The Effect of an Apparent Change to a Branded or Generic Medication on Drug Effectiveness and Side Effects
The Effect of an Apparent Change to a Branded or Generic Medication on Drug Effectiveness and Side Effects
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DOI：
10.1097/psy.0b013e3182738826
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发表时间：
2013-01-01
影响因子：
3.3
通讯作者：
Petrie, Keith J.
中科院分区：
文献类型：
--
作者：
Faasse, Kate;Cundy, Tim;Petrie, Keith J.
目的：与品牌药物相比，仿制药会降低感知有效性、增加感知不良反应以及增加不依从率。本研究探讨了明显的药物配方变化对药物有效性和药物副作用的主观和客观测量的影响。方法：62 名大学生参与了一项研究，据称该研究旨在测试速效 P 阻滞剂药物在减少考前焦虑方面的有效性。所有药片均为安慰剂。在第一节中，所有参与者都收到了一块黄色药片（“Betaprol”）。在第 2 节中，参与者被随机分配接受 Betaprol（无变化条件）或标有“Novaprol”（品牌变化条件）或“Generic”（通用变化条件）的白色药片。在服用片剂之前和之后测量血压和状态焦虑。评估了药物引起的副作用。结果：与品牌改变组（M = -2.75 mm Hg，SE = 1.44，p = .02）和一般改变组（M = -3.26 mm Hg，SE = 1.45，p = .03）相比，无改变组的收缩压下降幅度显着更大（平均 [M] [标准差] = -7.72 mm Hg，标准误差 [SE] = 1.45）。与品牌改变组（M = -0.50，SE = 0.33，p = .03）和一般改变组（M = -0.52，SE = 0.33，p = .04）相比，无改变组的状态焦虑（M = -1.53，SE = 0.33）显着下降。与无变化情况（M = 0.87，SE = 0.31，p = .03）相比，仿制药变化（M = 1.83，SE = 0.23）（但不是品牌变化）情况下的药物引起的副作用明显更多。结论：药物配方的改变，特别是仿制药的改变，似乎与药物有效性的主观和客观指标的减少以及副作用的增加有关。
Objective: Generic medications are associated with reduced perceived effectiveness, increased perceived adverse effects, and increased rates of nonadherence compared with brand-name medications. This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects. Methods: Sixty-two university students participated in a study purportedly testing the effectiveness of fast-acting P-blocker medications in reducing preexamination anxiety. All tablets were placebos. In session 1, all participants received a yellow tablet ("Betaprol"). In session 2, participants were randomly allocated to receive Betaprol (no change condition) or a white tablet labeled either as "Novaprol" (branded change condition) or "Generic" (generic change condition). Blood pressure and state anxiety were measured before and after tablet ingestion. Side effects attributed to medication were assessed. Results: The no change group showed significantly greater decreases in systolic blood pressure (mean [M] [standard deviation] = -7.72 mm Hg, standard error [SE] = 1.45) than the branded change (M = -2.75 mm Hg, SE = 1.44, p = .02) and generic change (M = -3.26 mm Hg, SE = 1.45, p = .03) groups. The no-change group showed significantly greater decreases in state anxiety (M = -1.53, SE = 0.33) than the branded change (M = -0.50, SE = 0.33, p = .03) and generic change (M = -0.52, SE = 0.33,p = .04) groups. Significantly more side effects were attributed to the medication in the generic change (M = 1.83, SE = 0.23) (but not the branded change) condition when compared with the no change condition (M = 0.87, SE = 0.31, p = .03). Conclusions: Medication formulation change, particularly to generic medication, seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects.