Treatment of Endometriosis with Epigallocatechin gallate:
a double-blind randomized placebo-controlled crossover pilot trial.

Endometriosis is defined as the presence of endometrial-like tissue (which is
in normal circumstances only inside the uterus) within the pelvis and other
extra-uterine sites. It is a common estrogen dependent disease which is thought
to affect up to 10% of women of reproductive age. This can rise up to 35-50% in
women presenting with pelvic pain or infertility or both. From our experience
of patients in our outdoor clinic (Endometriosis Centre, VU medical centre,
Amsterdam), endometriosis patients often notice that drinking a high amount of
green tea (15 cups a day or more), relieves their pain symptoms. This raised
our interest in this topic because this can be revolutionary in the treatment
of endometriosis.
The regular treatment of endometriosis is surgical, hormonal and/ or usage of
pain medication. Green tea seems to be the only non- hormonal therapy,
discovered by the patient itself by drinking many cups of tea.
Recently not only the patients experience but also scientific research showed
that green tea may be a promising new treatment in endometriosis. It has
recently been described that Epigallocatechin gallate (EGCG, the major
component of green tea) inhibits estrogen-induced activation of endometrial
cells in vitro and causes regression of endometriotic lesions in vivo in
hamsters (Laschke 2008). Another publication showed anti-angiogenic effects of
EGCG in an experimental mouse model (Xu 2009).The antioxidant activity which
removes free radicals and anti-angiogenic effects of EGCG could play a
promising role in the reduction of pain and may point to a new non- hormonal
treatment for endometriosis in humans without side effects of regular used
medication.

To evaluate if Epigallocatechin gallate (EGCG) is an effective treatment for
pain in endometriosis patients using oral contraceptives by using Visual
Analogue Scores (VAS)

* To evaluate if the VAS pain scores are lower after EGCG versus placebo
treatment.
* To evaluate if the dimension *Pain* within the EHP-30 improves after
treatment with EGCG versus placebo treatment.
* To evaluate if the serum Ca-125 level is lower after EGCG versus placebo
treatment.
* To investigate if the total dosage of rescue pain medication is lower during
EGCG versus placebo treatment.
* To investigate if the Biberoglu & Behrman severity profile is lower after
EGCG versus placebo treatment.
* To investigate if the total amount of bloodloss is lower during EGCG versus
placebo treatment.

To investigate the effect of EGCG on endometriosis a double-blind randomized
placebo-controlled crossover pilot trial (RCT) will be organized. Therefore 30
patients diagnosed with endometriosis using oral contraceptives with persistent
pain with VAS scores of at least 40mm, will be invited from our Endometriosis
Centre. 15 of these patients will receive EGCG 675mg (= 3 capsules) a day for 2
months, followed by placebo for 2 months. The other 15 patients will first
receive placebo capsules for two months, followed by EGCG for two months. In
case of severe pain all study patients are able to use their own chosen rescue
medication.
This study includes 3 visits to our centre. During each visit a blood sample
for the evaluation of the serum Ca-125 level will be taken, and patietns will
be asked to fill in a questionnaire on quality of life (EHP-30), menstruation
and pain scores(VAS score). Also a gynaecologic investigation will be performed
conform Biberoglu & Behrman severity profile. Every day the patient has to
fill in a diary for the use of study medication, total use of rescue medication
and menstrual blood loss.

The dialy use of 3 capsules (or placebo or EGCG). The capsule should be taken
0,5-1 hour before breakfast, afternoon- and evening meal combined with a fair
amount of water during 4 subsequent months.

The risk of this research is nil if in and exclusion criteria are followed.