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Risk-Benefit Ratio in Rosacea Research & Development


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Rosacea Research
Every medical student learns about the risk-benefit ratio in medical research and in treatment. "For research that involves more than minimal risk of harm to the subjects, the investigator must assure that the amount of benefit clearly outweighs the amount of risk. Only if there is a favorable risk–benefit ratio may a study be considered ethical. The Declaration of Helsinki, adopted by the World Medical Association, states that biomedical research cannot be done legitimately unless the importance of the objective is in proportion to the risk to the subject. The Helsinki Declaration and the CONSORT Statement stress a favorable risk–benefit ratio." [1]

Rosacea Treatment
For a rosacean, it would be prudent to understand what the risk-benefit data is for any rosacea treatment being considered. If you are seeking medical treatment from a physician, legally the risk/benefit ratio should be provided to the patient clearly in terms that the patient can understand. What are the risks involved and what are the benefits for a particular rosacea treatment? Clearly the benefits should outweigh the risks, however, because the Benefit-risk assessment (BRA) mainly relies on a qualitative assessment of quantitative data, there is sometimes subjective or qualitative bias involved in the presentation of the data by the medical practitioner and also in the decision of the rosacea patient. Also the placebo/nocebo effect may be involved as well, which is a factor not only in the outcome of the treatment, but also in the decision of the patient in the process of accepting or rejecting the treatment . [2]    

For an example, take the common bias in the perception of risk in flying vs driving. Some feel that flying is more risky than driving, however, statistics show otherwise. The bias in this case is subjective or qualitative on the quantitive data. "In the end in any given situation, the acceptable risk-to-benefit balance is an individual judgement on the part of the patient or the prescriber." [3]

Due to this bias, clinical research studies use 'double-blinded' techniques. "In a blind or blinded experiment, information which may influence the participants of the experiment is withheld (masked or blinded) until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources." [4] "Most often, single-blind studies blind patients to their treatment allocation, double-blind studies blind both patients and researchers to treatment allocations, and triple-blinded studies blind patients, researcher, and some other third party (such as a monitoring committee) to treatment allocations. However, the meaning of these terms can vary from study to study." [4]

"The double-blind randomized controlled trial (RCT) is accepted by medicine as objective scientific methodology that, when ideally performed, produces knowledge untainted by bias. The validity of the RCT rests not just on theoretical arguments, but also on the discrepancy between the RCT and less rigorous evidence (the difference is sometimes considered an objective measure of bias)." [7]

Placebo/Nocebo Effect
"Evidence for the relevance of placebo and nocebo effects in dermatology is also increasing...A large proportion of the success or failure of dermatological treatment can be explained by factors other than the treatment mechanisms themselves. Placebo and nocebo effects, in particular, strongly contribute to treatment outcomes, with explained variances comparable to, for example, effects of analgesics or antidepressants....the placebo responses and positive expectations of patients will only endure if they are based on trust in a long‐term authentic relationship. Highly optimistic promises followed by limited effects will probably result in nocebo instead of placebo effects." 

The placebo/noebo effect is a significant factor in whether a rosacean decides to accept a treatment or reject it as well as a huge factor in the outcome of the treatment. [5]

Criteria for Assessing Risk-Benefit
"The concept of risk is generally understood to refer to the combination of the probability and magnitude of some future harm. According to this understanding, risks are considered "high" or "low" depending on whether they are more (or less) likely to occur, and whether the harm is more (or less) serious." [6]


Benefit-risk Assessment
Of course, there are a number of rosaceans who give absolutely no consideration to the risk-benefits of any given rosacea treatment (rely totally on what a physician proposes without hesitation, inquiry or investigation into this subject), while others investigate these risks-benefits in methodical and incredible details. For example, what is involved in investigating PDT for rosacea? One other assessment is understanding the X-Factor in rosacea

Informed Consent
Informed consent is the right of each patient and the responsibility of the medical practitioner. However, in over the counter or non prescription treatments for rosacea the responsibility of gathering the risk-benefit data relies totally on the rosacean, who relies heavily on anecdotal reports and very little scientific data, if any, probably in both cases provided by the promoter of the rosacea treatment under consideration. Independent verified anecdotal reports are highly valued, but as many have discovered, anecdotal reports can be faked.

What can help in making an assessment with a proposed rosacea treatment?
A principle to consider is, 'a treatment causes benefit in many at the cost of serious injury in some.' Obviously if this principle is reversed, 'a treatment causes serious injury in many at the cost of benefit in some' would you accept the treatment? That would depend on how bad your rosacea is, now wouldn't it? The dilemma in this decision is understanding whether the data that is presented is valid or biased. That is what research and development is all about and why the RRDi was formed and a principle found in our mission statement (see Goal #4). 

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End Notes 

[1] Risk-benefit ratio, Wikipedia

[2] Dialogues Clin Neurosci. 2011 Jun; 13(2): 183–190.
Assessing the benefit:risk ratio of a drug - randomized and naturalistic evidence
François Curtin, MD and Pierre Schulz, MD

[3] Drug Saf. 1996 Jul;15(1):1-7.
Concepts in risk-benefit assessment. A simple merit analysis of a medicine?
Edwards R, Wiholm BE, Martinez C.

[4] Blinded Experiment, Wikipedia

Blinded Experiment, Terminology, Wikipedia

[5] Placebo/Nocebo Effect in Rosacea

[6] The Assessment of Risk and Potential Benefit, Chapter 4, Biotech Archive, Georgetown University

[7] J Clin Epidemiol. 2001 Jun;54(6):541-9.  doi: 10.1016/s0895-4356(00)00347-4.
The double-blind, randomized, placebo-controlled trial: gold standard or golden calf?
T J Kaptchuk  

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