Suboptimal reporting of randomized controlled trials on non-pharmacological therapies in Chinese medicine
Xuan Zhang1,2,3,4(), Han Li1, Hanzhi Tan1, Nana Wang1, Chung Wah Cheng1, Juan Wang1, Dongni Shi1, Lin Zhang5, Yumeng Liu4, Yao Wang4, Shufeng Luo4, Yaxin Lin4, Lihan Hu1, Xuanqi Zhang1, Ji Li6, Fei Han6, Ping Wang7, Aiping Lyu1,2,4, Zhaoxiang Bian1,2,3,4()
. Chinese EQUATOR Centre, Hong Kong Baptist University, Hong Kong 999077, China . Vincent V.C. Woo Chinese Medicine Clinical Research Institute, Hong Kong Baptist University, Hong Kong 999077, China . Centre for Chinese Herbal Medicine Drug Development, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong 999077, China . School of Chinese Medicine, Hong Kong Baptist University, Hong Kong 999077, China . Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China . Department of Pediatrics, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China . Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
With the successive release of the CONSORT extensions for acupuncture, moxibustion, cupping, and Tuina/massage, this review aims to assess the reporting characteristics and quality of randomized controlled trials (RCTs) based on these specific guidelines. A comprehensive review was conducted by searching multiple databases, including Embase, Ovid MEDLINE(R), All EBM Reviews, AMED, CNKI, VIP Chinese Medical Journal Database, and Wanfang Data, for publications from January 1 to December 31, 2022. Two reviewers independently evaluated the eligibility of the records, extracted predetermined information, and assessed the reporting based on the STRICTA, STRICTOM, STRICTOC, and STRICTOTM checklists. Among the included 387 studies (acupuncture, 213; Tuina/massage, 85; moxibustion, 73; cupping, 16), the overall reporting compliance averaged 56.0%, with acupuncture leading at 62.6%, followed by cupping (60.2%), moxibustion (53.1%), and Tuina/massage (47.9%). About half of the evaluated items showed poor reporting (compliance rate < 65%). Notably, international journals demonstrated significantly higher reporting quality than Chinese journals (P < 0.05). Although acupuncture trials had relatively higher compliance rates, deficiencies persist in reporting non-pharmacological therapies of Chinese medicine, particularly in areas like treatment environment details and provider background information.
Corresponding Author(s):
Xuan Zhang,Zhaoxiang Bian
Just Accepted Date: 02 July 2024Online First Date: 06 August 2024Issue Date: 29 October 2024
Cite this article:
Xuan Zhang,Han Li,Hanzhi Tan, et al. Suboptimal reporting of randomized controlled trials on non-pharmacological therapies in Chinese medicine[J]. Front. Med.,
2024, 18(5): 798-813.
Studies will be included if they are: ● Human studies without any limitation on age, geography, gender, and type of disease
Focus exclusively on: ● Non-human studies
Concept
Studies will be included if they are: ● RCTs of any one of four NPTCM (e.g., acupuncture, moxibustion, cupping, or Tuina/massage)
Focus exclusively on: ● Study interventions other than the four NPTCM (e.g., acupuncture, moxibustion, cupping, or Tuina/massage). OR ● Combined more than two studied interventions, or combined any other types of NPTCM interventions. OR ● Non-randomized or quasi-randomized controlled trials. OR ● Non-controlled trials. OR ● Observational studies. OR ● Case reports. OR ● Study protocols. OR ● Reviews
Context
Studies were included if they are: ● Published in English or Chinese. AND ● Published from 01/01/2022 to 31/12/2022
Focus exclusively on: ● Studies without abstracts or full text are not available. OR ● Repeat publications
Tab.1 Full inclusion and exclusion criteria
Fig.1
Fig.2
Fig.3
Fig.4
Fig.5 Overall flow chart of the search and selection process.
Geographical distribution
n (%)
China
368 (95.1)
South Korea
4 (1.0)
USA
3 (0.8)
Iran
2 (0.5)
Spain
2 (0.5)
Austria
1 (0.3)
Egypt
1 (0.3)
Germany
1 (0.3)
Indonesia
1 (0.3)
Lebanon
1 (0.3)
Malaysia
1 (0.3)
Pakistan
1 (0.3)
Poland
1 (0.3)
Turkey
1 (0.3)
Tab.2 Geographical distribution of the included studies (n = 387)
Information
Acupuncture n (%)
Moxibustionn (%)
Tuina/massagen (%)
Cuppingn (%)
Totaln (%)
Part 1 Information of included articles and journals
Language of publications
English
22 (5.7)
2 (0.5)
8 (2.1)
0
32 (8.3)
Chinese
191 (49.4)
71 (18.3)
77 (19.9)
16 (4.1)
355 (91.7)
Type of journalsa
English journal (SCIE), with impact factor > 3
8 (2.1)
0
3 (0.8)
0
11 (2.8)
Chinese core journal
25 (6.5)
3 (0.8)
1 (0.3)
1 (0.3)
30 (7.8)
Part 2 Participants
Type of disease/pattern(s) (top 3)b
Diseases of the musculoskeletal system or connective tissue
51 (13.2)
14 (3.6)
18 (4.7)
4 (1.0)
87 (22.5)
Diseases of the nervous system
59 (15.2)
7 (1.8)
6 (1.6)
3 (0.8)
75 (19.4)
Symptoms, signs or clinical findings, not elsewhere classified
35 (9)
7 (1.8)
17 (4.4)
2 (0.5)
61 (15.8)
Including CM pattern(s)
34 (8.8)
25 (6.5)
9 (2.3)
6 (1.6)
74 (19.1)
Type of CM pattern(s) (top 3)c
Pattern(s) of qi stagnation and blood stasis
6 (1.6)
1 (0.3)
2 (0.5)
2 (0.5)
11 (2.8)
Pattern(s) of liver and kidney depletion
4 (1.0)
0
1 (0.3)
0
5 (1.3)
Pattern(s) of qi deficiency with blood stasis
3 (0.8)
0
1 (0.3)
0
4 (1.0)
Age design of participants
< 18 years old
4 (1.0)
6 (1.6)
18 (4.7)
3 (0.8)
31 (8.0)
≥ 18 years old
209 (54.0)
67 (17.3)
66 (17.1)
12 (3.1)
354 (91.5)
Any age
0
0
1 (0.3)
1 (0.3)
2 (0.5)
Total sample size
≤ 50
19 (4.9)
9 (2.3)
9 (2.3)
1 (0.3)
38 (9.8)
51–100
147 (38)
53 (13.7)
52 (13.4)
12 (3.1)
264 (68.2)
101–200
38 (9.8)
10 (2.6)
19 (4.9)
3 (0.8)
70 (18.1)
> 200
9 (2.3)
1 (0.3)
5 (1.3)
0
15 (3.9)
Part 3 Study design
Study purpose
Efficacy
147 (38.0)
55 (14.2)
71 (18.3)
14 (3.6)
287 (74.2)
Both (efficacy and safety)
66 (17.1)
18 (4.7)
14 (3.6)
2 (0.5)
100 (25.9)
Number of assigned groups
2
193 (49.9)
70 (18.1)
78 (20.2)
15 (3.9)
356 (92.0)
3
18 (4.7)
3 (0.8)
5 (1.3)
1 (0.3)
27 (7.0)
4
2 (0.5)
0
2 (0.5)
0
4 (1.0)
Trial participating center
Single center
198 (51.2)
68 (17.6)
82 (21.2)
14 (3.6)
362 (93.5)
Multicenter
15 (3.9)
5 (1.3)
3 (0.8)
2 (0.5)
25 (6.5)
Type of randomizationd
Simple randomization
201 (51.9)
72 (18.6)
79 (20.4)
16 (4.1)
368 (95.1)
Others
12 (3.1)
1 (0.3)
6 (1.6)
0
19 (5.0)
Type of blinding
Open label
3 (0.8)
0
0
0
3 (0.8)
Blinding
38 (9.8)
7 (1.8)
4 (1.0)
1 (0.3)
50 (12.9)
Not reported
172 (44.4)
66 (17.1)
81 (20.9)
15 (3.9)
334 (86.3)
Part 4 Interventions
Types and duration
Single intervention
120 (31)
34 (8.8)
32 (8.3)
7 (1.8)
193 (49.9)
Complex interventions
93 (24)
39 (10.1)
53 (13.7)
9 (2.3)
194 (50.1)
Treatment duration (week, mean)
4.9
4.1
5.2
3.1
4.8
Part 5 Comparisons
Type of controlse
Including placebo control
20 (5.2)
1 (0.3)
2 (0.5)
0
23 (5.9)
Part 6 Outcomes
Including CM pattern-related outcome(s)
16 (4.1)
6 (1.6)
6 (1.6)
4 (1.0)
32 (8.3)
Part 7 Funding, registration, and protocol
Including funding supports
147 (38.0)
42 (10.9)
40 (10.3)
8 (2.1)
237 (61.2)
Including registration
22 (5.7)
5 (1.3)
8 (2.1)
1 (0.3)
36 (9.3)
Including protocol
17 (4.4)
2 (0.5)
6 (1.6)
0
25 (6.5)
Tab.3 Information of the included studies (n = 387)
Classification
Acupuncture n (%)
Moxibustionn (%)
Tuina/massagen (%)
Cuppingn (%)
Totaln (%)
Including adverse events (AEs) assessment in the studya
Tab.4 Adverse events identified in the included studies (n = 387)
Fig.6 Level of reporting compliance of the included studies.
Fig.7 Reporting percentage of different sections of the reporting checklists.
Fig.8 Reporting quality assessment of acupuncture RCTs.
Fig.9 Reporting quality assessment of moxibustion RCTs.
Fig.10 Reporting quality assessment of Tuina/massage RCTs.
Fig.11 Reporting quality assessment of cupping RCTs.
Fig.12 Subgroup analysis.
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