Objective: To summarize the diagnostic criteria of Chinese medicine patterns (CMPs) adopted by clinical and epidemiological studies of Parkinson’s disease (PD).

Background: One major reason for the inadequate quality of Chinese herbal medicine (CHM) clinical studies is concluded to be their unstandardized and ambiguous diagnostic criteria of CMPs. Hence, efforts were made to design protocolized CMP diagnostic criteria through population studies of PD, which could be used to guide CMP diagnosis in clinical settings. We performed a systematic review to summarize the CMP diagnostic criteria used in CHM clinical studies, and those derived from epidemiological studies.

Method: We performed a literature search in 7 databases, including Medline, Cochrane, and Chinese National Knowledge infrastructure until 6^th Mar 2023. Two types of studies were included: (1) randomized, controlled, add-on trial of CHM for PD with CMP diagnosis; and (2) epidemiological studies of PD that aimed at deriving CMP diagnostic criteria by analysing the correlation between CMPs and clinical presentations, which could be cross-sectional, case-control or cohort studies. Studies were screened by two reviewers.

Results: 5,467 studies were found in total after database searches. 22 clinical trials and 2 epidemiological studies were included. The CMP diagnostic criteria of all the included trials were based on a clinical guideline, The Chinese Medicine Diagnosis and Outcome Assessment of Tremor Syndrome. The guideline provided only vague descriptions of clinical presentations of each CMP, including symptoms, tongue manifestations, and pulse conditions, without a set of criteria for CMP diagnosis. The 2 included epidemiological studies were cross-sectional studies (Table 1). The derived diagnostic criteria consisted of lists of clinical presentations (symptoms, signs, tongue manifestations and pulse conditions), each with a weighted score. The criteria were fulfilled when the total score of all existing presentations reached the cut-off score. All criteria were not validated nor used in clinical studies.

Conclusion: The study-derived CMP diagnostic criteria are encouraged to be validated for clinical uses. More studies are also warranted to devise better epidemiological and statistical methodologies for CMP diagnostic criteria design.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/chinese-medicine-pattern-diagnostic-criteria-in-clinical-and-epidemiological-studies-of-parkinsons-disease-a-systematic-review/