《對心臟重症加護病房病人進行代禱對其心血管疾病病程的影響：隨機對照研究》兩篇RCT於1999, 2001分別得出不同的結論，值得我們好好的研究。 有些人覺得宗教只需要信仰，不需要科學解釋；但總會有些人試著用不同的方式，包括用EBM，來間接證明是否有個超然於科學的存在。然而，討論神學並不是這篇分享的目的；這次想挑這兩篇，是想要以一個看似「無顯見、已知機制」的介入對病人會有什麼影響，也想知道方法學上有什麼要注意的。

1. Evidence-Based
Religious Medicine
實證宗教醫學
A randomized, controlled trial of the effects of remote, intercessory
prayer on outcomes in patients admitted to the coronary care unit.
(Harris, 1999, JAMA)
v.
Intercessory prayer and cardiovascular disease progression in a
coronary care unit population: a randomized controlled trial.
(Aviles, 2001, Mayo Clin Proc)
2017.12.07 報告人 Gem Wu
JC4JC (1)
不是如來實證謝謝！

3. Research on the effect of
intercessory prayer
(代人禱告)
Arthur,
year
Byrd,
1988
Walker,
1997
Harris,
1999
Aviles,
2001
Leibovici,
2001
Lesniak,
2006
Benson,
2006
Hoşrik,
2017
Method RCT RCT RCT RCT RCT RCT RCT RCT
Condition CCU
patient
alcohol
abuse
CCU
patient
CCU
patient
Blood-
stream
infection
Wound
healing in
animals
CABG Warts
(Islamic
prayer)
Subject
(N)
393 40 990 799 3393 22 1802 45
Result beneficial
(better
score)
Not
significant
Beneficial
(better
score)
Not
significant
beneficial
(shorter
stay, fever)
Beneficial
(wound
size, RBC,
Hb)
Harmful
(complications)
Not
significant
嬰猴
從古至2001，Aviles發現212篇評估靈性因子(spiritual factor)對健康影響者，75%有正向效果，17%無效，7%負面

4. These interventions are based on faith and by definition require no evidence.
(Anaya, Religion and Health, 2002)
The medical community should welcome the scrutiny provided by religious thinkers and
writers, and these thinkers and writers should not fear scientific inquiry.
(Müller, Religion and Health–Reply–I, 2002)
Aviles, 2001

5. Basic characteristics and differences of [Harris,
1999] and [Aviles, 2001]
Harris, 1999 Aviles, 2001
population All patient admitted to CCU of MAHI > 12M
(exclude those admitted < 1 Day)
Patients admitted to Mayo CCU and
discharged alive with a CV diagnosis
Sample size 990 (total) =
524 (usual care group) + 466 (prayer group)
799 (total) =
399 (control) + 400 (prayer)
Control Standard care Standard care
intervention Being prayed remotely, daily for 28 days for
“a speedy recovery with no complications”
Being prayed remotely, at least weekly for
26 weeks consecutively. The exact
content is not regulated.
Method RCT RCT
randomization Last digit on medical record:
usual care = odd; Prayer = even
Stratified by sex, age (<65, 65-75, >75),
diagnosis (MI, CHF…), condition
blindness Double blind,
the patient is unaware of the trial
Double blind
Outcome Beneficial in MAHI-CCU score,
No significance in length, Byrd score
Primary end points: death, cardiac arrest,
coronary revascularization, re-admission, ER
visits due to CV problem (no significance)
住CCU 回家後
明訂禱告內容、一天一次 沒特別規範、一週一次
依病歷號分 分層
指標自己訂

6. Method – study population
Aviles, 2001
CCU
admissions
1965人
eligible, agreed 799
人 (41%)
Prayer group
400人 (50%)
control group
399人 (50%)
not eligible
1098人 (56%)
disagree
68人 (3%)

7. Method – Treatment groups
• prayed by 5 randomly selected
individuals or groups (1-65 prayer,
median 1)
• at least once a week
• for 26 weeks
• intercessor prayed for 1-100
patients (median 5, mean 7.4)
• assign patients’ first name, age,
sex, diagnosis, general condition
(under IRB approval)
• no direct contact with the patient
Aviles, 2001
為避免代禱者、護理師的霍桑效應(Hawthrone effect)，代禱在出院後才開始。

8. Method
– Randomization
& stratification
– Follow up
• follow up by:
• telephone (e.g. Quality of life)
• medical records
• death certificate
Aviles, 2001

9. Method – statistical analysis
項目 該項目適用檢驗 檢驗 該檢驗適用情況
Categorical variables
• Baseline patient
characteristics
• Primary events
Chi-square Chi-square 依變項類別變數
大樣本 (n > 30)
Continuous variables
• Baseline patient
characteristics
If 常態分佈：
T test, Z test
If 非常態分佈：無母數
Wilcoxon rank test 無母數 (非常態)
一組或成對樣本
CV disease
progression Odds ratio
Logistic regression
models
Logistic regression models 二元變項
其中一類為參考
Event-free survival time Kaplan-Meier method
log-rank test
Kaplan-Meier method
log-rank test
存活曲線
Quality of life
(ordinal responses)
Wilcoxon rank sum Wilcoxon rank sum 無母數 (非常態)
兩組獨立樣本
Quality of life
(binary responses)
Chi-square Chi-square 依變項類別變數
大樣本 (n > 30)
Aviles, 2001

10. Result – Endpoints
Aviles, 2001

11. Discussion
1. 研究設計：難掌握代禱的「劑量」、「內容」、「時間」；萬一
自己「加藥」也無法控制、沒統計被代禱病人的宗教傾向
2. 本研究的數量難以達到power。90%的power在800個病人中，
需要有25%的差異才能達成，但本研究只有13%。如以prayer
組27.8%、control組24.3%的endpoint率來看，應該要有3000
個病人才能達到power。
3. 神(如果真的有的話)的旨意難以預測：
e.g. 讓緊張的病人不緊張或也是神蹟，卻無法量測
e.g. 讓受苦的病人快快往生，或也是回應祈禱的神蹟(?)
4. 宗教可否EBM、EBM能否探討神學？

12. 來看一下另一篇paper
被炮得很慘的那一篇

13. 支持
基督徒：不可試煉耶和華你的神
方法/研究倫理有問題
Harris, 1999

14. Method – clinical outcome evaluation
Harris, 1999
Developed for this study (before the trial began).

15. Method – statistical analysis
項目 該項目適用檢驗 檢驗 該檢驗適用情況
Categorical variables:
• Baseline variables
(e.g. sex)
• Specific medical
outcomes (e.g.
antibiotics usage)
Chi-square Chi-square 依變項類別變數
大樣本 (n > 30)
Categorical variables Chi-square Fisher exact test 類別變數
小樣本 (n < 30)
Byrd score P trend analysis
(e.g. Cochran-Armitage)
Cochran-Armitage
test for trends
順序尺度型變數
Continuous variables
• length of stay
• Age
• MAHI-CCU scores
If 常態分佈：
T test
Z test
If 非常態分佈：無母數統計
T test 依變項連續變數
兩組
小樣本 (n < 30)
常態分佈資料
Harris, 1999文裡沒提資料分佈

16. Result – length, MAHI-CCU score,
Byrd score
MAHI-CCU
score
Byrd
score
number needed to treat (NNT)
= 1/ARR (absolute risk reduction)
= 1/(EER-CER)
1/(3.0-2.7)=3.33 (95% CI, 1.7-41.3)
(need to pray for 3.33 people
for 1 to prevent 1 event)
↓
Bonferroni procedure
95% CI → p < 0.05
0.05/40=0.00125
→ 99.875% CI
( -0.16, 0.76)
以此推斷NNT為 -6.4~1.3
 可能：幫1.3人祈禱防止一個不良事件
 or 不幫6.4人祈禱防止一個不良事件
眾多變數中只有這個顯著

17. 評論
Issues concerning the Harris, 1999 study (研究設計)
1. The study was not randomized. (按病歷號分而沒真正達成隨機
分配)
 24hr之內出院，被分在prayer組：被分在usual care組的比 = 3.7%
(18/484) : 0.9% (5/529)，已達顯著 P<.005，當時prayer (介入) 還沒
進行，足顯示其「隨機」有待商榷。
2. The designation approach more often results in accidental
unblinding. (易讓人不小心得知病人為實驗組或控制組)

18. 評論
Issues concerning the Harris, 1999 study (統計1)
1. Although the intercessors were instructed to pray for a speedy
recovery, the prayer and control groups did not differ in length of
stay in the CCU or in the hospital, nor did they differ on the Byrd
scale. (祈禱病人快好，結果只有分數比較好看而已)
2. Result only differed on the unvalidated Mid American Heart
Institute–Cardiac Care Unit (MAHI-CCU) scale constructed for the
purpose of this study. The lack of construct validity raises serious
questions about this finding. (評分系統未經驗證)
3. P values must be evaluated within the context of the prestudy
probability of efficacy. Extraordinary claims (e.g. miracle) require
extraordinary proof (e.g. lower p threshold). (奇蹟更應嚴加檢視)
It is out of control because of its propensity to encourage much pseudoscientific mischief.
(Sandweiss, 2000)

19. 評論
Issues concerning the Harris, 1999 study (統計2)
1. The authors used the t test to compare results on a clinical
outcomes scale. Such scale values are not ordinary number-
line numbers in their representation of clinical severity; one
cannot in any clinical sense say that a unit increment in one
portion of the scale in one patient means exactly the same
thing as a unit increment in a different part of the scale or in a
different patient. (不能對MAHI-CCU score用 t test，因為不同
項目加一分，在意義上是不同的)

20. 評論
Issues concerning the Harris, 1999 study (論述)
1. The statements that “we have not proven that God answers prayer
or that God even exists. It was the intercessory prayer and not the
existence of God that was tested here,‘’ seem a contradiction. If
the intent of the study was to determine whether God answers
prayer, then God‘s will and His existence were also being tested de
facto. (本次研究就在探討上帝回應祈禱的效應，如有效，亦可證實
上帝與祂的旨意存在)
2. the study “suggests that prayer may be an effective adjunct to
standard medical care” is exaggerated, given the statistical
weakness of the data and lack of a scientific basis for the
hypothesis. (「建議祈禱列入醫療常規」的結論太過誇張)
"Don't put Lord your God to test,"
Matthew 5:7

21. 評論
Issues concerning the Harris, 1999 study (倫理)
IRB inform-consent waiver, due to :
(1) "no known risk" associated with the procedure,
(2) the informed consent discussion with prospective subjects would be likely to
bias the study toward inclusion of a propensity of "prayer-receptive" subjects,
(3) that the informed consent inquiry itself could cause distress for the patient, in
that the patient would be forced to think about issues of faith at a time when it
may not have been that patient‘s desire to do so.
positive therapeutic effect
if to a non-believer,
will the Higher Power respond
unfavorably?
美國衛福部
只有說不用取得「同意書」，
沒有說不用取得「同意」
另有說如免除事前告知，也要事後提供資料

22. 評論
拿掉其中一項評分
Harris, 1999
《An RCT of intercessory prayer…》
Editor's Correspondence
《Does Prayer Really Set One Apart?》
score
of 3
<->
0.06
<->
0.25
Harris, 1999
One in 20 is classically what one would expect to be significant by chance.
(Hamm, 2000)

23. 一些做完報告、與朋友討論完的感想
1. 可以接受宗教對人心的正面影響，進而影響到身體狀況；但不
能理解在不知情的狀況下，病人還會接受到超自然力量的影響
(而這正是這兩篇paper想要討論的！)
2. 即使paper得出超自然力量對健康正/負/無影響，仍不太會改變
人的宗教行為。或許會改變醫療制度 (像是規定住CCU的病人
一定要被禱告N次)，但這需要更強而有力的證據。
3. 如果把這些介入當作一般的新治療/藥物來看，會發現這兩篇
(尤其是後者) 還是有許多方法學，甚至是倫理上的謬誤。而從
謬誤中，我們可以學到如何不重蹈覆轍。
4. 科學研究(與研究者)無法完全脫離社會各種因子的影響，像是
個人的宗教信念，就可能影響到對於結果的解讀。
5. 然而，我還是認為，醫學不用排斥宗教，而可視為互補，而方
式值得我們更去探究

24. Thank you
TESV: Skyrim, Dwemers