In order for a product to reach pharmacies, it is imperative that various tests are carried out beforehand. Once a potentially therapeutic substance has been identified, it is first tested on cell cultures and animals, usually laboratory rats or mice. These first tests analyze its possible toxicity and whether it causes serious side effects in addition to its expected therapeutic effectiveness. Once it is proven non-toxic, does not cause serious problems and has been shown to be effective in animal models, the final review will come, it will be tested on humans. This final and crucial test is called a clinical trial.
Marcela González Gross, PhD in Pharmacy and Director of the Department of Health and Human Performance at the Faculty of Physical Activity and Sport Sciences at the Polytechnic University of Madrid, also leads a research group specialized in conducting clinical studies. “We have gained a certain degree of recognition nationally and internationally,” explains González Gross. This specialist explains that because of this reputation, he was contacted by an Icelandic company that wanted to conduct “a clinical study of a dietary supplement for overactive bladder syndrome”.
This study, started in 2020 by the group led by González Gross, aims to prove that a dietary supplement is effective against the symptoms of a syndrome that, according to its director, “affects 12% of the population”. Overactive bladder syndrome causes a sudden and frequent urge to urinate that can be difficult to control and the complications of which can be as serious as the onset of emotional distress or depression, anxiety, trouble sleeping, or problems with sex, according to the American Mayo Clinic.
The research group’s clinical study will analyze whether the dietary supplement is effective in ending this problem in 200 volunteers. And I’m one of them.
Voluntary and unpaid
I got into the study by accident. A researcher friend of mine told me about him and that they had trouble finding volunteers. And since I met the requirements of the essay, I signed up. Spanish and European laws require that participation in a clinical trial is voluntary and unpaid. When the research group accepted me, the evidence arrived. Before I started, I had to fill out seven forms. From signing the consent form that I understand what it means to take part in the study, to in-depth interviews about my urinary frequency, lifestyle and diet.
Standing, Marcela González Gross, director of the clinical study, and Jaime López-Seoane Puente, responsible for contact with the volunteers participating in the study. Seated, Margarita Pérez Ruiz, Director of the Laboratory of Biochemistry of the Faculty of Physical Activity and Sport Sciences of the Polytechnic University of Madrid, Álvaro García
After sending you all this information, the day of starting my participation in the study comes. You make an appointment with me at the biochemical laboratory of the Faculty of Physical Activity and Sports Sciences of the Politecnico de Madrid. Jaime López-Seoane, a graduate student in Nutrition and Dietetics and a doctoral student whose thesis will focus on this clinical study, will be waiting for me there. In the process, he is responsible for contacting the people who volunteered.
Empty diary
When I arrive, the first thing they do is analyze my urine. Everything is fine, López-Seoane explains to me, especially the basics: I don’t have an infection that would exclude me from the process. Then he explains to me what my participation will entail. I have to keep a so-called voiding diary.
For three days, every time I urinate, I have to write down the time of urination, the degree of urgency I felt, whether I leaked, and the amount of urine. For this he gives me a measuring cup that catches my urine every time. We both laugh at the jug and López-Seoane tells me that some of the volunteers use the jug in the kitchen after taking part in the study: “Totally”, he assures, “after putting it in the dishwasher…” The truth is that it looks like a perfect candy jar, but before that it has to contain my urine.
A urine test is required prior to the start of the clinical study to rule out infections that would prevent participation.” Álvaro García
In the diary, I also have to write down all the liquids I drink throughout the day and how much. It doesn’t seem complicated at all, just a bit awkward, especially when you’re on the go. “When you leave the house, you have to take the jug with you,” they explain to me. The first thing I think about is what I plan to do in the next three days, nothing that complicates my life too much and if I have a big bag to take with me when I go out.
More information
After keeping a journal for three days, I will start taking the supplement. Two capsules daily. We discussed whether it is better for you to take it in the morning or in the evening. Or one in the morning and one in the evening. We decided to start with the two capsules in the morning and see how it goes. As soon as I have all the information, more tests come: he measures me and as he does so he explains that almost all people measure less than they think.
measurements and more measurements
I laugh, but when he tells me the result, much less than I thought he measured, I laugh less. She weighs me on a special scale that I have to step on barefoot and which, in addition to my weight (I don’t laugh at that either), analyzes my body composition, i.e. the amount and distribution of fat and muscles. They also measure my waist and hips.
And then there are the tests of my physical condition. Balance first, I have to sit down and get up quickly, placing my feet properly on some insoles and putting my hands on my shoulders. I don’t think I’ll be able to do it, but to my surprise – not López-Seoane’s – I’m doing very well. And the last one, a strength test where I have to squeeze a piece of equipment with each of my hands as hard as I can. In the seconds that the test lasts, he encourages me: “Come on, push, push, push…”. I don’t know if it was his encouragement but he tells me I did very well. And that, contrary to what usually happens, my final results are better than the first ones. Wow I think it seems I’m finally learning to thrive in adversity…
The tests on the condition of my muscles and those of all participants in the study relate to overactive bladder syndrome itself. It is an idiopathic disease, which means that its causes are unknown. So I think in the study they should also want to check if there’s a link between poor muscle tone, which to my surprise I don’t seem to have, and the onset of the syndrome.
All tests are over. López-Seoane gives me the bottle with the capsules to take in three days. It’s a metal tin with a label that says the number that identifies me in the essay, as this is completely anonymous; the product file and serial numbers; the name of the manufacturer and a warning: “For clinical trial use only.”
Victoria, do a dynamometer. This is a strength test that requires you to press a device with your hand while sitting and standing and twice with each hand. Alvaro Garcia
What I don’t know, nor does the person responsible for my study, is whether or not the capsules my bottle contains are from the dietary supplement being tested. Because the study I’m participating in is randomized and double-blind. According to a previous clinical study conducted in Iceland, it appears to have beneficial effects on people suffering from overactive bladder syndrome.
In a clinical trial, half of the subjects are given the substance being tested for effectiveness, and the other half are given a placebo, another harmless substance with no effect. The look is right, the content is not. This is necessary in order to be able to compare at the end of the study whether those who received the substance to be tested had any advantages over those who received the placebo.
Because the study I’m participating in is double-blind, neither the researchers nor the volunteers know if the supplement or placebo is in the bottle. These are the most rigorous clinical trials as this avoids biases that could alter the results. In addition, this is random, meaning that the selection of volunteers who receive the placebo is also random.
In six weeks that I have to take the capsules, I have the second appointment, again at the Biochemistry Laboratory of the Faculty of Physical Activity and Sport Sciences of the Politecnico de Madrid. Then Jaime will repeat all the tests they did in the first one. “It is important to do this repetition under the same conditions so that the results obtained with the substance we tested can be unequivocally attributed to the product itself,” explains López-Seoane. So I’ll step on the scale and Jaime will re-measure my height (I hope I haven’t shrunk any further), strength and balance. In the three days leading up to the appointment, I will fill out fluid intake and lifestyle forms and keep a new urination diary. On this day my participation in the trial ends. I will then also know if what I took was the tested product. In a few weeks I’ll tell you right here if I was lucky and didn’t get the placebo.
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