Evidence map›Paper›PMID 33883001›Full record

ArticleTrials2021

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.

Mike Armour, Mahmoud A Al-Dabbas, Carolyn Ee, Caroline A Smith, Jane Ussher, Susan Arentz, Kenny Lawson, Jason Abbott

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. New Potential Pharmacological Options for Endometriosis Associated Pain.International journal of molecular sciences · 2024
    Review
  2. Article
  3. Frontiers in pharmacology · 2022
    Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Mike ArmourNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia. M.Armour@westernsydney.edu.au.ORCID http://orcid.org/0000-0001-7539-9851
Mahmoud A Al-DabbasNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Carolyn EeNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Caroline A SmithNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Jane UssherTranslational Health Research Institute (THRI), Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Susan ArentzNICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Kenny LawsonTranslational Health Research Institute (THRI), Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Jason AbbottUniversity of New South Wales, Royal Hospital for Women, Randwick, NSW, 2031, Australia.
Western Sydney University · AURoyal Hospital for Women · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. DISCUSSION: This 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.

Indexed as

Cinnamomum aromaticumEndometriosisWolfiporiaAdultAustraliaDouble-Blind MethodFemaleHumansNew ZealandQuality of LifeRandomized Controlled Trials as TopicChinese herbal medicineEndometriosisGynoclearPelvic pain

Identifiers

PMID33883001
PMCPMC8058744
OpenAlexW3117170598

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.