Category: clinical trials

Painkillers may have effect on your baby’s fertility

Nope, you read right.

Scientists have studied data and suggested that the use of painkillers by women during a pregnancy may have effect on their offspring when it comes to future generations’ intent to conceive.

Scientists studied foetal human tissue and the effects that these had under treatment of paracetamol and ibuprofen. Both are common generic medicines used to manage pain, and hence a common feature of them is the management of pain receptors – the dulling of pain to the point that receptors are less responsive so that the body adapts and is less affected. The scientists found that in both cases, when the foetal human tissue was exposed to pain relief drugs, the number of germ cells, which are the ones that develop into sperm and eggs, were reduced after a week.

Hence, the use of painkillers by women during their pregnancy could lead to these effects being transferred to their off spring.

In other words, their children could have difficulty conceiving.

The problem with this research, as with many other similar kinds, is that it was done not on humans but on tissue-compatible cases. Tests were done on mice and tissues grown in laboratory, and while they have similar bearing to humans, we cannot say for definite if this is what would happen. Unfortunately, it is unethical to prescribe high doses of pain-relief to women only to observe the effects on their offspring a generation later. That cannot happen.

Current pregnancy guidelines do state that it is safe to take paracetamol, but only at the lowest dose and for the shortest space of time.

It is best prescribed under the supervision of a doctor, but it is difficult to prevent pregnant women to walk into a supermarket and get some for themselves!

The study was carried out by researchers from the University of Edinburgh and Copenhagen University Hospital. It was funded by the UK Medical Research Council, the Wellcome Trust, and a British Society of Paediatric Endocrinology and Diabetes Research Award. It was published in the peer-reviewed journal Environmental Health Perspectives.

The researchers did say their results suggested that painkillers have an effect on the level of germ cells, which may alter how DNA is formed and so could potentially affect future generations. But these results came from tests that were not performed in humans, and many other factors that contribute to fertility were also not accounted for.

And while these kinds of studies may never be fully conclusive, it is always better to be aware, than sorry!

Ibuprofen and the fertile imagination

There is an astounding variety of painkillers available for purchase both in supermarkets, chemists, and corner shops. Just take a look at the shelf of your nearest Tesco or Sainsbury. You have various types of paracetamol, both made by pharmaceutical companies as well as in house versions of the supermarkets.

What is the difference between them and why are there so many varieties?

When pharmaceutical companies take on the decision to manufacture a new drug, they are given a twenty-year patent which covers the research into the product, testing and manufacturing, and sales. The period of twenty years, a monopoly as such, is to reward them for the time invested into the research. In the course of the research into the product, pharmaceutical companies must publish various forms of medical evidence and put it into public domain, so that if there is any medical evidence that points to the contrary, these can be debated both by the medical community and the pharmaceutical world.

The problem, if we can call it that, is that business is a very competitive world, and if research is put out in the open without any form of intellectual protection, any manufacturer can pounce on the research undertaken by someone else who has taken the effort and trouble to do it, and produce their product off the back of it. They would have saved the time and cost investment.

Imagine if a writer has taken the time to research a topic, organise his thoughts succinctly, and find a publisher. And when his book is published, someone else photocopies it, binds the copied pages and subsequently peddles it as their own.

Within the period of twenty years, a pharmaceutical company has to research, market and sell enough of the product to recoup the investment costs and profit. It is after the twenty period has expired that the other sharks enter the fray. This is where you get the supermarket brands of the product, which are cheaper because they don’t need to pay for research.

What is the difference between brand names and generics? They essentially do the same thing. But if the original company has done a good job in making the product synonymous with its own brand, then you might think they are better. If you take Neurofen for headaches, then you might think it better than Tesco ibuprofen, even though they both contain the same active ingredient.

But pharmaceutical companies have to reinvent themselves, to make varieties of the same product, otherwise they will lose their market share and eventually die out. If you realise that Neurofen is matched in ability by the cheaper Tesco ibuprofen, you would buy the latter, unless you are persuaded that Neurofen for Flus and Colds, or Neurofen Muscle Pain has something clinically formulated for that specific purpose.

So the shelves of supermarkets are stacked with different priced products with the same active ingredient, as well as different varieties of the same product.

Painkillers are a common medicine because there will always be a demand for pain management.

The availability of pain relief medicine means it is easy for the average individual to obtain them. There is the possibility of overdose, and while this may be a rarity, there is a higher likelihood that the greater availability may mean individuals are taking more doses than they should.

What are the long term health impacts of taking ibuprofen for prolonged periods?

One problem is that the body adapts and so the long-term resistance is affected. In certain groups such as the elderly, aspirin also increased the risks of stomach bleeding.

A clinical trial seemed to suggest it may impact on testosterone production and hence affect fertility.

Test subjects were administered 2 x 600mg doses of ibuprofen daily for six weeks, much higher than the average dose. The sample size was only a small group of 30, and half received ibuprofen, while the others received a placebo. It would have been better if the subject group had been greater, so that there could be more confidence in the test results, but because a test of such nature is to examine human resistance to what is essentially toxicity, it would have been unethical to involve a large group of participants. The research findings found that there was no impact on testosterone already in the body, but the pain relieving nature of ibuprofen, as a relaxant of sorts, had impact on the production of testosterone and appeared to slow down production.

How did these reports end up in the media? The tabloids had a field day, and you would undoubtedly have found one with the usual wisecracks about balls and other man-related genitalia, along the lines of “Ibuprofen shrinks your balls” or “Ibuprofen smalls your balls”.

Maybe instead of Ibuprofen for colds or fast relief, we need Ibuprofen for Dummies.

Your daily sausage roll may exact its revenge on you in good time

Ever wonder why people go on a vegetarian or a vegan diet? There are many reasons I can think of.

The most common one is that people are very much against animal cruelty. People who avoid eating animal-based products are against the farming of animals, because they are convinced that animals are treated inhumanely. For example, battery hens are kept in small cages in large densities. Imagine if you and your fellow co-workers were put together in a small room, without any desks, and told to make the most of it. You’d all be up in arms about the way you were treated. The only difference between you and hens is that hens can’t protest about it.

The transition to a vegan diet is not just about not eating animals, although this can be a factor too. Vegans are against the eating of animal meat because of the way farm animals are killed. Cows, pigs and chickens, the main farm animals that are killed to provide the common English foods such as the English breakfast comprising sausages, bacon and eggs, are – in the opinion of vegans – inhumanely killed, despite the best of measures.

Do you know how a chicken is killed before it ends up deep fried in bread crumbs and served with your chips and bottle of cola? There are two main ways. The first is by electric methods. First of all, the birds are shackled to a conveyor belt by their legs, upside down. Needless to say, they don’t willingly walk to the machine and pick their positions. There is a lot of fluttering about, human exasperation, and rough handling of the birds which may result in broken bones – who cares, right? After all, the bird is going to be dead soon – before the conveyor belt brings the birds upside down into a water bath primed with an electric circuit. The moment the bird’s head touches the water, it is electrocuted to death.

The second method involves gassing to death. Birds are transported in their crates and exposed to suffocation. This method is arguably more humane, supporters say, because the birds are not manhandled. But don’t be fooled into thinking the bird’s welfare is under consideration. It is a faster, less human-intensive way of killing the birds. Sling them in the box and gas them to death. No messing around trying to catch the flapping things. Avoiding the need to shackle them also saves time.

There is a third reason often quoted for going further in being a vegan. Cows produce vast amounts of methane and if everyone stopped eating beef, it would be better for the enviroment. In this instance, it is not so much for the animal’s welfare, but more for the sake of avoiding the environmental pollution by the animal.

There may soon be another fourth reason for avoiding meat. Processed meats – which have been preserved using methods such as salting, curing, smoking or adding preservatives – have been linked with cancer.

A study involving 262,195 UK women showed links of breast cancer and processed meat. Postmenopausal women who ate processed meat had a 9% higher chance of getting breast cancer than women who ate no processed meat. Those who consumed more than 9g of processed meat had a 21% chance of getting cancer in comparison to those who avoided it altogether.

The study is significant because the sample size is large – not just 100 women, or a small negligible figure whose results may bias findings, but over 250,000 women; more than enough to be taken seriously.

The women were all between the ages of 40-69 and free of cancer when they were recruited for the study before 2010. They were followed for a period of seven years and the results examined.

Process meats are thought to possibly cause cancer because the methods involved in processing the meat may lead to the formation of cancer-causing compounds called carcinogens.

What is not so clear is whether it was the eating of processed meats in isolation that caused the development of cancer. There are other factors that should be taken into account, of course, such as alcohol, exercise, work stress, lifestyle factors and body mass index. Certain ethnicities may also be prone to developing cancer because of other dietary factors such as cooking with oil, ghee or lard.

The results also did not suggest that the findings would be equally applicable to men.

Nevertheless, it would be a good idea, if you were an older woman, to avoid eating processed meat every day. Instead the consumption could be limited to once every other day, or eating it as an occasional treat. Or cut out the meat completely – a switch to a vegetarian or a vegan diet would not only be good for your health. You would be considering the environment too.

A short history of non-medical prescribing

It had long been recognised that nurses spent a significant amount of time visiting general practitioner (GP) surgeries and/ or waiting to see the doctor in order to get a prescription for their patients. Although this practice produced the desired result of a prescription being written, it was not an efficient use of either the nurses’or the GPs’time. Furthermore, it was an equally inefficient use of their skills, exacerbated by the fact that the nurse had usually themselves assessed and diagnosed the patient and decided on an appropriate treatment plan.

The situation was formally acknowledged in the Cumberlege Report (Department of Health and Social Security 1986), which initiated the call for nurse prescribing and recommended that community nurses should be able to prescribe from a limited list, or formulary. Progress was somewhat measured, but The Crown Report of 1989 (Department of Health (DH) 1989) considered the implications of nurse prescribing and recommended suitably qualified registered nurses (district nurses (DN) or health visitors (HV)) should be authorised to prescribe from a limited list, namely, the nurse prescribers’formulary (NPF). Although a case for nurse prescribing had been established, progress relied on legislative changes to permit nurses to prescribe.

Progress continued to be cautious with the decision made to pilot nurse prescribing in eight demonstration sites in eight NHS regions. In 1999, The Crown Report II (DH 1999) reviewed more widely the prescribing, supply and administration of medicines and, in recognition of the success of the nurse prescribing pilots, recommended that prescribing rights be extended to include other groups of nurses and health professionals. By 2001, DNs and HVs had completed education programmes through which they gained V100 prescribing status, enabling them to prescribe from the NPF. The progress being made in prescribing reflected the reforms highlighted in The NHS Plan (DH 2000), which called for changes in the delivery of healthcare throughout the NHS, with nurses, pharmacists and allied health professionals being among those professionals vital to its success.

The publication of Investment and Reform for NHS Staff –Taking Forward the NHS Plan (DH 2001) stated clearly that working in new ways was essential to the successful delivery of the changes. One of these new ways of working was to give specified health professionals the authority to prescribe, building on the original proposals of The Crown Report (DH 1999). Indeed, The NHS Plan (DH 2000) endorsed this recommendation and envisaged that, by 2004, most nurses should be able to prescribe medicines (either independently or supplementary) or supply medicines under patient group directions (PGDs) (DH 2004). After consultation in 2000, on the potential to extend nurse prescribing, changes were made to the Health and Social Care Act 2001.

The then Health Minister, Lord Philip Hunt, provided detail when he announced that nurse prescribing was to include further groups of nurses. He also detailed that the NPF was to be extended to enable independent nurse prescribers to prescribe all general sales list and pharmacy medicines prescribable by doctors under the NHS. This was together with a list of prescription-only medicines (POMs) for specified medical conditions within the areas of minor illness, minor injury, health promotion and palliative care. In November 2002, proposals were announced by Lord Hunt, concerning ‘supplementary’prescribing (DH 2002).

The proposals were to enable nurses and pharmacists to prescribe for chronic illness management using clinical management plans. The success of these developments prompted further regulation changes, enabling specified allied health professionals to train and qualify as supplementary prescribers (DH 2005). From May 2006, the nurse prescribers’extended formulary was discontinued, and qualified nurse independent prescribers (formerly known as extended formulary nurse prescribers) were able to prescribe any licensed medicine for any medical condition within their competence, including some controlled drugs.

Further legislative changes allowed pharmacists to train as independent prescribers (DH 2006) with optometrists gaining independent prescribing rights in 2007. The momentum of non-medical prescribing continued, with 2009 seeing a scoping project of allied health professional prescribing, recommending the extension of prescribing to other professional groups within the allied health professions and the introduction of independent prescribing for existing allied health professional supplementary prescribing groups, particularly physiotherapists and podiatrists (DH 2009).

In 2013, legislative changes enabled independent prescribing for physiotherapists and podiatrists. As the benefits of non-medical prescribing are demonstrated in the everyday practice of different professional groups, the potential to expand this continues, with consultation currently under way to consider the potential for enabling other disciplines to prescribe.

The bigger issues that come with preventing hearing loss

Is there cause for optimism when it comes to preventing hearing loss? Certainly the latest research into this suggests that if positive effects experienced by mice could be transferred to humans and maintained for the long term, then hereditary hearing loss could be a thing of the past.

It has always been assumed that hearing loss is always down to old age. The commonly held view is that as people grow older, their muscles and body functions deteriorate with time to the point that muscle function is impaired and eventually lost. But hearing loss is not necessarily down to age, although there are cases where constant exposure to loud noise, over time, causes reduced sensitivity to aural stimuli. Over half of hearing loss cases are actually due to inheriting faulty genetic mutations from parents.

How do we hear? The hair cells of the inner ear called the cochlea respond to vibrations and these signals are sent to the brain to interpret. The brain processes these signals in terms of frequency, duration and timbre in order to translate them into signals we know.

For example, if we hear a high frequency sound of short duration that is shrill, our brain interprets these characteristics and then runs through a database of audio sounds, an audio library in the brain, and may come up with the suggestion that it has come from a whistle and may signify a call for attention.

What happens when you have a genetic hearing loss gene? The hairs on the inner ear do not grow back and consequently sound vibration from external stimuli do not get passed on to the brain.

With progressive hearing loss too, the characteristics of sound also get distorted. We may hear sounds differently to how they are produced, thereby misinterpreting their meaning. Sounds of higher and lower frequency may be less audible too.

How does that cause a problem? Imagine an alarm. It is set on a high frequency so that it attracts attention. If your ability to hear high frequencies is gradually dulled then you may not be able to detect the sound of an alarm going off.

As hearing gradually deteriorates, the timbre of a sound changes. Sharper sounds become duller, and in the case of the alarm, you may hear it, but it may sound more muted and the brain may not be able to recognise that it is an alarm being heard.

Another problem with hearing loss is the loss of perception of volume. You may be crossing the road and a car might sound its horn if you suddenly encroach into its path. But if you cannot hear that the volume is loud, you may perceive it to be from a car far away and may not realise you are in danger.

The loss of the hairs in the inner ear is a cause of deafness in humans, particularly those for whom hearing loss is genetic. Humans suffering from hereditary hearing loss lose the hairs of the inner ear, which result in the difficulties mentioned above. But there is hope. In a research experiment, scientists successfully delayed the loss of the hairs in the inner ear for mice using a technique that edited away the genetic mutation that causes the loss of the hairs in the cochlea.

Mice were bred with the faulty gene that caused hearing loss. But using a technology known as Crispr, the faulty gene was replaced with a healthy normal one. After about eight weeks, the hairs in the inner ears of mice with genetic predisposition to hearing loss flourished, compared to similar mice which had not been treated. The genetic editing technique had removed the faulty gene which caused hearing loss. The treated mice were assessed for responsiveness to stimuli and showed positive gains.

We could be optimistic about the results but it is important to stress the need to be cautious.

Firstly, the research was conducted on mice and not humans. It is important to state that certain experiments that have been successful in animals have not necessarily had similar success when tried on humans.

Secondly, while the benefits in mice were seen in eight weeks, it may take longer in humans, if at all successful.

Thirdly, we should remember that the experiment worked for the mice which had the genetic mutation that would eventually cause deafness. In other words, they had their hearing at birth but were susceptible to losing it. The technique prevented degeneration in hearing in mice but would not help mice that were deaf at birth from gaining hearing they never had.

Every research carries ethical issues and this one was no different. Firstly, one ethical issue is the recurring one of whether animals should ever be used for research. Should mice be bred for the purposes of research? Are all the mice used? Are they accounted for? Is there someone from Health and Safety going around with a clipboard accounting for the mice? And what happens to the mice when the research has ceased? Are they put down, or released into the ecosystem? “Don’t be silly,” I hear you say, “it’s only mice.” That’s the problem. The devaluation of life, despite the fact that it belongs to another, is what eventually leads to a disregard for other life and human life in general. Would research scientists, in the quest for answers, eventually take to conducting research on beggars, those who sleep rough, or criminals? Would they experiment on orphans or unwanted babies?

The second, when it comes to genetics, is whether genetic experimentation furthers good or promotes misuse. The answer, I suppose, is that the knowledge empowers, but one cannot govern its control. The knowledge that genetic mutation can be edited is good news, perhaps, because it means we can genetically alter, perhaps, disabilities or life-threatening diseases from the onset by removing them. But this, on the other hand, may promote the rise of designer babies, where mothers genetically select features such as blue eyes for their unborn child to enhance their features from birth, and this would promote misuse in the medical community.

Would the use of what is probably best termed genetic surgery be more prominent in the future? One can only suppose so. Once procedures have become more widespread it is certain to conclude that more of such surgeons will become available, to cater for the rich and famous. It may be possible to delay the aging process by genetic surgery, perhaps by removing the gene that causes skin to age, instead of using botox and other external surgical procedures.

Would such genetic surgery ever be available on the NHS? For example, if the cancer gene were identified and could be genetically snipped off, would patients request this instead of medical tablets and other external surgical processes? One way of looking at it is that the NHS is so cash-strapped that under QALY rules, where the cost of a procedure is weighed against the number of quality life years it adds, the cost of genetic surgery would only be limited to more serious illnesses, and certainly not for those down the rung. But perhaps for younger individuals suffering from serious illnesses, such as depression, the cost of a surgical procedure may far outweigh a lifetime’s cost of medication of anti-depressant, anti-psychotics or antibiotics. If you could pinpoint a gene that causes a specific pain response, you might alter it to the point you may not need aspirin, too much of which causes bleeds. And if you could genetically locate what causes dementia in another person, would you not be considered unethical if you let the gene remain, thereby denying others the chance to live a quality life in their latter years?

Genetic editing may be a new technique for the moment but if there is sufficient investment into infrastructure and the corpus of genetic surgery information widens, don’t be surprised if we start seeing more of that in the next century. The cost of genetic editing may outweigh the cost of lifelong medication and side effects, and may prove to be not just more sustainable for the environment but more agreeable to the limited NHS budget.

Most of us won’t be around by then, of course. That is unless we’ve managed to remove the sickness and death genes.

Ethically spending a million pounds on useful research

Does offering financial incentives encourage mothers of newborns to breastfeed? While this may seem incredulous, a study actually was implemented in parts of England to see if this would be the case.

More than 10,000 mothers across regions such as South Yorkshire, Derbyshire and north Nottinghamshire took part in the trial, where mothers were given a hundred and twenty pounds if they breastfed their babies, and a further eighty pounds if they continued up to the point the babies were six months old. That is to say mothers received two hundred pounds if their babies were breastfed up to the age of six months.

But why was this implemented in the first place? One of the reasons the study was done was to see if financial incentives would help raise the rate of breastfeeding in the UK. In some parts of the UK, only one in eight babies are breastfed past eight weeks. The early suspension of breastfeeding causes later problems in life for babies, and this was a study to see if it would be possible to save a reported seventeen million pounds in annual hospital admissions or GP visits.

How were these women chosen? They were picked from areas which were reportedly low-income ones. There was a suggestion that in low-income areas, mothers feel obliged to return to work quickly and breastfeeding is inconvenient and a reason why mothers stop it.

The financial incentive did result in a rise of six percentage points, from 32% to 38%. This meant that over six hundred more mothers in the ten thousand breastfed their babies for up to six months instead of the hypothetical eight week line.

Should we get excited about these results? Caution is to be exercised.

As a few leading academics noted, there was no way to monitor a reported increase. The mother’s word was taken at face value but there was no way to monitor that a prolonged breastfeeding period actually took place. It would not be inaccurate to say that of these six hundred mothers, some merely reported they had breastfed for longer but without actually doing it. If you live in an income-deprived area, and were offered two hundred pounds of shopping at a time when you needed it, without having to do much apart from saying “Yes, I breastfed”, wouldn’t you take the easy money?

It was mentioned that if the results did have a high percentage of trustworthiness to them, in other words, if mothers breastfed as they said they had done, it would help normalise breastfeeding in regions where it might cause embarrassment to the mother. Why might breastfeeding cause embarrassment? For example, in some social situations it might be slightly awkward to reveal normally covered parts of the body in public.

How much did the scheme cost? If we assume that 38% of 10000 mothers breastfed and claimed these financial vouchers, that’s around 4000 mothers each claiming two hundred pounds, at a cost of eight hundred thousand pounds.

Wow. Eight hundred thousand pounds of free shopping for which an outcome cannot be undisputably proven. Where does all the money come from?

The Medical Research Council was funded to the tune of up to seven hundred and fifty-five million pounds in 2016/17, or which nearly half was provided as grants to researchers. But while all that may sound as a lot of money, surely there should be more accountability in how the money is used. Using up nearly a million pounds of that money for a trial whose results cannot be justified is not a good use of money.

But perhaps the babies’ height, weight and other factors pertaining to breastfeeding could have been taken? For example, if we know that breastfeeding has benefits in certain areas, such as in growth charts, perhaps the babies that were breastfed in that study could have been measured against babies who had not been breastfed to see if there had been any positive gain, and something that could correlate to breastfeeding over the six month period?

Imagine if this had been a study about literacy. Imagine that mothers who read two stories to their child up to the age of four years would receive two hundred pounds. Surely, at the end of the period, the research scientists would not merely be going to the mothers and saying “Did you read to your child? Yes? Here’s two hundred pounds.” They would try to assess the child, perhaps by means of a literacy test of some form, to see if any reading had actually taken place.

Otherwise it is just money down the drain for results which cannot be proven and cannot be relied on. In that case, what is the purpose of spending money on hearsay?

Did giving eight hundred thousand pounds encourage mothers in income-deprived areas to breastfeed for longer periods? Who knows? The only thing we can be sure of is that eight hundred thousand pounds made them say they did it.

Migraines could be a headache of the past

Is there hope for the many millions of migraine sufferers in the United Kingdom and around the world? Researchers at King’s College Hospital certainly believe that this is the case. While they are cautious about the findings of their latest research, the results certainly are one that point towards optimism for migraine sufferers.

It is estimated that the number of migraine attacks everyday in the UK number over 190,000. This figure was estimated by the Migraine Trust, and it was probably obtained by taking a sample size of the population, taking into account the number of migraine attacks experienced within that group and then multiplying it by the general population in the United Kingdom. This of course means two things: firstly, the figure was proposed by a group that has an interest in promoting awareness about migraines and is hence slightly biased, probably over-estimated. Secondly, bearing in mind that the UK population is over 66 million, and it is unlikely that the Trust surveyed 1 million people – or even anywhere near that – any differences could have been amplified by over 66 times.

What is the difference between a migraine and a normal headache? A migraine is a headache which happens frequently. Migraines themselves are classed as two types. Headaches which happen more than 15 days a month are known as chronic migraine, while episodic migraine is a term used to describe headaches which happen less than fifteen times a month.

The research uncovered that a chemical in the brain was involved both in the feeling of pain and sensitivity to sound and light. This chemical is known as calcitonin gene-related peptide, or CGRP. If CGRP is neutralised, or if part of a brain cell which it interacts with is blocked, then pain receptors are dulled and migraines are reduced.

There are currently four drug companies in the race to develop a CGRP neutraliser.

Race is an accurate term, for the company that develops and trials the drug successfully may win the patent for developing and marketing the drug over twenty years. Drug companies or pharmaceuticals are normally granted that period to reward them for the time and cost invested into research.

One such company, Novartis, trialled an antibody, erenumab on episodic migraine sufferers. Those who took part in the trial suffered migraines on an average of eight days a month.

955 patients took part in the trial and half of those who received injections of erenumab successfully halved their number of migraine days per month. 27% of patients also reduced their number of migraine days without treatment. The results suggest that the drug was successful, particularly as it worked for over 450 people, and that if it were used for those with chronic migraine it might be equally successful. Even if the same percentage were maintained (50% vs 27%), the number of working days saved by migraine prevention could have significant savings for the economy.
Another pharmaceuticals company, Teva, produced another antibody, fremanezumab, and trialed it on 1130 patients. Unlike Novartis’s trials, the participants in Teva’s were those with chronic migraine, with over 15 or more attacks each month. In the Teva trial, 41% of patients reportedly halved the number of days that they suffered migraine attacks. 18% reported the same effect, so the confidence interval in the trial is pretty high and suggests a high degree of positive use.

The study is very important and useful because of the understanding it offers in treating migraine, and the medical products can reduce the frequency and severity of headaches. It makes for fewer days lost to the disease and more positive, functioning people.

Besides CGRP antibodies, there are other current treatments for migraine such as epilepsy and heart disease pills. Even botox is sometimes used. However, all three come with side-effects and are not necessarily the best for everyone.

The hope is that CGRP antibodies, which are traditionally more expensive to manufacture, will in the long term be available at a more affordable cost, and would benefit those who currently get no benefit from existing therapies.

If the estimation that one in seven people live with regular migraine is accurate, migraine reduction could have significant life-improvement effects for humans. Chronic migraine is in the top seven disabling conditions and improvements in understanding it and how to manage it would not only improve the quality of life for those who suffer with it, but also in reducing the number of work days lost for the economy. But the benefits do not just remain with migraine sufferers. Having to live with chronic disabling conditions often leads to other symptoms such as depression. Who knows? Perhaps CGRP antibodies may even negate the effect of depression, resulting in a secondary effect. It may be possible that those who suffer from migraine alongside depression may even not require treatment for the latter if the CGRP antibodies prove to be effective.
Can you imagine a world without anti-depressants? At the moment millions live on some pain-relief medication of some sort. It would be great if they could be phased out. Although it might not be so great for the economy!

Should we be excited about the results? Well, yes. The combined large sample size of both studies, of over 2000 migraine sufferers showed that there was some weight behind the study compared to if – for example – it had been done only on one hundred participants. Secondly, while the research was undertaken by pharmaceutical companies, the outcome was actionable, meaning that it produced a result that was useful, rather than one that merely formed the prelude to a more extensive study. In previous posts I demonstrated how some – such as the coffee umbrella review – did not produce any significantly useful outcome. But we know from this particular research that it may work to neutralise either CGRP, or lessen its interaction with the particular brain cells in order to lower the effect of migraine.

Did the media have a field day with this? Unsurprisingly, no. You see, good research does not lend itself to sensationalist headlines.