Steroids

Steroids

PEP Topic 
Chronic Pain
Description 

Steroids are a type of compound that contains a characteristic chemical structure. Steroid drugs have anti-inflammatory activity. Systemic administration of steroids has been examined for its effect on arthralgia associated with treatment of cancer using aromatase inhibitors.

Effectiveness Not Established

Research Evidence Summaries

Kubo, M., Onishi, H., Kuroki, S., Okido, M., Shimada, K., Yokohata, K., . . . Katano, M. (2012). Short-term and low-dose prednisolone administration reduces aromatase inhibitor–induced arthralgia in patients with breast cancer. Anticancer Research, 32, 2331–2336.

Print

Study Purpose:

To determine whether short-term and low-dose prednisolone reduces aromatase inhibitor (AI)–induced arthralgias in patients with breast cancer

Intervention Characteristics/Basic Study Process:

Prednisolone 5 mg was administered to women once daily in the morning for one week.

Sample Characteristics:

  • The study reported on a sample of 27 patients.
  • Mean patient age was 62.8 years, with a range of 51–81 years.
  • All patients were hormone receptor–positive women with breast cancer.
  • Of the sample, 25 were taking anastrazole, and 2 were taking letrozole; 68% had finger pain, and 29% had knee joint pain.

Setting:

  • Multisite
  • Outpatient setting
  • Japan

Phase of Care and Clinical Applications:

Patients were undergoing active antitumor treatment.

Study Design:

The study was a prospective intervention clinical trial.

Measurement Instruments/Methods:

  • Questionnaire for assessment of arthralgia symptoms (no mention of validation); symptoms were measured at one week, one month, and two months.
  • A visual analog scale also was used to measure percentage of relief.

Results:

Joint symptoms improved in 67% of patients immediately after prednisolone, 63% continued to report relief at one month, and 52% at two months. Thirty percent of patients reported an improvement in daily life at one week and one month and 26% at two months.

Conclusions:

Results suggest that a low dose of 5 mg of prednisolone given for one week at the initiation of AI therapy can relieve arthralgias in some patients.

Limitations:

  • The study had a small sample, with less than 30 participants.     
  • The study had baseline sample/group differences of import (two patients on letrozole and others on anastrozole).     
  • The study had risk of bias due to no control group.
  • Measurement/methods were not well described.  
  • Measurement validity/reliability were questionable.
  • Adverse effects were not delineated.

Nursing Implications:

While this study suggests that AI-related pain can be reduced in patients with breast cancer using prednisolone, randomized controlled trials are needed that reflect longer follow-up and adverse event monitoring. Insufficient evidence exists to recommend practice implementation.

Paulsen, O., Klepstad, P., Rosland, J.H., Aass, N., Albert, E., Fayers, P., & Kaasa, S. (2014). Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: A randomized, placebo-controlled, double-blind trial. Journal of Clinical Oncology. Advance online publication. 

doi: 10.1200/JCO.2013.54.3926
Print

Study Purpose:

To compare the analgesic efficacy of corticosteroid therapy versus a placebo

Intervention Characteristics/Basic Study Process:

The intervention was methylprednisolone 32 mg daily for seven days. The research team used a computerized randomization program to assign participants to intervention or placebo groups. Randomization stratification was based on study center and verified pain related to bone metastases. Both the research team and study participants were blinded to study assignment. Pain intensity, fatigue, and appetite loss were measured at baseline and day 7. Analgesic use was recorded daily. Satisfaction with the intervention was measured at day 7. Semistructured interviews were conducted at day 7 to determine any adverse effects experienced by study participants.

Sample Characteristics:

  • N = 49  
  • MEAN AGE: 64 years
  • MALES: 51%, FEMALES: 49% 
  • KEY DISEASE CHARACTERISTICS: Cancer diagnoses were breast, prostate, gastrointestinal, lung, gynecologic, and “other.” All patients but one in each arm of the study had metastatic disease. Seven participants were receiving chemotherapy and six were receiving hormonal therapy; pain score > 4.
  • OTHER KEY SAMPLE CHARACTERISTICS: Mean Karnofsky score was 62.5 (intervention group) and 66.0 (placebo group)

Setting:

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Norway

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care

Study Design:

Placebo-controlled, double-blind, randomized controlled trial

Measurement Instruments/Methods:

  • Brief Pain Inventory (BPI)
  • Edmonton Symptom Assessment System (ESAS)
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ–C30)
  • Satisfaction measured with intervention Numeric Rating Scale (NRS)
  • Patient diary for recording daily analgesics
  • Semistructured interviews

Results:

No significant difference was found between groups for average pain intensity at day 7, change in pain intensity from baseline, opioid intake, or adverse events. However, the intervention group did have a significant improvement in fatigue (p = .003) and appetite (p = .003) at day 7 compared to the placebo group. In addition, their overall satisfaction with treatment was also significantly greater (p = .001).

Conclusions:

Pain relief was not improved for patients with advanced cancer who were taking on average a 222 mg oral morphine equivalent dose (MED). It is unknown whether this may be effective for different patient populations such as those taking a lower MED. Improvement in fatigue and appetite and a low number of adverse events were important clinical outcomes. Further study is needed to determine the long-term effects of this intervention.

Limitations:

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Other limitations/explanation: Intervention group had a significantly higher dosage of MEDs compared to the control group

 

Nursing Implications:

Nurses should be aware that methylprednisolone 32 mg daily may not be effective for improving pain relief in patients with advanced cancer who are taking an average opioid dose of ≥ 220 MED; however, it may improve fatigue and appetite with minimal adverse effects. Long-term effects have not yet been established. Long-term steroid use can contribute to other adverse side effects and should be weighed carefully with benefit of treatment.

Systematic Review/Meta-Analysis

Paulsen, O., Aass, N., Kaasa, S., & Dale, O. (2013). Do corticosteroids provide analgesic effects in cancer patients? A systematic literature review. Journal of Pain and Symptom Management, 46, 96–105.

doi: 10.1016/j.jpainsymman.2012.06.019
Print

Purpose:

STUDY PURPOSE: To assess the evidence for use of corticosteroids as adjuvant analgesics in patients with cancer pain

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: PubMed, EMBASE, Cochrane Collaboration, Cochrane Central Register of Controlled Trials

KEYWORDS: Specific search terms for PubMed are provided.

INCLUSION CRITERIA: RCT; adult patients with cancer; compared corticosteroids when added to standard pain treatment; assessed outcomes in pain, analgesic use, and adverse events

EXCLUSION CRITERIA: Non-English language

Literature Evaluated:

TOTAL REFERENCES RETRIEVED = 514

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Grading of Recommendations Assessment, Development and Evaluation; overall study quality in terms of risk of bias was low.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = Four included, but only one study met all inclusion criteria
  • SAMPLE RANGE ACROSS STUDIES = 40–403
  • TOTAL PATIENTS INCLUDED IN REVIEW = 667
  • KEY SAMPLE CHARACTERISTICS: Primary cancers were gastrointestinal, breast, lung, and genitourinary. All patients were receiving palliative intervention.

Phase of Care and Clinical Applications:

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Results:

Of the four studies included, one showed lower pain severity and analgesic consumption with steroid, two had unclear results because of lack of findings reported, and one showed no benefit.

Conclusions:

The evidence regarding efficacy of adjuvant corticosteroids for pain management in patients with cancer is insufficient to draw firm conclusions. No current evidence is strong enough to show efficacy, and information is limited about adverse events with any long-term use.

Limitations:

  • Very few studies
  • Most studies had low quality.
  • 50% of studies did not provide reporting of any adverse events.
  • Studies were short-term.
  • Despite limitations, authors suggest at least a weak recommendation for the use of corticosteroids.

Nursing Implications:

Evidence is insufficient to demonstrate benefit from the addition of corticosteroids to usual pain management in patients with cancer, and evidence is very limited regarding adverse effects in this setting. Studies only have been reported with short-term use, so long-term adverse effects are not clearly known.


Menu