Skip to main content

Table 2 Frequency of reported adverse reactions by patients and physicians sorted by categories in frequencies and proportions, description in text form, and agreement as Cohen’s kappa (κ) coefficient with 95% confidence interval (CI) for 36,792 and 42,811 available data of 44,818 patients

From: Comparing physicians’ and patients’ reporting on adverse reactions in randomized trials on acupuncture—a secondary data analysis

 

Frequency n (%)

Descriptiona

Cohen’s kappa (κ)d

Patient reported

available data n = 36,792

Physician reported

available data n = 42,811

Patient reported

available data n = 36,792

Physician reported

available data n = 42,811

Kappa

95% CI

Bleeding/haematoma

2458 (6.681)

255 (0.596)

common

uncommon

0.11

0.10–0.11

Inflammation

136 (0.370)

16 (0.037)

uncommon

rare

  

 Inflammation

129 (0.351)

13 (0.030)

uncommon

rare

0.09

0.08–0.10

 Local infection

7 (0.019)

3 (0.007)

rare

very rare

0.00

−0.01 − 0.01

Pain

636 (1.729)

207 (0.484)

common

uncommon

  

 Other pain

215 (0.584)

38 (0.090)

uncommon

rare

0.08

0.07–0.09

 Headache

197 (0.535)

49 (0.114)

uncommon

uncommon

0.21

0.20–0.21

 Aggravation of symptoms

89 (0.242)

65 (0.152)

uncommon

uncommon

0.09

0.08–0.10

 Local muscle pain

73 (0.198)

21 (0.049)

uncommon

rare

0.02

0.01–0.03

 Strong pain during needling

61 (0.166)

33 (0.077)

uncommon

rare

0.02

0.01–0.03

 Generalized muscle pain

1 (0.003)

1 (0.002)

very rare

very rare

0.00

−0.01 − 0.01

Vegetative symptoms

229 (0.622)

136 (0.320)

uncommon

uncommon

  

 Vertigo

78 (0.212)

31 (0.072)

uncommon

rare

0.16

0.15–0.17

 Other cardiovascular disturbance

62 (0.169)

62 (0.145)

uncommon

uncommon

0.16

0.15–0.17

 Nausea

48 (0.130)

17 (0.040)

uncommon

rare

0.21

0.20–0.22

 Unconsciousness

10 (0.027)

8 (0.019)

rare

rare

0.27

0.26–0.28

 Breathing difficulties

9 (0.024)

6 (0.014)

rare

rare

0.00

−0.01 − 0.01

 Sweating

9 (0.024)

5 (0.012)

rare

rare

0.18

0.17–0.19

 Tachycardia

8 (0.022)

6 (0.014)

rare

rare

0.18

0.17–0.19

 Increase in blood pressure

2 (0.005)

1 (0.002)

very rare

very rare

0.00

−0.01 − 0.01

 Palpitationsb

1 (0.003)

0 (0.000)

very rare

0

 Constipationb

1 (0.003)

0 (0.000)

very rare

0

 Enterospasmb

1 (0.003)

0 (0.000)

very rare

0

Nerve irritation/injuries

90 (0.245)

35 (0.082)

uncommon

rare

  

 Hypaesthesia

44 (0.120)

7 (0.016)

uncommon

rare

0.04

0.03–0.05

 Nerve irritations

24 (0.065)

4 (0.009)

rare

very rare

0.08

0.07–0.08

 Paraesthesia

12 (0.033)

22 (0.051)

rare

rare

0.06

0.05–0.07

 Nerve injury

5 (0.013)

2 (0.005)

rare

very rare

0.00

−0.01 − 0.01

 Paresis b

5 (0.013)

0 (0.000)

rare

0

Others

420 (1.142)

158 (0.369)

common

uncommon

  

 Fatigue

80 (0.217)

16 (0.037)

uncommon

rare

0.16

0.15–0.17

 Swelling

70 (0.190)

11 (0.026)

uncommon

rare

0.12

0.11–0.12

 Other dermal phenomena

36 (0.098)

15 (0.035)

rare

rare

0.26

0.25–0.27

 Other neurological complaints

27 (0.073)

1 (0.002)

rare

very rare

0.00

0.00–0.00

 Itching

24 (0.065)

3 (0.007)

rare

very rare

0.09

0.08–0.09

 Worsening health state

23 (0.063)

10 (0.023)

rare

rare

0.07

0.06–0.08

 Redness

21 (0.057)

16 (0.037)

rare

rare

0.06

0.05–0.07

 Collapse

18 (0.049)

17 (0.040)

rare

rare

0.19

0.18–0.20

 Restricted movements

15 (0.041)

1 (0.002)

rare

very rare

0.00

−0.01 − 0.01

 Other mood swings

13 (0.035)

8 (0.019)

rare

rare

0.11

0.09–0.12

 Tinnitus

10 (0.027)

4 (0.009)

rare

very rare

0.29

0.28–0.30

 Vomiting

9 (0.024)

4 (0.009)

rare

very rare

0.17

0.16–0.18

 Feeling of coldness

8 (0.022)

3 (0.007)

rare

very rare

0.00

−0.01 − 0.01

 Menstrual problems

8 (0.022)

3 (0.007)

rare

very rare

0.25

0.24–0.26

 Anxiety

8 (0.022)

11 (0.030)

rare

rare

0.35

0.34–0.36

 Sleep disturbance

6 (0.016)

2 (0.005)

rare

very rare

0.00

−0.01 − 0.01

 Disturbed vision

6 (0.016)

2 (0.005)

rare

very rare

0.00

-0-01 − 0.01

 Diarrhoea

5 (0.014)

3 (0.007)

rare

very rare

0.29

0.28–0.30

 Needle forgotten

4 (0.011)

1 (0.002)

rare

very rare

0.00

−0.01-0.01

 Imbalance

4 (0.011)

1 (0.002)

rare

very rare

0.00

-0.01-0.01

Other gastrointestinal complaints

4 (0.011)

3 (0.007)

rare

very rare

0.00

-0.01-0.01

 Joint problems

3 (0.008)

3 (0.007)

very rare

very rare

0.00

-0.01-0.01

 Depressive mood

3 (0.008)

2 (0.005)

very rare

very rare

0.50

0.49–0.51

 Eye irritation

3 (0.008)

1 (0.002)

very rare

very rare

0.00

-0.01-0.01

 Burns after moxibustion

2 (0.005)

6 (0.014)

very rare

rare

0.00

-0.01-0.01

 Systemic infection

2 (0.005)

4 (0.009)

very rare

very rare

0.00

-0.01-0.01

 Poor concentrationb

2 (0.005)

0 (0.000)

very rare

0

 Gastrospasm

2 (0.005)

1 (0.002)

very rare

very rare

0.00

-0.01-0.01

 Vascular injuriesb

1 (0.003)

0 (0.000)

very rare

0

 Nightmaresb

1 (0.003)

0 (0.000)

very rare

0

 Restlessness/nervousness

1 (0.003)

3 (0.007)

very rare

very rare

0.00

-0.01-0.01

 Shiveringb

1 (0.003)

0 (0.000)

very rare

0

 Pneumothoraxc

0 (0.000)

1 (0.000)

very rare

0

Other organ injuriesc

0 (0.000)

1 (0.000)

very rare

0

 Disorientationc

0 (0.000)

1 (0.000)

very rare

0

Average kappa ( κ )

    

0.21

0.20–0.22

  1. Note: a kappa coefficient can only be calculated if both the patient and physician reported a reaction; kappa values above 0.2 indicate fair agreement and are marked in bold
  2. aDescription of the frequencies in text form according to the guideline of the European Commission to describe the frequencies of adverse effects or reactions of medical products: very common: (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000) and very rare (< 1/10,000) [37].
  3. bReported only by patient
  4. cReported only by physician
  5. dInterpretation of Cohen’s kappa (κ): < 0, poor; 0–0.20, slight; 0.21–0.40, fair; 0.41–0.60, moderate; 0.61–0.80, substantial; 0.81–1.00, almost perfect; 1, perfect agreement