalclub. com.
Josh:Please bear in mind that this is for educational and entertainment purposes only. Talk to your doctor before making any medical decisions, changes etc. Everything we're talking about that's to teach you guys stuff and have fun. We are not your doctors. Also, we would love to answer your specific questions on drjournalclub. com. You can post questions and comments for specific videos, but go ahead and email us directly at josh at drjournalclub. com. That's josh at drjournalclub. com. Send us your listener questions and we will discuss it on our pod.
Josh:I had like six cups of coffee yeah, um, I was supposed to do my run today. I've got a half marathon next week and I was supposed to do my run and I, like I had literally a back-to-back meetings the entire freaking day. I thought I'd sneak it in, but it did not happen.
Adam:Is it a half marathon. That's like a planned race, or is this just for funsies?
Josh:Yeah, yeah. No, this is a rock and roll one. They're fun.
Adam:They're just kind of like a way to hang out with the oh, this is in Tennessee or whatever.
Josh:In Nashville. Yeah, I'm excited Tennessee or whatever. In Nashville. Yeah, I'm excited we're staying in the music district. I guess I'm not sure I've never been in Nashville before. It should be a good time, I hear you're having a bachelorette party there In Nashville.
Josh:Is that a thing to do? Yeah, it's interesting because there's the downtown, there's all these interesting because like there's like the downtown, there's like music, there's all these different districts. It seems like a really fun place to hang and it should be a really fun place to run Like. It sounds like like the route looks pretty cool, but yeah.
Josh:And the rock and roll ones are just, they're fun. It's got like a zillion support tables and there's music everywhere and oh, I bet, yeah, it's like you don't even need to bring water if you don't want to. There's like people every mile.
Adam:If there's any rules against like no music, you'll have the entire town, yeah yeah, seems like a good place to do a rock and roll one, so yeah actually, the first time I did a race that wasn't rock and roll I was, because they like have their stuff so well together I was shocked.
Josh:There was no support, there was no water. I was like, oh my gosh, I'm going to start. So I realized how much they put into those sorts of things with the more organized ones. But yeah, yeah, all right, shall we jump in? What are we going to do? Oh wait, last thing I finally got a trainer, because you know how I'm going to die swimming. I finally got a trainer because I you know how I'm like the die swimming. So I finally got like a trainer, but she's a virtual trainer so she can't actually help me do anything. So she's like trying to describe these swim exercises. And if you've ever had someone try to explain a swim exercise to you and then say, well, just go YouTube it, it's just like it's not going well, not going well. I swim like a I don don't know porpoise, what, what, what, what, what, what are animals that don't swim well, I don't know, but that's me manatees. They just kind of float around with like little fins slapping the water. That's kind of how I feel. Can dogs swim?
Josh:can dogs can swim well, doggy paddle, that's a thing all right, yeah, well, there you go yeah, I'm a dog, I'm like uh, yeah, I'm like a puppy in the water for the triathlon.
Adam:Really, all you need to do is is run to each canoe. So hang out on the water. Just find out how far they are from each other. Swim on uh-huh. Hang out there for a good 10 minutes and then go to the next one like the safety canoes.
Josh:Yeah, okay, yeah, yeah. Well, I'm hoping there'll be a lot of people like there'll be safety people there like surfboards and and canoes and stuff. But yeah, I don't know. Man, you're a much better swimmer than I am, even though this is, like your, your least favorite sport at this point. You're doing like one and a half k's regularly.
Adam:Yeah, for swimming uh, I'm doing like when I train I typically do at least 1,000 meters, and so yeah, and that's just sort of like freestyling it. And then if I want to add in, you know, like the paddleboard for like leg strengthening, or if I'm using like the little floaty for more arm stuff, then you can kind of crank out, you can crank out more, so yeah then you can crank out more. I did a 1,000-meter freestyle and then at the end did a little paddleboard thingy.
Josh:Those things are tough man. I just got them now with these new exercises and I've got one of those awkward things you put between your legs, you know like the, the little styrofoam-like pillow yeah, I don't even know how to. I was like am I putting this? Because there's a more bulbous side and a a little styrofoam like pillow? Yeah, I don't even know how to. I don't even know how to. Unlike, I was like am I putting this because there's like a more bulbous side and less bulbous side?
Adam:I have the more bulbous side, facing like up down right uh wait, why up?
Josh:oh no, you're right, yeah down, because you'd want like more buoyancy, right like that. I had it the other way and then I was like and then how far in towards your crotch do you do it like I? First I had it like well into my thighs and then I was like this isn't gonna, this feels weird. And I tried the knees and that felt even stranger. And then I tried it by my ankles and I was like literally like like um, jackknifing. Every time I took like a stroke or something. So, yeah, I'm, I'm a freaking disaster in in the water. So we'll, we'll see All right, just gotta be comfortable.
Adam:What's that? I just use it like a saddle, like you just kind of make it this way. Saddle Like a saddle, yes, like you just sit on it and it's comfortable, and like you sit.
Josh:And it's comfortable. You don't sit on it, though. I don't understand. What do you mean? A saddle?
Adam:The meaning of it is as though it's a saddle. It just needs to be comfortable. You're overthinking it.
Josh:First of all, saddles are not comfortable. Second of all, I'm envisioning that there's no way you can mount it like a saddle. Okay, I'll try to remember that next time in the water.
Adam:Yeah, thanks a lot for that. That's like completely worthless. All right, so let's talk about what are we talking about today.
Josh:I think I think we should just keep going with this. Yeah, I think the coffee hit, okay, um, so where are we all right? So we're talking about we don't even know how to pronounce it. We're so. We're so excited about it. It's a great paper. We don't even know how to pronounce it.
Adam:How about we do a reverse podcast? Okay, we do a trial, we'll go over the entire trial, but people are going to be blinded to what the intervention is, and then they have to guess the study.
Josh:No, because if they haven't closed it already, with us blabbering about saddles in the water and awkward flailing, they're going to do it now. If they have to, like, wait an hour to actually know what the intervention is. No, that's a terrible idea, almost as bad as the idea it's about being a suspense, josh.
Josh:This is that's what we're doing now, dear listener, just rambling on giving you suspense about. Are we actually gonna talk about medicine today? Okay, no, we know how to pronounce it because we asked google and, according to google, it's she legit, like to legit, she legit, she legit, she legit. Hold on, how does this go? She legit, she legit, right. That's you know. That's what google says. That's what google says.
Josh:That's the way it is, and anyone that has like deep thousands of years tradition in Ayurveda, like you're just wrong. If it's not like the way Google says, then Google's always right. Yeah, totally so. But seriously, if you actually have experience in Ayurveda, I feel like we sound like total idiots. Last week we were doing acupuncture with no knowledge whatsoever about like acupuncture or meridians or anything like that. We barely knew the word chi, and now we don't even know how to pronounce the intervention from an Ayurvedic. So we beg your forgiveness, ayurvedic practitioners, but please correct us if we're wrong. Anyway, apparently it is this herbal extract, almost um, from the mountains in india, I believe. Right is that? Am I totally making that up?
Josh:I think it's off the moss of, like rocks in the mountains of india it sounds super like romantic, like it just sounds like a really cool thing, like you'd go out into the misty mountains and like harvest this stuff and it it was bringing me back. That's romantic to you. Oh yeah. Well, at least you know my early days when I was like herbal or little herbal kid, little herbal hippie with my dreads.
Josh:Oh my God, trying to collect herbs in Mexico on the mountainside, and that's what brought me to naturopathic medicine, and then I lost my way and got stuck in science as I went. So, yeah, I know it's like it was a different time, anyway. So, all right. So here we are. So we have a randomized, double-blind, placebo-controlled trial of this substance for osteopenia, which I thought was really interesting, and we've had a couple in postmenopausal women.
Josh:In postmenopausal women. So it seems very clinically relevant, right? So we're looking at a population of postmenopausal women with osteopenia and osteoporosis taking this intervention, this herbal intervention, to improve bone strength. So a very clinically relevant population. The only thing that was kind of surprising to me was there's like two authors and it's a very well conducted double blind randomized control trial Like how did you do this with two people? I don't know how that works, but I'm impressed. Okay, so should we set up the study design here?
Adam:Yeah, so it was actually a really well done study. When you and I were kind of texting back and forth about it, I was actually really impressed with this. It was a 48 week prospective randomized above-line placebo controlled trial, so essentially it was a year long of supplementation.
Josh:Which, you have to admit, is good, right, because anytime it's like a three month, four month, five month thing. You're like, oh, it was a great trial, but you know, anytime it's like a three month, four month, five month thing. You're like, oh, it was a great trial, but you know it's short-term outcome. So are we happy with an if it's a year-long?
Adam:I'm impressed by it, but with the results that they're like looking at um longer idea would be ideally better. Uh, because they're looking at bone mineral density and that's not going to change rapidly. Yeah Well, that's just one thing that we have to take into consideration. I am impressed, though, that they they kind of did take that sort of into account, and you know this is you know, to do it longer is going to take a lot of money. So the fact that they got basically a year's worth of data, I think is still important.
Josh:A year RCT with herbs like that, yeah. And to your point like bone mineral density outcomes, yeah. Three months wouldn't cut it Right, you'd almost need at least a year.
Adam:Yeah, it was a, it was registered. It looks like in sort of like an Indian database, which is great. And then they followed old consort guidelines for their reporting and I think, if I'm not mistaken, they made sure that the extract that they use was standardized and like, did contain what was in it in the exact amounts and kind of did keep tabs on that throughout the study. So the fact that they did that for a whole year is also very impressive.
Josh:Yeah, that's a good point and that's something herbal medicine folks will always say is. It depends when things are harvested, how they're harvested, et cetera, et cetera, and they mentioned that as well as being perhaps particularly relevant with this herbal product. But, yeah, exactly, so these are the things that you have to consider, and it looks like they took those into account.
Adam:And then they recruited postmenopausal women, where they define postmenopause as having no menstruation for 12 consecutive months, correct, correct Within five years of their last menses, between the ages of 45 to 60 years old, with a low bone mass of, basically, osteopenia. So a low T-score of negative one. And so I think that this is a very clinically relevant cohort of patients, because that's kind of the target audience that you're looking for. And then they make sure to exclude people on any sort of anti-resorptive medication. So making sure that people aren't coming in on things like, you know, their bisphosphonates and medications that we use for osteoporosis, osteopenia. Making sure that they were not exposed to systemic glucocorticoids within three months, because glucocorticoids such as prednisone do increase the risk for the development of osteopenia, osteoporosis.
Adam:They made sure that they weren't receiving hormone replacement therapy or selective estrogen receptor modulators within six months of study initiation. Made sure that no one had cancer within the last five years had an A1C of greater than 8%. Why they used 8% as a cutoff I am not sure, because diabetes is 6.4 or higher. So why they used 8% as the cutoff I would have to look into use of statins or other cholesterol lowering medications. Regular use of non-steroidal anti-inflammatory drugs so your ibuprofens or other anti-inflammatory drugs. Making sure individuals did not have a body mass of less than 20 or greater than 32. So making sure that people aren't on either spectrum of the BMI scale.
Josh:And just real quick with the anti-inflammatory drugs, like I think that probably speaks to their proposed mechanism, which is they believe that this would be working through inflammatory mechanisms. So it would make sense therefore, yeah.
Adam:Yes, and they also looked at inflammatory markers like CRP, and so if you're on something that can interfere with that, that's obviously going to interfere with that. Individuals who are smoking, chewing tobacco, alcohol abuse had any sort of abnormal thyroid, liver, kidney function, which makes sense because all three of those are heavily involved with bone turnover, osteopenia, osteoporosis.
Josh:And the smoking, you think, just because increased risk of osteoporosis.
Adam:I mean smoking just impacts literally everything. Everything just make it cleaner. And so I think, yeah, I think, even from both an osteopenia, osteoporosis standpoint and from an inflammatory marker standpoint, excluding that, it makes sense Fair enough. Individuals with low vitamin D levels defined as less than 20, so insufficient but not deficient. And then they were recruited from outpatient departments at, essentially, the university.
Josh:Yeah, and so, like you said, I mean it's, it's, this is the population that comes to you asking about you know what are some natural things to use for osteoporosis, osteopenia. So it just seems super, super relevant. It's not like a hospital cohort or anything like that. So, yeah, super relevant. So far, reasonable exclusion, inclusions, etc.
Adam:They then randomized subjects using a computer generated block randomization, which is great. We like to see that To one of three groups. One group received placebo, one group received 250 milligrams per day of Shilajit and then another group 500 milligrams. So that's pretty cool that they're looking at. Not only is it more effective than placebo, but if it were to be making some sort of impact, is there a dose response relationship there? You would expect that a higher dose. If it's doing what it's proposed to do with its mechanism of action, that you may see a greater effect.
Josh:Yeah, well, which is so? Which is so cool, right? Like I mean, technically you could have like a threshold effect and it's not better after a certain dose. But yeah, just from like a causation cause, you'd be like, oh, it's a small study, like maybe it's just random, but it's just further evidence. If you have that dose response effect, that yeah, this is a real thing that we're seeing.
Adam:Yep and the product they used, and we have no financial compensation through this. But I do think it's important to understand that not all products are created equal, especially when it comes to the supplement industry. They use the product called Prima V, and it looks like it's under some sort of a patent, and so it may not be.
Josh:An US patent, so maybe you can get it here.
Adam:Maybe it's available in the US, yeah and it's a purified Shilajit extract standardized to at least 10.3% dibenzoalpha pyrones and greater than 50% fulvic acid. So perhaps, if you're not using this product, at least look out for 10.3% dibenzoalpha pyrones within the product and at least 50% fulvic acid yeah, it's neat, they did a really good job describing the intervention and at least 50% fulvic acid.
Josh:Yeah, it's neat. They did a really good job describing the intervention and also the placebo, which was sort of standard guidelines. That, especially with herbal approaches like that's super, super important to be very, very clear about what it is and not just say Shilajit period versus placebo period. So they did a great job with reporting here.
Adam:Yeah, and then basically the placebo was just fiber. It was microstyling cellulose in identical white opaque capsules, and so this way no one knows what they're getting. You can't be like, oh, that's a blue pill and the other two are white. That person getting the blue pill is probably in the placebo group. That's a blue pill and the other two are white. That person getting the blue pill is probably in the placebo group, which is great. And they actually did use evidence to show that dose selection wasn't just kind of random. It was based on other studies showing beneficial effects on reducing oxidative stress and inflammation at higher doses. So that's why they used it. They were then basically. Then they got all their labs drawn and got a blood sample scan.
Josh:Right and just looked at a lot of stuff, yeah, which was also really cool because they're looking at again. This was a really well done study. So they're like we have a proposed mechanism, we are not only going to look at our clinical outcomes, we're going to look at all the blood markers that would support our mechanism of action, so inflammation, bone turnover markers, all of these as well as having a dose-dependent effect. So if they saw an effect which I'm not going to spoil the results yet you'd be able to see it across the board, both from molecular or chemical levels, showing the proposed mechanism here as well as the clinically relevant outcomes. Well, I guess you can argue semi-clinically relevant, bone mineral density. Probably the most important outcome, of course, would be fractures, but you would need massive cohorts of decades to really show that.
Josh:Look, the thing is we don't do this for money. This is pro bono and, quite honestly, the mothership kind of ekes it out every month or so, right? So we do this because we care about this, we think it's important, we think that integrating evidence-based medicine and integrative medicine is essential and there just aren't other resources out there. The moment we find something that does it better, we'll probably drop it. We're busy folks, but right now this is what's out there. Unfortunately that's it, and so we're going to keep on fighting that good fight. And if you believe in that, if you believe in intellectual honesty in the profession and integrative medicine and being an integrative provider and bringing that into the integrative space, please help us, and you can help us by becoming a member on Dr Journal Club. If you're in need of continuing education credits, take our NANSEAC-approved courses. We have ethics courses, pharmacy courses, general courses. Interact with us on social media, listen to the podcast, rate our podcast, tell your friends. These are all ways that you can sort of help support the cause.
Adam:And then, in order to have an 80% power to detect a clinically significant difference between the two groups, they needed at least 20 participants in each group, for a total of 60. And they ended up with, actually, they screened 68, which I thought was actually kind of low. I don't know why they only screened 68. And out of that 68, 60 were eligible.
Josh:Nice. Yeah, usually you do double, you do like 20% extra right to deal with dropouts and stuff. But yeah, so that was good. They had so basically approximately 20 people in each group and the population they had to at least be osteopenic, but they were also a bit of osteoporosis as well. So it's a mixed population of osteopenia and osteoporosis, which again would make any apparent effect even more impressive, because the folks with osteoporosis obviously have much more significant disease, and so if it impacts that, that's a good thing.
Adam:Yep. Overall, 19 were in the placebo and then 20 were in each of the Shilajit groups, and it seemed like the adherence rate was really impressive.
Josh:Especially over a year right, really really good.
Adam:Yeah, over 48 weeks, yeah, and then the average baseline T-score at the lumbar spine was minus two, which was consistent with osteopenia, and then at the femoral neck, which is usually the one that I actually pay a little bit more attention to, was between minus one and minus 2.5. So they really range from osteopenic to basically borderline osteoporosis. If I saw a minus 2.5, I would just say that that person's osteoporotic. But that's just me. But yeah, so these are people who are, at you know, at risk or at higher risk for bone fractures.
Josh:Yeah, important, clinically relevant population. You give them basically Shilajit for a year. Good response. And then let's look at the. Should we look at the effects Anything else for methods, or should we jump into that beautiful figure one?
Adam:Well, I just want to make sure that we do address what the primary outcome was. I'm just trying to find it right now. Sorry, I don't actually think they outright said what the primary outcome was. Was it just a pre-post bone mineral density from start of trial?
Josh:Yes, that was my understanding. Yeah, I don't think I specifically highlighted them saying that, but I probably just missed it because they did look at 24 weeks, so at the halfway mark they also looked at it reasonable, yeah, very reasonable, uh, yeah, so the primary outcomes here are DEXA scan and bone mineral density at one year right, yeah, and I actually didn't like how they reported the results.
Adam:They used figures, and figures can be kind of misleading if you're not paying attention to the scale, so it could look like there's a huge difference when really it's not much. I prefer tables, and so you had to kind of go back and forth with the figures and the text to kind of make sense of the data.
Josh:Yeah, I had the same experience and I got lost in the text as well. There was just so many different outcomes that they were reporting on. There were so many outcomes.
Adam:Yeah, yeah. So I just tried to pay attention to the bone mineral density and then I looked at, really, the week 48 results, because that's really what we care about. Yeah, the secondary outcomes which were all the other markers and those are a little bit easier to make sense of. But when we looked at the bone mineral density, the placebo group continued to have basically have a decrease in their bone mineral density. The placebo group continued to basically have a decrease in their bone mineral density over time, which would make sense, yep, whereas those with the Shilajit compared to placebo, actually had improved bone mineral density.
Josh:Yeah, and in a very nice dose dependent manner. So one of the things I like about. So I agree with you usually with tables, but when you have a nice dose response like this, it's like really it's so visually easy to see in a figure and so I just love that. So if you're following along and we'll include the paper link in the show notes, but there's on figure one, there's just this really beautiful section B which just really shows this perfect like dose response relationship. You see the placebo group having worsening bone mineral density in the lumbar spine. You see a slight improvement for the 250 milligram and then a better improvement for the 500. And it's just this really nice statistically significant effect. It's hard to say like well, I mean, maybe you're more familiar with the literature like on meds for this, like what would be considered a clinically relevant bone mineral density change as opposed to fracture change. But at least as far as like yeah, this is a real thing, you know, it really does seem quite convincing to me.
Adam:Yeah, and we also, you know, we did see a dose dependent improvement as well, which I think is really important to highlight.
Josh:Both femoral, neck and lumbar spine. Yes, dose dependent response Yep, yeah.
Adam:So I mean we're seeing just consistency of 250 is better than placebo, 500 is better than 250 and placebo. And we're seeing, at both the spine and the neck, the femoral.
Josh:And similar situations, less obvious, less visually appealing, but similar story with all the biomarkers of inflammation and bone turnover. So again the proposed mechanism here of being sort of an inflammatory-induced bone turnover. So again the proposed mechanism here of being sort of an inflammatory induced bone turnover issue, sort of mediated by menopause, I guess, is the argument that seems to bear out right, which is just really it's very convincing when you see the whole story kind of line up with the data.
Adam:Yeah, and all the inflammatory markers went in the right direction.
Adam:So the ones that would be associated with, you know, increased bone turnover went down at the higher doses but went up with the placebo.
Adam:And those that are associated with improved bone making went up with the intervention and then down with the placebo. So if we look at the marker CTX1, which is C-terminal telopeptide type 1 collagen, that is, an inflammatory marker associated with bone turnover, that went up by week 48, that went up by week 48. When you looked at the difference, it went up 11% in the placebo group but it went down 22% in the 500 milligram group and down 18% in the 250 milligram group. When we look at the biomarker rank L, which is actually an important one because there are newer medications that target the rank L, ligand, which is just a receptor activator of nuclear factor, kappa beta, and that went up with the placebo by 12% and went down by 10% with the 500 milligram dose. And then osteoprotegerin, which is basically doing what it sounds like it's pro-osteo, it's making bone growth, it's generating new bone, the placebo went down 4%, whereas with the 500 milligram it went up 57%.
Josh:That's pretty cool, yeah. And again, these very nice dose responses were 250 milligrams. So across all of those, I think for yeah, for all of them, you have a dose response effect. You have a relative improvement with a 250 milligram and then even more of an improvement with the 500 milligram. So all the bone turnover markers follow that same story and are statistically significant. And then it's a similar story with the inflammatory markers, right? So we're looking at high sensitivity, crp, mda, glutathione and nitric oxide, nitric oxide and it's a similar, similar story throughout.
Josh:So you see worsening in the placebo group over a year, which you would expect in this population. You see improvements at 250 milligrams and you see even more improvements at at 500. I mean, it's just, you know the only thing that I would you know. So I'm I'm of all of these mark I don't know which ones you you use a lot. I mean CRP I'm much more comfortable with as like a regular marker that I look at. So you know, 30%, uh, decrease in. You know CRP sounds really impressive, but if you look at the actual numbers, it's just it's not super huge Like you know they they're at, you know it's not, it's not a massive shift in absolute numbers because they're starting out at around, you know, point seven, eight or two or something like that.
Adam:Honestly, the only thing I cared about in this entire paper was the bone mineral density.
Josh:Yeah, fair enough. Yeah, totally yeah. So these, these are. It's just kind of cool to see such a consistent story.
Adam:Yeah I think it's important that we're seeing consistency and the the proposed mechanism of his action, is also holding up, which only helps to provide more evidence to um. You know the causality argument, um. So you know, we're seeing, and we're seeing it consistently with every single marker. It's not sort of random, it's, it's everything's going in the right direction. There's a magnitude, uh to that where we're getting a dose response, um, and we're seeing, you know, anti-inflammatory markers quote unquote go up and then the pro-inflammatory markers go down, go down more at higher doses and they're statistically significant. When we're looking at bone mineral density change, you're seeing a 4% improvement at the 500 milligram dose. So whether or not that's clinically relevant, I don't know versus a minus 4% worsening.
Josh:But even to stop bone loss, I mean that's just huge right. You've got this osteoporotic population and it's not only stopping it, like bones growing back. That's crazy.
Adam:Well, I think you know, even though it's, it's cool clinically, is that? Is that an important amount? If it went, if it improved by 4%%? Yes, I get what you're saying Per this study it's better than nothing. Doing nothing, you'll continue to have loss. So, yes, we could do better than that, right? However, is it worthwhile to tell all of my osteopenic post-menopausal individuals who have a uterus to say, or that were born with uterus to say, you should go out and supplement with this on a daily basis until you know for life, essentially Fair. And then, by improving your bone mineral density, are we also preventing fracture? So there's two things that we kind of have to answer Are we getting clinical benefit in the amount of improvement in bone mineral density and are we also achieving what we want to do in the sense of will this supplement actually prevent a fracture? So really, what we should be doing next for future trials is one compare this to standard of care.
Josh:That was going to be my question. Like, what do we? I don't, I don't know this space enough Like, what are the improvements that we see on the meds that are out there, right, what's the comparison to the standard of care?
Adam:Right, and I think I think that that's something that we would have to do is then compare Shilajit to something like a bisphosphonate, because that's typically the starting place, and then you would need another trial and, okay, in those who are bisphosphonate intolerant or people who have failed bisphosphonate therapy, how does it compare to something else? And then also we will need a clinical outcomes trial. Looking at Shilajit extract supplementation. Does supplementing with this prevent fracture?
Josh:Yes, and that you need a massive cohort for that. But, yes, 100% agree. And I think we're really struggling because this isn't our field and so just looking at these numbers, like we can see the story, but, to your point, like we just don't know how clinically relevant this is. So if you're, if you do a lot of this kind of work and you're a listener, you know, let us know is this, is this as impressive an outcome as maybe I suspect that it is? Clinically, how does that compare? And I think that was something missing from the discussion. You know that would be a great place to compare it to, or not even to directly compare, but basically to say, like the drugs on the market, the standard of care, do X, Y, Z right, Just so you have some yardstick about what we're dealing with here. So I would have liked to see that. But otherwise it's good and excellent points right. It's like it looks like a solid study, it looks like it's real. The question is, of course is it clinically relevant?
Josh:The other thing I wanted to point out it almost looked too good, the story was almost too good, and then it was like there's only two authors and it was a pretty involved study. And then they're harping on this very specific product. So my little red flaggy ears went up. And but you know, according to what they're saying, there's no funding or financial conflicts of interest. It's not funded by the company. That makes that they don't have any competing interests. So you know, I guess we take them at their word. It's just like it almost looked too good or something. I don't know, Maybe I'm just. I've gotten so cynical over the years with with these trials.
Adam:No, I mean, I think you know when it, if it sounds too good to be true, that's that really is when, like, your spidey senses should go up and be like, okay, well, what gives? I think one thing that gives is, you know, we're not comparing it to the standard of care, we're only comparing it to placebo. Not to belittle, you know, the amazing work the authors did. We don't have hard clinical outcome data, but I do think it's important because you're going to have patients who are medically hesitant or resistant, and if you're out of options and they're absolutely refusing care, I would say, okay, well, maybe we consider this, if you're, if you're up for it, just because doing nothing per this trial seems to be worse, and so if you're trying to do less harm, it seems like this would be at least something to consider. This is not medical advice.
Josh:Yeah, no, that's fair. I have a family member in mind. It's exactly the situation. It's like, well, I don't want to consider these meds, and basically they're telling me then there's nothing to do but just like wait for things to continue. So this might be something where we can say at least there's, but they're a little bit more open minded to natural approaches. So yeah, I think it's. It's a clinical context, of course, comparison, etc. So you know.
Josh:Another interesting thing is and I just don't know this space well enough and you're more clinically active than I am With the bisphosphonates. It's just a couple years. You do treatment for right, like it's not a forever thing, right. So it could be an interesting future study here too, where you're doing instead of instead of you're doing like an additive right, like you're doing this therapy for a few years, which is your limit anyway, and then you try something else, or maybe you add them together or something. So there could be some interesting things. To be fair, what we're describing are much more advanced level studies which would not come yet until the preliminary studies like this have been conducted right.
Josh:So no, but a study like this really paves the pathway for fun for that yes, yes, very clear mechanism, very clear data, totally okay, excellent, um, I don't know that I have anything else to add. My spidey sense went off enough that I was even googling that that hospital, the hospital clinic or the clinic, the university. Um, I was like there's got to be some connection here, but I couldn't find it with a little bit of google sleuthing I have an idea what I have an idea what that Heather Zwickey know that listens, okay, uh, yep and Zwickey.
Adam:Dr. Zwickey is awesome, agreed, and she's still affiliated with health guard and and we know that she listens to this very astutely every day because who wouldn't?
Josh:What smart person wouldn't right? Correct, correct. It's a syllogism, basically yeah exactly.
Adam:She would probably listen to this episode and be like, wow, these guys are great. They talked about an awesome study. I'm going to see if one of my students at health got would like to see if one of my students at HealthCott would like to conduct a randomized controlled trial. Looking at something like this, there you go, excellent connection with OHSU and I'm sure they get plenty of data.
Josh:So we just set it up, just like that Piece of cake. That's how trials get done, people, I'm just saying Excellent, excellent, excellent.
Adam:If you want to ask questions, you can put me in as third author.
Josh:There you go. There's all these rules about authorless right. It's like you know, if you were in the hallway or you attended a meeting where the authors met, you're like author number seven. So if you suggested a similar idea on a podcast, you're going to be positioned, you know, between what's that Intellectual property? There you go. I don't think that's a thing, but we'll. We'll take it. It's timestamped now. So, heather, don't even try to steal this idea. We gave it to you essentially, or exactly. There we go. There you go, until next time. Oh, we have a bunch. So thank you, listeners. So much, we've gotten like a whole flood of recommendations.
Adam:I'm really digging the involvement from the community. We're just like we cannot keep up.
Josh:Community's stepping up. Yeah, it's good. It's good we have our work cut out for us. We've got some really cool studies listed. We owe uh, mark davis, dr davis, a bunch. We got a great recommendation for the new d mano study, which I think we're just going to bump to front of the line for next week because it's time relevant and there's also a new uh april doctor journal club video looking at a lavender for anxiety oh, yeah, that was a really good one.
Josh:Lavender for depression. Excuse me, yeah, Depression for depression, which is interesting because all the studies that I've seen before just been on anxiety. So, yeah, Adam's been super busy. There's like some really awesome new content on the website and, yeah, keep the recommendations coming in community. This is awesome we're having back and forth. I just heard back from Eric Yarnell Dr Urnell, I love the podcast feedback on Ginger. He was like I knew there was something up. He said as he was listening to the podcast he was screaming out loud, being like how do they publish this garbage? So I think he's as passionate as we are about this stuff, Loving the feedback from the community but if you could please share these episodes, Spread the love.
Adam:The more that the integrative community can hear about us, the more that we can have these awesome discussions and kind of just spread more knowledge about evidence-based integrative therapies that are out there, because we're looking to stuff that I otherwise wouldn't come across. And so if more people can listen and more people are sharing and more people have ideas and want to comment and write us an email whether it's a good review or an issue that you have, all feedback is welcome please, beautiful Mic drop.
Josh:That perfectly said. All right, everybody. We'll see you next time. If you enjoy this podcast, chances are that one of your colleagues and friends probably would as well. Please do us a favor and let them know about the podcast and, if you have a little bit of extra time, even just a few seconds, if you could rate us and review us on Apple Podcast or any other distributor, it would be greatly appreciated. It would mean a lot to us and help get the word out to other people that would really enjoy our content. Thank you, hey y'all. This is Josh.
Josh:We talked about some really interesting stuff today. I think one of the things we're going to do that's relevant. There is a course we have on Dr Journal Club called the EBM Boot Camp. That's really meant for clinicians to sort of help them understand how to critically evaluate the literature, etc, etc. Some of the things that we've been talking about today. Go ahead and check out the show notes link. We're going to link to it directly. I think it might be of interest. Don't forget to follow us on social and interact with us on social media at DrJournalClub, drjournalclub on Twitter. We're on Facebook, we're on LinkedIn, etc. Etc. So please reach out to us. We always love to talk to our fans and our listeners. If you have any specific questions you'd like to ask us about research, evidence, being a clinician, et cetera, don't hesitate to ask. And then, of course, if you have any topics that you'd like us to cover on the pod, please let us know as well.
Introducer:Thank you for listening to the Doctor Journal Club podcast, the show that goes under the hood of evidence-based integrative medicine. We review recent research articles, interview evidence-based medicine thought leaders and discuss the challenges and opportunities of integrating evidence-based and integrative medicine. Be sure to visit www. dr rjournalclub. com to learn more.