Objective

To explore the criteria for identifying pattern elements of polycystic ovary syndrome (PCOS)

and to provide evidence for setting TCM clinical pattern differentiation criteria for PCOS.

Methods

Clinical data of 518 PCOS patients were collected. Latent variable analysis was made to establish TCM diagnostic criterion model of PCOS based on pattern element

after which

diagnoses made using the model were compared with clinical diagnoses made by TCM physicians.

Results

Both goodness of fit index (GFI) and GFI adjusted for degrees of freedom (AGFI) were close to 1

suggesting that the model was well-fitting. The root mean square error of approximation (RMSEA) was 0.063 7

which is≤0.08

indicating that the model was acceptable. The results of consistency test were as follows. TCM diagnosis of the pattern element of disease location or affected zang-fu organ (i.e. kidney

liver

and spleen) could be made when just one symptom in the model manifests itself (i.e. lumbosacral pain

frequent urination at night

and tinnitus for kidney; depression

impatience and irascibility

and frequent or excessive sighing for liver; and poor appetite and digestion

abdominal distention after eating

and diarrhea for spleen

respectively). The rates of consistency between the model diagnosis of disease location and pattern differentiation made by TCM physicians were 71.6%

88%

and 77% for kidney

liver and spleen

respectively. TCM diagnosis of the pattern element of disease nature (i.e. qi deficiency

qi stagnation

and phlegm-damp) could be made when just two symptoms in one category in the model manifest themselves (i.e. mental fatigue

lack of strength

and spontaneous sweating for qi deficiency; chest tightness

chest and rib-side distending pain

and distending pain of the breasts for qi stagnation; and somnolence

heaviness sensation in the head or dizziness as if the head is wrapped up

and expectoration of phlegm for phlegm-damp

respectively). The rates of consistency between the model diagnosis of disease nature and pattern differentiation made by TCM physicians were 86.3%

83.2%

and 80.5% for qi deficiency

qi stagnation

and phlegm-damp

respectively.

Conclusion

The preliminary diagnostic criteria for PCOS based on pattern elements have been set. After meeting basic diagnostic criteria for PCOS

disease locations such as kidney

liver

and spleen can be diagnosed based on just one symptom in the model

and disease nature like qi deficiency

qi stagnation

and phlegm-damp can be diagnosed based on just two symptoms in one category in the model.