18 3. 病人、醫生、研究者是否對治療不知情？YES!The PHS II was a randomized, double-blind, placebo-controlled trial evaluating the balance of risks and benefits of a multivitamin (Centrum Silver or placebo daily).
19 4. 病人的追蹤是否夠久、夠充足完整？YES!The trial began in 1997 with continued treatment and follow-up through June 1, 2011(a mean of 11.2 years of treatment and follow-up in men)Morbidity and mortality follow-up in PHS II were high—98.2% and 99.9%, respectively. In addition, morbidity and mortality follow-up as a percentage of person-time each exceeded 99.9%.
20 5. 是否所有的病人都被放到原先分派的組別中做分析？ YES!All primary analyses were based on the intention-to-treat principle.
21 6. 所有組別是否被平等對待？Yes!Every 6 months for the first year, then annually thereafter, PHS II participants were sent monthly calendar packs containing a multivitamin or placebo.Annual mailed questionnaires asked about adherence, adverse events, end points, and risk factors.
22 Multivitamins in the Prevention of Cardiovascular Disease in Men 文獻評讀之效度/信度Multivitamins in the Preventionof Cardiovascular Disease in MenJAMA, November 7, 2012病人的治療分派是隨機○對照組與實驗組在進入試驗時相似病人、醫生、研究者對治療不知情病人的追蹤夠久、夠充足完整所有的病人都被放到原先分派的組別中做分析所有組別被平等對待
23 研究結果During a median follow-up of 11.2 (interquartile range, ) years, there were 1732 confirmed major cardiovascular events.There was no significant effect of a daily multivitamin on major cardiovascular events.A daily multivitamin had no effect on total MI, total stroke, or CVD mortality.A daily multivitamin was also not significantly associated with total mortality.
24 Hazard Ratio(風險比值) ： 是被用來比較兩組的“發生事件所需時間 (time to event)” ，即是介入組死亡的風險除以對照組死亡的風險。
25 There were no significant difference in major cardiovascular events, total MI, total stroke between cumulative incidence curves.Cumulative incidence rate：某世代族群或某固定族群的人，經過某段觀察時間後，發生某事件﹙疾病﹚的人口佔該世代族群人口總數的百分比。
26 No significant interaction by baseline CVD history status (P= No significant interaction by baseline CVD history status (P=.62 for interaction) for primary (HR, 1.02; 95% CI, ) vs secondary (HR, 0.96; 95% CI, ) prevention.The cumulative incidence curves did not differ for primary (crude log-rank P=.71) or secondary (crude log-rank P=.94) prevention during up to 14 years of treatment and follow-up.對CVD的初級預防和次級預防都無顯著效果
28 Potential Adverse Effects No significant effects on gastrointestinal tract symptoms (peptic ulcer, constipation, diarrhea, gastritis, and nausea), fatigue, drowsiness, skin discoloration, and migraine (P=.05 for all).Participants taking the multivitamin vs placebo were more likely to have skin rashes (2125 in the multivitamin group and 2002 in the placebo group; HR, 1.07; 95% CI, ; P=.03).