We here at Sensible Medicine love randomized trials, but they don't always answer important questions especially when Medicine leaves its area of expertise
I certainly agree with your conclusions but would take it a step further. The key fact is that it is logistically impossible to conduct a dietary study in a free-living population that has any scientific validity. They are by their very nature observational and analyze data sets that are highly questionable in accuracy to say the least. The few large ones that have been conducted over a significant time period show no differences in any medically important outcomes. The fact that the subject study attributes statistical significance to the small differences in the measurement of a very variable metric (BP) also demonstrates that "statistical significance" has nothing to do with practical significance.
It is interesting that many who (quite properly) decry the dishonesty and avarice of BIG PHARMA will often be enthusiastic supporters of BIG NUTRITION which is largely the vitamin and supplement industry and producers of "healthy" food. Their balance sheets often rival those of the pharmaceutical industry. Their claims are unfalsifiable but, unlike the pharmaceutical companies, they probably do little harm.
My wife had knee replacement surgery and was told to eat more protein. So she bought a bunch of nutrition bars that say PROTEIN on the wrapper and are chocolate bars with some grainy stuff on the inside. ARRGGH! :-)
I reviewed that article in JAMA today prior to seeing this. I was struck by the same concerns that you did. All that for a change of 3mm lower bp. And the experimental group not had food delivery of appropriate foods but had support of nutritionist and education while the control group got nothing. I agree, so much work for so little of significance. And watch the headlines, say "STUDY SHOWS SIGNIFICANT LOWERING OF BP". Good old statistical significance, misleads again.
Speaking about diet and policy, I would like to hear your impressions about the new "food pyramid" proposed by HHS. Where's the evidence? What are the affiliations of the panel and authors?
I agree with you. Dr. Mandrola. Why spend this kind of money on a study like this. I was surprised to see a reduction in SBP when they took in office readings, even the 3 mmHG. Unbelievable
"I am not a policy expert but I can’t see how such a resource-intensive intervention could ever be scaled to large diverse populations. And if this was the prior, why should such a trial ever have been conducted?"
John, my goodness, come at this with an open mind.
This seems like the perfect use case for the "Vitality Rewards" credit card points program detailed here recently. Card administrators can check in with the experts over in the nutritional epidemiology department, find out what the current thinking on the best diet is and reward card holders who purchase appropriate foods.
That's a nice carrot. We could also have the CDC print up some paper cards that could be used as a nutrition passport.
I am not infantilizing people. I am looking at the econmoy that we live in right now that means people work multiple jobs and whole produce used to be cheaper but it is no longer. Think about it- you have the option to be lazy- some people don't.
I am with you ADWH. There are many factors that influence the luxury of being able to make choices when purchasing food products. Financial ability is a huge factor. And just as relevant is time- if you're working 2 jobs to be able to afford a place to live, you get 5 hours of sleep where is the time to prepare a lovely meal?- come on kids gather round I've just spent 2 hours preparing this lovely dinner.
I'm not saying that education about healthy meal choices isn't relevant; but everyone already knows that. It's about being able to implement it financially and in a 24 hour period. And it doesn't help that the food industry has been overtaken by heavy marketing of "healthy food choices" that are definitely not and the fact that everyone is a nutritionist, not a dietician.
While I agree that the study doesn’t help lower income folks much, and isnt generizable to tge whole population, it DOES help someone like “me”, who can afford higher quality food choices and prefers to not “ take the pill”….along as the “ cost” of the study ( taxes) pays for the study… but it’s not practical to generalize to everyone. I wouldn’t like it either if food subsidies were limited to only “ healthy” foods and only the “ wealthy” could afford to choose to not be “healthy “.
Food like many things is downstream from family, culture and community. It is very hard to influence and change. Say No to drugs or MADD are great examples of public policy campaigns that were pretty effective. But for nutrition and healthy eating to be impacted there are lots of $$$ corporations who don't really want us eating healthy so it's a lot harder to get the political and societal alignment on driving the change. - let alone the infrastructure and $ to pay for healthy eating (which I actually think is a lot more achievable than fighting corporations actually)
Dr. Mandrola, I agree with everything you said. As for "why should such a trial ever have been conducted?" Because it provides empirical evidence that supports your prior hypothesis: "The remedy for the substantial gaps in health outcomes in this country lie far upstream from modern medicine. I see the solutions as societal and political—not medical."
You are correct, this study was not worth the time or money. Not because changing one's diet doesn't help, but for a number of other reasons.
1. They gave people access to healthy food for 3 months which worked to lower blood pressure, but then also measured BP at 6 months. Did the researchers expect that eating healthy for 3 months would continue to keep BP low? What if people only took a BP med for 3 months and then we checked their BP in 6 months?
2. Was there any education on healthy eating given? Then again, even if there was, if people lived in a food desert it wouldn't help. This is a more complex topic than a 3 month study could help. Were all the confounders accounted for (economic situation, access to healthy food, educational level, etc.)?
3. Any study that looks at making a diet change for only 3 months is useless. The long-term effects that come from changing one's diet happen because it is a permanent change. As a society, we have to make healthy food accessible (location, price).
I see studies every once in a while that seem to want to discredit the impact of diet on HTN and diabetes as well as other chronic diseases. They are poorly designed, such as this one. Many people who have embraced changes in their diet (and other lifestyle changes) have lived longer and healthier lives (my mother and her brother are 2 that I personally know).
Speaking of Lifestyle Medicine, it is more than just changing diet. It's making sure you have tools to handle stress, having enough sleep, exercising, having purpose and having a social network. All these things work together, along with diet, to make for a healthier life.
My goodness : a minimal BP difference in an already highly selected group whose BP is already pretty good: what IS the point. Plus BP measurements even with a decent auto inflated cuff varies enough to make the small difference here even more suspect. General applicability of this type of intervention seems low.
If SBP is the goal, meds win. If overall health is the goal, a more nutritious diet may win.
I almost stopped at "food is medicine" and again almost stopped at "N=180" but I persevered.
If my patient has hypertension I offer them a BP lowering med and lifestyle. I support them any way I can to focus on the latter.
I certainly agree with your conclusions but would take it a step further. The key fact is that it is logistically impossible to conduct a dietary study in a free-living population that has any scientific validity. They are by their very nature observational and analyze data sets that are highly questionable in accuracy to say the least. The few large ones that have been conducted over a significant time period show no differences in any medically important outcomes. The fact that the subject study attributes statistical significance to the small differences in the measurement of a very variable metric (BP) also demonstrates that "statistical significance" has nothing to do with practical significance.
It is interesting that many who (quite properly) decry the dishonesty and avarice of BIG PHARMA will often be enthusiastic supporters of BIG NUTRITION which is largely the vitamin and supplement industry and producers of "healthy" food. Their balance sheets often rival those of the pharmaceutical industry. Their claims are unfalsifiable but, unlike the pharmaceutical companies, they probably do little harm.
My wife had knee replacement surgery and was told to eat more protein. So she bought a bunch of nutrition bars that say PROTEIN on the wrapper and are chocolate bars with some grainy stuff on the inside. ARRGGH! :-)
I reviewed that article in JAMA today prior to seeing this. I was struck by the same concerns that you did. All that for a change of 3mm lower bp. And the experimental group not had food delivery of appropriate foods but had support of nutritionist and education while the control group got nothing. I agree, so much work for so little of significance. And watch the headlines, say "STUDY SHOWS SIGNIFICANT LOWERING OF BP". Good old statistical significance, misleads again.
Thanks for having the audacity to say such common sense stuff.
Speaking about diet and policy, I would like to hear your impressions about the new "food pyramid" proposed by HHS. Where's the evidence? What are the affiliations of the panel and authors?
I agree with you. Dr. Mandrola. Why spend this kind of money on a study like this. I was surprised to see a reduction in SBP when they took in office readings, even the 3 mmHG. Unbelievable
"I am not a policy expert but I can’t see how such a resource-intensive intervention could ever be scaled to large diverse populations. And if this was the prior, why should such a trial ever have been conducted?"
John, my goodness, come at this with an open mind.
This seems like the perfect use case for the "Vitality Rewards" credit card points program detailed here recently. Card administrators can check in with the experts over in the nutritional epidemiology department, find out what the current thinking on the best diet is and reward card holders who purchase appropriate foods.
That's a nice carrot. We could also have the CDC print up some paper cards that could be used as a nutrition passport.
I think it's doable.
I am not infantilizing people. I am looking at the econmoy that we live in right now that means people work multiple jobs and whole produce used to be cheaper but it is no longer. Think about it- you have the option to be lazy- some people don't.
Very good points made. All that work for a 3 mm BP change? Will that make any difference in the body? Really guys?
You are not wrong...
I am with you ADWH. There are many factors that influence the luxury of being able to make choices when purchasing food products. Financial ability is a huge factor. And just as relevant is time- if you're working 2 jobs to be able to afford a place to live, you get 5 hours of sleep where is the time to prepare a lovely meal?- come on kids gather round I've just spent 2 hours preparing this lovely dinner.
I'm not saying that education about healthy meal choices isn't relevant; but everyone already knows that. It's about being able to implement it financially and in a 24 hour period. And it doesn't help that the food industry has been overtaken by heavy marketing of "healthy food choices" that are definitely not and the fact that everyone is a nutritionist, not a dietician.
That's ridiculous. A meal can be fixed in about 20-30 minutes. I do it all the time because I am too lazy to cook anymore.
And processed foods are way more expensive.
You are infantilizing people.
While I agree that the study doesn’t help lower income folks much, and isnt generizable to tge whole population, it DOES help someone like “me”, who can afford higher quality food choices and prefers to not “ take the pill”….along as the “ cost” of the study ( taxes) pays for the study… but it’s not practical to generalize to everyone. I wouldn’t like it either if food subsidies were limited to only “ healthy” foods and only the “ wealthy” could afford to choose to not be “healthy “.
Food like many things is downstream from family, culture and community. It is very hard to influence and change. Say No to drugs or MADD are great examples of public policy campaigns that were pretty effective. But for nutrition and healthy eating to be impacted there are lots of $$$ corporations who don't really want us eating healthy so it's a lot harder to get the political and societal alignment on driving the change. - let alone the infrastructure and $ to pay for healthy eating (which I actually think is a lot more achievable than fighting corporations actually)
Dr. Mandrola, I agree with everything you said. As for "why should such a trial ever have been conducted?" Because it provides empirical evidence that supports your prior hypothesis: "The remedy for the substantial gaps in health outcomes in this country lie far upstream from modern medicine. I see the solutions as societal and political—not medical."
You are correct, this study was not worth the time or money. Not because changing one's diet doesn't help, but for a number of other reasons.
1. They gave people access to healthy food for 3 months which worked to lower blood pressure, but then also measured BP at 6 months. Did the researchers expect that eating healthy for 3 months would continue to keep BP low? What if people only took a BP med for 3 months and then we checked their BP in 6 months?
2. Was there any education on healthy eating given? Then again, even if there was, if people lived in a food desert it wouldn't help. This is a more complex topic than a 3 month study could help. Were all the confounders accounted for (economic situation, access to healthy food, educational level, etc.)?
3. Any study that looks at making a diet change for only 3 months is useless. The long-term effects that come from changing one's diet happen because it is a permanent change. As a society, we have to make healthy food accessible (location, price).
I see studies every once in a while that seem to want to discredit the impact of diet on HTN and diabetes as well as other chronic diseases. They are poorly designed, such as this one. Many people who have embraced changes in their diet (and other lifestyle changes) have lived longer and healthier lives (my mother and her brother are 2 that I personally know).
Speaking of Lifestyle Medicine, it is more than just changing diet. It's making sure you have tools to handle stress, having enough sleep, exercising, having purpose and having a social network. All these things work together, along with diet, to make for a healthier life.
My goodness : a minimal BP difference in an already highly selected group whose BP is already pretty good: what IS the point. Plus BP measurements even with a decent auto inflated cuff varies enough to make the small difference here even more suspect. General applicability of this type of intervention seems low.