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OT: more odd studies/vitamin D/flu

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Posted 1/22/2018 6:30 PM (GMT -5)
I guess there is just something about the world of studies I will never understand. And I continue in frustration, and wondering "why don't you tell us something we really want to know, something really useful? You know, while you are already there with the people and the vitamin?". I suppose they must find it useful to them.

Not real long ago I started a thread titled something like: "Are studies sometimes designed to fail?". It was a Canadian study looking at children given vitamin D for colds. But was there a placebo? Or even a control group who were given nothing? A historical group to compare to, like the typical rates of colds when no one is given Vit D? Oh heck no, your 2 choices were very young kids given either 400 IU(pretty big dose for a 30lb kid) or 2000. And the headline was something like "2000 vit D shows no dif for colds in children". And you had to dig to find what should have been the headline IMO: Flu rates cut in half!

Well, here is yet another one. Once again, no placebo. No historical group to compare with. Just less vitamin D vs more vitamin D. confused Do these people just not want to know? Or do they not want us to know? Or is it that the fact that vitamin D protects against flu so well established that they think it would be unethical to not give vitamin D to a group? What is the reason for no placebo or at least a zero group?

So once again 400 IU is given, but this time to 200 INFANTS, vs 200 infants given 1200! shocked ( that would be about the same as 24,000 IU per day for a 200 lb adult! ) But yet once again, we do not know if there was any benefit against flu with 400 IU, but whatever the benefit may or may not have been, the bigger dose cut the incidence in half compared to the lower dose. ( same as the other crazy study) But at least this time the study was looking at flu and the conclusion is "High-dose vitamin D (1200 IU) is suitable for the prevention of seasonal influenza as evidenced by rapid relief from symptoms, rapid decrease in viral loads, and disease recovery. In addition, high-dose vitamin D is probably safe for infants.". (I had to dig the flu benefit out of the other study, it was not part of the headline).

On the bright side, that is now 2 randomized control studies(just no placebo! ), that BOTH show that the higher dose has 1/2 the flu incidence compared to the lower dose.(I can't help but thnk that probably, the lower dose already had some benefit compared to zero, but they didn't bother to tell us) I guess we would call that 50% effective, compared to the 10% effectiveness of this years flu shot. But I dare say that 90% of our doctors, while pounding the table for the flu shot, have not even mentioned to us that we should be taking a pretty high dose of Vitamin D if we REALLY want to cut our odds of getting the flu, and also reduce the severity and lessen the symptoms and speed the recovery if we do get it. Also, has anyone heard any of this on the news? I have not heard a word. But I often hear when the the results are useless. How odd.

Well, no doubt, now that there have been 2 randomized studies with similar very strong results, we can expect our doctors to suggest that we might want to take a pretty good dose of Vitamin d during flu season, to go along with our 10% effective flu shots! Right? Or probably not! I continue to dream that someday someone will do a placebo study.

/www.ncbi.nlm.nih.gov/pubmed/29315160

Somebody said...
Preventive Effects of Vitamin D on Seasonal Influenza A in Infants: A Multicenter, Randomized, open, Controlled Clinical Trial.
Zhou J1, Du J1, Huang L2, Wang Y3, Shi Y3, Lin H2.
Author information

1
Department Of Pediatrics, The First People's Hospital Of Yongkang, China.
2
Department Of Pediatrics, The Second Affiliated Hospital And Yuying Children's Hospital Of Wenzhou Medical University, Wenzhou, China.
3
Department Of Pediatrics, Jinhua People's Hospital, Jinhua, China.

Abstract
OBJECTIVES:

This study aimed to evaluate the clinical efficacy and safety of vitamin D for preventing influenza A in 400 infants in a multicenter, randomized, open, controlled clinical trial.
METHODS:

The infants were randomized into low-dose and high-dose vitamin D groups, and serum calcium, inorganic phosphorus and 25-hydroxyvitamin D levels were detected thrice in 4 months. Infants infected with influenza A were monitored for symptoms including fever, cough, and wheezing. Pathogen levels and safety of vitamin D treatment were also evaluated.
RESULTS:

Of 121 cases in total, 78 and 43 cases of influenza A infection occurred in the low-dose and high-dose vitamin D groups, respectively. There was a significant difference between the groups (χ = 14.6324, P = 0.0001). Among the cases of influenza infection, the median durations for fever, cough, and wheezing were shorter in the high-dose vitamin D group than in the low-dose vitamin D group. The viral loads showed a downward trend in both groups, and were significantly different between the groups at the second and third detections. Additionally, the incidences of adverse events and severe adverse events were very low and not significantly different between the two groups.
CONCLUSION:

High-dose vitamin D (1200 IU) is suitable for the prevention of seasonal influenza as evidenced by rapid relief from symptoms, rapid decrease in viral loads, and disease recovery. In addition, high-dose vitamin D is probably safe for infants



An article from Vit D Council about this study(remember, this years flu shot has been almost of no benefit, maybe 10% or so effective):

/www.vitamindcouncil.org/open-label-trial-discovers-1200-iuday-more-effective-than-400-iuday-in-managing-influenza-in-infants/

Somebody said...
Additionally, because immunity is slowly but gradually strengthening, the influenza vaccine is not approved for infants under six months of age.

So, if the flu vaccine is not an option, or not protective enough for an immunocompromised individual, what can be done to prevent or manage this virus in infants? The CDC is currently recommending frequent handwashing and avoiding contact with infected individuals. Although less well known, vitamin D may offer a possible prevention and management tactic as well. Past research suggests that vitamin D reduces the risk of the cold and flu. Therefore, a recent RCT evaluated the effect of vitamin D supplementation on management of influenza among infants.

The researchers included a total of 400 infants between 3 and 12 months of age who did not have influenza, nor did they develop influenza within one month of the study. Additionally, the participants did not show any evidence of heart, liver or kidney dysfunction.

The infants were randomly assigned to one of two groups: 200 infants received 400 IU vitamin D drops daily for four months, while the other 200 received 1,200 IU vitamin D drops daily for four months. At baseline and every two months, serum vitamin D and calcium levels were measured in all participants. Infants who were diagnosed with influenza were treated accordingly.

This is what the researchers found:

Of 121 cases in total, 78 and 43 cases of influenza A infection occurred in the 400 IU/day and 1200 IU/day vitamin D groups, respectively (p = 0.0001)
In the cases of influenza, fever duration was shorter in the higher dose vitamin D group than in the low dose vitamin D group (p = 0.0161).
Coughing duration of those with influenza was shorter in the higher dose group compared to the low dose group (p < 0.0001).
Wheezing duration was shorter in the higher dose vitamin D group compared to the low dose group (p = 0.0018).
Four infants showed signs of potential toxicity, but after analysis, this was due to gastrointestinal infection, not vitamin D supplementation.

The researchers concluded:

“Notably, the viral loads of influenza A in infants in the high-dose vitamin D group decreased more rapidly compared to those of infants in the low-dose vitamin D.”

They continued,

“These results suggested that high-dose vitamin D treatment exerted an antiviral effect to promote recovery.”

Post Edited (BillyBob@388) : 1/23/2018 8:17:16 AM (GMT-7)

Posted 1/23/2018 10:10 AM (GMT -5)
The reason I titled this "more odd studies" is because it seems odd to me that researchers go to all the trouble and expense to do a clinical and randomized trial, but leave out a crucial element like placebo. But maybe I'm ignorant about the reasons why. What could be a good reason why they would not bother with a placebo? Or, even good enough for me, if that had as part of the randomized groups an equal number who did not actually get a placebo(fake vitamin pill) but simply got nothing. And who were not told the reason they were being followed, only that they wanted to check them periodically? Or how about just supplying #s for the local population, which would include people who took the vitamin themselves and many who didn't? ( Or I don't know, in the case of the Chinese children, maybe very few would take it? )

Now for me personally, this sort of dose related response, in 2 different randomized clinical studies, is good enough for me until I see evidence to the contrary. Of especially good news is that, despite an absolutely enormous dose compared to the weight of these patients(infants), they observed no significant side effects. But though I think this is useful information, and am left to wonder if the improvement was even much more than 50%, because the lower dose had already improved things by some amount, I can see where someone might claim something else. Like: Hey, no placebo! So, how do you KNOW that the lower dose of vitamin D did not actually increase the flu rate and cause worse symptoms, which the higher dose only brought back towards normal, thus bottom line no actual improvement and even harm unless the dose was just right? Without the placebo, you don't really know anything.

And, true enough. As it is, all we really know for certain is that in 2 different clinical trials in 2 different countries, a really high dose of vitamin D cut the numbers of flu cases in half, and cut the severity of symptoms when they did get flu, compared to the benefit- if any, - that lower dose vitamin D had. But it sure would be nice to know what effect- if any, and if not actually harmful- the lower dose had. Another opportunity missed. I do not understand researchers, obviously. Having been in on a few clinical trials myself during my career, I have to say we never left out a control group who either had placebo or at least had zero dose of the drug in question.

Post Edited (BillyBob@388) : 1/23/2018 8:15:02 AM (GMT-7)

Posted 1/23/2018 10:44 AM (GMT -5)
As you know, the placebo effect is pretty strong and, supposedly, has been getting stronger. I recall one article that had 1/3 of patients getting better with placebos over a number of conditions. So, you are correct, in order to demonstrate that is the medicine rather than the mind that is causing improvement, it's important to include a placebo arm.

On the other hand, I can see room for early studies and, certainly, observational studies, that are done without a placebo. If the treatment arm does no better than the untreated, or does worse, you know that it's probably worse than useless, it even lacks placebo power. And if you want to maximize the chance of publication or continued funding, and can get away with it, why use a placebo?

Which brings the thought of, why not market sugar pills and sell them as wonder drugs, betting on the placebo effect? Oh, right, that's been done forever. And if they should be labeled as placebos, then they lose the placebo effect. The mind is a wonderful thing,
Posted 1/23/2018 12:39 PM (GMT -5)

reachout said...
As you know, the placebo effect is pretty strong and, supposedly, has been getting stronger. I recall one article that had 1/3 of patients getting better with placebos over a number of conditions. So, you are correct, in order to demonstrate that is the medicine rather than the mind that is causing improvement, it's important to include a placebo arm.

On the other hand, I can see room for early studies and, certainly, observational studies, that are done without a placebo. If the treatment arm does no better than the untreated, or does worse, you know that it's probably worse than useless, it even lacks placebo power. And if you want to maximize the chance of publication or continued funding, and can get away with it, why use a placebo?

Which brings the thought of, why not market sugar pills and sell them as wonder drugs, betting on the placebo effect? Oh, right, that's been done forever. And if they should be labeled as placebos, then they lose the placebo effect. The mind is a wonderful thing,

Thanks for your thoughts, Reachout!

Yes, the placebo effect is strong. All the more reason to have a placebo. Or at least, if there was some extra expense or difficulty involved with administering a fake pill, then why not at least have a group who is given nothing by the researchers, and simply told by them that they wish to keep an eye on them strictly for research purposes? But telling them nothing about what they were looking for? That seems to me it would come close to a placebo group. Why would they not do this, as two recent studies have done? It baffles me.

However, a thought has just occurred to me. Is it possible that for both the Canadian research on young children referred to in my previous thread, and this study on Chinese infants, the smaller dose of vitamin D is considered placebo? Maybe they are assuming the 400 IU ( in both studies) is not going to do anything, thus if any benefits did show up, it would be due to placebo? That seems like a heck of an assumption to me, but it is possible I suppose. So, if the large dose group sees an significant improvement (as both groups did regarding flu), they are considering this as the equivalent as a large improvement over placebo?

And it does make sense, it seems that probably if there was a large improvement with 1200 IU vs 400, that it is indeed the extra vitamin D that is providing the improvement. The 400 IU vitamin D should provide all of the placebo effect they need. The authors seem to think so.

But that(using the 400 dose as placebo) still leaves 2 possible scenarios as a needless mystery:
1: Seems reasonable to me to ask: did the 400 already provide a benefit which was made even better by the larger dose? Did the lower dose of vitamin D also had a helpful effect compared to either a placebo group or simply a zero group? If that is the case, then most likely the larger dose's 50% improvement in flu rates and severity is actually a good bit better than 50%, if compared to zero or placebo. For ex, say if 400 IU gave a 20% improvement compared to zero or placebo, so out of 100 patients in the zero group who got flu, only 80 in the 400 IU group got flu. But if the large dose improved that by another 50%, only 40 get the flu. Which is now total flu cut by 60% compared to zero, rather than 50. Or something like that, more or less. Or

2: Seems unreasonable to me, but you never know: The small dose actually made things worse, and the larger dose's apparent great effect was actually only bringing things back down to the rates for the group that gets nothing. Seems very unlikely, but if they were considering the small dose as the placebo, this later possibility can not be ruled out with total confidence. All of which leaves me baffled as to why researchers would choose to make such a choice. Does any one have a good explanation? How would it be to their benefit?

Post Edited (BillyBob@388) : 1/25/2018 11:57:02 AM (GMT-7)

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