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Observation, operation equal for treating psychological symptoms of primary hyperparathyroidism
Parathyroidectomy resulted in increased BMD at the lumbar spine and femoral neck.
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Patients with marginally elevated calcium levels due to mild hyperparathyroidism have decreased quality of life and more psychological symptoms compared with healthy controls, but no clinically significant benefit on psychological symptoms has been found with parathyroidectomy treatment compared with medical observation.
Researchers from Denmark, Sweden and Norway conducted a randomized, controlled study to determine if surgery improved the quality of life in patients with asymptomatic, mild hyperparathyroidism.
The results, published in The Journal of Clinical Endocrinology and Metabolism, indicate that parathyroidectomy yielded no improvement in psychological symptoms or quality of life but did decrease parathyroid hormone, resulting in improved BMD at the lumbar spine and femoral neck.
The researchers enrolled 191 patients from Denmark, Sweden and Norway from 1999 to June 2005. By the end of the inclusion period, 24 patients had withdrawn from the study. The remaining patients were randomly assigned to surgery (13 men; mean age, 63.8) or medical observation (13 men; mean age, 64.5).
Patients were seen three months after either the operation or randomization to medical observation and then once yearly. BMD was measured using DEXA. Quality of life was assessed using the generic Short Form-36 (SF-36) general health survey.
Eight percent of patients assigned to medical observation underwent surgery either due to medical reasons or by request. In the analysis, they were regarded as medical observation patients.
The results represent one-year data from 119 patients and two-year data from 99 patients.
Biochemical parameters, BMD
At baseline, the patients had significantly lower quality of life scores and more psychological symptoms than age- and sex-matched healthy controls. The two study groups had similar results at baseline.
No significant changes in parathyroid hormone or calcium levels were seen in the observation group after two years.
Patients in the surgery group had a decrease in parathyroid hormone from 10.51 pmol/L at baseline to 4.76 pmol/L at year one and 5.08 pmol/L at year two (P<.001 for both) and in calcium from 2.7 mmol/L at baseline to 2.4 mmol/L at years one and two (P<.001 for both).
Patients who had parathyroidectomy had a significant increase in BMD at the lumbar spine at one year and two years after surgery compared with baseline and the medical observation group.
An ANOVA analysis found a similar trend for the femoral neck; however, it was of borderline significance (P=.071). In women alone, this trend was significant (P=.048). No significant changes in forearm BMD were observed in either group.
“The increase in bone mass is explained by a decrease in bone turnover after the fall in parathyroid hormone and, thereby, a closure of the remodeling space,” the researchers wrote. “However, it is still unclear whether surgery will reduce the risk for fracture, compared with medical observation, in a prospective, randomized setting of mild primary hyperparathyroidism.”
Psychological improvement
The operation group had a significant difference over time in the physical domains of the SF-36. At one year, the operation group had a slightly higher score in the mental health subdomain and the mental component summary score (P<.05 for both), but not at two years. The observation group scored higher at two years compared with baseline (P<.05).
“These modest and minor changes are of questionable clinical significance and should be regarded with caution because the questionnaires used were not disease-specific,” the researchers wrote.
Follow-up data were obtained using the Comprehensive Psychopathological Rating Scale. Only minor changes were observed in both study groups, and no significant differences in delta values were observed over time, according to the researchers.
“Although the preliminary results of this study suggest that impaired quality of life and psychiatric symptoms are present in mild primary hyperparathyroidism, they do not demonstrate any clear benefit of surgery,” Marcella D. Walker, MD, instructor in the division of endocrinology, and Shonni J. Silverberg, MD, professor in the division of endocrinology at Columbia University College of Physicians & Surgeons, wrote in an accompanying editorial.
According to Walker and Silverberg, the rigorous design and size of this study should be commended; however, they point out that seven years, three countries and 10 centers were needed to yield the study population, and that further, this report represents an interim analysis of the data.
“Could the presence of psychiatric symptoms and impaired quality of life at baseline be explained by the possibility that those who were willing to be randomized had more symptoms of depression or more concern about their mental health than those who were not?” they wrote.
“Given these findings, it seems prudent not to add the presence of impaired quality of life or psychiatric symptoms to the list of criteria for surgery at this time,” they wrote.
For more information:
- Bollerslev J, Jansson S, Mollerup CL, et al. Medical observation, compared with parathyroidectomy, for asymptomatic primary hyperparathyroidism: A prospective, randomized trial. J Clin Endocrinol Metab. 2007; 92:1687-1692.
- Walker MD, Silverberg SJ. Editorial: Parathyroidectomy in asymptomatic primary hyperparathyroidism: Improves “bones” but not “psychic moans.” J Clin Endocrinol Metab. 2007;92:1613-1615.