The Hemp Connection + sibutramine

If only I had bet my money on whether Meridia would find itself in trouble…

In addition to PCOS, I specialize in the nutritional aspects of medications affecting the brain and nervous system. That includes psych meds, Parkinson's meds…pretty much any medication that has the potential to affect how the brain and nervous system function.

A few years ago, while compiling a series of fact sheets about the nutritional implications of these medications, I started reading about the anti-obesity medication called Meridia (generic name sibutramine). This drug appeared on the market after the famous phen-fen combination was deemed dangerous. It was supposed to be a kindler, gentler alternative. And it supposedly can reduce the severity of symptoms associated with PCOS.

I was floored by what was showing up, unedited, in the peer-reviewed literature about this medication. But not at all surprised with the announcement yesterday that this drug is potentially dangerous for people with heart conditions.

Repeatedly and consistently, researchers were reporting reactions. Some of the most common problems this medication seemed to incite, were anxiety, hypertension, and elevated heart rate.

If Meridia was a drug intended to treat cancer, or glaucoma, or hangnail, and it caused this battery of symptoms, I don't think the FDA would have tolerated consistent reports that it had the ability to send the cardiovascular system into a tailspin.

Yet, in the obese research subject, in the face of these observations, researchers continued to report some of the following conclusions:

**In a 21 patient study, 40% experienced sleep disturbances and 30% complained of irritability, unusual impatience, or"excitation".
RESEARCH CONCLUSION: Sibutramine, 5 and 20 mg, added to a multimodal program assisted participants in losing weight.
Weintraub M, Rubio A, Golik A, Byrne L, Scheinbaum ML. Sibutramine in weight control: a dose-ranging, efficacy study. Clin Pharmacol Ther. 1991 Sep;50(3):330-7.

**In a review study, the author reported,"In controlled studies, 84% of sibutramine-treated patients reported adverse events, compared with 71% of patients receiving placebo. The most frequently reported adverse events are related to pharmacological actions of sibutramine, and include dry mouth, decreased appetite, constipation and insomnia. Despite the high incidence of"side effects" in the control population, the author of this article attributed the problems in the tested population to"pharmacological actions of sibutramine".
Lean ME. Sibutramine--a review of clinical efficacy. Int J Obes Relat Metab Disord. 1997 Mar;21 Suppl 1:S30-6; discussion 37-9.

**In a study of 226 people comparing sibutramine to dexfenfluramine, researchers reported,"174 patients (77%) experienced adverse events; 17 patients withdrew due to adverse events. Pulse rate increased significantly in sibutramine-treated patients." Then they concluded,"Sibutramine (10 mg once daily) is at least as effective as dexfenfluramine (15 mg twice daily) in achieving weight loss in patients with obesity."
Hanotin C, Thomas F, Jones SP, Leutenegger E, Drouin P. A comparison of sibutramine and dexfenfluramine in the treatment of obesity. Obes Res. 1998 Jul;6(4):285-91.

**In a study of 235 people, the following was reported,"a significant increase in heart rate (about 4 beats/min) was noted for patients who received 10 mg or 15 mg sibutramine, compared with the placebo." Then it was concluded,"Doses of 10 mg and 15 mg once daily were shown to be similarly effective, well tolerated and significantly more effective than the placebo."
Hanotin C, Thomas F, Jones SP, Leutenegger E, Drouin P. Efficacy and tolerability of sibutramine in obese patients: a dose-ranging study. Int J Obes Relat Metab Disord. 1998 Jan;22(1):32-8.

**In a study of 11 men, it was observed that"the sibutramine-induced increase in energy expenditure was accompanied by an increase in plasma epinephrine, heart rate, blood pressure, and plasma glucose. The conclusion:"Sibutramine caused a significant increase in both energy expenditure and satiety, which may both contribute to its weight-reducing properties.
Hansen DL, Toubro S, Stock MJ, Macdonald IA, Astrup A. Thermogenic effects of sibutramine in humans. Am J Clin Nutr. 1998 Dec;68(6):1180-6.

As of 2006, I had found 14 studies reporting an elevated heart rate with use. You can easily find them yourself in http://www.ncbi.nlm.nih.gov/pubmed/; I encourage you to see for yourself. I've supported myself here with enough references and my Saturday has other obligations prohibiting me from using it to repeat work I've already done. I hope I've encouraged you to see for yourself what I've been talking about with colleagues for several years.

I like to call this the Biggest Loser Mentality. It doesn't matter if we make these people vomit, pull a muscle, or give them a bloody heart attack. This market of obese people is just too lucrative to ignore.

If you have PCOS and you are obese, you deserve better. You're not where you are because you have a deficiency of ANY kind of medication in your body. Don't let anyone convince you otherwise.

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If only I had bet my money on whether Meridia would find itself in trouble… + sibutramine