D H Barlow

University of Glasgow, Glasgow, Scotland, United Kingdom

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Publications (194)909.97 Total impact

  • David H Barlow
    Menopause (New York, N.Y.) 01/2015; 22(2). DOI:10.1097/GME.0000000000000415 · 2.81 Impact Factor
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    ABSTRACT: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Double-blind, randomized administration of two 12-week courses of ulipristal acetate. Gynecology centers. A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding. Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate. Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain. In the 5- and 10-mg treatment groups (62% and 73% of patients, respectively) achieved amenorrhea during both treatment courses. Proportions of patients achieving controlled bleeding during two treatment courses were >80%. Menstruation resumed after each treatment course and was diminished compared with baseline. After the second treatment course, median reductions from baseline in fibroid volume were 54% and 58% for the patients receiving 5 and 10 mg of ulipristal acetate, respectively. Pain and QoL improved in both groups. Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events. Repeated 12-week courses of daily oral ulipristal acetate (5 and 10 mg) effectively control bleeding and pain, reduce fibroid volume, and restore QoL in patients with symptomatic fibroids. NCT01629563 (PEARL IV). Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.
    Fertility and Sterility 12/2014; 104(2). DOI:10.1016/j.fertnstert.2014.10.038 · 4.59 Impact Factor
  • David H Barlow
    Menopause (New York, N.Y.) 06/2014; DOI:10.1097/GME.0000000000000269 · 2.81 Impact Factor
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    ABSTRACT: Objective To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids. Design Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo. Setting European clinical gynecology centers. Patient(s) Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding. Intervention(s) Patients received up to four 3-month courses of UPA 10 mg daily, immediately followed by 10-day double-blind treatment with NETA (10 mg daily) or placebo. Main Outcome Measure(s) Amenorrhea, fibroid volume, endometrial histology. Result(s) After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2–6 days). Median fibroid volume change was −45% (interquartile range, −66%; −25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were −63%, −67%, and −72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology. Conclusion(s) Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids. Clinical trial registration ClinicalTrials.gov (www.clinicaltrials.gov) registration numbers NCT01156857 (PEARL III) and NCT01252069 (PEARL III extension).
    Fertility and sterility 06/2014; 101(6). DOI:10.1016/j.fertnstert.2014.02.008 · 4.59 Impact Factor
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    ABSTRACT: Endometriosis is the presence of endometrial glands or stroma in sites other than the uterine cavity and is associated with pain and subfertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy. To assess the effectiveness and safety of laparoscopic surgery in the treatment of painful symptoms and subfertility associated with endometriosis. This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group including searching CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registries from inception to July 2013. Randomised controlled trials (RCTs) were selected in which the effectiveness and safety of laparoscopic surgery used to treat pain or subfertility associated with endometriosis was compared with any other laparoscopic or robotic intervention, holistic or medical treatment or diagnostic laparoscopy only. Selection of studies, assessment of trial quality and extraction of relevant data were performed independently by two review authors with disagreements resolved by a third review author. The quality of evidence was evaluated using GRADE methods. Ten RCTs were included in the review. The studies randomised 973 participants experiencing pain or subfertility associated with endometriosis. Five RCTs compared laparoscopic ablation or excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus diagnostic laparoscopy only. Two RCTs compared laparoscopic excision versus ablation. One RCT compared laparoscopic ablation versus diagnostic laparoscopy and injectable gonadotropin-releasing hormone analogue (GnRHa) (goserelin) with add-back therapy. Common limitations in the primary studies included lack of clearly-described blinding, failure to fully describe methods of randomisation and allocation concealment, and risk of attrition bias.Laparoscopic surgery was associated with decreased overall pain (measured as 'pain better or improved') compared with diagnostic laparoscopy, both at six months (odds ratio (OR) 6.58, 95% CI 3.31 to 13.10, 3 RCTs, 171 participants, I(2) = 0%, moderate quality evidence) and at 12 months (OR 10.00, 95% CI 3.21 to 31.17, 1 RCT, 69 participants, low quality evidence). Compared with diagnostic laparoscopy, laparoscopic surgery was also associated with an increased live birth or ongoing pregnancy rate (OR 1.94, 95% CI 1.20 to 3.16, P = 0.007, 2 RCTs, 382 participants, I(2) = 0%, moderate quality evidence) and increased clinical pregnancy rate (OR 1.89, 95% CI 1.25 to 2.86, P = 0.003, 3 RCTs, 528 participants, I(2) = 0%, moderate quality evidence). Two studies collected data on adverse events (including infection, vascular and visceral injury and conversion to laparotomy) and reported no events in either arm. Other studies did not report this outcome. The similar effect of laparoscopic surgery and diagnostic laparotomy on the rate of miscarriage per pregnancy was imprecise (OR 0.94, 95% CI 0.35 to 2.54, 2 studies, 112 women, moderate quality evidence).When laparoscopic ablation was compared with diagnostic laparoscopy plus medical therapy (GnRHa plus add-back therapy), more women in the ablation group reported that they were pain free at 12 months (OR 5.63, 95% CI 1.18 to 26.85, 1 RCT, 35 participants, low quality evidence).The difference between laparoscopic ablation and laparoscopic excision in the proportion of women reporting overall pain relief at 12 months on a VAS 0 to 10 pain scale was 0 (95% CI -1.22 to 1.22, P = 1.00, 1 RCT, 103 participants, low quality evidence). There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis reduces overall pain and increases live birth or ongoing pregnancy rates. There is low quality evidence that laparoscopic excision and ablation were similarly effective in relieving pain, although there was only one relevant study. More research is needed considering severe endometriosis, different types of pain associated with endometriosis (for example dysmenorrhoea (pain with menstruation)) and comparing laparoscopic interventions with holistic and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety.
    Cochrane database of systematic reviews (Online) 04/2014; 4:CD011031. DOI:10.1002/14651858.CD011031.pub2 · 5.70 Impact Factor
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    Cochrane database of systematic reviews (Online) 03/2014; 3. DOI:10.1002/14651858.CD011031 · 5.94 Impact Factor
  • D H Barlow · M A Lumsden · B C J M Fauser · P Terrill · E Bestel
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    ABSTRACT: What is the individualized bleeding experience of women with fibroids and anaemia in a 3 month randomized placebo controlled trial (PEARL I) of the selective progesterone receptor modulator (SPRM), ulipristal acetate (UPA)? In contrast to continuing excessive regular menstruation in the placebo group, a majority of women treated with UPA (63.1% of those on 5 mg/day and 71.3% of those on 10 mg/day) experienced the rapid onset of amenorrhoea or minimal blood loss [pictorial blood loss assessment chart (PBAC) < 12]. The remainder experienced various patterns of bleeding and intensity of blood loss that are described for the first time, including an association of irregular bleeding on UPA with sub-mucous fibroids. The majority experience on UPA is amenorrhoea but the bleeding experience of the others has not been characterized. A 13 week randomized controlled trial in women, eligible for surgery for uterine fibroids and anaemia, comparing placebo (n = 48), UPA 5 mg (n = 95) or UPA 10 mg (n = 94). The treatment aim was fibroid shrinkage and the primary definitions and outcomes are published elsewhere; here the secondary outcome measure of vaginal bleeding pattern is described. Women, 18-50 years old, with fibroids and haemoglobin ≤10.2 g/dl, justifying surgery. At least one fibroid was 3-10 cm diameter and uterus ≤16 weeks pregnancy size. All used the daily PBAC methodology in a screening cycle (Ps) and throughout treatment, and for the 4 weeks preceding Week 26 and Week 38 in those who did not have surgery. An excessive menstruation is PBAC > 100. The bleeding patterns were characterized using the classification of Belsey, developed under auspices of WHO. In the placebo group, all women had an excessive screening PBAC [median 376; interquartile range (IQR) 241-574]; 81.3% of them had regular menstrual bleeding and the intensity of bleeding remained similar, so that the median PBAC in the next three periods was 90, 92 and 93% of the screening value. Four of the 48 women had spontaneous improvement in bleeding and one developed amenorrhoea and elevation of gonadotrophins. In the placebo group, 22 women provided Week 26 and 21 women provided Week 38 PBAC data. The median Week 26 PBAC (312: IQR 102-524) and Week 38 PBAC (236; IQR 103-465) indicated ongoing excessive bleeding. In the UPA group, screening PBAC confirmed excessive bleeding (UPA 5 mg, median 358; IQR 232-621; UPA 10 mg, median 330; IQR 235-542). UPA was initiated from the start of a menstruation (P1) and no women had regular periods on treatment. Following P1 through the whole of the remaining 13 weeks of UPA treatment amenorrhoea or minimal loss (PBAC < 12 for whole phase) occurred in 63.1% (UPA 5 mg) or 71.3% (UPA 10 mg). The characterization of the individualized bleeding experience of the remaining women on 5 mg and 10 mg UPA, respectively, were infrequent bleeding in 17.9 and 12.8%; frequent or prolonged bleeding or both in 12.7 and 11.7% and irregular bleeding in 5.3 and 3.2%. In those with prolonged, frequent or irregular bleeding there was a high chance that sub-mucous fibroids were present (UPA 5 mg 100% and UPA 10 mg 78.6%) but no correlation with progesterone receptor modulator-associated endometrial changes. The follow-up PBAC data at Week 26 and Week 38 are only valid for women who did not have surgical intervention. These groups may not be representative of the groups at screening. This first detailed description of these SPRM bleeding patterns provides clinicians with an indication of potential responses in women using the SPRM UPA and provides an extended definition of bleeding in untreated women with excessive bleeding and fibroids. Funded by PregLem/Gedeon Richter. D.H.B. is a member of the Scientific Advisory Board of PregLem, and in this role participated in the study design and supervision. Stock originally held in PregLem was given up when PregLem was incorporated into Gedeon Richter; D.H.B. does not currently hold stock. M.A.L. has received payment from Gideon Richter to attend a meeting to present these data (Barcelona, April 2013) but no financial support in preparing the manuscript. B.C.J.M.F. is a member of the Scientific Advisory Board of PregLem and has received fees and grant support from the following companies: Andromed, Ardana, Auxogyn, Ferring, Genovum, Gedeon Richter, Merck Serono, MSD, Organon, Pantharei Bioscience, PregLem, Roche, Schering, Schering Plough, Serono, Watson Laboratories and Wyeth. P.T. is a paid statistical consultant for PregLem SA. E.B. is a full time employee of PregLem and received payment from stocks sold in October 2010 from the company's full acquisition by Gedeon Richter Group. ClinicalTrials.gov Identifier: NCT00755755 (PEARL I).
    Human Reproduction 01/2014; 29(3). DOI:10.1093/humrep/det467 · 4.59 Impact Factor
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    ABSTRACT: Selective progesterone receptor modulators (SPRMs) have beneficial effects in reducing the size of uterine fibroids and the amount of bleeding, but their endometrial effects have not been seen with other agents. This report describes the morphology of the endometrium after 3 mo of treatment with the SPRM, ulipristal acetate (UPA). In 2 Phase III randomized double-blind controlled clinical trials, 546 patients with uterine myomas were treated with 5 or 10 mg of UPA daily for 13 wk or placebo or gonadotropin-releasing hormone agonist. Endometrial biopsies were taken at screening, end of treatment (13 wk), and after treatment-free follow-up (38 wk). Biopsies were assessed independently by 3 pathologists according to a preset morphologic scheme. After 13 wk, the UPA-treated endometrium showed altered architectural glandular features including extensive cystic dilatation. The glandular epithelium appeared inactive or contained abortive subnuclear vacuolization, occasional mitoses, and apoptosis. Abnormal stromal vessels were commonly seen. There was a high level of agreement between pathologists on the presence or the absence of nonphysiological changes. One case of hyperplasia without atypia and 4 polyps were seen at 13 wk of UPA treatment. Six months after treatment, the endometrium returned to normal histology in the majority of the patients, with 1 polyp and no cases of hyperplasia in the UPA-treated groups, and 2 hyperplasias (1 with and 1 without atypia) in the placebo or the gonadotropin-releasing hormone-agonist groups. Mild reversible thickening of the endometrium occurs in a minority of cases. It is important that pathologists are aware of the spectrum of changes induced by SPRMs to avoid misdiagnoses of endometrial hyperplasia or polyps.
    International journal of gynecological pathology: official journal of the International Society of Gynecological Pathologists 09/2012; 31(6):556-69. DOI:10.1097/PGP.0b013e318251035b · 1.63 Impact Factor
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    ABSTRACT: Lipid profiles in women with early breast cancer receiving anastrozole with or without risedronate were examined within an international Phase III/IV study to assess for possible treatment related changes. Postmenopausal women with hormone receptor-positive breast cancer were assigned to 1 of 3 strata by risk of fragility fracture. Patients with the highest risk for fracture received anastrozole plus risedronate (A + R). Moderate-risk patients were randomized in a double-blind manner to A + R or anastrozole and placebo (A + P). Lower-risk patients received anastrozole (A) alone. Serial fasting blood samples were assessed for changes in lipid parameters relative to baseline after 12 months of treatment with anastrozole with or without risedronate. Samples were centrally analyzed for low-density lipoprotein cholesterol (LDL-cholesterol), high-density lipoprotein (HDL) cholesterol, total cholesterol (TC) and triglycerides (TG). Analysis was performed as primary analysis population for lipids (A plus A + P), lipid intention to treat population and secondary population (A + R). Of the 119 patients treated with A plus A + P, there were 66 patients eligible for inclusion in the primary analysis population. Of the 115 patients treated with secondary population (A + R) there were 65 patients eligible for lipid profiling. For LDL-cholesterol, HDL-cholesterol, TC and TG there were no significant changes between the baseline and 12 months assessments to suggest that any of these therapies have a negative impact on the lipid profile. In this study of postmenopausal women with early breast cancer receiving adjuvant anastrozole with or without risedronate, there was no adverse effect on LDL-cholesterol, HDL-cholesterol, TC or TG values over the 12 months monitoring period.
    Breast Cancer Research and Treatment 07/2012; 134(3):1141-7. DOI:10.1007/s10549-012-2147-9 · 4.20 Impact Factor
  • David H Barlow
    Menopause (New York, N.Y.) 01/2012; 19(1):8-9. DOI:10.1097/gme.0b013e31823cf08e · 2.81 Impact Factor
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    Climacteric 06/2011; 14(3):302-20. DOI:10.3109/13697137.2011.570590 · 2.24 Impact Factor
  • David H Barlow
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    ABSTRACT: Women may seek to prolong their reproductive span for a variety of reasons. For many this implies reproduction at a late age, possibly driven by lifestyle decisions, but for others affected by a natural or a cancer treatment-induced premature ovarian failure it may simply mean seeking to achieve the normal reproductive span. The range of interventions now available to address the issue of prolonging reproductive life has never been greater, although several of the approaches discussed remain in the realm of future application through being dependent on ongoing scientific developments.
    Annals of the New York Academy of Sciences 03/2011; 1221(1):1-9. DOI:10.1111/j.1749-6632.2011.05968.x · 4.31 Impact Factor
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    ABSTRACT: PURPOSE To investigate the management of bone health in women with early breast cancer (EBC) who were scheduled to receive anastrozole. PATIENTS AND METHODS Postmenopausal women with hormone receptor-positive EBC were assigned to one of three strata by risk of fragility fracture. Patients with the highest risk (H) received anastrozole 1 mg/d plus risedronate 35 mg/wk orally. Patients with moderate-risk (M) were randomly assigned in a double-blind manner to anastrozole and risedronate (A + R) or to anastrozole and placebo (A + P). Patients with lower-risk (L) received anastrozole (A) alone. Calcium and vitamin D were recommended for all patients. Lumbar spine and total hip bone mineral density (BMD) were assessed at baseline, 12 months, and 24 months. Results At 24 months, in the M group, treatment with A + R resulted in a significant increase in lumbar spine and total hip BMD compared with A + P treatment (2.2% v -1.8%; treatment ratio, 1.04; P < .0001; and 1.8% v -1.1%; treatment ratio, 1.03; P < .0001, respectively). In the H stratum, lumbar spine and total hip BMD increased significantly (3.0%; P = .0006; and 2.0%; P = .0104, respectively). Patients in the L stratum showed a significant decrease in lumbar spine BMD (-2.1%; P = .0109) and a numerical decrease in total hip BMD (-0.4%; P = .5988). Safety profiles for anastrozole and risedronate were similar to those already established. CONCLUSION In postmenopausal women at risk of fragility fracture who were receiving adjuvant anastrozole for EBC, the addition of risedronate at doses established for preventing and treating osteoporosis resulted in favorable effects in BMD during 24 months.
    Journal of Clinical Oncology 02/2010; 28(6):967-75. DOI:10.1200/JCO.2009.24.5902 · 18.43 Impact Factor
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    ABSTRACT: Endometriosis is the presence of tissue that normally lines the uterus in inappropriate sites (usually within the pelvic cavity). It can cause fertility problems and symptoms such as painful menstruation and painful sexual intercourse. Hormonal drugs including the oral contraceptive pill are used but have adverse effects and are not suitable for women wishing to become pregnant. Laparoscopic surgery (where small incisions are made in the abdomen) is performed to remove visible areas of endometriosis. The review of trials found that laparoscopic surgery may be of benefit in treating subfertility associated with mild to moderate endometriosis. However, the two studies on the subject show conflicting results. Additional studies in this field are needed before definitive conclusions can be drawn.
    Cochrane database of systematic reviews (Online) 01/2010; 1(1):CD001398. DOI:10.1002/14651858.CD001398.pub2 · 5.94 Impact Factor
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    ABSTRACT: Endometriosis is the presence of tissue that normally lines the uterus in inappropriate sites (usually within the pelvic cavity). It can cause fertility problems, painful menstruation and painful sexual intercourse. Hormonal drugs such as the oral contraceptive pill are used but may have adverse effects and are not suitable for women wishing to become pregnant. Laparoscopic surgery (where small incisions are made in the abdomen) is performed to remove visible areas of endometriosis. The review of trials found that laparoscopic surgery is effective in treating pelvic pain associated with endometriosis. More research is needed.
    Cochrane database of systematic reviews (Online) 10/2009; 4(4):CD001300. DOI:10.1002/14651858.CD001300.pub2 · 5.94 Impact Factor
  • S. Rozenberg · A. Gompel · D. Barlow
    International Journal of Gynecology & Obstetrics 10/2009; 107. DOI:10.1016/S0020-7292(09)60285-X · 1.56 Impact Factor
  • S. H. Kennedy · R. G. Forman · D. H. Barlow
    Journal of Obstetrics and Gynaecology 07/2009; 11(2). DOI:10.3109/01443619109013544 · 0.60 Impact Factor
  • Climacteric 08/2008; 11(4):267-72. DOI:10.1080/13697130802226866 · 2.24 Impact Factor
  • David H Barlow
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    ABSTRACT: The fractures that result from osteoporosis create a huge burden for both individuals affected and for societies across the world. This is especially aggravated as population age. Optimal policy in the management of osteoporosis should provide alleviation of suffering by reducing fracture events. In most health systems the interest is in achieving this at manageable cost. An important initiative is the WHO programme to provide tools for the individualisation of fracture risk which would have similarities to the approach familiar to doctors in the management of coronary heart disease risk. With individualised fracture risk it should be possible to focus resources on fracture prevention in those people most at risk. It is then a matter for the healthcare system to provide policies which guide clinicians on how far down the gradient of risk the system care afford to resource. This is the basis for a cost-effective approach. The paper explores the factors that enable valid risk assessment to be made and the difficulties that result for clinicians if resources are limited and affect the level of intervention that might be preferred.
    Maturitas 06/2008; 60(1):3-9. DOI:10.1016/j.maturitas.2008.02.012 · 2.86 Impact Factor
  • David H Barlow
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    ABSTRACT: The evidence concerning the effects of hormone therapy (HT) has been greatly expanded by the publication of very large randomized controlled trials. A consequence has been concern among women about the risks of HT such that the number of menopausal women using HT for relief of menopausal symptoms has declined. It is now appropriate to look at the best evidence available and to consider current policies. Women in the early postmenopausal phase, generally younger than 60 years of age, who are troubled by menopausal symptoms should be reassured that, for their circumstances, medical management of menopause in the form of HT is appropriate. If they go on to use HT for several years, it is possible that they will experience skeletal and coronary health benefits, but the evidence for such benefits is a matter of ongoing debate.
    Annals of the New York Academy of Sciences 05/2008; 1127:134-9. DOI:10.1196/annals.1434.002 · 4.31 Impact Factor

Publication Stats

6k Citations
909.97 Total Impact Points

Institutions

  • 2005–2015
    • University of Glasgow
      • College of Medical, Veterinary and Life Sciences
      Glasgow, Scotland, United Kingdom
  • 2014
    • Hamad Medical Corporation
      Ad Dawḩah, Baladīyat ad Dawḩah, Qatar
  • 2009–2010
    • Middlemore Hospital
      Окленд, Auckland, New Zealand
  • 1988–2009
    • Oxford University Hospitals NHS Trust
      • • Department of Obstetrics and Gynaecology
      • • Department of Paediatrics
      • • Department of Cellular Pathology
      • • Department of Radiology
      Oxford, England, United Kingdom
  • 2006
    • University of Auckland
      • Department of Obstetrics and Gynaecology
      Окленд, Auckland, New Zealand
  • 1991–2006
    • University of Oxford
      • Nuffield Department of Obstetrics and Gynaecology
      Oxford, England, United Kingdom
  • 1996
    • Chelsea and Westminster Hospital NHS Foundation Trust
      Londinium, England, United Kingdom
  • 1994
    • Yale University
      New Haven, Connecticut, United States