Effectiveness and safety of adjunctive non-drug measures in improving respiratory symptoms among patients with severe COVID-19: A multicenter randomized controlled trial.
10.1016/j.joim.2024.09.002
- Author:
Xuan YIN
1
;
Zhu JIN
2
;
Feng LI
3
;
Li HUANG
2
;
Yan-Mei HU
4
;
Bo-Chang ZHU
1
;
Zu-Qing WANG
1
;
Xi-Ying LI
1
;
Jian-Ping LI
4
;
Lixing LAO
5
;
Yi-Qun MI
6
,
7
;
Shi-Fen XU
7
,
8
Author Information
1. Acupuncture and Moxibustion Department, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.
2. Medical Department, Shanghai Seventh People's Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200137, China.
3. Acupuncture and Moxibustion Department, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China; Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai 200030, China.
4. Shanghai Xuhui District Central Hospital, Shanghai 200031, China.
5. Virginia University of Integrative Medicine, Fairfax, VA 22031, USA.
6. Acupuncture and Moxibustion Department, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China. Electronic address: miyiqun@
7. com.
8. Acupuncture and Moxibustion Department, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China. Electronic address: xu_teacher2006@
- Publication Type:Research Support, Non-U.S. Gov't
- Keywords:
COVID-19;
Non-drug measures;
Oxygen saturation;
Prone positioning;
Traditional Chinese medicine
- MeSH:
Adult;
Aged;
Female;
Humans;
Male;
Middle Aged;
Acupuncture Therapy/methods*;
China;
COVID-19/complications*;
Medicine, Chinese Traditional/methods*;
Moxibustion/methods*;
Oxygen Saturation;
Prone Position;
Respiration, Artificial;
Treatment Outcome
- From:
Journal of Integrative Medicine
2024;22(6):637-644
- CountryChina
- Language:English
-
Abstract:
BACKGROUND:The outbreak of coronavirus disease 2019 (COVID-19) infection posed a huge threat and burden to public healthcare in late 2022. Non-drug measures of traditional Chinese medicine (TCM), such as acupuncture, cupping and moxibustion, are commonly used as adjuncts in China to help in severe cases, but their effects remain unclear.
OBJECTIVES:To observe the clinical effect of TCM non-drug measures in improving respiratory function and symptoms among patients with severe COVID-19.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS:This study was designed as a multicenter, assessor-blind, randomized controlled trial. Hospitalized patients with COVID-19 were randomly assigned to the treatment or control group. The treatment group received individualized TCM non-drug measures in combination with prone position ventilation, while the control group received prone position ventilation only for 5 consecutive days.
MAIN OUTCOME MEASURES:The primary outcome measures were the percentage of patients with improved oxygen saturation (SpO2) at the end of the 5-day intervention, as well as changes of patients' respiratory rates. The secondary outcome measures included changes in SpO2 and total score on the self-made respiratory symptom scale. The improvement rate, defined as a 3-day consecutive increase in SpO2, the duration of prone positioning, and adverse events were recorded as well.
RESULTS:Among the 198 patients included in the intention-to-treat analysis, 159 (80.3%) completed all assessments on day 5, and 39 (19.7%) patients withdrew from the study. At the end of the intervention, 71 (91%) patients in the treatment group had SpO2 above 93%, while 61 (75.3%) in the control group reached this level. The proportion of participant with improved SpO2 was significantly greater in the intervention group (mean difference [MD] = 15.7; 95% confidence interval [CI]: 4.4, 27.1; P = 0.008). Compared to the baseline, with daily treatment there were significant daily decreases in respiratory rates in both groups, but no statistical differences between groups were found (all P ≥ 0.05). Compared to the control group, the respiratory-related symptoms score was lower among patients in the treatment group (MD = -1.7; 95% CI: -2.8, -0.5; P = 0.008) after day 3 of treatment. A gradual decrease in the total scores of both groups was also observed. Thirty-one adverse events occurred during the intervention, and 2 patients were transferred to the intensive care unit due to deterioration of their illness.
CONCLUSION:TCM non-drug measures combined with prone positioning can effectively treat patients with severe COVID-19. The combined therapy significantly increased SpO2 and improved symptom scores compared to prone positioning alone, thus improving the patients' respiratory function to help them recover. However, the improvement rate did not differ between the two groups.
TRIAL REGISTRATION:Chinese Clinical Trial Registry (ChiCTR2300068319). Please cite this article as: Yin X, Jin Z, Li F, Huang L, Hu YM, Zhu BC, Wang ZQ, Li XY, Li JP, Lao LX, Mi YQ, Xu SF. Effectiveness and safety of adjunctive non-drug measures in improving respiratory symptoms among patients with severe COVID-19: A multicenter randomized controlled trial. J Integr Med. 2024; 22(6): 637-644.
