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Article ; Online: Exploring the interface between adolescent dysmenorrhoea and endometriosis

Julia Hippisley-Cox / Sharon Dixon / Katy Vincent / Tom A Ranger / Judith Burchardt / Martina Patone / Andrew JHL Snelling

BMJ Open, Vol 13, Iss

a protocol for a cohort and nested case–control study within the QResearch Database

2023 Volume 2

Abstract: Introduction Dysmenorrhoea affects up to 70%–91% of adolescents who menstruate, with approximately one-third experiencing severe symptoms with impacts on education, work and leisure. Dysmenorrhoea can occur without identifiable pathology, but can ... ...

Abstract	Introduction Dysmenorrhoea affects up to 70%–91% of adolescents who menstruate, with approximately one-third experiencing severe symptoms with impacts on education, work and leisure. Dysmenorrhoea can occur without identifiable pathology, but can indicate underlying conditions, including congenital genital tract anomalies or endometriosis. There is a need for evidence about the management and incidence of dysmenorrhoea in primary care, the impact of treatments in adolescence on long-term outcomes and when to consider the possibility of endometriosis in adolescence.Methods and analysis This study aims to improve the evidence base for adolescents presenting to primary care with dysmenorrhoea. It comprises three interlinked studies. Using the QResearch Database, the study population includes all female at birth participants aged 10–19 years any time between 1 January 2000 and 30 June 2021. We will undertake (1) a descriptive study documenting the prevalence of coded dysmenorrhoea in primary care, stratified by demographic variables, reported using descriptive statistics; (2) a prospective open cohort study following an index cohort of all adolescents recorded as attending primary care with dysmenorrhoea and a comparator cohort of five times as many who have not, to determine the HR for a diagnosis of endometriosis, adenomyosis, ongoing menstrual pain or subfertility (considered singly and in combination) anytime during the study period; and (3) a nested case–control study for adolescents diagnosed with endometriosis, using conditional logistic regression, to determine the OR for symptom(s) preceding this diagnosis.Ethics and dissemination The project has been independently peer reviewed and received ethics approval from the QResearch Scientific Board (reference OX46 under REC 18/EM/0400).In addition to publication in peer-reviewed academic journals, we will use the combined findings to generate a resource and infographic to support shared decision-making about dysmenorrhoea in community health settings. ...
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Rodent Animal Models of Endometriosis-Associated Pain

Miguel A. Tejada / Carles Antunez / Paulina Nunez-Badinez / Bianca De Leo / Philippa T. Saunders / Katy Vincent / Antonio Cano / Jens Nagel / Raul Gomez

International Journal of Molecular Sciences, Vol 24, Iss 2422, p

Unmet Needs and Resources Available for Improving Translational Research in Endometriosis

2023 Volume 2422

Abstract: Chronic pain induced by endometriosis is a maladaptive pain experienced by half of women with this disease. The lack of pharmacological treatments suitable for the long-term relief of endometriosis-associated pain, without an impact on fertility, remains ...

Abstract	Chronic pain induced by endometriosis is a maladaptive pain experienced by half of women with this disease. The lack of pharmacological treatments suitable for the long-term relief of endometriosis-associated pain, without an impact on fertility, remains an urgent unmet need. Progress has been slowed by the absence of a reproducible rodent endometriosis model that fully replicates human physiopathological characteristics, including pain symptoms. Although pain assessment in rodents is a complicated task requiring qualified researchers, the choice of the behavioral test is no less important, since selecting inappropriate tests can cause erroneous data. Pain is usually measured with reflex tests in which hypersensitivity is evaluated by applying a noxious stimulus, yet this ignores the associated emotional component that could be evaluated via non-reflex tests. We conducted a systematic review of endometriosis models used in rodents and the number of them that studied pain. The type of behavioral test used was also analyzed and classified according to reflex and non-reflex tests. Finally, we determined the most used reflex tests for the study of endometriosis-induced pain and the main non-reflex behavioral tests utilized in visceral pain that can be extrapolated to the study of endometriosis and complement traditional reflex tests.
Keywords	endometriosis models ; pain ; reflex and non-reflex test ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Subject code	150
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: What are important areas where better technology would support women’s health? Findings from a priority setting partnership

Sharon Dixon / Sabrina Keating / Abigail McNiven / George Edwards / Philip Turner / Camilla Knox-Peebles / Neda Taghinejadi / Katy Vincent / Olivia James / Gail Hayward

BMC Women's Health, Vol 23, Iss 1, Pp 1-

2023 Volume 8

Abstract: Abstract Background Women’s health has historically lacked investment in research and development. Technologies that enhance women’s health (‘FemTech’) could contribute to improving this. However, there has been little work to understand which priority ... ...

Abstract	Abstract Background Women’s health has historically lacked investment in research and development. Technologies that enhance women’s health (‘FemTech’) could contribute to improving this. However, there has been little work to understand which priority unmet needs should be a focus for women’s health technology development. The voices of clinicians and those who experience and utilise these technologies (including those used at home or encountered in clinical settings) are needed to ensure that device development aligns with need, without risking exacerbating or creating health inequities. Method We undertook a priority setting partnership project exploring unmet needs in women’s health and well-being where physical technologies or innovations could help. This comprised gathering feedback from: patients and clinicians using both qualitative surveys and discussions; collating and publishing these responses and asking for feedback; evidence checking unmet needs identified, and holding a partnership priority setting event to agree a top 10 and top 20 list of priorities. Results We generated a ‘longlist’ of 54 suggestions for areas where better kit, devices or equipment could support women’s health. For three, we found evidence of existing technologies which mitigated against that need. We took the remaining 51 suggestions to a partnership priority setting meeting which brought together clinicians and service users. Through discussion as this group, we generated a list of the top 10 areas identified as priorities for technological development and improvement. These included better devices to manage examination, diagnosis and treatment of pelvic pain (including endometriosis), prolapse care, continence (treatment and prevention, related to pregnancy and beyond), menstruation, vaginal pain and vaginismus, point of care tests for common infections, and nipple care when breastfeeding. Conclusion The top priorities suggest far-reaching areas of unmet need across women’s life course and across multiple domains of health ...
Keywords	Femtech ; Priority-setting partnership ; Women's Health ; Priority unmet needs ; Gynecology and obstetrics ; RG1-991 ; Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2023-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women

Lucy H. R. Whitaker / Ann Doust / Jacqueline Stephen / John Norrie / Kevin Cooper / Jane Daniels / Lone Hummelshoj / Emma Cox / Laura Beatty / Patrick Chien / Mayank Madhra / Katy Vincent / Andrew W. Horne

Pilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-

study protocol for a randomised controlled feasibility trial (ESPriT1)

2021 Volume 8

Abstract: Abstract Background Endometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial ... ...

Abstract	Abstract Background Endometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial peritoneal endometriosis (SPE). Endometriosis is diagnosed by laparoscopy and, if SPE is found, gynaecologists usually remove it surgically. However, many women get limited pain relief from surgical removal of SPE. We plan to undertake a future large trial where women who have only SPE found at initial laparoscopy are randomly allocated to have surgical removal (excision or ablation) of SPE, or not. Ultimately, we want to determine whether surgical removal improves overall symptoms and quality of life, or whether surgery is of no benefit, exacerbates symptoms, or even causes harm. The primary objective of this feasibility study is to determine what proportion of women with suspected SPE undergoing diagnostic laparoscopy will agree to randomisation. The secondary objectives are to determine if there are differences in key prognostic parameters between eligible women that agree to be randomised and those that decline; how many women having laparoscopy for investigation of chronic pelvic pain are eligible for the trial; the range of treatment effects and variability in outcomes and the most acceptable methods of recruitment, randomisation and assessment tools. Methods We will recruit up to 90 women with suspected SPE undergoing diagnostic laparoscopy over a 9-month recruitment period in four Scottish hospitals and randomise them 1:1 to either diagnostic laparoscopy alone (with a sham port to achieve blinding of the allocation) or surgical removal of endometriosis. Baseline characteristics, e.g. age, index of social deprivation, ethnicity, and intensity/duration of pain will be collected. Participants will be followed up by online questionnaires assessing pain, physical and emotional function at baseline, 3 months, 6 months and 12 months. Discussion Recruitment to a ...
Keywords	Chronic pelvic pain ; Surgery ; Excision ; Ablation ; Feasibility trial ; Placebo ; Medicine (General) ; R5-920
Subject code	300
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Gabapentin to reduce pain in women aged between 18 and 50 years with chronic pelvic pain

Catherine A Hewitt / Katy Vincent / Lee J Middleton / Liana Romaniuk / Magda Koscielniak / Ann M Doust / Judy Birch / Heather Whalley / Jane P Daniels / Andrew W Horne

Efficacy and Mechanism Evaluation, Vol 7, Iss

the GaPP2 RCT

2020 Volume 7

Abstract: Background: Chronic pelvic pain affects 2–24% of women worldwide, and evidence for medical treatments is limited. Gabapentin is effective in treating some chronic pain conditions, but its effect on central pain processing is unknown. Objectives: To test ... ...

Abstract	Background: Chronic pelvic pain affects 2–24% of women worldwide, and evidence for medical treatments is limited. Gabapentin is effective in treating some chronic pain conditions, but its effect on central pain processing is unknown. Objectives: To test the hypothesis that gabapentin can reduce pain and improve physical and emotional functioning in women with chronic pelvic pain. We investigated the mechanism of action of gabapentin in a subset of women. Design: A randomised, double-blind, placebo-controlled, multicentre trial with a brain imaging substudy. Setting: This trial took place in 39 UK hospitals. Participants: A target of 300 women with a history of chronic pelvic pain in whom a laparoscopy revealed no obvious pelvic pathology. Intervention: Women were randomised to receive 300 mg of gabapentin (which was escalated to a maximum of 2700 mg daily) or a matched placebo over a 4-week dose-escalation period, followed by 12 weeks on optimal dose. A mechanistic substudy was also undertaken, in which a subset of participants had a functional magnetic resonance imaging scan of their brain before and following 16 weeks of treatment. Main outcome measures: The dual primary measure of the worst and average pelvic pain scores was assessed weekly by a numerical rating scale (0–10) in weeks 13–16 post randomisation. The secondary outcomes were patient-reported questionnaires, assessed physical functioning, fatigue, psychological health, sexual activity, work and productivity, and pain catastrophising. Health-care resource use, analgesic use and adverse events were also collected. The main outcome measure for the mechanistic study was brain activity at rest and in response to noxious stimuli. Results: In the main trial, 306 participants were randomised. The mean worst pain score was 7.1 (standard deviation 2.6) in the gabapentin group and 7.4 (standard deviation 2.2) in the placebo group (adjusted mean difference –0.20, 97.5% confidence interval –0.81 to 0.42; p = 0.47). The mean average pain score was 4.3 (standard ...
Keywords	pelvic pain ; gabapentin ; randomised controlled trial ; analgesia ; Medicine ; R
Subject code	150
Language	English
Publishing date	2020-11-01T00:00:00Z
Publisher	NIHR Journals Library
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Identification of Altered Evoked and Non-Evoked Responses in a Heterologous Mouse Model of Endometriosis-Associated Pain

Miguel A. Tejada / Ana I. Santos-Llamas / Lesley Escriva / Juan J. Tarin / Antonio Cano / Maria J. Fernández-Ramírez / Paulina Nunez-Badinez / Bianca De Leo / Philippa T. K. Saunders / Victor Vidal / Florent Barthas / Katy Vincent / Patrick J. Sweeney / Rowland R. Sillito / James Douglas Armstrong / Jens Nagel / Raúl Gomez

Biomedicines, Vol 10, Iss 501, p

2022 Volume 501

Abstract: The aim of this study was to develop and refine a heterologous mouse model of endometriosis-associated pain in which non-evoked responses, more relevant to the patient experience, were evaluated. Immunodeficient female mice (N = 24) were each implanted ... ...

Abstract	The aim of this study was to develop and refine a heterologous mouse model of endometriosis-associated pain in which non-evoked responses, more relevant to the patient experience, were evaluated. Immunodeficient female mice (N = 24) were each implanted with four endometriotic human lesions (N = 12) or control tissue fat (N = 12) on the abdominal wall using tissue glue. Evoked pain responses were measured biweekly using von Frey filaments. Non-evoked responses were recorded weekly for 8 weeks using a home cage analysis ( HCA ). Endpoints were distance traveled, social proximity, time spent in the center vs. outer areas of the cage, drinking, and climbing. Significant differences between groups for von Frey response, climbing, and drinking were detected on days 14, 21, and 35 post implanting surgery, respectively, and sustained for the duration of the experiment. In conclusion, a heterologous mouse model of endometriosis-associated evoked a non-evoked pain was developed to improve the relevance of preclinical models to patient experience as a platform for drug testing.
Keywords	endometriosis ; heterologous model ; pain ; evoked and non-evoked response ; Biology (General) ; QH301-705.5
Subject code	616
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Clinical profiling of specific diagnostic subgroups of women with chronic pelvic pain

Lysia Demetriou / Michal Krassowski / Pedro Abreu Mendes / Kurtis Garbutt / Allison F. Vitonis / Elizabeth Wilkins / Lydia Coxon / Lars Arendt-Nielsen / Qasim Aziz / Judy Birch / Andrew W. Horne / Anja Hoffman / Lone Hummelshoj / Claire E. Lunde / Jane Meijlink / Danielle Perro / Nilufer Rahmioglu / Kathryn L. Terry / Esther Pogatzki-Zahn /

Christine B. Sieberg / Rolf-Detlef Treede / Christian M. Becker / Francisco Cruz / Stacey A. Missmer / Krina T. Zondervan / Jens Nagel / Katy Vincent

Frontiers in Reproductive Health, Vol

2023 Volume 5

Abstract: IntroductionChronic pelvic pain (CPP) is a common condition affecting up to 26.6% of women, with many suffering for several years before diagnosis and/or treatment. Its clinical presentation is varied and there are frequently comorbid conditions both ... ...

Abstract	IntroductionChronic pelvic pain (CPP) is a common condition affecting up to 26.6% of women, with many suffering for several years before diagnosis and/or treatment. Its clinical presentation is varied and there are frequently comorbid conditions both within and outside the pelvis. We aim to explore whether specific subgroups of women with CPP report different clinical symptoms and differing impact of pain on their quality of life (QoL).MethodsThe study is part of the Translational Research in Pelvic Pain (TRiPP) project which is a cross-sectional observational cohort study. The study includes 769 female participants of reproductive age who completed an extensive set of questions derived from standardised WERF EPHect questionnaires. Within this population we defined a control group (reporting no pelvic pain, no bladder pain syndrome, and no endometriosis diagnosis, N = 230) and four pain groups: endometriosis-associated pain (EAP, N = 237), interstitial cystitis/bladder pain syndrome (BPS, N = 72), comorbid endometriosis-associated pain and BPS (EABP, N = 120), and pelvic pain only (PP, N = 127).ResultsClinical profiles of women with CPP (13–50 years old) show variability of clinical symptoms. The EAP and EABP groups scored higher than the PP group (p < 0.001) on the pain intensity scales for non-cyclical pelvic pain and higher than both the BPS and PP groups (p < 0.001) on the dysmenorrhoea scale. The EABP group also had significantly higher scores for dyspareunia (p < 0.001), even though more than 50% of sexually active participants in each pain group reported interrupting and/or avoiding sexual intercourse due to pain in the last 12 months. Scores for the QoL questionnaire (SF-36) reveal that CPP patients had significantly lower QoL across all SF-36 subscales (p < 0.001). Significant effects were also observed between the pain groups for pain interference with their work (p < 0.001) and daily lives (p < 0.001), with the EABP suffering more compared to the EAP and PP groups (p < ...
Keywords	endometriosis ; pelvic pain ; dyspareunia ; bladder pain syndrome ; dysmennorhoea ; chronic pelvic pain ; Reproduction ; QH471-489 ; Medicine (General) ; R5-920
Subject code	360
Language	English
Publishing date	2023-05-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2)

Scott C. Mackenzie / Jacqueline Stephen / Linda Williams / Jane Daniels / John Norrie / Christian M. Becker / Dominic Byrne / Ying Cheong / T. Justin Clark / Kevin G. Cooper / Emma Cox / Ann M. Doust / Priscilla Fernandez / Jeremy Hawe / Tom Holland / Lone Hummelshoj / Louise J. Jackson / Kathleen King / Abha Maheshwari /

Dan C. Martin / Lauren Sutherland / Jim Thornton / Katy Vincent / Sanjay Vyas / Andrew W. Horne / Lucy H. R. Whitaker

Trials, Vol 24, Iss 1, Pp 1-

protocol for a multi-centre randomised controlled trial

2023 Volume 15

Abstract: Abstract Background Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. ... ...

Abstract	Abstract Background Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain. Methods We plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons’ preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants’ preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at ...
Keywords	Endometriosis ; Pelvic pain ; Laparoscopy ; Surgical ablation ; Surgical excision ; Randomised controlled trial ; Medicine (General) ; R5-920
Subject code	616
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain

Giulia Bova / Anthony Domenichiello / Janelle E. Letzen / Daniela C. Rosenberger / Andrew Siddons / Ulrike Kaiser / Adam Anicich / Ralf Baron / Judy Birch / Didier Bouhassira / George Casey / Katie Golden / Smriti Iyengar / Barbara I. Karp / Hiltrud Liedgens / Winfried Meissner / Kate Nicholson / Leah Pogorzala / Deirdre Ryan /

Rolf-Detlef Treede / Peter Tugwell / Dennis C. Turk / Katy Vincent / Jan Vollert / Paula R. Williamson / Sarah A. Woller / Ruth Zaslansky / Laura D. Wandner / Esther M. Pogatzki-Zahn

EClinicalMedicine, Vol 66, Iss , Pp 102340- (2023)

results of the INTEGRATE-pain Delphi processResearch in context

2023

Abstract: Summary: Background: Pain is the leading cause of disability worldwide among adults and effective treatment options remain elusive. Data harmonization efforts, such as through core outcome sets (COS), could improve care by highlighting cross-cutting pain ...

Abstract	Summary: Background: Pain is the leading cause of disability worldwide among adults and effective treatment options remain elusive. Data harmonization efforts, such as through core outcome sets (COS), could improve care by highlighting cross-cutting pain mechanisms and treatments. Existing pain-related COS often focus on specific conditions, which can hamper data harmonization across various pain states. Methods: Our objective was to develop four overarching COS of domains/subdomains (i.e., what to measure) that transcend pain conditions within different pain categories. We hosted a meeting to assess the need for these four COS in pain research and clinical practice. Potential COS domains/subdomains were identified via a systematic literature review (SLR), meeting attendees, and Delphi participants. We conducted an online, three step Delphi process to reach a consensus on domains to be included in the four final COS. Survey respondents were identified from the SLR and pain-related social networks, including multidisciplinary health care professionals, researchers, and people with lived experience (PWLE) of pain. Advisory boards consisting of COS experts and PWLE provided advice throughout the process. Findings: Domains in final COS were generally related to aspects of pain, quality of life, and physical function/activity limitations, with some differences among pain categories. This effort was the first to generate four separate, overarching COS to encourage international data harmonization within and across different pain categories. Interpretation: The adoption of the COS in research and clinical practice will facilitate comparisons and data integration around the world and across pain studies to optimize resources, expedite therapeutic discovery, and improve pain care. Funding: Innovative Medicines Initiative 2 Join Undertaking; European Union Horizon 2020 research innovation program, European Federation of Pharmaceutical Industries and Associations (EFPIA) provided funding for IMI-PainCare. RDT acknowledges ...
Keywords	Core outcome sets ; Delphi method ; Acute pain ; Transition from acute to chronic pain ; Recurrent/episodic pain ; Chronic pain ; Medicine (General) ; R5-920
Subject code	306
Language	English
Publishing date	2023-12-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Hand Osteoarthritis

Ioana R. Marian / Megan Goff / Jennifer A. E. Williams / Malvika Gulati / Mae Chester-Jones / Anne Francis / Marion Watson / Tonia L. Vincent / Sue Woollacott / Charles Mackworth-Young / Victoria Glover / Dominic Furniss / Matthew Gardiner / Sarah E. Lamb / Katy Vincent / Vicki S. Barber / Joanna Black / Susan J. Dutton / Fiona E. Watt

Pilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-

investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial

2021 Volume 14

Abstract: Abstract Background Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA ... ...

Abstract	Abstract Background Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design. Methods This is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60–90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study. Discussion Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and ...
Keywords	Hand osteoarthritis ; Estrogen ; Hormone replacement therapy ; Clinical trial ; Feasibility ; Medicine (General) ; R5-920
Subject code	150
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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