What is a Blinded Study?
- Binding, or masking, refers to withholding information regarding treatment allocation from one or more participants in a clinical research study, typically in randomized control trials.
- A blinded study prevents the participants from knowing about their treatment to avoid bias in the research. Any information that can influence the subjects is withheld until the completion of the research.
- Blinding can be imposed on any participant in an experiment, including researchers, data collectors, evaluators, technicians, and data analysts.
- Good blinding can eliminate experimental biases arising from the subjects’ expectations, observer bias, confirmation bias, researcher bias, observer’s effect on the participants, and other biases that may occur in a research test.
- Studies may use single-, double- or triple-blinding. A trial that is not blinded is called an open trial.
Double-Blind Studies
Double-blind studies are those in which neither the participants nor the experimenters know who is receiving a particular treatment.
Double blinding prevents bias in research results, specifically due to demand characteristics or the placebo effect.
Demand characteristics are subtle cues from researchers that can inform the participants of what the experimenter expects to find or how participants are expected to behave.
If participants know which group they are assigned to, they might change their behavior in a way that would influence the results. Similarly, if a researcher knows which group a participant is assigned to, they might act in a way that reveals the assignment or influences the results.
Double-blinding attempts to prevent these risks, ensuring that any difference(s) between the groups can be attributed to the treatment.
On the other hand, single-blind studies are those in which the experimenters are aware of which participants are receiving the treatment while the participants are unaware.
Single-blind studies are beneficial because they reduce the risk of errors due to subject expectations. However, single-blind studies do not prevent observer bias, confirmation bias, or bias due to demand characteristics.
Because the experiments are aware of which participants are receiving which treatments, they are more likely to reveal subtle clues that can accidentally influence the research outcome.
Double-blind studies are considered the gold standard in research because they help to control for experimental biases arising from the subjects’ expectations and experimenter biases that emerge when the researchers unknowingly influence how the subjects respond or how the data is collected.
Using the double-blind method improves the credibility and validity of a study.
Example Double-Blind Studies
Rostock and Huber (2014) used a randomized, placebo-controlled, double-blind study to investigate the immunological effects of mistletoe extract. However, their study showed that double-blinding is impossible when the investigated therapy has obvious side effects.
Using a double-blind study, Kobak et al. (2005) found that S t John’s wort (Hypericum perforatum) is not an efficacious treatment for anxiety disorder, specifically OCD.
Using the Yale–Brown Obsessive–Compulsive Scale (Y-BOCS), they found that the mean change with St John’s wort was not significantly different from the mean change found with placebo.
Cakir et al. (2014) conducted a randomized, controlled, and double-blind study to test the efficacy of therapeutic ultrasound for managing knee osteoarthritis.
They found that all assessment parameters significantly improved in all groups without a significant difference, suggesting that therapeutic ultrasound provided no additional benefit in improving pain and functions in addition to exercise training.
Using a randomized double-blind study, Papachristofilou et al. (2021) found that whole-lung LDRT failed to improve clinical outcomes in critically ill patients admitted to the intensive care unit requiring mechanical ventilation for COVID-19 pneumonia.
Double-Blinding Procedure
Double blinding is typically used in clinical research studies or clinical trials to test the safety and efficacy of various biomedical and behavioral interventions.
In such studies, researchers tend to use a placebo. A placebo is an inactive substance, typically a sugar pill, that is designed to look like the drug or treatment being tested but has no effect on the individual taking it.
The placebo pill was given to the participants who were randomly assigned to the control group. This group serves as a baseline to determine if exposure to the treatment had any significant effects.
Those randomly assigned to the experimental group are given the actual treatment in question. Data is collected from both groups and then compared to determine if the treatment had any impact on the dependent variable.
All participants in the study will take a pill or receive a treatment, but only some of them will receive the real treatment under investigation while the rest of the subjects will receive a placebo.
With double blinding, neither the participants nor the experimenters will have any idea who receives the real drug and who receives the placebo.
For Example
A common example of double-blinding is clinical studies that are conducted to test new drugs.
In these studies, researchers will use random assignment to allocate patients into one of three groups: the treatment/experimental group (which receives the drug), the placebo group (which receives an inactive substance that looks identical to the treatment but has no drug in it), and the control group (which receives no treatment).
Both participants and researchers are kept unaware of which participants are allocated to which of the three groups.
The effects of the drug are measured by recording any symptoms noticed in the patients.
Once the study is unblinded, and the researchers and participants are made aware of who is in which group, the data can be analyzed to determine whether the drug had effects that were not seen in the placebo or control group, but only in the experimental group.
Double-blind studies can also be beneficial in nonmedical interventions, such as psychotherapIes.
Advantages
Reduces risk of bias
Double-blinding can eliminate, or significantly reduce, both observer bias and participant biases.
Because both the researcher and the subjects are unaware of the treatment assignments, it is difficult for their expectations or behaviors to influence the study.
Results can be duplicated
The results of a double-blind study can be duplicated, enabling other researchers to follow the same processes, apply the same test item, and compare their results with the control group.
If the results are similar, then it adds more validity to the ability of a medication or treatment to provide benefits.
It tests for three groups
Double-blind studies usually involve three groups of subjects: the treatment group, the placebo group, and the control group.
The treatment and placebo groups are both given the test item, although the researcher does not know which group is getting real treatment or placebo treatment.
The control group doesn’t receive anything because it serves as the baseline against which the other two groups are compared.
This is an advantage because if subjects in the placebo group improved more than the subjects in the control group, then researchers can conclude that the treatment administered worked.
Applicable across multiple industries
Double-blind studies can be used across multiple industries, such as agriculture, biology, chemistry, engineering, and social sciences.
Double-blind studies are used primarily by the pharmaceutical industry because researchers can look directly at the impact of medications.
Disadvantages
Inability to blind
In some types of research, specifically therapeutic, the treatment cannot always be disguised from the participant or the experimenter. In these cases, you must rely on other methods to reduce bias.
Additionally, imposing blinding may be impossible or unethical for some studies.
Costly
Double-blinding can be expensive because the researcher has to examine all the possible variables and may have to use different groups to gather enough data.
Small Sample Size
Most double-blind studies are too small to provide a representative sample. To be effective, it is generally recommended that double-blind trials include around 100-300 participants.
Studies involving fewer than 30 participants generally can’t provide proof of a theory.
Negative Reaction to Placebo
In some instances, participants can have adverse reactions to the placebo, even producing unwanted side effects as if they were taking a real medication.
It doesn’t reflect real-life circumstances
When participants receive treatment or medication in a double-blind placebo study, each individual is told that the item in question might be real medication or a placebo.
This artificial situation does not represent real-life circumstances because when a patient receives a pill after going to the doctor in the real-world, they are told that the product is actual medicine intended to benefit them.
When situations don’t feel realistic to a participant, then the quality of the data can decrease exponentially.
FAQs
What is the difference between a single-blind, double-blind, and triple-blind study?
In a single-blind study, the experimenters are aware of which participants are receiving the treatment while the participants are unaware.
In a double-blind study, neither the patients nor the researchers know which study group the patients are in. In a triple-blind study, neither the patients, clinicians, nor the people carrying out the statistical analysis know which treatment the subjects had.
Is a double-blind study the same as a randomized clinical trial?
Yes, a double-blind study is a form of a randomized clinical trial in which neither the participants nor the researcher know if a subject is receiving the experimental treatment, a standard treatment, or a placebo.
Are double-blind studies ethical?
Double blinding is ethical only if it serves a scientific purpose. In most circumstances, it is unethical to conduct a double-blind placebo controlled trial where standard therapy exists.
What is the purpose of randomization using double blinding?
Randomization with blinding avoids reporting bias, since no one knows who is being treated and who is not, and thus all treatment groups should be treated the same. This reduces the influence of confounding variables and improves the reliability of clinical trial results.
Why are double-blind experiments considered the gold standard?
Randomized double-blind placebo control studies are considered the “gold standard” of epidemiologic studies as they provide the strongest possible evidence of causality.
Additionally, because neither the participants nor the researchers know who has received what treatment, double-blind studies minimize the placebo effect and significantly reduce bias.
Can blinding be used in qualitative studies?
Yes, blinding is used in qualitative studies.
References
Cakir, S., Hepguler, S., Ozturk, C., Korkmaz, M., Isleten, B., & Atamaz, F. C. (2014). Efficacy of therapeutic ultrasound for the management of knee osteoarthritis: a randomized, controlled, and double-blind study. American journal of physical medicine & rehabilitation, 93(5), 405-412.
Kobak, K. A., Taylor, L. V., Bystritsky, A., Kohlenberg, C. J., Greist, J. H., Tucker, P., … & Vapnik, T. (2005). St John’s wort versus placebo in obsessive–compulsive disorder: results from a double-blind study. International Clinical Psychopharmacology, 20(6), 299-304.
Papachristofilou, A., Finazzi, T., Blum, A., Zehnder, T., Zellweger, N., Lustenberger, J., … & Siegemund, M. (2021). Low-dose radiation therapy for severe COVID-19 pneumonia: a randomized double-blind study. International Journal of Radiation Oncology* Biology* Physics, 110(5), 1274-1282.
Rostock, M., & Huber, R. (2004). Randomized and double-blind studies–demands and reality as demonstrated by two examples of mistletoe research. Complementary Medicine Research, 11(Suppl. 1), 18-22.
