Evidence-Based Medicine, Studies, and Hypertension

Important Terms for Studies:

• Randomized: Who receives a treatment is randomly selected.
  
  
• Placebo-controlled: Through a placebo or sham treatment, the participant does not know whether they are actually receiving the medication or treatment.
  
  
• Double-blind: Neither the participant nor the researcher knows who receives the placebo and who receives the medication or sham treatment.
  
  
• Significance: A study is significant if it can be statistically determined that the effect is not due to chance.
  
  
• Effect size: The effect size indicates how well the treatment works. For example, if there is a new medication for hypertension that only lowers it by 1 mmHg, then the effect would be very small, and despite any potential significance, the medication would likely not be recommended.

Problems

1. Study Quality
   Unfortunately, it is sometimes still difficult. As mentioned above, the gold standard is a randomized, placebo-controlled double-blind study. However, suppose one is investigating a specific surgical method. In this case, a sham surgery can be performed, making the patient believe they have been operated on, even if they have not. But the doctor performing the surgery knows what they have done or not. And that alone is enough to distort the results.
   
   When investigating therapies, such as psychotherapy or physiotherapy, the same problem arises. The practitioner knows whether they are actually providing the therapy or if it is a sham treatment. Here, there is also a high likelihood that the participant will notice.
   
   If one were to investigate an app, blinding is not possible at all. Therefore, the evidence of an app can never be definitively established. Stakeholders exploit this to oppose prescription apps. The necessary studies are thus inflated and made more expensive, without any guarantee of recognition. Even if they are recognized, the costs of such an app can be disproportionately high compared to the potential benefits.
   
   
2. Individual Differences
   Studies are made for the average person. However, there are no average people. When the American military wanted to determine how the cockpit should be designed last millennium, they measured hundreds of people and thus established the measurements for the average person. The surprising result: Not a single participant was exactly average. The cockpits were then designed to be adjustable simply because people are different.
   
   Regarding blood pressure:
   Lets take an example of a substance that would lower blood pressure in 5% of all participants, but it is unknown in whom and what the reason is. As long as this is the case, one would not be able to conduct a study that proves the effect of the substance. On average, the effect would be too small.
   Practical problems: Your doctor has a selection of well-researched medications that they could prescribe to you. So theoretically, adjusting blood pressure with medication should not be a problem at all. In practice, however, it looks different. Every person reacts differently. Some medications simply do not work, or there are side effects. No matter how good the evidence is.
   
   
3. Limited Data Availability or Poor Data
   For some medical questions, there may not be a sufficient evidence base, either due to a lack of research or due to ethical or practical constraints. A concrete example in hypertension is the differences in measuring blood pressure. It simply matters how, where, and by whom it is measured. There was a large study called SPRINT, the results of which led to the lowering of the normal values for hypertension in the USA. The problem was that the measurements were conducted differently than in previous studies. In Europe, therefore, there was no perceived need for action.

1. Unique Patient Cases: If a patient has a unique, complex, or rare disease or symptomatology, it may be necessary to deviate from general evidence-based guidelines and make individual medical decisions.
   
   
2. Innovation Potential: In some cases, new treatment approaches or technologies may be promising and have the potential to significantly improve patient outcomes, even though they are not yet sufficiently supported by evidence.
   However, special caution is required here. New procedures can also carry significant risks and unwanted side effects. One should remember the Contergan tragedy between 1957 and 1962 (https://de.wikipedia.org/wiki/Contergan-Skandal).
   
   
3. Traditional or Alternative Healing Methods: One area where evidence-based medicine can be deviated from is traditional or alternative healing methods that have a long history but often lack sufficient scientific evidence for their effectiveness. Many of these methods, such as herbal medicines or certain therapies, have been used for generations and may have a positive impact on health. Although they may not meet the strict criteria of evidence-based medicine, they can be considered as a complement, especially if they are preferred by patients and have no harmful effects. In such cases, it is important to maintain open communication between doctors and patients and to jointly develop the best possible treatment strategy that considers both the wishes and preferences of the patient as well as the effectiveness and safety of the treatment.

Conclusion:

• Evidence-Based Medicine, Studies, and Hypertension
• Blood Pressure Medication Comparison: Which Tablets Work Best
• The Polypill - a remedy for almost everything?
• Grapefruit and Blood Pressure Medications
• Placebo and High Blood Pressure