I came across this article today reporting on a study comparing four types of lower back pain treatment over 7 weeks: individualized acupuncture, standardized acupuncture, "sham" acupuncture using toothpicks, and a control group that just used painkillers and anti-inflammatories (all groups were allowed to use drugs). Though I don't have the original journal article (May 11 Archives of Internal Medicine), the sample size seems large enough that the effect size mentioned should be statistically significant. 40% of the control group reported "significant improvement in disabilities brought on by back pain", and 60% of each of the other three groups reported the same. What might this mean for recommended treatments and third-party payment?
First, keep in mind that the participants all knew that this was a study on acupuncture treatment in order for the study to get informed consent. Only people willing to receive acupuncture were involved, which means the study had self-selection biases. Then they were randomly assigned to the four groups. So, the control group knew it was not getting the treatment that the study was testing. This would definitely have led to expectation biases in reporting disability. This study compared people willing to try acupuncture who got what they were told was acupuncture to people willing to try acupuncture who were then not given it. The chances that the effect seen is due to the placebo effect are very high.
The placebo effect is real and practically significant. It is really amazing how thoughts and beliefs, activity in the pre-frontal cortex, affect other parts of our brains and bodies, stimulating immune response (or inhibiting it) among other phenomena. What is also nifty is that we can intentionally generate these effects in ourselves without being tricked. Once we understand that a placebo effect exists, we can mimic the effect on purpose through mindful concentration or meditation. Recent studies using MRI, PET, and SPECT scans have revealed many brain processes that we can harness to benefit ourselves.
Jonah Lehrer, in How We Decide, cited research that reported that 90% of cases of non-specific lower back pain go away with just 7 weeks of rest. That would make rest far more effective than acupuncture or drugs. Perhaps having an active treatment encouraged these participants to continue physical activities that aggravated their back problems. With the expectation that they would be better with acupuncture or drugs, maybe they pushed themselves harder than they should have.
Based on this information, and in the interest of best practices, it seems that the answers to our questions are that Doctors should prescribe seven weeks of rest before moving on to other treatments, and that third-party payers still have little to no call to reimburse for acupuncture. The evidence is not compelling that acupuncture works according to its theories, and the high likelihood of a placebo effect suggests that similar benefits could be achieved through optimism, which is free.
I am interested in any well-done, valid, peer-reviewed studies demonstrating real benefits to acupuncture beyond a placebo effect. Since one in twenty studies may fall prey to a type I error (alpha is usually 0.05), meta-analyses are preferred. Send them my way if you've got 'em.
Showing posts with label placebo. Show all posts
Showing posts with label placebo. Show all posts
Tuesday, May 12, 2009
Saturday, May 2, 2009
Homeopathy - A Political History in the US
This is not what I expected would be my first topic, but it is getting a lot of current exposure on scienceblogs.com and sciencebasedmedicine.com. Both of these sites are slamming homeopathy, and the support given to homeopathy by the Huffington Post. Though they make valid attacks on the effectiveness of homeopathy, readers still lack much of the history and politics of homeopathy in America. Here I will present a brief summary of a longer paper I wrote a few years ago on herbal and homeopathic products, and why they should be regulated by an empowered Food and Drug Administration, if not outright banned. Most of the paper was about herbal products, but I will save that for another time. Note: this content is several years old, and does not take into account any new laws or regulations passed after 2005.
Executive Summary: Homeopathy as a field has sanction to regulate itself, which it hardly does at all. The FDA does not have the resources to take action against homeopathy products that make false claims. Homeopaths make a great deal of money selling products and services to people who do not realize that homeopathy is only as effective as a placebo at treating or preventing any health problems.
History: Homeopathy was invented by Samuel Hahnemann in the 1790s. It is based on two theories: the law of similars, which states that substances which elicit the same symptoms as a disease will help the body cure itself of the disease, and the law of infinitesimals, which states that drugs are more powerful the more that they are diluted. Homeopathic medicines, despite frequently involving poisonous substances, are blanketly considered safe by virtue of their ingredients being diluted so much. Some are even diluted to the point that a purchase will contain no molecules of the key ingredient, but some practitioners insist that the medium retains a "spirit" or "vibration" of the active substance, and will still function as a remedy.
Regulation of homeopathic medicines has changed over time. In 1934, Senator Copeland, himself a practicing homeopath, drafted a bill (S 2000, later S 2800) intended to protect American citizens from quacks by making medicines illegal that were not listed in the United States Pharmacopœia, National Formulary, and Homœopathic Pharmacopœia of the United States (HPUS). Copeland's bill, enacted in 1938, made all HPUS drugs legal, and regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. The Durham-Humphrey Amendment in 1953 made all homeopathic medicines prescription-only, but the FDA often did not enforce this rule due to its view that these medicines were useless. The Kefauver-Harris amendments in 1962 further regulated that homeopathic medicines added to the HPUS after 1938 be tested and accepted by a governing body of experts, which homeopaths did not like since they had so many different opinions about what treatments were effective. The 1988 Compliance Policy Guide (CPG) finally allowed many homeopathic medicines to be sold over the counter (OTC), as long as they were indicated "solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment" (FDCA, sec 400) such as colds or headaches. The sudden flood of OTC products upon enactment of the CPG in 1990, labeled with legal claims of treatment as indicated by the HPUS, resurrected the homeopathic industry and set it growing. Changes to the HPUS are under the control of the Homœopathic Pharmacopœia Convention of the United States (HPCUS), a non-governmental, non-profit organization, and occur once or twice per year since 1998.
HPCUS, therefore, has the power to decide what is a drug by law, and whether it has OTC or prescription-only status. The HPUS has over 1,300 drugs, about 440 of which are prescription in some potencies, and about 20 of which are prescription-only. The organization's requirements for deciding are not particularly stringent. Besides requiring proof of safety (easy to accomplish with enough dilution), new drugs must satisfy only one of the following four conditions:
● The therapeutic use of a new and non-official homeopathic drug is established by a homeopathic drug proving and clinical verification acceptable to the HPCUS.
● The therapeutic use of the drug is established through published documentation that the substance was in use prior to 1962.
● The therapeutic use of the drug is established by at least two adequately controlled double blind clinical studies using the drug as the single intervention; the study is to be accompanied by adequate statistical analysis and adequate description of the symptom picture acceptable to the HPCUS which includes the subjective symptoms and, where appropriate, the objective symptomatology.
● The therapeutic use of the drug is established by a) data gathered from clinical experience, or b) data documented in the medical literature.
For the purpose of these requirements, a "proving" is just a trial that shows that the substance elicits the same symptoms as the problem it is purported to treat, and "medical literature" includes any source the HPCUS decides to accept for the case. Anything documented as in use before 1962 gets grandfathered in. Though the third option is preferred by scientists, and most resistant to criticism, it is the most difficult to satisfy, and is easily bypassed by meeting one of the other requirements, such as anecdotes from personal clinical experience. Also, adherents to the philosophy of similars will probably accept almost any "clinical verification" that accompanies a proving. In addition to these means of having a drug accepted into the HPUS, HPCUS cites a clause that allows non-official drugs to be marketed providing "the manufacturer to produce a proving or sufficient clinical data for the FDA to make a determination as to whether the drug was in fact homeopathic."
Each state has further authority over who can gain licensure to prescribe homeopathic medicines that require prescriptions. Though a national license is available through the National Center for Homeopathy for anyone who meets its requirements (MDs, PAs, naturopathic physicians, etc…), states may limit the practice to MDs only or any selection at their discretion. The National Center for Homeopathy (NCH) reports that Minnesota became the first state to allow unlicensed practice of homeopathy in 2001. Also, Pennsylvania has not recognized the HPUS as an arbiter of legal drugs since 1972, and Texas since 1985.
The overwhelming evidence is that homeopathy is founded on extremely flawed theories, and maintained by believers who rely on anecdotes, subject to availability heuristics and confirmation and expectancy biases. Consumers are being scammed out of money, and many are not getting the effective treatments that they need because they think homeopathy is enough. Homeopathy should be banned by the government in order to protect consumers who do not have the education to protect themselves. Let us not value the profits of an industry over the welfare of our citizens.
Executive Summary: Homeopathy as a field has sanction to regulate itself, which it hardly does at all. The FDA does not have the resources to take action against homeopathy products that make false claims. Homeopaths make a great deal of money selling products and services to people who do not realize that homeopathy is only as effective as a placebo at treating or preventing any health problems.
History: Homeopathy was invented by Samuel Hahnemann in the 1790s. It is based on two theories: the law of similars, which states that substances which elicit the same symptoms as a disease will help the body cure itself of the disease, and the law of infinitesimals, which states that drugs are more powerful the more that they are diluted. Homeopathic medicines, despite frequently involving poisonous substances, are blanketly considered safe by virtue of their ingredients being diluted so much. Some are even diluted to the point that a purchase will contain no molecules of the key ingredient, but some practitioners insist that the medium retains a "spirit" or "vibration" of the active substance, and will still function as a remedy.
Regulation of homeopathic medicines has changed over time. In 1934, Senator Copeland, himself a practicing homeopath, drafted a bill (S 2000, later S 2800) intended to protect American citizens from quacks by making medicines illegal that were not listed in the United States Pharmacopœia, National Formulary, and Homœopathic Pharmacopœia of the United States (HPUS). Copeland's bill, enacted in 1938, made all HPUS drugs legal, and regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. The Durham-Humphrey Amendment in 1953 made all homeopathic medicines prescription-only, but the FDA often did not enforce this rule due to its view that these medicines were useless. The Kefauver-Harris amendments in 1962 further regulated that homeopathic medicines added to the HPUS after 1938 be tested and accepted by a governing body of experts, which homeopaths did not like since they had so many different opinions about what treatments were effective. The 1988 Compliance Policy Guide (CPG) finally allowed many homeopathic medicines to be sold over the counter (OTC), as long as they were indicated "solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment" (FDCA, sec 400) such as colds or headaches. The sudden flood of OTC products upon enactment of the CPG in 1990, labeled with legal claims of treatment as indicated by the HPUS, resurrected the homeopathic industry and set it growing. Changes to the HPUS are under the control of the Homœopathic Pharmacopœia Convention of the United States (HPCUS), a non-governmental, non-profit organization, and occur once or twice per year since 1998.
HPCUS, therefore, has the power to decide what is a drug by law, and whether it has OTC or prescription-only status. The HPUS has over 1,300 drugs, about 440 of which are prescription in some potencies, and about 20 of which are prescription-only. The organization's requirements for deciding are not particularly stringent. Besides requiring proof of safety (easy to accomplish with enough dilution), new drugs must satisfy only one of the following four conditions:
● The therapeutic use of a new and non-official homeopathic drug is established by a homeopathic drug proving and clinical verification acceptable to the HPCUS.
● The therapeutic use of the drug is established through published documentation that the substance was in use prior to 1962.
● The therapeutic use of the drug is established by at least two adequately controlled double blind clinical studies using the drug as the single intervention; the study is to be accompanied by adequate statistical analysis and adequate description of the symptom picture acceptable to the HPCUS which includes the subjective symptoms and, where appropriate, the objective symptomatology.
● The therapeutic use of the drug is established by a) data gathered from clinical experience, or b) data documented in the medical literature.
For the purpose of these requirements, a "proving" is just a trial that shows that the substance elicits the same symptoms as the problem it is purported to treat, and "medical literature" includes any source the HPCUS decides to accept for the case. Anything documented as in use before 1962 gets grandfathered in. Though the third option is preferred by scientists, and most resistant to criticism, it is the most difficult to satisfy, and is easily bypassed by meeting one of the other requirements, such as anecdotes from personal clinical experience. Also, adherents to the philosophy of similars will probably accept almost any "clinical verification" that accompanies a proving. In addition to these means of having a drug accepted into the HPUS, HPCUS cites a clause that allows non-official drugs to be marketed providing "the manufacturer to produce a proving or sufficient clinical data for the FDA to make a determination as to whether the drug was in fact homeopathic."
Each state has further authority over who can gain licensure to prescribe homeopathic medicines that require prescriptions. Though a national license is available through the National Center for Homeopathy for anyone who meets its requirements (MDs, PAs, naturopathic physicians, etc…), states may limit the practice to MDs only or any selection at their discretion. The National Center for Homeopathy (NCH) reports that Minnesota became the first state to allow unlicensed practice of homeopathy in 2001. Also, Pennsylvania has not recognized the HPUS as an arbiter of legal drugs since 1972, and Texas since 1985.
The overwhelming evidence is that homeopathy is founded on extremely flawed theories, and maintained by believers who rely on anecdotes, subject to availability heuristics and confirmation and expectancy biases. Consumers are being scammed out of money, and many are not getting the effective treatments that they need because they think homeopathy is enough. Homeopathy should be banned by the government in order to protect consumers who do not have the education to protect themselves. Let us not value the profits of an industry over the welfare of our citizens.
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