Gabapentin for chronic pelvic pain in women (GaPP2):a multicentre, randomised, double-blind, placebo-controlled trial

BackgroundChronic pelvic pain affects 2–24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology.MethodsWe performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18–50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16–17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13–16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762.FindingsParticipants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13–16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was −1·4 (SD 2·3) in the gabapentin group and −1·2 (SD 2·1) in the placebo group (adjusted mean difference −0·20 [97·5% CI −0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was −1·1 (SD 2·0) in the gabapentin group and −0·9 (SD 1·8) in the placebo group (adjusted mean difference −0·18 [97·5% CI −0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group.InterpretationThis study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology.FundingNational Institute for Health Research

Septic arthritis of left shoulder in pregnancy following minor hand injury

Septic arthritis of the shoulder joint is rare and might affect around 3% of the general population [1]. A delay in diagnosis may increase morbidity and lead to bone and cartilage destruction [2]. Septic arthritis is an unusual complication of pregnancy and can progress to permanent arthropathy and disability [3]. Septic arthropathy in pregnancy requires multidisciplinary team involvement for prompt recognition and treatment to improve both maternal and fetal outcomes. High index of suspicion is vital when clinical and laboratory findings suggest septic arthritis. There are multiple predisposing factors reported previously for septic arthritis of the shoulder in pregnancy such as medical conditions, pyelonephritis and trauma. We report a 37 year old lady who presented at 26 weeks gestation with acute left shoulder pain and high temperature following minor left palm trauma. She also had left mastectomy with axillary clearance ten years earlier. She underwent arthroscopic wash out of her left shoulder joint and was covered with antibiotics with rapid improvement and recovery. We reinforce the importance of early multidisciplinary involvement when septic arthritis of the shoulder in pregnancy is suspected especially in women who have had previous mastectomy and axillary clearance which could be a predisposing factor for such a rare and serious joint condition in pregnancy

Luteal phase support in in-vitro fertilization

Objective: To compare the clinical pregnancy rate after the use of human chorionic gonadotropin (hCG) injections (Profasi, Serono Pharmaceuticals), to that after the use of oral Duphaston (Duphaston, Solvay Pharmaceuticals B.V., Weesp, The Netherlands) , or vaginal Cyclogest (Cyclogest, Cox Pharmaceuticals, Barnstaple, Ex32 8NS, England) used for luteal phase support in in-vitro fertilization-embryo transfer (IVF-ET) cycles using gonadotropin- releasing hormone agonist. Study design: A retrospective cohort study. Setting: Tawam Hospital Fertility Clinic (a tertiary referral center) in the United Arab Emirates. Materials and methods: A total of 305 consecutive IVF/ET cycles from 1st of January to 31st of May 2000 were included in the study. All women were < 40 years of age. 201 women were treated with hCG (66%) at a dose of 1,500-2,500 IU intramuscular (IM) given every second or third day for three to five doses. 44 women were treated with oral Duphaston (14.4%) given at a dose of 40mg/day and 60 were given vaginal Cyclogest pessaries (19.6%) at a dose of 400mg twice daily, until the date of the pregnancy test. Student t test was used for statistical analysis to measure significance. Main outcome measures: Clinical pregnancy rate. Results: The use of IM hCG for luteal phase support in IVF-ET cycles was associated with similar clinical pregnancy rate compared with vaginal Cyclogest pessaries and oral progesterone (Duphaston) (24.9%, 28.3% and 25% respectively), (P=1.000and P= 0.359). Conclusion: There is no significant difference in clinical pregnancy rate when different modalities of luteal phase support medications are used in IVF-ET cycles like hCG, oral Duphaston and vaginal Cyclogest. This conclusion is affected by the small number of studied cycles and the study design being retrospective