parathyroidectomy in mild asymptomatic primary hyperparathyroidism l.
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Parathyroidectomy in Mild Asymptomatic Primary Hyperparathyroidism POW Journal Club 7 July 2003 Camille Wu Clinical Question Symptomatic parathyroid disease with significant hypercalcaemia Vs Asymptomatic parathyroid disease with mild hypercalcaemia Role of parathyroidectomy

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parathyroidectomy in mild asymptomatic primary hyperparathyroidism
Parathyroidectomy in Mild Asymptomatic Primary Hyperparathyroidism

POW Journal Club

7 July 2003

Camille Wu

clinical question
Clinical Question
  • Symptomatic parathyroid disease with significant hypercalcaemia

Vs

  • Asymptomatic parathyroid disease with mild hypercalcaemia
  • Role of parathyroidectomy
search history
Search History
  • Hyperparathyroidism or primary hyperthyroidism or Hypercalcaemia
  • Parathyroidectomy or surgery
  • 1 and 2 limit to RCT
paper identified
Paper identified

Randomized trial of parathyroidectomy in mild asymptomatic primary hyperparathyroidism: Patient description and effects on the SF-36 health survey

Gary Talpos, Henry G Bone III, Michael Kleerekoper, et al

Surgery, 128:1013-21, Dec 2000

method recruitment
Method - recruitment
  • Patients referred to Henry Ford Hospital April 1994 – March 1997
  • Eligibility and Exclusion criteria applied
  • Baseline history, examination and investigations and SF-36 Health Survey
    • Repeated every 6 months
sf 36 health survey
SF-36 Health Survey
  • Physical functioning
  • Social functioning
  • Role functioning – physical
  • Role functioning – emotional
  • Mental health
  • Vitality
  • Body pain
  • General health perception

+ Health Change

method arms of study
Method – arms of study
  • “Block” randomisation into operative or non-operative (observation) groups
  • Operative group
    • Operation within 4 weeks of randomisation
    • Single surgeon
    • Standard parathyroidectomy bilateral approach
    • Removal of all enlarged glands
method analysis
Method - analysis
  • Baseline laboratory and medical history variables
  • Univariate analyses
method analysis9
Method - analysis
  • Tabulation of results
    • Success of outcome
    • Incidence of persistent disease
    • Incidence of resistant disease
    • Number and weight of involved glands
    • Complications of surgery
    • Non-operative group patients requiring surgery for new symptoms
    • Change over time measures on SF-36
results
Results
  • 53 patients
    • 25 operative group (2 refused op)
    • 28 non-operative group (3 later required operations)
  • Female preponderence (42F : 11M)
  • Both groups balanced
    • Op group older than non-op (66.7 vs 62.6)
  • Follow-up rate 100%
results and discussion
Results and Discussion
  • Multigland disease in 6/26 (23%)
  • Weight of glands
    • range 0.080g to 9.58g
  • No post-operative complications
results and discussion12
Results and Discussion
  • No persistent hypercalcaemia or raised PTH levels post-op and for > 1 year
    • Despite multigland disease
    • Normalisation of Ca2+ and PTH levels ascribed to bilateral approach
results and discussion13
Results and Discussion
  • Recurrence of hyperparathyroidism in 2/26 operated patients at slightly over one year post-op
    • Attributed to high rate of multigland disease
    • Unknown if recurrence rate will increase with time
results and discussion14
Results and Discussion
  • Number of non-operative patients developing symptoms and requiring operation is 3/28 (11%)
    • Reflects nature of disease?
    • Or bias due to close monitoring?
results15
Results
  • SF-36 favoured operative group on 2 scales:
    • Social functioning p<0.07
    • Role functioning (emotional) p<0.12
    • ? Detects patients at preclinical stage before physical changes occur and symptoms develop
conclusion of study
Conclusion of study
  • First RCT displaying significant improvement in SF-36 result
  • Supports parathyroidectomy soon after diagnosis of primary hyperparathyroidism
  • Ethical problem with sham surgery comparison group
  • Further studies…
critical appraisal
Critical Appraisal
  • Randomised controlled trial
  • Not blinded - possible placebo effect
  • ? block randomisation
  • Study population all within 100 mile radius of downtown Detroit – relevance to local population
  • Intention to treat analysis
  • 100% follow-up
critical appraisal18
Critical Appraisal
  • SF-36 Survey
    • Subjective? But tested
    • Statistical significance translating to clinical significance
    • 2/9 domains improved - ? significance
    • 6/9 domains worse – but not statistically significant