Abstract
BackgroundEndometriosis 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.MethodsThis 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 5 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 5 months’ worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-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 EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD.DiscussionThis study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, 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 registrationAustralia and New Zealand Clinical Trials Registry ACTRN12619000807156. Registered on 3 June 2019.
Highlights
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
Gui Zhi Fu Ling Wan is the most common Traditional Chinese herbal medicine prescription used in the treatment of endometriosis [23] and includes ingredients commonly recommended by naturopaths and western herbalists [24]
While many practitioners use variable complex herbal formulations as part of their treatment protocols [27], the convenience of an encapsulated ‘off-the-shelf’ formula, that can be dispensed through pharmacy and herbal medicine dispensaries may increase the availability of herbal medicine to women with endometriosis
Summary
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. Chronic pelvic pain (CPP) is pain in the pelvis of greater than 6 months duration, which is severe enough to cause functional disability or require medical intervention [1]. Chronic pelvic pain has a number of aetiologies including endometriosis, adenomyosis, chronic pelvic infection and functional disorders such as irritable bowel syndrome or interstitial cystitis. Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity [2] and is the most common cause of CPP [3]. Worldwide prevalence rates of all types of chronic pelvic pain range from 5.7 to 26.6% [4]. Accurate prevalence rates for endometriosis are difficult to estimate. Reports from clinical settings suggest a rate of around 10% globally [5], and in Australia, around 11% of women aged 40–44 have a diagnosis of endometriosis [6]
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