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