Chiropractic Safety and Informed Consent

With nearly the regularity of geyser eruptions from Old Faithful, we have witnessed the appearance of media releases on the topic of strokes being linked to chiropractic cervical manipulations. Very often this has been associated with the assertion that the patient was not properly informed.

In manner of fact, as John Triano and Gregory Kawchuk have pointed out in their comprehensive and well-balanced review,¹ hundreds of case reports of vertebral artery dissections (CVDs) following cervical spinal manipulations have actually appeared since 1934.² Since then, enough ink has been spilled on this topic to fill a Great Lake or two. In this controversy, however, several important pieces of information are commonly overlooked and need to be considered in the aggregate:

• fulfillment of criteria of causality,¹ as established more than 40 years ago by Bradford Hill;³
• disclosure that the majority of CVDs are spontaneous, cumulative, or caused by factors other than spinal manipulation;^4-6
• disclosure of the potential benefits of the procedure, as must be done in reporting true risk-benefit ratios;
• placement of the risks of manipulation in the context of those produced by other medical treatments or lifestyle activities;^6,7
• reporting of the actual frequency of spinal manipulations administered;⁷
• accounting for the possibilities that patients experiencing cerebrovascular artery accidents are reported more than once;⁸ and reporting the rates of CVDs following manipulation by parties other than licensed chiropractors.^1,2,9

What this entire imbroglio really comes down to is the fact that the public continues to lack the proper information concerning the safety of all medical procedures, not just chiropractic. Put in concrete terms, when was the last time warnings about the side effects of NSAIDs⁷ were given to you by your physician or presented in the lay media? Conversely, a highly provocative and informative article by James Meschino¹⁰ suggests that the freely available herbal supplement hawthorne might be considered at least in some instances to be a viable alternative to the widely prescribed angiotensin-converting enzyme (ACE) inhibitors commonly used to control hypertension.

In fact, it is suggested that hawthorne might be even more effective since it not only appears to have ACE-inhibiting properties, but also blocks voltage-gated calcium channels in muscle cells of the heart; and increases the release of nitric oxide to promote vasodilation, enabling the heart muscle to generate more ATP as a means of energy for myocardial contraction.¹⁰

This is but a tiny sampling of information that doesn't appear to have hit the tabloids. And yet the ramifications of hidden information such as the above are enormous. In terms of the consequences and numbers of people affected, they simply dwarf any discussions about CVDs. Such is not to diminish the significance of CVDs. Clearly, we constantly strive for ways to reduce their occurrence. But if CVDs are held to be important, the enormous body of medical information usually omitted from discussions needs to be brought into the limelight. For meaningful informed consent to take place, Sim suggests the following criteria be recognized:¹¹

• Information which discloses all risks must be comprehensible to the patient and provided/explained to them.
• The consent component must ensure that the patient is competent to offer consent and does so voluntarily.
• Written information be both legible and readable.
• Practitioners must be cognizant of existing legal precedents, legislative requirements, advice from professional associations, and directives from licensing and registration authorities.

For a patient to receive anything less than a full body of information - whether about treatment safety or treatment alternatives - could be argued to border upon malpractice. This was driven home about a decade ago by the unanimous Matthies v Mastromanaco decision by the New Jersey Supreme Court, which upheld a lower court decision. The court's decision emphasized in no uncertain terms the right of the patient to receive no less than a complete array of relevant information from the attending physician. In bold terms, the decision mandated: "Like the deviation from the standard of care, the doctor's failure to obtain informed consent is a form of medical negligence. Recognition of a separate duty emphasizes the doctor's obligation to inform, as well as treat, the patient."¹² (Italics mine)

Thus, if one encounters news articles that attempt to link strokes and chiropractic, the doors must be opened immediately to admit an avalanche of information regarding such topics as the risks of medical treatments for similar conditions or the full range of alternative interventions available. In addition to making sure "available" can become "accessible," both press and the medical community need to be especially mindful that possible risks and alternatives for all treatment options should not be kept from public view.

This, then, is the proverbial elephant in the bedroom. One can only hope that with the coming of spring, this beast of burden can be set free from its confines and allowed to roam unfettered in the public marketplace.

References

1. Triano JJ, Kawchuk G, editors. Current Concepts in Spinal Manipulation and Cervical Arterial Incidents. Iowa: NCMIC Group, Inc., 2006.
2. Terrett AG. Current Concepts in Vertebrobasilar Complications Following Spinal Manipulation. Iowa: NCMIC Group, Inc., 2001.
3. Hill AB. The environment and disease: association or causation? President's Address. Occupat Med, 1965;195-8.
4. Shievink WT, Mokri B, O'Fallon WM. Recurrent spontaneous cervical-artery dissection. New Engl J Med, 1994;330(6):393-7.
5. Rosner A. Spontaneous cervical artery dissections: another perspective. JMPT, 2004;27(2):124-32.
6. Rome PL. Perspectives: An overview of comparative considerations of cerebrovascular accidents. Chiro J Australia, 1999;29(3):87-102.
7. Dabbs V, Lauretti W. A risk assessment of cervical manipulation vs. NSAIDS for the treatment of neck pain. JMPT, October 1995;18(8):530-6.
8. Tauro J. Letter to the Editor. Neurology, 1996;46:884.
9. Terrett AG. Misuse of the literature by medical authors in discussing spinal manipulative therapy injury. JMPT, May 1995;18(4):203-10.
10. Meschino JP. "Hawthorne: The Three-in-One Natural Remedy for High Blood Pressure." Dynamic Chiropractic, Feb. 26, 2009;27(5):14,34.
11. Sim J. Informed consent and manual therapy. Manual Therapy, 1996;2:104-6.
12. Jean Matthies v Edward D. Mastromonaco, DO. Supreme Court of New Jersey (A-9-98). Pollock J. (Judgment dated July 8, 1999)