A Press Release Overstates Results

A Press Release Overstates Results

I received a press release today:

Massage Shown Effective Treating Female Infertility

In a landmark 10-year study, a therapeutic massage replaced surgery and was found effective treating the most common causes of female infertility.

The website certainly looks impressive but what might this landmark study be? It was

Ten-year Retrospective Study on the Efficacy of a Manual Physical Therapy to Treat Female Infertility

It has a number interesting methodological curiosities.

 

They use the Wurn technique, a form of massage which has 6 references in PubMed.. There is no independent supporting data for the technique that I can find and Aeta Insurance has it on the list of treatments called

experimental and investigational, because there is inadequate evidence in the peer-reviewed published medical literature of their effectiveness.

The rational behind the Wurn technique appears to have a chiropractic influence

the research team’s hypothesis is that the therapy affects 1 or more mechanical blocks in communication between the brain and the reproductive system—the hypothalamic-pituitary-gonadal axis or other mechanical paths. The research team theorizes that these blocks may be caused either by (1) misalignment of the cranium or spine, affecting nervous system communication; (2) dysfunctional tissues surrounding blood vessels; (3) nerves in the pelvic region decreasing efficient stimulation, or (4) a combinationof any of these causes

From my understanding of physiology, I would think that the prior plausibility that this approach would be effective for infertility would be low.

The Author Disclosure Statement says

“The research team received no funding for this study and have no conflicts of interest related to it.”

Yet the several of the authors work for a company that specializes in the therapy tested and invented the procedure used. Although mentioned in the author sections, to suggest no conflicts of interest is, in my opinion, disingenuous.

So people who invent a procedure and make a living offering it do a trial to look at efficacy. Nothing wrong with that; it is the big Pharma way of doing things. New procedures need to be evaluated by someone and it is the quality of the study that is important. A well done, double blind, randomized, placebo control trial, no matter who does it, has to be taken seriously.

And?

No blinding, no placebo control.

Retrospective. The cause of infertility was determined by

The physicians’ diagnoses and the patients’ self-reported medical histories were examined for causes of infertility, including elevated FSH levels, blocked fallopian tubes, endometriosis, PCOS, POF, and unexplained infertility

Self reports are not a rigorous way to make the diagnosis upon which to base an experimental treatment.

The intervention?

Patients were treated using a patient-centered, individualized treatment plan of physical therapy that is standard practice at the clinic and that included a comprehensive review of the patient’s medical history and an initial evaluation. The regimen and modalities included in the treatment plan are termed the CPA, which uses a variety of recognized techniques of manual physical therapy, together with refinements and modifications of those techniques… the CPA protocol was individualized to treat sites that presented with restricted mobility within each patient’s body. The therapy used various site-specific pressures across the restrictive bands of adhered tissues and structures, working progressively deeper from the most superficial tissues, to restore mobility via myofascial release. Adhesions within and between organs and interstitial. spaces within the viscera were addressed using the Wurn technique; decreased organ motility was then addressed using visceral manipulation.33 The amount of force and the length of time that the force was applied to each area had the potential to be significant, but the treatment was maintained within the tolerance of the patient. The standard treatment regimen was 20 hours, administered 4 hours per day for 5 days.

They refer to the Wurn technique but the reference used doesn’t really tell me what the technique is nor does the references from that paper, which says

The therapists palpated these soft tissues and assessed their

texture, tension, and relative temperature while feeling for decreased elasticity, distensibility, or increased heat. They used their palpation skills to access restrictions in these parameters in the tissues and organs surrounding the fallopian tubes by manipulating the peritoneum, uterine and ovarian ligaments, and neighboring structures.

The purpose of the methods is to know what was done so that another, independent researcher could reproduce the study or apply the results themselves. As best I can tell, it is not possible to know what was done to any patients to know if it worked as each intervention was idiosyncractic to the practitioner

And it is not stated in the paper if patients only used CPA or used CPA in addition to other infertility treatments.

They then compared their pregnancy rates in different groups to the various published pregnancy rates and did p value testing using

Correlations were identified using DataDesk version 6.2.1 (Data Descriptions, Ithaca, NY, USA), via a linear regression model in which items from past medical history were used as the variables against a determination of a positive or negative outcome for each measured condition.

As an example, 42% of their patients with endometriosis became pregnant. They compared that rate to 3 published studies of pregnancy and endometriosis.

Stepniewska A, Pomini P, Bruni F, et al. Laparoscopic treatment of bowel endometriosis in infertile women. Hum Reprod. 2009;24(7):1619–1625.

Zhu S, Liu D, Huang W, et al. Post-laparoscopic oral contraceptive combined with Chinese herbal mixture in treatment of infertility and pain associated with minimal or mild endometriosis: a randomized controlled trial. BMC Complement Altern Med. July 2014;14:222.

Lee HJ, Lee JE, Ku SY, et al. Natural conception rate following laparoscopic surgery in infertile women with endometriosis. Clin Exp Reprod Med. 2013;40(1):29–33

Why these three out of the 2665 articles searching PubMed for “endometriosis infertility treatment” is not explained in the text.

There are similar issues with the other comparisons. The success rates are compared to published rates, sometimes favorably, sometimes not, and never with justification as to why those particular papers were used as comparators.

Of the 23 p values reported, 4 were ‘significant’. It looks more like the random noise of retrospective data mining rather than a true effects.

It is not possible for me to draw any conclusions about the usefulness of the interventions offered after reading the paper and my conclusion from the paper is the intervention mostly didn’t work.

They also note the

Limitations of this study include a high rate of drop-out to follow-up and a dependence for a comprehensive medical history upon the patients’ self-reports of that history and on their provision of the surgical and test results.

But they do report the drop out rate.

If you apply the criteria of Why Most Published Research Findings Are False, to this paper, it appears they meet almost every one.

So when the press release calls it

a landmark study (that) can profoundly change the way physicians treat infertility in women.

I am not so certain. There are a sufficiency of methodologic flaws in the publication to make any positive conclusion suspect.

Points of Interest 04/03/2015
Points of Interest 04/02/2015

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