Surgery or Surveillance for Mild Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Clinical Trial

Abstract

Context:It is unclear whether patients with asymptomatic primary hyperparathyroidism (PHPT) do better with parathyroidectomy (PTx) as compared with conservative medical management. Objective:The aim of the study was to evaluate the beneficial effect of PTx vs. conservative management in patients with mild asymptomatic PHPT. Design:We conducted a prospective, randomized study. Setting:The study took place at a referral center. Patients:We studied 50 patients who did not meet any guidelines for parathyroid surgery as recommended by the National Institutes of Health Consensus Development Conference on Asymptomatic PHPT.Intervention: Patients were randomly assigned to PTx or no PTx and were evaluated at 6 months and at 1 yr. Main Outcome Measures:We compared changes (percentage of basal) of lumbar spine bone mineral density (BMD) between the two groups at 1 yr. Results:The change in BMD at lumbar spine was greater after PTx (ϩ4.16 Ϯ 1.13 for PTx vs. Ϫ1.12 Ϯ 0.71 for no PTx; P ϭ 0.0002). The change in BMD at the total hip was also significantly greater in the PTx group (ϩ2.61 Ϯ 0.71 for PTx vs. Ϫ1.88 Ϯ 0.60 for no PTx; P ϭ 0.0001). There was no difference in BMD after 1 yr between both groups at the one-third radius site. In comparison with those who did not undergo surgery, the PTx subjects, after 1 yr, showed significant differences in four quality of life measures as determined by the 36-item short form health survey scale: bodily pain (P ϭ 0.001), general health (P ϭ 0.008), vitality (P ϭ 0.003), and mental health (P ϭ 0.017). Conclusions:In patients with mild asymptomatic PHPT, successful PTx is followed by an improvement in BMD and quality of life.

Diagnosis and management of primary hyperparathyroidism: a scientific statement from the Department of Bone Metabolism, the Brazilian Society for Endocrinology and Metabolism

“…Three randomized clinical studies were conducted to evaluate the effect of PTx versus conservative treatment in patients with mild PHPT on neurocognitive symptoms, among other manifestations (57,68,69) (see details in the "Effects of Parathyroidectomy" section). The data from these studies suggest a significant difference in favor of surgical treatment (A-1A).…”

“…Randomized studies (57,68,69), but with limited follow-up time (1-3 years) have demonstrated benefits in quality of life and BMD in asymptomatic patients who undergo surgery (A-1B).…”

“…Some randomized clinical trials have demonstrated an increase in BMD after PTx (68,69,137) (Table 8). In one study, after 2 years of surgical treatment, there was a significant increase in lumbar spine BMD in the surgically treated group, when compared with conservative treatment, in which BMD remained unchanged (1.01 ± 0.18 vs. 1.13 ± 0.19, p < 0.01) (68) (A-1B).…”

Behandlingspraksis ved primær hyperparatyreoidisme

“…At pasienter enkelte steder i Norge blir henvist til og tilbudt behandling for primaer hyperparatyreoidisme og andre steder ikke, skyldes nok at det mangler godt dokumenterte kriterier for kirurgi ved tilstanden, spesielt ved såkalt asymptomatisk hyperparatyreoidisme (3,4).…”

“…I tillegg rapporterer mange pasienter symptomer som blant annet nedstemthet, at man lett blir trett, søvnpro-blemer og konsentrasjonsvansker (2). At kirurgisk behandling har effekt på de klassiske symptomene er veldokumentert, men fordelene med kirurgi hos pasienter uten de klassiske symptomene er omdiskutert (3,4). Retningslinjer for operasjonsindikasjoner ble vedtatt av en tverrfaglig internasjonal ekspertgruppe på en konsensuskonferanse ved National Institutes of Health i 1990 og revidert i 2002 (ramme 1) (5).…”