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Group versus individual acupuncture (AP) for cancer pain: a randomized noninferiority trial |
Reed EN, Landmann J, Oberoi D, Piedalue KL, Faris P, Carlson LE |
Evidence-Based Complementary and Alternative Medicine 2020;(7209548):Epub |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: A service delivery model using group acupuncture (AP) may be more cost-effective than individual AP in general, but there is little evidence to assess whether group AP is a comparable treatment in terms of efficacy to standard individual AP. The study aimed to compare the group to individual delivery of 6-week AP among cancer patients with pain. METHODS: The study design was a randomized noninferiority trial of the individual (gold standard treatment) versus group AP for cancer pain. The primary outcome was pain interference and severity, measured through the Brief Pain Inventory (BPI). Secondary outcomes included measures of mood, sleep, fatigue, and social support. Changes in outcomes from pre- to postintervention were examined using linear mixed effects modeling and noninferiority was inferred using a noninferiority margin, a difference of change between the two arms and 95% CIs. Pain interference was tested with a noninferiority margin of 1 on the BPI, while pain severity and secondary outcomes were compared using conventional statistical methods. RESULTS: The trial included 74 participants randomly allocated to group (35) or individual (39) AP. The noninferiority hypothesis was supported for pain interference (O-E -1, delta 1.03, 95% CI 0.15 to 2.20) and severity (O-E -0.81, delta 0.52, 95% CI 0.33 to 1.38) as well as for mood (O-E -7.52, delta 9.86, 95% CI 0.85 to 18.86), sleep (O-E -1.65, delta 2.60, 95% CI 0.33 to 4.88), fatigue (O-E 8.54, delta -15.57, 95% CI 25.60 to 5.54), and social support (O-E 0.26, delta -0.15, 95% CI -0.42 to 0.13), meaning that group AP was not inferior to individual AP treatment. Both arms evidenced statistically significant improvements across all symptoms before and after the intervention. Effect sizes for the group versus individual AP on outcomes of pain, sleep, mood, and social support ranged from small to very large and were consistently larger in the group condition. The total average cost-per-person for group AP ($221.25) was almost half that of individual AP ($420). CONCLUSIONS: This is the first study to examine the noninferiority of group AP with the gold standard individual AP. Group AP was noninferior to individual AP for treating cancer pain and was superior in many health outcomes. Group AP is more cost-effective for alleviating cancer pain and should be considered for implementation trials.
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