664 e-Letters

  • Jason Conviser, Ph.D., FACSM

    I have read the protocol for The LIFTMOR-M (Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men) trial: protocol for a semi-randomised controlled trial of supervised targeted exercise to reduce risk of osteoporotic fracture in older men with low bone mass and have questions and concerns that I wish your consideration and response:
    1. Your protocol calls for 8 months of exposure to the bio Density system. Manufacturers recommendations supported by peer reviewed studies have shown that BMD changes require a minimum of 9 months and many individuals begin to show changes with DEXA at the 11 and 12 month period.
    2. Those studies which have shown changes in DEXA as a result of bio Density exposure have done so with subjects who are in osteopenia and not osteoporosis. Your inclusion of males in osteopenia could complicate analysis and conclusions. The best that we have seen is a baseline of those with osteopenia (not getting worse). Also the greater the negative DEXA (ie -3.0, or greater we have seen the greatest change with bio Density exposure). Regression to the mean can be expected.
    3. The protocol allows for 2 x per week exposure. The manufacturers recommendations call for once a week.
    4. I question if it is appropriate to ask 50 year old men to not perform any form of exercise for 8 or more months while participating in this study. Will the health risk of not exercising be acceptable to the IRB? Other st...

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  • Note from the Editor in reference to the response from Dr Adam Balen

    The response below should have been posted in January 2017. It responds both to this BMJ Open article and to a related article in The BMJ (http://www.bmj.com/content/355/bmj.i6295). It was posted on bmj.com on January 18 2017 but failed to be replicated within BMJ Open. We apologise for this. The authors have been asked to respond.

  • Lack of evidence for interventions offered in UK fertility centres

    To The Editor, BMJ

    Dear Dr Godlee

    Re: Lack of evidence for interventions offered in UK fertility centres.

    We are writing to express our concern regarding the papers by Heneghan et al, (2016) and Spencer et al (2016) owing to their lack of scientific robustness.

    We would like to state at the outset that we oppose the provision of procedures or treatments that do not have a scientific basis and we welcome the initiative by the Human Fertilisation and Embryology Authority (HFEA), which has been endorsed by the British Fertility Society (BFS), to introduce a grading scheme for “add-ons”.

    Spencer, Heneghan and colleagues have unfortunately obscured their important message by mixing various categories of treatment, not all of which come under the category of “add-ons”. Indeed, a number are accepted components of routine treatment. The papers have grouped together three categories of care: (i) necessary investigations (e.g. assessment of ovarian reserve, which is vital in determining correct dosage of ovarian stimulation drugs to optimise outcome and ensure patient safety), (ii) essential treatments (e.g. surgical sperm retrieval) and (iii) interventions that can be termed “add-ons” - namely an addition to a pathway of care, whether as an additional drug or therapeutic procedure. Many of the items identified have a clearly defined role in specific situations; e.g. for a man with a physical blockage sperm has to be extracted surgically, frozen an...

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  • Newly developed spirometry prediction models for Indian adults

    I read the article written by Rajkumar et al. [1] with great interest and appreciate the efforts taken by the investigators to screen the prevalence of COPD in different age groups in India. However, there are two aspects on which I would like to make some comments. The authors have stated “Globally COPD was the fourth leading cause of death (5.1%) in 2004 and is projected to occupy the third position (8.6%) in 2030”, I assume that the statistics are quite overestimated. Mathers and Loncar (2006) [2], provided a more comprehensive picture about the projected scenario of COPD globally and they concluded that COPD is at present the 5th leading cause of mortality and morbidity globally and is likely to step up to 4th position by 2030 with an increment of 160%. I think that the authors need to consider the fact. Secondly, the authors might have missed that recently, Desai and colleagues (2016) have published spirometry prediction equations for Indian adults residing in the western parts of India [3]. The equations have successfully overcome a long-awaited aspiration for standard prediction models in Indian perspective and could be used as Indian standard. Most of the existing prediction models such as the global lung function equations developed by Quanjer et al. (2012) [4] which were developed for Europeans either under-diagnose or over-diagnose the disease, hence I think the newly published models would serve the purpose.

    1. Rajkumar P, Pattabi K, Va...

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  • Response to Uffe Ravnskov

    As the two comments posted on PubMed for the cited article by Dr Ravnskov et al clearly state, there are several major shortcomings in the design and analysis of their meta-analysis. In addition, benefits of statins in reducing risk of myocardial infarction in older age patients without cardiovascular disease have been shown in several randomized trials.
    Our analysis adds to the literature by providing an insight on how use of palm oil for cooking (as opposed to sunflower oil) may worsen lipid profiles in a population from a low-income country with implications for cardiovascular disease. As we have discussed, a large case-control study has already shown an association between palm oil use and non-fatal myocardial infarction.

  • Don't throw the baby out with the bath water

    In their recently published meta-analyses Brignardello-Petersen et al. (1) concluded that knee arthroscopy including partial meniscectomy for degenerative knee disease provides very small benefits in pain and function over conservative therapy in the short term, but that the evidence fails to support any long term effect. They also claimed that there was no evidence of any subgroup of patients more likely to benefit from the procedure. However, this statement is not substantiated by the results of their systematic review and meta-analysis. Besides, the design of their study is not suited for evaluating subgroups. By making such an unsubstantiated claim, and subsequently adopting it in a clinical practice guideline (2), the risk is that we “throw the baby out with the bath water”.

    Despite the accumulated evidence that questions the effectiveness of knee arthroscopy for degenerative meniscus tears, clinical practice does not seem to change.(3-7) Hence, the key question is what information is required in order to effectively change the practice of knee arthroscopy in degenerative knee disease.
    Orthopedic surgeons have expressed concerns about the generalisability of the individual trial results, and point out that the study populations may not be representative to the subjects they select for surgery in their day-to-day clinical practice.(8-18) These concerns point to the common perception that some subgroups of patients may still benefit from the procedure. Hen...

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  • Findings in line with studies of whole populations

    We read with interest the letter from Steele et al regarding the Northwick Park study of screening pregnant women for GBS carriage.

    While the study was not large enough to meet most of the statistical probability tests referred to by Steele et al, the results were entirely in line with studies of whole populations such as that in the United States of America, where the incidence of early onset GBS disease in neonates has fallen by more than 80% since screening was recommended. Thus, from a Bayesian perspective, the study increased the already high probability that the introduction of screening into the UK would produce a similar beneficial effect, and moreover showed that it was feasible within existing resources.

    We fully support the calls from Steele et al for more and better research on the long term effects of intrapartum antibiotic prophylaxis, and have been greatly encouraged by a letter to us on the 10th April 2017 from Philip Dunne MP (until the dissolution of Parliament, the Minister of State for Health) which states that “I have asked the National Institute of Health Research to commission a clinical trial to compare universal screening for GBS against usual risk-based care”. Such a trial would be of major importance not just in the UK but also to the international community.

    Until the results of such a trial are available, we will continue to advocate that women should be given the facts and allowed to choose for themselves the balance be...

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  • High cholesterol is an advantage for the elderly

    There is no reason to lower the intake of palm oil or other types of foods rich in saturated fat because elderly people with high levels of LDL-cholesterol (the "bad" one) live the longest. This is what we have documented in a meta-analysis of 19 cohort studies including more than 68,000 individuals.(1). Those with high LDL-cholesterol lived even longer than those on statin treatment.
    Our study has been heavily criticized by several groups of supporters of the cholesterol hypothesis, but hitherto nobody has been able to find a study showing the opposite.

    (1) Ravnskov U, Diamond DM, Hama R et al. Lack of an association or an inverse association between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review. BMJ Open 2016;6:e010401. doi: 10.1136/bmjopen-2015-010401

  • Health economic burden that wounds impose on the National Health Service in the UK: request for further methodological information.

    Guest et al use routinely collected primary care data to estimate an annual prevalence of wounds in the UK of 4.5%.(1) They then report annual prevalence estimates for different wound sub-types, including venous leg ulcers. We have become aware of differences in the venous ulcer prevalence estimates of Guest et al (1) and our own estimates from THIN (2) and from surveys in Leeds (3) and Greater Manchester (data on file). We have calculated an annual UK prevalence of venous leg ulcers of 1.3 per 1000 (or 0.13%) compared with Guest’s estimate of 5.6 per 1000 (or 0.56%).

    Briefly our annual estimate was calculated by combining our 2011 point prevalence values (row B and C from Table 1: rounded to 0.3 per 1000. Please note since response format does not allow tables we have converted to text) with the 2006 UK annual incidence rate of venous leg ulcers estimate (row D Table 1), assuming that the annual incidence has not changed since 2006. Our value is very similar to the crude estimate of annual UK venous leg ulcer prevalence of 1.4 per 1000 people directly calculated by Petherick et al (2) using THIN and G(C)PRD (Row E: Table 1).

    We note that the annual prevalence estimate for venous leg ulcers of Guest et al (row A: Table 1) is four times higher than the others presented here. We also note that this is the most conservative estimate of the UK annual prevalence from Guest’s data given the large number of unspecified leg ulcers reported in this paper– a large...

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  • Revisiting criteria for safe term breech delivery

    We read with great interest the population-based study of Bjellmo et al1, who evaluated from the Norwegian Medical Birth Registry from years 1999-2009 the risk for stillbirth, neonatal mortality (NNM) and cerebral palsy in children born vaginally at term in breech position, as compared with the children born vaginally in cephalic position. Indeed, thanks to this way to address the crucial question of the over risk associated with breech presentation, these authors demonstrated that children in breech had a nearly threefold increased Odds Ratio (OR) for NNM compared with children born vaginally in cephalic, regardless of whether they were born vaginally or by caesarean delivery.
    Moreover, Bjellmo et al1 also found a higher proportion of infants born small-for-gestational-age (SGA) among children born in breech than in cephalic position, and suggested that SGA foetuses (with their risk factors for adverse outcomes) are more likely to present in breech than in cephalic posi¬tion at birth.
    In line with these findings, in a recent Finnish population-based case-control study, Macharey et al2 , who revisited the risk factors associated with adverse perinatal outcome in planned vaginal breech labours at term, found that the stillbirth rate was significantly higher compared to cephalic presentation (0.2 vs 0.1%) in association with SGA, oligohydramnios, and gestational diabetes. Furthermore this same group, in another recent survey from the same cohort of mother-neonate...

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