The purpose of the study is to evaluate the efficacy and safety of green tea in endometriosis.
Women with endometrioma will be randomised into either the experimental group or the placebo comparator group in a 1:1 ratio. The subjects will be given SUNPHENON EGCg or placebo for 3 months prior to their planned surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
185
SUNPHENON EGCg Oral, 400mg, twice per day
Placebo
Prince of Wales Hospital
Shatin, Hong Kong
Change in endometriotic lesion size
Structural MRI will be performed with a 3T whole-body clinical scanner by a radiologist. The total volume of endometriotic mass in the endometrioma indicated by the positive enhanced image will be quantified. The endometriotic mass before treatment will be used as baseline for comparison and analysis. Prior to the planned surgery, another structural MRI will be performed again to assess the changes in endometriotic mass after treatment.
Time frame: At 0 and 3 months of treatment
Changes in pain scores assessed by ESS and VAS
The severity of the pain will be quantified and evaluated by an Endometriosis Symptom Severity verbal rating scale (ESS). With ESS, subjects will rate their pain from score 0 as absence of pain to 10 as the most severe intolerable pain. A modified Biberoglu-Behrman 10cm visual analogue scale (VAS) will also be used to evaluate the pain experienced by the subjects. For VAS, subjects will mark the level of pain that they encounter on a graphic scale which range from 0cm as absence of pain to 10cm as the pain becomes as bad as it could possibly be. The 2 measurements will be recorded separately.
Time frame: At 0, 1.5 and 3 months of treatment
Changes in quality of life assessed by SF36
Quality of life will be assessed using the standard SF36 instrument. SF36 consists of a medical survey which consists of 8 domains. The domain scores are rated onto a scale from 0 as worst health to 100 as best health. The Endometriosis Health Profile version 5 (EHP5) will as well be used to assess the quality of life. EHP5 contains 5 core and 6 modular questionnaires. Each item is rated on a 5-point scale (from 0=never to 4=always). The overall score will be transformed to a scale of 0 as best health and 100 as worst health.
Time frame: At 0, 1.5 and 3 months of treatment
Change in endometriotic growth assessed by pathology
Endometriotic cysts biopsies will be collected during the surgery. Endometriotic growth will be confirmed by the presence of endometrial epithelial glands and stroma in the biopsies. The biopsies will be compared to the endometriotic mass before treatment.
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Time frame: At 0 and 3 months of treatment
Change in total number of neovasculatures assessed by DCE-MRI
Subjects will undergo pelvic DCE-MRI for measurement of the total number of neovasculatures in the endometriotic mass.
Time frame: At 0 and 3 months of treatment
Change in density of neovasculatures assessed by DCE-MRI
Subjects will undergo pelvic DCE-MRI for measurement of the density of neovasculatures in the endometriotic mass.
Time frame: At 0 and 3 months of treatments
Number of Participants with adverse outcome and side effects
any related and unrelated severe adverse events and adverse events, side-effects
Time frame: At 0, 1.5 and 3 months of treatment