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The science

How our patches work and the research behind our approach

Science with empathy

We believe that, although so many times invisible, chronic pain, although often invisible, is real. It is not something that is in your head, that you can ‘snap out of’. Pain is a condition unto itself, one that deserves to be addressed in its own right, not merely a symptom of something else.

34% of people in england experience chronic pain

We need more science around pain but science also needs more empathy. Many in our community say that they have not been able to get the right support from their health services or still don’t know what is wrong with them and go without treatment. Some feel like they are not believed or trusted.

We also believe there is a lack of research around novel pain treatments as analgesics have a low success rate. This means our community of chronic pain sufferers live the double whammy of not always being supported by the services they need and not having alternatives for treatment beyond what they have tried already. As a consequence, we are working to create that balance in our support towards pain sufferers matched by our continuous investment in scientific research around vitamin D. At To Better Days, we believe that together, we can treat people better.

As a business, we have invested and will continue to invest in research to support a better understanding of living with pain.

We are investing in research to better understand vitamin D’s ‘journey’ through the body and especially within the epidermis. We have investigated the relationship of our patches to our overall vitamin D levels, to ensure safety and tolerability (there is an extremely remote risk with any vitamin D supplement of building up excessive vitamin D), as well as the possible use of the patches as a substitute for oral supplements. Our research to establish vitamin D’s effect on the nociceptors (pain receptors in the skin) is ongoing. We have learned a lot and we continue to learn more about this incredible vitamin.

To Better Days Research

Consumer Trial

A Consumer trial study carried out with 29 chronic pain sufferers over a week in January 2020 showed:

  • 83% felt the patches relieved their pain
  • 80% felt a difference within the first day
  • 63% experienced relief within the first 30 minutes of use
  • 59% of participants felt the patches worked the same or better than when taking other pain-relieving oral anti-inflammatory medicines such as paracetamol, ibuprofen or aspirin.

 

Safety and Tolerability Trial

  • A trial with 30 participants was conducted over 8 weeks from May to July 2021.
  • Participants used the patches daily to test for safety and tolerability.
  • Run by an independent contract organisation.
  • Results demonstrate no substantial or dangerous increases in OH (25) levels, showing the patches to be safe to use for a continuous period of time without the risk of vitamin D build-up.

Pharmacokinetics Research

 

We undertook research to compare the effect of a 30,000 IU dosage of cholecalciferol D3 administered topically versus orally.

The trial shows no substantial accumulation of the second metabolite, calcidiol (also abbreviated as 25 (OH) D3) in the blood when using patches and instead of an increase in the third metabolite, which is the biologically active form of vitamin D, calcitriol. The oral supplementation showed a spiked increase in all three forms of vitamin D, including calcidiol.

Calcidiol has a half-life of 15 days and can accumulate in adipose tissue over time, with the potential for toxicity and hypercalcemia. Calcitriol has a half-life of only 15 hours, with a very limited risk of cumulative build-up. It circulates as a hormone in the blood, regulating the concentration of calcium and phosphate in the bloodstream and promoting the healthy growth and remodelling of bone.

Our hero ingredient one:

Vitamin D

Research shows vitamin D helps to support healthy bones, nerves, joints and muscles. Our patches provide a strong dose of vitamin D directly to the affected area, where it’s safely absorbed by your body to the damaged nerve.

Our hero ingredient two:

Dextrose

Dextrose, which is chemically identical to glucose, provides sugars to the area that acts as a ‘cell food’ for regeneration. It has been proven to help calm pain receptors, so is a key ingredient in our active joint patches.

How our patches work:

Transdermal delivery

Transdermal delivery supplies active ingredients through the skin via a cream or in our case a patch. This is a widely used technology for the delivery of pharmaceuticals, for example, the use of nicotine patches to alleviate cigarette cravings. To Better Days holds the patent for transdermal delivery of vitamin D for pain conditions.

1: Pills are not always good for you

The main drugs for the treatment of pain and inflammation are NSAIDs – Non-Steroidal Anti-Inflammatory Drugs such as Ibuprofen, Paracetamol and Diclofenac (Voltarol) – and Corticosteroids. NSAIDs can cause gastrointestinal bleeding and thrombosis with long-term use. Steroids cause high blood pressure and fluid retention. These are all serious side effects. Furthermore, even topically their long-term benefit is questionable, so NSAIDs are unlikely to be able to be used permanently or long term. We believe it is fair to say that these treatments can never be a solution for a chronic condition.

2: Transdermal delivery is much more efficient than an oral dosage

Transdermal delivery provides what we need where we need it with less waste in between. Anything oral must be absorbed and metabolised through the digestive system and only then circulate throughout the body in the bloodstream. This is wasteful as much is lost in the first-pass effect of metabolism. In addition, there is an increased risk of side effects with oral delivery compared to transdermal delivery as there can be higher drug peak concentrations. Skin, on the other hand, absorbs gradually and consistently throughout time, meaning lower peak concentrations.

3: The source of pain is at skin level

The nociceptors, the specific receptors which give out pain signals, are located at skin level, fractions of a millimetre away from the surface. They usually protect us by causing pain when exposed to potential harm like burning temperatures or injury. The problem arises when they cause pain without any harm being threatened. Research has established that a shortage of energy, provided by glucose, or an inability to process the glucose to extract its energy, is the cause of this misfiring of pain signals, but not yet why that should arise. The issue is physiological, so targeted transdermal delivery of nutrients directly to the nociceptors makes sense.

Further Reading

Understanding the role in vitamin D in pain, inflammation and many other conditions is burgeoning. Ongoing research shows the essential and life-changing role that vitamin D can play in improving the lives of so many of those living with sustained discomfort.

Pain

Vitamin D and pain

There are literally thousands of research papers covering the great and growing role of vitamin D in a host of conditions. These are a few examples relevant to its mode of action on nociception.

NSAIDS

All non-steroidal anti-inflammatory drugs, known as NSAIDs, have almost identical modes of action: they inhibit the action of the enzyme cyclooxygenase, which would otherwise promote inflammation when a pain signal is triggered. Noteworthy then: none of these actually prevent the pain; they act only after the fact and only on the inflammation.

NICE guidelines

Dr John Lyftogt

  • Dr Lyftogt is a practising physician who discovered the topical application of Vitamin D3 for neuropathic pain on which our patches rely.
  • His primary work has been in guiding other physicians in his techniques and they have published a number of case studies evidencing their success.
  • Dr Lyftogt himself published two articles in the Australasia Musculoskeletal Medicine in November 2008:
  • Pain Conundrums: Which Hypothesis’ on page 72 lays down his guiding principle that pain lies in the body, not the mind.
  • Page 75 is a case study of the treatment of heel pain with a vitamin D3 cream.

Together, we treat people better.