Journal of Traditional Chinese Medicine ›› 2022, Vol. 42 ›› Issue (2): 242-249.DOI: 10.19852/j.cnki.jtcm.20211214.003
• Research Articles • Previous Articles Next Articles
Ginger-indirect moxibustion plus acupuncture versus acupuncture alone for chronic fatigue syndrome: a randomized controlled trial
MA Tingting1, WU Jie1(
), YANG Lijie1, FENG Fen1, YANG Huilin2, ZHANG Jinhua2, ZHONG Yanjin2, NING Qing2, HUANG Lirong2, LIN Youbing2, YAN Jue3, CHEN Guiquan3, HOU Tianshu4, WANG Li4, REN Yuanfang2, TAN Jing5
- 1 Center of Preventive Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China
2 College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China
3 Department of acupuncture, Center of Preventive Medicine, Affiliated TCM Hospital of Southwest Medical University, Luzhou 646600, China
4 Center of Preventive Medicine, Chengdu Integrated TCM and Western Medicine Hospital, Chengdu 610021, China
5 Center of Chinese Evidence-Based Medicine, Sichuan University West China Hospital, Chengdu 610041, China
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Received:2021-05-16Accepted:2021-08-22Online:2021-12-14Published:2021-12-14 -
Contact:WU Jie -
About author:WU Jie, Center of Preventive Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China. drwujie@163.com, Telephone: +86-028-87783128
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Supported by:Science and Technology Support Program of Sichuan Province Science and Technology Agency: Clinical Researches of Acupuncture for “Unhealthy Status” Based on the TCM Theory of “All Diseases Originate from Qi’s Problem”(2014SZ0152)
Cite this article
MA Tingting, WU Jie, YANG Lijie, FENG Fen, YANG Huilin, ZHANG Jinhua, ZHONG Yanjin, NING Qing, HUANG Lirong, LIN Youbing, YAN Jue, CHEN Guiquan, HOU Tianshu, WANG Li, REN Yuanfang, TAN Jing. Ginger-indirect moxibustion plus acupuncture versus acupuncture alone for chronic fatigue syndrome: a randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2022, 42(2): 242-249.
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Figure 1 Ginger-indirect moxibustion group A: ginger-indirect moxibustion manipulation; B: moxibustion box.
Figure 1 Ginger-indirect moxibustion group A: ginger-indirect moxibustion manipulation; B: moxibustion box.
Figure 2 Study flow ITT: intent-to-treat; PP: per-protocol.
Figure 2 Study flow ITT: intent-to-treat; PP: per-protocol.
Table 1 Characteristics of patients at baseline
| Item | Group A (n=138) | Group B (n=138) | |
|---|---|---|---|
| Age (years) [median (QL-QU)] | 27.5 (24.5-41.4) | 27.3 (24.5-38.2) | |
| 18-29.99 | 78 (56.52) | 82 (59.42) | |
| 30-39.99 | 22 (15.94) | 25 (18.12) | |
| 40-55.49 | 38 (27.54) | 31 (22.46) | |
| Female [n (%)] | 109 (78.99) | 113 (81.88) | |
| BMI (kg/m2) [mean (SD)] | 21.44 (2.55) | 21.20 (2.54) | |
| Duration of disease (month) [Median (QL-QU)] | 18 (10-30) | 18 (12-30) | |
| Expectant degree for effect [n (%)] | Low | 27 (19.57) | 20 (14.49) |
| Moderate | 68 (49.28) | 77 (55.80) | |
| High | 43 (31.16) | 41 (29.71) | |
| FSS at baseline [mean (SD)] | 39.69 (9.17) | 39.45 (9.13) | |
| SPHERE at baseline [mean (SD)] | 17.54 (4.79) | 17.46 (5.21) | |
| SDS at baseline [mean (SD)] | 48.21 (10.39) | 50.17 (10.99) | |
| HAMA at baseline [mean (SD)] | 12.86 (6.36) | 13.67 (8.22) |
Table 1 Characteristics of patients at baseline
| Item | Group A (n=138) | Group B (n=138) | |
|---|---|---|---|
| Age (years) [median (QL-QU)] | 27.5 (24.5-41.4) | 27.3 (24.5-38.2) | |
| 18-29.99 | 78 (56.52) | 82 (59.42) | |
| 30-39.99 | 22 (15.94) | 25 (18.12) | |
| 40-55.49 | 38 (27.54) | 31 (22.46) | |
| Female [n (%)] | 109 (78.99) | 113 (81.88) | |
| BMI (kg/m2) [mean (SD)] | 21.44 (2.55) | 21.20 (2.54) | |
| Duration of disease (month) [Median (QL-QU)] | 18 (10-30) | 18 (12-30) | |
| Expectant degree for effect [n (%)] | Low | 27 (19.57) | 20 (14.49) |
| Moderate | 68 (49.28) | 77 (55.80) | |
| High | 43 (31.16) | 41 (29.71) | |
| FSS at baseline [mean (SD)] | 39.69 (9.17) | 39.45 (9.13) | |
| SPHERE at baseline [mean (SD)] | 17.54 (4.79) | 17.46 (5.21) | |
| SDS at baseline [mean (SD)] | 48.21 (10.39) | 50.17 (10.99) | |
| HAMA at baseline [mean (SD)] | 12.86 (6.36) | 13.67 (8.22) |
Figure 3 Outcome change during treatment and follow-up Data were shown by mean and 95% confidence interval of difference from baseline, by setting the starting point as the absolute value of specific outcome at baseline. A: Fatigue Severity Scale (FSS) score at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. Group A demonstrated superiority after 4 weeks treatment, and its superiority sustained until week 20; B: Somatic and Psychological Health Report (SPHERE) at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. Group A demonstrated superiority after 2 weeks treatment, and its superiority sustained until week 20; C: Self-rating Depression Scale (SDS) at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. There was no statistical difference between A and B groups; D: Hamilton Anxiety (HAMA) scale at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. There was no statistical difference between A and B groups).
Figure 3 Outcome change during treatment and follow-up Data were shown by mean and 95% confidence interval of difference from baseline, by setting the starting point as the absolute value of specific outcome at baseline. A: Fatigue Severity Scale (FSS) score at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. Group A demonstrated superiority after 4 weeks treatment, and its superiority sustained until week 20; B: Somatic and Psychological Health Report (SPHERE) at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. Group A demonstrated superiority after 2 weeks treatment, and its superiority sustained until week 20; C: Self-rating Depression Scale (SDS) at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. There was no statistical difference between A and B groups; D: Hamilton Anxiety (HAMA) scale at baseline and changes after 2, 4, 6 and 8 weeks' treatment and during the follow-up period in A and B groups. There was no statistical difference between A and B groups).
Table 2 Outcome difference between groups A and B across various times
| Time | FSS | SPHERE | SDS | HAMA | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Group A (n =138) | Group B (n = 138) | MD (95% CI) | Group A (n = 138) | Group B (n = 138) | MD (95% CI) | Group A (n = 138) | Group B (n = 138) | MD (95% CI) | Group A (n = 138) | Group B (n = 138) | MD (95%CI) | ||||||||
| Week 2 | 7.47 (6.88) | 6.06 (6.62) | 1.41 (–0.18, 3.01) | 3.70 (3.90) | 2.27 (3.52) | 1.43 (0.56, 2.31) | 2.99 (7.57) | 2.01 (6.82) | 0.97 (–0.73, 2.67) | 1.96 (3.81) | 1.57 (3.54) | 0.38 (﹣0.48, 1.25) | |||||||
| Week 4 | 11.94 (8.42) | 9.12 (7.52) | 2.82 (0.94, 4.70) | 6.30 (4.37) | 4.89 (4.48) | 1.41 (0.36, 2.45) | 4.95 (9.13) | 4.69 (7.78) | 0.26 (–1.74, 2.26) | 3.28 (4.11) | 3.29 (4.72) | –0.01 (–1.06, 1.03) | |||||||
| Week 6 | 15.44 (9.61) | 11.76 (8.30) | 3.68 (1.56, 5.80) | 8.28 (5.09) | 6.41 (4.91) | 1.87 (0.69, 3.05) | 7.81 (9.77) | 6.74 (8.80) | 1.07 (–1.12, 3.27) | 5.05 (4.61) | 4.72 (5.29) | 0.33 (–0.85, 1.50) | |||||||
| Week 8 (Treat end) | 20.22 (10.46) | 14.03 (8.99) | 6.20 (3.89, 8.50) | 10.67 (5.36) | 7.89 (5.03) | 2.78 (1.56, 4.01) | 10.90 (9.68) | 8.83 (9.17) | 2.07 (–0.15, 4.30) | 6.76 (5.22) | 5.49 (5.84) | 1.27 (–0.04, 2.58) | |||||||
| Week 12 (Follow–up) | 20.10 (10.31) | 13.25 (8.85) | 6.86 (4.59, 9.12) | 10.83 (5.35) | 7.36 (5.31) | 3.48 (2.22, 4.74) | 11.14 (9.39) | 9.22 (9.29) | 1.92 (–0.28, 4.12) | 6.83 (5.46) | 5.52 (6.50) | 1.31 (–0.10, 2.73) | |||||||
| Week 20 (Follow–up) | 19.56 (10.64) | 13.68 (9.48) | 5.88 (3.50, 8.25) | 10.83 (5.26) | 7.37 (5.43) | 3.46 (2.20, 4.72) | 10.86 (9.75) | 9.59 (9.12) | 1.27 (–0.96, 3.49) | 6.86 (5.64) | 5.76 (6.76) | 1.09 (–0.37, 2.56) | |||||||
Table 2 Outcome difference between groups A and B across various times
| Time | FSS | SPHERE | SDS | HAMA | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Group A (n =138) | Group B (n = 138) | MD (95% CI) | Group A (n = 138) | Group B (n = 138) | MD (95% CI) | Group A (n = 138) | Group B (n = 138) | MD (95% CI) | Group A (n = 138) | Group B (n = 138) | MD (95%CI) | ||||||||
| Week 2 | 7.47 (6.88) | 6.06 (6.62) | 1.41 (–0.18, 3.01) | 3.70 (3.90) | 2.27 (3.52) | 1.43 (0.56, 2.31) | 2.99 (7.57) | 2.01 (6.82) | 0.97 (–0.73, 2.67) | 1.96 (3.81) | 1.57 (3.54) | 0.38 (﹣0.48, 1.25) | |||||||
| Week 4 | 11.94 (8.42) | 9.12 (7.52) | 2.82 (0.94, 4.70) | 6.30 (4.37) | 4.89 (4.48) | 1.41 (0.36, 2.45) | 4.95 (9.13) | 4.69 (7.78) | 0.26 (–1.74, 2.26) | 3.28 (4.11) | 3.29 (4.72) | –0.01 (–1.06, 1.03) | |||||||
| Week 6 | 15.44 (9.61) | 11.76 (8.30) | 3.68 (1.56, 5.80) | 8.28 (5.09) | 6.41 (4.91) | 1.87 (0.69, 3.05) | 7.81 (9.77) | 6.74 (8.80) | 1.07 (–1.12, 3.27) | 5.05 (4.61) | 4.72 (5.29) | 0.33 (–0.85, 1.50) | |||||||
| Week 8 (Treat end) | 20.22 (10.46) | 14.03 (8.99) | 6.20 (3.89, 8.50) | 10.67 (5.36) | 7.89 (5.03) | 2.78 (1.56, 4.01) | 10.90 (9.68) | 8.83 (9.17) | 2.07 (–0.15, 4.30) | 6.76 (5.22) | 5.49 (5.84) | 1.27 (–0.04, 2.58) | |||||||
| Week 12 (Follow–up) | 20.10 (10.31) | 13.25 (8.85) | 6.86 (4.59, 9.12) | 10.83 (5.35) | 7.36 (5.31) | 3.48 (2.22, 4.74) | 11.14 (9.39) | 9.22 (9.29) | 1.92 (–0.28, 4.12) | 6.83 (5.46) | 5.52 (6.50) | 1.31 (–0.10, 2.73) | |||||||
| Week 20 (Follow–up) | 19.56 (10.64) | 13.68 (9.48) | 5.88 (3.50, 8.25) | 10.83 (5.26) | 7.37 (5.43) | 3.46 (2.20, 4.72) | 10.86 (9.75) | 9.59 (9.12) | 1.27 (–0.96, 3.49) | 6.86 (5.64) | 5.76 (6.76) | 1.09 (–0.37, 2.56) | |||||||
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