Calcitonin for metastatic bone pain Stable (no update expected for reasons given in 'What's new')

Abstract

Abstract
Background

Pain is the most frequent symptom experienced by cancer patients, its intensity dependent on the site of the tumour. Tumours that compromise bone or nervous structures due to the bone destruction process are the most painful. There are several treatments to deal with pain (and other symptoms) caused by bone metastases. The hormone calcitonin has the potential to relieve pain and also retain bone density, thus reducing the risk of fractures. This review is an update of a previously published review in the Cochrane Library (2003, Issue 3) which was also updated in 2006 (Issue 3) and in 2011 (Issue 9).

Objectives

The main objective of the review is to determine the effectiveness of calcitonin to reduce metastatic bone pain in patients with painful bone metastases. Secondary objectives are to assess the benefits of calcitonin in reducing the incidence of bone complications (hypercalcemia, fractures and nervous compression) and improving patient survival, and to report any adverse effects of the treatment.

Search methods

We updated the electronic searches in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE up to February 2015. We also searched registers of clinical trials in progress up to February 2015.

Selection criteria

We included studies if they were randomised, double‐blind clinical trials of patients with metastatic bone pain, treated with calcitonin, where the major outcome measure was pain, assessed at four weeks or longer.

Data collection and analysis

Two independent review authors performed study selection and data extraction. Only two studies (90 participants) were eligible for inclusion in the review and therefore meta‐analysis of the data was not possible. We performed intention‐to‐treat (ITT) analysis by imputing all missing values as adverse effects.

Main results

The overall quality of the evidence was very low. In this update no new studies were identified for inclusion; one additional study was excluded. Of the two small included studies, one study showed a non‐significant effect of calcitonin on the number of patients with complete pain relief (risk ratio (RR) 2.50; 95% confidence interval (CI) 0.55 to 11.41). The second study provided no evidence that calcitonin reduced analgesia consumption (RR 1.05; 95% CI 0.90 to 1.21) in patients with painful bone metastases. There was no evidence that calcitonin was effective in controlling complications due to bone metastases, for improving quality of life or for patients' survival. Although not statistically significant, a greater number of adverse effects were observed in the groups given calcitonin in the two included studies (RR 3.50; 95% CI 0.77 to 15.88).

Authors' conclusions

Current available research evidence is of very low quality and there is a lack of evidence to support the use of calcitonin for managing bone pain from bone metastases. Since the last version of this review, we did not identify any additional studies.

Author(s)

Maria José Martinez-Zapata, Marta Roqué i Figuls, Elena Català, Yuani Roman, Pablo Alonso Coello

Abstract

Plain language summary

 Calcitonin used to treat metastatic bone pain 

People who have cancer which has spread to their bones and the nerves adjacent to the bones often suffer severe pain. There are several treatments to help relieve this pain: radiotherapy, analgesic drugs (pain killers) such as opioids, and bone‐modulating drugs such as bisphosphonates and calcitonin. Calcitonin has the potential to relieve pain and maintain bone strength, thus reducing the risk of broken bones. This review looked at the effectiveness of calcitonin for controlling pain from bone metastases. However, only two studies were found with very low quality evidence to support the use of calcitonin for patients suffering from bone pain. We updated the review in 2015 and did not find any more studies. There were slightly more side effects for the patients given calcitonin. Unless new studies provide additional relevant information about this treatment, other therapeutic approaches should be considered.

Author(s)

Maria José Martinez-Zapata, Marta Roqué i Figuls, Elena Català, Yuani Roman, Pablo Alonso Coello

Reviewer's Conclusions

Authors' conclusions

Implications for practice

There is very low quality evidence from two small studies on the effect of calcitonin on pain control and its associated adverse effects. There is a lack of evidence to support clinicians' use of calcitonin to control patients' pain from bone metastases. No additional studies were included in the present update. Until new studies provide additional information on this treatment, other therapeutic approaches should be considered.

Implications for research

Calcitonin has been assessed in studies with small sample sizes, risk of bias and short‐term evaluations. More double‐blind, parallel clinical trials using long‐term evaluations are needed. Future clinical trials should use realistic sample size calculations to evaluate the efficacy of calcitonin better, including adequate estimations of the number of participants likely to be lost to follow‐up. This is the only way to guarantee a minimum level of quality, significance and power to demonstrate the actual efficacy of interventions.

Alternatively, the variables studied should be confined to reduction/absence of pain, adverse effects and quality of life. Possible complications of bone metastases, such as hypercalcemia, bone fractures or radicular compression, should also be quantified.

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