Reed Erica Nicole, Landmann Jessa, Oberoi Devesh, Piedalue Katherine-Ann L, Faris Peter, Carlson Linda E
Division of Psychosocial Oncology, Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Vive Integrative Health Group, 1889 45 Street NW, Calgary, AB, Canada.
Evid Based Complement Alternat Med. 2020 Apr 13;2020:7209548. doi: 10.1155/2020/7209548. eCollection 2020.
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.
The study design was a randomized noninferiority trial of the individual (gold standard treatment) vs. 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.
The trial included 74 participants randomly allocated to group (35) or individual (39) AP. The noninferiority hypothesis was supported for pain interference [Ө - 1, Δ 1.03, 95% CI: 0.15-2.20] and severity [Ө - 0.81, Δ 0.52, 95% CI:.33-1.38] as well as for mood [Ө - 7.52, Δ 9.86, 95% CI: 0.85-18.86], sleep [Ө - 1.65, Δ 2.60, 95% CI: 0.33-4.88], fatigue [Ө 8.54, Δ - 15.57, 95% CI: 25.60-5.54], and social support [Ө.26, Δ - 0.15, 95% CI: - 0.42-0.13], 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 vs. 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).
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.
一般而言,采用集体针刺疗法(AP)的服务提供模式可能比个体针刺疗法更具成本效益,但几乎没有证据可评估集体针刺疗法在疗效方面是否可与标准个体针刺疗法相媲美。本研究旨在比较癌症疼痛患者接受为期6周的集体针刺疗法与个体针刺疗法的效果。
本研究设计为个体针刺疗法(金标准治疗)与集体针刺疗法治疗癌症疼痛的随机非劣效性试验。主要结局是通过简明疼痛量表(BPI)测量的疼痛干扰和严重程度。次要结局包括情绪、睡眠、疲劳和社会支持的测量指标。使用线性混合效应模型检查干预前后结局的变化,并使用非劣效性界值、两组之间的变化差异和95%置信区间推断非劣效性。疼痛干扰以BPI上的非劣效性界值1进行检验,而疼痛严重程度和次要结局则使用传统统计方法进行比较。
该试验纳入了74名参与者,随机分配至集体针刺疗法组(35人)或个体针刺疗法组(39人)。疼痛干扰[Ө - 1,Δ 1.03,95%置信区间:0.15 - 2.20]、严重程度[Ө - 0.81,Δ 0.52,95%置信区间:.33 - 1.38]、情绪[Ө - 7.52,Δ 9.86,95%置信区间:0.85 - 18.86]、睡眠[Ө - 1.65,Δ 2.60,95%置信区间:0.33 - 4.88]、疲劳[Ө 8.54,Δ - 15.57,95%置信区间:25.60 - 5.54]和社会支持[Ө.26,Δ - 0.15,95%置信区间: - 0.42 - 0.13]的非劣效性假设得到支持,这意味着集体针刺疗法不劣于个体针刺疗法。两组在干预前后所有症状方面均有统计学上的显著改善。集体针刺疗法与个体针刺疗法在疼痛、睡眠、情绪和社会支持结局方面的效应大小范围从小到非常大,且在集体针刺疗法组中始终更大。集体针刺疗法的人均总平均成本(221.25美元)几乎是个体针刺疗法(420美元)的一半。
这是第一项检验集体针刺疗法与金标准个体针刺疗法非劣效性的研究。集体针刺疗法在治疗癌症疼痛方面不劣于个体针刺疗法,且在许多健康结局方面更优。集体针刺疗法在缓解癌症疼痛方面更具成本效益,应考虑进行实施试验。