Diflunisal vs naproxen. No difference. No improvement. 11 solution as compared with. 13 treated by ionisation and a placebo, and these authors could not.
LACK
OF OF
SCIENTIFIC
EVIDENCE
LATERAL
EPICONDYLITIS AN
H. LABELLE,
We have
ATTEMPTED
R. GUIBERT,
From
the
Lateral and
for
lateral
epicondylitis results
185 articles
N. NEWMAN,
ofMontreal
epicondylitis
(LE)
published
TREATMENT
THE
ELBOW
META-ANALYSIS
J. JONCAS,
University
OF
THE
and
of the
or ‘tennis
elbow’
morbidity
and
in considerable
since
M. FALLAHA,
Sainte-Justine
elbow.
Of
cost.
In Sweden the prevalence is 1% to 3%, but increases 19% in men between 40 and 50 years of age (Allander 1 974).
The
involves
syndrome
is seen
repetitive
it is reported
mainly
movements
that
7.4%
in those
of the
forearm
of industrial
of tennis players affected by it (Dimberg
are
and at
to
work
and
workers
in the USA
50%
whose
185
RIVARD
Hospital
some
to
time
the scientific
evidence
78 discussed
treatment,
articles,
in Quebec
made
board
this
for
(Canadian) lost (1982 tion
Board Many
first
clinical
hand:
40%
In 198 1 , over 1 500 workers
1987).
1966
the
is common financial
to assess
C-H.
for methods of but since the natural history of the syndrome is uncertain we considered only those series with concurrent control groups. Only 18 of these were randomised and controlled studies. We then graded these papers for scientific validity, using the methods of Chalmers et al (1981). The mean score of the 18 articles was only 33%, with a range from 6% to 73%. A minimum of 70% is required for a valid clinical trial, and we therefore concluded that there was insufficient scientific evidence to support any of the current methods of treatment. There were too many methodological differences to allow a quantitative meta-analysis, but our qualitative review established the importance of the natural evolution of the syndrome and of the placebo effect of all treatments. Properly designed, controlled trials are needed. treatment
reviewed
FOR
claims
of Surgery,
University
Province
of Quebec,
statistics). papers have description
University
Service, Montreal,
Sainte-Justine Quebec, Canada
R. Guibert, MD, MSc, Medicine and Researcher Sante University of Montreal, Canada H3C 3J7.
Assistant Groupe
N. Newman, of Montreal
MD,
C, Assistant
H#{244}tel-Dieu
Hospital,
CanadaH2W
P0
FRCS 3840
physiotherapy
many
conventional of
MD,
Montreal,
Professor, de Recherche
Department of Interdisciplinaire
6128-Succ.
A,
Montreal,
ProfessorofSurgery, Street,
Sainte-Urbain
C, Assistant
Professor
Family en Quebec,
University Montreal,
British
$4442
Compensa-
on LE and
since
review
treatments
the
articles
used
either
anti-inflammatory techniques,
surgical
operations
such as radiotherapy,
cast and
less
acupuncture
vitamins.
The
choice
of
treatment
for
an
individual
case
remains controversial because it is empirical and based on the personal experience of the physician treating the patient. Our aim was to review the current literature to determine if there was any significant scientific evidence to favour a particular method of treatment for acute lateral
epicondylitis.
Quebec,
of Surgery,
University
We Hospital,
Quebec,
Correspondence
Canada
5415
L’Assomption
H1T 2M4.
should
be sent
Editorial
Society
030l-620X/92/5377 $2.00 J Bone Joint Surg [Br] 1992;
646
C#{244}teSainte-
of
MATERIAL FRCS
Maisonneuve-Rosemont
1992
3175
methods
lT8.
M. Fallaha, of Montreal
©
Box
Hospital, H3T 1C5.
1873),
These include
orthoses,
cost
of 62 days of work
published
drugs,
Montreal Orthopaedic Catherine,
been (Runge different
steroids,
compensation a
Workman’s
have reported over 40 alone or in combination.
and Surgery,
workers’
generating
per case and an average
immobilisation, H. Labelle, MD, FRCS C, Associate Professor of Montreal J. Joncas, RN, Research Assistant C-H. Rivard, MD, FRCS C, Professor of
to the
condition,
and
Joint
Surgery
1966 articles.
74-B
:646-51.
used
databases
surgery,
the
Medline
to make
French
to Dr H. Labelle. of Bone
Boulevard,
medical to
and
EMbase
a thorough
and paramedical
1990
(inclusive),
These
included
35 current
concepts
THE
JOURNAL
(Excerpta
review
literature
locating 78
of the
on
OF
and
BONE
studying treatment
articles,
AND
and
for the years
medical
or review
Medica) English
JOINT
27 on
SURGERY
185 or the
LACK
OF
SCIENTIFIC
Table I. The study on
the
EVIDENCE
FOR
design of 78 published of lateral epicondylitis
treatment
THE
TREATMENT
Case
series
without
Case
series
with
Controlled
historical
51
chronic
controls
2
trial
I
non-randomised trial
Controlled
randomised
single-blind
Controlled
randomised
double-blind
are two
important
history
the
in the II.
showing trial
Evaluation the I 5 items
form scored
Items I Selection
description
A, adapted to evaluate
from Chalmers the study design
Possible points
Items
0 to 3
9 Observer
blinded
et al (1981), of a clinical
0 to 3
log*
10
Prior
estimate
4 Control
regimen
appearance
0 to 3
1 1 Stopping
0 to 1 .5
12
to
of
rules
Testing
rate
ofrecovery
absence
tastet
6 Randomisation
blindability
blindability
*a full record
ofeligible
tconfirmation treatment
that does
the
not differ
compliance
0 to 3
0 to 8
15
Biological
0 to 3
Totalpossible
treated
that
the personal a few even
experience of earlier reports
Secondly, the results must remain doubtful
or improvement
III.
score
medication),
or the
and
groups
Possible points
Items
control
I classifies
design
We
the
78
reviewed
a minimum
sensation
of a
scoring therefore
intended
to
Possible points
sive
results. We used
a quantitative
2 Results
0 to 2
9 Statistical
0 to 4
and method photocopied,
0 to 4
published
analysis
4 Posttype2
Oto3
estimate 5 Confidence
limits
0 to 3
10 Withdrawals 11
Handling withdrawals
12 Side-effects
Oto4
were
conduct
and
analysis
VOL.
0 to 2
13 Retrospective evaluation
7 Timing
0 to 4
T otalpossible
74-B,
No.
ofevents
5, SEPTEMBER
1992
0 to 3
sco re 40
using which
of papers
by
research carried out. It the results appropriately,
technique
and results so that the
the paper, to the
the evaluators The
in Tables 6 Time series analysis
Chalmers’
unknown
among 0 to 3
meta-
is
results between two sizes and inconcluwith
great
care.
Two
evaluation forms, with 28 individually scored items, allowed for a maximum score of 100. These forms were completed independently by four trained health professionals (HL, JJ, NN, MF), with adequate experience in clinical trials. To reduce observer bias, only the material
0 to 2
0 to 4
validity.
study of the 18 selected papers by Chalmers et al (1981)
the design,
8 Regression! correlation
end-points
the
We made a trials in which
of internal
make
the quality of the possible to interpret
0 to 2
3 Major
on
but found it impossible to group the studies of the considerable variation in treatment, criteria and measures of efficacy. We therefore
1 Dates of study description of
differing
articles
from further analysis. of the 18 controlled
had
initially
analysis because selection
evaluates
from Chalmers to evaluate the
Items
randomisation
syndrome
The
selection of cases from one study to another must lead to potentially important differences in the stage of evolution of the disease, and make such uncontrolled studies
made a qualitative the system proposed
60
for the trial
Evaluation form B adapted showing the I 3 items scored of a clinical trial
et al (1981) data analysis
ofthe
is unknown.
especially when there are conflicting studies, or studies with small sample Table
First, ignortreatment
METHOD
14 Testing
between
consequences. means
of LE
0 to 3
0 to 10
(of oral
enor-
the study
0 to 3
taste
varied
0 to 3
blinding
not accepted
and
the and
therefore excluded more detailed study
1 3 Testing
population
the
0 to 3
0 to I .5
0 to 8
on
treatment of LE according to the design of the study. Most of them did not include control groups, and were
equivalence 8 Observer
articles
0 to 4
blinding 7 Patient
unclear
of treatment
randomisation S Control
to
six on
inconclusive. Table
numbers 3 Therapeutic definition
letters and
Possible points
results 2 Reject
were
of the natural
since
Table
24
which could explain definitions of acute
rather than on scientific evidence. of uncontrolled therapeutic trials
13
trial
disease, instruments
seems to be based on either the different authors, or on
1
trial
the
647
ELBOW
aspects of the syndrome. information in these
no
epicondylitis There
3
randomised
THE
mously.
ance Controlled
of
on measuring
natural course of the disease variations in treatment. The
7 controls
OF
pathology
15 articles
the biomechanical We found
Number reports
EPICONDYLITIS
and
editors,
elbow
Case
LATERAL
diagnosis
articles of the
Study
OF
contents
III.
of each paper names, the journal
the discussion researcher.
were ofthe
II and
sections authors’
resolved first
the conclusions
Differences
evaluation The
and
at group forms
form
were that
in scores
discussions.
are summarised
examined
the
study
design by giving particular importance to blinding patients, physicians and measuring observers, and presence
and
method
of randomisation
of the
patients
of the
648
H. LABELLE,
and of the physicians evaluated the quality
when applicable. The second form of the data analysis, the statistical
analysis
and
the
presentation
revision
of Chalmers’
in 1984
(personal
this
is the
first
orthopaedic
R. GUIBERT,
of results.
original
methods
communication), use
of this
J. JONCAS,
We
used
of 1981 and
we
evaluation
N. NEWMAN,
ultrasound a
in the
literature.
over
rest
that
there
possible
score,
applicable excluded The minimum and
give our evaluations results as percentages and
allowing
to every
for
study
and
from the calculations. average score for the of6%
of 73%
for the of the
items
which
which
were
18 trials
for the weakest
a maximum
for the
exceeding
for
our
1 8 studies
was
33%,
very
score
not
with
(Kivi
a
results, perspective. conflicting We
discussion This
a quality
and conclusion is
index
sections
particularly
results reported further classified
in different the papers
useful
et al 1985
Lundeberg
Stratford
Halle
et al 1988
et al 1989
et al 1986
studies
low,
only
; it
the
of a study
into
in
not
of 27%, accord-
tion
76
Ultrasound
48
Ultrasound ultrasound
with
with
to have
of 30%,
no
in
with
confirmed
the
difference placebo ultrastimulation
nerve
with hydrocortisone in samples were too small
have a therapeutic effect: from baseline values was but whether this effect is
significant
unclear. ointment
advantages.
The did More
(Table
V).
Three
reported
a significant
a diclofenac
examined
0.01). studies.
This was Vecchini
showed
only
treated
only and
with
partially Grossi
a score
ionisaa placebo
confirmed by (1984), with a
therapeutic
ionisation
and
effect
diclofenac
vs placebo
vs placebo vs rest
Quality score(%)
Conclusions Ultrasound (p
