Let’s take a couple of minutes and make sure that we know why we can allow ourselves to be impressed by the results of the Q-SYMBIO clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More (1), the KiSel-10 clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More (2), and the Morisco clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More (3).
The design of those clinical trials is the reason that we can trust the results.
All three of those CoQ10 trials were designed as randomized placebo-controlled double-blindA double-blind study is a study in which neither the investigators nor the study participants know which participants are receiving the active treatment and which participants are receiving the control treatment until the study has been completed and the seal on the code has been broken. More studies. Intervention trials of this sort, with a placebo group as a control group, are the gold standard of bio-medical research.
What do we mean when we say randomized, placebo-controlled, and double-blindA double-blind study is a study in which neither the investigators nor the study participants know which participants are receiving the active treatment and which participants are receiving the control treatment until the study has been completed and the seal on the code has been broken. More?
Two basic types of research
Basically, there are two types of bio-medical research: observational studies and experimental studies. The best (and most expensive) bio-medical studies are experimental studies in which participants in a treatment group (also called an intervention group) receive tablets or capsules containing the active ingredient that is being tested for safety or efficacy while participants in another group, called the control group, receive a placebo tablet or capsule that is as close as possible to the real thing in appearance, smell, and taste.
Randomization in studies of Q10
To avoid distortion of the trial results through selection bias or confounding bias, researchers randomly administer the active substance or the placebo substance to each one of the participants enrolled in the trial.
The theory is that, with a large enough sample and with random assignment, researchers will have formed a treatment group and a control group that are nearly identical with regard to all relevant parameters except for the taking of the active ingredient or the placebo ingredient.
If, then, at the end of the trial, there are differences in the results of the trial from one group to the other, the differences between the outcomes in the two groups are thought to be caused by the effect of the active ingredient.
Double blind studies involving Q10
Blinding of both the participants of the research and of the researchers themselves is done for the purpose of eliminating the possible effects of expectations on the part of the participants and on the part of the researchers.
No one knows, until the end of the trial when the code is unsealed, which participants were receiving which preparation, active or placebo. No one knows, in other words, who is in the active treatment group and who is in the placebo control group until the end of the trial.
Okay, yes, if the active ingredient, the CoQ10, is so effective that the trial participants who are getting it are looking stronger and more cheerful when they come in for check-ups and blood tests, then, of course, the researcher may think to himself that this participant is getting the CoQ10, but he won’t know for sure.
Proper Q10 clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More design
If the clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More is designed properly, we can assume that the trial has “internal validity,” that is to say, we can assume that the trial is, in fact, testing what we think that it is testing. In our case, we can assume that the researchers really were testing the efficacy of the Myoqinon/Bio-Quinone Q10 100 formulation used in the trials.
Given the solid design of the research, we think that the Q-SYMBIO trial and the KiSel-10 trial have yielded the results that they have because of the effect of the Pharma Nord preparation and not because of some other unaccounted for variable.
There is also something called “external validity,” which addresses the question of just how far the results of a clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More can be generalized to a broader community. For example, can results from male participants be generalized to females? Can results from one specific ethnic or racial group or from one specific age group be generalized to other groups? Researchers must be careful not to generalize too much.
Replications of Q10 heart failureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More trials
And, of course, we need replications of clinical trials to re-assure ourselves that the improvement in the condition of heart failureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More patients that we see does, in fact, occur again and again when the treatment with Q10 is given under similar circumstances.
Developing the rationale for the Q-SYMBIO studyQ-Symbio is the abbreviated name for the two-year multi-center, randomized, double-blind, placebo-controlled study of Coenzyme Q10 supplements as an adjunct treatment of chronic heart failure patients. The name reflects the focus of the study on the SYMptoms, BIomarker status (BNP), and long-term Outcomes (hospitalizations and mortality) of the supplementation. The data from the Q-Symbio study show that long-term supplementation with... More
In 2003, already, to develop a rationale for the multinational Q-SYMBIO clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More, Dr. Svend Aage Mortensen, a cardiologist at the Heart Centre at the Copenhagen University Hospital and the lead researcher in the Q-SYMBIO clinical trialClinical trials are research studies in which various treatments, interventions, or tests are investigated for their safety and efficacy when used to detect, prevent, or treat diseases and medical conditions in patients and healthy volunteers. The gold standard for clinical trials are randomized, double-blind, placebo-controlled studies. More, did a survey of published clinical trials testing the use of Q10 with heart failureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More patients.
Solid rationale for the Q-SYMBIO studyQ-Symbio is the abbreviated name for the two-year multi-center, randomized, double-blind, placebo-controlled study of Coenzyme Q10 supplements as an adjunct treatment of chronic heart failure patients. The name reflects the focus of the study on the SYMptoms, BIomarker status (BNP), and long-term Outcomes (hospitalizations and mortality) of the supplementation. The data from the Q-Symbio study show that long-term supplementation with... More
Dr.Mortensen found that, already to that point, researchers had conducted several double-blindA double-blind study is a study in which neither the investigators nor the study participants know which participants are receiving the active treatment and which participants are receiving the control treatment until the study has been completed and the seal on the code has been broken. More placebo-controlled trials focusing on Q10 treatment for heart failureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More. The results in 10 out of 13 clinical trials, enrolling more than 1000 patients, had been positive and had shown statistically significantThe outcome of a clinical trial is thought to have statistical significance, or to be statistically significant, if the outcome is likely not caused by chance at a given statistical significance level, typically at the 0.05 level. Statistically significant outcomes may or may not be clinically significant. More improvement in New York Heart AssociationSee NYHA More class, in exercise capacity, and in reductions in the number of readmissions to the hospital. The outcomes in just 3 out of the 13 double-blindA double-blind study is a study in which neither the investigators nor the study participants know which participants are receiving the active treatment and which participants are receiving the control treatment until the study has been completed and the seal on the code has been broken. More studies – equal to about 10% of the total number of patients treated with Q10—had been neutral.
Q10 in heart failureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More — statistically significantThe outcome of a clinical trial is thought to have statistical significance, or to be statistically significant, if the outcome is likely not caused by chance at a given statistical significance level, typically at the 0.05 level. Statistically significant outcomes may or may not be clinically significant. More outcomes
If we are going to do a gold standard study, then we must have a placebo control group to compare with, we must have randomized assignment of patients to the placebo group and to the treatment groups, and we must have both the researchers and the patients kept blind to who is and who is not getting the active ingredient.
You may ask, well, how do the researchers know that the results are not just the results of chance? How do they know whether the results are statistically significantThe outcome of a clinical trial is thought to have statistical significance, or to be statistically significant, if the outcome is likely not caused by chance at a given statistical significance level, typically at the 0.05 level. Statistically significant outcomes may or may not be clinically significant. More? I am going to address those questions in a separate article called Coenzyme Q10Coenzyme Q10 molecules are fat-soluble molecules that are both synthesized in the body and ingested in the diet and in supplements. Coenzyme Q10 is synthesized in the body in the same biological pathway as cholesterol. Bio-synthesis of Coenzyme Q10 begins to decline once humans reach their adult years. The reduced production of Coenzyme Q10 cannot be compensated in any practical... More and p-values and confidence intervals. And, then too, we might want to think about instances in which the results of a study might not make it over the line to be called statistically significantThe outcome of a clinical trial is thought to have statistical significance, or to be statistically significant, if the outcome is likely not caused by chance at a given statistical significance level, typically at the 0.05 level. Statistically significant outcomes may or may not be clinically significant. More but nonetheless seem to be clinically significantThe outcome of a clinical trial is thought to have statistical significance, or to be statistically significant, if the outcome is likely not caused by chance at a given statistical significance level, typically at the 0.05 level. Statistically significant outcomes may or may not be clinically significant. More.
Sources:
- Mortensen SA, Rosenfeldt F, Kumar A, et al. The Effect of Coenzyme Q10Coenzyme Q10 molecules are fat-soluble molecules that are both synthesized in the body and ingested in the diet and in supplements. Coenzyme Q10 is synthesized in the body in the same biological pathway as cholesterol. Bio-synthesis of Coenzyme Q10 begins to decline once humans reach their adult years. The reduced production of Coenzyme Q10 cannot be compensated in any practical... More on Morbidity and Mortality in Chronic Heart FailureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More: Results From Q-SYMBIO: A Randomized Double-BlindA double-blind study is a study in which neither the investigators nor the study participants know which participants are receiving the active treatment and which participants are receiving the control treatment until the study has been completed and the seal on the code has been broken. More Trial. JCHF. 2014;():. doi:10.1016/j.jchf.2014.06.008.
- Alehagen, U., Johansson, P., Björnstedt, M., Rosén, A., & Dahlström, U. (2013). Cardiovascular mortality and N-terminal-proBNP reduced after combined seleniumSelenium (symbol Se, atomic number 34) is a trace element that is an essential nutrient and an essential component of some of the most important antioxidants in the body, in particular the selenoproteins glutathione peroxidase, thioredoxin reductase, and selenoprotein P. Selenium is involved in the optimal functioning of the immune system. Professor Alehagen has pointed out that there exists a... More and coenzyme Q10Coenzyme Q10 molecules are fat-soluble molecules that are both synthesized in the body and ingested in the diet and in supplements. Coenzyme Q10 is synthesized in the body in the same biological pathway as cholesterol. Bio-synthesis of Coenzyme Q10 begins to decline once humans reach their adult years. The reduced production of Coenzyme Q10 cannot be compensated in any practical... More supplementation: a 5-year prospective randomized double-blindA double-blind study is a study in which neither the investigators nor the study participants know which participants are receiving the active treatment and which participants are receiving the control treatment until the study has been completed and the seal on the code has been broken. More placebo-controlled trial among elderly Swedish citizens. International Journal Of Cardiology, 167(5), 1860-1866. doi:10.1016/j.ijcard.2012.04.156
- Morisco, C., Trimarco, B., & Condorelli, M. (1993). Effect of coenzyme Q10Coenzyme Q10 molecules are fat-soluble molecules that are both synthesized in the body and ingested in the diet and in supplements. Coenzyme Q10 is synthesized in the body in the same biological pathway as cholesterol. Bio-synthesis of Coenzyme Q10 begins to decline once humans reach their adult years. The reduced production of Coenzyme Q10 cannot be compensated in any practical... More therapy in patients with congestive heart failureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More: a long-term multicenter randomized study. The Clinical Investigator, 71(8 Suppl), S134-S136.
- Mortensen, S. A. (2003). Overview on coenzyme Q10Coenzyme Q10 molecules are fat-soluble molecules that are both synthesized in the body and ingested in the diet and in supplements. Coenzyme Q10 is synthesized in the body in the same biological pathway as cholesterol. Bio-synthesis of Coenzyme Q10 begins to decline once humans reach their adult years. The reduced production of Coenzyme Q10 cannot be compensated in any practical... More as adjunctive therapy in chronic heart failureThe Mayo Clinic defines heart failure, also known as congestive heart failure and/or chronic heart failure, as the failure of the heart muscle to pump blood to the body adequately. In other words, heart failure is not a heart attack, and it is not death from heart disease, which its name might seem to imply. Heart failure is a condition... More. Rationale, design and end-points of “Q-symbio”–a multinational trial. Biofactors (Oxford, England), 18(1-4), 79-89.
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