The Effectiveness of a Modified Gui Zhi Fu Ling Wan Formulation (Gynoclear™) for The Treatment of Endometriosis: A Study Protocol for a Placebo Controlled, Double Blind, Randomised Controlled Trial.

Abstract

Background: Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills, and hormonal treatments have limited effectiveness and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis related pain based on the Endometriosis Pain Daily Diary (EPPD) scores.Methods: This randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participants across Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last five years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear’s active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of five months’ worth of pain diary entries via the EPDD v3, including one-month screening, three-months treatment period and one-month post-treatment follow up. The primary outcome variable is change in endometriosis related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD.Discussion: This study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals, and members of the public who suffer from endometriosis.Trial registration: Australia and New Zealand Clinical Trials Registry, ACTRN12619000807156 (https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377571). Registered on 03-Jun-2019.

Invasiveness of endometrial cancer cell lines is potentiated by estradiol and blocked by a traditional medicine Guizhi Fuling at clinically relevant doses

“…Control groups were untreated and vehicle-treated (0.04% DMSO). Gynoclear capsules contain Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) at 92 mg each and Salvia miltiorrhiza (Red sage) at 90 mg, in approximately equal proportions by dry weight (34).…”

“…The treatment combination not only lowered the risk of adverse effects associated with RU486 (irregular vaginal bleeding, hot flushes, abnormal liver function), but also improved pregnancy outcomes (32). Fuling is currently being investigated under the Registry of Australia New Zealand Clinical Trials (ACTRN12619000807156) as "A Clinical Trial to Test a Modified Traditional Chinese Herbal Medicine for the Treatment of Endometriosis" (33,34). In this trial, patients with endometriosis are receiving six Fuling (Gynoclear) capsules (3.3 g per day) orally for 12 weeks.…”