You wrote to me to suggest that supplements work…. but this highlights a problem for nutriceutical studies.
There is no patent protection to be had and so pharmaceutical companies are not willing to spend big bucks to do a study where anyone can come along and sell the product without any outlay for drug development.
So someone says let’s do a prevention study with supplement X….we hear about it all the time, but it is a small study done over a short time because it lacks financing. The trials give an iffy result but is an heroic failure and this gets done over and over again as there is enough info to allow a positive spin to be made.
But this study is different it is massive and done over 5 years and a prevention study to look at supplementation to stop autoimmunity. What does it find?
Well the paraphrased conclusions are “Vitamin D supplementation for five years, with or without omega 3 fatty acids, reduced autoimmune disease…..Both treatment arms showed larger effects than the reference arm (vitamin D placebo and omega 3 fatty acid placebo)”.
The media then say “Vitamin D supplements with or without Omega-3s decreased risk of autoimmune diseases”
Great we say and I have to say wow this study has over 25,000 participants over 5 years which is a long time to study if vitaminD and omega 3 supplementation stop autoimmunity. Now the glass half-empty person say “Has the magical statistical significance of P<0.05 been reached to suggest that results are not due to chance?” The answer should be…….NO. But that is not the interpretation given.
The answer is too tight to call, so I would say do it again or carry on to ten years as there was no difference for the first three years Maybe 5 years is not long enough . Maybe the dose was wrong, and I suspect the study population was wrong as this was done in adults and I am guessing looking at chldren may have been more fritful
But will they do it again?. I suspect not. People will look at the take home message that supplementation works after all P=O.O5 and the confidence interval does not cross one it is 0.99 after all. But Omega-3 (fish oils) fails to meet the statistical hurdle and theorectically should “bite the dust” as a single therapy in adults. I will keep taking my supplements in the belief they are useful but incremental
But, you have a trial of 25,000 people over 5 years and you got a p=0.05 with vitamin D supplementation, but if this happened for a pharmaceutical you probably would not be making it a best seller. Now a glass half-full person will take the positives from this, but it should warn you that if neutriceuticals work they are probably going to have an incremental effect.
My mantra: Low-side effect, expect low efficacy
Now this is not a treatment study, it is a prevention study and also it is not an MS study. The authors need to be congratulated but it shows the prevention road is not going to be quick and it is not going to be easy.
What if you looked at vitamin D and EBV inhibition?
Hahn et al. Vitamin D and marine omega 3 fatty acid supplementation and incident autoimmune disease: VITAL randomized controlled trial
Objective To investigate whether vitamin D and marine derived long chain omega 3 fatty acids reduce autoimmune disease risk. Design Vitamin D and omega 3 trial (VITAL), a nationwide, randomized, double blind, placebo controlled trial with a two-by-two factorial design. Participants 25 871 participants, consisting of 12 786 men ≥50 years and 13 085 women ≥55 years at enrollment. Interventions Vitamin D (2000 IU/day) or matched placebo, and omega 3 fatty acids (1000 mg/day) or matched placebo. Participants self-reported all incident autoimmune diseases from baseline to a median of 5.3 years of follow-up; these diseases were confirmed by extensive medical record review. Cox proportional hazard models were used to test the effects of vitamin D and omega 3 fatty acids on autoimmune disease incidence. Main outcome measures The primary endpoint was all incident autoimmune diseases confirmed by medical record review: rheumatoid arthritis, polymyalgia rheumatica, autoimmune thyroid disease, psoriasis, and all others. Results 25 871 participants were enrolled and followed for a median of 5.3 years. 18 046 self-identified as non-Hispanic white, 5106 as black, and 2152 as other racial and ethnic groups. The mean age was 67.1 years. For the vitamin D arm, 123 participants in the treatment group and 155 in the placebo group had a confirmed autoimmune disease (hazard ratio 0.78, 95% confidence interval 0.61 to 0.99, P=0.05). In the omega 3 fatty acids arm, 130 participants in the treatment group and 148 in the placebo group had a confirmed autoimmune disease (0.85, 0.67 to 1.08, P=0.19). Compared with the reference arm (vitamin D placebo and omega 3 fatty acid placebo; 88 with confirmed autoimmune disease), 63 participants who received vitamin D and omega 3 fatty acids (0.69, 0.49 to 0.96), 60 who received only vitamin D (0.68, 0.48 to 0.94), and 67 who received only omega 3 fatty acids (0.74, 0.54 to 1.03) had confirmed autoimmune disease.
Conclusions Vitamin D supplementation for five years, with or without omega 3 fatty acids, reduced autoimmune disease by 22%, while omega 3 fatty acid supplementation with or without vitamin D reduced the autoimmune disease rate by 15% (not statistically significant). Both treatment arms showed larger effects than the reference arm (vitamin D placebo and omega 3 fatty acid placebo).