{"id":31094,"date":"2014-02-17T19:02:46","date_gmt":"2014-02-17T18:02:46","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=31094"},"modified":"2014-02-18T15:09:54","modified_gmt":"2014-02-18T14:09:54","slug":"richard-lehmans-journal-review-17-february-2014","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/02\/17\/richard-lehmans-journal-review-17-february-2014\/","title":{"rendered":"Richard Lehman’s journal review\u201417 February 2014"},"content":{"rendered":"

\"richard_lehman\" NEJM<\/strong><\/em><\/a><\/p>\n

599<\/strong> Most weeks I quote you the conclusion of some pharma-funded trial which\u00a0overstates the benefit of an intervention. But in reality clinical trials of any kind can\u00a0be a form of marketing: doing them is difficult work, there are reputations and ideas\u00a0at stake, and the temptation to overstate results is always there for career academics\u00a0as well as for pharmaceutical marketing departments. And I really admire the work\u00a0that went in to the Multicenter Selective Lymphadenectomy Trial (MSLT-I) for\u00a0melanoma<\/a>, which commenced in 1994. Twenty years on, we are told that “Biopsy-based management prolongs disease-free survival for all patients and prolongs\u00a0distant disease-free survival and melanoma-specific survival for patients with nodal\u00a0metastases from intermediate-thickness melanomas.”<\/p>\n

Technically, that is true: but if\u00a0I were a melanoma patient deciding whether to have sentinel-node biopsy or not, I\u00a0would like to be shown the Kaplan-Meyer charts on Figure 1. I’d still probably go for\u00a0the biopsy, but the absolute differences in clinical outcomes are very small.<\/p>\n

610<\/strong> A title like “Oxantel Pamoate\u2013Albendazole for Trichuris trichiura Infection”\u00a0<\/span>always gives me a guilty start: should I have heard of oxantel pamoate and do I\u00a0know anything about Trichuris trichiura infection? I feel like the hapless Dr Watson in\u00a0The Dying Detective when Sherlock Holmes rounded on him and declared “you are\u00a0only a general practitioner with very limited experience and mediocre qualifications…What do you know, pray, of Tapanuli fever? What do you know of the black Formosa\u00a0corruption?” It turns out that Holmes was playing tricks on poor Watson and had\u00a0made up these fearful diseases, which do not exist. Trichuriasis, however, does\u00a0exist; but it is not fearful and it is not an infection. It is a worm infestation, extremely\u00a0common among the children of Mchangamdogo. “Now you really are raving,\u00a0Holmes. You cannot expect me to believe that the earth contains any place of\u00a0such name!”<\/p>\n

“My dear Watson, here is a paper<\/a> in the Journal of the Massachusetts\u00a0Medical Society<\/em> to prove it. Moreover, in this village in Africa, infestations of\u00a0whipworm are even now being treated with oxantel pamoate.” “Holmes, you astound\u00a0me! Yet I cannot deny the proof of my own eyes. I should never have believed\u00a0such a thing. These strange names are nothing to me – but that the medical men of\u00a0Boston should not know the difference between an infection and an infestation!”<\/p>\n

621<\/strong> There are some who say that restless legs syndrome is a non-diagnosis\u00a0<\/span>devised to sell drugs. And there are those who say pregabalin is just a me-again\u00a0drug devised by Pfizer to be marketed once the patent on gabapentin expired. Far\u00a0be it from me to give an opinion on such matters. I am only a general practitioner\u00a0with very limited experience and mediocre qualifications, and this is a paper<\/a> in the\u00a0New England Journal of Medicine<\/em>. The conclusion declares that in this mysteriously\u00a0common syndrome, ” Pregabalin provided significantly improved treatment outcomes\u00a0as compared with placebo, and augmentation rates were significantly lower with\u00a0pregabalin than with 0.5 mg of pramipexole.” That’s enough for me. (NB. In this\u00a0context, augmentation refers to a worsening of the condition thought to be due to treatment.<\/p>\n

JAMA Internal Medicine<\/strong><\/em><\/p>\n

251<\/strong> Goodness, it’s taken a long time for the diabetes community to come to terms\u00a0with the obvious. A study<\/a> of people over 60 with diabetes finds that the main ill\u00a0effects of their condition in old age are coronary artery disease and hypoglycaemia.\u00a0In people who develop diabetes after the age of 60, microvascular disease is so\u00a0uncommon it is hardly a consideration: whereas the commonest treatments given to\u00a0lower sugar frequently cause hypoglycaemia and have little or no effect on coronary\u00a0disease. Step back, guys: treating type 2 diabetes is a whole different ball game in\u00a0a 65 year old as compared with a 35 year old. One size does not fit all ages. In fact,\u00a0each patient of any age needs to be treated in accordance with his or her own goals\u00a0and informed preferences. People with diabetes have for so long been misinformed\u00a0about the benefits and harms of treatment that I suspect we often keep them on\u00a0drugs out of sheer embarrassment at admitting we didn’t know what we were doing.\u00a0And it’s still going on: we “put people on” drugs like incretin mimetics when we\u00a0haven’t a clue what they do to long-term outcomes, and then congratulate ourselves\u00a0just because their HbA1c has gone down.<\/p>\n

281<\/strong>\u00a0“All screening does harm: some screening does more good than harm,”\u00a0<\/span>is the sentence Muir Gray uses to begin his chapter on screening in the Oxford\u00a0Textbook of Medicine<\/em>. This is a huge topic, and every part of it is complex. So\u00a0I’m glad to see a lucid dissection<\/a> of the issues in the Less is More series, using\u00a0lung cancer screening as an example. This is a must-read for thoughtful criticS\u00a0of screening: “We propose a taxonomy with 4 domains of harm from screening:\u00a0physical effects, psychological effects, financial strain, and opportunity costs. Harms\u00a0can occur at any step of the screening cascade… the taxonomy also makes clear\u00a0where … we have useful information and where there are gaps in our knowledge.”<\/p>\n

Online<\/strong>\u00a0Another week, another great paper from a Yale medical student. If this is\u00a0<\/span>beginning to sound like advertising, I don’t care: I wish every medical school had a\u00a0Harlan Krumholz and Joe Ross who would encourage attached students to produce\u00a0work of such quality. This time the student’s name is Kyan Safavi, and he did a\u00a0massive survey<\/a> of data about variation in non-invasive cardiac imaging for suspected\u00a0ischaemia across US hospitals. “Hospitals with higher imaging rates did not have\u00a0substantially different rates of therapeutic interventions or lower readmission rates\u00a0for AMI but were more likely to admit patients and perform angiography.” So non-invasive imaging leads to invasive imaging without showing any clear benefit in\u00a0patient outcomes. Those Americans, eh? But I bet you would find exactly the same\u00a0variation in the UK, especially between district general and teaching hospitals.<\/p>\n

The Lancet<\/strong><\/em><\/p>\n

603<\/strong> It’s ninety years now since Geoffrey Keynes, the great surgeon and literary\u00a0<\/span>scholar, first tried out intra-operative local radiotherapy for breast cancer. At\u00a0the same time, he pioneered breast-conserving cancer surgery. Nobody took\u00a0much notice.<\/p>\n

Now breast-conserving surgery is standard and intra-operative\u00a0local radiotherapy is making a comeback. The TARGIT-A trial for invasive ductal\u00a0carcinoma<\/a> concludes that “single-dose targeted intraoperative radiotherapy\u00a0concurrent with lumpectomy within a risk-adapted approach should be considered as an option for eligible patients with breast cancer carefully selected as per the\u00a0TARGIT-A trial protocol, as an alternative to postoperative external beam RT.” Sir\u00a0Geoffrey lived to the age of 95: if only he’d hung on another 40 years, he could have\u00a0seen his work reach fruition. I wonder if somebody is going to rediscover his work\u00a0on the thymus next. In the mean time, enjoy his magnificent editions of the works of William Blake.<\/p>\n

614<\/strong> The ARUBA trial is described in the editorial as “a valiant effort to help improve\u00a0<\/span>understanding of brain arteriovenous malformation natural history and treatment\u00a0risks.” In fact the editorial spends most of its time showing how, with a highly\u00a0selective recruitment protocol and just 33 months of follow-up, it cannot hope to give\u00a0a true picture of the balance of harm and benefit between medical treatment (which\u00a0could mean anything), and invasive treatment, which could mean embolization,\u00a0radiotherapy or surgery. This prematurely terminated trial<\/a> is reported at the end of\u00a0the abstract as showing “that medical management alone is superior to medical\u00a0management with interventional therapy for the prevention of death or stroke in\u00a0patients with unruptured brain arteriovenous malformations followed up for 33\u00a0months.” Although this was not a pharma-funded trial, again I think this conclusion\u00a0overstates the importance and generalizability of the findings. Journal editors should\u00a0write these abstract conclusions themselves, and they should always contain caveats.<\/p>\n

622<\/strong> In the next paper<\/a>, the abstract conclusion (called Interpretation) can afford\u00a0<\/span>to be laconic: “Changes in blood pressure after renal denervation persist long term\u00a0in patients with treatment-resistant hypertension, with good safety.” This is indeed\u00a0true of the 88 out of 153 patients who had full follow-up data at 36 months in this\u00a0Medtronic-funded Symplicity HTN-1 trial. These were people whose blood pressure\u00a0remained high despite treatment with an average of five different agents. And the\u00a0drop in BP following percutaneous radiofrequency ablation of the renal nerve supply\u00a0was little short of spectacular: a mean fall of 32 mm Hg in systolic and 14.4 mm\u00a0diastolic. So something really big is happening here, and you could say that this is\u00a0the kind of intervention which did not get a randomized trial because it didn’t need\u00a0one. What it did need, however, was tighter follow-up. I know this is something\u00a0Medtronic are keen to carry out in the future, and to be fair they didn’t design this trial\u00a0themselves: it was instigated by a company they bought up half way through. But it\u00a0was a missed opportunity to do better from the outset in the evaluation of a treatment\u00a0which looks to have immense potential.<\/p>\n

Online<\/strong>\u00a0“Cognitive therapy significantly reduced psychiatric symptoms and seems to be\u00a0a safe and acceptable alternative for people with schizophrenia spectrum disorders\u00a0who have chosen not to take antipsychotic drugs. Evidence-based treatments should\u00a0be available to these individuals. A larger, definitive trial is needed.” Now that’s the\u00a0kind of <\/span>Interpretation<\/a> I like: modest and guarded, while optimistic about a major\u00a0breakthrough. I like the prospect of a world in which people with high blood pressure\u00a0can have a procedure which results in a permanent cure, and where people with\u00a0schizophrenia are not universally doped with drugs which blunt their minds and\u00a0shorten their lives. Perhaps medicine is turning in the right direction at last.<\/span><\/p>\n

The BMJ<\/em><\/strong><\/p>\n

“Impaired first trimester fetal growth is associated with an adverse cardiovascular\u00a0<\/span>risk profile in school age children. Early fetal life might be a critical period for\u00a0cardiovascular health in later life.” This is the conclusion of an important study<\/a>\u00a0of 1184 children in Rotterdam who had records of crown-rump length in the first\u00a0trimester and anthropometric and blood tests at the age of 6. Ah well. If only we\u00a0knew the determinants of first trimester fetal growth, we might be able to make\u00a0cardiovascular disease even rarer in generations to come.<\/p>\n

The BMJ<\/em> certainly has the scoop paper<\/a> this week: a 25-year follow up of the\u00a0<\/span>Canadian National Breast Screening Study showing that mammographic screening\u00a0as practised then had no effect on breast cancer mortality and resulted in a\u00a0high level of overdiagnosis. If you want to disbelieve this, you are welcome to\u00a0read several rapid responses which criticize the methods and internal validity\u00a0of the study. If you believe that mammography is a bad form of screening that\u00a0probably does more harm than good, this is one more piece in a formidable\u00a0edifice of evidence. On balance, I cannot see any justification for continuing with\u00a0mammography as a whole-population screening programme. There may perhaps be\u00a0a case for providing it to individual women on an informed choice basis.<\/p>\n

“Women who carry a germline mutation in either the BRCA1 or BRCA2 gene have\u00a0<\/span>a lifetime risk of breast cancer of 60-70%.” This study<\/a> from 12 US cancer genetics\u00a0clinics followed up 390 such women for a mean of 13 years. ” At 20 years the\u00a0survival rate for women who had mastectomy of the contralateral breast was 88%\u00a0(95% confidence interval 83% to 93%) and for those who did not was 66% (59% to\u00a073%).” So bilateral mastectomy improves all-cause mortality, overall.<\/p>\n

When the Quality and Outcomes Framework was introduced into British general\u00a0<\/span>practice, I gave it a cautious welcome. Over the years, this has turned into deep\u00a0loathing. Whatever marginal improvements it may have initially achieved in certain\u00a0areas, its dominating role in primary care has totally distorted clinical priorities,\u00a0disempowering both patients and doctors and leading to a complete travesty of\u00a0evidence-based medicine. The sooner it disappears, the sooner medicine can\u00a0move forwards to become a dialogue of choice made between informed individuals.<\/p>\n

This study<\/a> shows that when incentives are withdrawn, clinical care remains stable\u00a0in those small domains where it is measurable. The immeasurable expanses of\u00a0important personal care count for much more. If we could but return to those, we\u00a0might become a compassionate, highly motivated profession once again.<\/p>\n

Plant of the Week:<\/span> Galanthus nivalis<\/span><\/strong><\/a><\/em><\/p>\n

Midwinter spring is its own season,\u00a0Sempiternal though sodden towards sundown…\u00a0I have never understood why these verses have been so widely admired, and sadly\u00a0I find that I now much prefer Henry Reed’s parody Chard Whitlow to the real Four\u00a0Quartets by TS Eliot. But there is no denying that at present Oxfordshire is highly\u00a0sodden towards sundown. But since our copses and banks generally lie above the\u00a0flood plains, the snowdrops are not affected.\u00a0Wherever snowdrops appear, they give hope of new life to come. In the garden, they\u00a0must have space to form drifts, which can be interspersed with hepaticas or winter\u00a0aconites or early-flowering hellebores. But they are of course best seen as huge\u00a0carpets in woodland. And soon after there will be wood anemones, and wild daffodils\u00a0and then bluebells…In the days when he could still write poetry, Mr. Eliot declared that April is the\u00a0cruellest month. It is not. February is the cruellest month. It is a pointless sempiternal\u00a0time of freezing or drenching, and the snowdrops cannot fully make up for that. But\u00a0at least they try.<\/p>\n","protected":false},"excerpt":{"rendered":"

NEJM 599 Most weeks I quote you the conclusion of some pharma-funded trial which\u00a0overstates the benefit of an intervention. But in reality clinical trials of any kind can\u00a0be a form […]<\/p>\n

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