Sirs,
As a neuromodulator and instructor with extensive (30 year) experience
with both "wired " and "wireless " systems, I feel compelled to repond to
the conclusions of the cited case report.
While the authors mention lead migration as an known complication of
spinal cord stimulation, it is useful to consider that Cameron (1) cited
361 lead migration events in 2753 patients , a 13.2% incidence.
Anderson (2) , i...
Sirs,
As a neuromodulator and instructor with extensive (30 year) experience
with both "wired " and "wireless " systems, I feel compelled to repond to
the conclusions of the cited case report.
While the authors mention lead migration as an known complication of
spinal cord stimulation, it is useful to consider that Cameron (1) cited
361 lead migration events in 2753 patients , a 13.2% incidence.
Anderson (2) , in his report of spinal cord stimulation for angina
pectoris, found lead migration to be the most frequent complication
requiring reoperation (23%), an incidence verified by North.
This is not the first case report of cephalad lead migration, although
less common than caudal migration. McGreevy and colleagues (3) at Johns
Hopkins reported a case of cephalad lead migration from T9 vertebral
segment to T1 two weeks postoperatively. The Titan (Medtronic) anchor was
sutured to lumbosacral fascia with a strain relief loop (SRL). An
additional SRL was placed beneath the implanted IPG.
This issue is not confined to percutaneous cylindrical leads, as
significant cephalad paddle -lead migration has also been reported (4).
A multitude of published research has confirmed that spinal cord
stimulation is indeed a safe procedure (5).
The author performing the procedure (MF) states that "this was the
implanters first experience with this (wireless) device". I can personally
attest that implanting the StimWave system is distinctly different in many
respects, than competing "wired " systems.
When teaching physicians , I continually stress these differences.
The manufacturer recommends anchoring either with traditional sleeve
anchors, or their proprietary Sandshark anchor. In addition, a knot is to
be tied in the lead distal to the last mark . A separate subcutaneous
incision (0.5cm) is made to secure the distal lead tip to the subcutaneous
fascia. There is no indication that the author followed these recommended
techniques. The authors also relate " challenges with connectivity and
aberrant programming".
I was informed personally that the StimWave engineer was able to obtain
connectivity and paresthesia mapping at the non-migrated lead, hoever the
patient expressed a preference for the "wired " system rather than the
"wireless" external system.
I concur with the authors recommendations for locking anchors and silicone
elastomer adhesives. . I strongly disagree with the assertions made that
this case "demands more research into the safety of externally powered
devices". I have successfully implanted this system for three years
,without any lead migration, as have countless physicians worldwide.
]The proper conclusion of this report should be that this new wireless
spinal cord stimulator system is distinctly different than previous wired
systems, requiring proper triaining, strict adherence to recommended
operative techniques and implanter experience. It is unfortunate that the
authors first case utilizing this system was unsuccessful, however , their
contention that these systems are unsafe is completely unfounded.
Sincerely,
George J.Arcos D.O.,FAOCA
1) Safety and efficacy of spinal cord stimulation for the treatment
of chronic pain; A 20-year review.
Cameron,T J Neurosurg (Spine3) 100:254-267 2004
2) Anderson C Complications in spinal cord stimulation for the treatment
of angina pectoris. Acta Cardiologica 52:35-39 1995
3)McGreevy K, WilliamsKA,Christo PJ
Cephalad lead migration following spinal cord stimulator implantation
Pain Physician 2012 Jan-Feb; 15(1): E 79-87
4) DiSanto S, Ravera E
Significant cephalad laddle lead migration after lumbar spinal cord
stimulator implant.
Neuromodulation 2014 Jun ;17 (4): 385
5) Bendersky D, Yampolsky C
Is Spinal cord stimulation safe?
World Neurosurg 2014 Dec; 82(6): 1359-68.
Conflict of Interest:
No stock or investment ownership. Senior Consultant for BSC and StimWave.
Thankyou to Professor Bewley and colleagues for their comments.
We agree with many of the concerns raised and want to point out it is
essential to read and interpret this article for what it is - a case
report. As has been rightly pointed out, it is therefore only anecdotal
and is the lowest grade quality of evidence.
Our intention in writing this article is merely to point out a
temporal association...
Thankyou to Professor Bewley and colleagues for their comments.
We agree with many of the concerns raised and want to point out it is
essential to read and interpret this article for what it is - a case
report. As has been rightly pointed out, it is therefore only anecdotal
and is the lowest grade quality of evidence.
Our intention in writing this article is merely to point out a
temporal association between taking curcumin and the patient's disease
entering a quiescent and stable phase. But this is prone to many
confounding factors and like any case report, has severe limitations. The
only conclusion that can be drawn from this case is that further studies
are needed to establish whether curcumin is indeed beneficial for myeloma.
The media response has been disproportionate and regrettable. We
believe the article did use cautious language but for further clarity:
In no way do we endorse the use of curcumin in Myeloma, either in
addition to and especially not in place of established therapy. There is
insufficient evidence to support this, doing so can be potentially
dangerous and it can come at significant financial cost to patients.
The article should not be removed as we maintain there is still an
important observation to be noted - but this needs evaluation in the
context of a clinical trial.
I have seen now that a correction was asserted. It is not
satisfactory on its face for two reasons.
The first is that my criticism of the report was not acknowledged for
pointing out that the original claim was of swallowing a bleach tablet,
which meant that treatment could be understood as inappropriate or
inadequate.
The second is that a "correction" that ascribed the problem as that
the patient ing...
I have seen now that a correction was asserted. It is not
satisfactory on its face for two reasons.
The first is that my criticism of the report was not acknowledged for
pointing out that the original claim was of swallowing a bleach tablet,
which meant that treatment could be understood as inappropriate or
inadequate.
The second is that a "correction" that ascribed the problem as that
the patient ingested a 3.5g(!) tablet (!) of sodium hydroxide clarifies
little or nothing.
1. Sodium hydroxide does not appear as "tablets" in any pharmacopoeia
of which I am aware. I will withdraw my objection if there is such with
documented reference.
2. The article still refers to the treatment of bleach ingestion without
addressing the chlorine content thereof, thus misunderstanding the key
point I made in my previous email, and misses the value I brought to the
discussion.
3. "Prilled" sodium hydroxide, the only type of lye of which I am aware
might remotely be thought a "tablet" is typically 0.1 g in size, not 3.5g
(35 times a prilled version!). Nor would such a material be near the
counter of a random patient where it might be mistaken for a tablet (if I
may hone the point a bit).
I believe that there should be more explained about this unfortunate
event, that my email should be published for consideration by other
experts, and that the modality of treatment should be better addressed by
the physicians.
We sincerely thank the technical product manager of ACCU-CHEK
Performa (Roche) for going through our article entitled 'Erroneously
elevated glucose values due to maltose interference in mutant GDH-PQQ
based glucometer, Chakraborty PP, et al. BMJ Case Rep 2017.
doi:10.1136/bcr-2017-219928 with interest. We provide our response to the
issues raised by our learned colleague.
We sincerely thank the technical product manager of ACCU-CHEK
Performa (Roche) for going through our article entitled 'Erroneously
elevated glucose values due to maltose interference in mutant GDH-PQQ
based glucometer, Chakraborty PP, et al. BMJ Case Rep 2017.
doi:10.1136/bcr-2017-219928 with interest. We provide our response to the
issues raised by our learned colleague.
Regarding the removal of maltose-containing infusion tube from the
intravenous cannula by the patient himself; yes, it is unacceptable but
probably not that uncommon in real life. It is possible for an extremely
agitated patient experiencing respiratory distress to remove the IV line
himself if left unattended for fraction of a second without waiting for
medically trained staffs to do their jobs. They have also expressed their
concerns regarding measurement of capillary glucose from an uncleaned
hand. In an intensive care setting, it may not be possible to "wash the
hands in warm, soapy water. Rinse and dry completely" before checking
capillary blood glucose in a patient who is actively seizing or having
altered sensorium as instructed in the package insert of ACCU-CHEK
Performa.
The package insert of ACCU-CHEK Performa categorically mentions about
the elevated levels of galactose (>15mg/dl or >0.83 mmol/L),
triglycerides (>1,800mg/dl or >20.3 mmol/L) , ascorbic acid
(>3mg/dl or >0.17mmol/L), haematocrit (should be between 10-65%)
that may cause erroneous glucose values. It has pointed towards
"clinically relevant maltose interference" without mentioning the
concentration of maltose known to be associated with such interference.
This e-letter has discussed issues, which had already been focused in
our article. The probable reasons of erroneous capillary glucose values,
the difference of capillary glucose values between right and left hand
fingertips, the blood level of maltose which is unlikely to cause such
interference have already been highlighted in our article.
Sir, what we have discussed in our article is exactly what we had
experienced in our clinical ward rounds. We strongly believe proper
protocol has to be followed in each and every step and this article is
definitely a "reminder of important clinical lesson" of violating the
basic principles. We do not have the intention to spread false information
related to any manufacturing company & we do not endorse such ideas
ever. Having said that, we strongly believe that the package insert of
ACCU-CHEK Performa should specify the maltose concentration that may cause
overestimation of blood glucose.
HealthWatch UK is a charity that promotes ‘science and integrity in medicine’, values we might all expect to be shared by the BMJ and all its subsidiary journals. Accordingly, we ask you to think again about the Publishing Executive’s response (1) to the e-letter submitted by our colleague Les Rose (2) regarding a report by Zaidi et al. (3) about curcum...
HealthWatch UK is a charity that promotes ‘science and integrity in medicine’, values we might all expect to be shared by the BMJ and all its subsidiary journals. Accordingly, we ask you to think again about the Publishing Executive’s response (1) to the e-letter submitted by our colleague Les Rose (2) regarding a report by Zaidi et al. (3) about curcumin as a treatment for myeloma.
We regard the response as unsatisfactory because:
1. Zaidi et al. had little regard for the extensive published research on the medicinal chemistry of curcumin. Their conclusion made a clear case for the clinical use of curcumin in myeloma, when it would have been far more appropriate to call for rigorous clinical trials. The BMJ was wrong to say the language they used was ‘cautious’.
2. Zaidi et al. failed to respond to Rose and their use of citations of research by a discredited investigator was not commented upon (1). This should have been detected both by reviewers and editors and should have been put right.
3. It is poor judgment for BMJ Case Reports to deny responsibility for claims in other media – especially when our complaints to the BBC were rebutted by the justification that this was a peer-reviewed publication. Journal executives must know that such claims will be amplified by the lay media, especially when they are unusual and thus newsworthy. Indeed, journals often issue press releases for this purpose. Editors therefore have an obligation to ensure that peer review is rigorous and claims in published papers are made responsibly.
4. While case reports have a role in medicine, they are no more than a suggestion of where proper research should next be carried out. It is not appropriate even to suggest that a treatment should be prescribed on the basis of anecdote.
For all these reasons, HealthWatch UK considers that this report should be withdrawn and an editorial should be published explaining the reasons.
Susan Bewley, Professor of Women’s Health, Kings College London, Chair of HealthWatch UK
Nick Ross, writer, campaigner and broadcaster
Roger Fisken, consultant physician (retired)
On behalf of the Board of Trustees of HealthWatch UK.
References
(1) Thomas J. Association is not Causation. http://casereports.bmj.com/content/2017/bcr-2016-218148.full/reply#casereports_el_4149
(2) Rose L. Association is not Causation http://casereports.bmj.com/content/2017/bcr-2016-218148.full/reply#casereports_el_4149
(3) Zaidi A, Lai M, Cavenagh J. Long-term stabilisation of myeloma with curcumin. BMJ Case Reports 2017: published online 16 April 2017, doi:10.1136/bcr-2016-218148 http://casereports.bmj.com/content/2017/bcr-2016-218148.full
Authors: Sami Wardat, PhD, MBA(1), Oliver Hauss, PhD(2), and Rolf Hinzmann, MD, PhD(1)
Dear Editor,
Partha Pratim Chakraborty and Shinjan Patra recently reported on a potential risk for patients welfare from maltose interference with glucose measurements in their case report Erroneously elevated glucose values due to maltose interference in mutant GDH-PQQ based gluco...
Authors: Sami Wardat, PhD, MBA(1), Oliver Hauss, PhD(2), and Rolf Hinzmann, MD, PhD(1)
Dear Editor,
Partha Pratim Chakraborty and Shinjan Patra recently reported on a potential risk for patients welfare from maltose interference with glucose measurements in their case report Erroneously elevated glucose values due to maltose interference in mutant GDH-PQQ based glucometer, Chakraborty PP, et al. BMJ Case Rep 2017. doi:10.1136/bcr-2017-219928.
The authors are concerned that patients on maltose-containing therapies may receive an excessive dose of insulin due to falsely elevated blood glucose readings, leading to a hypoglycemic episode, and that, likewise, cases of hypoglycemia might not be treated if patients hypoglycemic states are masked by false blood glucose measurements.
Our review of this case reports circumstances indicates that the situation described is highly unusual and based on violation of proper protocol on multiple levels.
As for the course of events, the patient removed a maltose-containing infusion tube from the intravenous cannula himself. This is clearly not in line with the standards of medical practice and carries itself a significant risk to the patients safety. The removal of intravenous (i.v.) tubes should be left to properly trained medical personnel to avoid injuries. The infusion solution subsequently contaminated the patients left hand and a glucose measurement was taken from that very hand, without it being cleaned first. Our instructions for performing a blood glucose test for consumers clearly instruct patients to wash and dry their hands prior to using the lancing device (See Accu-Chek Performa manual page 10 available for India at https://www.accu-chek.in/meter-systems/performa ). We instruct healthcare practitioners to follow their institutional policies and assume these would suggest comparable standards of contamination prevention.
As a result of violating proper medical procedures on two levels, the glucose measurement device was exposed to 10% maltose solution, which contains 100 mg/mL maltose, i.e. 10 000 mg/dL = 100 g/L or 320 mmol/L. This is around 30 times higher than the maltose concentrations tested in the clinical evaluation report on Accu-Chek Performa (400 mg/dL or 11.7 mmol/L). Thus, the interference should not come as a surprise and is to be expected.
The 100 mL of i.v. human immunoglobulin (IVIG) solution provided would have been administered in a short time frame of 15 to 30 min (based on the dosage indication for PlasmaGlob, which is 1.2 mL/kg of bodyweight, and on the assumption that the patient weighs around 80-85 kg). This would mean that roughly 200 mg/dL of maltose could be expected in the blood circulation, which would normally not result in interference with the mutant GDH-PQQ enzyme in the test strips.
Furthermore, the situation is also not specific to maltose and the sensitivity to maltose interference of the enzyme used: if we assumed that the solution contained glucose, then the reading of any device, even one without sensitivity to maltose interference, would still show a false high concentration due to the undiluted solution present on the hands, thus preventing accurate measurement of the concentration within the circulating blood.
The 50% difference between the heavily contaminated left hand and the right hand, which was likely only cross-contaminated, indeed points to external contamination as the key factor in the observation.
The failure to heed the instructions concerning basic hand washing can hardly be seen as a significant risk posed by the product itself. It should be clear that blood should only be drawn from clean hands to prevent cases of cross-contamination.
Therefore, we do not mandate any further steps other than strongly appealing to both patients and medical personnel to abide by our instructions to wash their hands before obtaining capillary blood and by general protocol, which would have been sufficient to prevent this course of events.
Affiliations:
1. Roche Diabetes Care GmbH Global Medical & Scientific Affairs Sandhofer Strasse 116 68305 Mannheim / Germany
2. Dr. Hauss Training & Consulting Lorscher Str. 24 67133 Maxdorf / Germany
Conflict of Interest:
Sami Wardat and Rolf Hinzmann are employees of Roche Diabetes Care GmbH.
Oliver Hauss is an independent consultant contracted by Roche Diabetes Care GmbH
We thank the reader for appreciating our work. The said patient was
worked up for ARC syndrome and mutational analysis was done from outside
as the primary care center does not have these facilities. The patient got
the genetic analysis done from outside laboratory and came with the f...
We thank the reader for appreciating our work. The said patient was
worked up for ARC syndrome and mutational analysis was done from outside
as the primary care center does not have these facilities. The patient got
the genetic analysis done from outside laboratory and came with the final
reports during the last follow up. The mutation was noted in the case
sheet and patient was asked to be on regular follow up. However, the
patient did not report after that and was lost to follow up. We would have
liked to share further details of the mutation but the contact could not
be established. Furthermore, the patient as per clinical does does qualify
for the ARC syndrome with supportive laboratory evidence.
Dear Sir/Madam
This is a potentially interesting report suggesting unusual features such
as high GGT and absent kidney present in a clinically diagnosed case of
ARC syndrome. Whilst this finding might be of interest to Paediatricians
and Neonatologists, the author do not provide any evidence that their
diagnosis is factually correct.
They write that the VPS33B sequencing was suggestive of a mutation but no
report of the...
Dear Sir/Madam
This is a potentially interesting report suggesting unusual features such
as high GGT and absent kidney present in a clinically diagnosed case of
ARC syndrome. Whilst this finding might be of interest to Paediatricians
and Neonatologists, the author do not provide any evidence that their
diagnosis is factually correct.
They write that the VPS33B sequencing was suggestive of a mutation but no
report of the mutation is in evidence. It is disappointing that in 2018
BMJ can publish such case reports, which I would not expect of a reputable
journal.
Unfortunately, this is most unhelpful and probably a misleading way to
report clinical cases and in my opinion a corrigendum should be provided
with definitive mutation data if this report to remain published at all.
WIth respect
The article starts as a report of ingestion of sodium hydroxide
tablet and all but one reference within it is to sodium hydroxide.
The single reference to bleach is the reason for my letter. It is
not clear to me that anyone would have large tablets of sodium hydroxide
(usu prilled pellets are <<1g), and I confess that solid bleach
tablets are not an item I have used. I presume such would be to sanitize a...
The article starts as a report of ingestion of sodium hydroxide
tablet and all but one reference within it is to sodium hydroxide.
The single reference to bleach is the reason for my letter. It is
not clear to me that anyone would have large tablets of sodium hydroxide
(usu prilled pellets are <<1g), and I confess that solid bleach
tablets are not an item I have used. I presume such would be to sanitize a
dishwasher.
That said, sodium hypochlorite (bleach) has a pKa of ~7.5, so a
reference to the pKa of sodium hydroxide may not be warranted.
There is no doubt that solid bleach would do what was described, imo,
but some of the complications (lung irritation eg)may have arisen from the
release of chlorine (if it was indeed bleach the patient ingested), and
the concomitant inhalation.
I thought clarification would be useful, and that the potential for
chlorine ingestion/inhalation might be discussed by the physicians to keep
in mind should such a case arise again.
Was the substance that this patient was found with sent to an
analytic organic chemist to identify the specific chemical moeties
present? Synthesis of cannabinoids can result in a product that has
radically different pharmacologic properties than the desired compound.
The classic example is Ecstacy. Distillation at the wrong temperature,
just a few degrees off, results in a total body paralysis drug. In the
presented ca...
Was the substance that this patient was found with sent to an
analytic organic chemist to identify the specific chemical moeties
present? Synthesis of cannabinoids can result in a product that has
radically different pharmacologic properties than the desired compound.
The classic example is Ecstacy. Distillation at the wrong temperature,
just a few degrees off, results in a total body paralysis drug. In the
presented case it may be anything from an impure drug to co-synthesis of
the Dextro and Levo forms of the active agent. For instance Levo-methadone
is an opiate effective against nociceptive pain while Dextro-methadone is
an NMDA antagonist effective against neuropathic pain.
We really need to identify the specific agent that causes the
cardiovascular effects. If street chemists are manufacturing synthetic
cannabinoids we need to identify the specifics in order to identify the
product (urine drug screen?), look for the specific pathologic effects in
patients presenting with atypical symptoms, and hopefully develope a
treatment protocol to minimize any damage.
Sirs, As a neuromodulator and instructor with extensive (30 year) experience with both "wired " and "wireless " systems, I feel compelled to repond to the conclusions of the cited case report.
While the authors mention lead migration as an known complication of spinal cord stimulation, it is useful to consider that Cameron (1) cited 361 lead migration events in 2753 patients , a 13.2% incidence. Anderson (2) , i...
Thankyou to Professor Bewley and colleagues for their comments.
We agree with many of the concerns raised and want to point out it is essential to read and interpret this article for what it is - a case report. As has been rightly pointed out, it is therefore only anecdotal and is the lowest grade quality of evidence.
Our intention in writing this article is merely to point out a temporal association...
I have seen now that a correction was asserted. It is not satisfactory on its face for two reasons.
The first is that my criticism of the report was not acknowledged for pointing out that the original claim was of swallowing a bleach tablet, which meant that treatment could be understood as inappropriate or inadequate.
The second is that a "correction" that ascribed the problem as that the patient ing...
We sincerely thank the technical product manager of ACCU-CHEK Performa (Roche) for going through our article entitled 'Erroneously elevated glucose values due to maltose interference in mutant GDH-PQQ based glucometer, Chakraborty PP, et al. BMJ Case Rep 2017. doi:10.1136/bcr-2017-219928 with interest. We provide our response to the issues raised by our learned colleague.
Regarding the removal of maltose-contai...
Dear Editor
Case report should be withdrawn
HealthWatch UK is a charity that promotes ‘science and integrity in medicine’, values we might all expect to be shared by the BMJ and all its subsidiary journals. Accordingly, we ask you to think again about the Publishing Executive’s response (1) to the e-letter submitted by our colleague Les Rose (2) regarding a report by Zaidi et al. (3) about curcum...
Authors: Sami Wardat, PhD, MBA(1), Oliver Hauss, PhD(2), and Rolf Hinzmann, MD, PhD(1)
Dear Editor,
Partha Pratim Chakraborty and Shinjan Patra recently reported on a potential risk for patients welfare from maltose interference with glucose measurements in their case report Erroneously elevated glucose values due to maltose interference in mutant GDH-PQQ based gluco...
Vishal Gupta 1 , Aakash Pandita 2
1. Neonatology, Max Hospital, New Delhi, India.
2. SGPGI, Lucknow, U.P, India
We thank the reader for appreciating our work. The said patient was worked up for ARC syndrome and mutational analysis was done from outside as the primary care center does not have these facilities. The patient got the genetic analysis done from outside laboratory and came with the f...
Dear Sir/Madam This is a potentially interesting report suggesting unusual features such as high GGT and absent kidney present in a clinically diagnosed case of ARC syndrome. Whilst this finding might be of interest to Paediatricians and Neonatologists, the author do not provide any evidence that their diagnosis is factually correct. They write that the VPS33B sequencing was suggestive of a mutation but no report of the...
The article starts as a report of ingestion of sodium hydroxide tablet and all but one reference within it is to sodium hydroxide.
The single reference to bleach is the reason for my letter. It is not clear to me that anyone would have large tablets of sodium hydroxide (usu prilled pellets are <<1g), and I confess that solid bleach tablets are not an item I have used. I presume such would be to sanitize a...
Was the substance that this patient was found with sent to an analytic organic chemist to identify the specific chemical moeties present? Synthesis of cannabinoids can result in a product that has radically different pharmacologic properties than the desired compound. The classic example is Ecstacy. Distillation at the wrong temperature, just a few degrees off, results in a total body paralysis drug. In the presented ca...
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