About the studies of IQoro
Do you conduct your own studies?
No, we do not conduct our own studies.
The research on the results of training with IQoro is carried out by research teams with different professions in surgery, ear, nose and throat, speech pathology, medicine, specialist dentists, nurses, gastrointestinal and X-ray specialists at Swedish universities in Uppsala, Umeå, Linköping, Örebro and Karlstad.
Funding comes from the Swedish state and has been approved by an ethics committee.
All 17 studies on training with IQoro are internationally published and peer reviewed according to the standard practice for scientific studies.
Why don’t you have any control groups?
First, it is important to point out that these are not our own studies. The studies have been carried out by researchers at Swedish universities.
There are various reasons why the studies on training with IQoro do not have any control groups.
- There are no similar treatments to make comparisons with, so it is not possible to have one group train with IQoro and one group with another neuromuscular device.
- It is not ethically justifiable to allow a group of patients to stop taking their acid-suppressing medication during treatment with IQoro.
- It is also not ethically justifiable to allow a control group with symptoms of hiatus hernia to receive treatment that it is not certain will have a positive effect on their symptoms.
However, patients act as their own control group. The participants in the studies have consistently sought care and have had problems for at least one, and an average of four years. During that time, the participants have only received traditional treatment with acid-suppressing medications, but nevertheless have not improved. Only then have they been allowed to participate in the studies, allowing the researchers to see if and how the patient’s symptoms develop during the study.
The researchers also compared different groups of participants with each other. The results between these groups do not differ. All individual studies also show consistent positive results.
What is a control group?
A control group is a group of individuals that are included in a scientific study as a comparison. They are included in order to compare the experimental group with another group and thus be able to see if the results differ between the groups. For example, in a scientific study on medicinal products, the experimental group may receive effective medication, while the control group receives tablets without an effective substance, a placebo.
What does statistically significant mean?
In statistical contexts, the word significant means that the results are so certain that one knows that they are not down to chance. Determined models and methods exist to be able to state that the risk of the result being due to random factors is so small that it is possible to draw certain scientific conclusions from a study.
Accepted statistical models
When we write that the participants in a study improved significantly through training with IQoro, this means that according to accepted statistical models, we can conclude that the improvement genuinely occurred because of the treatment and not for any other reason.
How statistical significance is achieved in a study varies. It depends, among other things, on the number of participants in the study and how clear the result is.
There are different requirements for different types of studies
The requirement for the level of statistical significance in a study may also vary.
It therefore takes more participants to achieve statistical significance for a medical study where one needs to be able to assess the risk of unusual side effects, than is required for a scientific study on IQoro, for example.
It is known that IQoro is a class 1 medical device that is risk-free to use. Therefore, studies can be done comparing the efficacy of IQoro on different groups that have fewer participants in the number than you need when, for example, developing a completely new vaccine.
Collaboration with statisticians
Statistical significance is calculated through statistical models. In the studies on training with IQoro, the number of participants has been developed in collaboration with a statistician to provide a sufficient basis to be able to state that the result depends on the treatment and not on chance.
Significance is often expressed in studies as p < 0.05 for example, which means that there is less than a five percent chance that the result is down to chance or p < 0.001 which means that there is less than one per thousand risk (0.1 %) that the result is down to chance.
More statistically significant studies make the results even safer
Since it is almost never possible to completely exclude chance in a single study, or that a study is influenced by factors in different ways that are difficult to assess, further research is important.
The results of the studies on training with IQoro are in line with each other and each achieve statistically significant results.
Aren’t more participants needed for the studies of IQoro?
The number of participants in the studies of IQoro has been determined together with a statistician for the data to be sufficient to state that the results are statistically significant, that is they are not down to chance.
This question is usually about the comparison with large drug studies where changes in the body are made by adding a drug, for example to reduce the production of stomach acid.
Changes in the body involve a high risk that must be carefully balanced against the benefit, which requires a significantly larger basis for capturing unusual side effects or placebo effects.
IQoro is a CE marked medical device product, class 1, low risk. With that come other requirements and regulations.