CAM for Arthritis: Is There a Role?
CAM for Arthritis: Is There a Role?
Dr. Kay: What objective evidence is there that witch doctors and medicine men heal diseases in the same way that allopathic physicians do? If one is to consider the treatments of shamans to be equivalent to those of allopathic physicians, they must be subjected to the same degree of rigorous study using similar objective outcome measures. I am unaware of such studies and would appreciate your pointing me toward them.
I suspect that you and my other colleagues in rheumatology would consider it below the appropriate standard of care if I were to attempt to treat a patient with active seropositive RA by performing a rain dance in the examination room, rather than initiating treatment with methotrexate or another disease-modifying antirheumatic drug. Were I to begin treating patients in such a manner, I expect that this practice would be deemed to be unethical.
Dr. Wei: No, please don't do a rain dance for an RA patient. As you and I both know, it won't work, and you're not Fred Astaire. My point about shamans was not to put them head to head against allopathic physicians. It was merely to suggest that in the days before allopathic medicine, they were all that there was and sometimes the power of belief was enough to heal, sort of like the Wizard of Oz.
Believe me, if I'm sick, I'll take a cushy private room in a modern hospital any day of the week. Of course, I'll also make sure I have relatives, friends, and other advocates there to protect me from the numerous hospital errors that occur on a daily basis in this country. (In fact, a local hospital recently made an error that nearly cost one of my family members their life.)
There are abundant stories, perhaps apocryphal, of old-time general practitioners using sugar pills -- the original placebos -- to treat "disease." In rheumatology, we know that the placebo effect in clinical trials can be as high as 40%. Placebo might be the ultimate CAM.
Dr. Kay: You mention the potential use of placebo to treat disease. The clinical improvement observed among placebo-treated patients in clinical trials of antirheumatic drugs most likely reflects the natural course of RA, with periods of flare and remission. Most of these clinical trials have been conducted in patients who had been inadequately responsive to background antirheumatic drug therapy. The observed placebo response rate also may reflect additional clinical response to background drug therapy that can occur during the course of the trial, if study participants had not been compliant with background antirheumatic drug therapy before entering the trial. However, the intentional prescription of a placebo as a CAM to treat a patient with any disease is completely unethical.
Dr. Wei: Please stop sending me your emails in the evening. I had difficulty sleeping last night because one of your sentences kept haunting me: "The intentional prescription of a placebo as a CAM to treat a patient with any disease is completely unethical."
A few years ago, Bruce Moseley and colleagues at the Houston Veterans Affairs Medical Center performed a placebo-controlled, double-blind study comparing arthroscopic debridement of the joint for OA. One group received the real thing, and the other group received a sham procedure. The outcomes were similar for both groups. As you might guess, this study shook up the orthopods.
My question: Was this unethical? Any time we perform a placebo-controlled study, we are intentionally prescribing a "sugar pill" for treatment.
Dr. Kay: I did not mean for you to lose any sleep about the use of placebo in institutional review board (IRB)-approved clinical trials. When a study has been designed to assess the efficacy of a treatment in a double-blind manner and employs a placebo to maintain this blinding, it is certainly ethical to do so.
Before approving such a study, the members of an IRB review the protocol for its risk/benefit ratio and the ethical equipoise of its design. In a clinical trial, participants are followed closely and objective outcomes are measured. As long as the potential risk of the placebo treatment does not outweigh the potential benefit that might be derived from ascertaining the efficacy or lack of efficacy of the experimental therapy, it is appropriate to use placebo in this context.
Most important, subjects provide informed consent to participate in a placebo-controlled study. If "placebo" were administered as a treatment in clinical practice, the patient would have been misled to believe that he or she was receiving an active drug. Such an act violates the prescribing physician's Hippocratic Oath.
The Ethics of Placebo
Dr. Kay: What objective evidence is there that witch doctors and medicine men heal diseases in the same way that allopathic physicians do? If one is to consider the treatments of shamans to be equivalent to those of allopathic physicians, they must be subjected to the same degree of rigorous study using similar objective outcome measures. I am unaware of such studies and would appreciate your pointing me toward them.
I suspect that you and my other colleagues in rheumatology would consider it below the appropriate standard of care if I were to attempt to treat a patient with active seropositive RA by performing a rain dance in the examination room, rather than initiating treatment with methotrexate or another disease-modifying antirheumatic drug. Were I to begin treating patients in such a manner, I expect that this practice would be deemed to be unethical.
Dr. Wei: No, please don't do a rain dance for an RA patient. As you and I both know, it won't work, and you're not Fred Astaire. My point about shamans was not to put them head to head against allopathic physicians. It was merely to suggest that in the days before allopathic medicine, they were all that there was and sometimes the power of belief was enough to heal, sort of like the Wizard of Oz.
Believe me, if I'm sick, I'll take a cushy private room in a modern hospital any day of the week. Of course, I'll also make sure I have relatives, friends, and other advocates there to protect me from the numerous hospital errors that occur on a daily basis in this country. (In fact, a local hospital recently made an error that nearly cost one of my family members their life.)
There are abundant stories, perhaps apocryphal, of old-time general practitioners using sugar pills -- the original placebos -- to treat "disease." In rheumatology, we know that the placebo effect in clinical trials can be as high as 40%. Placebo might be the ultimate CAM.
Dr. Kay: You mention the potential use of placebo to treat disease. The clinical improvement observed among placebo-treated patients in clinical trials of antirheumatic drugs most likely reflects the natural course of RA, with periods of flare and remission. Most of these clinical trials have been conducted in patients who had been inadequately responsive to background antirheumatic drug therapy. The observed placebo response rate also may reflect additional clinical response to background drug therapy that can occur during the course of the trial, if study participants had not been compliant with background antirheumatic drug therapy before entering the trial. However, the intentional prescription of a placebo as a CAM to treat a patient with any disease is completely unethical.
Dr. Wei: Please stop sending me your emails in the evening. I had difficulty sleeping last night because one of your sentences kept haunting me: "The intentional prescription of a placebo as a CAM to treat a patient with any disease is completely unethical."
A few years ago, Bruce Moseley and colleagues at the Houston Veterans Affairs Medical Center performed a placebo-controlled, double-blind study comparing arthroscopic debridement of the joint for OA. One group received the real thing, and the other group received a sham procedure. The outcomes were similar for both groups. As you might guess, this study shook up the orthopods.
My question: Was this unethical? Any time we perform a placebo-controlled study, we are intentionally prescribing a "sugar pill" for treatment.
Dr. Kay: I did not mean for you to lose any sleep about the use of placebo in institutional review board (IRB)-approved clinical trials. When a study has been designed to assess the efficacy of a treatment in a double-blind manner and employs a placebo to maintain this blinding, it is certainly ethical to do so.
Before approving such a study, the members of an IRB review the protocol for its risk/benefit ratio and the ethical equipoise of its design. In a clinical trial, participants are followed closely and objective outcomes are measured. As long as the potential risk of the placebo treatment does not outweigh the potential benefit that might be derived from ascertaining the efficacy or lack of efficacy of the experimental therapy, it is appropriate to use placebo in this context.
Most important, subjects provide informed consent to participate in a placebo-controlled study. If "placebo" were administered as a treatment in clinical practice, the patient would have been misled to believe that he or she was receiving an active drug. Such an act violates the prescribing physician's Hippocratic Oath.
