Arora Ekta, Khajuria Vijay, Tandon Vishal R, Sharma Atul, Mahajan Annil, Gillani Zahid H, Choudhary Naiyma
Department of Pharmacology and Therapeutics, Government Medical College, Jammu, Jammu and Kashmir, India.
Department of Internal Medicine, Government Medical College, Jammu, Jammu and Kashmir, India.
Perspect Clin Res. 2015 Jan-Mar;6(1):39-44. doi: 10.4103/2229-3485.148812.
The aim of the following study is to evaluate the efficacy and safety of Caralluma fimbriata extract (CFE) in overweight and obese individuals in a prospective, randomized, placebo controlled trial.
Commercially available CFE was assessed in overweight and obese individuals. A total of 89 patients were randomized into a treatment group (n = 47) and placebo group (n = 42) to receive either CFE in the form capsules/oral 500 mg b.d. for 12 weeks or matching placebo in similar way. Patients were evaluated clinically and biochemically at 4, 8 and 12 weeks for anthropometric measurements, appetite, biochemical investigations and other safety parameters.
At the end of study period both CFE and placebo for 12 weeks caused only numerical reduction in weight, body mass index, waist circumference, hip circumference and waist hip ratio in overweight and obese individuals. However, these parameters failed to attain significant statistical levels (P ≥ 0.05). CFE and placebo both failed to elucidate any modification of the appetite. There were no significant changes in the biochemical and clinical parameters in both the test and placebo group. However, CFE was well-tolerated and adverse events noted were mild and transient in nature.
A commercially available extract of CFE in an oral dose of 1 g/day claimed to have anti-obesity effect failed to yield any positive results on anthropometry and appetite in overweight and obese individuals beyond placebo. There were also no significant differences in the clinical and biochemical parameters. However, CFE was well tolerated. Thereby, underscoring the need to carry more research before CFE is recommended as an anti-obesity drug.
以下研究的目的是在一项前瞻性、随机、安慰剂对照试验中评估肉苁蓉提取物（CFE）对超重和肥胖个体的疗效和安全性。
对超重和肥胖个体评估市售的CFE。总共89例患者被随机分为治疗组（n = 47）和安慰剂组（n = 42），分别接受胶囊形式的CFE/口服500毫克，每日两次，持续12周，或以类似方式接受匹配的安慰剂。在第4、8和12周对患者进行临床和生化评估，以测量人体测量学指标、食欲、生化指标及其他安全参数。
在研究期结束时，CFE和安慰剂治疗12周仅使超重和肥胖个体的体重、体重指数、腰围、臀围及腰臀比出现数值上的下降。然而，这些参数未达到显著的统计学水平（P≥0.05）。CFE和安慰剂均未能阐明对食欲的任何改变。试验组和安慰剂组的生化及临床参数均无显著变化。然而，CFE耐受性良好，所记录的不良事件性质轻微且短暂。
一种口服剂量为1克/天、声称具有抗肥胖作用的市售CFE提取物，在超重和肥胖个体中，除安慰剂作用外，在人体测量学指标和食欲方面未产生任何积极结果。临床和生化参数也无显著差异。然而，CFE耐受性良好。因此，强调在推荐CFE作为抗肥胖药物之前需要进行更多研究。
