Zeno's Blog

Time to take a closer look at some of the conclusions of the Bronfort report.

Otitis Media is, to the average parent, an ear infection — of the middle ear, to be precise. This can affect children and can be very painful and disturbing to both infant and parents. About one in five chiropractors I complained about made claims about ear or similar infections. It was also one of the childhood ailments that Simon Singh mentioned in the Guardian article the BCA had a hissy fit about.

Because of my complaints and because there appeared to be no definitive list (other than the ASA’s list of acceptable claims, of course) of what conditions were backed by robust evidence, the GCC commissioned five US chiropractic researchers to review the good evidence for all the conditions I complained about. I’ve already said something about the kinds of evidence Bronfort et al. decided should be included in the report: they were interested in only relying on quality evidence.

Bronfort’s evidence

Otitis Media

Definition

Otitis media is characterized by middle ear inflammation which can exist in an acute or chronic state and can occur with or without symptoms.

Diagnosis

Diagnosis of otitis media relies on otoscopic signs and symptoms consistent with a purulent middle ear effusion in association with systemic signs of illness [266].

Evidence base for manual treatment

Systematic reviews (most recent)

Hawk et al [230] found promising evidence for the potential benefit of spinal manipulation/mobilization procedures for children with otitis media. This was based on one trial [267]. Two other reviews specifically addressed spinal manipulation by chiropractors for non-musculoskeletal [247] and pediatric [248] conditions. Both found insufficient evidence to comment on manual treatment effectiveness or ineffectiveness for otitis media.

Evidence-based clinical guidelines

The American Academy of Pediatrics 2004 guidelines on the diagnosis and management of acute otitis media [268] concluded no recommendation for complementary and alternative medicine for the treatment of acute otitis media can be made due to limited data.

Recent randomized clinical trials not included in above

Wahl et al investigated the efficacy of osteopathic manipulative treatment with and without Echinacea compared to sham and placebo for the treatment of otitis media [269]. The study found that a regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media episodes. This study had a high risk of bias.

Evidence Summary (See Figure 7)

Inconclusive evidence in an unclear direction regarding the effectiveness of osteopathic manipulative therapy for otitis media [267,269].

Other effective non-invasive physical treatments or patient education

Patient education and “watch and wait” approach for 72 hours for acute otitis media [266,268]

Evidence summary

To summarise all the evidence cited (I’ll use Bronfort’s reference numbers to avoid confusion):

So that’s three systematic reviews, two guidelines and one RCT.

One of those systematic reviews (Hawk) cited just one RCT (Mills).

The other two reviews (Ernst, Gotlib) said there was insufficient evidence to comment.

One of the guidelines (SIGN) didn’t even consider chiropractic and the other (Pediatrics) only gave chiropractic a passing mention, correctly lumping it in with homeopathy and other woo and said:

To date there are no studies that conclusively show a beneficial effect of alternative therapies used for [acute otitis media].

They found an additional RCT (Wahl) that had not been covered in the systematic reviews.

Bronfort examined all this evidence and concluded there was:

Inconclusive evidence in an unclear direction regarding the effectiveness of osteopathic manipulative therapy for otitis media

However, he only relied on the Mills and Wahl papers for this conclusion so we need to take a closer look at these two trials.

Sleight of hand

Ref 230 (Hawk) is a review titled Chiropractic Care for Nonmusculoskeletal Conditions: A Systematic Review with Implications for Whole Systems Research, but they were only able to find one RCT for otitis media (267, Mills). They did rate it highly on several standard checklists, including Jadad, and from this single study, Hawk concluded:

Evidence was promising for the potential benefit of manual procedures for children with otitis media

Note it says ‘manual procedures’. More of that later.

Delving deeper still…

Mills is a small RCT (n=57) titled: The Use of Osteopathic Manipulative Treatment as Adjuvant Therapy in Children With Recurrent Acute Otitis Media.

The clue, as they say, is in the title.

The objective of the study was:

To study effects of osteopathic manipulative treatment as an adjuvant therapy to routine pediatric care in children with recurrent acute otitis media (AOM). (My emphasis)

Note that when Bronfort introduces this study, he omits to mention the fact that this trial was for osteopathic manipulation and simply says it was for “spinal manipulation/mobilization procedures”. Indeed Hawk uses it in a review of chiropractic care.

However, the study itself is just a bit clearer on what the treatment was:

OSTEOPATHIC MANIPULATIVE TREATMENT

Osteopathic manipulative treatment was provided to the intervention group at each visit, as indicated by the osteopathic examination results and the child’s cooperation. Treatments lasted 15 to 25 minutes, which is usual in most practices. Treatments were gentle techniques on areas of restriction consisting of articulation, myofascial release, balanced membranous tension (according to teachings of William Garner Sutherland, DO, and others 25), balanced ligamentous tension, facilitated positional release, and/or counterstrain treatments. These techniques are familiar to most recently trained osteopathic physicians, but it is not in the scope of this article to describe them in detail. Despite some expected variation in their application by different physicians, we attempted to standardize their approach by using only physicians with teaching experience in OMT. No high-velocity (popping) techniques were used. The entire body, with attention to the head and neck, was included in the osteopathic evaluation and treatment.

No spinal adjustments. No high-velocity low-amplitude thrusts. No ‘gentle but specific’ adjustments. No back cracking. No popping. Not chiropractic.

But since the paper refuses to give details about exactly what the half-dozen osteopathic treatments were and how they were randomised (if indeed they were) and administered to the 25 infants that were in the OMT arm of the trial, it is impossible to even be sure what effect any of the osteopathic treatments had.

On the subject of blinding:

The parents knew the child’s treatment group, though every effort was made not to let this information affect pediatrician recommendations, which we knew by means of medical record review.

Mills concluded:

Although a larger study is needed, it appears that [osteopathic manual treatment] offers a potential benefit as adjuvant therapy for children with recurrent AOM.

In summary:

• the treatment was osteopathy, not chiropractic;
• it was small and low powered;
• it looked at OMT as an adjuvant (ie as an additional treatment) to normal care by a pediatrician, including antibiotic use;
• the parents were not blinded to the treatment;
• there was no placebo group;
• the subjects were six months to six years, therefore not applicable to newborns;
• a larger study was recommended.

So what on earth made Bronfort think this was an appropriate quality study to include in a review of chiropractic?

Déjà vu

Of course, you may have realised by now that you’re read about this study before — it was in the BCA’s plethora (although they missed out the significant words “as an adjuvant therapy” in the title) that Gimpy took it apart in his blog — one of the many that demolished the BCA’s plethora within 24 hours of its publication.

Similarly, it was dismissed by Ernst in the BMJ as having nothing to do with chiropractic: it still has nothing to do with chiropractic.

So why did Bronfort include this study? We can only guess.

What I hadn’t noticed before was that both the Mills and the Hawk papers were included in the BCA’s plethora for otitis media (their references 9 and 11). Although they have tried to use Hawk to bolster other claims, this does look like a bit of double counting.

Next!

The only other paper Bronfort chose to rely on for his conclusion was reference 269 (Wahl). This is Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial.

This didn’t make an appearance in the BCA’s plethora, but it fails for the same reason as the Mills study — it’s about osteopathy, with a little bit of herbalism thrown in for good measure:

Treatment modalities were limited to cranial osteopathy, balanced membranous/ligamentous tension, and/or myofascial release (applied directly or indirectly). These treatments consist of gentle manipulations of the cranium, pelvis, diaphragm, and other structures. No high velocity or thrusting maneuvers were performed. At the discretion of the osteopathic physician, an osteopathic percussion hammer could also be used for treatment, which allowed gentle vibration in tissues at variable frequencies.

Not chiropractic, then either.

Note that Bronfort made no assessment of the quality of any of the RCTs it looked at:

While critical appraisal of the included reviews and guidelines would be ideal, it is beyond the scope of the present report.

They presumably weren’t getting paid enough or were in too much of a hurry.

However, even for osteopathy, they concluded:

A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media.

OMT was not significantly associated with the risk of AOM

Sham

Even if this was all about osteopathy and not chiropractic, it’s difficult to see how Bronfort reached the conclusions he did, based on these two studies — to recap:

Inconclusive evidence in an unclear direction regarding the effectiveness of osteopathic manipulative therapy for otitis media

What Bronfort should have concluded was not that there was inconclusive evidence but that there was no evidence for the use of chiropractic for otitis media.

Not a jot.

I have to wonder why otitis media even made it into the report, rather than being rejected outright through lack of any applicable RCTs.

Ah! I know why.

Claims

So, what will chiropractors be claiming on their websites and other advertising for otitis media?

As the GCC told Skeptic Barista:

The GCC’s guidance to the profession mirrors that of the Committee of Advertising Practice Copy Advice Team ie that any claims for chiropractic must be based on best research of the highest quality. This will almost certainly mean randomised controlled trials that produce high or moderate quality positive evidence.

Or, as Skeptic Barista succinctly put it:

No RCT = No evidence = No claim