scholarly journals A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa

2019 ◽  
Vol 104 (10) ◽  
pp. 4347-4355 ◽  
Author(s):  
Allison Kimball ◽  
Melanie Schorr ◽  
Erinne Meenaghan ◽  
Katherine N Bachmann ◽  
Kamryn T Eddy ◽  
...  
Keyword(s):  
Anorexia Nervosa ◽  
Placebo Group ◽  
Eating Disorder ◽  
Symptom Severity ◽  
Anxiety Symptom ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Symptom ◽  
Testosterone Therapy

Abstract Context Anorexia nervosa (AN) is a psychiatric illness with considerable morbidity and no approved medical therapies. We have shown that relative androgen deficiency in AN is associated with greater depression and anxiety symptom severity. Objective To determine whether low-dose testosterone therapy is an effective endocrine-targeted therapy for AN. Design Double-blind, randomized, placebo-controlled trial. Setting Clinical research center. Participants Ninety women, 18 to 45 years, with AN and free testosterone levels below the median for healthy women. Intervention Transdermal testosterone, 300 μg daily, or placebo patch for 24 weeks. Main Outcome Measures Primary end point: body mass index (BMI). Secondary end points: depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors. Results Mean BMI increased by 0.0 ± 1.0 kg/m2 in the testosterone group and 0.5 ± 1.1 kg/m2 in the placebo group (P = 0.03) over 24 weeks. At 4 weeks, there was a trend toward a greater decrease in HAM-D score (P = 0.09) in the testosterone vs placebo group. At 24 weeks, mean HAM-D and HAM-A scores decreased similarly in both groups [HAM-D: −2.9 ± 4.9 (testosterone) vs −3.0 ± 5.0 (placebo), P = 0.72; HAM-A: −4.5 ± 5.3 (testosterone) vs −4.3 ± 4.4 (placebo), P = 0.25]. There were no significant differences in eating disorder scores between groups. Testosterone therapy was safe and well tolerated with no increase in androgenic side effects compared with placebo. Conclusion Low-dose testosterone therapy for 24 weeks was associated with less weight gain—and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms—compared with placebo in women with AN.

scholarly journals MON-225 A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women with Anorexia Nervosa

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Allison Kimball ◽  
Melanie Schorr ◽  
Erinne Meenaghan ◽  
Katherine Bachmann ◽  
Kamryn Eddy ◽  
...  
Keyword(s):  
Anorexia Nervosa ◽  
Low Dose ◽  
Controlled Trial ◽  
Testosterone Therapy

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

Randomized controlled trial of digital cognitive behavior therapy for prenatal insomnia symptoms: Effects on postpartum insomnia and mental health

SLEEP ◽  
2021 ◽  
Author(s):  
Jennifer N Felder ◽  
Elissa S Epel ◽  
John Neuhaus ◽  
Andrew D Krystal ◽  
Aric A Prather
Keyword(s):  
Mental Health ◽  
Depressive Symptoms ◽  
Behavior Therapy ◽  
Cognitive Behavior Therapy ◽  
Symptom Severity ◽  
Standard Care ◽  
Anxiety Symptom ◽  
Controlled Trial ◽  
Cognitive Behavior ◽  
Insomnia Symptom

Abstract Study objectives To evaluate the effects of digital cognitive behavior therapy for insomnia (dCBT-I) delivered during pregnancy on subjective sleep outcomes, depressive symptoms, and anxiety symptoms through six months postpartum. Methods People up to 28 weeks gestation (N=208) with insomnia were randomized to six weekly sessions of dCBT-I or standard care. We report follow-up data at three and six months postpartum. The primary outcome was insomnia symptom severity. Secondary sleep outcomes included global sleep quality and insomnia caseness. Mental health outcomes included depressive and anxiety symptom severity. We evaluated between-condition differences in change from baseline for each postpartum timepoint and categorical outcomes. Results dCBT-I participants did not experience significantly greater improvements in insomnia symptom severity relative to standard care participants, but they did experience higher rates of insomnia remission and lower rates of insomnia caseness at six months postpartum. dCBT-I participants experienced greater improvements in depressive symptom severity from baseline to both postpartum timepoints, and in anxiety symptom severity from baseline to three months postpartum. The proportion of participants with probable major depression at three months postpartum was significantly higher among standard care (18%) than dCBT-I (4%, p=.006) participants; this between-condition difference was pronounced among the subset (n=143) with minimal depressive symptoms at baseline (18% vs 0%). Conclusion dCBT-I use during pregnancy leads to enduring benefits for postpartum insomnia remission. Findings provide strong preliminary evidence that dCBT-I use during pregnancy may prevent postpartum depression and anxiety, which is notable when considering the high frequency and importance of these problems.

scholarly journals Effect of Low-Dose (Single-Dose) Magnesium Sulfate on Postoperative Analgesia in Hysterectomy Patients Receiving Balanced General Anesthesia

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Arman Taheri ◽  
Katayoun Haryalchi ◽  
Mandana Mansour Ghanaie ◽  
Neda Habibi Arejan
Keyword(s):  
Single Dose ◽  
Postoperative Pain ◽  
General Anesthesia ◽  
Magnesium Sulfate ◽  
Pain Score ◽  
Normal Saline ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group

Background and Aim. Aparallel, randomized, double blinded, placebo-controlled trial study was designed to assess the efficacy of single low dose of intravenous magnesium sulfate on post-total abdominal hysterectomy (TAH) pain relief under balanced general anesthesia.Subject and Methods. Forty women undergoing TAH surgery were assigned to two magnesium sulfate (N=20) and normal saline (N=20) groups randomly. The magnesium group received magnesium sulfate 50 mg·kg−1in 100 mL of normal saline solution i.v as single-dose, just 15 minutes before induction of anesthesia whereas patients in control group received 100 mL of 0.9% sodium chloride solution at the same time. The same balanced general anesthesia was induced for two groups. Pethidine consumption was recorded over 24 hours precisely as postoperative analgesic. Pain score was evaluated with Numeric Rating Scale (NRS) at 0, 6, 12, and 24 hours after the surgeries.Results. Postoperative pain score was lower in magnesium group at 6, 12, and 24 hours after the operations significantly (P<0.05).Pethidinerequirement was significantly lower in magnesium group throughout 24 hours after the surgeries (P=0.0001).Conclusion. Single dose of magnesium sulfate during balanced general anesthesia could be considered as effective and safe method to reduce postoperative pain and opioid consumption after TAH.

scholarly journals Monitoring Changes in Depression Severity Using Wearable and Mobile Sensors

2020 ◽  
Vol 11 ◽  
Author(s):  
Paola Pedrelli ◽  
Szymon Fedor ◽  
Asma Ghandeharioun ◽  
Esther Howe ◽  
Dawn F. Ionescu ◽  
...  
Keyword(s):  
Depressive Symptom ◽  
Symptom Severity ◽  
Rating Scale ◽  
Wearable Sensors ◽  
Absolute Error ◽  
Preliminary Evidence ◽  
Activity Level ◽  
Depression Symptom ◽  
Model Combining ◽  
Depressive Symptom Severity

Background: While preliminary evidence suggests that sensors may be employed to detect presence of low mood it is still unclear whether they can be leveraged for measuring depression symptom severity. This study evaluates the feasibility and performance of assessing depressive symptom severity by using behavioral and physiological features obtained from wristband and smartphone sensors.Method: Participants were thirty-one individuals with Major Depressive Disorder (MDD). The protocol included 8 weeks of behavioral and physiological monitoring through smartphone and wristband sensors and six in-person clinical interviews during which depression was assessed with the 17-item Hamilton Depression Rating Scale (HDRS-17).Results: Participants wore the right and left wrist sensors 92 and 94% of the time respectively. Three machine-learning models estimating depressive symptom severity were developed–one combining features from smartphone and wearable sensors, one including only features from the smartphones, and one including features from wrist sensors–and evaluated in two different scenarios. Correlations between the models' estimate of HDRS scores and clinician-rated HDRS ranged from moderate to high (0.46 [CI: 0.42, 0.74] to 0.7 [CI: 0.66, 0.74]) and had moderate accuracy with Mean Absolute Error ranging between 3.88 ± 0.18 and 4.74 ± 1.24. The time-split scenario of the model including only features from the smartphones performed the best. The ten most predictive features in the model combining physiological and mobile features were related to mobile phone engagement, activity level, skin conductance, and heart rate variability.Conclusion: Monitoring of MDD patients through smartphones and wrist sensors following a clinician-rated HDRS assessment is feasible and may provide an estimate of changes in depressive symptom severity. Future studies should further examine the best features to estimate depressive symptoms and strategies to further enhance accuracy.

scholarly journals Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021531 ◽  
Author(s):  
Bethan Dalton ◽  
Savani Bartholdy ◽  
Jessica McClelland ◽  
Maria Kekic ◽  
Samantha J Rennalls ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Anorexia Nervosa ◽  
Eating Disorder ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Eating Disorder Symptoms ◽  
Randomised Controlled

ObjectiveTreatment options for severe, enduring anorexia nervosa (SE-AN) are limited. Non-invasive neuromodulation is a promising emerging intervention. Our study is a feasibility randomised controlled trial of repetitive transcranial magnetic stimulation (rTMS) in individuals with SE-AN, which aims to inform the design of a future large-scale trial.DesignDouble-blind, parallel group, two-arm, sham-controlled trial.SettingSpecialist eating disorders centre.ParticipantsCommunity-dwelling people with anorexia nervosa, an illness duration of ≥3 years and at least one previous completed treatment.InterventionsParticipants received 20 sessions (administered over 4 weeks) of MRI-guided real or sham high-frequency rTMS to the left dorsolateral prefrontal cortex in addition to treatment-as-usual.OutcomesPrimary outcomes were recruitment, attendance and retention rates. Secondary outcomes included body mass index (BMI), eating disorder symptoms, mood, quality of life and rTMS safety and tolerability. Assessments were conducted at baseline, post-treatment and follow-up (ie, at 0 month, 1 month and 4 months post-randomisation).ResultsThirty-four participants (17 per group) were randomly allocated to real or sham rTMS. One participant per group was withdrawn prior to the intervention due to safety concerns. Two participants (both receiving sham) did not complete the treatment. rTMS was safe and well tolerated. Between-group effect sizes of change scores (baseline to follow-up) were small for BMI (d=0.2, 95% CI −0.49 to 0.90) and eating disorder symptoms (d=0.1, 95% CI −0.60 to 0.79), medium for quality of life and moderate to large (d=0.61 to 1.0) for mood outcomes, all favouring rTMS over sham.ConclusionsThe treatment protocol is feasible and acceptable to participants. Outcomes provide preliminary evidence for the therapeutic potential of rTMS in SE-AN. Largest effects were observed on variables assessing mood. This study supports the need for a larger confirmatory trial to evaluate the effectiveness of multi-session rTMS in SE-AN. Future studies should include a longer follow-up period and an assessment of cost-effectiveness.Trial registration numberISRCTN14329415; Pre-results.

scholarly journals Pretreatment with Pectoral Nerve Block II Is Effective for Reducing Pain in Patients Undergoing Thoracoscopic Lobectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Ge Luo ◽  
Jianjun Zhu ◽  
Huadong Ni ◽  
Qinghe Zhou ◽  
Yaping Lu ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nerve Block ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Postanesthesia Care Unit ◽  
Total Consumption ◽  
Rescue Analgesia ◽  
Thoracoscopic Lobectomy ◽  
Pectoral Nerve

Background. Although video-assisted thoracoscopy has a smaller incision than traditional surgery, the postoperative pain is still severe. Ultrasound-guided pectoral nerve block (PECS) II is a new technique that can reduce pain in patients, and it had not been reported in the analgesia after thoracoscopic lobectomy. Methods. 40 patients scheduled for thoracoscopic lobectomy were randomly divided into two groups. Patients in the PECS II group received 0.5% ropivacaine 25 ml before the general anesthesia, while patients in the placebo group received 0.9% saline. Thirty minutes after the block was performed, a pin-prick test was used to analyze the sense of pain of T2-T6 segments. The primary endpoint was the total consumption of fentanyl. Data were collected in the postanesthesia care unit (PACU) and in the ward within 24 hours after operation. Results. The total consumption of fentanyl and the consumption of fentanyl in the intravenous analgesia pump within 24 hours after the operation were significantly lower in the PECS II group compared to the placebo group ( p < 0.05 ). The implementation rate of rescue analgesia during operation and in PACU in the PECS II group was significantly lower than that in the placebo group ( p < 0.05 ). The numerical rating scale (NRS) in 1 and 4 h after operation was lower in the PECS II group ( p < 0.05 ). Mean arterial pressure (MAP) and heart rate (HR) of the PECS II group at chest entering (T1) were significantly lower than those in the placebo group ( p < 0.05 ). Conclusion. Preconditioning of PECS II can stabilize the intraoperative circulation and significantly reduce pain and the consumption of opioids after operation.

scholarly journals Resolution of Severe Anorexia Nervosa Associated with Gender Dysphoria (Dysphorexia) by Testosterone Therapy in Two Male Transgender Youth

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Francisco Javier Martinez Martin
Keyword(s):  
Anorexia Nervosa ◽  
Eating Disorder ◽  
Hormone Therapy ◽  
Gender Dysphoria ◽  
Pubertal Development ◽  
Parental Consent ◽  
Testosterone Therapy ◽  
Transgender Youth ◽  
Limited Success ◽  
Pubertal Transition

Anorexia nervosa is a severe and potentially lethal eating disorder. In transgender youth with severe gender dysphoria, a severe eating disorder (proposed name: dysphorexia), coherent with anorexia nervosa may be triggered by the desire to avoid the cisgender pubertal transition. In these patients, gender-affirming hormone therapy can be extremely effective. We report hereby the cases of two female-to-male transsexual patients with severe gender dysphoria whose anorexia nervosa was related to their pubertal development and who promptly recovered when they started gender-affirming hormone therapy with testosterone, after very limited success with standard psychotherapy and pharmacotherapy for anorexia nervosa. Our patients could not access pubertal suppression due to lack of parental consent in one case and failure to express the conflict in the other. We postulate that avoiding the cisgender pubertal transition with GnRH agonist treatment might also be able to prevent the development of dysphorexia.

scholarly journals Low dose niacin versus placebo in the treatment of Parkinson’s Disease:  A Randomized Controlled Trial

2021 ◽  
Author(s):  
Chandramohan Wakade ◽  
Raymond Chong ◽  
Marissa Seamon ◽  
Sharad Purohit ◽  
Banabihari Giri ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Open Label ◽  
Double Blind ◽  
One Year ◽  
Time Point

Abstract BackgroundParkinson’s Disease (PD) patients have lower niacin levels compared to their spouses. The main objective was to study low-dose daily niacin supplementation versus placebo on motor symptoms in Parkinson’s disease subjects.MethodsA randomized, placebo-controlled, double-blind, single-center clinical trial in Parkinson’s disease patients was performed in Augusta, GA, between September 2016 to September 2019. Randomized participants were 47 PD patients who received either low-dose niacin (N = 21 ) or placebo (N = 26) for the first six months (mean age 68.4 SD, 8.7; mean duration of disease 5.8 SD 4.9; H&Y scores between 0.5 to 4; 64% subjects were Veterans). The Veterans Affairs Pharmacy generated the randomized sequence. After the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, six months, and one year of treatment. The main outcome measure was the Unified Parkinson’s Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue.Results39 subjects were analyzed with low-dose niacin (N = 18) and placebo (N = 21) for the completion of the first six months (randomized, double-blind), and 31 subjects were analyzed for the completion of the next six months (open-label) with low-dose niacin (N = 14) and placebo (N = 17). Niacin treatment was not tolerated by two subjects. The baseline mean UPDRS III score was 21.3 ± 15.8 for the niacin group and 22.4 ± 11.8 for placebo. The change with six months of placebo was 0.05 [95% CI, -2.4 to 2.32], and niacin was 1.06 [95% CI, -3.68 to 1.57]. From six to twelve months, the average UPDRS III score decreased for the placebo group by 4.58 [95% CI, -0.85 to 8.30] and the niacin group by 4.63 [95% CI, 1.42 to 7.83]. Eight subjects withdrew from the study before the 6-month time point and eight more before the one-year time point due to voluntary discontinuation, flushing, or inability to continue (SARS-CoV-2 shut-down).ConclusionLow-dose niacin supplementation may be helpful as an adjunct therapy in improving motor function in PD.Trial registrationClinicaltrials.gov, NCT03462680. Registered 12 March 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03462680?term=gpr109A&draw=2&rank=1

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