Sadly, few things in life come without effort. Being thin is one of them (at least for most, especially once outside of their 20s).
Being overweight is the norm now in America, although it ranges from a few extra pounds to obesity. Women seem to struggle with weight issues more than men, and things like eating disorders are far more prevalent amongst women.
So the success of Alli, the only FDA approved over-the- counter weight-loss aid for overweight adults, is not surprising. If we all could lose a few pounds by just taking a pill (in conjunction with a sensible diet and exercise, of course), why not?
Seeing the success of Alli, other drug companies are looking to market their own versions of safe, over-the-counter weight loss pills that are proven to work. One such drug is called rimonabant, an endocannabinoid receptor antagonist, meaning it works in the brain in the opposite way that marijuana makes people hungry.
People taking the drug lost on average about 10 pounds over the course of a year and a half. But there was an unintended side effect too:
However, 43% of those who took rimonabant had adverse psychiatric effects, mostly anxiety, depression and insomnia, compared with 28% of those who took the placebo.
That’s a one-third increase in such feelings, something that is both statistically and clinically significant. So you may have lost a few pounds, but now you’re depressed. Great.
And let’s put 10 lbs in the course of 18 months into perspective. That’s an average of 1 pound every 1 1/2 months. The average overweight person could easily achieve even better results simply through a proper diet and a regular exercise program.
The drug company Merck also reported unpublished results from a one-year study examining its weight-loss candidate drug, taranabant, a formulation that also works on the cannabinoid receptors:
The trial of 2,502 obese people showed that they lost nine to 12 pounds more than those taking a placebo.
Psychiatric side effects occurred in 20% of those taking a placebo and in 28% and 40% of those taking different doses of the drug.
Again, anywhere from 1 1/2 times to twice the amount of psychiatric side effects as those taking a placebo. Disturbing results, given the recent sensitivity to such side effects in existing medications.
Weight loss is a serious issue in America. But no pill is going to achieve the miracles many are looking for. And at the price of our mental health (exchanging one mental health concern, self-image, for another, depression), it doesn’t seem like a pill worth considering.
Results of this research were presented at the American College of Cardiology meeting this past week.
Read the full article: You’d be thinner, but possibly sad
(10 votes, average: 4.1 out of 5)
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18 Responses to “Thinner But Sadder” (Pingbacks/trackbacks not shown below)
alexandra_k at 4:51 am on
April 6th, 2008
I bet they haven’t studied the long term side effects of the medications either. To play the devils advocate a little, I wonder how many people who do manage to lose weight report those side effects simply as a by-product of losing weight. What you eat certainly does affect how you feel. If you eat a lot of carbs or high fat foods then it does have a sedative effect. Simply eating better could result in anxiety etc. People also say they feel protected by being overweight. Peoples gaze tends to pass them by. If you are a little thinner you tend to get unwanted attention too etc.
Would the side-effects really constitute mental illness since they are medication induced??
Cairn at 8:54 am on
April 6th, 2008
[…]But there was an unintended side effect too:
43% of those who took rimonabant had adverse psychiatric effects, mostly anxiety, depression and insomnia, compared with 28% of those who took the placebo.
That’s a one-third increase in such feelings, something that is both statistically and clinically significant. […]
Really? Using the incidence of side effects with exposure to rimonabant and their incidence to those taking a placebo, I get and Number Needed to Harm of between 6 and 7. That is, if 6 people are take rimonabant, then only 1 will develop the side effects that would not have otherwise.
So the clinical significance of these s/e’s are doubtful. And you can’t claim any statistical significance if you don’t know (or won’t tell) how many people participated in this study.
Come on. Don’t just throw out numbers that suits your agenda and expect everyone to just lap it up. You’re supposed to be a professional and cooking the conclusions to suit the point you want to make is no different than the “evil” pharmas you like to bang on here so much.
John M. Grohol, Psy.D. at 4:06 pm on
April 6th, 2008
You are welcomed to read the study and throw out your own numbers that are of interest to you. These are the numbers of interest to me and hence the reason I write about them.
I have never claimed any company is evil, but I have written when companies make mistakes and then try and cover their tracks. I write about drugs of dubious benefits, as these seem to be. I also write of drugs and other types of treatment that seem to help people, according to the research.
Alli does help some people, and no doubt, if another weight-loss medication was approved, it too would help some people. But there’s also a greater chance of serious psychiatric side effects that people should know about ahead of time and be prepared for if/when they take such medications. That is, after all, the purpose of this blog — information and education.
Cairn at 5:55 am on
April 7th, 2008
Could you tell me where I can find the study in the literature. I’m actually interested.
And you _are_ claiming “something that is both statistically and clinically significant;” but when you look at the numbers is simply not true. You _are_ cherry picking the numbers to suit your point.
I expected better from you.
John M. Grohol, Psy.D. at 6:41 am on
April 7th, 2008
I’ll let the authors speak for themselves:
Although rimonabant has been approved in several countries, an FDA Advisory Panel did not recommend approval and requested additional safety data on psychiatric adverse effects.17 In the current trial, to more fully characterize the safety of rimonabant in a broad population, we deliberately enrolled patients whether or not they had a history of psychiatric illness. In addition, we amended the protocol to include a questionnaire designed to standardize reporting of these adverse effects. Our findings confirm that inhibition of CB1 receptors with rimonabant does increase psychiatric and gastrointestinal tract adverse effects, specifically anxiety, depression, and nausea. The inclusion of patients with a history of psychiatric illness and the use of a questionnaire increased the rate of reported psychiatric disorders in the placebo and rimonabant groups compared with prior studies. Although these adverse effects resulted in an increase in drug discontinuations, 73% of patients were able to successfully complete 18 months of rimonabant therapy, compared with 84% in the placebo group.
Severe psychiatric adverse effects, including major depression, suicidal ideation, and attempted or successful suicide were relatively uncommon, occurring with similar frequency in the placebo- and rimonabant-treated patients (3.8% vs 4.7%, respectively; P = .52). However, the study was not powered to assess severe psychiatric effects. One placebo-treated patient attempted suicide, and a single rimonabant-treated patient completed suicide. In interpreting these data, it should be noted that obesity and body weight reduction have been linked to an increased incidence of depression.33 Overall, our findings demonstrate that rimonabant is associated with an increase in psychiatric symptoms.
Cairn at 4:33 pm on
April 7th, 2008
Thank you. But this quote is about people from the placebo and rimonabant who developed _severe_ psychiatric effects, which they class as major depression, suicidal ideation, and attempted or successful suicide. Not the group with milder psychiatric outcomes you were discussing originally. You’re changing patient groups on us now. Be consistent.
Continuing on since you brought this second group up, severe psychiatric side effects occurred at 3.8% in the placebo group and 4.7% in the rimonabant group. Looks like an increase but with a p=0.52 the number of patients who developed these symptoms is too small for the results to have any statistical significance. As far as clinical significance of these severe psychiatric outcomes, you get a Number Needed to Harm of 100 / (4.7-3.8) = 111. Whether the drug is worth taking when you have less than a one in a hundred chance of developing these severe effects is the patient’s and doctor’s call.
Back to the original group you were discussing, who developed much milder psychiatric side effects, such as anxiety, depression and insomnia, you had 43% of those who took rimonabant having these milder psychiatric effects compared with 28% of those who took the placebo. Now the paper gives a p
Cairn at 4:50 pm on
April 7th, 2008
Now the paper gives a p of less than 0.001, so the results have statistical significance. But the NNH of about 6 I calculated earlier is valid. Is it worth taking the 1 in 6 chance of developing these milder psychiatric side effects given a 10 pound weight loss over a year or so? Patient’s call again. But knowing it’s a one in six chance is more meaningful at the individual level than these aggregate percentages alone. That’s what NNT and NNH values are for. Is the medication worth it? And the numbers let you make a best call based on the price of the medication and its effectiveness.
John M. Grohol, Psy.D. at 6:56 am on
April 8th, 2008
I don’t disagree and we come to the same conclusion, but in different ways.
The number I wrote in the original entry is actually worse, expressed as a relative risk increase — it’s 53% (I had meant to say that 1/3rd more people taking the drug reported adverse psychiatric symptoms than those taking a placebo). You say it puts the NNH at 6 (it seems closer to 7).
But the reason I didn’t trot out the NNH statistic, used in diseases where “harm” is well defined (e.g., in schizophrenia, for instance, it’s used to describe serious problems [such as tardive dyskinesia] connected to the powerful antipsychotics prescribed), is because it doesn’t seem like we’re talking about “harm” as such with this drug. We’re talking about other problems which could, but not necessarily, lead to harm. To me, it’s more of a quality of life issue and understanding that the reason you’re suddenly depressed while taking this potential drug (it’s not on the market) is because of the drug, not you.
Given the continuing stigmatization in society of many common mental disorders, people may not be aware of this connection (or told of it, unless they read it buried in the patient information pamphlet, especially if sold over-the-counter).
FriedEgg at 3:02 pm on
April 9th, 2008
So you add additional depression and anxiety to an already anxiety-inducing activity, and then where do you stand when you do the near-inevitable and start gaining the weight back? The story doesn’t end the day the dial hits the ideal number, or that 10-lb weight loss.
If there was a real easy way to be thin and happy… no one would be obese. The problem is that the trigger for the change in life style is inside us and, is hard to reach it when one is so depressed that can hardly move. From people like us is that the “magic weight lose companies” feed… so, what if from depressed one go down to dangerously depresed?…The companies don’t care, after all, the money is already in their pockets.
AlanaRae at 7:03 pm on
October 20th, 2008
there is a problem much larger than these conversations.Im an 18 year old girl who weighs 90 pounds. In the past 3 months i have lost 30 pounds. My appetite is completely gone, and now that i see my problem i still cannot gain weight. i continue to drop pounds even though i struggle to consume food. Once i forced myself to bring back up food, now it is enevitable at times even though i try to keep it down. The problem with the desire to be thin and struggle against obesity doesnt stop once you’ve lost excess weight, is that mentally and physically the problem only worsens.
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I bet they haven’t studied the long term side effects of the medications either. To play the devils advocate a little, I wonder how many people who do manage to lose weight report those side effects simply as a by-product of losing weight. What you eat certainly does affect how you feel. If you eat a lot of carbs or high fat foods then it does have a sedative effect. Simply eating better could result in anxiety etc. People also say they feel protected by being overweight. Peoples gaze tends to pass them by. If you are a little thinner you tend to get unwanted attention too etc.
Would the side-effects really constitute mental illness since they are medication induced??
[…]But there was an unintended side effect too:
43% of those who took rimonabant had adverse psychiatric effects, mostly anxiety, depression and insomnia, compared with 28% of those who took the placebo.
That’s a one-third increase in such feelings, something that is both statistically and clinically significant. […]
Really? Using the incidence of side effects with exposure to rimonabant and their incidence to those taking a placebo, I get and Number Needed to Harm of between 6 and 7. That is, if 6 people are take rimonabant, then only 1 will develop the side effects that would not have otherwise.
So the clinical significance of these s/e’s are doubtful. And you can’t claim any statistical significance if you don’t know (or won’t tell) how many people participated in this study.
Come on. Don’t just throw out numbers that suits your agenda and expect everyone to just lap it up. You’re supposed to be a professional and cooking the conclusions to suit the point you want to make is no different than the “evil” pharmas you like to bang on here so much.
You are welcomed to read the study and throw out your own numbers that are of interest to you. These are the numbers of interest to me and hence the reason I write about them.
I have never claimed any company is evil, but I have written when companies make mistakes and then try and cover their tracks. I write about drugs of dubious benefits, as these seem to be. I also write of drugs and other types of treatment that seem to help people, according to the research.
Alli does help some people, and no doubt, if another weight-loss medication was approved, it too would help some people. But there’s also a greater chance of serious psychiatric side effects that people should know about ahead of time and be prepared for if/when they take such medications. That is, after all, the purpose of this blog — information and education.
Could you tell me where I can find the study in the literature. I’m actually interested.
And you _are_ claiming “something that is both statistically and clinically significant;” but when you look at the numbers is simply not true. You _are_ cherry picking the numbers to suit your point.
I expected better from you.
I’ll let the authors speak for themselves:
Although rimonabant has been approved in several countries, an FDA Advisory Panel did not recommend approval and requested additional safety data on psychiatric adverse effects.17 In the current trial, to more fully characterize the safety of rimonabant in a broad population, we deliberately enrolled patients whether or not they had a history of psychiatric illness. In addition, we amended the protocol to include a questionnaire designed to standardize reporting of these adverse effects. Our findings confirm that inhibition of CB1 receptors with rimonabant does increase psychiatric and gastrointestinal tract adverse effects, specifically anxiety, depression, and nausea. The inclusion of patients with a history of psychiatric illness and the use of a questionnaire increased the rate of reported psychiatric disorders in the placebo and rimonabant groups compared with prior studies. Although these adverse effects resulted in an increase in drug discontinuations, 73% of patients were able to successfully complete 18 months of rimonabant therapy, compared with 84% in the placebo group.
Severe psychiatric adverse effects, including major depression, suicidal ideation, and attempted or successful suicide were relatively uncommon, occurring with similar frequency in the placebo- and rimonabant-treated patients (3.8% vs 4.7%, respectively; P = .52). However, the study was not powered to assess severe psychiatric effects. One placebo-treated patient attempted suicide, and a single rimonabant-treated patient completed suicide. In interpreting these data, it should be noted that obesity and body weight reduction have been linked to an increased incidence of depression.33 Overall, our findings demonstrate that rimonabant is associated with an increase in psychiatric symptoms.
Thank you. But this quote is about people from the placebo and rimonabant who developed _severe_ psychiatric effects, which they class as major depression, suicidal ideation, and attempted or successful suicide. Not the group with milder psychiatric outcomes you were discussing originally. You’re changing patient groups on us now. Be consistent.
Continuing on since you brought this second group up, severe psychiatric side effects occurred at 3.8% in the placebo group and 4.7% in the rimonabant group. Looks like an increase but with a p=0.52 the number of patients who developed these symptoms is too small for the results to have any statistical significance. As far as clinical significance of these severe psychiatric outcomes, you get a Number Needed to Harm of 100 / (4.7-3.8) = 111. Whether the drug is worth taking when you have less than a one in a hundred chance of developing these severe effects is the patient’s and doctor’s call.
Back to the original group you were discussing, who developed much milder psychiatric side effects, such as anxiety, depression and insomnia, you had 43% of those who took rimonabant having these milder psychiatric effects compared with 28% of those who took the placebo. Now the paper gives a p
Now the paper gives a p of less than 0.001, so the results have statistical significance. But the NNH of about 6 I calculated earlier is valid. Is it worth taking the 1 in 6 chance of developing these milder psychiatric side effects given a 10 pound weight loss over a year or so? Patient’s call again. But knowing it’s a one in six chance is more meaningful at the individual level than these aggregate percentages alone. That’s what NNT and NNH values are for. Is the medication worth it? And the numbers let you make a best call based on the price of the medication and its effectiveness.
I don’t disagree and we come to the same conclusion, but in different ways.
The number I wrote in the original entry is actually worse, expressed as a relative risk increase — it’s 53% (I had meant to say that 1/3rd more people taking the drug reported adverse psychiatric symptoms than those taking a placebo). You say it puts the NNH at 6 (it seems closer to 7).
But the reason I didn’t trot out the NNH statistic, used in diseases where “harm” is well defined (e.g., in schizophrenia, for instance, it’s used to describe serious problems [such as tardive dyskinesia] connected to the powerful antipsychotics prescribed), is because it doesn’t seem like we’re talking about “harm” as such with this drug. We’re talking about other problems which could, but not necessarily, lead to harm. To me, it’s more of a quality of life issue and understanding that the reason you’re suddenly depressed while taking this potential drug (it’s not on the market) is because of the drug, not you.
Given the continuing stigmatization in society of many common mental disorders, people may not be aware of this connection (or told of it, unless they read it buried in the patient information pamphlet, especially if sold over-the-counter).
So you add additional depression and anxiety to an already anxiety-inducing activity, and then where do you stand when you do the near-inevitable and start gaining the weight back? The story doesn’t end the day the dial hits the ideal number, or that 10-lb weight loss.
If there was a real easy way to be thin and happy… no one would be obese. The problem is that the trigger for the change in life style is inside us and, is hard to reach it when one is so depressed that can hardly move. From people like us is that the “magic weight lose companies” feed… so, what if from depressed one go down to dangerously depresed?…The companies don’t care, after all, the money is already in their pockets.
there is a problem much larger than these conversations.Im an 18 year old girl who weighs 90 pounds. In the past 3 months i have lost 30 pounds. My appetite is completely gone, and now that i see my problem i still cannot gain weight. i continue to drop pounds even though i struggle to consume food. Once i forced myself to bring back up food, now it is enevitable at times even though i try to keep it down. The problem with the desire to be thin and struggle against obesity doesnt stop once you’ve lost excess weight, is that mentally and physically the problem only worsens.
