Parathyroidectomy in mild asymptomatic primary hyperparathyroidism
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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

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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


Search History

  • Hyperparathyroidism or primary hyperthyroidism or Hypercalcaemia

  • Parathyroidectomy or surgery

  • 1 and 2 limit to RCT


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

  • 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

  • Physical functioning

  • Social functioning

  • Role functioning – physical

  • Role functioning – emotional

  • Mental health

  • Vitality

  • Body pain

  • General health perception

    + Health Change


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

  • Baseline laboratory and medical history variables

  • Univariate analyses


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

  • 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

  • Multigland disease in 6/26 (23%)

  • Weight of glands

    • range 0.080g to 9.58g

  • No post-operative complications


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 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 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?


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

  • 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

  • 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 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


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