Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

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.

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 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.

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.

This outcome measures the change in acne severity using a standardized acne grading scale such as the Global Acne Grading System (GAGS). Acne will be evaluated at baseline and 12 weeks post-intervention, considering factors like lesion type (comedones, papules, pustules, nodules), anatomical location, and number of lesions. Scores will be categorized into mild, moderate, severe, or very severe acne. A reduction in GAGS score following the intervention will indicate improvement in acne symptoms, likely reflecting decreased androgen activity in the skin.

This outcome assesses the change in hirsutism severity using the modified Ferriman-Gallwey (mFG) score, a validated clinical tool that evaluates terminal hair growth in nine androgen-sensitive areas of the body. Each area is scored from 0 (no hair) to 4 (extensive hair growth), with a total score range of 0 to 36. Assessments will be performed at baseline and at 12 weeks post-intervention by trained female healthcare providers. A decrease in the mFG score after Hijama therapy will indicate a reduction in androgen-related clinical manifestations.

This outcome evaluates changes in serum total testosterone concentrations, a key marker of hyperandrogenism in PCOS patients. Blood samples will be collected at baseline and 12 weeks after the intervention, and testosterone levels will be measured using standardized immunoassay methods. Results will be expressed in ng/dL. The outcome will help determine whether wet cupping (Hijama) contributes to reducing elevated androgen levels, which are associated with clinical manifestations such as hirsutism, acne, and ovulatory dysfunction. This measurement serves as a critical indicator of the intervention's effect on the hormonal imbalance characteristic of PCOS.

This outcome assesses changes in the LH to FSH ratio, a key hormonal marker often altered in PCOS. The ratio will be calculated from measured LH and FSH values at baseline and 12 weeks post-intervention. The LH/FSH ratio provides a more sensitive indicator of hormonal imbalance and is important in understanding the effect of Hijama therapy on reproductive endocrinology.

This outcome measures the variation in serum FSH concentrations before and after the intervention. Blood samples will be collected at baseline and at 12 weeks post-intervention. Laboratory analysis will use standard immunoassay techniques, and values will be expressed in IU/L. The results will help assess the potential endocrine-modulating effects of wet cupping on FSH levels in women with PCOS.

This outcome refers to the variation in serum LH concentration measured before and after the intervention. Blood samples will be collected from participants at baseline and again at 12 weeks post-intervention.

Laboratory analysis will be conducted using standardized immunoassay techniques at the hospital's certified clinical laboratory. LH levels will be expressed in IU/L, and changes will be evaluated as continuous variables.

The purpose of this outcome is to assess the impact of wet cupping (Hijama) on hormonal regulation in women diagnosed with PCOS. Results will be compared between the intervention and control groups using appropriate statistical tests (e.g., t-test), and a p-value < 0.05 will be considered statistically significant.

Detailed Description:

This outcome will assess the frequency and types of adverse events (AEs) observed in participants receiving wet cupping (Hijama). Events will be monitored both immediately after each cupping session and again at 4 weeks post-intervention.

Assessment Time Points:

Immediate (within 1 hour post-session)

Delayed (at 4-week follow-up)

Assessment Method:

A structured adverse event checklist will be completed by the research team after each Hijama session and during follow-up. Participants will also self-report any symptoms.

Types of Adverse Events to Be Monitored:

1. Immediate Adverse Events (Post-Hijama)

• Syncope (fainting)
• Dizziness
• Nausea
• Hypotension
• Bleeding Headache
• Localized pain
• Bruising
• Bullae (blister-like lesions).

1. Delayed Adverse Events (4 Weeks Post-Hijama)

• Wound infection
• Persistent scars
• Hyperpigmentation