Leave the yoghurts alone! The patients didn't die from them!
Sofia Kornienko, Radio Liberty
In the Netherlands, a clinical trial using probiotics resulted in the death of at least 15 patients. Probiotics are the so–called "good bacteria", as a rule, normalizing the intestinal flora. However, in combination with some acute diseases, the same bacteria can behave unexpectedly dangerously.
As one of the authors of the study said: "We are aware of what happened. In addition to the cold scientific explanation, there is also a lot of emotions, and a feeling of depression, especially after talking with surviving patients and relatives of the deceased. Our entire research group was deeply impressed by this conversation."
When, at the end of January, Dutch doctors first reported the tragic outcome of a clinical trial in which 15 of the country's largest clinics took part, their statement shocked foreign colleagues: probiotics are not considered a dangerous drug, it is not a medicine at all, they are even part of healthy yoghurts with live cultures.
The story of the medical drama was picked up by all the Dutch TV channels, the hosts began the explanation with a story about "yoghurts, the names of which they have no right to name," while recognizable packages appeared on the screens behind them.
Incorrect associations with innocent dairy producers were suppressed on February 14 by an official press release issued by the doctors of the Utrecht University Clinic (UMC Utrecht): "With a high degree of probability, it can be argued that probiotics were the cause of death of the patients participating in the clinical trial," the press release says, "but yoghurts have nothing to do with it. Volunteers were injected with a mixture of different strains of probiotic bacteria through a probe. The mixture was developed specifically for this study and is not available on the dairy market or in pharmacies. The concentration of bacteria in this experimental mixture was much higher than the usual probiotic dose."
It should not be forgotten that only very sick people with severe acute pancreatitis, that is, with acute pancreatic disease, participated in the study as volunteers.
It is seriously ill people who are ready to take risks, says Bert van Oostwein, a patient with acute pancreatitis, who did not have time to take part in the experiment: "The pain is so unbearable, you become so obsessed with pain that I personally would go to any experiment. They would have told me to eat crushed stone – and I would have eaten crushed stone, if only it would help."
And yet human rights activists and journalists continue to accuse doctors of short-sightedness, of experiments on living people, of not warning about the real danger.
The head of the Dutch research group on acute pancreatitis, Hein Gooszen, who was called to the carpet on the NOVA TV program, admitted that the probability of an unexpected outcome of the study always remains, and it is impossible to insure against it: "Of course, we are well aware of the composition of the probiotic mixture that we used, but the behavior of bacteria in these specific conditions turned out to be unexpected. After all, dozens of studies using probiotics are currently taking place in the world, including in patients with the most serious diseases – for example, probiotics are effective in the case of liver transplantation."
The study has been conducted since 2005 – it was conducted in the Netherlands, because there are a dozen and a half strong research centers located here at a short distance from each other, well-equipped and not competing with each other. There are no such conditions in other countries. All 296 volunteers participating in the study had acute inflammation of the pancreas (pancreatitis). In this disease, the blood supply to the small intestine is in any case reduced. The tragic outcome of the study showed that the ingestion of additional foreign bacteria into the patient's body can lead to increased circulatory disorders in the intestine and, as a result, its perforation.
Hain Hossen commented on the incident: "In the main, experimental group, 24 patients (16 percent) died, in the control group – 9. This means that if patients from the main group had not received probiotics, then no more than 9 people among them would also most likely have died. Statistically, the relationship with probiotics is obvious. Our initial goal was simply to reduce a number of infections. That's why we resorted to probiotics. Previously, the use of probiotics was not associated with a fatal outcome anywhere else in the world."
The surviving patient from the main group of volunteers , Joachim Vromans , told the Pauw & Witteman TV program: "When in 2005 I was brought by ambulance to the Tilburg clinic and diagnosed with acute pancreatitis, the doctors immediately asked me if I wanted to volunteer in a new nationwide study. They said that it was completely safe, that there should be no side effects, and that we are talking about probiotics. I say, "What is it?" They replied that it was just like drinking yogurt, that it was not even a medicine, but a dietary supplement... Now both me and my relatives are haunted by the thought that I, too, might not have returned home. My condition has only worsened. In total, I spent 93 days in intensive care."
Studies of the use of probiotics in many other diseases – for example, giardiasis, antibiotic-associated diarrhea – give excellent results. Yoghurts with probiotics are eaten by millions of people in the world, and they only improve their health. The danger in the use of probiotics can exist only in cases of some acute diseases, since probiotic bacteria can stimulate inflammation as a protective reaction of the body, the statement of the Dutch doctors emphasizes.
Portal "Eternal youth" www.vechnayamolodost.ru18.02.2008