What "cold" medicine causes infertility in men? There are plenty of similar questions and reviews on the Internet. What is the reason for fears that Kagocel affects male fertility? For example, there is an opinion that gossypol, a cotton pigment and the active component of kagocel, reduces the chances of conception in men. Is it really?
It is believed that antiviral drugs such as Kagocel, which contains gossypol, a substance secreted from the vegetative parts of cotton, can suppress spermatogenesis and in some cases act as a male contraceptive. By its chemical nature, gossypol is a toxic alkaloid necessary for the plant to protect itself from harmful insect pests.
It is known that gossypol reduces the motility of mature sperm and leads to inhibition of developing forms of sperm, especially at the spermatid stage. It is also capable of inhibiting a number of proteins and enzymes contained in sperm and spermatogenic epithelial cells. It turns out that Kagocel can also cause infertility?
Kagocel: composition and dosage form of the drug
The active component of the medicine is a sodium salt based on carmoxymethylcellulose and a polyphenol compound of plant origin. Kagocel stimulates the formation of human interferons, immune proteins that suppress harmful microflora:
- macrophages;
- lymphocytes;
- endothelial cells;
- granulocytes;
- fibroblasts.
The drug has antimicrobial, immunomodulatory, radioprotective effects. Active against pathogens of ARVI and herpes simplex.
Kagocel is available in the form of tablets for oral use: biconvex, light brown in color with small inclusions. Packaging: contour blisters with 10 cells.
The drug tablet contains 12 mg of gossypol copolymer and auxiliary components:
- starch;
- calcium salts;
- lactose;
- povidone.
Mechanism of action
After administration, the active substance is concentrated mainly in the tissues of the liver, lungs, spleen, and kidneys during the day. A small amount accumulates in muscles, brain and blood plasma.
The protective level of interferons grows in the body over 48 hours and lasts up to 5 days from the moment of taking the medicine. This property makes it necessary to prescribe Kagocel at an early stage of the disease - no later than 4 days from the moment of infection.
It is excreted from the body through the intestines. It is not deposited in tissues, has no toxic effect, and does not cause cell mutations.
How to check effectiveness
Photo: PA Images/TASS
In the modern world, the presence of studies in which a drug has demonstrated a therapeutic or preventive effect in one way or another is not yet a reason to declare it effective.
Typically, a drug candidate goes through several stages.
Its effect is studied in vitro: scientists observe how a potential therapeutic agent interacts with living cells of the body and with pathogens. Once convinced that it has therapeutic potential, it is tested on laboratory animals.
If a drug candidate does not cause serious adverse reactions in animals, it is tested in humans.
Typically, scientists first observe the effects of a drug in small groups of people, and then carefully design and conduct clinical trials according to very strict rules. Let's talk about the most important ones.
Firstly, such studies are carried out in three stages.
Phase I and II clinical trials may be conducted on a small sample of participants. As for phase III trials, they should be:
a) multicenter (which means research centers in different countries);
b) be carried out on a large number of participants (thousands) in order to minimize possible statistical errors in determining the effectiveness of the drug, as well as to establish all possible, including relatively rare, for example, 1:1000, unwanted side effects.
Such requirements are imposed on clinical trials by certifying agencies in all developed countries. They take the standards of the FDA and the US Food and Drug Administration as a model.
Secondly, clinical trials must have a control group.
This means that comparable numbers of participants take the drug candidate and the placebo (dummy). This allows you to separate the real effect of the drug from random improvements.
In this case, the groups must be randomized, that is, approximately the same in various parameters. You can't have one group dominated by men, another by women, one by people aged 20 to 30, another by people aged 40 to 50, one by rich people and another by people with low incomes.
Finally, clinical trials must be double-blind studies. This means that neither the patients themselves nor the doctors assessing the participant's condition at various stages of his treatment should know whether they are dealing with a real agent or a placebo.
This is absolutely necessary so that the results are not influenced by the “human factor”.
Only after passing all three phases of double-blind randomized controlled trials can a drug qualify for approval by the FDA or the relevant European agencies.
No pharmaceutical company can claim the effectiveness of their drug unless it meets the very strict modern standard outlined above.
How to take Kagocel
The tablets are taken orally without chewing or breaking into pieces. Drink plenty of water. Meal times don't matter. Gastric juice does not affect the absorption of the drug into the bloodstream.
For prevention, adults and adolescents over 12 years of age are recommended to use Kagocel in cycles:
- 2 tablets each once within 2 days;
- repeated 2-day intake after a break of 5 days.
This scheme contributes to the formation and maintenance of the body’s defenses for a week after the next use of the medicine.
For the treatment of ARVI, the following is prescribed:
- 2 pills three times a day for the first 2 days;
- 1 pill three times a day on days 3–4.
A total of 18 tablets are enough for a 4-day course. Longer treatment is irrational.
When treating herpes, Kagocel is taken for 5 days: 2 pills three times a day. The course is designed for 30 tablets.
Does Kagocel threaten infertility?
Buyers in the Moscow pharmacy hypermarket of the “36.6” chain.
Photo: Artem Geodakyan/TASS The active ingredient of the drug is gossypol (a natural compound found in cotton), associated with oxidized carboxymethylcellulose.
Gossypol can inhibit spermatogenesis and has even been studied in clinical studies for use as a male contraceptive. However, this idea had to be abandoned. Firstly, in 20% of cases the effect of the drug was irreversible, that is, it made the man infertile forever, and secondly, according to preliminary data, there is a possibility that gossypol has genetic toxicity.
The manufacturer of Kagocel claims that gossypol is included in the drug in bound form and is not released during chemical transformations in the body, and therefore cannot inhibit spermatogenesis. At the same time, a number of experts, for example, the authors of the work “Leaders in Sales of Over-the-Counter Drugs and Problems of Their Safety,” question this statement.
If we assume that high-molecular-weight Kagocel is broken down into smaller molecules during absorption in the gastrointestinal tract, then, according to Doctor of Medical Sciences, Professor of RUDN University E. Ushkalova and her co-author, research fellow at the Scientific Center for Advanced Medical Practice named after. V.I. Kulakova N. Chukhareva, taking the drug “in the prepubertal and pubertal period (that is, in children and adolescents) is even more dangerous in terms of its effect on reproductive functions than in adulthood.”
The authors of the article believe that until the results of targeted studies are obtained to study the long-term consequences of Kagocel use in males, including children and adolescents, the drug cannot be characterized as safe with a high degree of confidence.
How to take Kagocel for children
Children 3–6 years old with the flu are prescribed:
- 1 pill twice a day for the first 2 days;
- on days 3 and 4 - 1 pill once.
Children 6–12 years old can take:
- three times a day, 1 pill in the first 2 days;
- in the remaining 2 days - 1 pill twice a day.
To prevent diseases in childhood, 2 tablets are enough for 7 days: 1 pc. daily for the first 2 days, then at a 5-day interval. Preventive treatment can be repeated throughout the epidemic season.
What is your evidence?
A child sick with the flu.
Photo: Vladimir Smirnov/TASS Kagocel's research consists mostly of in vitro studies, studies in animal models and observational studies. Only a few of these are clinical trials, and none of the age cohorts have undergone three-phase trials in large samples.
In the study “Clinical efficacy of Kagocel in ARVI with stenosing laryngotracheitis in children,” the sample included only 60 children aged 6 to 13 years (29 in the Kagocel group), which is acceptable for stage I clinical trials.
Domestic flu vaccines: advice for those who decide to get vaccinated
If the result is positive, it should be followed by larger phase II and III samples. However, since no subsequent trials were conducted, the conclusion about effectiveness seems premature, especially since, in accordance with the results obtained, the difference in the duration of symptoms of ARVI and laryngotracheitis between the Kagocel group and the placebo group was no more than a day.
If we take into account that only 29 children took the drug, then a final conclusion about the safety of the drug after testing on such a small sample cannot be made, since it is impossible to trace even those side effects that occur with a frequency of 1:100, not to mention the more rare ones. .
The situation is similar with the study “Clinical effectiveness of the drug “Kagocel” for influenza and ARVI in children from 2 to 6 years old.” The drug was also studied in a cohort of only 60 children. There are also no follow-up tests for this age group.
There is another study by the same authors in 2012 on the same modest sample and their same work for the age group from 6 years on a sample of 120 participants (2009) to assess the preventive effectiveness of Kagocel, which is also not a valid sample for final conclusions about the effectiveness and safety in accordance with international standards.
Two clinical trials were conducted on adult cohorts: “The therapeutic effectiveness of Kagocel in the treatment of patients with uncomplicated influenza and influenza complicated by sore throat” and “The use of the drug Kagocel for the treatment and prevention of influenza and other acute respiratory viral infections” (not publicly available) .
The first is on a sample of 264 people, the second is on a sample of 331 people. This is the only Kagocel study carried out on a sample that meets the standards, however, it is also a single-stage one, and in addition, it evaluates the effectiveness not in treatment, but in prevention.
Production of the antiviral agent “Kagocel”. Photo: Valery Melnikov / RIA Novosti
Thus, even if there were no further complaints about the design of the studies, their extreme smallness (especially for children) already makes them not meet international standards for this type of scientific work.
There is, however, another very serious limitation. The studies are single-blind, not double-blind, which does not guarantee objectivity and does not in any way correspond to international standards.
And finally, as noted above, according to the research results, the difference in the duration of symptoms, at best, was about one day - this is a rather modest result for a particular patient, taking into account the fact that he pays for this drug, which is not at all cheap, usually from your pocket.
There is one more very important circumstance. Influenza and ARVI are self-limiting infections, that is, they have a limited duration and in the vast majority of cases resolve without intervention (excluding complications).
In this situation, the requirements for evidence of effectiveness are particularly stringent. We must be sure that the disease did not go away on its own, but as a result of the study therapy, and in the case of Kagocel we do not observe compliance with even the basic rules.
So, the effectiveness of Kagocel, alas, has not been proven.
It is possible that someday he will conduct clinical trials according to all the rules and prove to us the usefulness of his product, but for now, sales success is based on skillful marketing, and not on solid scientific data.
What about security?
Is it possible to combine Kagocel with alcohol?
There is no data on the interaction of the drug components with ethanol and the formation of toxic compounds when used together. However, under the influence of alcohol, the mechanism of interferon formation may be disrupted. In such cases, the therapeutic effect of Kagocel will be insufficient or will disappear.
In addition, alcohol may increase the risk of allergic reactions and side effects while taking the medication. For these reasons, you should abstain from alcohol for a period of at least 5 days from the last time you took Kagocel.
