Daily Archives: May 7, 2024

Phase 2 RCT: Preventive subcutaneous L9LS monoclonal antibody reduces malaria incidence by 66-70% in Malian children – N Engl J Med

7 May, 2024 | 15:31h | UTC

This phase 2 randomized clinical trial investigated the safety and efficacy of the monoclonal antibody L9LS in preventing Plasmodium falciparum infection and clinical malaria in children aged 6 to 10 years in Mali. The trial was structured in two parts: initial dose assessment in adults followed by a randomized, placebo-controlled test in children over a 6-month malaria season. A total of 225 children participated, divided equally among three groups to receive either 150 mg of L9LS, 300 mg of L9LS, or a placebo. Results demonstrated a significant reduction in the rate of P. falciparum infection—66% efficacy with the 150-mg dose and 70% efficacy with the 300-mg dose. Similarly, efficacy against clinical malaria was 67% with the 150-mg dose and 77% with the 300-mg dose. Both doses were well-tolerated with no safety concerns reported, underscoring the potential of L9LS as a preventative treatment against malaria in endemic regions.

 

Reference (link to abstract – $ for full-text):

Kayentao, K. et al. (2024). Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria. N Engl J Med, 390(17), 1549-1559. DOI: 10.1056/NEJMoa2312775

 

---

Meta-Analysis: Acute adverse effects of therapeutic psilocybin doses in treating depression and anxiety – JAMA Netw Open

7 May, 2024 | 15:29h | UTC

This meta-analysis examined the acute adverse effects of psilocybin when used in therapeutic doses for treating depression and anxiety. The study analyzed data from six randomized, double-blind clinical trials involving a total of 528 participants. Significant adverse effects identified included headaches, nausea, anxiety, dizziness, and elevated blood pressure, compared to controls. No significant risks of paranoia or transient thought disorder were associated with psilocybin use. Overall, the adverse effects were tolerable and typically resolved within 48 hours, although the study calls for further research into their management.

 

Reference (link to free full-text):

Akhila Yerubandi et al. (2024). Acute Adverse Effects of Therapeutic Doses of Psilocybin A Systematic Review and Meta-Analysis. JAMA Network Open, 7(4): e245960. DOI: 10.1001/jamanetworkopen.2024.5960

 

---

RCT: Effects of combined time-restricted eating and high-intensity functional training on body composition and cardiometabolic health in women with obesity – PLOS One

7 May, 2024 | 15:28h | UTC

This randomized clinical trial investigated the effects of time-restricted eating (TRE) and high-intensity functional training (HIFT), both separately and in combination, on body composition and cardiometabolic health in inactive women with obesity. Sixty-four participants were assigned to three groups: TRE alone, HIFT alone, and both TRE and HIFT (TRE-HIFT). Over 12 weeks, the TRE-HIFT group showed the most significant improvements in waist and hip circumference, fat mass, total cholesterol, triglyceride levels, insulin sensitivity, and blood glucose levels compared to the other groups. Weight and BMI reductions were also more substantial in the TRE-HIFT group than in the HIFT-only group. Furthermore, while all groups exhibited improvements, those combining both interventions experienced more pronounced changes in cardiometabolic parameters, suggesting the potential of integrated lifestyle interventions for enhancing health outcomes in this population.

 

Reference (link to free full-text):

Ranya Ameur et al. (2024). Unlocking the power of synergy: High-intensity functional training and early time-restricted eating for transformative changes in body composition and cardiometabolic health in inactive women with obesity. PLOS ONE. DOI: https://doi.org/10.1371/journal.pone.0301369

 

---

RCT: Oral and topical minoxidil equally effective for male hair loss treatment – JAMA Dermatol

7 May, 2024 | 15:26h | UTC

This study examines the effectiveness, safety, and tolerability of oral minoxidil compared to topical minoxidil in treating male androgenetic alopecia. Conducted as a double-blind, placebo-controlled randomized clinical trial, 90 men aged 18 to 55 with varying degrees of hair loss were recruited and followed for 24 weeks. Participants were divided into two groups: one receiving oral minoxidil 5 mg daily and the other using topical minoxidil 5% twice daily. The primary endpoint was the change in terminal hair density in both the frontal and vertex regions. Results showed that oral minoxidil did not outperform topical minoxidil in terms of increasing hair density on the frontal scalp, though it did show a slight superiority on the vertex area. Common side effects for the oral minoxidil group included hypertrichosis and headaches. Overall, oral minoxidil demonstrated similar efficacy to its topical counterpart and offers an alternative for patients preferring oral treatment or those intolerant to topical formulations.

 

Reference (link to abstract – $ for full-text):

Mariana Alvares Penha et al. (2024). Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia A Randomized Clinical Trial. JAMA Dermatology, Published online April 10, 2024. doi:10.1001/jamadermatol.2024.0284

 

---