Dataset Information

The Use of Resveratrol as an Adjuvant Treatment of Pain in Endometriosis: A Randomized Clinical Trial.

ABSTRACT: Context:Resveratrol has been used for the treatment of endometriosis. Objective:To compare resveratrol (40 mg/d) with monophasic contraceptive pill (COC) to COC with placebo for the reduction of pain scores. Design:A randomized clinical trial. Setting:University Hospital. Patients:Women (ages 20 to 50) with laparoscopic diagnosis of endometriosis were eligible for the study. Exclusion criteria: pregnancy, allergy to resveratrol, or contraindications to COC, use of agonists of gonadotropin release hormone or danazol in the last month, or had used depot medroxyprogesterone acetate or Mirena®. Intervention:Subjects were randomized using a computer-generated randomization list to receive COC for 42 days to be taken with identical capsules containing 40 mg of resveratrol or placebo in coded bottles (1:1 ratio). Allocation was concealed in coded, sequenced, opaque-sealed envelopes. Main Outcome:Median pain scores measured with a visual analog scale on day 42. Results:Between 18 June and 6 November 2015, 44 subjects were enrolled. Mean [95% confidence interval (CI)] pain scores on day 0 were 5.4 (4.2 to 6.6) in the placebo group and 5.7 (4.8 to 6.6) in resveratrol groups. After treatment, pain values were [3.9 (2.2 to 5); n = 22] and [3.2 (2.1 to 4.3); n = 22] in the placebo and resveratrol groups, respectively (P = 0.7; Mann-Whitney U test). Median (95% CI) difference between groups was 0.75 (-1.6 to 2.3). Conclusion:Resveratrol is not superior to placebo for treatment of pain in endometriosis.

SUBMITTER: Mendes da Silva D

PROVIDER: S-EPMC5686687 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Use of Resveratrol as an Adjuvant Treatment of Pain in Endometriosis: A Randomized Clinical Trial.

Mendes da Silva Daniel D Gross Luiza Azevedo LA Neto Ernesto de Paula Guedes EPG Lessey Bruce A BA Savaris Ricardo Francalacci RF

Journal of the Endocrine Society 20170315 4

<h4>Context</h4>Resveratrol has been used for the treatment of endometriosis.<h4>Objective</h4>To compare resveratrol (40 mg/d) with monophasic contraceptive pill (COC) to COC with placebo for the reduction of pain scores.<h4>Design</h4>A randomized clinical trial.<h4>Setting</h4>University Hospital.<h4>Patients</h4>Women (ages 20 to 50) with laparoscopic diagnosis of endometriosis were eligible for the study. Exclusion criteria: pregnancy, allergy to resveratrol, or contraindications to COC, us ...[more]

PMID: 29264492

Similar Datasets

Project description:ImportanceImproved strategies are needed to decrease opioid use after cesarean delivery but still adequately control postoperative pain. Although transcutaneous electrical stimulation devices have proven effective for pain control after other surgical procedures, they have not been tested as part of a multimodal analgesic protocol after cesarean delivery, the most common surgical procedure in the United States.ObjectiveTo determine whether treatment with a noninvasive high-frequency electrical stimulation device decreases opioid use and pain after cesarean delivery.Design, setting, and participantsThis triple-blind, sham-controlled randomized clinical trial was conducted from April 18, 2022, to January 31, 2023, in the labor and delivery unit at a single tertiary academic medical center in Ohio. Individuals were eligible for the study if they had a singleton or twin gestation and underwent a cesarean delivery. Of 267 people eligible for the study, 134 (50%) were included.InterventionParticipants were randomly assigned in a 1:1 ratio to a high-frequency (20 000 Hz) electrical stimulation device group or to an identical-appearing sham device group and received 3 applications at the incision site in the first 20 to 30 hours postoperatively.Main outcomes and measuresThe primary outcome was inpatient postoperative opioid use, measured in morphine milligram equivalents (MME). Secondary outcomes included pain scores, measured with the Brief Pain Inventory questionnaire (scale, 0-10, with 0 representing no pain), MME prescribed at discharge, and receipt of additional opioid prescriptions in the postpartum period. Normally distributed data were assessed using t tests; otherwise via Mann-Whitney or χ2 tests as appropriate. Analyses were completed following intention-to-treat principles.ResultsOf 134 postpartum individuals who underwent a cesarean delivery (mean [SD] age, 30.5 [4.6] years; mean [SD] gestational age at delivery, 38 weeks 6 days [8 days]), 67 were randomly assigned to the functional device group and 67 to the sham device group. Most were multiparous, had prepregnancy body mass index (calculated as weight in kilograms divided by height in meters squared) higher than 30, were privately insured, and received spinal anesthesia. One participant in the sham device group withdrew consent prior to treatment. Individuals assigned to the functional device used significantly less opioid medication prior to discharge (median [IQR], 19.75 [0-52.50] MME) than patients in the sham device group (median [IQR], 37.50 [7.50-67.50] MME; P = .046) and reported similar rates of moderate to severe pain (85% vs 91%; relative risk [RR], 0.77 [95% CI, 0.55-1.29]; P = .43) and mean pain scores (3.59 [95% CI, 3.21-3.98] vs 4.46 [95% CI, 4.01-4.92]; P = .004). Participants in the functional device group were prescribed fewer MME at discharge (median [IQR], 82.50 [0-90.00] MME vs 90.00 [75.00-90.00] MME; P < .001). They were also more likely to be discharged without an opioid prescription (25% vs 10%; RR, 1.58 [95% CI, 1.08-2.13]; P = .03) compared with the sham device group. No treatment-related adverse events occurred in either group.Conclusions and relevanceIn this randomized clinical trial of postoperative patients following cesarean delivery, use of a high-frequency electrical stimulation device as part of a multimodal analgesia protocol decreased opioid use in the immediate postoperative period and opioids prescribed at discharge. These findings suggest that the use of this device may be a helpful adjunct to decrease opioid use without compromising pain control after cesarean delivery.

Project description:BackgroundTo study the effectiveness of an aromatase inhibitor (Anastrozole) associated with levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.MethodsProspective, randomized clinical trial.SettingUniversity Hospital (single center). Elegibility criteria: Endometriomas > 3 × 4 cm, CA-125 > 35 U/mL and endometriosis symptoms.PatientsThirty-one women randomized to anastrozole + Mirena® + Conservative Surgery(CS) (n = 8), anastrozole + Mirena® + transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n = 7), Mirena® + CS (n = 9), or Mirena® + TUGPA (n = 7).InterventionsAnastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment.Main outcome measuresVisual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.ResultsA significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients including anastrozole in their treatment (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed in patients not taking anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena® + anastrozole). After CS for endometriosis, a reduction of ultrasound findings of endometriomas and long-term recurrence occurred, with or without anastrozole. At 4.2 ± 1.7 years (95% CI 3.57-4.85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p = 0.019).ConclusionsDosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces significantly the painful symptoms and delays recurrence, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Trial registrationEudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

Project description:BackgroundEndometriosis (where endometrial-like tissue is found outside the uterus) affects ~?176 million women worldwide and can lead to debilitating pelvic pain. There is an unmet need for new medical treatment options for endometriosis. Pelvic peritoneal mesothelial cells of women with endometriosis exhibit detrimental metabolic reprogramming that creates an environment favouring the formation and survival of endometriosis lesions. We have generated powerful preclinical proof-of-concept data to show that it is possible to correct this metabolic phenotype using dichloroacetate (DCA), a non-hormonal compound previously used to treat rare metabolic disorders in children. We plan a single-arm, open-label, single site exploratory clinical trial to inform the design of a future randomised controlled trial (RCT) to determine the efficacy of DCA for the treatment of endometriosis-associated pain.MethodsWe will recruit 30 women with endometriosis-associated pain over a 6-month period. All participants will receive approximately 6.25?mg/kg oral DCA capsules twice daily for 6?weeks, with a dose increase to approximately 12.5?mg/kg twice daily for a further 6?weeks if their pain has not been adequately controlled on this dose regime and side-effects are acceptable. If pain is adequately controlled with minimal side-effects, the lower dose will be continued for a further 6?weeks. The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within the defined exclusion and inclusion criteria. Secondary objectives are to determine the acceptability of the trial to participants, including the proposed methods of recruitment, treatment, follow-up frequency and number of questionnaires. The recruitment rate will be determined by the proportion of patients recruited from the pool of eligible women. The retention rate will be determined by the proportion of participants who attended the final trial visit.DiscussionThis is a feasibility study to explore effectiveness and acceptability of the proposed field methodology (recruitment, retention, study processes and compliance with treatment). The results will be used to inform the design of a future RCT.Trial registrationClinicalTrials.gov, NCT04046081 Registered 6 August 2019.

Dataset Information

The Use of Resveratrol as an Adjuvant Treatment of Pain in Endometriosis: A Randomized Clinical Trial.

Publications

The Use of Resveratrol as an Adjuvant Treatment of Pain in Endometriosis: A Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets