Journal of Traditional Chinese Medicine ›› 2024, Vol. 44 ›› Issue (1): 172-181.DOI: 10.19852/j.cnki.jtcm.20231110.001
• Original articles • Previous Articles Next Articles
YANG Yi, YE Huijun, ZHENG Huiling, JIN Lihua
Received:
2023-04-16
Accepted:
2023-08-29
Online:
2024-02-15
Published:
2023-11-10
Contact:
Prof. JIN Lihua, Department of Obstetrics and Gynecology, the Second Affiliated Hospital of Zhejiang Chinese Medical University, Xinhua Hospital of Zhejiang Province, Hangzhou 310005, China. Telephone: +86-13666683596
Supported by:
YANG Yi, YE Huijun, ZHENG Huiling, JIN Lihua. Clinical observation on 90 cases of primary dysmenorrhea treated by buccal acupuncture therapy: a randomized controlled study[J]. Journal of Traditional Chinese Medicine, 2024, 44(1): 172-181.
Variable | Observation group (n = 30) | Control group (n = 30) | Placebo group (n = 30) | P value |
---|---|---|---|---|
Age (years) | 22.3±2.5 | 21.7±2.8 | 22.2±2.1 | 0.648 |
Age at menarche (years) | 12.5±1.2 | 12.9±1.5 | 12.6±1.3 | 0.447 |
Menstrual cycle (days) | 28.8±1.8 | 29.0±1.9 | 28.6±1.6 | 0.644 |
Menstruation (days) | 6.5±0.9 | 6.6±0.9 | 6.4±0.9 | 0.553 |
Duration of disease (years) | 5.1±1.6 | 4.2±1.6 | 4.9±1.4 | 0.049 |
Table 1 Baseline characteristics of patients in the three study groups, collected on the first day of the intervention cycle ($\bar{x}±s$)
Variable | Observation group (n = 30) | Control group (n = 30) | Placebo group (n = 30) | P value |
---|---|---|---|---|
Age (years) | 22.3±2.5 | 21.7±2.8 | 22.2±2.1 | 0.648 |
Age at menarche (years) | 12.5±1.2 | 12.9±1.5 | 12.6±1.3 | 0.447 |
Menstrual cycle (days) | 28.8±1.8 | 29.0±1.9 | 28.6±1.6 | 0.644 |
Menstruation (days) | 6.5±0.9 | 6.6±0.9 | 6.4±0.9 | 0.553 |
Duration of disease (years) | 5.1±1.6 | 4.2±1.6 | 4.9±1.4 | 0.049 |
Time | Observation (n = 30) ( | Control (n = 30) ( | Placebo (n = 30) ( | Observation vs control (time*group) | Observation vs control | Observation vs placebo (time*group) | Observation vs placebo | Control vs placebo (time*group) | Control vs placebo | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FTime* Group | P value | Adjusted mean difference (95% CI) | P value | F value | FTime* Group | P value | Adjusted mean difference (95% CI) | P value | F value | FTime* Group | P value | Adjusted mean difference (95% CI) | P value | F value | ||||
0 min (before first treat-ment) | 6.80±1.19 | 6.47± 1.31 | 6.00± 1.39 | 55.23 | < 0.001 | 0.33 (-0.31, 0.98) | 0.305 | 1.02 | 93.61 | < 0.001 | 0.80 (0.13, 1.47) | 0.021 | 5.67 | 109.775 | < 0.001 | 0.47 (-0.24, 1.17) | 0.189 | 1.77 |
After 5 min | 2.87±1.59 | 6.40± 1.33 | 6.00± 1.39 | - | - | -3.53 (-4.29, -2.78) | < 0.001 | 87.12 | - | - | -3.13 (-3.91, -2.35) | < 0.001 | 64.74 | - | - | 0.40 (-0.31, 1.11) | 0.263 | 1.28 |
After 30 min | 1.07±1.02 | 1.83± 1.14 | 5.72± 1.44 | - | - | -0.77 (-1.33, -0.21) | 0.008 | 7.52 | - | - | -4.66 (-5.30, -4.01) | < 0.001 | 207.99 | - | - | -3.89 (-4.57, -3.21) | < 0.001 | 132.60 |
After 2 h | 0.67±0.84 | 0.20± 0.66 | 5.62± 1.86 | - | - | 0.47 (0.07, 0.86) | 0.021 | 5.66 | - | - | -4.95 (-5.70, -4.21) | < 0.001 | 175.57 | - | - | -5.42 (-6.14, -4.70) | < 0.001 | 225.29 |
After 1 d | 0.20±0.55 | 0.03± 0.18 | 2.17± 1.98 | - | - | 0.17 (-0.05, 0.38) | 0.121 | 2.47 | - | - | -1.97 (-2.73, -1.22) | < 0.001 | 27.49 | - | - | -2.14 (-2.87, -1.41) | < 0.001 | 34.62 |
Table 2 VAS scores at short-term effect analysis following the start of the first intervention, in the three groups ($\bar{x}±s$)
Time | Observation (n = 30) ( | Control (n = 30) ( | Placebo (n = 30) ( | Observation vs control (time*group) | Observation vs control | Observation vs placebo (time*group) | Observation vs placebo | Control vs placebo (time*group) | Control vs placebo | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FTime* Group | P value | Adjusted mean difference (95% CI) | P value | F value | FTime* Group | P value | Adjusted mean difference (95% CI) | P value | F value | FTime* Group | P value | Adjusted mean difference (95% CI) | P value | F value | ||||
0 min (before first treat-ment) | 6.80±1.19 | 6.47± 1.31 | 6.00± 1.39 | 55.23 | < 0.001 | 0.33 (-0.31, 0.98) | 0.305 | 1.02 | 93.61 | < 0.001 | 0.80 (0.13, 1.47) | 0.021 | 5.67 | 109.775 | < 0.001 | 0.47 (-0.24, 1.17) | 0.189 | 1.77 |
After 5 min | 2.87±1.59 | 6.40± 1.33 | 6.00± 1.39 | - | - | -3.53 (-4.29, -2.78) | < 0.001 | 87.12 | - | - | -3.13 (-3.91, -2.35) | < 0.001 | 64.74 | - | - | 0.40 (-0.31, 1.11) | 0.263 | 1.28 |
After 30 min | 1.07±1.02 | 1.83± 1.14 | 5.72± 1.44 | - | - | -0.77 (-1.33, -0.21) | 0.008 | 7.52 | - | - | -4.66 (-5.30, -4.01) | < 0.001 | 207.99 | - | - | -3.89 (-4.57, -3.21) | < 0.001 | 132.60 |
After 2 h | 0.67±0.84 | 0.20± 0.66 | 5.62± 1.86 | - | - | 0.47 (0.07, 0.86) | 0.021 | 5.66 | - | - | -4.95 (-5.70, -4.21) | < 0.001 | 175.57 | - | - | -5.42 (-6.14, -4.70) | < 0.001 | 225.29 |
After 1 d | 0.20±0.55 | 0.03± 0.18 | 2.17± 1.98 | - | - | 0.17 (-0.05, 0.38) | 0.121 | 2.47 | - | - | -1.97 (-2.73, -1.22) | < 0.001 | 27.49 | - | - | -2.14 (-2.87, -1.41) | < 0.001 | 34.62 |
Time | Observation (n = 25) ( | Control (n = 23) ( | Placebo (n = 22) ( | Observation vs control (time*group) | Observation vs control | Observation vs placebo (time*group) | Observation vs placebo | Control vs placebo (time*group) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FTime*Group | P value | Adjusted Mean Difference (95% CI) | P value | F value | FTime*Group | P value | Adjusted Mean Difference (95% CI) | P value | F value | FTime*Group | P value | |||||
Before first treatment | 6.9±1.2 | 6.4±1.3 | 5.9±1.4 | 41.89 | <0.01 | 0.43 (-0.28, 1.12) | 0.23 | 1.47 | 38.67 | <0.01 | 0.91 (0.17, 1.64) | 0.02 | 6.15 | 0.51 | 0.63 | |
After completion of first treatment | 5.2±1.4 | 6.4±1.1 | 6.1±1.1 | - | - | -1.21 (-1.93, -0.49) | <0.01 | 11.43 | - | - | -0.91 (-1.64, -0.18) | 0.02 | 6.32 | - | - | |
After completion of second treatment | 3.4±1.2 | 6.3±1.5 | 5.9±1.3 | - | - | -2.91 (-3.66, -2.16) | <0.01 | 61.31 | - | - | -2.47 (-3.18, -1.76) | <0.01 | 49.27 | - | - | |
After completion of third treatment | 2.1±1.6 | 6.4±1.2 | 5.9±1.4 | - | - | -4.29 (-5.12, -3.46) | <0.01 | 108.47 | - | - | -3.77 (-4.64, -2.89) | <0.01 | 75.40 | - | - | |
3 months after treatment | 2.4±1.7 | 6.1±1.8 | 5.4±1.6 | - | - | -3.77 (-4.77, -2.78) | <0.01 | 58.33 | - | - | -3.00 (-3.95, -2.07) | <0.01 | 41.27 | - | - | |
6months after treatment | 2.6±1.8 | 6.6± 1.2 | 5.8±1.2 | - | - | -3.92 (-4.82, -3.02) | <0.01 | 76.72 | - | - | -3.13 (-4.04, -2.22) | <0.01 | 47.37 | - | - |
Table 3 VAS scores at long-term effect analysis following the start of the first intervention, in the three groups ($\bar{x}±s$)
Time | Observation (n = 25) ( | Control (n = 23) ( | Placebo (n = 22) ( | Observation vs control (time*group) | Observation vs control | Observation vs placebo (time*group) | Observation vs placebo | Control vs placebo (time*group) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FTime*Group | P value | Adjusted Mean Difference (95% CI) | P value | F value | FTime*Group | P value | Adjusted Mean Difference (95% CI) | P value | F value | FTime*Group | P value | |||||
Before first treatment | 6.9±1.2 | 6.4±1.3 | 5.9±1.4 | 41.89 | <0.01 | 0.43 (-0.28, 1.12) | 0.23 | 1.47 | 38.67 | <0.01 | 0.91 (0.17, 1.64) | 0.02 | 6.15 | 0.51 | 0.63 | |
After completion of first treatment | 5.2±1.4 | 6.4±1.1 | 6.1±1.1 | - | - | -1.21 (-1.93, -0.49) | <0.01 | 11.43 | - | - | -0.91 (-1.64, -0.18) | 0.02 | 6.32 | - | - | |
After completion of second treatment | 3.4±1.2 | 6.3±1.5 | 5.9±1.3 | - | - | -2.91 (-3.66, -2.16) | <0.01 | 61.31 | - | - | -2.47 (-3.18, -1.76) | <0.01 | 49.27 | - | - | |
After completion of third treatment | 2.1±1.6 | 6.4±1.2 | 5.9±1.4 | - | - | -4.29 (-5.12, -3.46) | <0.01 | 108.47 | - | - | -3.77 (-4.64, -2.89) | <0.01 | 75.40 | - | - | |
3 months after treatment | 2.4±1.7 | 6.1±1.8 | 5.4±1.6 | - | - | -3.77 (-4.77, -2.78) | <0.01 | 58.33 | - | - | -3.00 (-3.95, -2.07) | <0.01 | 41.27 | - | - | |
6months after treatment | 2.6±1.8 | 6.6± 1.2 | 5.8±1.2 | - | - | -3.92 (-4.82, -3.02) | <0.01 | 76.72 | - | - | -3.13 (-4.04, -2.22) | <0.01 | 47.37 | - | - |
Time | Mean±SD | Mean±SD | Observation group vs Control group (Time*Group) | Observation group vs Control group | |||
---|---|---|---|---|---|---|---|
FTime*Group | P value | Adjusted mean difference (95% CI) | P value | F value | |||
Before first treatment | 35.6±7.8 | 31.7±6.8 | 106.48 | <0.01 | 3.90 (0.63, 6.18) | 0.06 | 3.33 |
After completion of third treatment | 17.1±4.6 | 16.7±5.7 | - | - | 0.38 (-2.62, 3.39) | 0.80 | 0.07 |
6 months after treatment | 16.6±4.5 | 30.5±6.7 | - | - | -13.92 (-17.23, -10.61) | <0.01 | 71.79 |
Table 4 COX following the start of the first intervention, observation group vs control group ($\bar{x}±s$)
Time | Mean±SD | Mean±SD | Observation group vs Control group (Time*Group) | Observation group vs Control group | |||
---|---|---|---|---|---|---|---|
FTime*Group | P value | Adjusted mean difference (95% CI) | P value | F value | |||
Before first treatment | 35.6±7.8 | 31.7±6.8 | 106.48 | <0.01 | 3.90 (0.63, 6.18) | 0.06 | 3.33 |
After completion of third treatment | 17.1±4.6 | 16.7±5.7 | - | - | 0.38 (-2.62, 3.39) | 0.80 | 0.07 |
6 months after treatment | 16.6±4.5 | 30.5±6.7 | - | - | -13.92 (-17.23, -10.61) | <0.01 | 71.79 |
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