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BMJ Editors Hit--and Hit Hard--Over Careless Interpretation of Acupuncture for Chronic Knee Pain Study (JAMA 10/1/2014)

Let's start with the conclusion, lest I lose you between here and the end.

Acupuncture is more likely to provide relief for chronic knee pain due to osteoarthritis than any other modality. Pooled studies (a meta analysis) that compared physical interventions for chronic knee pain showed the following "effect sizes:"

(Electro-) Acupuncture: ES of 0.89
Warm baths: ES 0.65
Exercise: ES 0.55

To put this in perspective, the "Minimum Clinically Important Difference" or minimally significant Effect Size, according to patients suffering from chronic knee pain, is 0.39. And the Effect Size threshold the UK's National Institute for Health and Care Excellence (NICE) uses to determine reimbursement is 0.50.

Call them acupuncture activists. And really brainy ones.

When an Australian group published (in October 1st JAMA) an impressively large (N=282, but there were 4 groups) clinical trial of 12 weeks of acupuncture for chronic (moderate to severe) knee pain in persons 50 years and older, they concluded no difference between the sham control and actual acupuncture. Editors of the premier acupuncture journal in the world (the BMJ group's Acupuncture In Medicine), however, cried foul. And lamented the lost opportunity to help millions of chronic knee pain suffers. There were determined to set the record straight.

Their protest and clarification letter to JAMA was summarily rejected.

But guess what? They just happen to have their own journal. (Take that, AMA.) And not one of the enumerable, embarrassing American titles. As noted above, we're talking The British Medical Journal (Even if the quality of the studies AIM publishes sometimes causes a cringe here and there, the White and his staff are doing the best with what they have to work with.) And so AIM editor and British Medical Acupuncture Society chief Mike Cummings proceeded to publish their quibbles today for inclusion, I imagine, in the January 2015 print edition, and set about to educate folks about how to consider clinically relevant results.

For expediency's sake, I will extract the key arguments from their brilliantly prepared letter today. Then over the next week or so I will work on paraphrasing and whittling it down.

1. BACKGROUND OF THE CLINICAL PROBLEM. Patients with OA knee pain are suffering the commonest cause of pain and disability in older people. More than half have inadequate pain relief.2 They face a choice between ineffective paracetamol, non-steroidal drugs that can harm the heart, (kidneys) and gastrointestinal tract, gels that scarcely work, physiotherapy, opioids that cause dependency and lose effectiveness, arthroscopic washouts that do nothing or surgery.3 They deserve a fuller, more considered answer to their question: "Is it worth trying acupuncture?"

2. NIFTY DESIGN OF TRIAL. The neat part of the Zelen design that Hinman et al used was that the control group, who were not given acupuncture, were not even aware that their pain scores were used in a trial of acupuncture so disappointment could not influence their scores, as was claimed for other studies. This 'no acupuncture' group was compared with acupuncture (manual) and with sham laser (and with real laser, which is not considered here, to keep things simple).

3. WHERE THE ANALYSIS BEGINS TO STUMBLE. The problems started with the trialists' choice of the threshold minimum clinically important difference (MCID) to estimate sample size. They chose a value based on one chosen by six self-styled 'expert' physicians,4 namely a 35% fall in baseline pain score (1.8/sample mean baseline 5.1). This is equivalent to an effect size (ES) of 0.6, calculated using their assumed baseline SD of 30 (the actual SD was 21, giving a higher threshold ES of 0.86). A different figure for MCID was generated by 192 patients with OA, who registered improvement scores as well as changes in pain.5 This showed a more modest MCID, equivalent to an ES of 0.39 (shown in figure 1). The National Institute for Health and Care Excellence (NICE) did not regard any value for MCID as valid6 and chose a generic value of 0.5 (see figure 1). Hinman et al chose a high threshold and also failed to discuss the effect that alternative threshold MCID values would have on the interpretation of their findings. We also note that the MCID for any treatment should be chosen to take account of acceptability, safety and cost-effectiveness,7 which would argue for a lower threshold for acupuncture for knee pain.

4. THE OLD "BETA ERROR" BUGABOO: SHORT ON STATISTICAL POWER. Hinman et al applied this 'clinically important' difference to a 'clinically irrelevant' comparison--acupuncture versus sham laser. Sham laser is not an available therapy. The only reason for comparing acupuncture with sham would be to estimate the effects of the needles themselves, but this is already well known from the Cochrane review8 and an individual patient data meta-analysis (figure 1).9 It is known that the effect of needles alone is small, and so is unlikely to be identifiable reliably with sample sizes of less than about 800.10 The sample size in the study by Hinman et al (n=70) clearly appears to be inadequate for the question, according to the existing evidence, and not best use of resources. The resulting ES of acupuncture against sham that was actually found by Hinman is similar to that shown by the best evidence8 (see figure 1), although the wide CI means the data can only be of any importance when they are included in a meta-analysis in the future.

5. WHO DECIDES WHAT TREATMENT EFFECT IS MEANINGFUL? Hinman et al found that, after 12 weeks, knee pain was significantly reduced by acupuncture compared with no acupuncture control, with an ES of 0.6 (data from their table 2; see figure 1). The difference did not quite meet the MCID they had postulated--although the estimated ES is the same size as the MCID--but it more than meets the MCID chosen by patients themselves (ES 0.39) and that selected by NICE (ES 0.5). In interpreting this result, the secondary outcomes should also have been brought into thoughtful consideration: there were significant differences in favour of acupuncture for six out of eight secondary outcomes (see eTable 5 in their paper) and the response rate, which is the most patient-orientated measure of success,7 was 76% in the acupuncture group compared with 32% in the no acupuncture control group.

6. TO MAKE MATTERS WORSE, THE AUSTRALIANS STUDIED THE LEAST EFFECTIVE ACUPUNCTURE TECHNIQUE. Hinman et al did not apply optimal acupuncture. Use of electroacupuncture has been shown superior to manual stimulation for knee pain in 2010.8

A couple of weeks ago, I also came across a study of "needle-less" acupuncture, also for chronic knee pain of the OA variety. Basically it involved warming the knee with these stick on cones of burning mugwort--sort of like (very carefully) burning incense around your knee cap. That too showed clinical effectiveness, although now I am prompted to dig up the original study and see if we can fit that "effect size" into our acupuncture, warm baths, exercise line-up above. Stay tuned.
According to the Centers For Disease Control and Prevention (CDC), approximately 5-20% of people in the U.S. will catch the flu virus, 200,000 of whom will be hospitalized due to the complications.  Although you can catch the influenza virus at any time of the year, it's alot easier during the fall and winter months--cuz we're all cooped up inside, often more sedentary, sweating less, moving less--and touching our noses and maybe eyes more often. The added dryness in the air also depletes the protective mucus in our nasal passages, throats and lungs, which seems to make it easier for pathogens to get to their preferred habitats. To protect yourself against the flu, colds and other illnesses this fall, check out the following 4 tips.

#1) Stay Active

Exercise (sweating quite possibly being the most important part) plays a direct role in the human body's immune function. Whether it's running, jogging, playing tennis, or using your preferred machine at the gym, physical activity stimulates white blood cells and antibodies, sending them throughout the body. This improves the immune system's ability to fight off infectious diseases, so be sure to exercise on a regular basis this fall.

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#2) Increase Your Vitamin C Intake

Vitamin C is a naturally occurring antioxidant that can improve your health and protect against illness. A study conducted in 2007 found that a daily 200 mg dose of vitamin C when taken at the onset of a cold shortened its duration by 8% in adults and 14% in children. (Some report greater success with zinc, especially zinc lozenges.) With fall and winter being prime time for colds, it might be a good idea to push your daily food intake into the direction of getting a minimum of 75 mg of this powerful antioxidant.


Some sources you might not have considered: Pineapple (fresh) 16mg, asparagus 31 mg, grapefruit 26 mg, broccoli (raw) 89 mg, sundried tomatoes in oil 101 mg, raw parsley 133 mg. The humble apple contains so many phytonutrients that it has an antioxidant equivalent of 1,000 mg (as in 1g) of vitamin C.

  • Eat plenty of green, leafy vegetables. This includes broccoli, cabbage, Brussels sprouts and collard greens. Eat the vegetables raw or steam them, using only a small amount of water, to maximize the amount of vitamins the vegetables retain.
  • Choose fresh and frozen fruits with high vitamin C levels, such as grapefruit, oranges and other citrus fruit, as well as strawberries, cantaloupe, mango, guava, and papaya. All berries are great sources of vitamin C.
  • Have a salad with spinach leaves instead of lettuce. Spinach is a better source of vitamin C when eaten raw. Toss in green and red bell peppers and tomatoes for added vitamin C.
  • Eat the skin when having a baked potato, as the skin has the highest concentration of vitamin C.
  • Use plenty of tomato sauce on your pasta, pizza or vegetables. Or, have a cup of (home made) tomato soup. Tomatoes are a great source of vitamin C no matter how you eat them.
Vitamin C does not last in storage, and is steadily lost the longer the food item is stored. As such, be prepared to eat your food as fresh as possible rather than leaving it to linger in the refrigerator or pantry. For example, leaving your broccoli in the fridge and then boiling it will reduce the vitamin C content considerably compared to freshly picking the broccoli and steaming it that same day. It's a good motivation to become a vegetable gardener even if you just grow a few balcony broccoli or potatoes in a pot or crate.
  • Do not soak fruits or vegetables or store them in water.  The vitamin C will leach out into the water. Vitamin C also leaches out in cooking water--so better to steam (even nuke) or stir-fry/lightly sauté.

#3) Remember the Rainbow ("ROY-G-BIV")

Yet another way to improve your health is to do your best to get every color in your food, every day: red, orange, yellow, especially (dark, bitter) GREENS, blue and purple (violet). (I'm going to substitute white or beige for the indigo. Let's hear it for the beige: cauliflower, leeks, fennel, celeriac, parsnips, rutabagas, the all powerful mushrooms, even potatoes--which I know will be controversial.) With some notable exceptions, the more color you have on your breakfast, lunch or dinner plate, the better. Foods that are bright orange, red and green are all excellent sources of vitamins and antioxidants. Some ideas include squash, bell peppers, broccoli rabe, Swiss chard, bok choi, escarole--all of which will help keep you healthy throughout the darker, drearier, indoor months.

#4 Make a Soup

There's no better time than the chilly fall and winter seasons to lovingly prepare a hearty soup. Avoid store-bought soups (and stocks--or read labels carefully), which are usually loaded in sodium and preservatives. Instead, make your own from scratch. This allows you to include a variety of beneficial vegetables and seasoning, tailoring it to your own personal preference.

Lieque (Broken Sequence) and Zusanli (Leg Three Mile)

Although they are invisible to the naked eye, we are exposed to millions upon millions of germs. Bacteria, viruses, fungi and protozoa are found on nearly every surface, including doorknobs, furniture, office supplies, phones, remote controls, and even the food we eat. Thankfully, most of these germs are harmless and pose no direct threat to our health, but there are others that aim to cause infection and illness. You can safeguard yourself against these foreign invaders, however, by utilizing the Lieque and Zusanli acupuncture points.

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Lieque Acupuncture Point

Lieque (also known as Lung 7 in our ordinalized and Anglicized system of points) is an acupuncture point that's commonly used to treat bodily infections while subsequently boosting the immune system. To locate it, form a "thumbs up" gesture with your hand and look for the small crease in your skin at the base of your thumb. The Lieque acupuncture point is found roughly 2 finger-breadths up the wrist from this crease. It's most easily identified by feeling around this area of your wrist for a subtle depression at the bottom of two tendons.

Lieque is known to offer relief of the following symptoms:

  • Sore throat
  • Runny nose
  • Nasal congestion
  • Chest congestion
  • Body aches
  • Fever
  • Headache
  • Muscle cramps

Zusanli Acupuncture Point

Zusanli (Stomach 36 in the English-speaking countries) is another powerful immune-boosting acupuncture point. Don't let its name fool you into thinking it's located on the stomach though. Zusanli is actually located on the lower leg, just past the ridge of the tibia where the fibers of the tibialis anterior muscle attach.

Zusanli receives its namesake for the symptoms it's used to treat. While Lieque focuses on cold and febrile symptoms, Zusanli is used more digestive problems.

Zusanli is known to offer relief of the following symptoms:

  • Constipation
  • Diarrhea
  • Acid reflux
  • Heartburn
  • Gas
  • Low energy

How Lieque and Zusanli Can Improve Immune System Function

The human body's built-in mechanism for defending against germs and foreign invaders is the immune system. This complex system is comprised of a variety of different white blood cells, such as neutrophilis, eosinopholis, monocytes and basophils, that actively seek out and neutralize harmful germs. Acupuncture treatments using the Lieque and Zusanli stimulate the immune system so it produces more of these "fighters," which in turn keeps us healthy while protecting against disease and illness.


Michael Barr is a board certified acupuncturist and herbalist and can be reached at Manhattan Acupuncture Associates, with offices at Columbus Circle and Flatiron. His expertise and interests include sports acupuncture, pain syndromes, liver health, immunological support, low energy, mood disorders, anxiety, insomnia, GI complaints, and herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.

Photo Credit:  Thunderchild7 via Flickr Creative Commons

Drs. Feeney and Chung (Mass General, Boston) in a July 7th clinical review for the BMJ report that over the next 1-2 years, "several new agents and classes of direct-acting antiviral are likely to be licensed," expanding the options for interferon-free regimens. "These interferon-free regimens," they write, "could enable many patients with HCV (even those with cirrhosis and those who have not responded to previous PI-based treatment) to be cured with an oral course of antiviral without the use of interferon and its associated side effects."

A year or so ago, I came across a journal article reporting the use of weekly ear (aka auricular) acupuncture for help managing the side-effects of interferon therapy. While the number of people treated was small (14) and effectiveness was assessed by self-report, the results are intriguing nonetheless.

Severity of fatigue, muscle aches (myalgia), irritability and nausea were all reported to decrease.

If  you're curious, the ear points these clinicians used were Shen Men, Thalamus, Lung, Liver "and/or" Sympathetic. Interestingly, they used 32-gauge (0.18 x 25 mm) needles. Retention time: 30-45 minutes. All results were statistically significant, although the nausea change just barely so. Reductions in irritability showed the most impressive decrease, followed by muscle aches (myalgia).

One wonders if the results might have been even better if the treatments could have been performed more frequently (it appears that folks had only 4 treatments over a period of 6 months), maybe using ear seeds, tacks or magnets for home or office stimulation between visits, and if some body points could have been added. (BaiHui and HeGu were employed in an undisclosed number of cases, presumably in accordance with individual pattern presentations.)

There does not appear to be much published research on the use of acupuncture--ear or otherwise--to manage the side effects of interferon therapy. And except for a few lucky souls (mostly those with genotypes 2 and 3) who can expect to clear the virus with a non-interferon based hep-C combo, it seems we are stuck with at least 12 weeks of weekly sub-Q interferon injections.

I contacted the author of the paper, an acupuncturist MD at the VA in Portland, OR, to try to find out additional information on her study and any plans for follow-up investigation. She explained their plans for a larger and "cleaner" study in order to tease out the exact contribution of the acupuncture intervention, as well as to better understand the optimal timing of the acupuncture treatment in relation to self-administration of interferon injection.

(Readers might also want to check out the medhelp.org (or other) online community forum for other peoples' experiences. The one I happened onto this morning yielded several helpful first-hand experiences: One person writes that s/he heads to acupuncturist the morning after the previous night's interferon jab, and that it really helps. Of course, not everyone can afford or has the required insurance plan to cover weekly (or, perhaps better: biweekly) visits to an acupuncturist in private practice. But as someone from the Bay Area wrote in, communal or group acupuncture places (officially called "community" acupuncture) offer scaled-down but completely adequate services for a fraction of the cost of a private session. This person was going to a community acupuncture place in Berekley, CA for all of $15 a visit! And don't forget massage. Many folks report that a monthly massage also really helps.

I haven't seen any $15 price points in NYC (more like $40, $45, $55), but there are a handful of group/community acupuncture places in metro NYC: Manhattan Community Acupuncture (UWS), New York Community Acupuncture (West 36th Street),  Harlem Village, Olo, City Acupuncture, Bae (Williamsburg) and Third Root (Ditmas Park). (I have first-hand experience with only Olo Acupuncture (West 23rd Street, between Sixth and Seventh), City Acupuncture (Fulton Street) and Third Root (on the Q and M trains! And I once studied with the woman who started NYCA); the others I found through a search engine.) I am told that City Acupuncture is  soon to open a second location across the Hudson in Hoboken or Jersey City. Anyway, there seem to be more community acu places in the Garden than Empire state at the moment. Stay tuned...)

Housing Works, with Positive Health Project centers in East New York, downtown Brooklyn, West 13th Street and East 9th Street in Manhattan, offers an acupuncture option to its HIV+ clients ("every Tuesday and Thursday from 1pm-5pm") but to my knowledge is not currently offering acupuncture services to their HCV+ folks. (Please correct me if I am wrong!)

Of course, for hep-C infected folks who are not ready (or willing) to take the peg-interferon/ribavirin-PI plunge or waiting for easier-to-take, better tolerated drug combos and are concerned about their liver health, there are quite a few good herbal formulas out there reported to support healthy hepatocyte regeneration, prevent further liver damage and reduce the risk of fibrosis. (This would apply equally to HBV-infected folks who are not on suppressive antiviral therapy.) More on that in a future post though! In the meantime, I would love to see some of the HCV service centers in the city begin to offer this ear acu option to their clients.

Mike Barr is a board certified acupuncturist and herbalist and can be reached at Manhattan Acupuncture Associates, with offices at Columbus Circle and Flatiron. His expertise and interests include sports acupuncture, pain syndromes, liver health, immunological support, low energy, mood disorders, anxiety, insomnia, GI complaints, and herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.

CL found that because coconut water contains lots of potassium (and very little sodium), sports drinks might actually be a better choice. Large quantities of potassium could impart a laxative effect (desirable or undesirable, you decide) while coconut water drinks without added sodium are probably not as good as sports drinks after "intense, prolonged exercise."

And they add, "plain water may be sufficient for simple rehydration." In a 2012 study all 3--sport drink, coconut water (both pure as well as reconstituted from concentrate), water--were shown to be of equal utility.

Or you could give the Mother Earth a break and just make your own electrolyte post-workout beverage.

Basically these drinks are just a quarter cup or so of fruit or fruit juice (containing variable proportions of glucose, fructose, sucrose) with a little salt (sodium chloride +/- potassium iodide and possibly some other trace minerals if it's fancy) mixed into water. For help choosing from among isotonic, hypertonic and hypotonic options, this BBC page might be useful.


Michael Barr is a board certified acupuncturist and herbalist and can be reached at Manhattan Acupuncture Associates, with offices at Columbus Circle and Flatiron. His expertise and interests include sports acupuncture, pain syndromes, liver health, immunological support, low energy, mood disorders, anxiety, insomnia, GI complaints, and herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.



I realize it's not the first time something like this has happened, but really??

The Reproductive Health Drugs Advisory Committee of FDA voted 10-4 AGAINST approval of the antidepressant paroxetine (basically low-dose Paxil) for menopausal hot flashes in women. But their superiors decided to approve it anyway.

Surely GSK and its shareholders welcome a new indication for a novel reformulation of a blockbuster drug that lost patent protection some 10 years ago.

The evidence of benefit? Median of 5.0 vs. 5.6 "moderate to severe" hot flashes per day (at Week 12), paroxetine vs. placebo.

Admittedly it will be an apples to oranges comparison, but I will look up the effect size from acupuncture and, if available, herbal medicine trials and post later today. (I finally got around to looking up the Norwegian (AcuFlash) study stats: number of hot flashes decreased by average (mean) of 5.8 per 24 period in the acupuncture group--vs. mean reduction of 3.7 in the control ("advice on self-care") group. Hot flash intensity also decreased by roughly twice as much in the acupuncture group compared to control group: 3.2 vs. 1.8. All results were statistically significant: p<0.001.)

And the Black Box warning on the medication?: Although the risk of suicidality associated with Brisdelle is uncertain, it is noteworthy that the concerns about suicidality associated with higher doses of paroxetine pertain to children and young adults, a population for whom Brisdelle clearly is not indicated. Nonetheless, the Brisdelle label recommends monitoring patients for suicidal thoughts and behaviors and discontinuing treatment if there is worsening depression or suicidality.

Plus... as a potent inhibitor of cytochrome P450-CYP2D6 paroxetine, even at this relatively low dose, also has the potential for a wide array of drug-drug interactions: most notably, with tamoxifen, where it reduces plasma levels of the drug by 64%.

This decision is particularly surprising because the current FDA Commissioner, Peggy (aka Margaret, former NYC health chief) Hamburg has historically been very women's health and "community" friendly--or at least she used to be before, maybe, she obtained so much power or responsibility? Maybe she doesn't know about the AcuFlash studies or the bevvy of Chinese herbal formulas for managing menopausal symptoms: Er Xian Tang, Geng Nian An Pian, Da Bu Yin Tang and (Zhi Bai) Di Huang Tang aka "Rehmannia 6." (Personally, I prefer Health Concerns' tweaking of the classic formula, which they playfully call Three Immortals. They add Er Zhi to Er Xian--plus magnolia tree and lycium root bark (Mu Dan Pi, Di Gu Pi, respectively).) Should we write Dr. Hamburg--or the committee members--a letter?

A "Perspective" of the FDA's decision to override its own advisory committee appears in this week's New England Journal of Medicine. Read the full (free) text here. The NEJM editors conclude that: "Recognizing that no hormone-free drug product has been approved to treat vasomotor symptoms, and after careful review of the efficacy results, the FDA concluded that Brisdelle offers a clinically meaningful benefit for some menopausal women."

Clearly we have alot of work still to do.


Michael Barr is a board certified acupuncturist and herbalist and can be reached at Manhattan Acupuncture Associates, with offices at Columbus Circle and Flatiron. His expertise and interests include sports acupuncture, pain syndromes, liver health, immunological support, low energy, mood disorders, anxiety, insomnia, GI complaints, and herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.




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