title: The use of continuous intrathecal infusion of octreotide in patients with chronic pain of noncancer origin: an evaluation of efficacy in a prospective double-blind fashion.
abstract: Objective.  We evaluated the efficacy of octreotide when administered in a continuous fashion by intrathecal infusion. Materials and Methods.  We used a prospective, randomized, controlled, double-blinded method of analysis to evaluate the efficacy of intrathecal octreotide in a population of patients with noncancer pain diagnoses. The patients in this study had an unacceptable response to intrathecal opioids. In the analysis, the patients served as their own controls with a two-armed approach using a phase of treatment with preservative-free saline and a phase of treatment with preservative-free octreotide to assess pain relief. Assessment tools used included visual analog scales and brief pain inventories. Results.  Of the 20 patients randomized in the study, 18 completed all data-collection points. One patient withdrew a week after the first refill because of uncontrollable pain, and the other patient withdrew early due to a lack of transportation. Statistical analysis showed no improvement in efficacy in the octreotide arm at the 6-week end-point when compared to saline. No significant differences were seen in any of the other end-points between the saline and intrathecal drug group. Conclusions.  Intrathecal octreotide did not show significant improvement in pain relief when compared to saline in chronic noncancer pain. It did show significant relief when compared to baseline, suggesting a positive effect of placebo in the control phase. While the overall data showed no clinical efficacy, a small group of patients did well and continued on the therapy in an open label fashion after the study concluded. These patients had pain consistent with a neuropathic pain diagnosis. The patients had noncancer pain, which was not responsive to intrathecal morphine. The lack of side-effects suggests that the dose selected for the study should be increased for future analysis of this agent, and patients with neuropathic pain should be more closely examined.
authors.affiliation: The Center for Pain Relief, Inc., Charleston, West Virginia 25301, USA.
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Deer
authors.forename: Richard
authors.initials: R
authors.lastname: Penn
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Kim
authors.forename: Richard G
authors.initials: RG
authors.lastname: Bowman
authors.forename: Matthew
authors.initials: M
authors.lastname: Norris
authors.forename: C Douglas
authors.initials: CD
authors.lastname: Stewart
authors.forename: Tina G
authors.initials: TG
authors.lastname: Garten
authors.forename: Wilfrido
authors.initials: W
authors.lastname: Tolentino
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Khan