Background
Methods
Registration
Literature review
Items extraction
Consensus meeting
Delphi exercise
Explanation and elaboration preparation
Revision and finalization
Results
Highlights of PRISMA-M 2020
The Chinese medicine (CM) theoretical system evolved over centuries. Its fundamental principle is that the determination of CM interventions must be based on pattern differentiation (also called syndrome differentiation, or “Bian-Zheng-Lun-Zhi” in Chinese), a primary CM method of understanding and treating diseases. According to CM theory, a pattern (also termed a syndrome or “Zheng” in Chinese) is a pathological cluster or summary of signs and symptoms at a particular stage of a disease. The pattern may include the cause(s), pathological features, properties, and the relationship between any pathogens involved and the body’s resistance. The patterns are named according to a cluster of associated signs and symptoms described in terms of yin, yang, exterior, interior, cold, heat, deficiency, and excess. In general, a pattern is composed of “location of disease” and “feature of disease.” A “pattern” (Zheng) is obtained through analyzing the “symptoms,” while the “disease,” especially in Western terms, comprises the whole morbid process and may include several different patterns. Specifically, pattern differentiation refers to the analysis and summarization of the clinical symptoms obtained through the four diagnostic methods of CM (inspection, auscultation and smell, inquiry, and pulse taking and palpation), after which CM practitioners can accordingly determine the specific treatment. In practice, one disease may include several different CM patterns, and conversely, different diseases may exhibit the same CM pattern in the course of their development. Thus, the application of pattern differentiation may “treat the same diseases with different methods,” or it may “treat different diseases with the same therapeutic method.” Accurate CM pattern differentiation is critical. It provides a diagnostic label, it guides the choice of CM interventions, such as moxibustion, and it gives access to the historical record of the treatments other doctors over centuries have used. In clinical practice, pattern diagnosis can help the practitioner determine a treatment principle and methods of moxibustion therapy, including the selection of acupoints, types, materials, and techniques. For example, the treatment principles of moxibustion used for excessive syndrome and deficiency syndrome are very different. For SRs of moxibustion, if the primary studies included pattern differentiation, the concept of the studied pattern should be carried out throughout the entire process with regard to the rationale of the review design, inclusion and exclusion criteria, selection of moxibustion intervention(s), outcomes, data interpretation and additional analyses, etc. |
Section/topic | Item number | PRISMA original item | Extension for moxibustion | Reported on page number |
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Title | ||||
Title | 1 | Identify the report as a systematic review, meta-analysis, or both | 1a. Statement of the specific type of moxibustion treatment, such as direct moxibustion or heat-sensitive moxibustion. 1b. Statement of whether the review targets the (1) Western medicine–defined disease(s), (2) Western medicine–defined disease(s) with specific CM pattern(s), or (3) CM pattern(s), if applicable. | |
Abstract | ||||
Structured summary | 2 | Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number | ||
Introduction | ||||
Rationale | 3 | Describe the rationale for the review in the context of what is already known | Describe the rationale for what is already known about moxibustion utilized for the target disease and/or CM pattern (if any). If applicable, relevant theory of CM should be included. | |
Objectives | 4 | Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS) | ||
Methods | ||||
Protocol and registration | 5 | Indicate if a review protocol exists, if and where it can be accessed (e.g., web address), and, if available, provide registration information including registration number | ||
Eligibility criteria | 6 | Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale | 6a. Describe the diagnostic criteria of the target condition in Western medicine and/or CM pattern (if any). All criteria utilized should be universally recognized, or reference(s) where detailed explanation can be found should be given. 6b. Specify the types of moxibustion to be included, such as moxa burner moxibustion, natural moxibustion, or heat-sensitive moxibustion. 6c. State whether CM-related outcome(s) were included, such as the change of degree and scope of symptoms and signs related to CM pattern, or validated pattern survey, if applicable. | |
Information sources | 7 | Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched | ||
Search | 8 | Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated | ||
Study selection | 9 | State the process for selecting studies (i.e., screening, eligibility, included in the systematic review, and, if applicable, included in the meta-analysis) | ||
Data collection process | 10 | Describe the method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators | ||
Data items | 11 | List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made | 11a. List and define the data of CM pattern(s) in detail, considering the inclusion and exclusion criteria, if applicable. 11b. List and define the data of moxibustion interventions and controls (e.g., sham moxibustion), give details referring to STRICTOM and TIDieR. 11c. List and define the data of CM pattern outcome(s), considering the methods and timepoints, if applicable. | |
Risk of bias in individual studies | 12 | Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level) and how this information is to be used in any data synthesis | ||
Summary measures | 13 | State the principal summary measures (e.g., risk ratio, difference in means) | ||
Synthesis of results | 14 | Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g., I2) for each meta-analysis | ||
Risk of bias across studies | 15 | Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies) | ||
Additional analyses | 16 | Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified | Describe methods of subgroup analyses in terms of different types of included moxibustion interventions and/or included CM pattern participants (if applicable), if done, indicating which were pre-specified. | |
Results | ||||
Study selection | 17 | Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram | ||
Study characteristics | 18 | For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations | 18a. Present characteristics for the data of participants, which include CM pattern(s), considering (1) diagnostic criteria; (2) baseline data, if applicable. 18b. Present characteristics for the data of moxibustion intervention(s) and controls (e.g., sham moxibustion) for each study referring to STRICTOM and TIDieR. 18c. Present characteristics for the data of outcomes which include CM pattern(s), considering (1) name and measuring methods; (2) measuring timepoints and length of follow-up, if applicable. | |
Risk of bias within studies | 19 | Present data on the risk of bias of each study and, if available, any outcome-level assessment (see item 12) | ||
Results of individual studies | 20 | For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group and (b) effect estimates and confidence intervals, ideally with a forest plot | ||
Synthesis of results | 21 | Present results of each meta-analysis done, including confidence intervals and measures of consistency | ||
Risk of bias across studies | 22 | Present results of any assessment of the risk of bias across studies (see item 15) | ||
Additional analysis | 23 | Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see item 16]) | Give results of subgroup analyses based on the different types of moxibustion interventions and participants with CM patterns (if any), if done. | |
Discussion | ||||
Summary of evidence | 24 | Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., health care providers, users, and policymakers) | ||
Limitations | 25 | Discuss limitations at study and outcome level (e.g., risk of bias) and at review level (e.g., incomplete retrieval of identified research, reporting bias) | ||
Conclusions | 26 | Provide a general interpretation of the results in the context of other evidence, and implications for future research | ||
Funding | ||||
Funding | 27 | Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review |