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BRIEF COMMUNICATIONS:
M. Strupp, O. Schueler, A. Straube, S. Von StuckradBarre, and T. Brandt
"Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches
Neurology 2001; 57: 2310-2312
[Abstract][Full text][PDF]
mstrupp{at}nefo.med.uni-muenchen.de Michael Strupp, et al.
We thank Toyka et al. for their comments on our study. Our originally
submitted full-length manuscript cited the study of Müller et al. [1] as
did also two of our previous publications. [2, 3] Their study had two
methodological shortcomings. First, the diameter of the atraumatic needle
was smaller (22 gauge) than that of the Quincke needle (20 gauge). Second,
the orientation of the bevel was not mentioned. Since both factors
influence the incidence of postlumbar puncture headaches (PLPH), they
might explain the observed differences. Moreover, after evaluating all
published studies, the "Therapeutics and Technology Assessment
Subcommittee of the AAN on prevention of post-lumbar puncture headaches"7
concluded that "...the data [on the atraumatic needle] are conflicting in
the diagnostic LP literature, but the studies have, in general, been
inadequate to assess the question." A major aim of our study, therefore,
was to consider all known methodological problems.
Ad 1.: The methodological aspects of our study were originally given
in detail, but the Brief communication form necessitated shortening all
sections and reducing the references. Patients were randomized according
to Efron before LP. A total of 306 patients underwent LP; 51 did not
fulfill the inclusion criteria and were not randomized; 25 did not return
the evaluation sheet. Ad 2.: The numbered evaluation sheets were unblinded
only at the end of the study. A colleague who did not perform any LP in
this study did the analysis of the data. Ad 3.: Patients were asked about
headache before LP, and only those with no recent headaches, (i.e. at
least up to one week before LP), were included and randomized. Ad 4.: The
number of patients not returning the evaluation sheet did not differ
between the two groups. Ad 5.: An introducer was used in both groups to
minimize differences between the two needle types. Ad 6.: We stated that
the two groups did not significantly differ; we did not claim that
influence of these factors was excluded. Ad 7.: Our study was not designed
to give new insights into the pathophysiology of PLPH. Ad 8.: The opening
of the atraumatic and traumatic cannulas was kept identical, since (a) an
effect cannot be excluded for the atraumatic cannula, (b) a double-blind
design would have otherwise not been possible, and (c) the conditions in
both groups remained as similar as possible.
Our study differed from Müller study [1] in that (1) we used needles
with an identical diameter in both groups and (2) the orientation of the
needle bevels in both groups was parallel to the dura, as recommended by
the AAN.
2. Strupp M, Brandt T. Should one reinsert the stylet during lumbar
puncture? [letter]. N Engl J Med 1997; 336(16):1190.
3. Strupp M, Brandt T, Müller A. Incidence of post-lumbar puncture
syndrome reduced by reinserting the stylet: a randomized prospective study
of 600 patients. J Neurol 1998; 245(9):589-592.
4. Evans RW, Armon D, Frohman EM, Goodin DS. Assessment: prevention
of post-lumbar puncture headaches. Neurology 2000; 55:909-914.
"Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches
3 May 2002
Klaus V Toyka University of Wurzburg Germany, Bettina Muller and Heinz Reichmann
kv.toyka{at}mail.uni-wuerzburg.de Klaus V Toyka, et al.
We read with interest the paper by Strupp et al. [1] The authors have
largely confirmed (yet not cited) our double -blind controlled study on
100 patients [2] using the atraumatic cannula which was designed by
Sprotte at this Medical School some years ago. [3]
As the principal result of our study, the incidence of the post-
lumbar puncture headache syndrome (post LPS) was dramatically reduced,
even more so than described by Strupp et al. [1] In our subsequent "open
label" - type use of the Sprotte cannula it became clear that post LPS is
further reduced with continuous practice. [4]
We have a number of concerns with the study design and the interpretation
of data:
1) It is not indicated how exactly and at what time the randomization
of patients took place during their hospital stay nor is it clear how many
patients were actually randomized. The numbers are given only for the
patients "included in the final analysis". There is also no stratification
for nor an account on disorders which in them are prone to cause headache.
2) The evaluation sheet given to patients for eligibility to participate
in the study seems to have included items that were only available post
lumbar puncture such as coffein intake post LP and medication post LP.
This could potentially unblind the evaluating physician who is, upon
knowing the results from other studies and ours, likely to be biased
towards an advantage for the atraumatic needle.
3) In the questionnaire provided after randomization the patients were
asked about previous headache yet this should have excluded them from
being randomized in the first place. It is unclear when the patients were
questioned about suffering from previous headache.
4) The authors state that patients were not included in the study if they
did not return the evaluation sheet. According to pertinent nomenclature
these patients would be rated as included in the study but excluded from
the evaluation; in an intention-to-treat study these patients would have
to be evaluated. This may be clarified.
5) The authors state in Methods that all LP was performed by "experienced
neurologists who were unaware of the type of the needle". How can blinding
be obtained if the atraumatic needle is (a) much more prone to bending and
(b) the resistance that is to overcome when punching through the ligaments
and dura is so much higher than with the sharp and stiffer Quincke needle
(cf. fig.1 of the paper)? Only inexperienced neurologists would not
realize the difference.
6) The authors state that several group comparisons did not reveal
significant differences and go on to claim that this excludes an influence
of these factors on the study result. This kind of conclusion is not
substantiated by the set of data presented (ß - error).
7) The type of evaluation for post LPS as done by Strupp et al. falls
short of giving new clues as to the underlying pathogenesis. The leakage
(liquorrhea) hypothesis, which they propose, is at variance with our
findings. In our study we saw a higher number of immediate symptoms and
signs that may be related to autonomic nervous system reactions in those
patients who later developed post LPS. It is unlikely that CSF leakage
could account for this.
8) Strupp et al. propose that the circular position of the side opening of
the atraumatic cannula may be important for the frequency of post LPS.
Since this needle does not cut through the longitudinal ligaments and the
dura but rather spreads its filaments apart it is not clear how the
orientation of the burr hole might bear on post LPS.
References:
1. Strupp M, Schueler O, Straube A, Von Stuckrad-Barre S, Brandt T.
"Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture
headaches. Neurology 2001;57:2310-2312.
The authors mention that previous studies do not take into account the direction of
the needle bevel nor the stylet replacement when comparing
traumatic and atraumatic needles. The authors explain in the Methods section that biases
were indeed controlled. However, it does not mention what was done to
control for bevel direction and stylet pre-withdrawal replacement or if
local anesthesia was given. As a former heavy user of Quincke needles and
a strong supporter of "atraumatic" needles, I also wonder how experienced
neurologists may have been ignorant of the type of needle used. If
kept blind to it, how they could they ascertain that the bevel direction with
Quincke needles was optimal for fair comparison with atraumatic needles?
Was the needle oriented by somebody else ?