Effectiveness

…and his Foundation for Integrated Health. An excellent analysis of a recent meeting held at the King’s Fund in London at David Colquhoun’s website .

Squeamishness is relative. I am unfazed by childbirth, urinary catheters and vomit. I am less good with injuries to the ends of fingers or toes, which always make me want to look away. My biggest fear, however, is of eyes.

Operative ophthalmology, in particular, sets me on edge – the eyelid clamped back, the surrounds of the eye draped to keep the area clean and, all the while, the conscious eye watching the approach of the surgeon’s hand. But not everyone is troubled by this prospect. Indeed, a number of FT readers have asked me about laser eye surgery – whether it really works, and what, if any, are the complications?

The information about laser eye surgery on the Royal College of Ophthalmologists’ website gives a useful overview. Laser eye surgery is not suitable for all spectacle-wearers, and some may still have to wear glasses either post-op or at a later stage. Surgery is also expensive – the bill can run to many thousands of pounds.

The remainder of the article can be read here. Please post comments below.

Boots the chemist are making much of research just published in the British Journal of Dermatology. It involves their Protect and Perfect product, which is on sale in my local store, where there are signs saying that customers are allowed to buy only 6 bottles. Clearly they are anticipating great demand.

In 2007, the BBC program Horizon revealed results of a test of Protect and Perfect. They used it on 15 people over 12 days, applying the cream to the forearm and then assaying skin samples for fibrillin, which – say Boots may ”perhaps clinically improve photoaged skin”. 

Rightly, this experiment was criticised, and it was announced that proper trials were going to be done, and here, in the BJD, they are.

This is what Boots says about it:

“The trial was an independent study of 60 volunteers over an initial period of six months. Half the volunteers used No7 Protect & Perfect Intense Beauty Serum and the other half used a placebo product (the same formula, but without the anti-ageing ingredients). Neither group knew which product they had been given.

The results for No7 Protect & Perfect Intense Beauty Serum were astounding. After the initial six months were over, skin on the volunteers using the real No7 Protect & Perfect Intense Beauty Serum showed some repair of the damage caused by sun exposure. No changes were seen for the group using the placebo product.

Use of the No7 Protect & Perfect Intense Beauty Serum for an additional six months led to clinical reduction in the appearance of wrinkles, assessed by an independent dermatologist. Seventy per cent of people perceived a marked improvement in their skin, thus proving that the skin looks better the longer you use No7 Protect & Perfect Intense.”

I don’t think that’s quite how I’d put it. Certainly, it was an RCT, and that’s good. The 60 participants were blinded to either the placebo cream or the test cream for six months. After six months the groups were unblinded and they all used the test cream. However the study used linear regression analysis to “extrapolate the vehicle response to 12 months, thus allowing comparisons with the test product”. This seems like a bad idea to me: this technique is not as true to life as doing the comparative test in real life would be.  The assessments of skin changes were made by two dermatologists, and I am not convinced that we know this is a reliable and reproducible tool. But very interestingly, in the abstract summary it says “at six months, the test product produced statistically significant improvement in facial wrinkles as compared to baseline assessment (p=0.013) whereas vehicle-treated skin was not significantly improved (p=0.11).” A p value of less than 0.05 is usually treated as being statistically significant in medical papers. However, in the discussion section, please note (and my caps):

“Compared to the baseline, the test product did lead to a noticeable clinical improvement in facial wrinkles (P=0.013) in 43 per cent of treated individuals after six months, compared with only 22 per cent of those treated with the vehicle where there was no significant improvement in appearance (p=0.11). In a comparison between groups THIS IMPROVEMENT WAS NOT STATISTICALLY SIGNIFICANT but does indicate that larger clinical trials of cosmetic products might be expected to show useful clinical improvement after six months’ use.”

I interpret that as bit of a wish-list. I’m not astounded either.

I live with an Irishman, which means that at home we drink Barry’s Tea. In my early married life I was “not allowed” this Irish brand, as apparently I did not appreciate it enough. Now, there is a supplier in Glasgow and we no longer have to import boxes of the elusive blend from Dublin. I am still not allowed to make it, however, as there is a very specific brewing time – at least five minutes, so I’m told.

This method of preparation may be a good thing, for in the process of brewing, then adding milk, the tea is never piping hot. According to a recent study in the British Medical Journal, the temperature of tea could be a risk factor for cancer. The habit of drinking of hot tea in Iran, where the study was conducted, seemed to increase the likelihood of developing oesophageal cancer.

More than 80 per cent of oesophageal cancers are diagnosed in the developing world; men, too, are at increased risk, accounting for almost two-thirds of sufferers. In Iran, there are 17.6 cases per 100,000 of the male population; in China, the rate is 24; and in England, it is 14.

The remainder of the article can be read here. Please post comments below.

Independent Sector Treatment Centres (ISTCs) were part of this governments plans for the NHS. GPs were encouraged to use them: this was meant to be the epitome of ”patient choice”. But not only have many contracts been issued on a “take or pay” basis, the cost efficiencies of these units have not been hauled up for scrutiny. Professor Allyson Pollock and Graham Kirkwood obtained data under the Freedom of Information Act in Scotland – no such data has been released elsewhere in the UK – and write in this week’s British Medical Journal about what it means. Poor value for money, and much missing data, they say: “If the same patterns apply in England, up to £927m of the £1.5bn may have been paid to ISTCs for patients who did not receive treatment under the wave one ISTC contracts”.

They conclude that “Contracts should not be renewed and new contracts should not be signed until a proper independent evaluation has been published assessing referrals, actual treatments carried out, and payments made for work done along with value for money analysis. Full contract details and costs must be placed in the public domain for this assessment to take place.”

Surely that can’t be argued with?

We all know that radiation from X-rays, along with other ionising radiations, is potentially harmful. Indeed, it’s quite easy to start worrying about the “risk” involved in having an X-ray – even though most of the radiation we’re exposed to comes from naturally occurring environmental sources.

Still, the sensible use of X-rays is rightly drummed into medical students, the message being that there must be a good reason to take one. Chest X-rays used to be taken routinely before an operation – a kind of “just in case”. The practice was abandoned when doctors realised that if there were no symptoms or examination findings to suggest an X-ray was needed, it could not be justified. Similarly, X-rays used to be standard for people with low back pain, until it was shown that they did not pinpoint the source of the trouble. These days, for low back pain, they are used only in specific circumstances.

Of course, being overly concerned about the health risks of X-rays can also be dangerous. For example, an unwell woman who is also pregnant will probably not be given one for fear of harming the foetus, even though this reluctance has been cited as a potentially avoidable contribution towards maternal – and foetal – death.

The remainder of the article can be read here. Please post comments below.

The New England Journal of Medicine recently published research findings on prostate cancer screening. The results, from my reading at least, showed that screening was not terribly useful. So I was bewildered by subsequent media coverage that urged men to exercise “their right” to a prostate specific antigen blood test or PSA. A number of people called for the UK urgently to review its PSA screening policy.

The problem is that many prostate cancers are “benign” in their behaviour – men die with, rather than from, them – and the treatment is worse than the disease. The difficulty is in distinguishing these more placid tumours from aggressive ones.

The NEJM reported on two randomised controlled trials, one from Europe and the other from the US, where the PSA test is already widely used. The US study, involving almost 77,000 men, assigned half to PSA screening for six years and rectal examination for four years. The other group had “usual care”. After seven to 10 years’ follow-up, there was no significant difference in the mortality rate between the two groups.

The remainder of the article can be read here. Please post comments below.

Or perhaps not so much a makeover, but a radical shift in how drug research is decided upon, performed and reported. The suggestions come from Sir Iain Chalmers, who is editor of the James Lind Library in Oxford, and Silvio Garattini, director of the Mario Negri Institute for Pharmacological Research in Milan. Writing in the British Medical Journal, they say that their proposals would not only benefit patients but also industry, which is not winning any prizes for popularity at present.

They are:

1) Patients to be involved in shaping the research agenda – in other words, making sure research questions have resonance in real life and real-world situations

2) Legal requirements for research to be published, including trial protocols, by all (mandatory publication of trial data has had legal backing in the US since late 2007; no such protection for patients currently exists in the UK)

3) Independent evaluation of drugs. As the paper says: “The monopoly that the drugs industry has in evaluating its own products, and the secrecy surrounding this process, leads to biased evidence that is currently only rarely questioned by independent studies.”

4) A requirement to demonstrate “added value” for all new drugs – is this drug better than the current best drug treatment, or does it benefit in addition to it, and is it better than non-drug treatments? Too often, trials are done comparing a new treatment to placebo where there is a known intervention which is better than placebo. This means that uncertainty about how to use it best persists.

The authors say that these would help improve public confidence in pharma, would improve returns from investment in R&D, but could also improve efficiency in other ways. For example: “Tim Mant, a director of a major contract research organisation, has acknowledged how frustrating it is to be commissioned to organise a clinical trial that he knows is going up a scientific blind ally because he has been there previously with another company but cannot divulge information that is commercially confidential.”

I hope that people in the pharmaceutical industry take notice: I would genuinely love to write about the improvements that are being made.

Pleased to see that ripples from the UK have now reached the US.

“And so,” said my extremely pregnant friend while ordering lunch, “we’ve talked about it, and we’re going for nipple stimulation.” Nipples do not normally come up over coffee. I must have looked alarmed. No, no, my friend insisted, this was an evidence-based endeavour to bring on labour. She thought that I would approve. And what’s more, she said, lowering her voice conspiratorially, this method was free, easy and – quite possibly – fun. Gleefully, she ordered a large helping of curry to be washed down with raspberry tea.

So I had to go and look it up. And indeed, there is a reasonable amount of research showing that gentle breast stimulation, while not guaranteed to induce labour, does seem to have a better chance of beckoning baby out than no stimulation at all. The woman has to be at the right point in pregnancy for it to work. Also, more research on safety has been recommended – and no one, of course, should be trying to induce birth unless their midwife or doctor agrees. In any case, this method is not for the easily bored. Some studies suggest that between one-and-a-half and three hours of such stimulation a day are required to produce the desired effect.

But when it comes to the supposed methods women can use to induce labour, old wives tell many tall tales. Having sex is the most mentioned and near-mythical birth inducer. But there is not a lot of evidence to tell us whether the theory, which hinges on the labour-inducing effects of the prostaglandins in semen, is sound.

The remainder of the article can be read here. Please post comments below.

Margaret McCartney’s Blog

This blog is no longer updated but it remains open as an archive.

A forum on healthcare policy and professional issues, by Glasgow-based GP and FT Weekend columnist Margaret McCartney.

FT Blogs