New Mothers' Perceptions of Pressure to Breastfeed
Perceived pressure to breastfeed may be an important psychosocial factor to consider when aiming to improve women's breastfeeding experiences.
KEY FINDINGS: Perceived pressure to breastfeed may be an important psychosocial factor to consider when aiming to improve women's breastfeeding experiences. Reducing perceived pressure may be beneficial for promoting breastfeeding outcomes.
BACKGROUND: Purpose of the study is to develop a measure to quantitatively assess perceived pressure to breastfeed and examine associations between perceived pressure, emotional distress, and the breastfeeding experience and self-efficacy among women with 2- to 6-month-old infants.
DETAILS: A cross-sectional study using an online survey to assess perceived pressure to breastfeed, emotional distress, and the breastfeeding experience and self-efficacy was conducted. Participants were recruited through ResearchMatch, a national online service that matches potential participants to research studies, and online community forums (e.g., Facebook). Women (n = 187) reported themselves and society as the greatest sources of pressure. Pressure to breastfeed was negatively associated with the breastfeeding experience (r = -.34, p < .01) and self-efficacy (r = -.39, p < .01), but not emotional distress. Pressure to breastfeed remained a significant explanatory factor, even when considering demographic covariates, with the final models accounting for 16% and 20% of the variance in the breastfeeding experience and self-efficacy, respectively.
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Source: Korth, C. X., Keim, S. A., Crerand, C. E. et al. (2022). New Mothers' Perceptions of Pressure to Breastfeed. MCN, The American Journal of Maternal/Child Nursing. 2022: 47(3): 160-167. Published: May/June, 2022. DOI: 6307642.
Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health
TRUE METRIX glucose meters recalled after FDA identifies software-related safety concerns involving E-5 Error Code interpretation. Misinterpretation may result in delayed recognition of severe hyperglycemia or inappropriate treatment of normal glucose levels. FDA recommends switching to alternative glucose monitoring systems, especially for high-risk patients on insulin or sulfonylureas.
KEY FINDINGS: The FDA recommends that users of TRUE METRIX blood glucose monitoring systems seek alternative testing methods as soon as feasible while continuing glucose monitoring without interruption. The primary concern involves the E-5 Error Code being unable to distinguish between severe hyperglycemia and a test strip malfunction. This ambiguity may lead to delayed treatment or inappropriate interventions. High-risk patients, particularly those using insulin intensively or prone to unstable glucose levels, should prioritize switching to another glucose monitoring system. The recall has already been associated with 114 serious injuries and one reported death, emphasizing the potential severity of the issue.
BACKGROUND: The U.S. Food and Drug Administration (FDA) issued a safety communication regarding potential risks associated with the use of TRUE METRIX Blood Glucose Monitoring Systems manufactured by Trividia Health. The recall affects all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO Self-Monitoring Blood Glucose Systems, and the TRUE METRIX PRO Professional Monitoring Blood Glucose System, including co-branded versions marketed under partner or store names. The communication highlights concerns related to the software design of the device’s E-5 Error Code, which may create confusion during blood glucose testing and potentially delay or lead to inappropriate treatment decisions.
DETAILS: The FDA reported that the E-5 Error Code used in TRUE METRIX devices is programmed to represent two separate situations: either a very high blood glucose level greater than 600 mg/dL or a test strip error. Because the same code is displayed for both conditions, users may incorrectly interpret the meaning of the error message. Patients experiencing severe hyperglycemia may mistakenly assume the issue is due to a defective test strip and delay urgent medical care. Conversely, some users may believe the reading indicates severe hyperglycemia when their glucose levels are actually normal or low, potentially resulting in unnecessary corrective treatment.
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The FDA advised all users to transition to alternative blood glucose monitoring methods whenever possible. Patients were instructed not to discontinue glucose monitoring until another reliable testing method becomes available. Particular concern was raised for individuals receiving intensive insulin therapy, taking sulfonylureas, or those with frequent episodes of hypo- or hyperglycemia, as these groups are considered especially vulnerable to complications arising from inaccurate interpretation of glucose readings.
Healthcare professionals were advised to promptly notify affected patients and support them in transitioning to alternative glucose monitoring systems. Medical facilities were also encouraged to display the FDA communication in areas where the affected products are stored or used.
The FDA classified the February 2026 TRUE METRIX recall as a Class I recall, which represents the most serious category of medical device recalls. As of January 16, 2026, Trividia Health reported 114 serious injuries and one death associated with this issue. Potential consequences of delayed recognition or mismanagement of abnormal glucose levels include dehydration, altered mental status, loss of consciousness, and death. The FDA stated that it will continue monitoring device performance reports and work closely with the manufacturer to evaluate additional mitigation strategies and provide updated public information when necessary.
Source: Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication. FDA. Published: May 19, 2026.
Safety and Antitumour Activity of Ipatasertib Combined With Endocrine Therapy and A CDK4/6 Inhibitor in HR+/HER2- Metastatic Breast Cancer (TAKTIC)
The combination of fulvestrant, ipatasertib, and palbociclib showed preliminary signs of clinical activity and showed expected adverse events in heavily pretreated patients with HR+/HER2 metastatic breast cancer, warranting further evaluation in those with CDK4/6 inhibitor-refractory disease.
KEY FINDINGS: The combination of fulvestrant, ipatasertib, and palbociclib showed preliminary signs of clinical activity and showed expected adverse events in heavily pretreated patients with HR+/HER2- metastatic breast cancer, warranting further evaluation in those with CDK4/6 inhibitor-refractory disease.
BACKGROUND: PI3K/AKT pathway activation is implicated in CDK4/6 inhibitor resistance. The use of AKT inhibition with continued CDK4/6 blockade after CDK4/6 inhibitor resistance remains unexplored. We evaluated the safety of ipatasertib and an antioestrogen with or without palbociclib in patients with treatment refractory HR+/HER2- metastatic breast cancer.
DETAILS: This single-centre, open-label, phase 1b trial was conducted at the Massachusetts General Hospital (Boston, MA, USA). Eligible patients were women older than 18 years with biopsy proven HR+/HER2- locally advanced, unresectable, or metastatic breast cancer; an Eastern Cooperative Oncology Group performance status of 0-2; disease progression on at least one previous therapy for metastatic disease; and measurable disease or bone lesions. Patients received 400 mg oral ipatasertib with standard 500 mg intramuscular fulvestrant dosing (ipatasertib and fulvestrant group) or with an aromatase inhibitor (oral anastrozole 1 mg per day, exemestane 25 mg per day, or letrozole 2.5 mg per day; ipatasertib and aromatase inhibitor group) on days 1-28 of each cycle. The ipatasertib and fulvestrant plus palbociclib group included a dose-escalation phase with patients assigned sequentially to escalating doses of ipatasertib and palbociclib using a standard 3 + 3 design starting at the recommended dose of palbociclib (125 mg on days 1-21) and the lowest dose of ipatasertib (200 mg on days 1-21). The primary endpoint was safety and progression-free survival was a key secondary endpoint. Safety was analysed in all patients who received at least one dose of ipatasertib and progression-free survival was assessed in all enrolled participants. This study is registered with ClinicalTrials.gov, NCT03959891 (active, not recruiting). Between June 5, 2019, and Feb 16, 2022, 77 patients were enrolled (19 assigned to ipatasertib and fulvestrant, 16 to ipatasertib and aromatase inhibitor, and 42 to ipatasertib and fulvestrant plus palbociclib). All patients were female (77 [100%]); 75 were White (97%) and two (3%) were Asian. The median age was 62 years (range 32-88) and 66 (86%) of 77 patients received previous CDK4/6 inhibitor (median number of previous lines was 3 [range 1-13]). The median follow-up was 12.5 months (IQR 7.6-19.7). The recommended phase 2 dose was established at 400 mg ipatasertib on days 1-21 with 100 mg palbociclib on days 8-28 and standard fulvestrant 500 mg. Median progression-free survival was 5.5 months (95% CI 3.8-7.4). Serious adverse events related to study treatment occurred in seven (17%) patients in the ipatasertib and fulvestrant plus palbociclib group and one (5%) in the ipatasertib and fulvestrant group, which were related to neutropenia, leukopenia, thrombocytopenia, and hyperglycaemia. Common grade 3-4 adverse events related to study treatment (occurring in >5% of patients) were neutropenia (30 [39%] of 77), leukopenia (15 [19%]), diarrhoea (14 [18%]), rash (seven [9%]), lymphopenia (three [4%]), and anaemia (four [5%]). Four deaths occurred during the study (one possibly treatment-related due to grade 5 hyperglycaemia in the ipatasertib and fulvestrant group and two due to infectious issues and one due to pulmonary complications in the ipatasertib and fulvestrant plus palbociclib group), deemed unrelated to study treatment.
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Copyright © Elsevier Ltd. All rights reserved.
Source: Wander, S., Lloyd, M., Keenan, J. C., et al. Safety and Antitumour Activity of Ipatasertib Combined With Endocrine Therapy and A CDK4/6 Inhibitor in HR+/HER2- Metastatic Breast Cancer (TAKTIC): A Single-Centre, Open-Label, Phase 1b Trial. Lasers Oncology. 2026; 27(5), 580-591. Published: May, 2026. DOI: 10.1016/S1470-2045(26)00059-8.
Efficacy of Low-Dose Oral Isotretinoin Combined with Fractional Microneedle Radiofrequency Versus Low-Dose Oral Isotretinoin Monotherapy in the Treatment of Moderate-To-Severe Acne Vulgaris
Early active treatment with isotretinoin and FMRF is safe and better than isotretinoin monotherapy over 44 weeks regarding severity, reduced erythema, and improved surface roughness in moderate-to-severe acne vulgaris. This encourages early and effective treatment of acne to mitigate acne scarring and improve patients' quality of life.
Summary
A Randomized Controlled Comparative Study
[Posted 19/May/2026]
AUDIENCE: General Surgery, Family Medicine
KEY FINDINGS: Early active treatment with isotretinoin and FMRF is safe and better than isotretinoin monotherapy over 44 weeks regarding severity, reduced erythema, and improved surface roughness in moderate-to-severe acne vulgaris. This encourages early and effective treatment of acne to mitigate acne scarring and improve patients' quality of life.
BACKGROUND: Oral isotretinoin is the standard therapy for severe acne. However, scarring may persist. Fractional microneedling radiofrequency (FMRF) improves both inflammatory lesions and scars with minimal downtime. In this study, we compare isotretinoin monotherapy and concurrent isotretinoin and FMRF for active acne regarding clinical outcomes. The GAGS scores of isotretinoin and FMRF were significantly lower than those of isotretinoin monotherapy from weeks 12-44 (-79.69% vs. -60.34% at week 44, respectively; p < 0.001). Isotretinoin and FMRF showed significantly greater lesion count reductions than isotretinoin monotherapy at follow-up visits from weeks 12-44. Isotretinoin and FMRF showed significantly lower hemoglobin levels than isotretinoin monotherapy at weeks 32 and 44 (p = 0.029 and p < 0.001, respectively). Skin surface roughness improved substantially and persistently from week 12-44.
DETAILS: In this parallel two-group comparative study, patients received either low-dose isotretinoin monotherapy for 20 weeks (n = 34) or low-dose isotretinoin concurrently with 5 monthly FMRF sessions (n = 36). Outcomes were assessed at baseline and weeks 12, 20, 24, 32, and 44. The primary endpoints were Global Acne Grading System (GAGS) scores and inflammatory/non-inflammatory lesion counts. Secondary endpoints were hemoglobin indices and skin roughness.
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Source: Disphanurat, W., Leeyangyuen, P,, and Srisantithum, B. Efficacy of Low-Dose Oral Isotretinoin Combined With Fractional Microneedle Radiofrequency Versus Low-Dose Oral Isotretinoin Monotherapy in the Treatment of Moderate-To-Severe Acne Vulgaris: A Randomized Controlled Comparative Study. Lasers in Surgery and Medicine. 2026; 58(4): 321-330. Published: April, 2026. DOI: 10.1002/lsm.70120.
Comparative Efficacy and Safety of Nitazoxanide-based Triple Therapy Versus Standard Triple Therapy in Treating Helicobacter Pylori Infections
NTZ-based therapy significantly improved eradication rates, with risk ratios of 1.40 and 1.36 in different patient analyses, indicating better outcomes than standard therapy. While NTZ showed non-significant reductions in symptoms like abdominal pain and nausea, the certainty of evidence was consistently high, although the risk of bias varied from low to high. Further research is needed on NTZ's optimal use and safety.
Summary
An Updated Systematic Review and Meta-analysis of Randomized Controlled Trials.
[Posted 18/May/2026]
AUDIENCE: Gastroenterology, Internal Medicine
KEY FINDINGS: NTZ-based therapy significantly improved eradication rates, with risk ratios of 1.40 and 1.36 in different patient analyses, indicating better outcomes than standard therapy. While NTZ showed non-significant reductions in symptoms like abdominal pain and nausea, the certainty of evidence was consistently high, although the risk of bias varied from low to high. Further research is needed on NTZ's optimal use and safety.
BACKGROUND: Helicobacter pylori infections are the major cause of gastrointestinal disease, mainly chronic gastritis, peptic ulcer, and gastric carcinomas, affecting half of the population globally. Due to the emergence of antibiotic resistance, the efficacy of current standard therapies, particularly clarithromycin and metronidazole, has been reduced.
DETAILS: Nitazoxanide (NTZ), a broad-spectrum antimicrobial drug, has shown promising efficacy against H. pylori infections. This study aims to assess the comparative efficacy and safety of NTZ-based regimens versus standard triple therapy in H. pylori infections. A comprehensive literature search was conducted across 4 databases. Eight randomized controlled trials, comprising 1286 participants, comparing NTZ-based regimens with standard triple therapy, were included. A random-effects model was used to estimate pooled risk ratios (RRs) with 95% confidence intervals (CIs). NTZ-based therapy showed significant improvement in primary outcome, which includes H. pylori eradication rate compared to standard triple therapy. In per-protocol (PP) and intention-to-treat patients, durational analysis showed significant improvement in H. pylori eradication rates (RR=1.40; 95% CI: 1.19-1.56; P<0.0001) and (RR=1.36; 95% CI: 1.19-1.56; P<0.0001), respectively. In addition, post follow-up assessment also shows significant effects in both patients per-protocol (RR= 1.40; 95% CI: 1.21-1.62; P<0.0001) and intention-to-treat (RR=1.36; 95% CI: 1.19-1.56; P<0.0001). In secondary outcomes, NTZ-based therapy showed non-significant reduction in abdominal pain (RR=0.50) and nausea (RR=0.78). Risk of bias was reported as low to high, although certainty of evidence was consistently high. Egger’s test shows non-significant publication bias (P=0.161). Future research should focus on NTZ’s optimal duration, resistance pattern, safety, and symptom relief.
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Source: Ali, S. H., Shaikh, U. A., Shahzad, A., et al. Comparative Efficacy and Safety of Nitazoxanide-based Triple Therapy Versus Standard Triple Therapy in Treating Helicobacter Pylori Infections: An Updated Systematic Review and Meta-analysis of Randomized Controlled Trials. Journal of Clinical Gastroenterology. 2026; 60(5): 373-384. Published: May/June 2026. DOI: 10.1097/MCG.0000000000002328
FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
The FDA approval of Auvelity for agitation in Alzheimers dementia represents a clinically meaningful advancement, introducing the first non-antipsychotic pharmacologic option for this challenging condition. Supported by randomized clinical trials demonstrating both symptomatic improvement and relapse prevention, Auvelity offers a promising alternative for managing agitation while potentially avoiding risks associated with antipsychotics. Careful patient selection and monitoring remain essential given its safety profile.
KEY FINDINGS: The FDA approval of Auvelity for agitation in Alzheimer’s dementia represents a clinically meaningful advancement, introducing the first non-antipsychotic pharmacologic option for this challenging condition. Supported by randomized clinical trials demonstrating both symptomatic improvement and relapse prevention, Auvelity offers a promising alternative for managing agitation while potentially avoiding risks associated with antipsychotics. Careful patient selection and monitoring remain essential given its safety profile.
BACKGROUND: The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer's disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.
DETAILS: "This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer's disease," said FDA Commissioner Marty Makary, M.D., M.P.H. "With today's action, patients and their families have access to an additional important treatment for complications of this devastating disease."
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Agitation is a common and distressing symptom in patients with Alzheimer's disease dementia, characterized by excessive motor activity, or verbal or physical aggression. It can significantly impact quality of life for patients and caregivers.
"Auvelity was found to be efficacious for treating agitation in Alzheimer's disease in two randomized trials and now represents an additional option to address one of the most difficult sequelae of the disease, especially as it progresses,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of the FDA's Center for Drug Evaluation and Research. "We hope this approval will provide meaningful benefit to patients, their families, and caregivers."
The first randomized study (NCT 03226522) was a five-week trial in which participants received either Auvelity or a placebo. The primary endpoint was the change from baseline to week five in the total score of the Cohen-Mansfield Agitation Inventory (CMAI), a survey that assesses the frequency of manifestations of agitated behaviors in elderly patients, based on caregiver reports. Auvelity was significantly superior to placebo in The Cohen-Mansfield Agitation Inventory score improvements.
The second randomized study (NCT 04947553) was a withdrawal study in participants who responded to Auvelity. Upon reaching a sustained clinical response to Auvelity, patients were randomly assigned to continue treatment with Auvelity or switch to placebo. The primary endpoint was time to relapse. Participants who continued Auvelity treatment had a significantly longer time to relapse of agitation symptoms compared to patients receiving the placebo.
The most common side effects include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and uncontrolled sweating. Auvelity has a Boxed Warning about increased risk of suicidal thoughts and behaviors in adolescents and young adults taking antidepressants. Health care providers should monitor patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during initial treatment. The medicine can cause seizures, with risk increasing with dose. It can also cause elevated blood pressure and hypertension, and may activate mania or hypomania (irritable mood) in susceptible patients.
Before starting Auvelity, health care providers should assess blood pressure, screen for personal or family history of bipolar disorder, and determine if patients are taking other medications containing bupropion or dextromethorphan.
The FDA granted breakthrough therapy designation and priority review designation for this action. The approval of Auvelity for agitation associated with dementia due to Alzheimer's disease was granted to Axsome Therapeutics.
Source: FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia. FDA. Published: April 30, 2026.
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