The temporal trend of placebo response in migraine prevention from 1990 to 2021: a systematic literature review and meta-analysis with regression.

BACKGROUND: Migraine affects 1.1 billion people globally and is the second leading cause of disability worldwide. In clinical trials, treatment efficacy is evaluated by comparing the differential responses in the treatment and placebo arms. Although placebo response in preventive migraine trials has been studied, there is limited research examining temporal trends. This study evaluates the trend of placebo response over thirty years in migraine prevention trials and investigates the association of potential confounders, such as patient, treatment, and study characteristics on placebo response using meta-analysis with regression. METHODS: We conducted literature searches from January 1990 to August 2021 in bibliographical databases (PubMed, Cochrane Library, and EMBASE). Studies were selected according to PICOS criteria and included randomized, double-blind, placebo-controlled trials evaluating preventive migraine treatments in adult patients diagnosed with episodic or chronic migraine, with or without aura. The protocol was registered with PROSPERO (CRD42021271732). Migraine efficacy outcomes included were either continuous (e.g., monthly migraine days) or dichotomous (e.g., ≥ 50% responder rate (yes/no)). We assessed the correlation of the change in outcome from baseline in the placebo arm, with the year of publication. The relationship between placebo response and year of publication was also assessed after accounting to confounders. RESULTS: A total of 907 studies were identified, and 83 were found eligible. For the continuous outcomes, the change from baseline in mean placebo response showed an increase over the years (rho = 0.32, p = 0.006). The multivariable regression analysis also showed an overall increase in placebo response over the years. The correlation analysis of dichotomous responses showed no significant linear trend between publication year and mean placebo response (rho = 0.08, p = 0.596). Placebo response also varied by route of administration. CONCLUSION: Placebo response increased over the past 30 years in migraine preventive trials. This phenomenon should be considered when designing clinical trials and conducting meta-analyses.

Impact of patient-centered prescription medication labels on adherence in community pharmacy.

BACKGROUND: Prescription medication labels are often constructed in a manner which hinders safe and appropriate use of medicines. The United States Pharmacopeia released voluntary standards to revise medication labels in an effort to support patients' understanding and improve medication use. OBJECTIVE: To examine the impact of label changes on medication adherence before and after pharmacy implementation of the United States Pharmacopeia patient-centered prescription medication label standards. METHODS: This study used a retrospective pre-post cohort design. Prescription fill claims data were obtained from a community health plan serving Medicaid patients for 1 independent community pharmacy organization across 8 retail pharmacy sites. We calculated medication possession ratios (MPR) and proportion of days covered (PDC) for medications used for contraception, asthma, hypertension, and depression from 15 months before to 13 months after implementation of the label changes. RESULTS: Findings showed significant increases in mean MPR for asthma controller (increased by 0.111 [t = 0.290, P<0.0001]), antihypertensives (increased by 0.062 [t = 0.146, P < 0.0002]), and contraceptives medications (increased 0.133 [t = 0.209, P < 0.0001]) from preintervention to postintervention periods. Results also revealed increases in mean PDC for asthma controllers (increased by 0.193 [t = 0.267, P < 0.0001]), antihypertensives (increased by 0.067 [t = 0.175, P = 0.049]), and contraceptives (increased by 0.111 [t = 0.208, P < 0.0119]) from preintervention to postintervention periods. CONCLUSION: We report an association between a change to more patient-centered prescription medication labels and increased medication adherence based on MPR and PDC among Medicaid recipients.

Using a theoretical approach to predict college students' non-medical use of prescription drugs - a survival analysis.

OBJECTIVES: This study assesses students' non-medical use of prescription drugs (NMUPD) from college entrance to graduation, and examines factors that predict NMUPD. Participants: The study was conducted between May 2011 and September 2015 with 338 students. Methods: Longitudinal cohort study design was used to examine NMUPD across time, and NMUPD-related attitudes and subjective norms. Five yearly interviews were conducted to collect data. Cox proportional hazards regression analysis was used to examine time to NMUPD. Results: Thirty-five percent of study participants reported NMUPD; the majority of those initiated non-medical use before their third year in college. Analyses indicated that more positive attitudes towards NMUPD (HR = 1.73, p < 0.001), increased subjective norms regarding NMUPD (HR = 1.01, p < 0.01), and gender (male) (HR= 1.89, p < 0.001) were significantly associated with sooner NMUPD. Conclusions: Findings suggest that NMUPD prevention efforts that target mutable factors such as attitudes and subjective norms should be implemented early during students' college careers.