Should also mention that Tinnitus Talk is the forum they are discussing in the article but it isn't mentioned by name
@Markku @Steve
A translation of the article generously provided below by
@Samir (thanks!).
I'm going to make some inquiries in an effort to find out what kind of data Antinitus presented (if they did - they said they were planning to in the article) at
the World Tinnitus Congress (which was earlier this week).
FIRST SECTION:
There is no evidence that the tinnitus patch is working
A medical patch that's claimed to relieve tinnitus is now being sold to patients in Sweden. But the critics say that there is no evidence that the product is working.
- "At first glance I think this is a little strange. I find it difficult to understand that it is allowed to sell this type of treatment without having hard evidence that it is working," says Gerhard Andersson, a tinnitus researcher and professor in clinical psychology at Linköping university.
We are talking about the Antinitus patch that's being sold directly to consumers by the Swedish company Sensori. After being aimed at foreign patients at first, there is a now a Swedish version of the site where one can order the patch at a cost of 790 Swedish crowns for a three week treatment regime.
The patch is attached behind the ear and is said to convert incidenting light into fractal light through a raster. This fractal light is in turn supposed to produce water molecules and give "biological tissue a more coherent state." According to the company's hypothesis, this "could" relieve tinnitus.
Control group missing
There is no basic scientific study published that would directly support this mechanism. But a small pilot study has recently been published where five of ten patients reported less tinnitus distress after using the patch for three weeks. According to the company, a similar result has been achieved in another study with one hundred patients that is yet to be published.
- "It is difficult to draw any conclusion from these two studies, where there is no control group and no blindfolding of the participants. I hope that the company will do a proper placebo controlled study," says Gerhard Andersson.
The company claims that there barely is any placebo effect in tinnitus treatment. Gerhard Andersson is doubtful about that.
- "My clinical experience is that there is a placebo effect in caring for the patient alone. Just because no significant placebo effects have been observed in other studies does not free the company from doing a controlled study for the treatment," he says.
Threatened to sue
In several previous blog posts, Dagens Medicins' blogger Mats Reimer has raged against the patch which he considers to be a pure scam product.
- "The company is making money off of tinnitus sufferers' inability to find another treatment. There is only one placebo effect here. As far as I understand it is the unreasonable and unproven biological principle that the patch is said to work by," says Mats Reimer, who works as a children's doctor in Mölnlycke and himself is suffering from tinnitus.
Similar criticism has also been founded on the world's largest web forum for tinnitus sufferers, the British Tinnitus Talk. But that time around, the company threatened to sue for slander.
- "They knew that we would have limited resources to defend the freedom of speech of our members. But we were fortunate to find a lawyer who worked pro bono. In the end, we found a compromise where we took away the most critical posts," says Markku Vesala, one of the founders of Tinnitus Talk.
The Swedish Medical Products Agency is investigating
Antinitus is a medical device in the lowest risk class. This means that it can be put on market with low proof requirements for its medical claims. The Medical Products Agency is now investigating the product, but the agency is not willing to comment the case until the investigation is finished after the summer.
SECOND SECTION:
The Company: "We know that the patch is beneficial"
At Sensori, the founder and CEO Tommy Rönngren is upset over the statements saying that the Antinitus patch is a placebo product and that the company is using tinnitus sufferers to their advantage.
- "We are likely the biggest on tinnitus research in the world. We have invested over 100 million Swedish crowns since the year 2000. It's strange that we are receiving critique instead of applause for having a Swedish innovation that's reaching the World's height," he says.
"We know that it has effect"
Tommy Rönngren states that the patch is not a placebo and motivates that by saying that the placebo effect when tinnitus studies are concerned is very small - at least according to a review that the ENT doctor Peter Åhnblad has recently done, using eight recently published placebo controlled tinnitus studies.
Furthermore, Tommy Rönngren points out that within the studies that the company has done so far, it seems that the relief of symptoms was greatest four weeks after completing the treatment, and that one of three had a lasting relief two years after the treatment.
What evidence do you have that fractal light can affect the hearing experience?
- "Data on the mechanisms is due for publication. The mechanism is in part a hypothesis, but we know that it has effect because we see positive results in clinical studies", says Tommy Rönngren.
But your uncontrolled patient studies have very weak evidence value...
- "Two clinical studies have been conducted and a third study is in progress. All the studies have been conducted and continue to be conducted in accordance with the regulatory framework for medical device products. Evidence value is very high, just as in our post market follow ups. We will present more data on the World Tinnitus Congress in May."
How do you comment the fact that you conducted a legal process against a patient forum because critical comments were posted there?
- "We were slandered and pure inaccuracies were claimed."
Hoping for breakthrough
The turnover of Sensori for year 2016 was 1.3 million Swedish crowns while the revenue was a loss of 14.2 million Swedish crowns. According to the latest annual report, the company believes that year 2017 could be the product's commercial breakthrough.
Member
Founder
,i think it's hilarious how a product that is a patch gets bought by a gaming company.It's just beyond irony them threatening with legal actions is laughable (although i'm aware it's serious) A " patch " is going to cure my Tinnitus,yeah right,the explanation of how it works is like Geralt using his alchemy inventory to mix all kinds of potions and herbs.
