Building Belief Alliance

New Study: SSRI Antidepressants ‘Clinically Insignificant’ For Most People

Posted: 26 Feb 2008 08:54 AM CST - Repost from PsyBlog

A new study published today is sure to set off another storm in the ongoing debate about the widespread prescription of antidepressants. Professor Irving Kirsch at the University of Hull and colleagues in the US and Canada report that new generation ‘SSRI’ antidepressants like Prozac or Seroxat mostly fall, “below the recommended criteria for clinical significance” (Kirsch et al. 2008). In other words, the most modern drugs prescribed for depression generally don’t work.

The study was particularly interested in whether the drugs had different effects on people with different levels of depression. Here is what they found:

• Mild depression: not tested as mild depression is usually treated with a ‘talk therapy’ rather than antidepressants.
• Moderate depression: antidepressants made “virtually no difference”.
• Severe depression: antidepressants had a “small and clinically insignificant” effect.
• Most severe depression: antidepressants had a significant clinical benefit - but see below…

Effectiveness limited even for severe depression

When Professor Kirsch and colleagues looked more closely at the data for those who were most severely depressed they uncovered more bad news for drug manufacturers. The antidepressant effect the drugs appeared to have, though small, was largely due to differences in the effects that the placebo had on the control group rather than better response to the drug.

Let’s unpack this a little.

The placebo effect means that even when you give someone a ‘fake’ antidepressant they still improve a little, simply because they expect to. This effect is so powerful and reliable that to be taken seriously drug studies have to compare depressed people taking an antidepressant to a control group taking a placebo.

What Professor Kirsch and colleagues found was that while the placebo effect was present for moderately depressed people, it disappeared for those who were the most severely depressed. This meant that antidepressants weren’t having any more effect on those who were more depressed, it’s just that in comparison to the control group that’s how it appeared. In reality what was happening was that the control group weren’t responding to the placebo.

The authors, therefore, conclude that there’s no point prescribing SSRI antidepressants to anyone but the most severely depressed people, unless other treatments have been tried and have failed.

Can we believe this study?

So the question is: can we believe the results? Well, the study used data from 47 clinical trials that had been submitted to the US Food and Drugs Administration (FDA). The FDA already has a rigorous set of criteria for including studies, so this suggests only quality studies were included.

The data from all these studies were then combined using a statistical technique called ‘meta-analysis’. This means all the studies were collected together and analysed as though they were all one huge study. By doing this you can increase the power of the study significantly.

Like many statistical techniques, though, there is some debate about the use of meta-analyses. For example it is often argued that they lump together studies with different protocols so that effectively you end up comparing apples with oranges. Whether this sort of criticism is valid depends on the study’s nitty-gritty details.

High stakes

More broadly, we have to be careful about drawing conclusions from a single piece of work. There’s no doubt how high the stakes are for everyone: Professor Irving Kirsch has built a career on showing the power of the placebo effect, pharmaceutical companies have built their fortunes on studies proclaiming the benefits of SSRI antidepressants, while patients are stuck in the middle.

Despite this, the evidence does seem to be mounting up against SSRI antidepressants. Although previous studies seemed to show SSRIs were effective, recent work has suggested this might be due to a bias in the way research is reported (Turner et al., 2008). Studies which show no effect have a tendency to be ‘filed’ rather than being submitted for publication. This can result in a much more rosy picture being painted of a drug’s effectiveness than is really the case.

Either way, considering the number of people worldwide currently taking SSRI antidepressants, we can be sure this isn’t the end of the story.

» If you enjoyed this post, subscribe to PsyBlog (RSS).

[Image credit: selva]

References

Kirsch, I., Deacon, B. J., Huedo-Medina, T. B., Scoboria, A., Moore, T. J., & Johnson, B. T. (2008). Initial severity and antidepressant benefits: a meta-analysis of data submitted to the food and drug administration, PLoS Medicine, 5(2), e45 EP

Turner, E. H., Matthews, A. M., Linardatos, E., Tell, R. A., & Rosenthal, R. (2008). Selective publication of antidepressant trials and its influence on apparent efficacy, New England Journal of Medicine, 358(3), 252-260.

Once regarded as a cheap stage trick, hypnotism is proven to be a powerful medical treatment - and now it’s available on the NHS. Roger Dobson reports

There’s no magic, no swinging pendulums or swaying watches, and no one is counting backwards as they slump into unconsciousness. This is medical rather than stage or movie hypnotism, and it is increasingly being used to treat the symptoms of diseases and conditions as diverse as asthma, cystic fibrosis, snoring, migraines and warts.
It’s been used to allow surgery and dental work without anaesthesia, and for pain-free childbirth without medication. And new evidence from the UK’s first and only NHS centre offering hypnotherapy shows that it’s highly effective in treating some types of chest pain as well as irritable bowel syndrome.
New research from America has also found that more than half the people who used hypnotherapy to give up smoking were able to kick the habit, while researchers in France have successfully used the therapy to lower blood pressure.
Hypnosis has been used for centuries to treat diverse ills, but it went into relative decline with the rise of modern medicine, and in the last 200 years it’s been more associated with stage magicians and movie villains than medicine.

Film-makers take a lot of blame for damaging the image of hypnotism: “When a hypnotist appears on screen, expect evil. If his induction features magnetic hand passes, he’s probably about to compel someone to commit a crime. If he hypnotises with an intense stare, his intent is likelier seduction,” says Dr Deirdre Barrett of Harvard Medical School, who has studied more than 200 films about hypnotism.

At the University Hospital of South Manchester, Professor Peter Whorwell, a gastroenterologist who heads the only NHS-funded hypnotherapy centre in Britain, which has been pioneering the therapy as a treatment of irritable bowel syndrome, agrees. “One of the problems is the name,” he says. “If we started off again with a name like neuromodulation, for example, it would be more readily accepted. The name hypnotism has so much baggage attached. Cognitive behavioural therapy is now reasonably well accepted, and so, too, is psychotherapy, but of the three, I would say hypnotism is potentially the most powerful. It is becoming a treatment of choice for IBS.

“When I am dead and gone, people are going to suddenly realise that hypnotism is an incredibly powerful tool and question why it has been ignored for so long.”

Just how it works is not clear, and some critics suggest it’s simply a way of relaxing. But practitioners say there’s more to it, and that under hypnosis the patient can concentrate intensely on a specific thought, memory, feeling or sensation while blocking out distractions.

“The first thing you have to do is get past the myths and misconceptions about clinical hypnosis,” says Dr Carol Ginandes who led a study into its use for anxiety at Harvard Medical School. “It’s not used for entertainment. There are no Svengali-like figures in power-dominant relationships. It’s not a sleep state or something that someone can make you do. It’s a state of heightened, focused attention that we can all shift into very naturally.”

In a report in the Harvard Magazine, she explains how it has an effect: “We don’t yet understand the mechanisms by which these suggestions are transplanted by the mind into the language of the body, but let’s say someone is a smoker. When he’s in a hypnotic state, I could suggest that he’s going to find himself craving cigarettes less and less over a period of time. If he’s ready to quit, that suggestion will be planted at a deep level in his mind, like seeds planted beneath the soil rather than scattered over the top, helping him tap into some useful physical and psychological resources.”

Smoking
In a study at the Scott and White Memorial Hospital in Texas, smokers were given eight sessions of therapy over two months, and told to quit smoking one week after beginning the course of treatment.

Carbon-monoxide concentration tests were carried out on the patients to see whether they had smoked after treatment, and results showed that by the end of treatment 40 per cent had given up. At a follow-up 12 weeks later, 60 per cent had quit.

Dental
Hypnotherapy is increasingly being used in a number of areas of dentistry, including dental phobia, teeth-grinding and extractions and fillings. It has also been used for dental surgery that is usually done under local or general anaesthetic.

In one reported case, a patient in Scotland has also had a tooth implant, which involved putting a titanium rod into her jaw. In her case, hypnosis was used to alter the sensation in the areas where surgery was taking place. She was asked to imagine a dial where zero meant no pain.

Chest pains
Up to one-third of patients who have angina-like chest pain are found to have normal coronary arteries, but many continue to suffer painful symptoms despite no evidence of heart disease. Non-cardiac chest pain is a problem because there is little or no treatment.

In a new NHS-funded trial at Manchester, 28 patients were given 12 sessions of hypnotherapy or a placebo treatment. After being hypnotised, patients were told to focus on the chest, and given repetitive suggestions about reducing pain. Patients were also given a tape of a session and encouraged to practise at home. Results show that of those who had the therapy, eight out of 10 had an all-round improvement in symptoms.

Wound healing
Researchers at Harvard Medical School have shown that broken bones and surgical wounds heal faster in patients who have hypnotherapy. Six weeks after breaking their ankles, patients being treated with hypnotherapy were three weeks ahead in their healing schedule than those who were just put in plaster.

In a second study, the researchers had similar results with surgical wounds. Before surgery, suggestions were made under therapy on pain and anxiety, and on decreased inflammation, reduced scar tissue, and accelerated wound-healing. Results show the women who had the therapy healed significantly faster.

Irritable bowel syndrome
One of the most common gastrointestinal disorders, with research showing that between five and 20 per cent of us suffer at some time. Its main symptoms include abdominal pain, diarrhoea or constipation. The exact cause is not known, but in some people changes in the balance of bacteria that line the gut are thought to be involved, as well as inflammation. Existing treatment for the condition can be only moderately effective.

Research at the University Hospital of South Manchester, where the first trial of hypnotherapy for the condition was carried out, shows that the majority of sufferers can benefit. “We have found that IBS patients treated with hypnotherapy remain well in the long term, with dramatically reduced medication needs,” say the researchers.

Cystic fibrosis
According to a University of Michigan report, hypnotherapy can reduce symptoms of cough, shortness of breath, anxiety and other symptoms of cystic fibrosis.

A study at the Robert C Schwartz Cystic Fibrosis Center at the State University of New York also shows that self-hypnosis can be highly effective. “Many of the patients used hypnosis for more than one purpose, including relaxation (61 per cent of patients), relief of pain associated with medical procedures (31 per cent), headache relief (16 per cent), changing the taste of medications to make the flavour more palatable (10 per cent), and control of other symptoms associated with CF (18 per cent). The patients successfully utilised self-hypnosis 86 per cent of the time.”

Childbirth
Research at the Women’s and Children’s Hospital in Adelaide, where hypnosis is used for women in labour, shows it is highly effective. Women who had the therapy, which was given after 37 weeks gestation, used fewer epidurals - 36 per cent compared with 53 per cent in other women. A second study showed that women taught self-hypnosis reduced their need for analgesia by half, epidurals by 70 per cent, and were more than twice as likely to be satisfied with their pain management in labour compared with other women.

Snoring
According to Harley Street psychiatrist Dr Tom Kraft, snoring can be treated with hypnotherapy by suggesting under hypnosis that the sufferer turns on his side every time he begins to snore.

“I have reported on the case of a 53-year-old man who came to see me after his snoring led to his wife throwing him out of the bedroom,” he says. “After I treated him, his snoring went, and he was allowed back in the bedroom, for which he was eternally grateful. After 10 sessions, the patient no longer snored, and when he was followed up later the improvements had been maintained.”

What is hypnotism?
What hypnotism doesn’t do is put people to sleep, or make them lose control, or do things against their will. “Many see it as the mind being taken over by the hypnotist and loss of control, which is completely erroneous,” says Professor Peter Whorwell at the University Hospital of South Manchester. “As a consequence of this, the whole subject is surrounded by a cloud of mystery.”

In hypnotherapy, patients are helped by the therapist to reach what’s described as a relaxed state of consciousness, like being absorbed in a good book. Therapists may start by describing images that create a sense of security and well-being. They may then suggest ways of achieving specific goals, such as getting rid of phobias.
Just how it works is not clear. Practitioners say the patient can concentrate intensely on a specific thought, memory, feeling or sensation while blocking out distractions.

Source: Independent, Published: 30 January 2007
http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/hypnotism-its-all-in-the-mind-434295.html