Tag Archives: venous thromboembolism

Rehab Journal Review: July 2014

Journal of Neurosurgery, July 2014

‘A nose could grow in your back’, the creepy and till-recently unsubstantiated salvo that was used to deter people from falling prey to unscrupulous ‘stem cell treatments’ has become almost true. This is the first report of such an “occurrence of a spinal cord mass after olfactory mucosal cell transplantation in a patient with a spinal cord injury.” The tumor was excised, and its biopsy revealed “respiratory epithelium with underlying submucosal glands identical to that seen in normal nasal mucosa.” The lesson: please, let’s wait. Until “better understanding of how to control cell proliferation, survival, migration, and differentiation in the pathological environment to foresee or prevent uncontrolled or abnormal cell growth in human patients.” Thanks Prashanth, for sending the links.

Archives of PMR, July 2014

1289 South Indian film industry is turning back time. Once again, there are talented female actors who can sing well as well as they can act and dance. The recent hit Fy-Fy-Fy sung by actor Ramya Nambeesan is an example. Why did I go off-track? Because of this similar rhyming functional independence tool from the US for spinal cord injury, the SCI-Fi short form, which is claimed to have good good internal consistency, and minimal ceiling and floor effects. We could have a look at this, but we’ve just transitioned to SCIM-II.

Spinal Cord, July 2014

511 This review on use of catheters for clean intermittent catheterization raises more questions than providing answers. Should off-label reuse be encouraged? If yes, how frequently should the catheters be changed? How should they be cleaned/sterilized before each use? How should they be stored? Are hydrophilic self-lubricating catheters better than uncoated tubes for off-label use? What is the overall health economic benefit/liability of each option? It is a shame that in spite of the blanket encouragement for off-label re-use in our practice for more than 3 decades, we don’t have have answers to these questions, and continue based only on ‘belief’. Worse,  “off-label reuse is not supported by legal requirements in Europe or the United States, or in Australia or Canada”. Hunting for post-graduate thesis topics? Do consider these very relevant questions that need answers.

547 One more answer that is long pending: is pharmacological prophylaxis for thromboembolism necessary for everyone with acute spinal cord injury? Do benefits outweigh risks and costs? As I’d mentioned in an earlier post, in spite of the existence of this clinical equipoise, a study proposal from my colleagues was (wrongly) shot down by our institutional review board, judging that a placebo arm is unethical. Dr HS Chhabra has apparently had no such troubles in getting approval for this RCT comparing LMWH Vs ‘No treatment’ in acute SCI. There was no difference between the two arms in the incidence of symptomatic DVT or complications, though the control arm had more asymptomatic DVT, which is of uncertain clinical significance. Hmm… one more clinically relevant thesis topic, awaiting a samaritan.

Lancet, 24 July 2014

Online “Elementary” Holmes would have remarked if he’d read this article. The RCT, comparing paracetamol Vs placebo for low back pain, is an example for how a seemingly simple study could get primetime spotlight if 1) there is real clinical relevance (I’m itching to use that ‘equipoise’ word again) 2) the publisher or the author has  good media relations. Should we continue to use paracetamol? Of course, yes, because it is at least “as good as placebo“.

BMJ, July 2014

Is Dabigatran really that good? Surprise (er…should we really be?)! One more instance of a drug company that has suppressed trial data to improve income. Internal documents accessed through a lawsuit found that “Optimally used (=titrated) dabigatran has the potential to provide patients an even better efficacy and safety profile than fixed dose dabigatran and also a better safety and efficacy profile than a matched warfarin group”. But, “Boehringer Ingelheim, the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity”, in order not to dilute the marketing USP- ‘use without testing INR’. Lesson for our practice: Do use Dabigatran, but with INR checks to titrate dose for better effectiveness and to reduce bleeding risks.

Practice tid-bits

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doughnut diet

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Rehab Journal Review: November 2013

After a few roller coaster weeks of curricular, co-curricular and extra-curricular activities, here is the delayed follow-up act.

Spinal cord, Volume 51, Issue 8, August 2013

596 A few years ago, a couple of junior consultants in our department submitted a study proposal to the institutional review board- an RCT to study whether anticoagulants offered clinically appreciable benefits as against no treatment in persons with acute/post-acute spinal cord injury. Our proposal was shot down by the IRB, saying it was unethical to have a placebo/no-treatment group. Seems it probably might not have been unethical. Heparin for venous thromboembolism prophylaxis in acute SCI, a review article from China (Open access in Spinal Cord is a rarity) reports a few such studies with no-treatment groups. After you wade through the typos in page 601, the authors conclude that “in acute SCI, low dose unfractionated heparin (LDUH) have no thromboprophylaxis effect compared to placebo or no treatment (0/4 studies). LMWH reduce bleeding risk, but cannot prophylaxis thromboembolism compared with LDUH (8/9 studies). [Tinzaparine is the exception here (Green D 1994), but I don’t remember ever discussing that name for clinical use. Anyone??] Because no good quality studies existed in this setting, well-designed RCTs are urgently needed.”

The related clinical dilemma expressed by this BMJ article in July 2013 adds to the intrigue in situations warranting therapeutic anticoagulation. Combination of large increase in incidence, reduced case fatality (in-hospital deaths among people with a diagnosis of pulmonary embolism), and a minimal decrease in mortality (deaths from pulmonary embolism in the population) suggests that many of the extra emboli being detected are not clinically important. Harms from overdiagnosis—Substantial increase in complications from anticoagulation. Anxiety and inconvenience for patients following diagnosis and treatment”. So, are there clots that we don’t need to treat? “Without prospectively observing untreated patients, it is impossible to be certain which emboli are not clinically important”.

Now, I’m keen to revive the rejected study proposal.

642 Assisted Reproductive Techniques in SCI is a retrospective cohort analysis of 32 patients, reported from Israel. The authors claim testicular aspiration success rates of almost 90%. Primary testicular failure and elevated FSH levels are reported to be associated with poor pregnancy outcomes. “Clinical pregnancy rate was 32/106 (30.2%) per cycle, and 19/32 (59.3%) per couple.” Not bad, just that most of our patients cannot afford one cycle of IVF.

645 Compliance with clean intermittent catheterization in spinal cord injury patients from Turkey. This is a retrospective review of medical notes of 164 patients in 10 years. At discharge, 63% on CIC, 10% indwelling catheter, 15% reflex voiding. Compliance with CIC at followup (54months±28) was 58%. Of those who stopped, 74% started reflex voiding. Commonest cause for stopping CIC was urinary tract infections. All these numbers do not mean much since no data is provided on clinical end points related to long term urological health.

Spinal Cord Volume 51, Number 9, September 2013

694 Gluteal blood flow and oxygenation during electrical stimulation-induced muscle activation pressure relieving movements in wheelchair users with a spinal cord injury. The learning point is not in the results but in the notion that electrical stimulation can potentially reduce pressures over the ischial tuberosity. Could this be a viable alternative to those not capable of doing pressure-relief measures?

715 Studies on telehealth in general are yet to come out with anything substantial to justify resources spent. A pilot study of a telehealth intervention for persons with spinal cord dysfunction doesn’t break the trend. Though the authors report that women who listened to telephonic health education instructions had 100% ulcer healing, it must be noted that only stage 1 and 2 ulcers were included. Other interventions were neither controlled for, nor data collected. Hence, no clinically meaningful interpretations can be made.

Archives of PMR, Volume 94, No. 8, August 2013

Functional benefits (emerging evidence do not support them) versus Complications (common in clinical practice) of partial foot amputations is the subject of this article from the editor’s desk. They looked at outcomes of ankle power generation and energy expenditure during gait, as well as Quality Of Life. They conclude “Despite high rates of complications experienced by persons with partial foot amputation, …is still preferred to transtibial amputation… we should adopt practices that minimize the likelihood of ulceration and secondary amputation…”. There might be some truth in this, going by what we see in our diabetic foot clinic (We don’t have actual numbers).

1473 Meta-Analysis of Botulinum Toxin A Detrusor Injections in the Treatment of Neurogenic Detrusor Overactivity After Spinal Cord Injury. The topic of the study seemed very relevant to our practice, and I was keen to look at the results. One look at the forest plots and the diamonds seemed impressively in favor of BTX-A. Into the text then. The study selection flowchart says that of the 269 potentially relevant studies, 14 studies met inclusion criteria. Good so far. “Only one study was a randomized controlled trial”. Dud. 12 of those studies had no control group. The conclusion still inexplicably states “BTX-A injections into the detrusor muscle were associated with significant beneficial treatment effects”. The abstract too makes no mention of the fact that 12 of 14 studies reported only pre-post data and were not RCTs. The one RCT included in the meta-analysis would have sufficed to make interpretations, but the authors chose (and Archives colluded) to unnecessarily beef up the thin evidence. Read the conflict of interest section and you might understand why. Gullible readers could be tricked to believe this is level I stuff.

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Top among the few things I came to know about the past couple of months that made me pause and reflect on lines of the road taken and not taken:

1. a book written by a friend from schooldays

2. a tamil movie being produced by my namesake batch-mate from MBBS days.

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