MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

How often have I pointed out that most studies of chiropractic (and other alternative therapies) are overtly unethical because they fail to report adverse events? And if you think this is merely my opinion, you are mistaken. This new analysis by a team of chiropractors aimed to describe the extent of adverse events reporting in published RCTs of Spinal Manipulative Therapy (SMT), and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.

The Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analysed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analysed using tests for equality of proportions with continuity correction.

Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.

The authors concluded that although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.

We conducted a very similar analysis back in 2012. Specifically, we evaluated all 60 RCTs of chiropractic SMT published between 2000 and 2011 and found that 29 of them did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred (which I find hard to believe since reliable data show that about 50% of patients experience adverse effects after consulting a chiropractor). Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors. Our conclusion was that adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The new paper suggests that the situation has improved a little, yet it is still wholly unacceptable. To conduct a clinical trial and fail to mention adverse effects is not, as the authors of the new article suggest, against current guidelines; it is a clear and flagrant violation of medical ethics. I blame the authors of such papers, the reviewers and the journal editors for behaving dishonourably and urge them to get their act together.

The effects of such non-reporting are obvious: anyone looking at the evidence (for instance via systematic reviews) will get a false-positive impression of the safety of SMT. Consequently, chiropractors are able to claim that very few adverse effects have been reported in the literature, therefore our hallmark therapy SMT is demonstrably safe. Those who claim otherwise are quite simply alarmist.

6 Responses to Adverse events of (chiropractic) spinal manipulations: the unethical behaviour persists

  • I’m puzzled by “Data were analysed using descriptive statistics”, but they go on to provide analytical stats.

  • Whilst empirical, from my own experience as a practising chiropractor with 33 years experience and who has not had ONE complaint of CVA from a patient intervention, according to AHPRA the risk of CVA due to chiropractic spinal manipulation is real but rare.
    We can have you pay the bill for excessive regulation of an intervention that has proven effectiveness compared to pharmacological intervention for chronic spinal pain. Let us spend more money on how the musician Prince died due to drug overdose before you demand a low-risk profession spend limited resources on regulatory oversight.

    • ahh yes, chiros like to be out of control!

    • at Michael Epstein: How many of those patients would have improved without smt? Neither meds nor smt cure back or neck pains, but time, and healthy back care instructions often do. Meds do help for comfort . Persistent symptoms without RED FLAGS often benefit from Physical Therapy or more time. More persistent or red flag signs or symptoms require urgent evaluation for possible surgical intervention. Cracking joint space bubbles(SMT) does not heal strained muscles, tendons or ligaments beyond a theatrical placebo show, and certainly has no effect on herniations, even though time and proper back care can help small HNP’s.

      • I read these blogs with great interest…30+years as a DC (and teacher) has proven to me unequivocally that Chiropractic IS and always was a religious dogma, whose proponents can only utilize logical fallacy (post hoc ergo proptor hoc and ad hoc hypothesis….very similar to well-entrenched Scientologists) in order to placate themselves and give the appearance of argument.
        Interesting enough is the accumulation of data suggesting:
        1. Palpation of the spine (as well as ALL the nonsensical “subluxation tests” e.g. leg checks, applied kinesiology, occipital & Atlas mis-placement, x-ray etc etc) are both unreliable, invalid and logically untenable….supra-mundane guesswork disguised to the gullible as ‘science’.
        2. “Hyper”-mobile vertebra segments (sequestered via force closure maneuvers i.e. increased muscle stiffness) are the most likely attributes of back pain….NOT the elusive “hypo”-mobile/fixation…which offer no validating findings other than a DCs whim….and not coincidentally that “thrusting” to move shuff “more” is what we sell.
        Aren’t fused segments the most stable and least likely pain-generators? I’d suggest that is a scientifically valid premise.
        IF a shear instability/hyper-mobile segment is causative of many if not most “back events” (and pain chronicity) why pray tell add more, possibly damaging motion? And wouldn’t a thrust cavitate the already “too mobile” segment (as segmental ‘specificity’ is just more dogma)? I believe that is a logical conclusion.
        A Religious burden is why logic cannot dissuade proponents.
        Finally, ALL pre-“modern” science concepts have ignominious beginnings….however they evolve as knowledge grows….and replace the bad with the better. Dogmas and religions by their very nature refuse to expand. Chiropractic has been forced to change but its done so blithely and stubbornly using fallacious arguments to try to remain relavent. Chiropractic ‘works’ based on shallow-effects accomplished via innumerable less dangerous and expensive means…and based on psychology of its proponents….not on substantial biomechanical or anatomical actions.

  • @Michael Epstein

    … from my own experience as a practising chiropractor with 33 years experience and who has not had ONE complaint of CVA from a patient intervention, according to AHPRA the risk of CVA due to chiropractic spinal manipulation is real but rare.

    How do you know? People who suffer VAD rarely come back to their chiropractor for more neck wringing. They are usually unable to even tell that they jst visited the chiro due either to death or destruction of brain tissue.
    Do you follow up on every patient how they did after they left your theatre? Especially, have you followed systematically up on all cervical manipulations who did not return, in order to pick up possible adverse events?

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories