Mañas, A., Ciria, J.P., Fernández, M.C., Gonzálvez, M.L., Morillo, V., Pérez, M., . . . López-Gómez, V. (2011). Post hoc analysis of pregabalin vs. non-pregabalin treatment in patients with cancer-related neuropathic pain: Better pain relief, sleep and physical health. Clinical and Translational Oncology, 13, 656–663.doi: 10.1007/s12094-011-0711-0
To assess whether the use of pregabalin in combined therapy provides better health outcomes in patients with cancer-related neuropathic pain
This study was a post hoc analysis of data from a previous epidemiologic study of clinical prevalence and analgesic management of neuropathic pain. Patients who received pregabalin versus those who did not were compared. Analgesic management was done at the individual physician’s discretion. Patients had a baseline visit and a final visit at eight weeks. In the initial study, patients were not randomized to different treatment, and numerous other interventions for analgesia were done.
Patients were undergoing active antitumor treatment.
The study was a post hoc analysis of data from a previous epidemiologic study.
The most frequent cause of neuropathic pain was the tumor itself, and cisplatin was the most frequently used chemotherapeutic agent. Fentanyl patches were used more frequently in the pregabalin group. Pain intensity improved in all patients at eight weeks, but improved more with pregabalin (change = 0, 9 points, p = 0.0084). Depression and anxiety decreased significantly in both groups. Physical component and mental component scores on the SF-12 improved in all patients, but improved more in those on pregabalin. When data were adjusted for age and sex, differences from baseline scores were less than 1. There were significant differences in groups in other medications used, numbers of analgesic interventions, and amount of radiation therapy treatment.
It is difficult to draw any firm conclusions regarding efficacy of pregabalin from this study due to the differences in multiple other variables between study groups that could also affect the outcome measures used here. Changes from baseline measures seen at eight weeks were significant, but very small, raising the question of the clinical significance of results.
No firm conclusions can be drawn from these results due to study limitations. Findings aim to show that use of pregabalin for neuropathic pain improves symptoms and health outcomes. Differences from baseline reported here were small, suggesting lack of meaningful differences from a clinical perspective. Results point to the need for nurses to recognize the difference between statistical and clinical significance in evaluating intervention effects.