Endometriosis : Traditional Medicine vs Hormone Therapy

What Was Tested

The trial (phase 1, phase 2) is built around Nafarelin for endometriosis.

The registry classes the interventions as drug and procedure.

More on the Plan

Women with laparoscopy-diagnosed endometriosis will be randomly assigned to either TCM or hormone therapy.

Women assigned to TCM will be divided into four sub-groups on the basis of the diagnostic categories of endometriosis recognized by TCM.

A pre-established acupuncture protocol and herbal formula specific for each sub-group will be followed.

This aspect of the research design permits an important feature of the clinical practice of TCM (matching treatment to sub-group diagnosis) to be adopted in a clinical trial.

Who Took Part

50 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women with laparoscopy-confirmed endometriosis within the past 6 years. Experiencing chronic pelvic pain, dysmenorrhea (painful periods) and dyspareunia (painful intercourse), at least one of which is moderate to severe.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: use of any form of hormone-based contraception during the 12-week treatment and 24-week follow-up periods; diagnosed with any chronic condition other than endometriosis, or any other acute condition that causes pain; pregnancy or breast feeding.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The endometriosis participants were allocated by chance, so the Nafarelin group and the comparison group should start out alike.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Being open-label, the Nafarelin study did not mask who received what.

It started in 2002-09 with completion listed for 2006-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pain assessments.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Nafarelin in 50 people with endometriosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Nafarelin compound page, Endometriosis research.