Background
Methods
Patients
Design
Interventions
Data monitoring and Statistics
Results
General characteristics of patients
Characteristic | Clinical Trials | Total(%) | |||
---|---|---|---|---|---|
MI-RCT | FD-RCT | BP-RCT | |||
Gender
| Male | 82 | 173 | 474 | 729 (37.0) |
Female | 393 | 420 | 426 | 1239 (63.0) | |
Marriage
| Unmarried | 134 | 191 | 211 | 536 (27.2) |
Married | 341 | 402 | 689 | 1432 (72.8) | |
Educational Background
| Primary school | 34 | 39 | 90 | 163 (8.3) |
Middle school | 206 | 213 | 405 | 824 (41.9) | |
University and above | 235 | 341 | 405 | 981 (49.9) | |
Acupuncture experience
| Not experienced | 346 | 588 | 491 | 1425 (72.4) |
Have experienced | 129 | 5 | 409 | 543 (27.6) | |
BMI (kg/m
2
)
| < 18.5 | 53 | 92 | 24 | 169 (8.6) |
18.5~23.9 | 342 | 428 | 495 | 1265 (64.3) | |
24.0~27.9 | 80 | 73 | 381 | 534 (27.1) | |
Age (year)
| 18~29 | 178 | 215 | 258 | 651 (33.1) |
30~39 | 104 | 119 | 191 | 414 (21.0) | |
40~49 | 90 | 118 | 175 | 383 (19.5) | |
50~59 | 83 | 105 | 179 | 367 (18.7) | |
60~69 | 20 | 36 | 97 | 153 (7.8) |
AEs and sequent treatments
Characteristics | Clinical Trials | Total (%) | |||
---|---|---|---|---|---|
MI-RCT | FD-RCT | BP-RCT | |||
Gender
| Male | 6 | 1 | 12 | 19 (25.68) |
Female | 29 | 10 | 15 | 54 (72.97) | |
Marriage
| Unmarried | 6 | 1 | 2 | 9 (12.2) |
Married | 30 | 10 | 25 | 65 (87.84) | |
Educational Background
| Primary school | 6 | 2 | 2 | 10 (13.51) |
Middle school | 12 | 3 | 14 | 29 (39.19) | |
University and above | 18 | 6 | 11 | 35 (47.3) | |
Acupuncture experience
| Not experienced | 25 | 11 | 18 | 54 (72.97) |
Have experienced | 11 | 0 | 9 | 20 (27.03) | |
BMI (kg/m
2
)
| < 18.5 | 3 | 1 | 0 | 4 (5.4) |
18.5~23.9 | 30 | 9 | 18 | 57 (77.03) | |
24.0~27.9 | 3 | 1 | 9 | 13 (17.57) | |
Age (year)
| 18~29 | 8 | 1 | 4 | 13 (17.57) |
30~39 | 7 | 2 | 9 | 18 (24.32) | |
40~49 | 6 | 2 | 8 | 16 (21.62) | |
50~59 | 8 | 4 | 4 | 16 (21.62) | |
60~69 | 7 | 2 | 2 | 11 (14.86) |
Type of AEs | Total patients with AEs (N = 74) | Physiotherapy (N = 19) | Self-treatment (N = 37) | Others (N = 3) | No treatment (N = 15) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
MI-RCT n (%) | FD-RCT n (%) | BP-RCT n(%) | MI-RCT n (%) | FD-RCT n (%) | BP-RCT n(%) | MI-RCT n (%) | FD-RCT n (%) | BP-RCT n(%) | MI-RCT n (%) | FD-RCT n (%) | BP-RCT n(%) | MI-RCT n (%) | FD-RCT n (%) | BP-RCT n(%) | ||
Local reactions
| Subcutaneous haematoma | 6 (8.11) | 3 (4.05) | 23 (31.08) | 6 (31.58) | 3 (15.79) | 3 (15.79) | 0 | 0 | 9 (24.32) | 0 | 0 | 0 | 0 | 0 | 11 (73.33) |
Minor haemorrhage in needling position | 23 (31.08) | 2 (2.70) | 3 (4.05) | 0 | 0 | 0 | 23 (62.16) | 2 (5.41) | 3 (8.11) | 0 | 0 | 0 | 0 | 0 | 0 | |
Subcutaneous bruise | 6 (8.11) | 1 (1.35) | 0 | 2 (10.53) | 1 (5.26) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 (30.77) | 0 | 0 | |
Prolonged pain at the site of needling | 0 | 1 (1.35) | 0 | 0 | 1 (5.26) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Systemic reactions
| Acupuncture fainting | 0 | 1 (1.35) | 1 (1.35) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33.33) | 1 (33.33) | 0 | 0 | 0 |
Abdominal distension | 0 | 1 (1.35) | 0 | 0 | 1 (5.26) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Dizziness/vertigo | 0 | 1 (1.35) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33.33) | 0 | 0 | 0 | 0 | |
Leg weakness | 1(1.35) | 0 | 0 | 1 (5.26) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Muscle spasm | 0 | 1 (1.35) | 0 | 0 | 1 (5.26) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Logistic regression analysis of AE risk factors related with acupuncture treatment
Score | df |
p
| |||
---|---|---|---|---|---|
Step 1 | Variables | Gender (1) | 4.055 | 1 | 0.044 |
Educational Background | 1.141 | 2 | 0.565 | ||
Educational Background (1) | 0.932 | 1 | 0.334 | ||
Educational Background (2) | 0.644 | 1 | 0.422 | ||
Acupuncture experience (1) | 0.966 | 1 | 0.326 | ||
BMI | 2.649 | 1 | 0.104 | ||
Overall Statistics | 7.407 | 5 | 0.192 | ||
Step 2 | Variables | Educational Background | 0.824 | 2 | 0.662 |
Educational Background (1) | 0.554 | 1 | 0.456 | ||
Educational Background (2) | 0.607 | 1 | 0.436 | ||
Acupuncture experience (1) | 1.199 | 1 | 0.274 | ||
BMI | 1.422 | 1 | 0.233 | ||
Overall Statistics | 3.382 | 4 | 0.496 |
B | S.E. | Wald | df |
P
| Exp(B) | 95% C.I. for EXP(B) | |||
---|---|---|---|---|---|---|---|---|---|
Lower
|
Upper
| ||||||||
Step 1a
| Age | 0.018 | 0.008 | 4.897 | 1 | 0.027 | 1.018 | 1.002 | 1.034 |
Constant | -3.965 | 0.361 | 120.618 | 1 | 0.000 | 0.019 | |||
Step 2b
| Age | 0.018 | 0.008 | 4.719 | 1 | 0.030 | 1.018 | 1.002 | 1.034 |
Gender(1) | -0.539 | 0.271 | 3.967 | 1 | 0.046 | 0.583 | 0.343 | 0.991 | |
Constant | -3.782 | 0.369 | 105.284 | 1 | 0.000 | 0.023 |