Sunday, January 25, 2015

Empiric Therapy in IVF - Science vs Emotions


A number of patients who have failed an IVF cycle (either in our clinic or elsewhere) want us to try something new and different for their next cycle. The common requests are whether we can prescribe steroids, IV immunoglobulins or Intralipids for them.

IVF failure can come as a rude shock, and patients are desperate to do something differently in the next cycle in order to make it succeed. Patients who have failed an IVF cycle can become quite frantic and are happy to clutch at straws. When they read about “new and latest” treatment advances, they want us to try those out for them too. The stumbling block is that a number of these treatments are empirical. Empirical therapy is that which is based on experience , and has not been proven to be effective in controlled clinical trials.

Doting on Anecdotes

However, these are supported by umpteen anecdotal case reports of success, where some patients have benefited from trying that particular treatment intervention. At this point, it’s important to understand that the lack of clinical trial proof doesn’t really reflect that the treatments don't work - it's just that no clinical trials have been conducted about them. 

Remember that just because there was a pregnancy after the treatment does not mean that the pregnancy was a result of that treatment. This is a natural bias and this logical fallacy is called the “post hoc, ergo propter hoc” fallacy. Sadly, it’s very easy for people to fall prey to this, which is why there are so many accounts online of patients who swear by unproven treatments such as IVIg (IV immunoglobulins) therapy , and swear that it helped them get pregnant.

The Emotion Quotient

These are very emotive stories; it’s easy to conclude that when a patient who has failed her first IVF cycle gets pregnant in her second cycle , after taking IV immunoglobulin, this means that the IV IgG "worked" and helped her to have a baby. However, this is flawed logic.

If IV immunoglobulins were really effective, what’s stopping IVF doctors from using them routinely for all their patients?  Why would they wait for the cycle to fail before using a therapeutic intervention which has been proven to improve pregnancy rates? While I have nothing against empiric interventions, I think patients also need acknowledge that these have many limitations. Not only can they be prohibitively expensive, but have hazardous side effects as well. For example, the overuse of steroids can cause hip necrosis, and actually harm the patient.

Inadequate Documentation


Unfortunately, patients as well as doctors are under a lot of pressure. Doctors are sceptical about using methods that have no clinical basis while patients are very easily influenced by the success stories they read online (even if these accounts have no scientific basis). Therefore, patients who get pregnant after taking IV immunoglobulin will wax eloquent about how effective the treatment is – while the ones who don’t get pregnant will keep mum, or will go on and try something different. This is exactly why documentation about the failures of empiric therapy is so inadequate.

A Matter of Science

The major risk is the false hope these treatments create in patient’s minds and hearts. I'm perfectly alright with using simple empirical therapy, such as acupuncture, DHEA, vitamin D and other supplements , which maybe unproven, but inexpensive and safe. However, when it comes to giving the nod for treatments that involve use of IV immunoglobulins that are expensive, risky and unproven, I wouldn’t approve unless the patient arm-twists me. 

As a scientist, I am compelled to depend upon reliable scientific evidence, but patients are not shackled by these considerations and have the freedom to do as they please. For me, a patient’s health and wellness is of paramount importance and I am happy to honour patient preferences, as long as there are no chances of harm.

Failed an IVF cycle and not sure what to do next? Please send me your medical details by filling in the form at http://www.drmalpani.com/free-second-opinion so I can guide you sensibly!

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