Articles

IVF and CAM Use

Perhaps the biggest hurdle to broader acceptance of the need for a consistent scientific basis for medical interventions is the attitude that worthless treatments are harmless. I often have the experience, after reviewing the evidence showing lack of efficacy for a specific intervention, of getting the head-tilt and shrug along with some variation of the dismissive attitude,  “Well, if people feel better, then what’s the harm?” In my opinion, ethics and intellectual honesty indicate that we have to do better than that.

The “what’s the harm” refrain is so tired and overused that it prompted a website by that name, documenting direct harm caused by unscientific treatment modalities. This is a helpful reminder that any intervention that actually does something (has biological activity) must also contain some risks. But this site also has significant limitations. First, it is anecdotal. But also it emphasizes direct harm, while the indirect harm of unscientific methods (for example by delaying definitive treatment) likely vastly outweighs the direct harm. However, indirect harm is extremely difficult to quantify.

Studies looking at the net clinical effects of using or relying upon unscientific methods is therefore desirable. Recently Danish researchers have published one such study:  Use of complementary and alternative medicines associated with a 30% lower ongoing pregnancy/live birth rate during 12 months of fertility treatment.

The study is a prospective follow-up cohort study, which means they followed a group of in-vitro fertilization (IVF) patients for 12 months and tracked their outcomes. (This is also a follow up of earlier data they presented two years ago with the same results.) They assessed their use of so-called CAM at the onset and at 12 months, and found:

About 30.6% (n = 223) of women used CAMs during the observation period. At T2 the ongoing pregnancy and live birth rate was 31.3% lower in CAM users (42.2%) compared with non-users (61.4%). Adjusted odds of pregnancy/live birth remained lower in CAM users versus non-users, odds ratio = 0.467 (95% confidence interval 0.306–0.711) after controlling for prognostic indicators (age, parity, years infertile).

The effect size is substantial – 31.3%, and the power of the study was robust. There are weaknesses, however. While they report that CAM modalities include acupuncture, reflexology, herbal and aromatherapy, they did not collect data in such a way as to assess the effect of specific CAM modalities on IVF success rate. Also, this study is not randomized. This means that the door is open for confounding factors. While the researchers controlled for obvious things, such as known prognostic factors for IVF success, it is always the unknown factors that cannot be controlled for. In other words, it is possible that another factor leads to CAM use and low IVF success, rather than CAM use directly causing low IVF success. But of course the latter interpretation is possible also – we just cannot tell from this one study.

Specific CAM modalities, like the use of herbal drugs, may have a direct adverse effect on IVF success. Herbal drugs are poorly controlled and are known in some cases to cause drug-drug interactions. There may also be indirect effects, such as reliance upon an ineffective CAM modality reducing compliance with the IVF procedure.

While this one study does not prove a specific adverse effect, it does reinforce what mainstream medical researchers already understand – a treatment that is unproven may in fact be harmful. This is precisely why unproven interventions should be used with extreme caution – either in the context of a clinical trial, for compassionate use, or perhaps with high plausibility in the absence of proven alternatives – and always with proper informed consent.

A major problem with proponents of CAM therapies is that the usual ethics of clinical care seem not to apply – as if they practice by a separate standard where treatments either work or have yet to be proven to work, but risks are generally ignored.

As an example, a recent study comparing acupuncture to placebo acupuncture showed that patients receiving placebo acupuncture had a higher pregnancy rate. In reality, most outcome measures were not statistically different – the study is consistent with a negative result and noisy data that just happened to favor placebo. The best scientific conclusion from this study is that acupuncture does not work for IVF, however the authors concluded: “Placebo acupuncture may not be inert.”

Although I think it’s most likely that this study is just negative, it may also be true that placebo acupuncture did better because real acupuncture has a negative effect on IVF rates. This latest study might lend support to this conclusion.

The authors concluded that CAM use in IVF patients should be monitored, but I think we can make a stronger conclusion that it should be discouraged. There is no evidence for benefit, and there is a suggestion of harm – in the real world of medicine this should lead to a suspension of using these techniques, at least until better studies show they are safe and effective. This is even without considering the extreme scientific implausibility of many CAM modalities, which makes the case for their continued use even worse.

Continued research into implausible treatments remain controversial precisely because those using these modalities in the first place do not follow standard medical ethics – they don’t base their practice on the evidence. I am still waiting for proponents to abandon a CAM modality because research shows it is not safe or that it is ineffective.

Posted in: Science and Medicine

Leave a Comment (9) ↓

9 thoughts on “IVF and CAM Use

  1. DevoutCatalyst says:

    “…however the authors concluded: “Placebo acupuncture may not be inert.”…”

    Would they feel the same about a lucky rabbit’s foot? Would NCCAM support a study of the rabbit’s foot? A rabbit’s foot has the same implausibility, it too has a tradition, why isn’t it in their armamentarium?

  2. hatch_xanadu says:

    Very, very sound analysis — thank you. And yes, it’s certainly true that the pregnancy/live birth rates were lower in people who used CAM because there were other factors that led to them using CAM in the first place. If a person has had multiple unsuccessful pregnancies (in which case the odds are already), it’s possible that they may be led to try CAM as sort of a last-ditch effort.

  3. Versus says:

    DevoutCatalyst is right. Someone should propose a rabbit’s foot study to NCCAM. Placebo rabbit’s feet could be made out of non-rabbit materials. You could also add comparisons to other modalities, such as four-leaf clovers (Traditional Irish Medicine) and horseshoes (Traditional American Rural Medicine).

    Re: “There is no evidence for benefit, and there is a suggestion of harm . . . ” I realize you are addressing physical harm here, but I would argue that there is always harm in the form of cost when the ineffective treatment is paid for by the patient, a consideration which, in my limited understanding of medical ethics, is appropriate in determining the ethical propriety of a treatment.

    In addition, as I have said on this site before, such treatments are legally fraudulent. I am just waiting for this to dawn on the plaintiffs’ attorneys — it could solve the whole problem. The tobacco companies started paying attention when the class actions and multi-billion dollar judgments came around.

  4. Traveler says:

    “While the researchers controlled for obvious things, such as known prognostic factors for IVF success, it is always the unknown factors that cannot be controlled for.”

    I think the headline shouldn’t be about CAM being associated with a 30% lower success rate, but that there are still unknown factors that are responsible for a 30% lower success rate. It would be surprising if any of the CAM modalities, other than herbal supplements, had any effect of outcome. I think the interesting question is whether there is something common in the lifestyle of CAM followers that might cause the effect.

    My pet hypothesis is that they don’t have enough red meat and refined sugar in their diets.

  5. Scott says:

    “I think the headline shouldn’t be about CAM being associated with a 30% lower success rate, but that there are still unknown factors that are responsible for a 30% lower success rate.”

    The title is the correct way to phrase it. The study was looking for an association. It found one. The association does not imply causality, merely correlation, therefore the title is a simple statement of fact and your objection has no merit.

  6. hatch_xanadu says:

    Yeesh, ’twas long ago, but in my comment above I meant “certainly possible,” not “certainly true”!

  7. rmgw says:

    “In addition, as I have said on this site before, such treatments are legally fraudulent. I am just waiting for this to dawn on the plaintiffs’ attorneys — it could solve the whole problem. The tobacco companies started paying attention when the class actions and multi-billion dollar judgments came around.”

    I always wonder when the psychanalysed are going to wake up to this…………………..

  8. cloudskimmer says:

    Great article, Steve. The term ‘harm’ could be considered two ways in this study, however. For those of us who think overpopulation is a huge unaddressed problem which makes all other environmental problems worse, and may result in the destruction of our civilization, anything that causes lower fertility rates sounds great! So, if there really is some causal connection between IVF failure and use of SCAM ‘treatments,’ I would certainly recommend those methods to all who are undergoing IVF.

Comments are closed.