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All rapid responses

Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on Although a selection of rapid responses will be included online and in print as readers' letters, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window. Letters are indexed in PubMed.

Re: Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data John F Aloia, Peter Bergman, Gal Dubnov-Raz, Susanna Esposito, et al. 356:doi 10.1136/bmj.i6583

Rather than attacking the press for hyped, fashionably called "fake" news, as do several of the rapid responders, missed are the important issues raised in (1).

1. There is a highly significant benefit in respiratory tract infections in those with the lowest baseline level, <25nmol/L hydroxyvitamin D, which is a clear deficiency never found in those who regularly expose their skin to >45º above the horizon sun, an angle needed for the required UV-B to reach ground level, or in those regularly taking above minimal amounts of supplements.

2. The presence of such low common deficiency levels(2) alone is worthy of extensive press and medical world attention.

Regardless of a putative benefit in infections in some, all cell types have vitamin D receptors, indicating a system wide need that also includes bone health. Clearly we need more studies and I would propose one inspired by the cheapest and most creative ones ever by Trividi, Doll and Khaw(3), using the mail system and Freepost response cards. Supplied were 800 IU/d of D3 (as 100,000 IU 3x/year) and a 30% reduction of fractures of the "main osteoporotic sites" was found after 5 years, with other main events trending in the right direction. Unfortunately there was no question about respiratory illness.

For some perspective and while the experts debate, here in North America bottles with 1000 (25 mcg) or 2000 IU daily doses are on store shelves. However without that daily bother, 50,000 IU pills, a small bolus, taken in the order of monthly are available on-line at about $0.30 each, a consumer decision based on season and on personal risk, all over-the-counter thus indicating safety, as reported in (1).

1. A.R. Martineau et al. doi:
2. 2. K.D. Cashman et al
3. Trivedi, Doll & Khaw.

Competing interests: No competing interests

20 February 2017
Eddie Vos
127 Courser Sutton QC Canada J0E 2K0
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Re: A painful tingling hand Claire Burton, Linda S Chesterton, Graham Davenport. 355:doi 10.1136/bmj.i6386

Dear Sir/Madam,

Thank you to the authors for a helpful and readable overview of carpal tunnel syndrome. This article is of particular value to general practitioners faced with often the first 'filtering' process of a patient presenting with upper limb neurological deficit. Carpal tunnel is often akin to the diagnosis of appendicitis. It can be the hardest or easiest diagnosis to make. Examination findings and nerve conduction studies are helpful as a guide (and often most useful when negative to support exclusion of the diagnosis). It is however, in my experience and I'm sure a view shared by all carpal tunnel surgeons, almost exclusively the history that will eventually steer a patient to surgery. In an attempt to find the 'magic bullet' question relevant to all patient age groups that almost guarantees a positive diagnosis of carpal tunnel syndrome, I have settled on the following:

"Do you get symptoms when peeling the paper tear off the top of milk bottles?"

This is a complex movement involving a pinch grip (which tests controlled and sustained thenar power in abduction and opposition), coupled with a modified phalen's test, predominantly in the morning (ie breakfast time!), often when symptoms are still pronounced from the night before.

Elderly patients may not be able to drive or own a mobile phone or use carrier bags to exacerbate their symptoms. More or less everyone pours themselves a bowl of cereal at some point!

I would value others history magic bullet suggestions for comparison.

Competing interests: No competing interests

20 February 2017
Daniel J. Lashbrook
GP and carpal tunnel surgeon
Independent Health Group
Widcombe Surgery, 3-4 Widcombe Hill, Bath BA2 4JT
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Re: Rethinking brief interventions for alcohol in general practice Jim McCambridge, Richard Saitz. 356:doi 10.1136/bmj.j116

The responses to this paper are diverse, and there are many challenges to be addressed in giving attention to the issues we raised. We were struck by the breadth, clarity and force of our INEBRIA colleague Sven Andreasson’s response, which emphasizes the scale of the scientific challenge, and raises a range of issues with which many will disagree. Allan Braillon also emphasizes the need for change and the scale of the policy challenge, particularly taking issue with the limitations of brief advice and brief counselling.

Perhaps one recent study that I was involved in provides an example of one part of the way forward that they, and we, would agree on. PREMIUM evaluated a 4 session counselling intervention designed to address the needs of harmful (i.e. already problematic, not hazardous) drinkers in a contextually valid way, and identified promising short term self-reported effects in a large trial (1). Although dependent drinkers participating in this intervention were excluded from this study, they were all randomized to a pilot trial whose findings have yet to be reported. The trial was designed with generalizability and implementation considerations in mind. Obviously the agenda for change is much more ambitious than this, though this is a start.

1. Nadkarni A, Weobong B, Weiss HA, McCambridge J, Bhat B, Katti B, et al. Counselling for Alcohol Problems (CAP), a lay counsellor-delivered brief psychological treatment for harmful drinking in men, in primary care in India: a randomised controlled trial. Lancet. 2017;389(10065):186-95.

Competing interests: No competing interests

20 February 2017
Jim McCambridge
University of York
Department of Health Sciences
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Re: Low back pain and sciatica: summary of NICE guidance Ian A Bernstein, Qudsia Malik, Serena Carville, Stephen Ward. 356:doi 10.1136/bmj.i6748

As an expatriate I was very intrigued to read the advice given to people with back ache by the nice people back home. I would suggest that in the real world the patient needs a very different sort of advice.

When I was a student in Liverpool we were told that it is a good idea to ask what makes a symptom worse since this may give a clue to what the pathophysiology is, and maybe even give a clue to what should be avoided. The advice given by NICE makes no reference to the fact that back ache can be brought on or made worse by lifting heavy articles and so should be avoided at all cost. My experience has been that if a patient is unaware of this simple correlation and continues to lift heavy articles his chances of improvement are minimal. Pain medication may be very helpful in enabling the patient to sleep at nights but it should be remembered that it may make things worse since the pain relief may encourage a premature return to lifting. The situation is often made worse by a complicating condition called BITE (Because I’m Too Embarrassed ).They are unwilling to ask for help and continue to suffer as a result. My advice is for them to carry a light weight cane since this will result in help being offered spontaneously by passers by without the need to have to request help.

Competing interests: No competing interests

20 February 2017
Ian J Cohen
General Practioner and retired Pediatric HematoOncologist
Tel Aviv University
Elkanah 44814 Israel
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Re: Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies Thomas Witte, Dieter Hüsgen, Ulrich Keil, et al. 356:doi 10.1136/bmj.j337

Dear Editor,

The BMJ recently published an article by Angela Spelsberg and colleagues entitled ‘Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies’. In their article, the authors made statements regarding dabigatran etexilate (Pradaxa®) and the post-marketing studies 1160.85 and 1160.84, several aspects of which, in the opinion of Boehringer Ingelheim, require correction.

Dabigatran etexilate has been assessed for the indication of the primary prevention of venous thromboembolism (deep vein thrombosis/pulmonary embolism) in patients undergoing knee or hip replacement in four phase III clinical studies, and not in only two as stated by the authors. After approval for this first indication in 2008, the European Medicines Agency (EMA) recommended that two post-approval studies should be conducted to evaluate the risk of bleeding in a more general population of patients (study 1160.85) and in patients with moderate renal impairment (study 1160.84). The purpose of these studies was to further evaluate the risk of haemorrhage and not to detect rare adverse drug reactions. It is not unusual that post-authorisation safety studies (PASS) are conducted to further characterise a specific at-risk population, as reflected in Module VIII of the EU Good Pharmacovigilance Guidelines. In studies 1160.85 and 1160.84 data on more than 5,000 dabigatran-treated patients from the general population and more than 400 dabigatran-treated patients with moderate renal impairment were collected; these studies therefore provide substantially more information than that suggested by the authors, who referred to patient numbers of 2,036 and 300, respectively.

The studies started in 2009 and ended in 2011 and 2014, respectively. During all times, Boehringer Ingelheim regularly submitted safety update reports in line with regulatory obligations and continuously informed the EMA on the status of the studies, including the rescheduling of the finalization date that was agreed with EMA. The adaptation of the end date was necessary due to continuous slow recruitment, despite several efforts for improvement.

Boehringer Ingelheim reported all serious adverse events (AEs) to the health authorities and collected data on all AEs, according to regulatory obligations. It is good clinical practice to analyse a study upon completion and if not prespecified to avoid interim analyses during conduct to avoid bias. Boehringer Ingelheim did perform continuous safety signal detection activities during the above mentioned studies. Boehringer Ingelheim submitted the study reports including AE listings to the EMA in 2012 (study 1160.85) and 2015 (study 1160.84) after study finalisation and in line with the timelines previously agreed with the EMA.

The results of both studies (1160.85 and 1160.84) were reported in due time and were published in journals in 2016 (1, 2) as well as on in 2012 and 2015, respectively (NCT00846807, NCT00847301).

As a research-driven pharmaceutical company, Boehringer Ingelheim supports the principle of transparency by seeking publication of the scientific results from all our studies in peer-reviewed journals and at scientific meetings, regardless of study outcome. Boehringer Ingelheim publicly registers all sponsored clinical studies and discloses the results (Boehringer Ingelheim Trial Results Web Application (3)).


1. Rosencher N, Samama CM, Feuring M, Brueckmann M, Kleine E, Clemens A, Frostick S. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting. Thromb J. 2016 Apr 1;14:8. doi: 10.1186/s12959-016-0082-4.

2. Samama CM, Rosencher N, Kleine E, Feuring M, Brueckmann M, Clemens A, Gullberg J, Frostick SP. Observational study of dabigatran etexilate 150 mg in patients with moderate renal impairment undergoing elective total hip or knee replacement. Thromb Res. 2016 Jul;143:103-10. doi: 10.1016/j.thromres.2016.05.014.

3. Boehringer Ingelheim Trial Results Web Application.

Competing interests: All authors are employees of Boehringer Ingelheim.

20 February 2017
Martin Feuring
Medic at Boehringer Ingelheim
Martina Brueckmann, Jörg Kreuzer
Boehringer Ingelheim
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
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Re: Five minutes with . . . Stephen Westaby Susan Mayor. 356:doi 10.1136/bmj.j769

In every story (well at least those non-fake new stories that we have in most parts of the world) there are at least 3 sides or facets to consider. Having been at the coal face of teaching clinical audit theory and practice to clinicians for the past decade and witnessed the overt and covert resistance to this "new development" in that period of time, I would put it to Mr Westaby that no system is perfectly designed but if the general thrust of the surveillance is to increase the participation of our clinical colleagues in continuous professional development. The statement "I am an innovator" is probably enough to satisfy any continuous professional education requirement; topped off with a monumental track record of publishing and mentoring, I think Mr Westaby has more than ample reason to complain when his clinical director suggested deficiencies in his personal development planning. The organization is failing; the level of distrust and poor communication that caused that email to be sent suggests that the clinical director needs to work on his or her professional development plan.

However, there are many doctors (and we need to recognize how many) that have been practising in their own little world of medicine for decades using treatments and clinical managements that are many years out of date, who are exposing patients to harm or who are denying patients best medical care, because of a lack of reflection on their part as to the requirements for continued skills updating and continued exposure to clinical innovation. Putting in place a system that requires some tick boxing is a small price to pay for the continued and treasured opportunity to keep self regulation as a prerogative.

Lastly I would say that to any doctor of average diagnostic acumen, putting together sufficient cme points should not be beyond their intellectual capacity. Not being able to do this task might point up a deficiency in clinical reasoning as well as a lack of creativity on their part.

Competing interests: No competing interests

20 February 2017
Ian Callanan
St Vincents University Hospital Dublin
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Re: Making uncertainty work Sophie Cook. 356:doi 10.1136/bmj.j815

Tantalized, we can never quite connect with ourselves or others. Perhaps communication is like an asymptote. Asymptotes are geometrics with curved lines that approach, but never quite reach, straight lines; while our communication is dialectics that approach, but never quite reach, the straight truth. Trapped in our asymptotic identity and asymptotic relationships, we live without the nexus of context and impact of contact.

Competing interests: No competing interests

20 February 2017
Hugh Mann
New York, NY, USA
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Re: NHS cuts have played part in rise in excess deaths, study claims Adrian O’Dowd. 356:doi 10.1136/bmj.j875

From one old man - despite my alliterative occupation - to another, Anand is correct in saying there is still a CMO at DH, and the present postholder is Prof Dame Sally Davies. There is also a Chief Scientific Adviser for DH, Professor Chris Whitty, who has overall responsibility for the DH R&D budget, which includes the NIHR. And there is, of course, PHE, which must have an interest. Why then, I idly speculate, have none of them attempted to explain the spike in deaths which ONS data showed, and which must surely be multi-factorial? Perhaps they might be passing the buck, in the fine tradition of Whitehall, or is that far too cynical? And where is the S of S for Health in all this?

Competing interests: No competing interests

19 February 2017
John G Gooderham
locum lollipop lady
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Re: Making uncertainty work Sophie Cook. 356:doi 10.1136/bmj.j815

One problem in the debate on Vitamin D supplementation lies in the RDI itself which seems to be based on the amount needed to resolve acute deficiency as in rickets. There is also the problem of norms based on what is found in assumedly “healthy” individuals in a very much sun deficient country. The problem of optimal levels of 25-hydroxyvitamin D concentrations, which from my research would appear to be in the range >50 nmol/L-100+nmol/L. As a consequence the optimal daily oral supplement dose recommended by the Vitamin D Council which is an independent organization uninfluenced by commercial interests ( -an independent organization uninfluenced by commercial interests) is in the order of 5,000IU (~125µg) (Vitamin D 1 IU (International Unit)= 0.025 microgram (μg) cholecalciferol or ergocalciferol)

From my reading of the referenced papers it seems to me that the dose rates used along with the achieved blood levels of 25-hydroxyvitamin D are far from optimal. Also it seems from my searches of Pubmed that there are several conditions that benefit from high dose Vitamin D including COPD and MS. Of course large scale trials similar to those for statins will never be done despite the possibility of better outcomes because there is no perception of adequate profit.

Furthermore, it seems odd that the NHS does not provide simple access for testing despite the UK CMO’s repeated warnings on the problem of widespread defiency of vitamin D, particularly in the elderly.. At least one organization provides such an analysis for as little as £28. I personally will be trying the system in the near future to confirm that I have an adequate level.

Competing interests: No competing interests

19 February 2017
Michael J. Hope Cawdery
Retired veterinary researcher
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Re: Could we see a prescription opioid epidemic in the UK? Michael H Basler. 356:doi 10.1136/bmj.j790

People with chronic pain that does not respond to other analgesia struggle to get adequate pain control due to measures already in place. Tramadol is now a controlled drug. This has had the effect that repeat prescriptions cannot be sent electronically with other prescription items often and needs to be collected. Many of those who rely on tramadol or other controlled drugs are not mobile and completely dependent on pharmacy delivery services who do not ensure collection of the hand signed scripts. A few CCGs appear to have a blanket ban on some benzodiazepams to stop drug addicts getting them, affecting patients who gained benefit in the past and now some end up sedated for most of the day on alternatives.

Drug addicts are now abusing other drugs for neuropathic pain such as pregabalin and gabapentin. They will try anything they can get. In the past co-proxamol had its licence removed to stop addicts getting it and overdosing. This had the effect of removing the only effective pain relief from many with arthritis who could not take NSAIDs.

It is vital that drug addicts do not get all the attention and that those with long term pain have access to effective drugs along with other coping mechanisms for pain control. The needs of end of life care must not be forgotten.

ATOS clinicians appear to think that tramadol and NSAIDs at their maximum recommended dose are not significant pain medication when doing Personal Independent Payment assessments for the DWP. Are they suggesting that we should be drug addicts to qualify?

Competing interests: No competing interests

19 February 2017
Sarah Bowness
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