Appendix 1.
Acupuncture-related Adverse Event Report Form
Adverse Event Around The Acupuncture Site
Adverse Event
1.
Needle site bleeding
Definition: Hemorrhage caused by
needling
Severity
2=moderate
Blood clots after 5 minutes
0=Absent
Absent or
blood clots
within 2
minutes
Absent
1=mild
Present and blood
clots after 2 minutes
but less than 5 minutes
3=severe
Any medical treatment
required
Bruise less than 1 cm
in diameter and pain
resolves in 1 day
Bruise more than 1 cm in diameter
or is relieved by non-prescription
medication
Any medical treatment
required
2.
Bruise or
subcutaneous bleeding
Definition: An injury of soft tissue
characterized by leakage of blood
into surrounding tissue
3.
Needle site reaction
Definition: An intense adverse
reaction resulting in Itchiness or
redness (usually immunologic)
around the needle site
Absent
Less than 1 cm in
diameter or resolves in
1 day
More than 1 cm in diameter,
persists for more than 1 day, or is
relieved by non-prescription
medication
Any medical treatment
required
4.
Needle site pain
Definition: A sensation of marked
discomfort, distress or agony
around the needle site
Absent
Resolves in 1 day and
does not affect daily
activities
Affect daily activities or relieved by
non-prescription medication
Any medical treatment
required
5.
Needle site infection
Definition: An infectious
process involving the skin around
the needle site
Absent
Localized, local
intervention indicated
Oral intervention indicated
(e.g., antibiotic, antifungal,
antiviral)
IV antibiotic, antifungal, or
antiviral intervention
indicated; radiologic or
operative intervention
indicated
6.
Stuck, bent or broken needle
(Specify,___________)
Definition: Inability or difficulty in
removing needle or bent or broken
needle
Absent
Stuck, bent or broken
needle is corrected
without causing
discomfort
Stuck, bent or broken needle is
corrected but resulting in
discomfort
Stuck, bent or broken needle is
corrected with surgery
7.
Forgotten needle
(Specify,___________)
Definition: Needle left on patient
Absent
Forgotten needle is identified
outside treatment room, but causes
no complications
Forgotten needle is identified
outside treatment room, and
causes complications
8.
Burn injury
(Specify,___________)
Definition: An injury to flash
caused by heat, electricity,
chemicals, light, radiation or
Absent
Forgotten needle is
identified and
corrected at treatment
room
First degree, with pain
and redness
Second degree (superficial partial
thickness), with pain, redness and
blisters or is relieved by
non-prescription medication
Second degree (deep partial
thickness) or more severe or
any medical treatment
required
Terminate
acupuncture
□
Causality
□
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1
friction.
Appendix 1. (continued)
Systemic Adverse Event
0=Absent
1=mild
Absent
Symptom resolves in 1
day and does not affect
daily activities
10. Dizziness or fainting during or
immediate after treatment
Definition: A disturbing sensation of
light headedness, unsteadiness,
giddiness, spinning or rocking that
occur at the treatment room
Absent
Mild unsteadiness or
sensation of movement
11. Dizziness or fainting after
treatment
Definition: A disturbing sensation of
light headedness, unsteadiness,
giddiness, spinning or rocking that
occur after leaving the treatment
room.
Absent
12. Headache or other painful
symptoms
(Specify,
)
Definition: A sensation of marked
discomfort in various parts of the
head or any parts of the body.
13. Paresthesia
Definition: An abnormal cutaneous
sensation of tingling, numbness,
pressure, cold, and warmth that are
experienced in the absence of a
stimulus.
14. Tiredness or fatigue
Definition: A state of generalized
weakness with a pronounced
inability to summon sufficient
energy.
Adverse Event
9. Unusual feeling of relaxation
Definition: A subjective feeling of
relaxation after treatment
Severity
2=moderate
3=severe
Symptom persists for more than 1
day, affects daily activities, or is
relieved by non-prescription
medication
Moderate unsteadiness or sensation
of movement
Any medical treatment
required
Mild unsteadiness or
sensation of movement
like light headedness
Moderate unsteadiness or sensation
of movement with vertigo/ nausea/
fainting with no impaired
consciousness or relieved by
non-prescription medication
Any medical treatment
required
Absent
Pain resolves in 1 day
and does not affect
daily activities
Pain persists for more than 1 day,
affects daily activities, or is relieved
by non-prescription medication
Any medical treatment
required
Absent
Symptom resolves in 1
day and does not affect
daily activities
Symptom persists for more than 1
day, affects daily activities, or is
relieved by non-prescription
medication
Any medical treatment
required
Absent
Symptom resolves in 1
day and does not affect
daily activities
Symptom persists for more than 1
day, affects daily activities, or is
relieved by non-prescription
medication
Any medical treatment
required
Impaired consciousness or
any medical treatment
required
Terminate
acupuncture
□
Causality
□
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2
15. Nausea or other gastrointestinal
symptoms
(Specify,
)
Definition: A queasy sensation
and/or the urge to vomit, or other
gastrointestinal symptoms.
Absent
Symptom resolves in 1
day and does not affect
daily activities
Symptom persists for more than 1
day, affects daily activities, or is
relieved by non-prescription
medication
Any medical treatment
required
□
□
Appendix 1. (continued)
Systemic Adverse Event
Adverse Event
16. Organ injuries 1
(Specify,
)
Definition: A damage to an organ
due to acupuncture
0=Absent
Absent
1=mild
---
Severity
2=moderate
No treatment required
3=severe
Any medical treatment required
17. Foreign bodies 2
(Specify,
)
Definition: Any unwanted or
unexpected objects left inside
patients’ bodies due to
acupuncture
18. Infection 3
(Specify,
)
Definition: A disorder
characterized by an infectious
process involving any parts of
patients’ bodies due to
acupuncture
Absent
---
No treatment required
Any medical treatment required
□
□
Absent
---
No treatment required
Any medical treatment required
□
□
19. Dermatological
problems 4
(Specify,
)
Definition: Pathological reactions
of the skin
20. Others
(Specify,
)
Absent
---
No treatment required
Any medical treatment required
□
□
Absent
Symptom resolves in 1
day and does not
affect daily activities
Symptom persists for more than 1
day, affects daily activities, or is
relieved by non-prescription
medication
Any medical treatment required
□
□
Terminate
acupuncture
□
Causality
□
1
Pneumothorax, cardiac tamponade, injury to brain, eye, thyroid, stomach, intestines, gallbladder, kidney, artery, peripheral nerve, inferior laryngeal nerve, spinal cord, subarachnoid hemorrhage,
epidural hematoma, subdural hemoatoma; 2 Needle fragment in urinary tract, retroperitoneum, lung and diaphragm, liver, maxilla, cervical interspinous ligament, hip joint and other organs. 3
Acute hepatitis B, HIV infection, septicemia, spinal infection, erysipelas, pyothorax, skull tuberculosis and other infections; 4 Localized argyria, cutaneous chromatosis, nodular lesion, skin
tumour, skin sarcoid and other dermatological problems.
3
Appendix 1. (continued)
Evaluation of Causality
Certain
Probable/likely
Possible
Unlikely
Unclassified
/unclassifiable
• Plausible time relationship to acupuncture treatment
• Cannot be explained by disease or other drugs
• Response to discontinuance of acupuncture treatment plausible
• Rechallenge satisfactory, if necessary
• Reasonable time relationship to acupuncture treatment
• Unlikely to be attributed to disease or other drugs
• Response to discontinuance of acupuncture treatment clinically reasonable
• Rechallenge not required
• Reasonable time relationship to acupuncture treatment
• Could also be explained by disease or other drugs
• Information on discontinuance of acupuncture treatment may be lacking or unclear
• a time to acupuncture treatment makes a relationship improbable (but not impossible)
• Disease or other drugs provide plausible explanations
•Insufficient information to permit judgment
•Insufficient information to assess whether an important correlation between treatment and adverse event
exists
•Insufficient rationale or evidence that an identified problem will introduce an adverse event
Remarks:
4