BACKGROUND Paracetamol is recommended as first-line treatment for pain control in osteoarthritis because it has fewer side effects than do other therapeutic options, including nonsteroidal anti-inflammatory drugs (NSAIDs). Prescribing proton pump inhibitors (PPIs) as gastric bleeding prophylaxis in chronic NSAID users is also common, although not recommended. In Italy, paracetamol is not reimbursed by the National Health System. The aim of this trial was to test whether the availability to osteoarthritis patients of free paracetamol would decrease their use of NSAIDs and, as a secondary objective, whether opioid and PPI consumption would also decrease. METHODS Eight general practitioners (GPs) (59 patients) were randomized to usual care and 8 (58 patients) to the experimental arm, where prescribed paracetamol was directly distributed for free by the local hospital. After 6 months, paracetamol was also available for free in the control arm. The main outcome was the pre/post difference in average NSAID and PPI consumption. Differences between experimental and control arms in pre/post differences are reported, as registered by the drug prescription information system. RESULTS Average NSAID consumption decreased non-significantly, from 6.79 to 2.16 defined daily dose (DDD) in the experimental arm and from 3.19 to 2.97 DDD in the control group (p = 0.067). No changes were observed for PPIs (from 11.27 to 14.65 DDD and from 9.74 to 12.58 DDD in experimental and control arms, respectively, p = 0.788) or opioids (from 1.61 to 1.14 DDD and from 1.41 to 1.56 DDD in experimental and control arms, respectively, p = 0.419). When the intervention was extended to the control arm, no decrease in NSAID consumption was observed (from 2.46 to 2.43 DDD, p = 0.521). CONCLUSIONS Removing small economic barriers had small or no effect on the appropriateness of opioid or PPI prescribing to patients with osteoarthritis; a reduction in NSAID consumption cannot be ruled out. TRIAL REGISTRATION NUMBER NCT02691754 (Approved February 24, 2016).

中文翻译：

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一项随机分组试验，旨在评估向意大利开具免费的对乙酰氨基酚分配给骨关节炎患者对非甾体抗炎药和质子泵抑制剂的影响。

背景技术扑热息痛被推荐作为骨关节炎疼痛控制的一线治疗，因为它比其他治疗选择（包括非甾体类抗炎药（NSAIDs））具有更少的副作用。尽管不建议在慢性NSAID使用者中使用质子泵抑制剂（PPI）预防胃出血。在意大利，国家卫生系统不偿还扑热息痛。该试验的目的是测试向骨关节炎患者提供游离对乙酰氨基酚是否会减少他们对非甾体抗炎药的使用，并且作为次要目标，阿片类药物和PPI的消耗量是否也会减少。方法将8名全科医生（59名患者）随机分配至常规护理组，将8名（58名患者）分配至实验组，处方的扑热息痛由当地医院直接免费分发。6个月后，对照组还免费提供扑热息痛。主要结果是平均NSAID和PPI消耗量的前后差异。如药品处方信息系统所记录，报告了实验组与对照组之间在前/后差异方面的差异。结果NSAID的平均消费量无明显下降，实验组从6.79降低到2.16 DDD，对照组从3.19降低到2.97 DDD（p = 0.067）。实验组和对照组的PPI（分别为11.27至14.65 DDD和9.74至12.58 DDD，p = 0.788）或阿片类药物（实验组和对照组的1.61至1.14 DDD和1.41至1.56 DDD）均未观察到变化，分别为p = 0.419）。当将干预扩大到对照组时，未观察到NSAID消耗量减少（从2.46 DDD降至2.43 DDD，p = 0.521）。结论消除小的经济障碍对处方阿片类药物或PPI对骨关节炎患者的适用性影响很小或没有影响。不能排除NSAID消费量的减少。试用注册号NCT02691754（2016年2月24日批准）。