Recently, on the CBC television program, The Dragon’s Den (Episode 3, available here), a product that the sales team for Roxon claimed to prevent and treat migraine and tension headaches was demonstrated. The product, Cefaly, is a tiara-like headband worn over the forehead delivers small electrical impulses. Their demonstration satisfied the Dragons, as they received $100,000 in return for 5% royalties.
The question is: does it work? The answer, it appears, is maybe, but not perhaps the way the marketing campaign claims.
First of all, anyone who has ever suffered from chronic headaches knows they can be totally debilitating for the duration of the pain and sometimes longer. The sufferer often remains in bed in the dark and quiet for hours and sometime days. There can be major negative impacts on work, relationships, and quality of life for the 300 million migraine sufferers.
Secondly, it is critical to have your pain evaluated by a MD to rule out such causes as brain tumours, hypertension, diabetes, or other diseases that may be life threatening.
Over the years, a lot of research money has been spent determine the causes of, and most effective treatments for Chronic Daily Headaches. Treatments range from lifestyle changes (diet, exercise, etc), to drugs and surgically implanted electrodes. None of these work 100% of the time in 100% of patients.
Since medical science has not developed a 100% effective cure, and pain is something that most often waxes and wanes over time, it is ripe for alternative practitioners to jump in with exaggerated or fabricated claims. It is important for sufferers and physicians to evaluate effective versus frivolous treatments.
The company is very careful not to make any definitive medical claims beyond pain relief.
Now available in Canada, Cefaly is a drug-free method for treating migraine pain and preventing migraine headaches from ever coming on.
Much of their advertising is based around their certifications.
Cefaly is a CE and ISO certified medical device designed to treat and prevent migraine headaches. Cefaly can considerably reduce or replace the consumption of side effect producing medications. Cefaly is the first cranial analgesic electrotherapeutic device to acquire ISO medical certification proven effective on migraine pain with no side effects.
Sounds very good. However, neither of these certifications has anything to say about effectiveness. CE or “Conformité Européene”, is primarily about consumer safety.
CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.
CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.
Certainly you can be assured that the product is built to high standards, and devices that do not deliver the specified charges will not be on the market.
How comfortable can you be that the product will actually reduce or remove your pain? They have a page of medical references that I have evaluated below. Their website bases their treatment modality on two somewhat related concepts. Transcutaneous Electrical Nerve Stimulation (TENS), something that many of us who have been for physiotherapy are familiar with, and electro-acupuncture.
I will not comment on acupuncture, electro or other, in this article, as that would no doubt side-track any discussion. If you want more information, you can learn from the experts at Science Based Medicine.
Although TENS has been widely used for many years, the value of the practice in long term pain relief is far from settled. There are numerous studies that support TENS and some that are less than enthusiastic. For example, in a review published by Cochrane in 2008, concludes:
Published literature on the subject lacks the methodological rigour or robust reporting needed to make confident assessments of the role of TENS in chronic pain management.
A somewhat older review from 1998, published in the journal Health Technology Assessment reports:
Transcutaneous electrical nerve stimulation (TENS) has been shown not to be effective in postoperative and labour pain. In chronic pain, there is evidence that TENS effectiveness increases slowly, and that large doses need to be used. There is lack of evidence for the effectiveness of TENS in chronic pain.
On their website, Cefaly refers to a number of studies that specifically evaluate their product.
12 laboratory studies to determine the choice of the most effective and precise parameters
8 case report studies to confirm the effectiveness on patients regarded as ‘difficult cases’
3 pilot studies on series of patients suffering from tension headaches or migraines
2 blind studies to confirm the extent of the effectiveness
In total, more than 5,000 treatments were included in the studies to validate Cefaly’s clinical effectiveness.
However, searches in both Medline and PubMed did not yield any results referencing Cefaly by name. Without exact references, it is impossible to verify these studies. If anyone can find these, we could evaluate them in the discussion.
So is Cefaly an effective treatment for migraine headaches? Maybe, but any effect is probably due to the placebo effect. In other words, doing something can be better than doing nothing. It it worth the $300 purchase price? Only you can decide. I have merely attempted to bring a little bit of balance to their marketing claims.
Here is one of Cefaly’s marketing ads.
Below I have attempted to examine the studies that are listed on their site. In the left-hand column is their list hyperlinked. In the right-hand column are my comments, some quotes from the papers and some hyperlinks for further reading. In most cases I only had access to abstracts and the entire papers would assuredly have more details on study design and evaluation.
Very few, if indeed any, can be directly tied to the claims made by the company. This raises the question—why include the list other than to give the marketing claims the pretence of scientific validity?
The results of this review are inconclusive; the published trials do not provide information on the stimulation parameters which are most likely to provide optimum pain relief, nor do they answer questions about long-term effectiveness.
Link to guidelines. Comment on TENS: On Tens and acupuncture: Patients who enquire about transcutaneous electrical stimulation and acupuncture should be made aware of the lack of firm evidence as to the benefits and cost- effectiveness of these treatments in the management of migraine
Repeated measure analysis of variance indicated that grouping variables of Biofeedback treatment, symptoms being evidenced less than 2 years and receiving over 15 treatment sessions best predicted successful intervention.
Based upon animal models: The experimental model of electrical trigeminal ganglion stimulation or systemic capsaicin administration has proven effective in detecting cellular activation in brainstem trigeminal nuclei
Article is in French. Bing english translation: Serotonin (5-hydroxytryptamine, 5-HT) is a neurotransmitter involved in the control of many brain functions: cycles/sleep, thermoregulation, behaviour of hunger/satiety, sexual behaviour, nociception, etc. In addition, neuropsychiatric disorders such as depression, dementia and anxiety are associated with functional abnormalities of serotonergic neurons. This diversity of functions of the 5-HT is most likely related to the multiplicity of its receptors (at least ten), some of them being coupled with several effector systems.
Physical Therapy 58 : 1467-1473 (1978)
Peripheral neural excitability. Implications for transcutaneous electrical nerve stimulation.
Experiments were performed with a peripheral neurostimulator, used clinically for pain relief, on isolated cat cutaneous peripheral nerve to determine the effect of electrical stimulation on components of the compound action potential. The results show that neurostimulation alters the conduction velocity and the amplitude of both the A-alpha and beta and the A-delta waves with the more slowly-conducting A-delta component showing the greatest changes. This direct alteration of peripheral nerve activity distal to the first synapse in the spinal cord might contribute to the mechanism of pain relief.
John Underhay, also known as Peicurmudgeon, is just your average atheist, left leaning, SCUBA diving, snorkeling, biker. He lives on PEI and spends some of his time attempting to point out the flaws and or dangers in promoting ideas that run contrary to the laws of physics, chemistry, or biology. He has a BSc (Biology) and an MSc (Pharmacology) from the University of Prince Edward Island, and is currently retired.
You can read more of his posts at http://peicurmudgeon.wordpress.com/