The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea

Document the number of episodes of menstruation during the treatment and follow-up period

Measure the levels of sex hormones in the blood, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Dehydroepiandrosterone Sulfate (DHEA-S), and Anti-Müllerian Hormone (AMH).

Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 × L × W × AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound.

The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.

Total ovarian volume (cm³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 × length × width × thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound.

Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II). Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome).

Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms (worse outcome).

Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).

Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) . Total scores range from 0 to 78 , with higher scores indicating more disordered eating pathology (worse outcome) . A score of 20 or higher is considered indicative of an elevated risk for an eating disorder, warranting further clinical evaluation

Participants were followed up at the hospital every 3 months during the treatment period. At each follow-up visit, adverse events (AEs) were documented, and their causality (relationship to the treatment) was assessed by the investigators. The severity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Serum alanine aminotransferase (ALT) levels were measured to assess liver function. Elevated ALT levels indicate hepatocellular injury (worse outcome).

Renal function was assessed by measuring serum creatinine (SCr) levels. Serum creatinine levels were measured, with higher levels indicating worse renal function (worse outcome) .

Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) . Total physical activity was calculated as metabolic equivalent of task (MET)-minutes per week, ranging from 0 to 14,280 MET-minutes/week (theoretical maximum), with higher scores indicating greater physical activity levels (better outcome) . Total sitting time was recorded as minutes per week, ranging from 0 to 1,440 minutes/week, with higher scores indicating more sedentary behavior (worse outcome) .