05 March 2012

Comparison of the proven effectiveness of Arbidol and Tamiflu

"Tamiflu" and "Arbidol" – score 111:9

Comparison of the evidence base of the effectiveness of such well-known flu drugs as Arbidol and Tamiflu in his lecture on Gazeta.Ru" is presented by a therapist from Belarus, the author of a project about the flu grippozus.ru Pavel Shkutko.

Merging the pharmaceutical business with medicineIn the last lecture, I already wrote that in 90% of cases, flu treatment does not require the use of medications.

The remaining episodes require the use of chemicals, but this should not happen as it is happening now, uncontrollably, by the sick themselves and randomly, by eye. Any medicine should be prescribed by a doctor, since only he knows the features of a particular medicine and, depending on the patient's concomitant diseases and conditions, can choose a competent treatment.

Anticipating the skepticism of readers, I approach a topic that is not customary to raise in medical circles, but which increasingly casts a shadow on the profession. This is a solid fusion of the pharmaceutical business with doctors, which takes place in our countries (I cannot say for the far abroad, I do not have such information, but I suspect that this topic also occurs there, although control by the same insurers has a disciplining effect there). This "cooperation" leads to both open forms of bribery of medical personnel (percentages of medicines sold by a doctor's prescription fall into his pocket from medical representatives of drug manufacturing companies), or hidden forms of such pseudo–cooperation (for example, a modern model mobile phone may be offered for a certain number of prescriptions of expensive medicines and other forms of such "cooperation").

The country does not matter: where there is a market for medicines, there is an opportunity to contemplate such forms of criminal interaction.

Naturally, all people are different. Some of the doctors have the courage, if not to refuse, then to ignore the information and continue to prescribe those medications that they consider objectively necessary to prescribe. The problem lies in the very essence of the healthcare system, in which either the Soviet or still tsarist principle is still alive – a doctor can be paid scanty: the people will feed their aesculapius. In the current realities, this principle can be continued with the words "and if the people do not feed, then caring pharmaceutical companies will feed." And this is the trouble of the entire healthcare system, which no one wants to fight. And what is there to fight with, even if they don't want to admit the problem? The entire official vertical is silent about the problem, starting from ministers and ending with heads of departments.

Such a long introduction led to the fact that not all doctors can prescribe medications objectively.

Someone out of self-interest prescribes an absolutely unnecessary, but expensive drug to this patient. Someone is simply too lazy to sort out arrays of information about new medicines and treats outdated adelphans and corvalols, and all diseases at once (although there are good medicines-old people, we will not indiscriminately gnobit them). So let's try to compare two "megagigants" in the fight against influenza, two antiviral drugs: the domestic drug Arbidol and the foreign Tamiflu (oseltamivir).

I will not touch on instructions for use, indications and side effects in the framework of the lecture: this information is available in any reference book on medicines. Also, I will not say about the harm of these drugs: they have the appropriate permits and cannot harm absolutely healthy people, and those who have concomitant pathology, as I advised above, should contact competent doctors for individual selection of suitable drugs and dosages.

We will compare both drugs according to their proven effectiveness – it is proven, since what the company itself will write (some of its "internal" research) – we will leave all this on the conscience of the companies themselves, although there is no smell of objectivity here. Firms need to beat off research, taxes, salaries – what kind of objectivity can there be in business? We also need objective data that will show that this drug has been studied so many times and it has such and such research results.

An objective measure of effectiveness can be the number of double-blind, randomized (randomly selected), stratified placebo-controlled multicenter studies conducted. To put it more simply, this is when approximately equal samples of subjects are collected in different medical research centers (most objectively, if in different countries), who are randomly (randomly) divided into two groups equal in gender, age, disease and other criteria (the more homogeneous these groups are for health and other criteria, the more objective the result).

One of the groups will take a drug, the other will take a placebo, a dummy drug that will be the same shape and size as the drug, but will contain an indifferent substance that does not affect human health.

An option is possible when the effectiveness of two drugs is compared, then two groups can be observed: one takes drug number one, the other takes drug number two, ideally, a placebo group is also added to these two for control.

At the end of the study, the data obtained is analyzed and the result is announced. This may be a reduction in the duration or severity of the disease, fewer complications compared to the placebo group, or a smaller number of cases (for a drug that is declared as a preventive agent). If two drugs are compared, it is reasonable to show how much one of them is more effective than the other.

The difficulty of conducting such multicenter studies is their high cost, which starts from hundreds of thousands of dollars. I must say that the revenues of the pharmaceutical industry (stated in the annual statistical reports) allow us to conduct these studies without prejudice to the development of companies. Unless, of course, these companies have nothing to hide and there is a place to develop.

All data obtained as a result of research are systematized and published in open sources. In my work, I use the authoritative foreign database Medline, where domestic research is published, among other things (that is, it does not have a filter "its own" or "someone else's", and we will leave conspiracy theories against some drugs or in their favor on the conscience of the creators of these versions). There is a sensible and properly designed study – get your cell in this database; no – goodbye, write this in the booklets.

Let's start by comparing the number of clinical trials that meet all the requirements, that is, conducted according to the rules that I indicated above. For Arbidol, the database found 9 studies conducted (5 domestic studies, 4 conducted in China), for oseltamivir (the main active ingredient of the drug Tamiflu) – 111 studies (among the countries where studies were conducted, France, China, USA, Germany, Canada, Japan and many others). At the same time, you can not say that these drugs are newcomers: the industrial production of Arbidol was started in Russia in 1992, it is known about Tamiflu that in 1996 the company F. Hoffmann-La Roche acquired the rights to develop and market drugs based on oseltamivir.

This is an almost tenfold excess of the number of studies at relatively identical intervals since the creation of the drugs.

Now let's look at some clinical studies. I want to say right away that studies not related to influenza will not be considered, since they tested different hypotheses of the effect of Tamiflu and Arbidol on other viruses and bacteria, which does not relate to the topic under study; therefore, we will delve into the influenza problem

Studies of Arbidol and Tamiflu"Arbidol"

The first study of Arbidol was conducted by Chinese scientists.

232 participants were divided into approximately equal groups, one of which took Arbidol, the other – placebo. Of this number of people, about half managed to infect with the flu in the laboratory (that is, they were infected with the flu on purpose). Side effects and the time from the onset of the disease to recovery were evaluated. In the Arbidol group, the time from the onset of the disease to recovery was 72 hours, in the placebo group – 96 hours. Side effects were insignificant and identical in both groups.

The second study was conducted by domestic specialists, it investigated the combined effect of the drugs "Viferon" and "Arbidol" on the flu. The sample size and division into groups are not presented. According to the results of the study, it was found that taking these drugs in the first 24-36 hours from the onset of the disease reduces the duration of fever, intoxication and catarrhal symptoms (cough, rhinitis).

The third study, which deserves the attention of readers, was also conducted by domestic researchers. It compared the effectiveness of the Russian drugs Arbidol and Ingavirin with placebo. 105 patients were selected with a confirmed diagnosis of "flu" (according to symptoms), they were divided into three groups who took Ingavirin, Arbidol and placebo in therapeutic dosages, respectively. The study showed that taking in the first 24-36 hours from the onset of the disease shortens the duration of the febrile period (in patients taking Ingavirin, it was 34.5 hours, in patients taking Arbidol – 48.4 hours, in the placebo group – 72 hours). It was concluded that Ingavirin is more effective than Arbidol.

This is the end of the clinical studies of Arbidol in relation to the use of this drug for the treatment of influenza.

The remaining 6 studies related to Arbidol are not related to this topic: other tasks were set there.

"Tamiflu"Since "Tamiflu" is a commercial (brand) name, I used the main active ingredient oseltamivir to search the Medline database – the substance that has a therapeutic and preventive effect in the drug.

So I will use both names in the future: it's the same thing. Since the patent of the manufacturer "Tamiflu" is valid until 2016, any other drugs based on oseltamivir violate international patent law (in China, this is constantly used – their analogues based on oseltamivir are produced there).

It is impossible to cover all the research results: there are a lot of them. Therefore, I will concentrate on numerous studies in terms of the number of subjects or having an interesting result.

The first study, which we will tell you about, was conducted by domestic scientists, it concerns the effectiveness of Tamiflu and Ingavirin in the treatment and relief of flu symptoms. The study involved 194 patients with a confirmed clinical diagnosis of influenza. They were randomized into two equal groups: one took Ingavirin, the other – oseltamivir in therapeutic dosages, the duration of treatment was 5 days. As a result, it was found that taking these drugs in the early stages (the first 26-34 hours from the onset of the disease) reduces the duration of the febrile syndrome for Ingavirin to 35.1 hours, for oseltamivir – to 26.3 hours.

Two studies of Chinese medicine are also interesting. In one case, the effectiveness of oseltamivir was compared with sets of Chinese herbs, in another – with Chinese phytocapsules. Both studies were conducted on the basis of Chinese clinics and showed approximately equal totals: the same duration of the fever period – 85 hours (an amazing difference compared to data from Russian studies!). There was also a decrease in catarrhal symptoms, intoxication, but it is unclear what was taken as the standard, since two drugs were compared without a placebo group. In addition, in one of the studies, scientists directly admit to violating the course of the experiment (removing some patients from groups without reasonable reasons).

In a word, it looks more like a custom-made study aimed at proving the advantage of a local manufacturer over an imported one.

The following study (11 randomized tests were conducted in one study) evaluated the effectiveness of oseltamivir in relation to the risk of post-influenza complications of the lower respiratory tract. It was found that 37% of patients who took the drug and had a confirmed diagnosis of "flu", there was a decrease in the risk of complications from the lower respiratory tract (pneumonia is standard) compared with the placebo group.

Also noteworthy is a large study by French scientists conducted on 541 volunteers. The sample consisted of half men and women, the average age of the subjects was 39 years. The combination of oseltamivir with inhaled Zanamivir (Relenza trademark) was investigated: this drug is similar to Tamiflu and is a representative of its previous generation. Two groups were used as controls: one was given oseltamivir and an inhaled placebo, the other "Zanamivir" and an oral placebo. The study showed that monotherapy with oseltamivir is even more effective than therapy with a combination of oseltamivir and Zanamivir or pure Zanamivir. But the frequency of side effects from the use of the combination increases, since two chemical drugs are given in combination and the negative effect of chemistry in these drugs is potentiated.

In a study by scientists from Finland, a sample of 408 randomized children was used as observables (205 took placebo, 203 – oseltamivir). It was found that taking oseltamivir in the early stages of influenza can reduce the recovery time by three days (3.5 days in children on oseltamivir, 6.5 days took recovery in children from the placebo group). In addition, it was found that taking oseltamivir in the early stages reduces the frequency of otitis media (as a complication of influenza) by 85%.

The effectiveness of the drug was observed only in children with diagnosed influenza type A, the effectiveness was not demonstrated in influenza type B.

Also noteworthy is a study by American scientists who evaluated the effectiveness of oseltamivir on the frequency of transmission of influenza in families. For this purpose, 362 households were selected, which were randomized into two groups. In the control group, members from 135 families were infected with influenza, and early administration of oseltamivir prevented infection of the rest of the family members – they were 50% less compared to family members from the placebo group.

Another study was conducted in Oxford. The effectiveness of oseltamivir and Zanamivir was tested here. A total of 1,766 children participated in the study. The strength of the therapeutic and preventive effect of the use of these drugs was investigated. The results showed that the use of oseltamivir and "Zanamivir" in the treatment of influenza allows for 0.5-1.5 days to reduce the duration of influenza compared to the placebo group. Prophylactically, these drugs showed an 8% reduction in the incidence of influenza compared to the placebo group. There is a reduction in the duration of the disease during treatment or cases of infection with preventive administration, but not so significant.

There was another study of the drugs "Zanamivir" and oseltamivir, conducted by Japanese scientists, which evaluated the effectiveness of drugs against different types of influenza – A and B. 1113 patients with different types of influenza were selected. The study showed greater effectiveness of Zanamivir against influenza type B compared to oseltamivir (although this is not denied by the manufacturers of Tamiflu, in the sense that their drug is more effective against influenza A, but not B).

ConclusionThese data personally convinced me as a specialist at the time of the greater effectiveness of the drug "Tamiflu" in comparison with the Russian drug "Arbidol".

Yes, Arbidol is cheaper, and much cheaper. But his clinical studies conducted in all forms, or rather, the insufficiency of these studies raises great doubts about the effectiveness of this drug as an unambiguous means in the fight against influenza.

The patient should be given the right to choose for himself what he wants to get from treatment – an undoubted result (which, of course, will not give him a 100% guarantee of recovery from infection, but will significantly increase the percentage of recovery), but for a lot of money, or a cheap, but poorly studied drug. It should be understood here that the annual losses of the world economy from influenza amount to millions, if not billions of US dollars, and a really effective drug would very quickly make its way to the pharmaceutical markets of many countries. There can be no conspiracies here, just as there can be no unequivocal certainty that tomorrow a new flu virus will not appear, against which the same "Tamiflu" or "Arbidol" will be powerless.

I repeat, both drugs are safe to use, which is confirmed by their registration in Russia. But the purpose of this lecture was to compare the evidence base of the effectiveness of both drugs.

I think that these examples clearly demonstrate who is who in the pharmaceutical market. And if it's time to be treated with chemicals, since the body itself is not able to cope with the disease that has arisen, then everyone will be able to make the right choice depending on their financial situation and the effect they want to achieve in the treatment of influenza infection.

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