Background: Abdominal pain due to menses (primary dysmenorrhea) is an extremely pervasive and debilitating symptom affecting up to 90% of menstruating individuals. Objective: The objective of this randomized control trial was to investigate the effect of a commercial transcutaneous electrical nerve stimulation unit, Therabody PowerDot ® (Therabody Inc., Los Angeles) on dysmenorrhea compared with non-steroidal anti-inflammatory drug use. Design: This was a randomized cross-over study. Methods: A total of 47 participants agreed to participate in the study, with 34 completing it. Participants completed treatments across three consecutive menstrual cycles in randomized order: single-unit transcutaneous electrical nerve stimulation (Uno), dual unit transcutaneous electrical nerve stimulation (Duo), and non-steroidal anti-inflammatory drug use (Control). Upon onset of dysmenorrhea, participants applied transcutaneous electrical nerve stimulation to their abdomen for a minimum of 30 min. Control participants were instructed to take non-steroidal anti-inflammatory drugs as needed. Surveys were used to record pain before and after treatment. We hypothesized that the PowerDot would decrease self-reported pain scores, and decrease non-steroidal anti-inflammatory drug consumption during menses. Results: Participants experienced a statistically and clinically significant reduction in pain during the Control (−3.52 ± 1.9), Uno (−2.10 ± 1.6), and Duo (−2.19 ± 1.7) cycles ( p < 0.001). The doses of non-steroidal anti-inflammatory drugs consumed during the Control cycle (3.5 ± 2.6), was significantly different as compared with that of Uno (1.5 ± 3.0), or Duo (1.1 ± 2.6) ( p = 0.004). Conclusions: Use of a commercial transcutaneous electrical nerve stimulation unit results in significant decrease in pain. Although not as robust as the relief in pain induced by non-steroidal anti-inflammatory drugs, the adverse events of transcutaneous electrical nerve stimulation are minimal in comparison. Therefore, transcutaneous electrical nerve stimulation appears to be a viable alternative to pain relief from dysmenorrhea. Clinical Trial Registration: NCT05178589
Abstract STUDY QUESTION Does increased daily energy intake lead to menstrual recovery in exercising women with oligomenorrhoea (Oligo) or amenorrhoea (Amen)? SUMMARY ANSWER A modest increase in daily energy intake (330 ± 65 kcal/day; 18 ± 4%) is sufficient to induce menstrual recovery in exercising women with Oligo/Amen. WHAT IS KNOWN ALREADY Optimal energy availability is critical for normal reproductive function, but the magnitude of increased energy intake necessary for menstrual recovery in exercising women, along with the associated metabolic changes, is not known. STUDY DESIGN, SIZE, DURATION The REFUEL study (trial # NCT00392873) is the first randomised controlled trial to assess the effectiveness of 12 months of increased energy intake on menstrual function in 76 exercising women with menstrual disturbances. Participants were randomised (block method) to increase energy intake 20–40% above baseline energy needs (Oligo/Amen + Cal, n = 40) or maintain energy intake (Oligo/Amen Control, n = 36). The study was performed from 2006 to 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS Participants were Amen and Oligo exercising women (age = 21.0 ± 0.3 years, BMI = 20.8 ± 0.2 kg/m2, body fat = 24.7 ± 0.6%) recruited from two universities. Detailed assessment of menstrual function was performed using logs and measures of daily urinary ovarian steroids. Body composition and metabolic outcomes were assessed every 3 months. MAIN RESULTS AND THE ROLE OF CHANCE Using an intent-to-treat analysis, the Oligo/Amen + Cal group was more likely to experience menses during the intervention than the Oligo/Amen Control group (P = 0.002; hazard ratio [CI] = 1.91 [1.27, 2.89]). In the intent-to-treat analysis, the Oligo/Amen + Cal group demonstrated a greater increase in energy intake, body weight, percent body fat and total triiodothyronine (TT3) compared to the Oligo/Amen Control group (P < 0.05). In a subgroup analysis where n = 22 participants were excluded (ambiguous baseline menstrual cycle, insufficient time in intervention for menstrual recovery classification), 64% of the Oligo/Amen + Cal group exhibited improved menstrual function compared with 19% in the Oligo/Amen Control group (χ2, P = 0.001). LIMITATIONS, REASONS FOR CAUTION While we had a greater than expected dropout rate for the 12-month intervention, it was comparable to other shorter interventions of 3–6 months in duration. Menstrual recovery defined herein does not account for quality of recovery. WIDER IMPLICATIONS OF THE FINDINGS Expanding upon findings in shorter, non-randomised studies, a modest increase in daily energy intake (330 ± 65 kcal/day; 18 ± 4%) is sufficient to induce menstrual recovery in exercising women with Oligo/Amen. Improved metabolism, as demonstrated by a modest increase in body weight (4.9%), percent body fat (13%) and TT3 (16%), was associated with menstrual recovery. STUDY FUNDING/COMPETING INTEREST(S) This research was supported by the U.S. Department of Defense: U.S. Army Medical Research and Material Command (Grant PR054531). Additional research assistance provided by the Penn State Clinical Research Center was supported by the National Center for Advancing Translation Sciences, National Institutes of Health, through Grant UL1 TR002014. M.P.O. was supported in part by the Loretta Anne Rogers Chair in Eating Disorders at University of Toronto and University Health Network. All authors report no conflict of interest. TRIAL REGISTRATION NUMBER NCT00392873 TRIAL REGISTRATION DATE October 2006 DATE OF FIRST PATIENT’S ENROLMENT September 2006
The prevalence of osteoporosis among women aged 50 years and older is expected to reach 13.6 million by 2030. Osteoporosis is characterized by compromised bone strength due to reduced bone mineral density (BMD) and bone quality, representing a major public health issue that necessitates effective treatment regimens that are safe, cost-effective, and associated with fewer adverse effects than pharmaceutical agents. Alternative dietary interventions such as prunes (dried plum) have been extensively studied to mitigate bone loss in preclinical models of osteoporosis. In postmenopausal women, estrogen deficiency triggers an upregulation of inflammatory pathways, which promotes bone loss, thus increasing risk of fractures. Our understanding of the effect of prune consumption on inflammatory markers in humans is limited, warranting further investigation. This study aimed to evaluate the effects of 12 months of prune consumption (two doses) on inflammatory mediators. Postmenopausal women (n=106, 55-75 years old) with low BMD were randomized to consume 0g prunes/day (control), 50g prunes/day, or 100g prunes/day for 12 months. All participants received 1200mg calcium and 800 IU vitamin D3 as standard of care. We hypothesized that prune consumption at 50g/day and 100g/day will reduce inflammatory markers in postmenopausal women with low BMD compared to control group (0g/day). At baseline and after 12 months of prune consumption, serum and peripheral blood mononuclear cells (PBMCs) were isolated to quantify C-reactive protein (CRP) using a high-sensitivity CRP immunoassay, the number of circulating monocytes using flow cytometry, and pro-inflammatory cytokines [interleukin (IL)-1β, IL-6, IL-8, monocyte chemoattractant protein (MCP)-1, and tumor necrosis factor (TNF)-α] from lipopolysaccharide (LPS)-stimulated PBMCs using a multiplex enzyme-linked immunosorbent assay. Differences among groups were assessed using one-way ANOVA or Kruskal-Wallis test. No significant differences in baseline characteristics were found among the three treatment groups. Prune consumption did not alter serum CRP or the number of monocytes. However, consumption of 100g prunes/day resulted in a significant reduction from baseline in IL-1β (p=0.013), IL-6 (p=0.007), and IL-8 (p=0.049) secretion and consumption of 50g prunes/day resulted in a significant reduction from baseline in TNF-α (p<0.001) secretion from LPS-stimulated PBMCs compared to the control group. Our findings demonstrate that 12 months of prune consumption suppresses inflammatory cytokines from LPS-stimulated PBMCs. Thus, daily consumption of 50g-100g of prunes may reduce inflammatory mediators that can contribute to bone loss in postmenopausal women.
BACKGROUND: Lower abdominal pain during menses, affects up to 91% of individuals who menstruate. The most common method of menstrual pain relief is non-steroidal anti-inflammatory drugs (NSAIDS). However, evidence suggests transcutaneous electrical nerve stimulation (TENS) may provide an alternative to such pharmacological interventions. PURPOSE: This was a feasibility study that is part of an ongoing investigation into the efficacy of an entirely remote study using a wireless and app based commercial TENS for menstrual pain relief. METHODS: Eight menstruating individuals (25 ± 4.24 years old, 22.13 ± 2.76 BMI) completed three consecutive menstrual cycles using the Therabody Power Dot TENS unit in randomized order: single-unit (Uno), dual-unit (Duo), NSAID (control). The Uno cycle used a single Power Dot pod connected to 2 electrode pads through a set of lead cables. The Duo cycle utilized two Power Dot pods connected to 4 electrode pads through a set of two lead cables. Whoop was used to collect physiologic quantitative and qualitative data during each menstrual cycle. During the Uno and Duo cycles, participants were instructed to place Power Dot on their abdomen over the area of pain and to increase the device stimulation to a comfortable intensity. Scores were collected through the Power Dot application. During all cycles, including control, participants were instructed to record NSAID use along with pre-and post-pain scores. Compliance was assessed based on completion of a daily Whoop survey, reporting pre/post pain scores each cycle, and completing all treatments. RESULTS: Seven (7/8) participants completed all three months of treatment. All eight (8/8) participants successfully answered the Whoop survey each day of participation in the study. Lastly, all participants (8/8) reported pre/post pain scores in the Power Dot app upon use, and reported NSAID use in the Whoop app. CONCLUSION: To our knowledge, this is the first study that was conducted on dysmenorrhea and TENS outside of a lab setting. Collection of data through a mobile application is not only more representative of how participants would use the device outside of the laboratory setting, but it also would mitigate error that is introduced from retrospective recall.
The use of non-pharmacological alternatives to pharmacological interventions, e.g., nutritional therapy, to improve or maintain bone mineral density (BMD) in postmenopausal women has gained traction over the past decade, but limited data exist regarding its efficacy. The purpose of this case report was to compare changes in BMD of an osteopenic postmenopausal woman over the course of 28 months, including an abrupt change in diet. For the first 12 months, a participant assigned to the control arm of a randomized controlled trial (RCT) only took calcium and vitamin D3 supplements, but in the following 16 months after completing the RCT, she introduced and maintained daily consumption of 50 g of dried plums in addition to calcium and vitamin D3 supplements. This case report provides a unique opportunity to follow the trajectory of distinct changes in bone in response to one dietary modification.
PURPOSE: To counter the deleterious effects of weightlessness on the cardiopulmonary system, astronauts living on the International Space Station exercise on a variety of countermeasure equipment including the Cycle Ergometer Vibration Isolation and Stabilization System (CEVIS). Operational since 2001, the onboard CEVIS will be replaced by a new model, known as Teal CEVIS (TC). As a part of ground evaluation, TC hardware underwent human-in-the-loop (HITL) testing to verify that the TC hardware produces workloads that elicit physiologic responses comparable to a laboratory cycle ergometer (LAB). METHODS: Seven subjects (5 M/2 F) performed submaximal cycle ergometer testing with indirect calorimetry measures on TC and LAB on separate test days. Testing consisted of graded 30 watt increases in workload until subjects reached 85% of his/her age-predicted max heart rate (HR). Exercise outcomes included rate of oxygen uptake (VO2; liters/min), rate of energy expenditure (REE; kcal/min), and HR (beats/min). Linear mixed models (LMM) were fitted to compare VO2, REE, and HR responses between devices across power outputs with fixed effects for power (P) and device (D) and with random effects for subject. LMM effect coefficients (β), std errors (SE), pseudo-partial R2 of effects (pR2), and model likelihood ratio statistics (χ2, Pr(> chisq); α < .05) are provided. RESULTS: LMM main effects for P and D were observed for VO2 (βp = .0107, SE = .0002, pR2 = 0.97; βd = -0.075, SE = 0.019, pR2 = 0.14; χ2(1) = 13.57, p < .001), such that VO2 was higher across stages on TC. Main effects of P and D were observed for REE (βp = .0586, SE = 0.001, pR2 = 0.97; βd = -0.33208, SE = 0.099, pR2 = 0.056; χ2(1) = 10.481, p < .01), such that REE was higher across power outputs on TC. A P x D interaction was observed for HR, along with main effects for P and D (βp x d = -0.048, SE = 0.02, pR2 = 0.048; βp = 0.42, SE = 0.016, pR2 = 0.87; χ2(1) = 5.398, p = 0.02), such that higher workloads elicited a greater difference in HR between devices. CONCLUSIONS: HITL results show, TC elicits greater physiologic responses across power outputs compared to LAB. However, pR2 for device effects show small differences between devices. Therefore, TC can be expected to provide appropriate physiological stimulus across workloads and be considered a reliable tool to mitigate the effects of weightlessness.
The use of non-pharmacological alternatives to pharmacological interventions, e.g., nutritional therapy, to improve or maintain bone mineral density (BMD) in postmenopausal women has gained traction over the past decade, but limited data exist regarding its efficacy. This paper describes the design of the Prune Study, a randomized controlled trial (RCT) that explored the effectiveness of a 12-month intervention of daily prune consumption on bone density, bone structure and strength estimates, bone turnover, various biomarkers of immune function, inflammation, and cardiovascular health, as well as phenolic and gut microbiota analyses. Postmenopausal women between the ages of 55-75 years were randomized into either control group (no prune consumption; n = 78), 50g prune (50g prune/day; n = 79), or 100g prune (100g prune/day; n = 78). All participants received 1200 mg calcium +800 IU vitamin D
