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Parathyroidectomy in Mild Asymptomatic Primary Hyperparathyroidism

Parathyroidectomy in Mild Asymptomatic Primary Hyperparathyroidism

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Parathyroidectomy in Mild Asymptomatic Primary Hyperparathyroidism

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  1. Parathyroidectomy in Mild Asymptomatic Primary Hyperparathyroidism POW Journal Club 7 July 2003 Camille Wu

  2. Clinical Question • Symptomatic parathyroid disease with significant hypercalcaemia Vs • Asymptomatic parathyroid disease with mild hypercalcaemia • Role of parathyroidectomy

  3. Search History • Hyperparathyroidism or primary hyperthyroidism or Hypercalcaemia • Parathyroidectomy or surgery • 1 and 2 limit to RCT

  4. 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

  5. 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

  6. SF-36 Health Survey • Physical functioning • Social functioning • Role functioning – physical • Role functioning – emotional • Mental health • Vitality • Body pain • General health perception + Health Change

  7. 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

  8. Method - analysis • Baseline laboratory and medical history variables • Univariate analyses

  9. 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

  10. 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%

  11. Results and Discussion • Multigland disease in 6/26 (23%) • Weight of glands • range 0.080g to 9.58g • No post-operative complications

  12. 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

  13. 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

  14. 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?

  15. 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

  16. 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…

  17. 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

  18. 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