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Caffeine as an adjuvant therapy to opioids in cancer pain: a randomized, double-blind, placebo-controlled trial.

Author(s): Suh SY(1), Choi YS, Oh SC, Kim YS, Cho K, Bae WK, Lee JH, Seo AR, Ahn HY.

Affiliation(s): Author information: (1)Department of Medicine, Dongguk University, Seoul, Korea; Department of Family Medicine, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi-do, Korea. Electronic address: lisasuhmd@hotmail.com.

Publication date & source: 2013, J Pain Symptom Manage. , 46(4):474-82

CONTEXT: Opioid therapy often shows insufficient efficacy and substantial adverse events in patients with advanced cancer. OBJECTIVES: To assess the efficacy of caffeine infusion as an adjuvant analgesic to opioid therapy in patients with advanced cancer. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in the palliative care wards of two teaching hospitals in South Korea. A total of 20 of 41 participants were assigned to the caffeine group and 21 to the placebo group. The participants received caffeine (200mg) or normal saline intravenously once a day for two days. The primary outcome was pain, which was measured using a 10-point rating scale. Other outcomes included drowsiness, confusion, nausea, sleep disturbance, fatigue, and sadness. RESULTS: Three participants (two in the caffeine group and one in the placebo group) dropped out after the first intervention because of insomnia; thus, 38 participants completed the trial. Pain score was significantly lower in the caffeine group than in the placebo group after the second trial (P=0.038). The mean reduction in pain intensity in the caffeine group was 0.833 (95% confidence interval [CI] 0.601-1.066), whereas that in the placebo group was 0.350 (95% CI 0.168-0.532). Considering an improvement higher than 30% from baseline as the threshold value, drowsiness improved significantly in the caffeine group after the first trial (P=0.041). Adverse event rate did not differ between the two groups. CONCLUSION: Caffeine infusion significantly reduced pain and drowsiness, but the reduction did not reach clinical significance in patients with advanced cancer undergoing opioid therapy. Further investigations are warranted.

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