”Sunshine vitamin 'may treat asthma'”, BBC News informs us, as a new lab-based study suggests vitamin D could help control symptoms of severe asthma.

Asthma is caused by inflammation of the airways, related to malfunctioning of the body’s immune system. In theory, the immune system mistakes harmless substances, such as dust mites, as a threat and triggers inflammation of the lungs and airways (which causes the symptoms of asthma).

The study in question looked at IL-17A, which is one of the molecules thought to be associated with the malfunctioning immune response seen in asthma. Researchers examined whether vitamin D had an effect on the levels of the molecule produced by white blood cells in a laboratory experiment.

Researchers found that vitamin D reduced the levels of IL-17A produced by cells from people with asthma. This included cells from people who had previously failed to respond to the treatment of choice for severe asthma – oral corticosteroids – often referred to as steroids.

While this study suggests that vitamin D can have an effect on IL-17A levels in the laboratory, it is certainly too early to hail vitamin D as a potential “cure” for asthma. A positive effect on cells in the lab does not guarantee vitamin D supplements will improve symptoms for people with asthma. Clinical trials in people with asthma are ongoing to test whether this will be the case.

Where did the story come from?

The study was carried out by researchers from King’s College London; Queen Mary, University of London, and the Homerton University NHS Foundation Trust. It was funded by Asthma UK and the National Institute for Health Research, and some researchers received Medical Research Council Funding. The study was published in the peer-reviewed Journal of Allergy and Clinical Immunology.

This study was reported by the BBC, Daily Mail, and the Daily Express. The BBC correctly points out that treating asthma patients with vitamin D “has not yet been tested”. The main text of the Mail’s coverage is generally accurate, although their headline suggests that “Vitamin D ‘helps beat the symptoms of asthma’”, when this was not assessed by the study. The Express’s coverage over-interprets the results by suggesting that “Soaking up sun could be a cure for asthma” or could be “the best way of treating asthma”.

What kind of research was this?

This was a laboratory study looking at the effect of vitamin D on one type of white blood cell (T helper cells called TH17 cells) from people with asthma.

One type of T helper cell called TH2 is known to be involved in inflammation of the airways in asthma. However, some evidence suggests that other T cells may also play a role.

TH17 cells are involved in defending the body against bacterial and fungal infections. There is some evidence that these cells may be involved in severe asthma. Also, one of the inflammatory substances produced by these cells, called IL-17A, may exacerbate asthma and reduce patients’ ability to respond to standard treatment for severe asthma – oral corticosteroids (steroids).

Previously, studies had shown that vitamin D could influence the T cells from patients with severe asthma, and also affect TH17 cells. The researchers in the current study wanted to see if vitamin D affected IL-17A production by TH17 cells collected from asthma patients. They also wanted to see whether this effect was different in people who were resistant to steroid treatments.

What did the research involve?

The researchers took blood from 10 healthy adults and 28 patients with moderate to severe asthma and extracted white blood cells, including T cells. The patients had to have had diagnosed asthma for at least six months. Of the patients, 18 had asthma that did not respond as well to oral steroid treatment (steroid resistant asthma), and 10 had asthma that responded to steroids.

The researchers grew the white blood cells in the laboratory, either with or without vitamin D and the steroid dexamethasone, and looked at how much IL-17A was being produced. They assessed whether this varied between people with and without asthma, or in people with steroid resistant asthma.

What were the basic results?

White blood cells from people with asthma produced higher levels of IL-17A than those from non-asthmatic patients. Furthermore, white blood cells from people with steroid resistant asthma produced the highest levels of IL-17A.

Treating the white blood cells with vitamin D reduced the production of IL-17A. This reduction occurred in cells from people with steroid-resistant asthma and steroid-sensitive asthma, and was not affected by adding the steroid dexamethasone.

How did the researchers interpret the results?

The researchers concluded that their results support the hypothesis that vitamin D could improve disease control in people with asthma by reducing IL-17A levels, regardless of whether the person’s asthma is steroid-resistant.

Conclusion

The current laboratory study suggests that vitamin D can reduce white blood cell production of an inflammatory molecule implicated in asthma.

These results were obtained from cells in the laboratory, and further research will be needed to determine whether this effect will also be seen if people with asthma are given vitamin D.

While the results perhaps give a reason to investigate vitamin D further, not all treatments showing initially positive results in laboratory studies go on to have a positive effect on real-world clinical outcomes.

The good news is, as the Daily Mail reports, the results of this study are being followed up with a randomised controlled trial in participants with steroid resistant asthma.

Randomised controlled trials are the best way of testing if treatments are effective. This trial, and others, will tell us if vitamin D works as a treatment for asthma and if so, who it might be effective at treating. 

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Links To The Headlines

Sunshine vitamin 'may treat asthma'. BBC News, May 20 2013

Vitamin D 'helps beat symptoms of asthma’. Daily Mail, May 20 2013

Soaking up sun could be a cure for asthma. Daily Express, May 20 2013

Links To Science

Nanzer AM, Chambers ES, Ryanna K, et al. Enhanced production of IL-17A in patients with severe asthma is inhibited by 1α,25-dihydroxyvitamin D3 in a glucocorticoid-independent fashion. The Journal of Allergy and Clinical Immunology.

“Double drug hope for brittle bone sufferers”, reports the Daily Mail.

This headline follows a small but well-designed trial of treatments for postmenopausal osteoporosis. As women go through the menopause, levels of the hormone oestrogen begin to fall. This drop in oestrogen can lead to a thinning and weakening of the bones, increasing the risk of broken bones (fractures).

While current treatments can help prevent further weakening of the bones, they are not particularly effective at restoring bone strength – known as bone mineral density (BMD). In this study, researchers found that using a combination of teriparatide (Forsteo) and denosumab (Prolia) led to a significant improvement in BMD, when compared to using either medicine on its own.

While this research is encouraging, there are still questions that need answering. For instance, it isn’t clear whether this combination treatment is effective at preventing fractures (more participants would be required) or safe past 12 months (the length of this study).

Similarly, the research was mainly in white, city-dwelling postmenopausal women, so the effectiveness may differ in women from different places and ethnic backgrounds. Similarly, it is not clear whether it would benefit men with osteoporosis (which is less common, but still accounts for roughly 20% of cases).

Aside from these limitations, this research is a positive step forward in the search for new treatment options for osteoporosis. The encouraging results are likely to lead to further, larger studies.

Where did the story come from?

The study was carried out by researchers from at the Massachusetts General Hospital, Boston (US) and was funded by the National Center for Research Resources as well as the pharmaceutical manufactures Amgen and Eli Lilly.

Amgen manufactures denosumab and Eli Lilly manufactures teriparatide.

However, the publication states that the funders of the study had no role in study design, data collection, data analysis, data interpretation, or the writing of the report.

The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

The study was published in the peer-reviewed medical journal The Lancet.

The media reporting generally described the research findings accurately although discussion about the limitations of the research was minimal.

What kind of research was this?

This research used a randomised control trial (RCT) to test whether combining two approved osteoporosis medicines (teriparatide and denosumab) would improve bone mineral density in postmenopausal women.

Osteoporosis is a condition that affects the bones, causing them to become weak and fragile and more likely to break (fracture). These fractures most commonly occur in the spine, wrist and hips, but can affect other bones such as the arm or pelvis. Approximately 3 million people in the UK are thought to have osteoporosis. Although commonly associated with postmenopausal women, osteoporosis can also affect men, younger women and children.

The two drugs, teriparatide and denosumab, are already used individually to treat osteoporosis but they work in slightly different ways. So the researchers wanted to test whether there was any added benefit of using the two drugs together.

Despite drugs being available for osteoporosis, the researchers’ say no currently approved treatment actually restores normal bone density in most patients with osteoporosis – they merely halt the decline. And options for those with severe osteoporosis are limited; the resulting risk of fracture, aside from affecting people’s quality of life, puts a considerable strain on the NHS. It is estimated that there are around a quarter of a million fractures each year in the UK. This means there is a continual need for new or improved treatments.

An RCT is one of the most reliable ways of testing whether a new drug, or in this case combination of drugs, is effective.

What did the research involve?

Between September 2009 and January 2011 the researchers enrolled 100 postmenopausal women (aged 45 years or older, with at least 36 months since last period) with osteoporosis who were at high risk of bone fracture. Women were enrolled through a mailing advertisement and on referral to Massachusetts General Hospital in Boston (US).

Bone mineral density is measured by ‘T-score’ and is simply the number of units, known as standard deviations, above or below the expected average for a healthy 30-year-old adult of the same sex and ethnicity as the patient. Only about 2.5% of women would have a T-score less than -2.0, for example.

The researchers defined high fracture risk as either:

• T-score –2.5 or less at the spine, hip, or femoral neck
• T-score –2.0 or less with at least one risk factor; fracture after age 50 years, parental hip fracture after age 50 years, previous overactive thyroid, inability to get up from a chair with arms raised, or current smoking
• T-score –1.0 or less already with history of a fracture from osteoporosis

Women were split into three equal groups to receive 20 microgram teriparatide daily, or 60 milligram denosumab every six months, or both.

Bone mineral density was measured at 0, 3, 6, and 12 months. This included measuring bone density at the lumbar spine, hip bone and neck of the femur using low-dose x-rays and bone biomarkers. Calcium intake (which can influence bone strength) was also recorded at the start of the study through a food frequency questionnaire.

Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat analysis. Physicians interpreting bone mineral density assessments and the laboratory staff doing bone-marker assays were unaware of patients’ treatment groups.

The analysis compared changes in bone density from baseline (the start of the study) to the different time points (3, 6, and 12 months) for each of the different locations (spine, hip bone, and neck of femur).

What were the basic results?

Of the 100 eligible women, 94 completed the 12 month study. At 12 months, the main findings were that:

• Lumbar spine bone density had increased significantly more in the combination group (9.1%, standard deviation (SD) 3.9) than in the teriparatide (6.2%, SD 4.6) or denosumab (5.5%, SD 3.3) groups.
• Femoral-neck bone density also increased more in the combination group (4.2%, SD 3.0) than in the teriparatide (0.8%, SD 4.1) and denosumab (2.1%, SD 3.8) groups.
• Total hip bone density also increased more in the combination group (4.9%, SD 2.9; teriparatide, 0.7% SD 2.7; denosumab 2.5%, SD 2.6).

All these results were statistically significant.

How did the researchers interpret the results?

The researchers concluded that, “combined teriparatide and denosumab increased bone mineral density more than either agent alone and more than has been reported with approved therapies.” Furthermore, “combination treatment might, therefore, be useful to treat patients at high risk of fracture.”

Conclusion

This small but well-conducted RCT showed that combining licensed osteoporosis medicines teriparatide and denosumab may increase bone density more than either medicine used on their own, in postmenopausal women at high risk of bone fracture.

The researchers highlighted that their results were not consistent with previous trials looking at combination therapies for osteoporosis, which found no benefit of combining them.

However, previous research did not use the same combination of medicines in the same dose as the present trial. It could be the case that the dosages used in previous research were not given at the optimal level.

And while the study showed statistically significant differences in bone density at 12 months, this does not necessarily mean the treatment lead to a reduced rate of fractures – which is the ultimate aim of treating osteoporosis. Larger, longer-term studies are required to see what impact this combination treatment has on fracture risk, as well as assessing how safe and effective both drugs are in the longer-term.

This is particularly relevant because teriparatide is only licensed to be used for a maximum of 24 months (a point the Daily Mail usefully highlighted). It remains to be seen what would happen when this combination of therapies were stopped – would the benefits be reversed, and would it be safe to continue using the medicine longer than recommended?

These issues would need to be thoroughly addressed before this potentially useful combination could feasibly be routinely used in the NHS.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on twitter.

Links To The Headlines

The double drug hope for brittle bone sufferers. Daily Mail, May 15 2013

Links To Science

Tsai JN, Uihlein AV, Lee H, et al. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. The Lancet. Published online May 15 2013

News that back pain could be "cured" by antibiotics has prompted wide media coverage, with The Independent reporting that "Half a million sufferers of back pain 'could be cured with antibiotics'."

The headlines are based on research into chronic lower back pain that showed some cases may be caused by a bacterial infection. Researchers found evidence that antibiotic treatment of a specific type of chronic lower back pain was more effective than placebo pills at reducing back pain and disability one year after treatment began.

Although antibiotics may also be effective for other types of back pain, this was not established by this study. While the results appear genuinely encouraging, this study involved patients with a very specific type of lower back pain. This means the results may be different in other people with different types of back pain.

There is also the potential risk this research could lead to the indiscriminate use of antibiotics in the hope of curing all back pain. This has negative consequences for both the individual and the community, as bacteria become resistant to antibiotics over time.

The study authors themselves say they do not support the idea that all patients with lower back pain should have a trial course of antibiotics, and state that excessive use of antibiotics should be avoided.

The findings of this research are positive but, as the study authors acknowledge, they will need to be confirmed in bigger studies in more diverse populations.

Where did the story come from?

The study was carried out by researchers from university hospitals in Denmark and was funded by the Danish Rheumatism Association and other foundations.

It was published in the peer-reviewed European Spine Journal.

A related study in the same journal and by the same researchers, also discussed in the media, provided good quality evidence that some types of lower back pain are associated with bacterial infection.

The media coverage was overexcited and may have generally overstated the significance of this research, implying that most people with lower back pain may benefit from antibiotics. The research was in a subgroup of lower back pain sufferers, so any treatment developed further down the line would not be suitable for all.

While the researchers had no conflicts of interest, much of the UK media's reporting of the study included quotes from neurosurgeon Peter Hamlyn, who claimed the research was "the stuff of Nobel Prizes…[and] is going to require us to rewrite the textbooks".

Hamlyn was not involved in the research, but he was reported to have funded a website that promotes the type of treatment used in the study, Modic Antibiotic Spinal Treatment. Only The Independent highlighted this potential conflict of interest.

What kind of research was this?

The research was a double-blind randomised control trial (RCT) looking at how well an antibiotic worked at treating long-term back pain in a subgroup of lower back pain sufferers.

The specific subgroup of lower back pain sufferers being studied had signs of bone swelling in their lower back that can only be detected through an MRI scan. The exact medical term for these changes is Modic type 1 changes, or bone oedema.

The theory was that, in some cases, this bone swelling might be caused by a bacterial infection. This meant that treatment with antibiotics represented a new avenue for the researchers to explore in an effort to treat this type of lower back pain.

A randomised control trial is an appropriate study design to test this hypothesis.

What did the research involve?

The researchers recruited 162 adult patients who had lower back pain for more than six months following a spinal disc herniation, commonly known as a slipped disc. To take part in the study they also had to have disease-related changes in the vertebrae next to the previous slipped disc site, so-called Modic type 1 changes, or bone oedema. These were confirmed through multiple MRI scans.

This select group of patients was randomised to receive either 100 days of antibiotic treatment with amoxicillin clavulanate tablets three times a day, or 100 days of an identical placebo.

Their health was evaluated at the start of the study, with participants unaware of which group they would be randomised to. Further evaluation of their health was also done without them knowing whether they had received placebo or antibiotics. Evaluation took place at the end of the 100-day treatment and again one year from the start of the study.

The researchers focused on changes in disease-specific disability and back pain. Disease-specific disability was measured using the Roland Morris Disability questionnaire (RMDQ). This is a 23-item questionnaire where the patient answers 23 yes or no questions related to the impact back pain has on their daily activities and quality of life. The questionnaire results in a scale score from zero to 23, with higher scores being worse.

Back pain was also measured using a patient-completed rating scale. Clinically relevant improvements in both measures were defined in advance of the results of the study – for instance, a 30% reduction for the RMDQ.

They also recorded changes in leg pain, number of hours with pain in the last four weeks, perceived health, days with sick leave, "bothersomeness", constant pain and disease-related changes observed under MRI.

The statistical analysis of the results was appropriate, and compared pain and disease changes in the group given antibiotics with those given placebo.

What were the basic results?

Of the 162 patients enrolled at the start, 147 (90.7%) completed the end-of-treatment questionnaires after 100 days, and 144 (88.9%) completed the one-year follow-up MRI scans, questionnaires and physical health checks.

Patients assigned to the placebo and antibiotic groups generally had similar characteristics at the start of the study.

The key results were:

• The group given antibiotics improved their disease-specific disability and back pain scores after treatment (100 days) and showed even larger improvements at the one-year time point.
• Back pain assessed by the RMDQ improved from 15 in the antibiotic group to 11.5 at 100 days and seven at one year, compared with a fall from 15 in the placebo group to 14 at 100 days remaining unchanged at 14 after one year.
• In comparison with the placebo group, the improvements observed using antibiotics were statistically significantly better.
• The magnitude of the improvement in disease-specific disability and back pain scores after treatment with antibiotics was also deemed clinically important using criteria defined before the start of the study.
• Patients reported that pain relief and improvement in disability started gradually – for most patients, six to eight weeks after starting antibiotic tablets, and for some at the end of the treatment period (100 days).
• Improvements reportedly continued long after the end of the treatment period – at least for another six months – and some patients reported continuing improvement at one-year follow-up.
• Less disease-related changes were detected in the vertebrae of the spine in patients given antibiotics than those given placebo. Changes were assessed from the start of the study to the one-year time point, with statistically significant differences seen.
• Overall, side effects were more common in the antibiotic group (65%) compared with the placebo group (23%). However, these side effects were described by the researchers as generally minor and were related to stomach upsets such as loose bowel movements, flatulence (farting) and burping.

How did the researchers interpret the results?

The researchers concluded that, "The antibiotic protocol [treatment] in this study was significantly more effective for this group of patients than placebo in all the primary and secondary outcomes."

They highlighted how "for the primary outcome measures, disease-specific disability and lumbar pain, the effect magnitude was also clinically significant."

Conclusion

This well-designed double-blind RCT shows that the antibiotic treatment of chronic lower back pain caused by swelling of the spinal vertebrae is more effective than placebo at reducing back pain and disease-related disability

The study had many strengths, including its randomised double-blind design, adequate sample size and one-year follow-up point.

However, it did have some limitations, including the fact that:

• Patients varied at the start of the study. More people in the placebo group had lower grades of vertebrae change. This is hard to explain if allocation to the two groups had been completely concealed and fair, although it may have favoured improvements in the placebo group and therefore may not have influenced the results.
• Blinding of the participants may have been broken unintentionally. As this antibiotic caused such predictable bowel side effects in 65% of people taking the active treatment, it is possible that the participants knew they were taking an active treatment and therefore may have reported the subjective scores differently form the placebo group. The researchers did not report any testing for fidelity of the blinding, such as asking participants if they could guess which group they were in. 

As strong as this research it is, it is not definitive. Further research, most likely with larger numbers of people in the study, will be needed to confirm these findings before any treatment is likely to be approved and licensed for routine use in UK. There will also need to be extensive safety investigations.

Crucially, the study recruited a very select group of lower back pain sufferers who showed small changes in their vertebrae next to the site of a previous slipped disc. This select group therefore is not representative of all lower back pain sufferers.

This research certainly does not advocate giving antibiotics to all lower back pain sufferers. However, if the results are confirmed in subsequent studies and this form of treatment is deemed safe, it may provide a new treatment option for this type of lower back pain in the future. This is cause for much optimism.

The researchers' estimate that approximately 35-40% of long-term back pain sufferers experience excess fluid in the spinal vertebrae and could potentially benefit from this type of treatment in the future. However, it is unclear how accurate this estimate is, and may indeed be an overestimate.

Even if all these hurdles are overcome, media talk of a "back pain cure" could still be premature. Antibiotics may help relieve symptoms, but there is currently no conclusive evidence that they can correct the underlying causes of chronic back pain.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Links To The Headlines

How back pain can be beaten with antibiotics: Breakthrough could cure 40% of sufferers. Daily Mail, May 7 2013

Back pain breakthrough could eliminate need for major operations. The Guardian, May 7 2013

Antibiotics could cure 40pc of chronic back pain patients. The Daily Telegraph, May 7 2013

Back pain 'can be cured with a £114 dose of antibiotics'. Metro, May 7 2013

'The stuff of Nobel prizes': The backache breakthrough? Half a million sufferers 'could be cured with antibiotics'. The Independent, May 7 2013

Antibiotics could relieve back pain for 40% of sufferers. ITV News, May 7 2013

Miracle cure for back pain: Agony ended by everyday antibiotics. Daily Express, May 8 2013 

Links To Science

Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. European Spine Journal. Published online April 2013

“Cure for grey hair is on its way say scientists,” the Daily Mirror reports, with The Daily Telegraph adding that grey hair will become ‘a thing of the past’.

You may be surprised to learn that the study the media reports on had absolutely nothing to do with grey hair. In fact, the stories were loosely based on a tiny study into what happens in a common skin condition called vitiligo. Vitiligo causes depigmentation (loss of colour) of the skin, leading to white patches on the skin and hair.

The current study included 10 people with what is called ‘segmental’ vitiligo, where the condition affects the area of skin supplied by a particular nerve. They found that changes in skin colour were accompanied by the accumulation of two chemicals in the skin: hydrogen peroxide and peroxynitrite.

The researchers then demonstrated that using a compound that when exposed to ultraviolet light was known to reduce hydrogen peroxide levels led to white patches on skin and eyelashes becoming repigmented.

While the results of the study could theoretically be extrapolated as providing a potential treatment for grey hair, much more research is required to see if such a treatment would be both safe and effective.

This study does offers possible hope of a treatment for segmental vitiligo though, again, further research is required.

Where did the story come from?

The study was carried out by researchers from E. M. Arndt University, Germany and the University of Bradford, UK. It was funded by the American Vitiligo Research Foundation and by private donations.

The study was published in the peer-reviewed Federation of American Societies for Experimental Biology (FASEB) journal.

This story was poorly reported in the media, with all headlines speculating that the findings could lead to a cure for grey hair. The current study did not investigate the causes of, or possible treatments of, grey hair. However, the research focused on vitiligo, specifically looking at segmental vitiligo.

Though the blame for the poor reporting of the study can be put at the door of the press office of the FASEB, which issued a press release almost entirely focused on the grey hair angle. This is a textbook example of public relations officers ‘sexing up’ a dry but worthy piece of research in order to gain maximum media coverage. And – credit where credit is due – they did an excellent job of that. Unfortunately, in doing so they obscured the truth.

Whether peer-reviewed journals should be engaging in these types of disingenuous practises, which arguably damage the public understanding of science, is a matter of debate. However, FASEB are not alone in this, as recent research found that academics, journals and news reporters all share the blame for the spin found in around half of all medical reporting.

What kind of research was this?

This was a laboratory study and case series report into the mechanics of the skin condition vitiligo and whether learning more about it could lead to new treatments.

Vitiligo can be divided into two forms: segmental and nonsegmental vitiligo. Nonsegmental vitiligo is the more common, in which the white patches that appear are symmetrical (the same places on both sides of the body, for example both hands could be affected). In nonsegmental vitiligo, two chemicals – hydrogen peroxide and peroxynitrite – accumulate in the skin.

Nonsegmental vitiligo can be treated with a pseudocatalase, which is activated by narrow-band UVB light. This reduces the concentrations of hydrogen peroxide, allowing the lost skin colour to return.

In the less common segmental form of vitiligo, the affected skin lies in a dermatome, which is a particular area of skin supplied by a single nerve, so it usually affects only one side of the body.

Segmental and non-segmental vitiligo can also co-exist, giving rise to ‘mixed’ vitiligo.

This study aimed to see whether the accumulation of hydrogen peroxide and peroxynitrite which occurs in nonsegmental vitiligo also occurs in segmental vitiligo, and if so, if the light activated pseudocatalase could also be of use in segmental vitiligo.

The laboratory study is the ideal study design to investigate the mechanism behind segmental vitiligo. However, the treatment was only tested in a very small number of people with vitiligo. Well-conducted trials involving much larger numbers of people are needed before it can be determined how effective it is.

What did the research involve?

The researchers looked to see whether hydrogen peroxide and peroxynitrite (and the oxidation products produced when these chemicals react with other molecules in the cell) are present in the skin of people with segmental vitiligo. To do this they examined four people with segmental vitiligo and six people with mixed vitiligo (where the person has both segmental vitiligo and nonsegmental vitiligo). For comparison, they selected five healthy controls matched for age and skin type.

The researchers then determined whether treatment with narrow-band UVB activated pseudocatalase, which reduces the levels of hydrogen peroxide, could allow repigmentation.

What were the basic results?

The researchers found that hydrogen peroxide and peroxynitrite (and substances that are formed by reactions of these chemicals with molecules in the cell), are present in the skin of people with segmental vitiligo.

The researchers report that treatment with narrow-band UVB activated pseudocatalase, which reduces the levels of hydrogen peroxide, allowed repigmentation of the skin and eyelashes of five people with vitiligo regardless of whether they had segmental vitiligo only, or in association with nonsegmental vitiligo.

How did the researchers interpret the results?

The researchers conclude that their findings, “offer new treatment intervention for lost skin and hair colour”.

Conclusion

This study aimed to investigate whether two chemicals – hydrogen peroxide and peroxynitrite – accumulate in the skin of people with segmental vitiligo, which affects up to a quarter of people with vitiligo.

They then looked at whether treatment with a light-activated pseudocatalase, that reduces the concentration of hydrogen peroxide, would allow the lost skin colour to return.

They found that the treatment was successful in five people with segmental vitiligo (either isolated or in combination with nonsegmental). The study offers hope of a possible treatment for segmental vitiligo, although so far it has been tested in only very few patients.

Well-conducted trials in much larger numbers of people will be needed before it can be determined how effective it is.

Although previous research has demonstrated that hydrogen peroxidase also accumulates in grey hair follicles, this study did not look at whether treatment with pseudocatalases or other substances could be used to treat grey hair.

For this rather fundamental reason, it is not possible to say from this study whether or not there could be a cure for grey hair.

However, the potential market for an effective hair colouring treatment is huge: recent figures show that the hair dye market is essentially recession-proof. It would be surprising if this study did not lead to further research into the applications of the techniques used in the study.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Links To The Headlines

Cure for grey hair is on its way say scientists. Daily Mirror, May 7 2013

Grey hair 'a thing of the past' after scientists discover why follicles become discoloured. The Daily Telegraph, May 6 2013

Is this the end of costly dyes? Scientists working on cure for grey hair. The Independent, May 6 2013

Grey Hair Treatment Discovered By Scientists. Sky News, May 6 2013

Links To Science

Schallreuter KU, Salem MAEL, Holtz S, Panske A. Basic evidence for epidermal H2O2/ONOO−-mediated oxidation/nitration in segmental vitiligo is supported by repigmentation of skin and eyelashes after reduction of epidermal H2O2 with topical NB-UVB-activated pseudocatalase PC-KUS. The FASEB Journal. Published online April 29 2013

“Hormone treatments can cut breast cancer rates in at-risk women by 38%,” reports the Daily Mirror.

The news, covered by much of the media, is based on research into selective oestrogen receptor modulators (SERMs), a class of drug that binds to oestrogen receptors in breast cells and elsewhere.

The study making today’s news suggests that SERMs could be effective for preventing breast cancer. Researchers combined the results of several studies that had compared SERMs with other drugs in women without breast cancer.

Most of the trials recruited women who were either at high risk of breast cancer or who had osteoporosis.

Researchers found that SERMs reduced the incidence of breast cancer during 10 years of follow-up.

Links To The Headlines

500,000 to be offered daily breast cancer pill. The Times, April 30 2013

Breast cancer drug 'benefits at-risk patients'. The Daily Telegraph, April 30 2013

Drug that PREVENTS breast cancer could soon be given to half a million women on the NHS. Daily Mail, April 30 2013

Four drugs 'can reduce chance of breast cancer in at-risk women'. The Guardian, April 30 2013

Hormone treatments can cut breast cancer rates in at-risk women by 38%. Daily Mirror, April 30 2013

Links To Science

Cuzick J, Sestak I, Bonanni B, et al. Selective oestrogen receptor modulators in prevention of breast cancer: an updated meta-analysis of individual participant data. The Lancet. Published online April 30 2013

The MMR vaccine should be given to all unvaccinated schoolchildren aged from 10 to 16 as part of a national catch-up campaign, the government has announced.

This MMR vaccination catch-up campaign aims to prevent further measles outbreaks, following recent outbreaks in Wales.

Speaking at the launch of the national MMR catch-up programme, Professor David Salisbury, director of immunisation at the Department of Health, said that the outbreaks in Wales had been "a wake-up call for parents", and warned that "what is happening in Swansea could happen anywhere in England".

Professor Salisbury urged parents to get their children vaccinated with MMR if they were unsure whether they had previously had the jab.

Why is a catch-up programme required?

A catch-up programme is required to protect a generation of children, born between 1997 and 2003, who are unvaccinated or only partially vaccinated against measles.

Low levels of vaccination in this generation were caused by an unsubstantiated scare about the MMR vaccine. The scare was based on an entirely discredited piece of research that claimed that MMR could trigger autism.

Targeting this group of children, estimated to be around one million, will help reduce the potential population in which further measles outbreaks could occur.

Why is measles a threat now?

Due to the success of earlier vaccination programmes measles was extremely rare during the 1990s.

This began to change after researcher Andrew Wakefield published a piece of research claiming that there was a link between the MMR vaccine and the developmental condition autism. Despite serious flaws in this research, it received widespread coverage in the media. The research has been proven to be worthless and Wakefield has been struck off the medical register for acting "dishonestly and irresponsibly" in his research and “bringing the medical profession into disrepute”.

Sadly, the damage had already been done – there was a drop in coverage rates (the proportion of people vaccinated against a disease) for measles and this has led to the disease becoming more widespread. In the first quarter of 2013, there were a record 587 cases in England and, worryingly, a number of outbreaks in schools.

Many people mistakenly assume that measles is a harmless childhood disease like chickenpox. This is not the case. Immunisation expert, Dr Mary Ramsey, said: “Measles is not a mild illness – it is very unpleasant and can lead to serious complications as we have seen with more than 100 children in England being hospitalised so far this year”.

Complications of measles include:

• hearing loss, which may be partial or total
• learning difficulties, which may be temporary or permanent
• epilepsy – a condition that causes someone to have repeated fits
• cerebral palsy – a general term for a set of conditions that affect movement and co-ordination
• vision loss, which may be partial or total

How will the catch-up programme work?

Around a million at-risk children have been identified using GP records and similar data. Letters are to be sent to their parents recommending that they get their children vaccinated.

Vaccination can take place at GP clinics. There are also plans to set up temporary ‘vaccine clinics’ in schools, community centres and similar locations.

The programme will also be publicised in schools and on Facebook: Get Vaccinated England and Twitter at #gethemmr. The government hopes that the catch-up programme will be completed by the start of the new school year in September.

How accurate is the data being used by the programme?

It is thought that the data is both accurate and robust, and that the at-risk children have been identified. Even if a child is wrongly identified as being unvaccinated, receiving extra doses of the MMR vaccine will do them absolutely no harm.

Can I get my child vaccinated now?

Yes. You do not have to wait to be sent a letter to get your child vaccinated. If you are worried about your child’s vaccination status make an appointment with your GP as soon as possible.

Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Links To The Headlines

Vaccination campaign launches with hope of halting measles outbreak. The Guardian, April 25 2013

Nationwide Drive To Boost MMR Vaccination. Sky News, April 25 2013

Measles outbreak: race to give a million children MMR jabs. The Independent April 25 2013

MMR vaccine 'only way to protect your child', says immunisation expert. The Daily Telegraph, April 25 2013

Measles epidemic fears: Campaign to urge parents of million children to get MMR jab. Daily Mirror, April 25 2013

One million children and teenagers to get measles jab amid fears of English outbreaks. Daily Mail, April 25 2013

"Statins could be a cheap and effective treatment for erectile dysfunction," reports the Daily Mail.

Sadly, for those affected by erectile dysfunction (impotence), the Mail’s claim is not supported by the evidence presented by the study.

The news is based on a relatively small study involving just 60 men with erectile dysfunction who had failed to respond to treatment with sildenafil (more commonly known as Viagra).

The study aimed to see whether treatment with a statin drug called atorvastatin (typically used to treat high cholesterol) was effective in improving erectile dysfunction compared with treatment with vitamin E or placebo.

After six weeks of treatment, men who received atorvastatin showed a significant improvement in some measures of erectile dysfunction. However, the improvement was modest and, after treatment, the erectile function of the men was not considered to be within the normal range.

In other words, the statins helped improve symptoms of erectile dysfunction, but not to such an extent that it could be considered an effective treatment.

Larger trials that assess the safety and effectiveness of atorvastatin over periods longer than six weeks are required to draw firmer conclusions about the potential benefits of this drug to treat erectile dysfunction in men who do not respond to sildenafil.

At the current time, statins are not licensed for the treatment of erectile dysfunction and cannot be recommended for this use.

Where did the story come from?

The study was carried out by researchers from Tanta University in Egypt and was funded by the same university. It was published in the peer-reviewed International Journal of Impotence Research.

The coverage of the study in the Daily Mail was accurate and appropriate, but the headline was misleading.

While the study suggests that a statin-like drug may be of some, apparently limited, benefit for men who fail to respond to sildenafil, it certainly does not show that “Statins [are a] cheap and effective treatment”.

It is also important to stress that statins should only be taken when recommended by the doctor in charge of your care. They are not safe or suitable for everyone.

What kind of research was this?

This was a blinded randomised controlled trial (RCT) comparing three interventions:

• a statin drug (atorvastatin)
• vitamin E
• placebo

Participants in the RCT were men with erectile dysfunction who had previously received Viagra and failed to respond to treatment. While effective in many cases, a minority of men fail to respond to treatment with Viagra, often due to underlying problems with the blood vessels (endothelial dysfunction) that are connected to the penis.

What did the research involve?

Researchers recruited to their study 60 men aged between 40 and 60 years from the Sexual Health Inventory for Men (SHIM), who had all had erectile dysfunction for at least one year. To be included the men had to have previously received a drug called sildenafil (Viagra) and shown no improvement in their erectile function while taking the drug. They also had to have normal cholesterol levels. Men were excluded from the study if they had a history of cardiovascular disorders, listed in the study as either chest pain (angina) or heart attack (myocardial infarction), liver disorders, diabetes or a history of cancer.

The men were randomly split into three groups consisting of 20 men in each group and assigned to the following treatments for six weeks:

• 80mg atorvastatin (brand name Lipitor) daily
• 400 international units (IU) vitamin E daily
• placebo capsules daily (control group)

Assessments were carried out before treatment, after treatment and every two weeks during treatment. The assessments included erectile function tests as well as other biochemical and blood tests.

To assess erectile dysfunction, the men were asked to answer five questions and given a score out of 25 on the International Index of Erectile Dysfunction.

This is a validated ‘checklist’ consisting of questions such as “How often were you able to get an erection during sexual activity?” and “When you attempted intercourse, how often were you able to penetrate (enter) your partner?”

The scores were then categorised into five categories – severe, moderate, mild-to-moderate, mild and no erectile dysfunction.

Erectile function was also assessed using a device called RigiScan that allows measurement of penis rigidity (hardness), duration of an induced erection and blood flow (it is an increase in blood flow that causes the penis to become erect). 

What were the basic results?

After six weeks of treatment, only the group receiving atorvastatin showed a significant improvement from baseline in subjective and some objective assessments on RigiScan of erectile function.

The subjective score in the atorvastatin group increased from a baseline average of 11.75 to 18.15 after six weeks.

However, despite this improvement, none of the men in the atorvastatin group had an erectile function score within the normal range at the six-week mark (a score less than 22 was considered to indicate erectile dysfunction).

The researchers report that five people dropped out of the study, three of whom were taking atorvastatin and dropped out because of side effects (mainly severe muscle pain).

Apart from this brief explanation of people who dropped out of the study, no other information is provided about the side effects associated with taking this drug, despite the fact that the authors report that side effects were assessed fortnightly.

How did the researchers interpret the results?

The researchers conclude that atorvastatin but not vitamin E is a promising drug for men with erectile dysfunction that have not responded to treatment with sildenafil (Viagra).

Conclusion

Overall, this study provides some evidence that treatment for six weeks with atorvastatin (Lipitor) improved some measures of erectile dysfunction (but not to within the normal range) compared with vitamin E or placebo. There are some limitations to this study, some of which are described by the authors:

• As this study only included men who had previously had their erectile dysfunction treated with sildenafil (Viagra) and showed no improvement, the study findings do not apply to men yet to receive drug therapy for their erectile dysfunction.
• This study was of short duration (six weeks), so long-term outcomes of atorvastatin (Lipitor) to treat erectile dysfunction in men that have failed to improve on sildenafil (Viagra) are not known.
• Despite the fact that the authors describe three people who dropped out of the study while taking atorvastatin “mainly due to severe muscle pain”, and the fact that side effects were assessed fortnightly, no further details about side effects are described.
• More information about side effects is crucial to determining how safe the drug is when used to treat erectile dysfunction.
• The authors report that a major limitation of the study was that they did not assess whether sildenafil (Viagra) was effective as a follow-up treatment for erectile function after therapy with atorvastatin (Lipitor) or vitamin E. This means that they did not test whether men were more responsive to Viagra after treatment.

Larger randomised controlled trials that assess the effects and safety of atorvastatin over longer periods are required to draw firmer conclusions about its effects on erectile dysfunction in men that have not responded to treatment with sildenafil.

At the current time, statins are not licensed for the treatment of erectile dysfunction and cannot be recommended for this use.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Links To The Headlines

Treatment with statins can perk up a man's love life. Mail Online, April 23 2013

Links To Science

El-Sisi AA, Hegazy SK, Salem KA, AbdElkawy KS. Atorvastatin improves erectile dysfunction in patients initially irresponsive to Sildenafil by the activation of endothelial nitric oxide synthase. International Journal of Impotence Research. Published online  January 17 2013

"Popping paracetamol could also help treat EMOTIONAL pain," is the surprising suggestion on the Mail Online website.

In this study, "emotional pain", also referred to as "existential dread", was taken to be distress experienced during perceived threats to our existence or world view. This study tested two related concepts:

• whether emotional pain causes distress that people then feel the need to compensate for
• whether painkillers such as paracetamol can dull this emotional pain, lessening the need for compensation

The researchers tested their theory on two groups of psychology students who were placed under two very specific examples of existential dread. These examples were:

• asking people to contemplate their own death, and
• watching an unsettling surrealist film by director David Lynch.

They were then asked to assess two compensation mechanisms – hypothetically either setting bail for a prostitute or setting punishment for rioters. The researchers found that people who had taken the paracetamol did not seek as much compensation (punishment). The researchers say that this implies that paracetamol reduced emotional pain and lessened the desire for compensation.

As interesting as this study is, it certainly should not be regarded as a recommendation to take paracetamol on a regular basis in order to cope better with emotional pain.

Where did the story come from?

The study was carried out by three researchers from the University of British Columbia, and was funded by the Social Sciences and Humanities Research Council of Canada.

The study was published in the peer-reviewed journal Psychological Science.

The Mail Online website has exaggerated the findings of an interesting if very unusual psychological study looking at how paracetamol may blunt psychological response to stress.

The two experimental scenarios used in the study are highly unlikely to occur in most people’s day-to-day experiences. So the results of the study arguably have little to no ‘real-world’ application.

Also, the reporting could give the impression that emotional painkilling is a unique effect that this particular brand of paracetamol (Tylenol) has been found to have. In fact, this is just the brand of paracetamol (or acetaminophen as it is called in the US) that the researchers happened to use in their study.

The news report from the Mail Online also quotes the author of the research paper as saying that the results may shed light on chronic anxiety. As this study was not in people with chronic anxiety it cannot tell us what the effects of paracetamol would be in people with anxiety.

Perhaps most importantly, the Mail Online does not make it clear that paracetamol has not been through the formal testing and application process required for it to be approved by drug regulatory bodies as an effective treatment for “emotional pain”. It is irresponsible not to highlight the risks of taking paracetamol outside of its approved use.   

What kind of research was this?

The current research investigated “the common foundation that underlies people’s reactions to various kinds of events that cause anxiety, unease and pain”. The theory is that we get distressed when we experience events that are surprising or confusing, or in complete opposition to what we had been expecting. This leads us to find ways to ‘compensate’ for this unpleasant arousal, or make it better. The researchers call this the “meaning-maintenance model” (MMM).

However, as the researchers say, in many cases it is not possible to resolve or compensate for unpleasant experiences we have suffered, often because the situation is too difficult or because we have not clearly identified the precise aspect that’s making us so distressed.

The researchers say that the area of the brain that responds to physical pain (the dorsal anterior cingulate cortex (dACC) is also the area of the brain that responds to ‘social pain’, such as rejection. Therefore, they theorised that as paracetamol can reduce physical pain, it may also have an effect on social pain, and could be effective for preventing the meaning-maintenance response. They predicted that if a person took paracetamol and then experienced a social threat, such as rejection, then the resulting “emotional pain” from the threat would be dulled, and so they would not seek compensation for this threat. They conducted two experiments using different threats to examine this.

What did the research involve?

Experiment one: contemplating death

This study involved 121 people, of whom 67% were female, and the biggest group (45%) were of East Asian origin. They were recruited from university psychology classes. The participants were made aware of the aims of the study – to look at the cognitive and emotional effects of paracetamol.

Participants in the study were randomly assigned to a single dose of either paracetamol (1g of a rapid release tablet from the Tylenol brand) or 1g of sugar placebo in a similar gel capsule. They were then given 30 minutes’ free time before being asked to complete 25 minutes of ‘filler tasks’ (such as completing sudoku puzzles).

The participants then took the main test, in which they were asked to write about either:

• what would happen to their body after they died, and how they felt about this, or 
• about dental pain (as a control).

Thoughts about death are believed to produce a unique type of anxiety – often described in the field of philosophy as ‘existential dread'. The writing task about dental pain was used as a control because it was thought it would stimulate unpleasant associations but not surprising or confusing associations. The researchers theorised that using this control would help rule out negative mood as an explanation for any findings.
 
The participants were then asked to complete a questionnaire to assess how they were feeling at that time. This consisted of questions such as “how many times have you felt excited/proud/upset/afraid over the course of the last week”.

To assess any “compensatory” response to the distress, the participants were then asked to read a hypothetical arrest report about a prostitute and were allowed to set the amount for bail (on a scale from $0 to $999). The theory was that people who had experienced the ‘threat’ (of writing about their own death) would set a higher bail.

Experiment two: surrealism

This second experiment focused on the concept of surrealism, which involves the juxtaposition of unfamiliar elements in familiar settings.

For this experiment 207 students were recruited, of whom 60% were female, and most (52%) were of European origin. They were recruited in the same way as the participants in the first experiment. They were also randomly assigned to receive paracetamol or placebo.

Links To The Headlines

Popping paracetamol could also help treat emotional pain. Mail Online, April 19 2013

Links To Science

Randles D, Heine SJ, Santos N. The Common Pain of Surrealism and Death - Acetaminophen Reduces Compensatory Affirmation Following Meaning Threats. Psychological Sciences. Published online April 11 2013

“Parkinson's drug 'helps' the elderly think younger and reap the rewards from the choices they make,” according to the Mail Online. It reports that as you age you lose the ability to learn from experiences, which can lead to poor decision making. But the drug levodopa, used to treat Parkinson’s disease, could help the elderly to think again in a ‘younger manner’, it says.

Researchers speculate that the lower levels of dopamine found as people grow older could be harmful to the part of the brain that judges whether choices lead to beneficial rewards. Levodopa can increase levels of dopamine, so researchers wanted to see if it improved decision making skills.

In this study, a small group of older people performed tasks where making the correct decision could win them money. The researchers then looked at the effect that dopamine treatment had on their performance. They also compared the performance of these older adults with 22 healthy young adults.

They found that half of the older people improved performance with levodopa, but there was no improvement in the other half.

The research doesn’t tell us much more than how ageing may affect the chemical processes of the brain. Levodopa is only licensed for use in Parkinson’s conditions. Given the side effects of the drug, and that in this small study it only gave some benefit to half the participants, it is very unlikely that its use would ever be extended to all older adults, simply to boost decision making.

Where did the story come from?

The study was carried out by researchers from University College London and other institutions in the UK and Europe. Funding was provided by the Wellcome Trust.

The study was published in the peer-reviewed Nature Neuroscience.

Overall, the Mail Online’s reporting takes this small scientific research study a step too far, suggesting that the Parkinson’s drug can be used to treat older adults to help improve their decision making. This was scientific research exploring the chemical processes in the brain and how they may affect decision making, but it certainly has no therapeutic implications. Levodopa is licensed only for the treatment of Parkinson’s disease and related conditions.

Even if the medication was found to be effective (which is unproven by this study) it is unlikely it would be used simply to aid decision making, as the small benefits of the drug are unlikely to outweigh the risks. Most people would be unwilling to tolerate the side effects that can occur after levodopa use, such as nausea, vomiting, tiredness and dizziness.

What kind of research was this?

The researchers’ report that older adults are worse at making decisions when there are outcomes with different probability of reward led them to question what accounts for this poor decision making. Evidence from previous human and animal study suggests that an area of the middle of the brain, called the nucleus accumbens, has a key role in any decisions that may involve the likelihood of potential rewards and pleasurable emotions.

The nucleus accumbens is targeted by the chemical dopamine. Previous studies of brain samples of older adults have shown that there is a loss of dopamine nerve cells in certain areas of the brain that increases with age. So the reduction in dopamine levels and the subsequent effects on the nucleus accumbens may be responsible for the poorer reward-based decision making associated with ageing.

The current research used a sample of healthy older adults and gave them a task where they had two choices. At the same time they had functional magnetic resonance images (fMRI) taken, which measures the blood flow in the brain to show what areas of the brain are active.

They also had another special type of MRI scan called diffusion tensor imaging (DTI), which can identify any areas of the brain that are lacking oxygen. For this reason DTI is useful for examining people who have had a stroke, but also is a good technique for looking at conditions involving the nerve fibres (white matter).

The researchers compared the results for the older adults with the results from a sample of adults in their 20s. They also examined the effect of a placebo or the chemical levadopa (L-dopa - which is converted to dopamine in the brain and used in the treatment of Parkinson’s disease) on the older adults’ performance in the tasks.

What did the research involve?

The study involved 32 healthy adults aged 65-75 years. These people attended the study centre on two occasions, one week apart, and performed the same task on both occasions. They were randomised to receive in random order either placebo or L-dopa (both mixed into an orange juice drink).

Participants performed five practise trials of the two-armed bandit task before performing the same task before placebo or L-dopa. The task involved being shown two images, selecting one of these and being shown what the monetary reward of this image was. They used statistical tests to compare task performance (how much money was won) under L-dopa or placebo, in addition to monitoring brain activity using fMRI and DTI. Participants were also monitored for any adverse effects of the drugs.

They also compared the performance of the older adults with 22 healthy young adults (average age 25 years) who performed the tasks without taking L-dopa or placebo.

What were the basic results?

The researchers found that the older adults had similar choice reaction times after taking L-dopa and placebo, but overall they had slower reaction times than the younger participants.

Overall there was also no significant difference in the amount of money won by the older participants when L-dopa was given compared to placebo. Fifteen older people won more money with L-dopa than placebo, and 17 won less with L-dopa than placebo. When they analysed in more detail the differences between these two groups they found that those with lower baseline task performance with no treatment (on placebo) improved when they were given L-dopa. However, those older adults who had higher baseline performance with no treatment did not improve with L-dopa.

Those older participants who improved with L-dopa then had similar task performance to the younger participants. Those who did not improve with L-dopa had similar task performance to the younger participants without treatment.

Of those who won more on L-dopa, L-dopa appeared to be improving their learning behaviour with successive tasks. Meanwhile, in those who did not perform better with L-dopa, the drug did not seem to be having any effect on their learning behaviour.

Looking at the fMRI images, the researchers found that older adults had less of a ‘reward prediction error’ signal in the nucleus accumbens. This reward prediction error is thought to be a spike in dopamine levels that occurs when the brain experiences an unexpected reward.

Using DTI to look at the dopamine nerves supplying the nucleus accumbens, they found that within individuals, the structure of their nerve connections was related to whether they had an RPE signal. In older adults with poorer nerve connections, giving L-dopa restored the RPE signal.
 
Four of the 32 older participants experienced vomiting a few hours after taking L-dopa, but they were still to take part in the tasks before experiencing this side effect.

How did the researchers interpret the results?

The researchers conclude that their results identify that chemical signalling problems in the dopamine nerves underlie the abnormal reward processing in older adults, and suggest that this problem can be modulated by the drug L-dopa.

Conclusion

Overall, this research is of scientific interest – it furthers our understanding how ageing may affect the chemical processes of the brain. Specifically it suggests that the reason our ability to make rewards-based choices declines as we age may, in part, be related to poor dopamine signalling to the nucleus accumbens.

However, this small study in 32 older adults tells us little more than that.

These older adults were healthy and were not reported to be suffering from any cognitive impairment. Their results cannot be generalised to all older adults, and not to those who may be suffering from neurodegenerative conditions such as Alzheimer’s disease.

While levodopa has been hailed by the media as a solution for making better decisions in older age, the drug is currently licensed only for conditions related to Parkinson’s disease. It is associated with adverse effects and would not be suitable for everyone. 

It should be noted that taking levodopa did not actually improve the decision-making ability of everyone – for half the older adults who had similar decision making ability to younger participants, taking levadopa reduced their decision making ability instead.

 It is highly unlikely that this will ever be offered as a treatment for every person over a particular age to preserve their decision making ability.

Overall, this research has no immediate implications for the prevention or treatment of cognitive decline or dementia in older adults.   

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on twitter.

Links To The Headlines

Parkinson's drug 'helps' the elderly think younger and reap the rewards from the choices they make. Mail Online, March 25 2013

Links To Science

Chowdhury R, Guitart-Masip M, Lambert C, et al. Dopamine restores reward prediction errors in old age. Nature Neuroscience. Published online March 24 2013

“Breast cancer survivors who cut short preventative treatment ‘risk early death’,” The Guardian reports, saying that women who have only three years of preventative treatment rather than five are more likely to die earlier.

The newspaper reports on a Scottish study that looked at women who had been prescribed a course of hormone treatment after having surgery to treat oestrogen receptor positive breast cancer. In this type of cancer, cancerous cells are stimulated by the hormone oestrogen.

Drugs such as tamoxifen are used after surgery in order to prevent the cancer from returning. It is generally recommended that hormone treatments are taken for five years following surgery.

Looking at prescription data the researchers found women were on average less likely to stick to their treatment over time. This is known as adherence to treatment. In the first year, for example, women adhered to treament 90% of the time. This figure dropped to 50% by the fifth year.

The researchers found that women who had low adherence (those who took their drugs less than 80% of the time) over the five years of their treatment were at increased risk of death from any cause. However, there was no significant difference in risk of dying specifically from breast cancer in those with low adherence compared with those with high adherence, nor was there a difference in the risk of recurrence of breast cancer.

The researchers also looked at women who had good adherence (who took their drugs at least 80% of the time) but who stopped taking their treatment after three years or less. They found that these women were at increased risk of death from any cause, death due to breast cancer and recurrence of breast cancer compared with women who had good adherence for five years.

Limitations of the study include that its findings may not be applicable to other populations and that it relied on prescription data that may be inaccurate. But, overall, this study supports current treatment recommendations for a five-year period of hormone treatment following surgery for oestrogen receptor positive breast cancer.

Where did the story come from?

The study was carried out by researchers from the University of Dundee and the University of Glasgow and funded by Breast Cancer Campaign.

The study was published in the peer-reviewed British Journal of Cancer.

The Guardian’s reporting of the study is accurate and appropriate.

What kind of research was this?

This was a retrospective cohort study designed to review all women living in the Tayside region of Scotland who had been diagnosed with breast cancer between 1993 and 2008, who had been prescribed hormone therapy after they had been treated with surgery. This is called adjuvant hormone therapy – meaning it is given after surgery.

The study aimed to look at how long women were receiving prescriptions for hormone therapy for and whether women who persisted with treatment for longer had better outcomes (including survival) than those who didn’t.

Hormone therapy includes treatments such as tamoxifen and aromatase inhibitors, which are given to women with oestrogen receptor positive breast cancers. They work by preventing oestrogen from stimulating the breast cancer cells to grow, and so reduce the risk of breast cancer coming back after surgical treatment.

Tamoxifen has been shown to reduce recurrence and mortality risk in both premenopausal and postmenopausal women. Meanwhile, aromatase inhibitors are specifically used in women who have gone through the menopause and who are no longer producing oestrogen from their ovaries. These drugs prevent a small amount of oestrogen from being made by fat cells in the body.

Adjuvant hormone therapy is usually recommended for at least five years after surgery in women with oestrogen receptor positive breast cancers.

What did the research involve?

The women in this study were Tayside residents with a hospital discharge or cancer registry record for breast cancer dated between January 1993 and December 2008. Prescribing records, cancer audit and General Registrar’s Office death certificates were obtained for all the women in the study.

The researchers extracted information on the date and the woman’s age at diagnosis, the time between diagnosis and treatment, and the characteristics of the cancer.

The researchers also used each woman’s postcode to estimate the likelihood of them living in poverty (deprivation index) and determined whether each woman had other medical illnesses using hospital and prescribing records.

Prescribing records for tamoxifen and aromatase inhibitors were examined. For each woman the researchers looked at adherence to treatment up to the recommended five years, based on the total days covered by prescriptions and their duration of use.

Women who took hormone treatment for less than 80% of the five years were described as having low adherence.

The main cancer outcomes examined were:

• death from any cause (all-cause mortality)
• breast cancer deaths
• recurrence of breast cancer

What were the basic results?

The researchers identified 3,361 women who started hormone treatment after surgery for breast cancer, 85% of whom started on tamoxifen and 15% on aromatase inhibitors. These women were followed up for 4.37 years on average. Of these 3,361 women who received hormone treatment, 36% (1,194) died during the study period.

Overall adherence to hormone treatment was high, but declined with each year after surgery. Average adherence was:

• 90% in year one
• 82% in year two
• 77% in year three
• 59% in year four

By year five only 51% were still receiving prescriptions for hormone treatment.

When women with high adherence (those who received prescriptions for at least 80% of the five-year period after surgery) were compared with those with low adherence (less than 80%), one-third of the 2,785 women with high adherence died from any cause during follow-up compared with 46% of the 576 women with low adherence. After adjustment for other factors associated with mortality (for example age and tumour stage) the researchers calculated that women with low adherence had a 20% increased risk of dying from any cause compared with women with high adherence (hazard ratio (HR) 1.20, 95% confidence interval (CI) 1.03 to 1.40).

However, interestingly, there was no significant difference in risk of dying specifically from breast cancer between women with high and low adherence, the only difference was in all-cause mortality.

A similar pattern was seen in the risk of breast cancer recurrence – with no significant difference between groups.

The researchers found that women who had good adherence (at least 80%) for three years or less were at increased risk of death from any cause, death due to breast cancer and recurrence compared with women who had good adherence for the total five years. This suggests that the longer a woman is adherent, the less her risk of all-cause and breast-cancer-specific mortality and recurrence.

How did the researchers interpret the results?

The researchers conclude that low adherence to hormone therapy after surgery increases the risk of dying from any cause.

Conclusion

This is a valuable study that looked at a large body of data on the treatment of breast cancer in women in the Tayside region of Scotland over a 15-year period.

Overall, it found that 90% of women who were prescribed hormone treatment to take after surgery (tamoxifen or aromatase inhibitors) took the prescribed drugs during the first year, but adherence gradually declined after this. Only 50% of women were taking hormone treatment by year five – five years being the recommended treatment duration for hormone therapy.

Women who adhered to treatment for less than 80% of the recommended five-year period had 20% increased risk of dying from any cause compared with women who had higher adherence (taking treatment for more than 80% of the five-year period). This was even after adjustment for other factors significantly associated with risk of death (for example age and tumour stage).

Interestingly, adherence had no overall effect on risk of dying specifically from breast cancer, or on risk of breast cancer recurrence.

However, the number of years of good adherence did. Women who had good adherence for three years or less were at increased risk of death from any cause, death from breast cancer and recurrence compared with women who had good adherence for at least five years.

It is not known whether the same results would be seen elsewhere outside of this Scottish region, though the researchers do say that other studies have shown similarly high rates of discontinuation (up to 50%) over the course of hormone treatment. 

Another recognised limitation of the study is that it relies on prescription data to examine adherence to medication, and this may include some inaccuracy. The researchers did not directly ask each woman how long she took hormone therapy for, nor whether she took all drugs that they identified a prescription for.

Overall, this study supports current treatment recommendations. For women with oestrogen receptor positive breast cancer, hormone therapy after surgery is usually recommended for a five-year period.

If you are having problems with side effects speak to the doctor in charge of your care. There may be additional treatment options available that can help.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Links To The Headlines

Breast cancer survivors who cut short preventative treatment 'risk early death'. The Guardian, March 22 2013

Links To Science

Makubate B, Donnan PT, Dewar JA, et al. Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality. British Journal of Cancer. Published online March 21 2013