title: Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Queen Elizabeth Hospital, Birmingham, Birmingham, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Williams
authors.forename: Steven
authors.initials: S
authors.lastname: Gill
authors.forename: Thelekat
authors.initials: T
authors.lastname: Varma
authors.forename: Crispin
authors.initials: C
authors.lastname: Jenkinson
authors.forename: Niall
authors.initials: N
authors.lastname: Quinn
authors.forename: Rosalind
authors.initials: R
authors.lastname: Mitchell
authors.forename: Richard
authors.initials: R
authors.lastname: Scott
authors.forename: Natalie
authors.initials: N
authors.lastname: Ives
authors.forename: Caroline
authors.initials: C
authors.lastname: Rick
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
authors.forename: Smitaa
authors.initials: S
authors.lastname: Patel
authors.forename: Keith
authors.initials: K
authors.lastname: Wheatley
mesh_terms: D000328:Adult; D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use; D046690:Deep Brain Stimulation / Q000009:adverse effects / Q000379:methods*; D018450:Disease Progression; D020820:Dyskinesias / Q000188:drug therapy / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy / Q000628:therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000978:Antiparkinson Agents