Placebo Effects & the

Penetrating Divine
Illumination

Ted Kaptchuk
Professor of Medicine
Harvard Medical School

Giovanni Maciocia
February 28,1945 – March 9, 2018

1
 HOW DO WE KNOW EAST ASIAN
MEDICINE WORKS?

Experience and Observation:

Learning from teachers, mentors, and colleagues
Clinical experience & feedback from patients
Compiled clinical cases
Scholarship:
Critical reading of canonical texts and commentaries
Theory:
Inference from theory
Celestial Voices:
Divine Illumination
Contemporary Bottom Line:
OBSERVED PATIENT OUTCOMES

Largest study ever performed from East Asian Medicine Perspective

2
STUDY RESULTS
454,920 patients
3,840,000 acupuncture treatments
3 Conditions:
Chronic low back pain (45.0%)
Osteoarthritis (35.7%)
Headache (12.0%)

OUTCOME
21.8% “marked improvement”
54% “moderate improvement” (“decided”)
16.1% “minimal” (“slight”)
3.9% no change or worsening
4.2% unable to judge
9.4% discontinued because of scheduling, absence of improvement, side effects or new
illness

3
 ADVERSE EFFECTS
7.9% reported adverse effect
• Pain (4.0%)
• Hematoma (3.3%)
• Bleeding (1.6%)
• Less frequent: orthostatic problems, forgotten needles, local
skin irritation, sensation of warmth

PIVOTAL CHANGE: 1948

RANDOMIZATION & PLACEBO RCT

VERUM PLACEBO

1. Create placebo effects: An artifact of a

research methodology

2. New rational for effectiveness: Method

not outcome

4
 “Acupuncture…provides improvement in function and pain relief…for
osteoarthritis of the knew when compared with credible sham acupuncture.”

Annals Internal Medicine 2004. N=570 patients

“After 8 weeks of treatment, pain and joint function are improved more with
acupuncture than with minimal acupuncture or no acupuncture in patients with
osteoarthritis of the knee. However, this benefit decreases over time.”

Lancet 2005 N=294

5
“Although acupuncture was found effective for chronic low back pain, tailoring
needling sites to each patient and penetration of the skin appear to be
unimportant in eliciting therapeutic benefit.”

Archives Internal Medicine 2009 N=638

17,922 patients; 29 RCTs

20 trials with sham controls (5,230 patients)
18 trials with non-acupuncture controls (14,597 pts)
Conditions:
1) headache/migraine
2) low back & neck pain
3) osteoarthritis

Archives Internal Medicine 2012

6
Acupuncture vs. Sham controls (n= 5,230)

Indication Effect size

Acupuncture vs Sham Acupuncture

Migraine/headache -0.15 (-0.24, -0.07) P<0.001
Osteoarthritis -0.16 (-0.25, -0.07) P<0.001
LBP & Neck Pain -0.23 (-0.33, -0.13) P<0.001

Acupuncture vs. Non-acupuncture controls

(n= 14,597)

Indication Effect size

Acupuncture vs. non-acupuncture controls

Migraine/headache -0.42 (-0.46, -0.37) P<0.001
Osteoarthritis -0.57 (-0.64, -0.50) P<0.001
LBP & Neck Pain -0.55 (-0.58, -0.51) P<0.001

7
“For patients with chronic low back pain clinicians and patients should initially select
nonpharmacologic treatments with…acupuncture…. Grade: strong recommendation.”
Annals Internal Medicine 2017
.

Annals of Internal Medicine 2017

A second perspective on acupuncture & placebo

8
 fMRI Results
Brain regions associated with acupuncture analgesia and placebo analgesia

Thalamus

PAG
Insula

medulla

Gyrus
ambiens

Amygdala

rACC /
mPFC

Red indicates brain regions associated with pain intensity used as mask. Green
indicates the main effects of acupuncture treatment. Blue indicates the main effects
of placebo evoked by expectancy manipulation.

Brain 2017; 140:914-27

9
80 CARPAL TUNNEL SYNDROME PATIENTS
8 WEEKS
16 TREATMENTS

Three arms:
1. Verum local: TW5, PC7 (electro) (add: HT3, PC3, SI4, LI5,
LI10, LU5
2. Verum distal: SP6, LV4 (electro) (add: GB34,Kid3,SP5)
3. Sham: (detuned sham electro) 3 points on arm & 2 on calf
Outcomes:
1. Standard pain/paraesthesia measures (subjective)
2. Nerve conduction assessment of median nerve sensory latency
(objective)
3. fMRI assessing somatotopy at primary sensory cortex focused
on digit 2/3 cortical separation distance (objective)

10
Significant neural
plasticity towards
health
normal…specific to
local or distal

11
 2011

A THIRD PERSPECTIVE ON ACUPUNCTURE &

PLACEBO:

EAST ASIAN MEDICINE FOUNDATIONAL TEXTS

12
 (DE QI) (GRASP
THE QI)
(chap 3): “the acupuncturist must de qi.”
(chap 1): “successful acupuncture must first have qi
arrive (qi zhi)

Kikko story

TREAT SPIRIT

Su Wen (chap 27): “if Shen ( ) not moved…illness

cannot move”
Ling Shu (chap 7): use needle but don t neglect
Shen ( )”
Sun Wen (chap 29): need needle but first Shen
( )”
Sun Wen (chap 15): “for all needling to be reliable,
one must first regulate the Spirit.”
Sun Wen (chap 14): “when Spirit fails to enter …a
disease cannot be healed.”

This Spirit has nothing to do with the Heart spirit.

13
 Su Wen Chapter 13.
“Move Jing Transform Qi Chapter”

“In ancient times, when a physician

treated illness, he moved the Jing and
transformed the Qi….now, the patient is
treated with toxic herbs and
needles….The older method is
incantation ).… Jiu Dao-ji used the
…”penetrating divine illumination” (
). Unshuld: “communicates with the spirit brilliance”
.
As treatment….

Su Wen Chapter 26.

“Eight Upright - Divine Illumination”

“When the physician’s eyes are clear,

his heart is open and his mind ahead,
he alone apprehends [it as if it were]
clearly perceivable. But the mouth
cannot speak [of it.] Everyone looks
out, (but) he alone sees [it]…As if the
wind has blown away the clouds.
Hence one speaks of “divine” (Unshuld:
“spirt”) .

As Diagnosis..…

14
 PENETRATING DIVINE ILLUMINATION

Bian Que: “pulse taking is like looking at the sky through a tube or
looking for the pattern by peering through a crack.” (Bian Que d. 310
BCE) (Shi ji 94 CE)

Mentioned several times especially as the Spirit

method of diagnosis. Pulse is middle level. (Su
Wen Chap 8, Ling Shu Chap 2, Ling Shu Chap 4) (Can’t we tell the truth!)

Nan Jing (Chap 61)

Shen-nong Ben-cao: dozen times. Divine Husbandman’s Material
Medica Sabine Wilms translates as “breakthrough of spirit
illumination” (Shen is usually translated Divine in the title of the
book)

PENETRATING DIVINE ILLUMINATION IN HISTORY

“Feel better before taking medicine is the most

direct method” Xu Shu-wei (1132 CE)
“Medicine Without Form” ( Wu Kun (1584
CE)

“By using this method the process begins even

before the medicine reaches the mouth” Eastern
Precious Mirror, Dong-yi Bao-jian (1611 CE)

15
 PENETRATING DIVINE ILLUMINATION

“Whenever I treat ‘inner injury illness,’ I must first

use incantation ( )…must examine carefully
hidden feelings and relations with women, use
tactful words to lead, use imploring words, use
shocking words…patient’s acceptance [of
words] and emotions (of the words), they are
absorbed…this is the Spirit doctor.”
Wu Zhu-tong, 1796.

Disappears! Will answer later

PENETRATION DIVINE ILLUMINATION IN

BOTH DIAGNOSIS AND TREATMENT

Penetrating Divine Illumination (PDI) intimately and intuitively

apprehends and treats the person in their entirety.
Before and after all the details, intimate knowing and
profound witnessing effortless become the elixir for
transforming jing and moving qi.
PDI is the capacity to initiate and accomplish transformation
inherent in the therapeutic encounter
Causality…..

16
CAUSALITY:
WEST AND EAST
Modern West: Matter inert. Measureable forces applied. Billiard ball
causality. Change is from external movement. Any physical
leftovers in biomedicine are called placebo effects.
East: Qi: & Resonance/Gan Ying
Qi is propensity, inclination. Change primarily an inner
transformation.
Resonance: Interpenetration of propensities. Practitioner can feel
intuitively for diagnosis. Treatments (e.g., ginseng and
practitioner) move jing and transform qi.
Penetrating Divine Illumination intuitively or by embodiment
apprehends and transforms. It grows within as the craft is
honed. The ancients thought you could take herbs and
acupuncture to enhance this . In modern times, I think, to have
to cultivate with without too much effort but with deep sincerity.

SUMMARY
Biomedicine: Placebo is an important artifact broadly
accepted concept that assumes you can easily isolate the
physical effects from non-physical effects of intervention.
Biomedicine is real. Placebo is real. We need to deal with
it. It is not Asian medicine.
East Asian Medicine: The Penetrating Divine Illumination is
connects to and infuses every dimension of Chinese
medicine. Don’t expect it be acknowledged by
biomedicine or modern TCM. It’s real. But it is not a left-
over non-specific placebo effect. It’s real. It happens the
day you step into the clinic. The Illumination is refined
and deepened every time you continue to work with
patients.

17
 Thank you!

WHY DISAPPEARS? LITERATE MEDICAL PROFESSION

NEEDS TO DIFFERENTIATE WITH VARIOUS MEDICAL
PRACTICES AT DIFFERENT TIMES.

In early days, Chinese medicine had to demarcate from

shamans. So adopts a more narrow focus on physical.
In modern days have to demarcate from “magic”/”spiritual”
components of tradition. So adopts a narrow focus on
physical.
In China, even since early 19th century, must be able to say
“scientific” and compatible with science.
Classical texts make space for non-physical (spiritual) but
not necessarily primary focus. Modern TCM texts since
the Republican period are scrubbed clean by materialistic
editors and materialistic readers. Foundational texts
speak about the “penetrating divine illumination.”

18
DOES EAST ASIAN MEDICAL THEORY
ACCOUNT FOR PLACEBO EFFECTS?

Acupuncture represents a co-mingling of:

(obtain the qi)
(treat spirit)

CONCLUDING REMARKS

East Asian medicine understands healing as the interaction

of “ intervention” with how the practitioner aligns the
patient to receive, absorb and transform different energy.
“Intervention” is actually a unity of the “person” and
“practitioner” at the point of clinical encounter.
Acupuncture and herbs use needles but also co-mingle with
spirit and “penetrating divine illumination.” There is no
simple boundary.

19
ACUPUNCTURE PROFESSIONS’
RESPONSE TO ACUPUNCTURE RCTS

Methodological weakness
Placebo controls not meaningful: complex system
Placebo acupuncture not inert
Rejection of biomedical epistemology
RCTs underestimate real world effects
Acupuncture theory needs to be re-evaluated
Placebo acupuncture has enhanced placebo
effects ßI’ll focus here as this is why I went into placebo studies

20
GERMAN INSURANCE COMPANIES
RESPONSE

CHERKIN ET AL. A RANDOMIZED TRIAL COMPARING

ACUPUNCTURE, SIMULATED ACUPUNCTURE, AND
USUAL CARE FOR CHRONIC LOW BACK PAIN. 2009.

N=629

21
WITT ET AL. ACUPUNCTURE IN PATIENTS WITH
OSTEOARTHRITIS OF THE KNEE: A RANDOMIZED TRIAL.
LANCET 2005.

N=294

Belief can interact with real treatment and

influence treatment results….

病不 治者, 病必不治，治之无功矣.
《 , 》

It is futile to treat a patient who does not want to

be treated. (NeiJing, SuWen Chapter 11)

22
 Playing with Placebo is Playing with Fire:
Does having placebo controls change outcomes?
Bergmann. Clincal Trials Meta-analysis 1994

What does these data mean

for patients?

AN EXAMPLE Non acupuncture intervention

Pain score of 45
Baseline pain score
of 60 on 0–100 scale Sham acupuncture intervention
Pain score of 35
True acupuncture intervention
Pain score of 30

23
 Meta-analysis of acupuncture versus placebo acupuncture
Madsen et al. BMJ 2009;338:a3115

Copyright ©2009 BMJ Publishing Group Ltd.

“Those who have cured 100% of their patients are

graded in the first class, those who have had
90% recoveries are in the second class, those
who have been 80% successful are placed third,
those who have cured 70% are considered
fourth class, and the lowest grade of all contains
those who could not cure more than 60%.”

24
 Zhou Li text of ideal Zhou (early Han): “The
chief medical officer of the Chou imperial
government is in charge of the whole medical
administration of the country and he collects all
efficacious drugs for the purpose of healing
diseases. All those suffering from external
maladies, whether of the head or body, are
treated separately by appropriate specialists. At
the end of the year, he uses the records of each
physician to decide on his rank and salary.”

25
Asthma Study

26
Outcome on Global
Measures
Adequate Relief
70

60

50

40

30 62

20 44
28
10

0
Intake + Intake + Placebo but Intake +
No Treatment NO engaged care Placebo +
Engaged Care

Kaptchuk BMJ 2008

27
HYPOTHESIS:

{INTAKE} < {NTAKE + PLACEBO} < {INTAKE + PLACEBO + ENGAGEMENT}

Intake + Intake + Intake +

No Placebo but Placebo +
Treatment No engaged care Engaged
care

Flow of Participants in Placebo-IBS Study

Randomized (n=262)

Augmented Placebo Limited Placebo Waitlist

(n=87) (n=88) (n=87)
Treatment
(3 weeks)

Completed Completed Completed

Augmented Placebo Limited Placebo Waitlist
(n=82) (n=71) (n=77)
(3 wks additional treatment)

Genuine Genuine
Follow-up

Acupuncture Acupuncture
(n=41) (n=37)

Completed Completed Completed

Follow-Up Follow-Up Follow-Up
Augmented Placebo Limited Placebo Waitlist
(n=39) (n=31) (n=72)

28
Annals Internal Medicine 2002

29
 Cherkin et al. Archives Internal Medicine 2009 (n=638 cLBP)_

IS PENETRATING AND
PLACEBO SAME?
Chinese medicine was opposed to shamnic medicine…but
no spiritual medicine…NOW a new front…NO. Placebo is
the shadow of physical interventions. Left over from
physical..TCM occupies liminal space between its old self
and needing to be respectable…
TCM doesn’t want to contradict but also wants to occupy
physical causality…(herbs and acpuncture)…nothing
spiritual
Physical interventions are the shadow the spiritual

What is spiritual: independent of time and space…hun po yi

zhi and shen….and are always profoundly tied to personal
subjective experiences….
LING SHU is spiritual pivot
We are part of this complex history…..Chiknese medicine in

30
 PENETRATING DIVINE ILLUMINATION

Core dialectic of healing: the point with receptivity

(yin) automatically and either instantaneously or
incrementally becomes transformative (yang).
Assessment and treatment, patient and doctor, yin
and yang merge. Assessment and intervention
become one.
The jing moves, the qi transforms. Healing
happens.

Pain Reduction from Morphine

8

7
(0-10)

4
Basel ine 30 mins 60 mins

Lancet Neurology 2004

31
 Sham acupuncture > pill placebo.
Sham acupuncture = ultrasound & PT placebo
Forschende Komplementarmedizin 2010
______________________________________________________________________________________________

Acupuncture, sham surgery & procedures > oral pills

JAMA Internal Med 2013

CONCLUDING REMARKS

LOCATION: Contemporary researchers (and practitioners) of

East Asian medicine are influenced by and immersed in
two distinct worlds.
ACHIEVEMENTS: Adopting modern methods for acupuncture
research has informed our community, the medical
community, and the public. It has helped us improve care.
It will continue informing basic biological questions.
BOTTOM LINE: We cannot abandon our epistemological
roots. The wisdom of Asian medicine provides patients
with unimpeachable experiences of health and wellbeing.

32
N=601
Factorial design 2x2 + 1 (usual care)
Placebo enhanced vs placebo neutral X Montelukast enhanced
vs montelukast neutral + no usual care

J Allergy Clin Immunol 2009

BERGMANN ET AL.
A RANDOMIZED CLINICAL TRIAL OF THE EFFECT OF
INFORMED CONSENT ON THE ANALGESIC ACTIVITY OF
PLACEBO AND NAPROXEN IN CANCER PAIN.

CLINICAL TRIALS META-ANALYSIS 1994; 29.

n = 49 cancer pts. Mild to moderate cancer pain not

requiring opiates. Randomly assigned to be
informed or not informed in a cross-over
placebo controlled RCT.
Not informed 25: thought routine care
informed 18/24: agree to enter

33
ANALGESIA FOR OPERATIVE DENTISTRY:
A COMPARISON OF ACUPUNCTURE AND
PLACEBO
TAUB ET AL. ORAL SURGERY 1979;43:205-10.

OUTCOME MEASURES &

HYPOTHESIS
IBS Adequate Relief
IBS Global Improvement
IBS Symptom Severity Scale
IBS QoL

Hypothesis:
augmented > limited > waitlist

34
35
STREITBERGER
PLACEBO NEEDLE

SHAM ACUPUNCTURE VERSUS PLACEBO PILL

Randomized
n=270

Sham Device Placebo Pill

n=133 n=133

Sham Device Acupuncture Amitriptyline Placebo Pill

n=60 N=59 n=59 n=59

36
OUTCOME MEASURES

NAS
Pransky function scale
Grip strength

37
38
POPE INNOCENT III (1198-1216)
CLEMENT VII (1536-1605)

First Placebo Controls: c.1565

Kaptchuk. Lancet 2009

39
PENETRATING DIVINE ILLUMINATION

The hidden implications of Chinese medicine: 1) if

one needs to apprehend the whole to interpret
the parts, 2) the whole infuses the parts, then 3)
the whole is always a palpable presence in the
immediate encounter of the patient-physician.
Cannot be taught. Eludes the novice. Grows as
craft is honed.
Basis of success of every clinical encounter.

PENETRATING DIVINE ILLUMINATION

“Feel better before taking medicine is the most

direct method” Xu Shu-wei (1132 CE)
“Medicine Without Form” ( Wu Kun (1584
CE)

“By using this method the process begins even

before the medicine reaches the mouth” Eastern
Precious Mirror, Dong-yi Bao-jian (1611 CE)

40
 PENETRATING DIVINE ILLUMINATION

“Whenever I treat ‘inner injury illness,’ I must first

use incantation ( )…must examine carefully
hidden feelings and relations with women, use
tactful words to lead, use imploring words, use
shocking words…patient’s acceptance [of
words] and emotions (of the words), they are
absorbed…this is the Spirit doctor.” Wu Zhu-
tong, 1796.

PENETRATING DIVINE ILLUMINATION

Core dialectic of healing: the point with receptivity

(yin) automatically and either instantaneously or
incrementally becomes transformative (yang).
Assessment and treatment, patient and doctor, yin
and yang merge. Assessment and intervention
become one.
The jing moves, the qi transforms. Healing
happens.

41
CONCLUDING REMARKS

East Asian medicine understands healing as the interaction

of “ intervention” with how the practitioner aligns the
patient to receive, absorb and transform different energy.
“Intervention” is actually a unity of the “thing” and
“practitioner.”
Acupuncturists use needles but also the “penetrating divine
illumination.” There is no simple boundary.

42