Odineal David D, Marois Maria T, Ward Deborah, Schmid Christopher H, Cabrera Rima, Sim Ida, Wang Youdan, Wilsey Barth, Duan Naihua, Henry Stephen G, Kravitz Richard L
Department of Medicine, Madigan Army Medical Center, Joint Base Lewis McChord, Tacoma, WA, USA.
School of Medicine, University of California Davis, Sacramento, CA, USA.
J Gen Intern Med. 2020 Jan;35(1):102-111. doi: 10.1007/s11606-019-05303-0. Epub 2019 Aug 28.
Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for chronic musculoskeletal pain, despite limited evidence of effectiveness and well-documented adverse effects. We assessed the effects of participating in a structured, personalized self-experiment ("N-of-1 trial") on analgesic prescribing in patients with chronic musculoskeletal pain.
We randomized 215 patients with chronic pain to participate in an N-of-1 trial facilitated by a mobile health app or to receive usual care. Medical records of participating patients were reviewed at enrollment and 6 months later to assess analgesic prescribing. We established thresholds of ≥ 50, ≥ 20, and > 0 morphine milligram equivalents (MMEs) per day to capture patients taking relatively high doses only, patients taking low-moderate as well as relatively high doses, and patients taking any dose of opioids, respectively.
There was no significant difference between the N-of-1 and control groups in the percentage of patients prescribed any opioids (relative odds ratio (ROR) = 1.05; 95% confidence interval [CI] = 0.61 to 1.80, p = 0.87). There was a clinically substantial but statistically not significant reduction of the percentage of patients receiving ≥ 20 MME (ROR = 0.58; 95% CI = 0.33 to 1.04, p = 0.07) and also in the percentage receiving ≥ 50 MME (ROR = 0.50; 95% CI = 0.19 to 1.34, p = 0.17). There was a significant reduction in the proportion of patients in the N-of-1 group prescribed NSAIDs compared with control (relative odds ratio = 0.53; 95% CI = 0.29 to 0.96, p = 0.04), with no concomitant increase in average pain intensity. There was no significant change in use of adjunctive medications (acetaminophen, gabapentenoids, or topicals).
These exploratory results suggest that participation in N-of-1 trials may reduce long-term use of NSAIDs; there is also a weak signal for an effect on use of opioids. Additional research is needed to confirm these results and elucidate possible mechanisms.
ClinicalTrials.gov Identifier: NCT02116621.
尽管有效性证据有限且不良反应记录详尽，但阿片类药物和非甾体抗炎药（NSAIDs）仍常用于慢性肌肉骨骼疼痛的治疗。我们评估了参与结构化、个性化自我试验（“单病例试验”）对慢性肌肉骨骼疼痛患者镇痛药物处方的影响。
我们将215例慢性疼痛患者随机分组，一组参与由移动健康应用程序辅助的单病例试验，另一组接受常规治疗。在入组时和6个月后对参与患者的病历进行审查，以评估镇痛药物处方情况。我们设定了每天≥50、≥20和>0毫克吗啡当量（MME）的阈值，分别用于确定仅服用相对高剂量药物的患者、服用低-中等剂量以及相对高剂量药物的患者，以及服用任何剂量阿片类药物的患者。
单病例试验组和对照组在开具任何阿片类药物的患者百分比方面无显著差异（相对比值比（ROR）=1.05；95%置信区间[CI]=0.61至1.80，p=0.87）。接受≥20 MME的患者百分比有临床上显著但统计学上不显著的降低（ROR=0.58；95% CI=0.33至1.04，p=0.07），接受≥50 MME 的患者百分比也有类似情况（ROR=0.50；95% CI=0.19至1.
