Les, I read a provocative argument somewhere that says that the placebo effect doesn’t exist—in that there is nothing that causes our brains to effect a lessening of symptoms.  It’s ALL perception, and has a lot to do with a certain series of events:  most illnesses increase and decrease in severity over their course, and people tend to seek a new treatment when it’s in its worst phase, so their swing into feeling slightly better happens to coincide with the treatment.  So they believe the treatment is responsible for making them feel better, when actually it’s just a matter of timing.

This would explain why the “placebo” effect doesn’t work for everybody, and why it doesn’t work for diseases that have a definite linear progression.

With regard to your statement “one of the main reasons people actually believe homeopathic remedies actually do something”:

If someone does something that effectively triggers the “placebo effect” and reduces their pain, then it was an effective remedy. I’m perfectly happy with the thought that that is a legitimate solution since it can have real, beneficial results (like a reduction in the intake of another medicine with real side effects).

Unfortunately, the placebo effect is usually exploited to make money (enter homeopathy, chiropractic, etc). Unfortunately, the fact that something is “expensive” often improve the effect for some people making it ripe for exploitation.

If someone puts a potato in their pocket, or $12 magnets in their shoes and gains, in their eyes, some benefit then more power to them. There is a gain without harm. If they put $399 magnets in their shoes, that’s just criminal exploitation.

I’m ranting.

I guess my point is that I think placebos are valid science, so I’m glad they’re trying to research it at last.

Well not all alternative remedies are useless. For example acupuncture seems to be the most reliable for alternative remedies.

For example in UK they are training vets with acupuncture. Dogs which was suffering from pain for a long time and had trouble moving was cured by acupuncture and I would think that there is no placebo effect on animals.

Emphasis on “seems.”  I’d feel a lot better about acupuncture if they’d stop explaining its use in terms of invisible, fictional “energy lines” and actually talk about the real anatomy that’s already there. 

And just because a lot of people are using it doesn’t mean it actually works.  It just means they THINK it does.  See my previous posting about coincidences.

(And you know, if I were a dog and were being poked with needles, I’d get motivated enough to start moving again, pain or no pain.)

Frac, if the only goal is to relive pain then, yes, placebos can be useful. Most homeopathic remedies, however, make bigger claims than just reliving pain. And a lot of the homeopathic pills are literally sugar pills with a drop of the “remedy” on it. Magnets in your shoes isn’t homeopathic though it is still just a scam. Is it really gain without harm? Depends on the ailment I would say. With some of the more serious conditions that homeopathy claims to cure you could be risking your life by relying on a false sense of comfort.

Pop tarts, acupuncture is most reliable? There has yet to be any proof that it does much of anything. The fact that in the UK vets are being trained in it just means there’s money to be made. Major hospitals in the U.S. have set up “alternative medicine” divisions not because there’s any proven validity, but because their patients insist on it and there’s money to be made at it.

Agreed. I was trying to be careful to say that. Homeopathy in particular is bunk that might trigger placebo effects. Anyone even a little familiar with statistics will balk at the claim that homeopathic remedies gain potency with doublings.

My main point is that a placebo is scientically valid. Exploiting it is not.

I feel like ranting on religious “cures” now… but I won’t.

I’ll take the oportunity to take another poke at chiropractic, though. Witch doctors that have managed to manufacture credibility.

I have to disagree with your position on chiropractic Frac. I as well as my brother were skeptical but have recently changed our minds. I had a job where I sat all day and for whatever reason my hips are susceptible to leaning to one side. After two years of this my hips titled heavily to one side. This caused the muscles in my back to shorten on one side and lengthen on the other. Eventually the situation got more and more painful until they had a spasm and I couldn�t walk, literally. I could only lie on the floor and could not get up without help. I figured it would go away but it didn�t. After two days it became unbearable and I was convinced by a friend to go to a chiropractor. I was thinking, �yeah whatever,� but it was worth the try. The problem was fixed and I felt not only better but there were other parts of my body that felt better as well.
I told the same thing to my brother. He�s just as skeptical as me. He got in a car accident and his neck was messed up. He could never move it very quickly without excruciating pain. He went to the doctor and was told that he would have to have an operation. He was afraid of that. After a year he got desperate enough to go to massage therapy. That didn�t do shit. He eventually decided to live with it, for three years. After my visit I told him to try. He did the same thing and has since had absolutely no problems. Though it took many visits to achieve this. My situation was severe enough for me to say that the relief I felt wasn�t in my head.  Also, if it was a placebo effect than the other method my brother tried should have helped him and after three years I don�t think he timed his visit with the injury�s rebound. Unlike a witch doctor the chiropractic went through my x rays and a model of a spine with the nervous system and told me what was causing the problem and how the adjustments were going to fix it. It seemed to make sense to me and I do have a pretty rational mind. What I liked as well was that he also had a medical degree.

Having said that. We do have a problem with their claims that it will cure more problems than we think it can and they also want you to visit far more than I think one should. Also, I don�t think it is something that everyone needs to do if they already feel okay. Of course there were plenty of areas in my neck and back that had nothing to do with my hips but felt a million times better and my thoughts shortly after the procedure was, �damn so this is how you�re supposed to feel.”

I know this sounds like some crusade for the industry but I just wanted to ad my two cents. I guess I should prepare for the storm that may be about to come my way.

I think that alternative medicine, placebo effects, and homeopathy need scientific study to determine whether or not they are effective.  Just b/c something sounds crazy doesn’t automatically mean it’s b-s, although it’s more likely to be.

I think the REALLY weird part about placebos is how often “side-effects” occur with people taking a placebo in a study. So it’s not always the positive result that takes place.

Personally, I think mental attitude has a great deal of influence on healing, and so do plenty of studies. I�ve often had to read studies on this where folks try to debunk prayer as an effective healing agent (indicating it�s the same as having a positive attitude). But even if you accept that, how do we get negative side effects out of a placebo?

Maybe it�s like that episode in Red Dwarf �Making Better than Life� where Rimmer�s fantasies turn out to make him even more miserable � he just can�t imagine himself actually being happy.

And, oh, sorry for double-dipping. But as long as we’re on a related topic of testing things for actual effectiveness, I agree with ragman 100%. I’m tired of hearing herbal medicines claims to all kinds of wonders while the same ads talk about the harm of real pharmaceuticals.

Most of the time real pharmaceuticals are derivatives or analogs of the herbal, and the dosages are known. The companies are required to test the snot out of them and then prove they actually do what they claim. Herbals are not proven (except anecdotally) and not held to any standards, including any idea of potency. You can kill yourself on St Johns Wort and no one is at fault. Take 20 times the recommended dosage of aspirin and get ill, take BMS to court and win millions. I�m not a big fan of the FDA, but this is one place where I�d like to see some equity in enforcement.

Here is a CNN report on a scientific study on acupuncture:

http://www.cnn.com/2004/HEALTH/conditions/03/15/acupuncture.headaches.reut/index.html

Let me copy and paste the article here:

Study: Acupuncture eases chronic headaches
LONDON, England (Reuters)—Acupuncture is a useful, cost-effective treatment for patients who suffer from chronic headaches or migraine, researchers said on Monday.

In one of the largest randomized studies to assess the effectiveness of the ancient Chinese treatment, scientists found it worked better than just conventional treatments alone.

“People using acupuncture had fewer headaches, less severe headaches and they used less health resources over the course of the following year,” Dr. Andrew Vickers, of Memorial Sloan-Kettering Cancer Center in New York, said in an interview.

The scientists compared acupuncture plus standard treatment to normal therapy alone in 401 patients in England and Wales who suffered from headaches several days each week. Their research is published online by the British Medical Journal.

Patients who had been assigned acupuncture plus standard treatment received up to 12 treatments over three months.

Initially there was not much difference between the two groups but at the end of the year-long trial the scientist noticed a big change.

Patients receiving acupuncture had 22 fewer days of headaches per year, used 15 percent less medication, made 25 percent fewer visits to their family doctors and took fewer days off sick than the other group.

There were not many side effects and Vickers and his colleagues also found that the treatment was cost effective.

“For severely affected patients, acupuncture reduced the severity and the frequency of their headaches to make a real difference in their lives,” Vickers said.

Acupuncture was first used in China about 2,000 years ago, according to Vickers. It involves inserting very fine needles into the skin at specific points in the body. It is one of the most popular forms of alternative medicine and has been shown to relieve nausea and pain.

German researchers have also said it could help women undergoing fertility treatment to conceive.

Here is the PDF link to the article in the Britsh Medical Journal. Copy and pasting will not work since there are graphs and tables. So check it out.

http://bmj.bmjjournals.com/cgi/reprint/bmj.38029.421863.EBv2

Also you should know that acupuncture is not suppose to result in pain.

Also, modern medicine no longer view them as fictional energy lines but rather that of your nerves. So it is much like the quinine bark for malaria fever, when it was first used the explanation for how it works its unbelievable but that does not mean that it does not work.

MODERN VIEWS

When the human body was finally described in terms of cells, biochemicals, and specific structures (most of this accomplished less than 150 years ago), the Chinese method of acupuncture and its underlying concepts were evaluated in these new terms.  As a first effort, researchers sought out physical pathways that might correspond to the meridians, and even a fluid substance that might correspond to qi.  Neither of these were found.  Nonetheless, the action of performing acupuncture was shown to have effects on the body that required some detailed explanation.

From the modern perspective, diseases and injuries are resolved by a complex set of responses; the responses are coordinated by several signaling systems.  The signaling systems mainly involve peptides and other small biochemicals that are released at one site, travel to other sites, interact with cells, and stimulate various biologically programmed responses.  Rather than blockages of circulation described in the old Chinese dogma, diseases are understood to be caused by microorganisms, metabolic failures, changes in DNA structure or signaling, or breakdown of the immune system.  Some of these disorders are resolved by the cellular functions that are designed for healing, while others become chronic diseases because the pathological factors involved have either defeated the body�s normalizing mechanisms or because something else has weakened the body�s responses to the point that they are ineffective.  For example, poor nutrition, unhealthy habits, and high stress can weaken the responses to disease.

Modern studies have revealed that acupuncture stimulates one or more of the signaling systems, which can, under certain circumstances, increase the rate of healing response.  This may be sufficient to cure a disease, or it might only reduce its impact (alleviate some symptoms).  These findings can explain most of the clinical effects of acupuncture therapy.

According to current understanding, the primary signaling system affected by acupuncture is the nervous system, which not only transmits signals along the nerves that comprise it, but also emits a variety of biochemicals that influence other cells of the body.  The nervous system, with over 30 peptides involved in transmitting signals, is connected to the hormonal system via the adrenal gland, and it makes connections to every cell and system of the body.

In a review article, Acupuncture and the Nervous System (American Journal of Chinese Medicine 1992; 20(3�4): 331�337), Cai Wuying at the Department of Neurology, Loyola University of Chicago, describes some of the studies that implicate nervous system involvement.  According to a report of the Shanghai Medical University, cranial nerves, spinal nerves, and their terminals were dispersed in the area surrounding the acupuncture points for about 5 millimeters.  They also found that the nervous distribution of the Bladder Meridian points (which run along the spine) was in the same area of the spine as that of the corresponding viscera.  In Japanese research, it was reported that when acupuncture points were needled, certain neurotransmitters appeared at the site.  In laboratory-animal acupuncture studies, it was reported that two such transmitters, substance P and calcitonin gene-related peptide, were released from primary sensory neurons.  Acupuncture analgesia appears to be mediated by release of enkephalin and beta-endorphins, with regulation of prostaglandin synthesis: all these have an effect on pain perception.  One of the dominant areas of research into acupuncture mechanisms has been its effect on endorphins.  Endorphins are one of several neuropeptides; these have been shown to alleviate pain, and have been described as the body�s own �opiates.� One reason for the focus on these biochemicals is that they were identified in 1977, just as acupuncture was becoming popular in the West, and they are involved in two areas that have been the focus of acupuncture therapy in the West: treatment of chronic pain and treatment of drug addiction. 

According to traditional Chinese doctors, one of the key elements of a successful acupuncture treatment is having the person who is being treated experience what is called the �needling sensation.� This sensation may vary with the treatment, but it has been described as a numbness, tingling, warmth, or other experience that is not simple pain (pain is not an expected or desired response to acupuncture treatment, though it is recognized that needling certain points may involve a painful response).  Sometimes the needling sensation is experienced as propagating from the point of needling to another part of the body.  The acupuncturist, while handling the needle should experience a response called �getting qi.�  In this case, the needle seems to get pulled by the body, and this may be understood in modern terms as the result of muscle responses secondary to the local nervous system interaction.

According to this interpretation, acupuncture is seen as a stimulus directed to certain responsive parts of the nervous system, producing the needling sensation and setting off a biochemical cascade which enhances healing.  Some acupuncture points are very frequently used and their applications are quite varied: needling at these points may stimulate a �global� healing response that can affect many diseases.  Other points have only limited applications; needling at those points may affect only one of the signaling systems.  It is common for acupuncturists to combine the broad-spectrum points and the specific points for each treatment.  Some acupuncturists come to rely on a few of these broad-spectrum points as treatments for virtually all common ailments.

This modern explanation of how acupuncture works does not explain why the acupuncture points are arrayed along the traditional meridian lines.  At this time, no one has identified�from the modern viewpoint�a clear series of neural connections that would correspond to the meridians.  However, acupuncturists have identified other sets of points, such as those in the outer ear, which seem to be mapped to the whole body.  The description, in the case of the ear, is of a layout of the body in the form of a �homunculus� (a miniature humanoid form).  Such patterns might be understood more easily than the meridian lines, because the brain, which is adjacent to the ear, also has a homunculus pattern of neurological stimulus that has been identified by modern research.  Similarly, acupuncturists have identified zones of treatment (for example, on the scalp or on the hand) that correspond to large areas of the body, and this may also be more easily explained because there are connections from the spinal column to various parts of the body which might have secondary branches elsewhere.  In fact, acupuncture by zones, homunculi, �ashi� points (places on the body that are tender and indicate a blockage of qi circulation), and �trigger� points (spots that are associated with muscle groups) is becoming a dominant theme, as the emphasis on treating meridians fades (for some practitioners).  The new focus is on finding effective points for various disorders and for getting biochemical responses (rather than regulating qi, though there is no doubt some overlap between the two concepts).

During this modern period (since the 1970�s) an increasing number of ways to stimulate the healing response at various body points have been advocated, confirming that needling is not a unique method (the idea that the needle would produce a hole through which pathogenic forces could escape has long been fading).  In the past, the main procedures for affecting acupuncture points were needling and application of heat (moxibustion).  Now, there is increasing reliance on electrical stimulation (with or without needling), and laser stimulation.  Since the basic idea of acupuncture therapy is gaining popularity throughout the world while the practice of needling is restricted to certain health professions and is not always convenient, other methods are also becoming widely used.  Lay persons and practitioners with limited training are applying finger pressure (acupressure), tiny metal balls held to the to the skin by tape, magnets (with or without tiny needles attached), piezoelectric stimulus (a brief electric discharge), and low energy electrical pulsing (such as the TENS unit provides with electrical stimulus applied to the skin surface by taped electrodes).  Some of these methods may have limited effectiveness, but it appears that if an appropriate body site is stimulated properly, then the healing response is generated.

For many nervous system functions, timing is very important, and this is the case for acupuncture.  The duration of therapy usually needs to be kept within certain limits (too short and no effect, too long and the person may feel exhausted), and the stimulation of the point is often carried out with a repetitive activity (maintained for a minute or two by manual stimulation�usually slight thrusting, slight withdrawing, or twirling�or throughout treatment with electrostimulation).  It has been shown in laboratory experiments that certain frequencies of stimulus work better than others: this might be expected for nervous system responses, but is not expected for simple chemical release from other cells

Alternative medicine should be seen as complementing Western medicine rather than replacing it outright. Western medicine do not really have a good history in treating long term ailments and conditions while alternative medicine seem to be more effective. So moral of the story is when you break you arm go to a Western doctor but if several months after recovery you are still feeling pain then go to alternative medicine.

Also another point on Chinese herbs/insects. I have a friend who is allergic (lung stopping) to the chemicals used in most fever medicine. There is this particular brand of pill will not trigger her allergy but it cost quite a bit few dollars per pill. She purchased those traditional herbs from one of those Chinese medicine stores and ever since then whenever she has fever she uses the herbs.

Pop tarts, I’m all in favor of anything “complementing” Western medicine AS LONG AS IT REALLY DOES WORK.  The problem is that if you can’t describe how it works in terms of what we have already proven, I can’t really buy into it (this mystery “qi” and all that).  The long article you quoted above at first glance seems to be integrating “real words” about nerves and muscle responses along with the “magical words,” but I have a real problem with some of its conclusions.

For example, suppose that you CAN simply stimulate the production of endorphins by sticking needles into someone.  Why does it matter where you stick them?  For that matter, why can’t you stimulate the release of endorphins a different way (have them eat a bar of chocolate or jog around the block for half an hour)?

I’m very suspicious of anything that uses a part of the body as an analogue for the whole (where, for example, parts of the hand or foot are supposed to connect directly to the bladder, spleen, head, whatever).  This is a very common folk belief that has no basis in anatomical fact.  If there were a direct anatomical connection (not a “mystical energy meridian line”) between a point on the spine and the bladder, I’m sure someone with a scalpel would have found it by now.

I’ve had acupuncture myself.  Just because it tingled didn’t mean it was doing anything.  I did have a nice rest on the table while it was going on, though, and I got up nice and refreshed.  So I guess it wasn’t all bad.  (Let’s not forget that as primates, we are relaxed just by being “groomed.”  Just being touched in some way by another human being, especially in a repetitive or rhythmic way, makes us feel better.  That’s why most spa treatments are so popular; it has very little to do with what’s being smeared on and wiped off again.)

I’d like to see some real, peer-reviewed, double-blind studies on Chinese medicine before I started believing their efficacy was anything but coincidence.

Oh, and PT, did your friend actually get demonstrable fever relief from these herbs?  Or did she just take them until her fever went away on its own?  There’s a difference, you know.  That’s why anecdotal evidence is so unreliable.

If there were a direct anatomical connection ... I�m sure someone with a scalpel would have found it by now.

Yes, but if I pull a hair out of your butt crack, your eyes will water!

One problem I have with the study reported by CNN is that it lacks a proper control group.

There should have been at least a third group of patients that received placebos in addition to conventional treatment. How this kind of research can be conducted as a double-blind study is a bit of a puzzle, though.

Yes, but if I pull a hair out of your butt crack, your eyes will water!

I stand corrected.  Behold the POWER of QI!!

Yeah, it would be hard to do a double-blind study of acupuncture, unless you had people stick needles in at random, or something.  And if you had too many combos going at once, it would be hard to control for all the factors.  But I would still like to see more research AND a more understandable explanation on how these things are supposed to work.

Oh, and this isn’t to mean that I think “Western medicine = GOOD” and “everything else = BAD.”  There are a lot of Western practices that have never been placed under the loupe either.  We keep changing our minds all the time about whether something works.  Estrogen replacement therapy is good, then it’s bad, soy works, then it doesn’t, your body needs 64 ounces of water a day, no, it doesn’t.  A lot of Western doctors prescribe things just because they’re told they work, or their patients believe they work and demand them.

I’m all for rigorous testing standards—the SAME ones—for all medical claims, regardless of origin or length of tenure.

Well I am pretty sure my friend got relief from the fever. Or at least as certain as me getting relief from fever when I take Western medicine when I get fever.

So GeekMom, did the acupuncture work? Never tried it myself.

Here is the article from the British Medical Journal in case folks do not have PDF. Could not get the tables and graphs in:

Primary care
Acupuncture for chronic headache in primary care: large,
pragmatic, randomised trial
Andrew J Vickers, Rebecca W Rees, Catherine E Zollman, Rob McCarney, Claire Smith, Nadia Ellis, Peter Fisher,
Robbert Van Haselen

Abstract
Objective To determine the effects of a policy of �use
acupuncture� on headache, health status, days off sick, and use
of resources in patients with chronic headache compared with a
policy of �avoid acupuncture.�
Design Randomised, controlled trial.
Setting General practices in England and Wales.
Participants 401 patients with chronic headache,
predominantly migraine.
Interventions Patients were randomly allocated to receive up to
12 acupuncture treatments over three months or to a control
intervention offering usual care.
Main outcome measures Headache score, SF-36 health status,
and use of medication were assessed at baseline, three, and 12
months. Use of resources was assessed every three months.
Results Headache score at 12 months, the primary end point,
was lower in the acupuncture group (16.2, SD 13.7, n = 161,
34% reduction from baseline) than in controls (22.3, SD 17.0,
n = 140, 16% reduction from baseline). The adjusted difference
between means is 4.6 (95% confidence interval 2.2 to 7.0;
P = 0.0002). This result is robust to sensitivity analysis
incorporating imputation for missing data. Patients in the
acupuncture group experienced the equivalent of 22 fewer days
of headache per year (8 to 38). SF-36 data favoured
acupuncture, although differences reached significance only for
physical role functioning, energy, and change in health.
Compared with controls, patients randomised to acupuncture
used 15% less medication (P = 0.02), made 25% fewer visits to
general practitioners (P = 0.10), and took 15% fewer days off
sick (P = 0.2).
Conclusions Acupuncture leads to persisting, clinically relevant
benefits for primary care patients with chronic headache,
particularly migraine. Expansion of NHS acupuncture services
should be considered.
Introduction
Migraine and tension-type headache give rise to notable
health,1 2 economic,2 and social costs.2 3 Despite the undoubted
benefits of medication,4 many patients continue to experience
distress and social disruption. This leads patients to try, and
health professionals to recommend, non-pharmacological
approaches to headache care. One of the most popular
approaches seems to be acupuncture. Each week 10% of general
practitioners in England either refer patients to acupuncture or
practise it themselves,5 and chronic headache is one of the most
commonly treated conditions.6

A recent Cochrane review of 26 randomised trials of
acupuncture for headache concluded that, although existing evidence
supports the value of acupuncture, the quality and
amount of evidence are not fully convincing.7 The review identifies
an urgent need for well planned, large scale studies to assess
the effectiveness and cost effectiveness of acupuncture under
�real� conditions. In 1998 the NHS National Coordinating Centre
for Health Technology Assessment commissioned us to conduct
such a trial (trial number ISRCTN96537534). Our aim was
to estimate the effects of acupuncture in practice8: we established
an acupuncture service in primary care; we then sought to determine
the effects of a policy of �use acupuncture� on headache,
health status, days off sick, and use of resources in patients with
chronic headache compared with a policy of �avoid acupuncture.�
This reflects two real decisions: that made by general practitioners
when managing the care of headache patients and that
made by NHS entities when commissioning health services.
Methods
The protocol and recruitment methods have been published
previously.9 10 The study included 12 separate sites consisting of a
single acupuncture practice and two to five local general
practices. Study sites were located in Merseyside, London and
surrounding counties, Wales, and the north and south west of
England.
Accrual of patients
Practices searched their databases to identify potential
participants. General practitioners then sent letters to suitable
patients, providing information about the trial. A researcher at
the study centre conducted recruitment interviews, eligibility
screening, and baseline assessment by telephone. Patients� conditions
were diagnosed as migraine or tension-type headache, following
criteria of the International Headache Society (IHS).11
Patients aged 18-65 and who reported an average of at least two
headaches per month were eligible. Patients were excluded for
any of the following: onset of headache disorder less than one
year before or at age 50 or older; pregnancy; malignancy; cluster
headache (IHS code 3); suspicion that headache disorder had
specific aetiology (IHS code 5-11); cranial neuralgias (IHS code
12); and acupuncture treatment in the previous 12 months. Eligible
patients completed a baseline headache diary for four weeks.
Patients who provided written informed consent, had a mean

weekly baseline headache score of 8.75 or more, and completed
at least 75% of the baseline diary were randomised to a policy of
�use acupuncture� or �avoid acupuncture.� Given a power of 90%
and an
of 5%, we estimated that we would require 288
evaluable patients to detect a reduction in headache score of
35% in the acupuncture group, compared with 20% in controls.
We assumed a dropout rate of about 25% and planned to
randomise 400 patients.
Randomisation
We used randomised minimisation (�biased coin�) to allocate
patients. The minimised variables were age, sex, diagnosis
(migraine or tension-type), headache score at baseline, number
of years of headache disorder (chronicity), and number of
patients already allocated to each group, averaged separately by
site. We used a secure, password protected database to
implement randomisation, which was thus fully concealed.
Treatment
Patients randomised to acupuncture received, in addition to
standard care from general practitioners, up to 12 treatments
over three months from an advanced member of the
Acupuncture Association of Chartered Physiotherapists. All acupuncturists
in the study had completed a minimum of 250 hours
of postgraduate training in acupuncture, which included the
theory and practice of traditional Chinese medicine; they had
practised acupuncture for a median of 12 years and treated a
median of 22 patients per week. The acupuncture point
prescriptions used were individualised to each patient and were
at the discretion of the acupuncturist. Patients randomised to
�avoid acupuncture� received usual care from their general practitioner
but were not referred to acupuncture.
Outcome assessment
Patients completed a daily diary of headache and medication use
for four weeks at baseline and then three months and one year
after randomisation. Severity of headache was recorded four
times a day on a six point Likert scale (box) and the total
summed to give a headache score. The SF-36 health status questionnaire
was completed at baseline, three months, and one year.
Every three months after randomisation, patients completed
additional questionnaires that monitored use of headache treatments
and days sick from work or other usual activity.While the
study was under way we added an additional end point: we contacted
patients one year after randomisation and asked them to
give a global estimate of current and baseline headache severity
on a 0-10 scale. This enabled us to obtain data from patients who
were unwilling to complete diaries, for use in sensitivity analysis.
Statistical considerations
The primary outcome measure was headache score at the one
year follow up. Secondary outcome measures included headache
score at three months, days with headache, use of medication
scored with the medication quantification scale (MQS),12 13 the
SF-36, use of resources, and days off usual activities. We revisedthe statistical plan to employ adjusted rather than unadjusted
analyses after publication of the initial protocol but before we
conducted any analyses. We analysed our data on Stata 8
software (Stata Corporation, College Station, Texas) using
ANCOVA for continuous end points, 2 for binary data, and
negative binomial regression for count data such as number of
days of sick leave. We entered minimisation variables into
regression models as covariates. We analysed data according to
allocation, regardless of the treatment received. We conducted
sensitivity analyses to examine the possible effect of missing data
(see appendix on bmj.com).
Results
Recruitment took place between November 1999 and January
2001. Figure 1 shows the flow of participants through the trial.
Compliance of patients was good: only three patients in the control
group reported receiving acupuncture outside the study.
Acupuncture patients received a median of nine (interquartile
range 6-11) treatments, with a median of one treatment per
week. The dropout rate was close to that expected and approximately
balanced between groups. Patients who dropped out were
similar to completers in terms of sex, diagnosis, and chronicity,
but they were slightly younger (43 v 46 years, P = 0.01) and had
higher headache score at baseline (29.3 v. 25.6, P = 0.04). Table 1
shows baseline characteristics by group for the 301 patients who
completed the trial: the groups are highly comparable. Thirty
one of the patients who withdrew provided three month data,
and an additional 45 provided a global assessment. Only 6% of
patients (12 in each group) provided no data for headache after
randomisation.
Table 2 shows results for medical outcomes for patients
completing 12 month follow up. In the primary analysis mean
headache scores were significantly lower in the acupuncture
group. Scores fell by 34% in the acupuncture group compared
with 16% in controls (P = 0.0002). This result was highly robust
to sensitivity analysis for missing data (smallest difference
between groups of 3.85, P = 0.002; see appendix on bmj.com).
When we used the prespecified cut-off point of 35% as a
clinically significant reduction in headache score, 22% more
acupuncture patients improved than controls, equivalent to a
number needed to treat of 4.6 (95% confidence interval 9.1 to
3.0). The difference in days with headache of 1.8 days per four
weeks is equivalent to 22 fewer days of headache per year (8 to
38). The effects of acupuncture seem to be long lasting;
although few patients continued to receive acupuncture after
the initial three month treatment period (25, 10, and 6 patients
received treatment after 3, 6, and 9, months, respectively), headache
scores were lower at 12 months than at the follow up after
treatment. Medication scores at follow up were lower in the acupuncture
group, although differences between groups did not
reach significance for all end points. In an unplanned analysis
we summed and scaled all medication taken by patients after
randomisation and compared groups with adjustment for base-line scores. Use of medication use fell by 23% in controls but by
37% in the acupuncture group (adjusted difference between
groups 15%; 95% confidence interval 3%, 27%; P = 0.01). SF-36data generally favoured acupuncture (table 3), although
differences reached significance only for physical role functioning,
energy, and change in health.We conducted interaction analyses to determine which
patients responded best to acupuncture. Although improvements
in mean headache score over control were much larger
for migraine patients (4.9; 95% confidence interval 2.4, 7.5,
n = 284) than for patients who did not meet the criteria for
migraine (1.1; 95% confidence interval − 2.4 to 4.5, n = 17), the
small numbers of patients with tension-type headache preclude
us from excluding an effect of acupuncture in this population.
The interaction term for baseline score and group was positive
and significant (P = 0.004), indicating larger effects of treatment
on patients with more severe symptoms, even after controlling for regression to the mean. Predicted improvements in headache
score for each quartile of baseline score in acupuncture patients
are 22%, 26%, 35%, and 38%; figure 2 shows comparable data for
days with headache. Neither age nor chronicity nor sex
influenced the results of acupuncture treatment.
Table 4 shows data on use of resources. Patients in the
acupuncture group made fewer visits to general practitioners and
complementary practitioners than those not receiving acupuncture
and took fewer days off sick. Confirming the excellent safety
profile of acupuncture,15 the only adverse event reported was five
cases of headache after treatment in four subjects.
Discussion
Main findings
Acupuncture in addition to standard care results in persisting,
clinically relevant benefits for primary care patients with chronic
headache, particularly migraine, compared with controls. We
also found improvements in quality of life, decreases in use of
medication and visits to general practitioners, and reductions in
days off sick. Methodological strengths of our study include a
large sample size, concealed randomisation, and careful follow
up. We have maximised the practical value of the trial by
comparing the effects of clinically relevant alternatives on a
diverse group of patients recruited directly from primary care.8
Limitations
Control patients did not receive a sham acupuncture
intervention. One hypothesis might be that the effects seen in the
acupuncture group resulted not from the physiological action of
needle insertion but from the �placebo effect.� Such an argument
is not relevant to an assessment of the clinical effectiveness of acupuncture because in everyday practice, patients benefit from
placebo effects. None the less, good evidence from randomised
trials shows that acupuncture is superior to placebo in the treatment
of migraine.7 16 Furthermore, this study was modelled on
Vincent�s earlier double blind, placebo controlled trial in
migraine,17 which makes direct comparison possible. If placebo
explained the activity of acupuncture we would expect patients
in our control group, who received no treatment, to experience
smaller improvements than Vincent�s placebo treated controls,
leading to a larger difference between groups. However,
improvements in our controls (7.1% from a baseline headache
score of 26.7) were similar to those in Vincent�s trial (10.5% from
27.2) and differences between groups are non-significantly
smaller in the current trial (4.1 v 8.1). This implies that our findings
perhaps cannot be explained purely in terms of the placebo
effect. That said, we are unable to rule out such an explanation
given our lack of placebo control.
Patients in the trial were not blinded and may therefore have
given biased assessments of their headache scores. Measures to
minimise bias included minimum contact between trial
participants and the study team, extended periods of
anonymised diary completion and coaching patients about bias.
The difference between groups is far larger (odds ratio for
response 2.5) than empirical estimates of bias from failure to
blind (odds ratio 1.2).18 The similarity of our results to those of
the prior blinded study provides further evidence that bias does
not completely explain the apparent effects of acupuncture.
Patients recorded all treatments for headache during the
course of the study. Use of medication and other therapies (such
as chiropractic) was lower in patients assigned to acupuncture,
indicating that the superior results in this group were not due to
confounding by off-study interventions.
Comparison with other studies
A strength of the current trial is that its results are congruent
with much of the prior literature on acupuncture for headache.
Effects found in this study that have been previously reported
include: differences between acupuncture and control for
migraine7 16 19 that increased between follow up after treatment
and one year16; unconvincing effects for tension-type headache20�
23; improvements in severity as well as frequency16 24 and
increased benefit in patients with more severe headaches.16

Conclusion
A policy of using a local acupuncture service in addition to
standard care results in persisting, clinically relevant benefits for
primary care patients with chronic headache, particularly
migraine. Expansion of NHS acupuncture services for headache
should be considered.

The views are those of the authors and not that of the NHS. We thank the
following for their contributions: Claire Allen was consumer representative;
Tim Lancaster provided advice on recruitment methods; Kate Hardy was
the study nurse. Acupuncture was provided by Kyriakos Antonakos, Ann
Beavis, Reg D�Souza, Joan Davies, Nadia Ellis (who is a coauthor of this
paper), Sara Jeevanjee, Maureen Lovesey, Bets Mitchell, Alison Nesbitt,
Steve Reece, Stephanie Ross, and Hetty Salmon-Roozen.
Contributors: AJV conceived, designed and analysed the study and is its
guarantor; RWR, CEZ, CMS, and NE contributed to the original design with
particular contributions to outcome assessment (RWR, CMS); patients and
treatment (CEZ); acupuncture treatment (NE). RM contributed to design of
resource outcome assessment; RM, RvH and PF contributed to
development of data collection methods for sensitivity analysis.
Funding: The trial (ISRCTN96537534) was funded by NHS R&D National
Coordinating Centre for Health Technology Assessment (NCCHTA) grant:
96/40/15.
Competing interests: NE provides acupuncture as part of her private
physiotherapy practice.
Ethical approval: South West Multicentre Research Ethics Committee and
appropriate local ethics committees.
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1997;48(suppl):S10-15.
2 Stewart WF, Lipton RB. The economic and social impact of migraine. Eur Neurol
1994;34(suppl 2):S12-7.
3 Lipton RB, Scher AI, Steiner TJ, Bigal ME, Kolodner K, Liberman JN, et al. Patterns of
health care utilization for migraine in England and in the United States. Neurology
2003;60:441-8.
4 Goadsby PJ, Lipton RB, Ferrari MD. Migraine�Current understanding and treatment.
New Engl J Med 2002;346:257-70.
5 Thomas KJ, Nicholl JP, Fall M. Access to complementary medicine via general practice.
Br J Gen Pract 2001;51:25-30.
6 Wadlow G, Peringer E. Retrospective survey of patients of practitioners of traditional
Chinese acupuncture in the UK. Complement Ther Med 1996;4:1-7.
7 Melchart D, Linde K, Fischer P, Berman B, White A, Vickers A, et al. Acupuncture for
idiopathic headache. Cochrane Database Syst Rev 2001;(1):CD001218.
8 Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical
research for decision making in clinical and health policy. JAMA 2003;290:1624-32.
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headache in primary care: a protocol for a pragmatic, randomized trial. Complement
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10 McCarney R, Fisher P, van Haselen R. Accruing large numbers of patients in primary
care trials by retrospective recruitment methods. Complement Ther Med 2002;10:63-8.
11 International Headache Society. Classification and diagnostic criteria for headache disorders,
cranial neuralgias and facial pain. Cephalalgia 1988;8:1-96.
12 Masters-Steedman S, Middaugh SJ, Kee WG, Carson DS, Harden RN, Miller MC.
Chronic-pain medications: equivalence levels and method of quantifying usage. Clin J
Pain 1992;8:204-14.
13 Kee WG, Steedman S, Middaugh SJ. Medication quantification scale (MQS): update of
detriment weights and medication additions. Am J Pain Management 1998;8:83-8.
14 Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ, et al.
Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia
2000;20:765-86.
15 White A, Hayhoe S, Hart A, Ernst E.Adverse events following acupuncture: prospective
survey of 32 000 consultations with doctors and physiotherapists. BMJ 2001;323:485-6.
16 Melchart D, Thormaehlen J, Hager S, Liao J, Linde K,WeidenhammerW. Acupuncture
versus placebo versus sumatriptan for early treatment of migraine attacks: a
randomized controlled trial. J Intern Med 2003;253:181-8.
17 Vincent CA. A controlled trial of the treatment of migraine by acupuncture. Clin J Pain
1989;5:305-12.
18 Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions
of methodological quality associated with estimates of treatment effects in controlled
trials. JAMA 1995;273:408-12.
19 Allais G, De Lorenzo C, Quirico PE, Airola G, Tolardo G, Mana O, et al. Acupuncture
in the prophylactic treatment of migraine without aura: a comparison with flunarizine.
Headache 2002;42:855-61.
20 White AR, Eddleston C, Hardie R, Resch KL, Ernst E. A pilot study of acupuncture for
tension headache, using a novel placebo. Acupuncture Med 1996;14:11-5.
21 Karst M, Rollnik JD, Fink M, Reinhard M, Piepenbrock S. Pressure pain threshold and
needle acupuncture in chronic tension-type headache�a double-blind placebocontrolled
study. Pain 2000;88:199-203.
22 Karakurum B, Karaalin O, Coskun O, Dora B, Ucler S, Inan L. The �dry-needle
technique�: intramuscular stimulation in tension-type headache. Cephalalgia
2001;21:813-7.
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tension-type headache: a randomized, placebo-controlled study. Cephalalgia
2001;21:637-42.
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(Accepted 21 January 2004)
doi 10.1136/bmj.38029.421863.EB
Integrative Medicine Service, Biostatistics Service, Memorial Sloan-Kettering
Cancer Center, 1275 York Avenue, NY, NY 10021
Andrew J Vickers assistant attending research methodologist
Evidence for Policy and Practice Information and Co-ordinating Centre
(EPPI-Centre), Social Science Research Unit, Institute of Education, London
WC1H 0NS
Rebecca W Rees research officer
Montpelier Health Centre, Bristol BS6 5PT
Catherine E Zollman general practitioner
Department of Psychological Medicine, Imperial College London, London W2 1PD
Rob McCarney research officer
Academic Rheumatology,Weston Education Centre, King�s College, London
SE5 9RJ
Claire M Smith senior trials coordinator
Department of Health and Social Sciences, Coventry University, Coventry CV1 5FB
Nadia Ellis lecturer
Royal London Homeopathic Hospital, London W1W 5PB
Peter Fisher director of research
Robbert Van Haselen deputy director of research
Correspondence to: A J Vickers (JavaScript must be enabled to view this email address)

You know, Pop Tarts, I’m not too keen on your argument, I’m actually leaning towards Geekmom on this one (which has left ME pretty much speechless).  But I’m lovin’ your name. I’m just a bit confused as to why you chose the plural…

Wow, seems these threads grow faster than I can keep up with them these days. Just the same there are a few points I’d like to touch on (if you’ll pardon the pun).

Chiropractic: As a means of dealing with lower-back pain and various neck injuries there’s a quite a bit of evidence that supports the idea that chiropractic therapy is an effective means of treating these ailments. Indeed, I visit a chiropractor regularly specifically due to lower-back problems and have had fewer problems as a result. Though in all honesty I could probably do more to alleviate my problems if I lost some weight. There is growing evidence in support of chiropractic for treatment of headaches and other pains as well.

That said, the school of thought that claims chiropractic therapy is a means of treating whatever ails you (cancer, liver problems, the common cold, etc.) through the unblocking of nerves or “bio-energetic synchronization” is pretty much bunk. One of the more ridiculous claims some chiropractic practitioners make is that germ theory is wrong and all diseases are the result of nerve blockages.

There are plenty of Chiropractors out there who don’t make ridiculous claims of being able to cure every problem you might have by twisting your spine around and if you do a little looking they’re not hard to find. I made it clear when I first visited my current Chiropractor that I was looking for someone who wasn’t of the cure-anything camp and he not only understood my concerns, but agreed with them. You may not even need question a Chiropractor directly, though. Many of the cure-anything camp will have plenty of posters and signs in their office windows making the claims boldly before you ever walk in the front door. The office I visit is absent of such materials.

Acupuncture: More than likely this concept is largely bunk. Traditional Chinese medicine isn’t based on any understanding of biology or any known healing process and is almost entirely mystical in its explanation on how it achieves its supposed cures. The National Council Against Health Fraud (NCAHF) put out a position paper back in 1990 that said “Research during the past twenty years has failed to demonstrate that acupuncture is effective against any disease” and that “the perceived effects of acupuncture are probably due to a combination of expectation, suggestion, counter-irritation, operant conditioning, and other psychological mechanisms.”

That said, the number of Empirical studies is still on the small side and there does seem to be some evidence that acupuncture may be a useful method of pain control. Probably the best summary out there for the claims and realities of acupuncture can be found in the Skeptic’s Dictionary entry on acupuncture, which is where I got some of the information in this summary. GeekMom may be interested in it particularly as it discusses the potential reason behind why the location of a needle on the body would make a difference in pain control. In short, there may be some benefits, but nothing on the scale of the claims often made in regards to it. Just the same, there is motivation for some more studies.

Absence of evidence is not evidence of absence as they say, hehe.

Actually I do not really hold any opinion on alternative medicine. My point is that based on what I have read acupuncture seems to show the greatest promise. Either that their effects outweigh placebo or that it equals placebo (meaning it most probably does not work). Or at least I have yet to hear much negative news concerning acupuncture.

But the thing is while acupuncture may become more popular I do not think that there would be much research in the area. The problem is that phamaceutical giants are not going to invest their cash into researching something they cannot patent. Unless of course the patent law changes and one can patent surgical methods but that is not likely. So I guess acupuncture will remain an “alternative” medicine for sometime until public funds or university research shows whether it positively works or not.

As an aside, the plural removes the idea that I am a “tart” in the negative connotation.

Absence of evidence is not evidence of absence as they say, hehe.

Indeed, but it also does nothing to support the claims being made. After all, extraordinary claims require extraordinary proof. We can sit here and play the maxim game all day.

Actually I do not really hold any opinion on alternative medicine. My point is that based on what I have read acupuncture seems to show the greatest promise. Either that their effects outweigh placebo or that it equals placebo (meaning it most probably does not work). Or at least I have yet to hear much negative news concerning acupuncture.

Shows the greatest promise of what? To cure AIDS? To end hunger in our lifetime? To answer the question of why we are here? Greatest promise of what… exactly?

But the thing is while acupuncture may become more popular I do not think that there would be much research in the area. The problem is that phamaceutical giants are not going to invest their cash into researching something they cannot patent. Unless of course the patent law changes and one can patent surgical methods but that is not likely. So I guess acupuncture will remain an �alternative� medicine for sometime until public funds or university research shows whether it positively works or not.

There’s more to the medical industry than just the pharmaceutical giants. There’s plenty of money to be made by hospitals and doctors offering these services (indeed, some already do) and thus an incentive on their part to prove it’s real. Plus there’s research conducted by various medical universities. Simply because the drug makers may not care to test it doesn’t mean there aren’t people who would have a vested interest in doing so.

Greatest promise of doing what it claimed to do. Solving chronic pains.

Research: As I pointed out money may come from university research or public funding. While there is lots of money to be made by hospitals and doctor, the problem is who is going to take the first dip for those profit driven organisation. You need to capture the market to get returns on one’s investment. Having monopoly profits for 20 years is very different from inventing something then competiting with the rest of the market in selling it. In fact all else being equal the company that discover it without monopoly protection will be worse off. They would have spent the additional cost on research the other hospitals would not need to.

Well, Les’s question was legitimate:  advocates of acupuncture have claimed all sorts of benefits outside of simple pain relief (such as curing infertility, which I think is an especially cruel promise to extend to hurting, desperate people).

I think it’s most likely that research will come from the universities, or POSSIBLY from public funding, if it becomes provocative enough a concept that the FDA decides it has a vested interest in settling the question.  I hope so, at any rate.