deThe evidence question: why doctors demand it – and why it is difficult to deliver
Hemoperfusion and apheresis have established themselves as valuable procedures for reducing inflammatory processes, lowering toxic loads and relieving the immune system. Numerous patients who come to us with chronic illnesses or treatment-resistant complaints report significant improvements in their state of health – in some cases even lasting relief of previously persistent symptoms. However, while the clinical success of this method is clearly evident in everyday practice, doctors and scientists often face a methodological challenge when it comes to proving this effectiveness in standardized studies.
Why are traditional study formats problematic?
A crucial problem lies in the great heterogeneity of the patients who make use of hemoperfusion or apheresis. Many of them suffer from multimorbid clinical pictures that are made up of a complex interaction of inflammatory processes, environmental stresses, metabolic disorders and immunological dysregulation. Traditional clinical trials, especially randomized, placebo-controlled trials (RCTs), are designed to test a single variable in isolation, whereas hemoperfusion is used in a holistic context where multiple factors play a role simultaneously.
Furthermore, there are no uniform biomarkers that make the success of hemoperfusion or apheresis objectively and universally measurable in a short period of time. While medications, for example, can often be evaluated on the basis of clear laboratory values or defined endpoints, the effectiveness of blood purification is often reflected in a subjective improvement in general condition, energy levels or the reduction of non-specific symptoms – aspects that are difficult to squeeze into a standardized study design.
Experience speaks a clear language
Despite these methodological challenges, our clinical experience provides a clear trend: 9 out of 10 patients report a significant improvement in their health after hemoperfusion or apheresis. These improvements can be observed in various areas and are frequently reported by patients:
- Possible reduction of inflammatory parameters
- Relieving the body of toxic stress (e.g. heavy metals, environmental toxins, oxidative stress)
- Supports blood circulation and cell regeneration
- Reduction of fatigue and exhaustion symptoms
- Increased resilience, stress resistance and cognitive performance
Even if these results cannot always be quantified by a single metric, they are noticeable and lasting for the patients concerned. Anyone who works with people on a daily basis who have suffered from health restrictions for years and have regained their quality of life through therapy knows that the effect of blood purification is real.
High costs and lengthy processes – challenges of scientific recognition
A further obstacle to the broad scientific recognition of hemoperfusion and apheresis lies in the enormous costs and the lengthy process of clinical trials. Conducting large-scale, randomized, placebo-controlled trials (RCTs) requires considerable financial resources, which are usually provided by pharmaceutical companies or government institutions. However, as extracorporeal blood purification is not a drug therapy and there is no direct dependence on pharmaceutical manufacturers, there is little commercial interest in investing in large-scale studies.
In addition, such studies are not only cost-intensive, but also time-consuming. Even if a scientific study is started, it can take years before reliable data is available, published and recognized by medical societies. During this time, patients are already benefiting from the practical successes of the therapy without these being formally included in the guidelines of conventional medicine.
The challenge is therefore to create a scientific basis that overcomes both the high costs and the methodological hurdles, while at the same time allowing patients who are already ill to benefit from hemoperfusion and apheresis. This requires a rethink in medical research, an openness to new study designs and an interdisciplinary commitment in order to anchor these innovative procedures in evidence-based medicine in the long term.
Invitation to a scientific dialog
The question is therefore no longer whether hemoperfusion or apheresis works, but how its benefits can be proven in a scientifically valid way. Instead of rigidly adhering to classic study designs, a new, practice-oriented approach is needed to objectively assess the effectiveness of individualized therapies.
We invite physicians, scientists and therapists to discuss the results of our patients, discuss new study designs and work together on a modern understanding of extracorporeal blood purification. Because only through interdisciplinary exchange and a consideration of clinical symptom improvements in patients can we unlock the full potential of these innovative forms of therapy – for the benefit of patients and medicine as a whole.
