Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

Change in Menstrual Cycle Duration

This outcome refers to the change in the length of the entire menstrual cycle, measured in days, defined as the time from the first day of one menstrual period to the first day of the next. This measure reflects the regularity and timing of menstrual cycles, which are commonly disrupted in patients with Polycystic Ovary Syndrome (PCOS). Data will be collected through a structured self-report questionnaire administered at baseline and again at 12 weeks post-intervention. The difference in reported cycle length will be analyzed to evaluate the effect of wet cupping (Hijama) therapy on menstrual cycle regulation. This outcome aims to provide insight into the potential therapeutic impact of the intervention on menstrual irregularities, a hallmark clinical feature of PCOS.

Change in the Duration of Menstrual Bleeding

This outcome refers to the change in the number of days of menstrual bleeding experienced by each participant, measured from the first day of visible menstrual blood flow to the last day of bleeding (excluding spotting). Data will be collected using a structured questionnaire administered at baseline and 12 weeks after the intervention. The reported number of bleeding days at follow-up will be compared to baseline values to assess the impact of the intervention. This outcome is intended to capture clinically relevant changes in the menstrual pattern of participants with PCOS following the wet cupping therapy. It will also contribute to understanding the potential therapeutic benefits of Hijama on menstrual regulation.

Change in the Volume of Menstrual Bleeding

This outcome refers to the change in the volume of menstrual bleeding, measured by the maximum number of sanitary pads used per day during the heaviest day of menstruation. This is a commonly used proxy to estimate menstrual blood loss in clinical studies. Data will be collected using a questionnaire at baseline and again at 12 weeks after the intervention. Participants will be asked to report the number of full-sized pads used per day at their heaviest bleeding before and after the study period. The goal of this outcome is to assess whether wet cupping (Hijama) has a regulatory or therapeutic effect on abnormal uterine bleeding, which is a frequent symptom in women with PCOS.

Change in Dysmenorrhea

This outcome refers to the change in the severity of dysmenorrhea (menstrual pain) among participants, assessed before and after the intervention. Dysmenorrhea severity will be measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will report the maximum pain intensity experienced during menstruation over the past three cycles. Data will be collected using a structured questionnaire at baseline and again 12 weeks after the intervention. The purpose of this outcome is to evaluate whether wet cupping therapy (Hijama) can effectively reduce menstrual pain, which is a commonly reported symptom in PCOS patients and a contributor to reduced quality of life.

Change in Insulin Sensitivity

Definition: This outcome assesses the change in insulin sensitivity in participants from baseline to 12 weeks after the intervention. Measurement Method: Fasting Insulin and Fasting Glucose will be measured at baseline and at the end of the study. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using the formula:HOMA-IR= Fasting Insulin (μU/mL) × Fasting Glucose (mg/dL)/405 Lower HOMA-IR values indicate improved insulin sensitivity. Timepoints: At baseline then after 12 weeks.

Change in Metabolic Syndrome Status

Definition: This outcome will assess any changes in participants' metabolic syndrome status from baseline to 12 weeks post-intervention, based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria. Criteria include the presence of at least three of the following five: Waist circumference \>88 cm in females, Triglycerides ≥150 mg/dL, HDL cholesterol \<50 mg/dL in females, Blood pressure ≥130/85 mmHg or use of antihypertensive medication, and Fasting plasma glucose ≥100 mg/dL or use of anti-diabetic medications. Measurement Method: Clinical assessments (e.g., blood pressure, waist circumference). Laboratory tests (e.g., fasting glucose, lipid profile). Timepoints: At baseline then after 12 weeks.

Quality of Life among PCOS Patients

Quality of life will be assessed using a validated PCOS-specific tool, the PCOSQ (Polycystic Ovary Syndrome Questionnaire), which measures health-related quality of life across relevant domains including: Emotional well-being, Body hair and appearance, Infertility concerns, Menstrual problems, and Weight-related issues. Participants will complete the questionnaire at baseline and again 12 weeks after the intervention. Each item will be rated on a Likert scale, and domain-specific as well as overall scores will be calculated. Higher scores will indicate better quality of life. Changes from baseline will be compared between the intervention and control groups.

Change in Ovarian Morphology

This outcome will evaluate the structural changes in ovarian morphology using pelvic ultrasound imaging, performed at baseline and 12 weeks post-intervention. Measurements will include: Ovarian volume (in cm³) for each ovary, calculated using the ellipsoid formula (length × width × thickness × 0.523), Number of antral follicles per ovary (2-9 mm in diameter) and Presence of peripheral "string of pearls" follicle pattern or increased stromal echogenicity. Ultrasounds will be conducted by certified radiologists blinded to group assignment to reduce assessment bias. Improvement will be indicated by a reduction in the number of follicles, normalization of ovarian volume, or resolution of typical PCOS-specific morphological features.