June 2010
Williams Am Gill S, Varma T, Jenkinson C, Quinn N, Mitchell R, Scott R, Ives N, Rick C, Daniels J, Patel S, Wheatley K on behalf of the PD SURG Collaborative Group
Background: Surgical
intervention for advanced Parkinson's disease is an option if medical
therapy fails to control symptoms adequately. We aimed to assess whether
surgery and best medical therapy improved self-reported quality of life
more than best medical therapy alone in patients with advanced
Parkinson's disease.
Methods: The PD SURG trial is an ongoing randomised, open-label trial.
At 13 neurosurgical centres in the UK, between November, 2000, and
December, 2006, patients with Parkinson's disease that was not
adequately controlled by medical therapy were randomly assigned by use
of a computerised minimisation procedure to immediate surgery (lesioning
or deep brain stimulation at the discretion of the local clinician) and
best medical therapy or to best medical therapy alone. Patients were
analysed in the treatment group to which they were randomised,
irrespective of whether they received their allocated treatment. The
primary endpoint was patient self-reported quality of life on the
39-item Parkinson's disease questionnaire (PDQ-39). Changes between
baseline and 1 year were compared by use of t tests. This trial is registered with Current Controlled Trials, number ISRCTN34111222.
Findings: 366
patients were randomly assigned to receive immediate surgery and best
medical therapy (183) or best medical therapy alone (183). All patients
who had surgery had deep brain stimulation. At 1 year, the mean
improvement in PDQ-39 summary index score compared with baseline was 5·0
points in the surgery group and 0·3 points in the medical therapy group
(difference −4·7, 95% CI −7·6 to −1·8; p=0·001); the difference in mean
change in PDQ-39 score in the mobility domain between the surgery group
and the best medical therapy group was −8·9 (95% CI −13·8 to −4·0;
p=0·0004), in the activities of daily living domain was −12·4 (−17·3 to
−7·5; p<0·0001), and in the bodily discomfort domain was −7·5 (−12·6
to −2·4; p=0·004). Differences between groups in all other domains of
the PDQ-39 were not significant. 36 (19%) patients had serious
surgery-related adverse events; there were no suicides but there was one
procedure-related death. 20 patients in the surgery group and 13 in the
best medical therapy group had serious adverse events related to
Parkinson's disease and drug treatment.
Interpretation: At
1 year, surgery and best medical therapy improved patient self-reported
quality of life more than best medical therapy alone in patients with
advanced Parkinson's disease. These differences are clinically
meaningful, but surgery is not without risk and targeting of patients
most likely to benefit might be warranted.
