key: cord-0819559-a2c58zmu
authors: Hu, Haiyin; Ji, Zhaochen; Feng, Chaonan; Pang, Wentai; Chen, Zhe; Zhang, Junhua; Wang, Hui
title: PROSPERO's Systematic Review Protocols of Traditional Chinese Medicine for COVID-19: An Overview
date: 2021-09-08
journal: Integr Med Res
DOI: 10.1016/j.imr.2021.100774
sha: c6e3928338eaf5ed68318c03a39ffd19091c1cdd
doc_id: 819559
cord_uid: a2c58zmu

BACKGROUND: At present, many protocols for Systematic Reviews (SR) of Traditional Chinese Medicine (TCM) for coronavirus disease 2019 (COVID-19) have been registered in the International Prospective Register of Systematic Reviews (PROSPERO). This study aimed to analyze the innovativeness and rigorousness of the SR protocols and make recommendations for the design and implementation of future SRs on TCM for COVID-19. This effort is likely to enhance the value of the produced information and prevent the futility of the research. METHODS: PROSPERO was searched comprehensively for identifying SRs of TCM for COVID-19 from the inception of the database to August 2020. Two researchers independently screened the literature, extracted the data, and cross-checked the retrieved information for consistency. The following details were recorded: database, registration time, organizations, types of research included, participants, interventions, and outcome indicators. All extracted data were analyzed by an overview. The “P - participants, I - interventions, C - controls, and O - outcomes (PICO)” included in the protocols were compared for similarity. The outcomes of the included SR protocols were compared with the newly published Core Outcome Sets (COSs). RESULTS: Eighty protocols of SR related to TCM for COVID-19 were obtained after a primary search; finally, 71 protocols were included. The majority of the protocols were from China. Thirty-two organizations participated in the protocol registrations, including 11 hospitals and 21 universities/colleges. However, some protocols were not innovative or rigorous enough. Such as, the PICO of some protocols were similar. The searched literature was incomprehensive, and PICO was not specific and correct. In addition, outcome indicators—arterial oxygen partial pressure, a fraction of inspired oxygen, respiratory failure, and WHO Clinical Progression Scale—in the newly published COSs were infrequently used and often neglected. CONCLUSIONS: Registering and implementing an innovative and rigorous SR ensures the usefulness of the produced information and avoids the duplication of research and the wastage of resources. It is important to focus on and solve the methodological problems, such as non-specific PICO, incomprehensive literature retrieval, COS application, and incorrect indicator name, in future SR protocols.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 1 a highly pathogenic and infectious virus, initially appeared in Wuhan. 2, 3 The coronavirus disease 2019 (COVID- 19) pandemic caused by SARS-CoV-2 started in China and resulted in a large-scale outbreak in many parts of the world. 4 The global impact of the disease has been much higher than could have been foreseen. 2 Until 13 th June 2021, COVID-19 has caused 3,792,777 deaths all over the world (https://covid19.who.int/). As an emerging disease, the diagnosis, treatment, and prognosis of COVID-19 are unclear. 4 To quickly control the spread of the epidemic and restore normalcy, researchers from all over the world have indulged in studies on COVID-19. Traditional Chinese Medicine (TCM) has played a key role in the treatment of COVID-19 in China. Extensive studies have been carried out to evaluate the effectiveness of TCM for COVID-19. 5 However, further scientific basis is required for preventing the infection, improving the curative effect, controlling the spread of the epidemic, and reducing the mortality rate. 4 High-quality evidence generated by appropriately powered and controlled trials is essential. 6 Systematic reviews (SRs) can provide objective and reliable evidence by systematically analyzing the results of trials, which is useful for informing clinical practice. 7 Publishing an SR protocol with a robust methodological design before the conduct of the SR is the first step 8, 9 that can guard against selective reporting and arbitrary decision making, facilitate transparency, and ensure reproducibility and usability of the SRs. 10, 11 Publishing a protocol for SRs can be done in two ways: except for publishing a peer-reviewed protocol in a specific collection of reviews produced by the Cochrane Collaboration, 12 an author can register SRs free of charge in PROSPERO, an international prospective register of SRs with health outcomes, which is freely accessible online (www.crd.york.ac.uk/PROSPERO) . 8, 13 The PROSPERO register accepts any SR with a health-related outcome, and the new protocols for Cochrane have been added to it since November 2013. 10 Research has shown that as of October 10, 2017, 26,535 SRs were registered in PROSPERO and that the monthly submission rates were up to 800. 10, 14, 15 Since the outbreak of the epidemic, the prodigious rise in COVID-19 research has caught our attention. 2, 16, 17 An overwhelming number of SRs of TCM for COVID-19 have been registered in PROSPERO. However, whether these registrations are innovative and the protocol designs are rigorous is yet to be determined.

The present study analyzed the protocols of SRs on TCM for COVID-19 registered in PROSPERO to assess their innovativeness as well as rigorousness and make recommendations for the design and implementation of future SRs, thereby enhancing the value of the research information obtained and avoiding wastage. 18 

(1) SR protocols on TCM for COVID-19 (referred to as -protocol‖) were included.

(2)All types of interventions in TCM were included. TCM is the traditional medicine that originated in China and is characterized by holism and treatment based on pattern identification/syndrome differentiation, which includes Chinese herbal medicine, Chinese patent medicine, acupuncture, moxibustion, and traditional Chinese exercises. 19, 20 (3)All control measures and outcome indicators were eligible for inclusion in this overview.

(4) There was no language restriction.

(1) Non-SR protocols were excluded.

(2) All non-COVID-19 SR protocols, as well as protocols for COVID-19 combined with other diseases, were excluded.

(3) SR protocols focusing on non-Chinese Medicine therapy were excluded.

PROSPERO was searched for SR protocols on TCM for COVID-19 from the date of inception to August 2020. All SRs in the Chinese medicine category of the PROSPERO COVID-19 filter were retrieved.

Two researchers independently conducted literature screening according to the established inclusion and exclusion criteria. Literature that did not meet the inclusion criteria was excluded. Two researchers extracted the data and cross-checked for consistency; disagreements were resolved by discussion with a third researcher. The following details were recorded: registration ID, title, database, types of the study included, participants, interventions, outcomes, organizations, funding, and time of registration.

All extracted data were analyzed by an overview. The -P -participants, I -interventions, Ccontrols, and O -outcomes‖ included in the protocols were compared for similarity. -P‖ was sorted by similarity using Excel to distinguish between the different protocols. According to the above method, -I,‖ -C,‖ and -O‖ in the protocols were compared. Protocols that met the following conditions simultaneously were considered to be similar: 1) identical participants; 2) identical interventions or at least one of the interventions is the same; 3) identical controls or at least one of the controls is the same; 4) identical outcomes or at least one of the outcomes is the same.

The outcomes of the included protocols were compared with the newly published Core Outcome Sets (COSs). Since the outbreak of COVID-19, three COVID-19 COSs have been released.

The first COS-Core Outcome Set for Clinical Trials on Coronavirus Disease 2019(COS-COVID) 21 -was published by the Chinese Clinical Trials Core Outcome Set Research Center on March 18, 2020. The COS can use for mild, ordinary, severe, critical, and rehabilitation period patient assessment, and consists of eight outcomes, namely, time to 2019-nCoV reverse transcription-polymerase chain reaction (RT-PCR) negativity, length of hospital stay, composite events, the score of clinical symptoms, arterial oxygen partial pressure (PaO 2 )/fraction of inspired oxygen (FiO 2 ), duration of mechanical ventilation, all-cause mortality, pulmonary function.

The Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint program, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium developed a Minimal Common Outcome Measure Set for COVID-19 Clinical Research. 22 This set was published on June 14, 2020, and includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or 60 days), and a measure of patient progression through the healthcare system by use of the WHO Clinical Progression Scale.

Core Outcomes Set for Trials in People with COVID-19 23 was published by the University of Sydney on August 14, 2020, which informed the researchers that mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are the critically important outcomes to be consistently reported in COVID-19 trials.

Eighty protocols of SRs related to TCM for COVID-19 were obtained after a primary search. Nine protocols were excluded after full-text reading, including five protocols 24-28 for non-COVID-19, two protocols 29,30 for COVID-19 combined with other diseases, one protocol 31 for COVID-19 guidelines, and one protocol 32 for nature therapy. Finally, 71 protocols 33-103 were eligible for inclusion in this paper. Information pertaining to the included protocols is shown in Supplement 1 and Supplement 2.

Among these protocols, 66 were from China, 1 from Australia, 95 1 from Singapore, 98 51, 62 These protocols were related to the effectiveness or safety of TCM for COVID-19 ( Figure 2 ).

Seventy protocols reported searching Chinese databases, of which 45 stated that four databases, [33] [34] [35] [36] [37] [38] 41, 43, 44, 47, 48, 51, [53] [54] [55] [57] [58] [59] [62] [63] [64] [69] [70] [71] [72] [73] 75, 80, 82, 83, 85, 86, [89] [90] [91] [92] [93] [94] 96, 97, [99] [100] [101] [102] [103] namely, CNKI, CBM, VIP, and Wanfang, were searched. The CNKI was the most frequently searched database. All protocols documented that English databases were searched, and one of them 76 retrieved six English databases. Ten protocols 33, 44, 51, 53, 61, 62, 82, 89, 90, 94 

Randomized controlled trial (RCT) was the most included type, followed by observational studies and controlled trials. Two protocols 35, 95 merely reported including all trials but did not describe the specific type of trials. Two protocols 100,101 did not state the types of studies included.

Among the 71 protocols, the inclusion criteria for participants were not rigorous in 4 protocols. 35 39, 53, 74, 83, 89, 91, 98 were most widely used in oral Chinese patent medicine, followed by Shufeng-Jiedu capsules/granules (n = 4), 45, 46, 74, 100 Tanreqing capsule (n = 1), 83 Xuanfei-Baidu granule (n =1), 39 and Huoxiang-Zhengqi capsules/granules (n = 1). 74 Xuebijing (n = 8) 39, 40, 73, 80, 83, 93, 98, 101 was the most widely used injection, followed by Xiyanping (n = 2), 83, 93 Tanreqing (n = 1), 93 Reduning (n = 1), 93 Xingnaojing (n = 1), 93 Shenfu (n = 1), 93 Shengmai (n = 1), 93 and Shenmai injection (n = 1). 93 Qingfei-Paidu decoction (n = 5) 39,53,69,92,98 was most widely used, followed by Maxing-Shigan decoction (n = 2), 37, 53 Huashi-Baidu decoction (n = 2), 39, 98 Yupingfeng powder (n = 1), 53 Xuanfei-Baidu decoction (n = 1), 98 and Pingwei powder (n = 1). 37 

Seventy-one protocols reported the outcome indicators. The maximum number of outcome indicators reported was 15, while the minimum number was 1. Totally, 76 kinds of outcome indicators were present, and 3 of them were reported for more than 35 times, namely, adverse event (n = 42), 33 Figure 4B ).

Five outcomes of COS for Trials in People with COVID-19 23 are shown in Figure 4C . Forty protocols 33, 34, 37, 38, 42, [44] [45] [46] [49] [50] [51] [52] [53] 56, 57, [60] [61] [62] [63] 66, 68, 69, 71, [76] [77] [78] [79] [81] [82] [83] [84] 88, [91] [92] [93] [94] [95] 98, 101, 102 used at least one outcome of COS, of which mortality was most frequently employed (n = 36). 33, 34, 37, 38, 42, 44, 46, [49] [50] [51] [52] [53] 57, [60] [61] [62] [63] 66, 68, 69, 71, [77] [78] [79] [81] [82] [83] [84] 88, [91] [92] [93] [94] [95] 101, 102 A few protocols used respiratory failure, multiorgan failure, shortness of breath, and recovery as the outcome indicators ( Figure 4C ). Fig. 4 . The usage frequency of core outcomes] 4 

After analyzing the protocols of SRs on TCM for COVID-19 registered in PROSPERO, we found that more than half were similar and were aimed at similar problems. Furthermore, their participants, interventions, control, and outcomes (PICO) were comparable and hence not innovative.

Protocol registration is the first and most critical step in the process of SR. The purpose of registration is to ensure transparency, reproducibility, and usability of the protocols, and the quality of the SRs. Therefore, the design of the protocols must be rigorous.

SRs are characterized by a systematic and replicable methodology and presentation, which involve a comprehensive search and a systematic integration of the search results. 104 Several clinical studies pertaining to TCM for COVID-19 have been published in Chinese journals and have been listed in Chinese databases. Therefore, Chinese databases are as important as English databases. Twenty-six protocols 39, 40, 42, 45, 46, 49, 50, 52, 56, 60, 61, [65] [66] [67] [68] 74, [76] [77] [78] [79] 81, 84, 87, 88, 95, 98 did not perform a comprehensive search on Chinese databases, which may lead to a lack of evidence, low confidence of the SR conclusions, selection bias, and language constraints. Besides, 30 protocols [33] [34] [35] [36] [37] [38] [39] [40] [51] [52] [53] 56, 59, [61] [62] [63] [64] 70, 74, 76, 83, 85, 86, [88] [89] [90] 93, 94, 98, 103 additionally searched clinical trial protocol platforms, which are the key sources of SRs and warrant attention.

SR is a synthesis of all the relevant studies on a specific clinical topic. 105 The homogeneity of the included studies is critical to the reliability of the evidence synthesis results. SRs of RCTs are located on the top of the evidence pyramid. 106 Most protocols reported the specific type of studies included, and RCT was the most common one. However, two protocols 35, 95 only reported that all trials were included and did not describe the specific type of trials, and two 100,101 more did not report the included studies.

PICO, a method to approach clinical problems according to evidence-based medicine, 107 needs to be strictly defined for accurate clinical questions and meaningful SRs. However, only 18 protocols 40, 41, 43, 47, 48, 55, 60, 63, 64, 75, 79, 81, 90, 91, 94, 95, 102, 103 identified the specific type of participants, such as disease severity, patient age, symptoms, and population. In addition, four protocols 35, 39, 45, 49 were not rigorous in the criteria for the included participants. Differences in the diagnostic criteria of the participants mean that the comparability of the subjects is low, which reduces the credibility of the comprehensive results.

TCM was the most widely used intervention in the protocols, but only 28 protocols [35] [36] [37] [39] [40] [41] 43, 45, 46, 53, 69, [72] [73] [74] 80, 81, 83, 84, 86, 89, [91] [92] [93] [96] [97] [98] 100, 101 reported the specific medicine. Some protocols only reported the name of the Chinese medicine and did not provide information on dosage form, dosage frequency, course of treatment, and follow-up time, which may prejudice the evidence evaluation and decision-making of the SR.

A total of 76 kinds of outcome indicators were reported in the included protocols. Among the three outcome indicators reported most frequently (>35 times), only one, i.e., mortality, was recommended by the COSs. The outcome of the protocol is the key point for evaluating the effect of the intervention. COS is an agreed-upon standard set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or healthcare. 108 COS can not only improve the practicability of the results but also reduce the inhomogeneity and the risk of selective reporting of the outcomes in clinical trials and enhance the value of the research results. 109 Therefore, the use of COS in SRs/meta-analysis of evidence evaluation and decision-making is advocated. 21 At present, three COSs 21-23 for COVID-19 have been published. 21 was published on March 18, 2020. Since then, 70 protocols have been registered, of which 57 used these core outcome indicators. [33] [34] [35] [36] [37] [38] [39] 41, 42, [44] [45] [46] [49] [50] [51] [52] [53] [54] [55] [56] [57] [60] [61] [62] [63] [64] [66] [67] [68] [69] [70] [71] [72] [73] [74] [75] [76] [77] [78] [79] [81] [82] [83] [84] [85] [86] 88, [91] [92] [93] [94] [95] [98] [99] [100] [101] [102] A Minimal Common Outcome Measure Set for COVID-19 Clinical Research 22 was published on June 14, 2020. The included protocols that were registered before its publication were 66, [33] [34] [35] [36] [37] [38] [39] [40] [41] of which 44 used these core outcome indicators; 33,34,37,38,49-63,66,68,69,71-75,77-79,81-85,88,91-95,101-103 5 protocols 42-46 were registered after its publication, all of which used the indicators. COS for Trials in People with COVID-19 23 was published on August 14, 2020. Prior to its publication, 71 included protocols were registered, of which 40 used these core outcome indicators. 33, 34, 37, 38, 42, [44] [45] [46] [49] [50] [51] [52] [53] 56, 57, [60] [61] [62] [63] 66, 68, 69, 71, [76] [77] [78] [79] [81] [82] [83] [84] 88, [91] [92] [93] [94] [95] 98, 101, 102 However, 10 protocols did not use any of the outcome indicators among the three COSs. 40, 47, 48, 65, 80, 87, 89, 90, 96, 97 Failing to use the COS might mean that the results of the studies could not be combined, thereby hampering the research value. [109] [110] [111] COS application must be given due importance, especially arterial oxygen partial pressure, the fraction of inspired oxygen, respiratory failure, and the WHO Clinical Progression Scale.

Furthermore, the information provided in the study protocols tends to be incomplete. Some protocols did not report the indicator names correctly or used inspection methods as the indicator name. When the information pertaining to the studies is inaccessible, the investment is wasted, bias is introduced, and the care of the patients is affected. 112 COVID-19 is now the focus of research all over the world. Since the outbreak of the epidemic, the prodigious rise in COVID-19 research has caught the attention of the global community. 2, 16, 17 Until August 2020, 148 COVID-19 clinical studies on TCM have been registered in the China Clinical Trial Registration Center (http://www.chictr.org.cn/) and ClinicalTrials.gov (http://www.clinicaltrials.gov) (Supplement 3). At the same time, up to 71 SR protocols on TCM for COVID-19 have been registered in PROSPERO; an average of 2.08 clinical studies produces 1 SR. It was found that the growth rate of TCM clinical studies did not catch up with that of the SRs. The TCM SRs for COVID-19 may be over-registered. Researchers should focus on trying to solve the contentious issues associated with COVID-19, including vaccines, public health, mental health, and economics, 2 instead of chasing hotspots, repeating studies, and wasting precious resources. 113 For example, two clinical trials on remdesivir have been terminated in China because of an insufficient number of subjects meeting the inclusion criteria. 114, 115 During the period of the COVID-19 epidemic, multiple clinical studies have been carried out synchronously, resulting in the insufficiency of participants since the same subject cannot simultaneously participate in two clinical studies. This situation may lead to the termination of some studies, and the same is true for SRs. If the relevant clinical study is not completed, SRs cannot be performed owing to insufficient studies, resulting in an invalid registration. Moreover, similar SRs being conducted by different research groups is a waste of time and energy. In addition, some organizations have registered nearly 20 protocols in the short term, which may lead to inefficient management of the procedural conduct of single research, thereby influencing the reliability of the results, which is also futile.

Based on the evaluation performed in this study, we believe that there are several points worth considering and improving:

First, studies should not be repeated. Secondly, an innovative and rigorous SR should be registered and implemented, enhancing the value of the obtained information. Thirdly, a comprehensive search must be carried out to locate all relevant published and unpublished literature. 104 Chinese databases and clinical trial registration platforms should be appreciated. Besides, The same type of studies should be included, RCTs are recommended. Scientific inclusion criteria for COVID-19 patients should be devised based on authoritative diagnostic guidelines. Disease severity should be given due importance. The details of the intervention must be completely reported, rather than general TCM or acupuncture. The main outcomes need to refer to the published COSs. Finally, correct indicator names should be reported. The limitation of this study is that, as this study performed an overview of the SR protocols included in PROSPERO only, all the protocols of SRs on TCM for COVID-19 registered at other registries were not considered. In order to avoid misleading generalizations, this limitation should be taken into account.

In conclusion, registering and implementing an innovative and rigorous SR is necessary to ensure the usefulness of the generated information, avoid duplication of research, and prevent the wastage of resources. At present, SR protocols for COVID-19 with TCM are not rigorous enough. Some problems, such as non-specific PICO, incomprehensive literature retrieval, COS application, and incorrect indicator names, need to be examined closely and solved. 

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Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people

Increasing value and reducing waste: addressing inaccessible research

Exploring the Mechanisms to Balance COVID-19 Emergency Drug Use and Compliance with Moral Norms

A Trial of Remdesivir in Adults With Mild and Moderate COVID-19

A Trial of Remdesivir in Adults With Severe

Score of clinical symptoms, Dosage and treatment time of broad-spectrum antiviral drug, Body temperature, Disease duration, HAMD (Hamilton Depression Scale), IES-R (Impact of Event Scale-Revised), Pcl-c (The PTSD Checklist Civilian Version), Rate of severe patients, The rate of appearance of main symptoms, Usage of hormone, Length of ICU stay, Frequency of respiratory progression, Rate of chest imaging recovery, Biological results, Blood pressure, Chronic conditions, COVID-19 attack rate, Duration of oxygen intaking, HAMA (Hamilton Anxiety Scale), Kidney function, Liver function, The incidence of sequelae, Productivity of healthy baby

We would like to thank the authors of the protocols in PROSPERO. We would also like to express our gratitude to the Journal's editorial team for their services and assistance to the authors.