Tag: Safety Profile

Lipid-lowering effect of berberine in human subjects and rats

This 2012 pilot study assessed the lipid-lowering effects of berberine in obese human subjects and Sprague-Dawley rats. Participants received 500 mg of berberine orally three times daily for 12 weeks. In humans, berberine administration resulted in a significant reduction in triglyceride levels by 23% and total cholesterol by 12.2%, along

Read More »

Effects of Coleus Forskohlii Supplementation on Body Composition and Hematological Profiles in Mildly Overweight Women

This 12-week randomized, double-blind, placebo-controlled study assessed the effects of Coleus forskohlii (CF) supplementation on body composition and hematological profiles in 23 mildly overweight women. Participants received either 250 mg of 10% CF extract twice daily or a placebo. The CF group showed a trend toward mitigating weight gain, with

Read More »

Clinical experience and safety using phosphatidylcholine injections for the localized reduction of subcutaneous fat: a multicentre, retrospective UK study

This 2006 multicentre retrospective study evaluated the safety and patient satisfaction associated with subcutaneous phosphatidylcholine injections for localized fat reduction. Thirty-nine trained UK physicians reported outcomes from 10,581 treatments over an average of 13.1 months. Local adverse effects such as swelling, erythema, and tenderness were mostly rated as mild or

Read More »

Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity

This 12-month, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of pramlintide, an amylin analog, as an adjunct to lifestyle intervention (LSI) in 411 obese, non-diabetic adults. Participants were assigned to various dosing regimens of pramlintide (120, 240, or 360 µg administered twice or three times daily) or placebo,

Read More »

Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study

This 12-week, randomized, double-blind, placebo-controlled study assessed the efficacy and safety of canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in 383 Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise. Participants were randomized to receive placebo or canagliflozin at doses of 50, 100, 200, or

Read More »

A Review on the Relationship between SGLT2 Inhibitors and Cancer

This review examines the potential association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and cancer risk. Early clinical trials of dapagliflozin indicated an imbalance in reported cases of breast and bladder cancer, raising safety concerns. However, these findings lacked statistical significance and may be attributed to early cancer detection rather than

Read More »

Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis

This systematic review and meta-analysis evaluated the safety profile of oral naltrexone by analyzing serious adverse events (SAEs) reported in placebo-controlled randomized controlled trials (RCTs). A total of 89 RCTs involving 11,194 participants across various conditions—including alcohol use disorders, psychiatric disorders, impulse control disorders, obesity, Crohn’s disease, fibromyalgia, and cancer—were

Read More »

Pilot Phase I Clinical Trial of Methioninase on High-Stage Cancer Patients: Rapid Depletion of Circulating Methionine

This Phase I clinical trial evaluated the safety and efficacy of methioninase (METase) and recombinant methioninase (rMETase) in depleting serum methionine (MET) levels in high-stage cancer patients. MET dependence is a metabolic vulnerability in cancer cells, making MET depletion a potential therapeutic strategy. Three patients received non-recombinant METase, showing significant

Read More »