Picking the Hive's brain: Would you help me evaluate this medical study?

[Laurie4b]

I am looking for help evaluating this small medical study, so even if the topic isn't your thing, if you have experience evaluating medical studies, I would very much appreciate your perspective.

 

I have a strong family history of Alzheimer's and so keep up on the news both for the sake of family members standing on the precipice and for myself and my siblings and cousins who feel like we're on a conveyor belt headed in that direction. 

 

Anyway, there is a hopeful but very small study out of UCLA and I'd like your thoughts on evaluating it. It's so small (11 participants) that it is essentially 11 case studies ie anecdotal evidence) but it has been published in a peer-reviewed journal and looks quite interesting. I've read that he hopes to start a larger trial this coming year.

 

1 person had severe Alzheimer's and didn't improve and the other 10 had one of the following:

•  "subjective cognitive impairment" (a sense by the patient that their memory is "off" compared to peers even if they can pass tests. I have been told in a family support group that this also often progresses into Alz.)
•  "amensiac mild cognitive impairment" (that means memory loss associated with the rest of the cognitive impairment; it is quite likely to evolve into Alz)
• or early stage Alzheimer's 

All 10 improved; some dramatically. 

 

The doctor's overall approach makes intuitive sense to me and a lot of his specific adjustments for a patient make sense for other health reasons. He appears to me to be approaching the problem from a perspective similar to functional medicine. 

 

I want to be open-minded, but I am also cautiously skeptical. Here's the link: http://www.impactaging.com/papers/v6/n9/full/100690.html

 

I would value reading other people's thoughts and analysis. 

 

 

[trulycrabby]

Promising, but I would look at it in the same way the researchers do; that the results indicate "a need for a controlled clinical trial of the therapeutic program."

[klmama]

Thank you for sharing this. 

[Laurie4b]

Given that it is a preliminary study so no strong conclusions can be drawn, does his approach make sense to you? Why or why not?

[Sunshine State Sue]

I ran across this link on TWTM boards the other day and have been mulling it over.  I believe this is the same study.

 

Here are my thoughts with the disclosure that I am no expert, just someone who is interested in nutrition and thinks that an ounce of prevention is worth a pound of cure.  My mother suffered with dementia for 5 years before she passed away.

 

• eliminating all simple carbohydrates, gluten and processed food from her diet, and eating more vegetables, fruits and non-farmed fish
• meditating twice a day and beginning yoga to reduce stress
• sleeping seven to eight hours per night, up from four to five
• taking melatonin, methylcobalamin, vitamin D3, fish oil and coenzyme Q10 each day
• optimizing oral hygiene using an electric flosser and electric toothbrush
• reinstating hormone replacement therapy, which had previously been discontinued
• fasting for a minimum of 12 hours between dinner and breakfast, and for a minimum of three hours between dinner and bedtime
• exercising for a minimum of 30 minutes, four to six days per week

 

healthy diet (mine is whole foods, plant based, generally gluten free), meditation/yoga, sleep, oral hygiene, 12hr fast, exercise can only help and not harm you.

not convinced about the vitamins/supplements unless there is evidence of deficiency

not convinced about the HRT - just like I'm not convinced that foreskins need to be removed

 

The doctor's overall approach makes intuitive sense to me and a lot of his specific adjustments for a patient make sense for other health reasons. He appears to me to be approaching the problem from a perspective similar to functional medicine.

I think you should follow your intuition.

[Sunshine State Sue]

let's see what happens if we take this to a larger trial ...

Call me cynical, but there's not enough money to be made to warrant a larger trial.  :rant:

[Laurie4b]

I ran across this link on TWTM boards the other day and have been mulling it over.  I believe this is the same study.

 

Here are my thoughts with the disclosure that I am no expert, just someone who is interested in nutrition and thinks that an ounce of prevention is worth a pound of cure.  My mother suffered with dementia for 5 years before she passed away.

 

healthy diet (mine is whole foods, plant based, generally gluten free), meditation/yoga, sleep, oral hygiene, 12hr fast, exercise can only help and not harm you.

not convinced about the vitamins/supplements unless there is evidence of deficiency

not convinced about the HRT - just like I'm not convinced that foreskins need to be removed

 

I think you should follow your intuition.

 

 Besides the things you listed as things that we know do good to our health anyway, I noticed in reading the journal article that oral hygiene (electric toothbrush, flossing) was one of the interventions. I was already doing quite a bit for my health, but I think that seeing my loved one begin to struggle cognitively has provided more motivation and some willingness to *consider* some options that are a little out of the box. 

 

I listened to the People's Pharmacy recording when Bredesen was on. He said that he did do blood testing to determine people's levels of various substances in their blood such as Vit D, Vit B12, homocystine, etc. The supplements were not given willy-nilly, but were individualized. One important point is that he was looking to move the values to the optimal level, not just within the accepted normal level. 

[Sunshine State Sue]

I listened to the People's Pharmacy recording when Bredesen was on.

Oooh.  Found it.  But, I must get some sleep as it's nearly midnight here.  Will have to wait until tomorrow to listen.  I've been trying to stay up late to reset my biological clock after the time change... ;)

[Laurie4b]

I wonder just how a study could be done in order to isolate what was having the positive effect. Each person was doing some similar things with the others, but not entirely the same. There are a lot of variables and possible combinations.

 

I do think that he is on to something.

 

I think his underlying premise is that there are numerous variables that must all be in place, which makes sense to me. If each one plays a tiny role but synergistically they get to where one wants to go, that doesn't fit into the current model of scientific inquiry. I guess he could do something similar to an elimination diet: after achieving success, take someone off one factor and see if they maintain gains... or maybe do a study with all but one of the variables now covered. 

 

It's hard because there are not a lot of options right now. Vigorous exercise is the one intervention that has data, and it's only one study I believe (in terms of improving things once memory loss starts. There is lots of data on vigorous exercise as being correlated with less chance of getting it or of later onset.) The insulin nasal spray studies have been successful. Maybe pitting success in those against success in his model? But it couldn't be double blind. It's pretty obvious which study one would be in....

 

It's really a conundrum from a typical scientific experiment standpoint. Bredesen tried to float the idea of start with his program as the base, then test drugs on top of that. He was turned down in Australia b/c they said it was too complicated. 

 

As someone at high risk, if I began to develop memory problems, I would want to throw all the spaghetti against the wall! 

[Mergath]

I have a strong family history of Alzheimer's (and sudden fatal aneurysms, yay <_<) so I'm pretty invested in the research too, but I'm skeptical. Not that I think he's lying or anything like that, but more that I wonder if these changes are actually having any effect on the Alzheimer's itself. The list of lifestyle changes quoted above seems to be his individual program for one woman, if I'm reading the article right, and it sounds like her symptoms were fairly mild (as far as cognitive impairment goes, anyway). Really, I think if anyone is eating a crappy diet, not sleeping more than four hours a night, and stressed out, they're going to have some issues thinking clearly, and by getting them to exercise, sleep a full night, filling them up with vitamins, and teaching them to meditate and deal effectively with stress, you're going to see an improvement in their thinking processes. I had a massive improvement in my ability to think clearly and remember things just by starting a vitamin d supplement a few years ago, and I'm 32, so no Alzheimer's yet. So to me the study seems to be a case of "everyone should do this and they'll think and feel better," not that this is somehow curing Alzheimer's specifically. I hope that I'm wrong, but only time will tell. 

[Mergath]

Has anyone seen this study yet? This looks promising for a whole host of conditions: http://www.npr.org/sections/health-shots/2015/10/17/448323916/can-a-cancer-drug-reverse-parkinsons-disease-and-dementia  They haven't tried it on Alzheimer's yet, but they think it should work for that, too.

[Laurie4b]

I have a strong family history of Alzheimer's (and sudden fatal aneurysms, yay <_<) so I'm pretty invested in the research too, but I'm skeptical. Not that I think he's lying or anything like that, but more that I wonder if these changes are actually having any effect on the Alzheimer's itself. The list of lifestyle changes quoted above seems to be his individual program for one woman, if I'm reading the article right, and it sounds like her symptoms were fairly mild (as far as cognitive impairment goes, anyway). Really, I think if anyone is eating a crappy diet, not sleeping more than four hours a night, and stressed out, they're going to have some issues thinking clearly, and by getting them to exercise, sleep a full night, filling them up with vitamins, and teaching them to meditate and deal effectively with stress, you're going to see an improvement in their thinking processes. I had a massive improvement in my ability to think clearly and remember things just by starting a vitamin d supplement a few years ago, and I'm 32, so no Alzheimer's yet. So to me the study seems to be a case of "everyone should do this and they'll think and feel better," not that this is somehow curing Alzheimer's specifically. I hope that I'm wrong, but only time will tell. 

 

It was 11 people, not just one woman. If you look at Table 2, you will see the level of impairment of each. The mildest category was subjective cognitive impairment, in between is amnesiac mild cognitive impairment (the word "mild" is misleading imo) and the others had early Alzheimer's, except for one with severe Alzheimer's. The one with severe Alzheimers was the only one of the 11 who did not improve. 

[Laurie4b]

Call me cynical, but there's not enough money to be made to warrant a larger trial.  :rant:

 

On the other side of that, given that the Baby Boomers are of the age to develop Alzheimer's now, there is a lot of money to be saved by the government if a treatment is found. Alzheimer's is extremely expensive medically, so that may give us some hope that there is financial incentive on the side of work to find a cure. 

[Laurie4b]

Has anyone seen this study yet? This looks promising for a whole host of conditions: http://www.npr.org/sections/health-shots/2015/10/17/448323916/can-a-cancer-drug-reverse-parkinsons-disease-and-dementia  They haven't tried it on Alzheimer's yet, but they think it should work for that, too.

 

Yes, that study was posted in another thread on Alzheimer's prevention and looks extremely promising. I'm glad that you pointed out that it hadn't yet been tried on Alzheimer's patients. I misread it the first time through and thought that it has been. The expense of the drug will be a big issue. :(

[Mergath]

It was 11 people, not just one woman. If you look at Table 2, you will see the level of impairment of each. The mildest category was subjective cognitive impairment, in between is amnesiac mild cognitive impairment (the word "mild" is misleading imo) and the others had early Alzheimer's, except for one with severe Alzheimer's. The one with severe Alzheimers was the only one of the 11 who did not improve. 

 

Oh, I know, I was just saying that it appears from the article that the list of lifestyle changes they included was that one woman's specific plan, not the general plan for everyone. My point is that it seems impossible to tell if the improvements in cognitive function are what you'd see in anyone who began sleeping and eating better or if there is some mechanism that's actually fixing the brain. I mean, we see people here all the time who talk about how transformative it is when they begin a healthy lifestyle, or begin supplements when they're deficient in something. 

[Mergath]

Yes, that study was posted in another thread on Alzheimer's prevention and looks extremely promising. I'm glad that you pointed out that it hadn't yet been tried on Alzheimer's patients. I misread it the first time through and thought that it has been. The expense of the drug will be a big issue. :(

 

That was my thought when I saw it, too. And you know if it turns out to be some kind of magical cure for Alzheimer's, the price is only going to go up. :( 

[Sandragood1]

Scientifically, wouldn't the correct methodology be to construct a study to Disprove his hypothesis?

 

look for Alz patients with a history of great lifestyle choices (per the researcher). Or non Alz aged persons who had decades of poor health choices. In large numbers.

 

Depending on the results it could support the researcher's request to conduct a larger study or dismiss the issue.

[Laurie4b]

Oh, I know, I was just saying that it appears from the article that the list of lifestyle changes they included was that one woman's specific plan, not the general plan for everyone. My point is that it seems impossible to tell if the improvements in cognitive function are what you'd see in anyone who began sleeping and eating better or if there is some mechanism that's actually fixing the brain. I mean, we see people here all the time who talk about how transformative it is when they begin a healthy lifestyle, or begin supplements when they're deficient in something. 

 

I think that is part of the point: to include all parts of a healthy lifestyle. So that part is good news. We can all safely incorporate those parts into our daily lives without negative side effects. 

 

Also, if you google the People's Pharmacy show when he was on, he goes into some more detail of other things they do. They do a lot of blood testing and intervene to get people's levels to "optimal" not just "normal" for each of the things they test, like C-reactive protein, blood glucose, Vit B 12, etc. 

[Laurie4b]

Scientifically, wouldn't the correct methodology be to construct a study to Disprove his hypothesis?

 

look for Alz patients with a history of great lifestyle choices (per the researcher). Or non Alz aged persons who had decades of poor health choices. In large numbers.

 

Depending on the results it could support the researcher's request to conduct a larger study or dismiss the issue.

 

There is already a significant body of correlational research: exercise, Mediterranean diet, MIND diet,  social connectedness, high level of education, complex job, continued mental stimulation are all correlated with lower incidence of Alz. However, some people with these factors still get it. 

 

Thyroid disease, low Vit D, poor diet, no exercise, etc. are all associated with an increase in Alz. 

 

HIs study goes beyond a "healthy lifestyle" to other factors as well--stuff you would only know from bloodwork.

 

However, his longterm goal is to use this protocol as a baseline and test drugs on top of that. 

[Mergath]

Scientifically, wouldn't the correct methodology be to construct a study to Disprove his hypothesis?

 

look for Alz patients with a history of great lifestyle choices (per the researcher). Or non Alz aged persons who had decades of poor health choices. In large numbers.

 

Depending on the results it could support the researcher's request to conduct a larger study or dismiss the issue.

 

That describes my family in a lot of ways, actually. My aunt, for example, has always been slender and in good physical shape, healthy vegetarian diet for years, got plenty of exercise thanks to a job as a hotel maid for most of her adult life.  And now she has such severe Alzheimer's she barely recognizes family members. :( My grandfather who died of Alzheimer's was the same way. He was always active and outdoorsy, in great shape, rode his bike everywhere, ate healthy foods that he and my grandmother grew in their garden, went to bed early every night. And my mom is an absolute health nut. Gluten/grain/sugar/dairy free, everything organic, lots of supplements and tons of exercise. She's starting to have the same early symptoms as my grandfather did.

 

Obviously three people don't disprove this guy's theory, but the kind of Alzheimer's that we get in my family doesn't seem to be affected much by a healthy lifestyle. 

[Sunshine State Sue]

 I listened to the People's Pharmacy recording when Bredesen was on. He said that he did do blood testing to determine people's levels of various substances in their blood such as Vit D, Vit B12, homocystine, etc. The supplements were not given willy-nilly, but were individualized. One important point is that he was looking to move the values to the optimal level, not just within the accepted normal level. 

 

I've listened to 45/58min of the People's Pharmacy program.  Here's one thing I don't understand.  He talks about figuring out the WHY of Alzheimer's and checking Vit D, Vit B12, homocystine, thyroid, etc.  But, if these things are not at "optimum" values, he supplements.  I want to know WHY they are not at optimum values.  Of course, cynical me says he would say it's due to aging.  IME, doctors pick a cause you can't do a darn thing about.

 

That said, I'm totally intrigued.  I like the idea of functional medicine ever since I read one of Mark Hyman's books.  The one doc I visited who had a functional medicine certification really wasn't well versed.

 

Sorry I'm no help with your original question.  I don't know anyone IRL who cares a bit about this kind of stuff, and I long for discussion on the topic.

 

[Sunshine State Sue]

That describes my family in a lot of ways, actually. My aunt, for example, has always been slender and in good physical shape, healthy vegetarian diet for years, got plenty of exercise thanks to a job as a hotel maid for most of her adult life.  And now she has such severe Alzheimer's she barely recognizes family members. :( My grandfather who died of Alzheimer's was the same way. He was always active and outdoorsy, in great shape, rode his bike everywhere, ate healthy foods that he and my grandmother grew in their garden, went to bed early every night. And my mom is an absolute health nut. Gluten/grain/sugar/dairy free, everything organic, lots of supplements and tons of exercise. She's starting to have the same early symptoms as my grandfather did.

 

Obviously three people don't disprove this guy's theory, but the kind of Alzheimer's that we get in my family doesn't seem to be affected much by a healthy lifestyle. 

Eek!  I do try to have a healthy lifestyle.  And I wonder if it will help me have a long miserable life instead of a short miserable life.  :crying:

[Pawz4me]

I've listened to 45/58min of the People's Pharmacy program.  Here's one thing I don't understand.  He talks about figuring out the WHY of Alzheimer's and checking Vit D, Vit B12, homocystine, thyroid, etc.  But, if these things are not at "optimum" values, he supplements.  I want to know WHY they are not at optimum values.  Of course, cynical me says he would say it's due to aging.  IME, doctors pick a cause you can't do a darn thing about.

 

That said, I'm totally intrigued.  I like the idea of functional medicine ever since I read one of Mark Hyman's books.  The one doc I visited who had a functional medicine certification really wasn't well versed.

 

Sorry I'm no help with your original question.  I don't know anyone IRL who cares a bit about this kind of stuff, and I long for discussion on the topic.

 

 

 

I believe that statistically most thyroid issues are due to auto-immune diseases (Hashimoto's and Graves' diseases).

[Soror]

Listening along. In dh's father's family there is a strong line of Alzheimers, his grandma and all her siblings had it. It seems it is likely like many things, there are multiple causes, some of which are genetic. I worry about my own husband and his father. Interesting about vit D, I know right now dh's D levels are crazy low, not sure as to the cause

[Laurie4b]

Eek!  I do try to have a healthy lifestyle.  And I wonder if it will help me have a long miserable life instead of a short miserable life.  :crying:

 

The epidemiological studies show correlations for groups  of people and associations with certain activities and certain outcomes. No correlational study can be applied to individuals. However, you are placing your bet on the better chance for a good outcome when you choose the healthier option, even when there are no guarantees. Heart health is correlated with lower incidence of Alz, for instance. The two seem to run together. It could be because of a common underlying factor.... or because of healthy choices. 

 

People with the APOe-4 gene are most likely to develop Alz and if you are homogenous for it, that is not good news. But people who have one copy of it might have their healthy choices better affect their outcomes. 

 

Also, in my family, for instance, I have wondered about exposure to chemicals used in farming. If one had a predisposition and then got exposed to various chemicals (my GF used to come home covered in arsenic from spraying the peach trees according to my dad, for instance), perhaps what looks genetic in a family might actually be genetic susceptibility combined with environmental triggers, since family members will have highly overlapping exposures.