How to Make a Study Look Favorable for Reflux Surgery Compared to Medical Treatment

A recent study (SJ Spechler et al. NEJM 2019; 381: 1513-23) on first glance appears to support surgery as more effective than medical treatment for refractory heartburn.

Only ~20% of enrolled patients were included in the reported outcomes!

Here’s what happened.  Among a cohort of VA patients (n=360, mean age 48 years) who were reportedly refractory to PPI-treatment:

  • 78 were excluded during prerandomization
  • 42 had relief of their heartburn during a 2-week omeprazole lead-in (20 mg BID)
  • 70 did not complete trial procedures
  • 23 had non-GERD disorders
  • 99 had functional heartburn

This left 78 patients who underwent randomization.  All patients in this highly-selected group had undergone endoscopy with biopsy, impedance-pH testing, and esophageal manometry.  18 of 27 (67%) had treatment success with surgery compared to 7 of 25 patients treated with baclofen/PPI and 3 of 26 with control medical treatment (PPI alone).

Key points:

  • Careful evaluation is needed in any patient with refractory heartburn, especially if contemplating surgery.  Most will either respond to PPI treatment or have a disorder other than reflux; the authors note that 122 patients (out of 360 patients) did NOT have reflux –99 had functional heartburn.
  • Careful instruction in PPI use can be helpful.  Omeprazole and similar agents should be taken 30 minutes before meals.
  • The authors noted that in addition to reflux, that reflux hypersensitivity can “respond to fundoplication…treatment success was 71% among the 14 with reflux hypersensitivity and 62% among the 13 with abnormal acid reflux.”

Limitations: The VA population is not representative of the general population; this trial had a predominance of white males. Also, it is hard to exclude that some of the ‘success’ of the procedure could relate to a powerful placebo response.

My take: This trial reinforces the notion that reflux surgery is helpful in very few highly-selected patients.

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