Acupuncture and adverse effects.

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References

1. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed.

Boston, Mass: Little Brown and Company; 1991. p. 206-7.

2. Brown J, Fortier M, Khan AA, Rowe T. An evidence- based review of the management of osteoporosis. JOGC 2001;(Apr):2-7.

3. Yuen CK, Kendler D, Khan AA, Brown J, Fortier M.

Canadian consensus on menopause and osteoporosis.

JOGC 2001;(Oct):1-11.

4. Brown JP, Josse RG, for the Scientific Advisory Council of the Osteoporosis Society of Canada. 2002 Clinical practice guidelines for the diagnosis and management of osteoporosis in Canada. Can Med Assoc J 2002;167(10 Suppl)S1-S34.

Acupuncture and adverse effects

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he recent article¹ by Chung et al entitled “Adverse effects of acupuncture. Which are clinically significant?” makes for confusing reading.

While the title of the paper implies that the intent is to alert readers to clinically significant adverse events, the paper itself gives considerable prominence to minor effects, such as bleeding at the site of needle insertion, nausea, fainting, and drowsiness. This begs the question as to what exactly constitutes an adverse effect.

Drowsiness is a known conse- quence of eating lunch. Bleeding, nausea, and fainting are common events when blood is drawn for laboratory testing and accepted as “normal” by patients and health care practitioners alike. Many over-the-counter drugs have known adverse effects. The antiulcer drug ranitidine (Zantac), available at any corner store, lists headache; abdominal discomfort or pain; nausea and vomiting; constipa- tion; diarrhea; and occasional cases of gynecomastia, impotence, and loss of libido as possible side effects.² But these adverse effects are rare or considered acceptable when risks are weighed against benefits.

The inclusion of psychiatric disturbance as a common adverse effect in Table 1 should be questioned. Are readers of the paper to conclude that not only physical but also psychologi- cal scarring is a frequent outcome of acupuncture treatment? This statement is not supported by my reading

of the research literature. The authors should have been required to sub- stantiate their claim with appropriate references and to define what exactly constitutes a psychiatric disturbance.

While it is important to alert the medical community to adverse effects of any treatment, no intervention can be expected to have no adverse effects. Safety issues, therefore, need to be considered in context. The most important question to ask regarding the safety of acupuncture is how does it compare with similar treatments for the same health problems? According to a 1997 consensus statement³ from the National Institutes of Health, one of the advantages of acupuncture is

“that the incidence of adverse effects is substantially lower than that of many drugs or other accepted medical pro- cedures used for the same conditions.”

—Aileen Burford-Mason, PHD

Director of Communications and Scientific Affairs Acupuncture Foundation of Canada Toronto, Ont by e-mail References

1. Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician 2003;49:985-9.

2. Glaxo. Complete prescribing information, Zantac (ranitidine HC1) (ranitidine HC1/Glaxo). In: Compendium of Pharmaceuticals and Specialties. Ottawa, Ont: Canadian Pharmacists Association; 2002.

3. National Institutes of Health. Acupuncture. NIH consensus statement. Bethesda, Md: National Institutes of Health; 1997.

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he recent article¹ “Adverse effects of acupuncture. Which are clinically significant?” begs for comment and correction.

First, no definition of acupuncture of which I am aware describes acupuncture as the placing of needles

“transcutaneously,” as these authors describe. The needles puncture the dermis and are often inserted deeply into muscle, adjacent to ner ves, or intra-articularly. Transcutaneous electrical nerve stimulation (TENS) machines use electrode pads on the skin to transcutaneously stimulate acupuncture points.

Traditional Chinese medicine concepts of acupuncture should be respected and used to tap into the full richness of that tradition with its many health benefits. However, there is plenty of experimental evidence regarding the physiologic responses of the human body to acupuncture needling.^2-5 The authors of this article chose not to acknowledge the huge body of scientific knowledge on the neurophysiology of acupuncture, suggesting that there is debate about

“the physiologic effects and therapeutic mechanisms of acupuncture therapy.” What they could have correctly pointed out is that more well designed, randomized trials on the therapeutic benefits of acupuncture for a range of conditions, for which there is mas- sive anecdotal evidence of efficacy and safety worldwide, are needed. In spite of that, systematic reviews have shown that acupuncture works for back pain, migraine headaches, nausea and vomiting of pregnancy, and dental pain.^6-8

The statement on page 986¹ that acupuncture is used by family physicians to treat cancer must be a typo- graphical error. Acupuncture can be used in the management of cancer pain, but no one treats cancer with acupuncture; Chinese herbs, yes, but not acupuncture. Many types of cancer pain can be managed well at home by using a high-tech, sophisticated, Canadian TENS device (Codetron™) on acupuncture points.⁹

Family physicians wishing to learn acupuncture have been well served by two Canadian continuing education programs for many years. The Acupuncture Foundation of Canada Institute (AFCI) program began in 1974 and has been accredited by the University of Toronto Continuing Education department since 1998.

Family doctors from all 10 provinces and the territories have availed them- selves of this excellent program. The CME Certificate Program in Medical Acupuncture at the University of Alberta was established in the early 1990s and, like the AFCI program, has

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study credits and an examination that is used in some provinces as a prereq- uisite for physicians to use acupuncture within their medical practices.

Neither of these programs was mentioned in the article. The McMaster University program, which was mentioned, offers a series of weekend courses on anatomical acupuncture.

This article is about adverse effects of acupuncture and asks the question, “Which are clinically significant?” Unfortunately, it fails to answer that question clearly. While the two prospective studies,^10,11 which most accurately reflect real- world practice experience, are discussed in the body of the article and demonstrate how safe acupuncture is in well trained hands, the errone- ous impression is given that some ver y rare adverse effects are common. That is the message one gets by simply reading Table 1, which lists “common adverse effects” and

“rare complications.” No data in the body of the article support some of the “common” adverse effects, most notably “psychiatric disturbance,”

“diarrhea,” and “needle breakage.”

In fact, one could argue, using the prospective study data, that there are no common adverse effects at all, because the highest incidence of an adverse effect in a total of 66 000 acupuncture treatments was 3.1% for needle site bleeding. When one con- siders that the typical “bleeding” is a single drop of blood, this hardly qual- ifies as a serious adverse effect.

While one always sees anticoagulants listed as a risk factor for complications of acupuncture, personal experience using acupuncture to treat several hundred patients at a spinal cord injury rehabilitation hospital in Toronto over an 11-year period has shown not a single incident of bleeding in any patient taking either warfa- rin or heparin. Because the percentage of this patient population who are taking anticoagulants is very high, and our experience involves thousands of treatments, the inference is that

anticoagulation is actually rarely an issue with acupuncture treatment.

A more detailed review of adverse effects of acupuncture is available in the article by Rampes and Peuker in Acupuncture—a Scientific Appraisal, edited by Edzard Ernst and Adrian White from the Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences at the University of Exeter in the United Kingdom.¹²

This critique is not meant to contra- dict the main message of the paper in question. It is imperative that all practitioners of acupuncture be well trained in safe techniques and be able to recognize complications when they arise so they can be dealt with properly. Acupuncture is unquestionably an attractive method of treatment, based on its efficacy and its outstanding safety profile, when it is per- formed appropriately.

—Linda M. Rapson, MD, CAFCI

Executive President, Acupuncture Foundation of Canada Institute

Toronto, Ont by e-mail References

1. Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician 2003;49:985-9.

2. Pomeranz B. Scientific basis of acupuncture. In: Stux G, Pomeranz B, editors. Acupuncture textbook and atlas. New York, NY: Springer Verlag; 1987. p. 1-34.

3. Kho HG, Robertson EN. The mechanisms of acupuncture anal- gesia: review and update. Am J Acupuncture 1997;25(4):261-81.

4. Cho ZH, Chung SC, Jones JP, Park JB, Park HJ, Lee HJ, et al. New findings of the correlation between acupoints and corresponding brain cortices using functional MRI. Proc Natl Acad Sci USA 1998;95(5):2670-3.

5. Lundeberg T. Peripheral effects of sensory nerve stimulation (acupuncture) in inflammation and ischemia. Scand J Rehabil Med Suppl 1993;29(Suppl):61-86.

6. Ernst E, White AR, Wider B. Acupuncture for back pain:

meta-analysis of randomised controlled trials and an update with data from the most recent studies. Schmerz 2002;16(2):129-39.

7. National Institutes of Health. Acupuncture. NIH consensus statement. 1997;15(5):1-34.

8. Ernst E, Pittler MH. The effectiveness of acupuncture in treating acute dental pain: a systematic review. Br Dent J 1998;184(9):443-7.

9. Librach SL, Rapson LM. The use of transcutaneous electrical nerve stimulation (TENS) for the relief of pain in termi- nal care. Palliat Med 1988;2:15-20.

10. White A, Hayhoe S, Hart A, Ernst E. Adverse events follow- ing acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists. BMJ 2001;323:485-6.

11. MacPherson H, Thomas K, Walters S, Fitter M. The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists. BMJ 2001;323:486-7.

12. Rampes H, Peuker E. Adverse effects of acupuncture. In:

Ernst E, White AR, editors. Acupuncture—a scientific appraisal.

Oxford, Engl: Butterworth-Heinemann; 1999. p. 128-52.

Response

Acupuncture offers a relatively safe form of treatment for various health problems. Nonetheless, no treatment carries zero adverse effects.

Responsible practitioners should always keep in mind some of the potential, although rare, adverse effects of acupuncture.

Although our article only briefly mentioned the benefits of acupuncture, it should be emphasized that it does have many benefits. Acupuncture has been used effectively for conditions ranging from pain management for childbirth¹ and musculoskeletal conditions² to improving the pregnancy rate for women undergoing assisted reproduction.³ The statement on page 986 of our article about use of acupuncture should be read as that family physicians use acupuncture for pain management for cancer patients.⁴ Acupuncture is not used on its own to treat cancer per se. In keeping with the focus of the article, however, we chose not to discuss at length the benefits of acupuncture.

Even though the likelihood of adverse effects from acupuncture is substantially lower than it is with many drugs and other accepted medical pro- cedures used for the same conditions, acupuncture practitioners are likely to encounter some adverse effects as acupuncture becomes more popular in health care. Psychiatric disturbance was included as one of the potential common adverse effects because of the widespread fear of needles in the general population. Some patients get anxious at the site of needles. White et al⁵ reported that two acupuncture patients experienced anxiety and panic (one episode lasted 60 hours).

Although it is not known whether the anxiety and panic were triggered by fear of needles, it is important for practitioners to address any potential fear factor before acupuncture treatment.

We agree with Dr Rapson’s comment that there are no common adverse events. Table 1 simply

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presents potential complications and should not be interpreted as common occurrences. Overall, complications were rare, but if they did occur, the most common ones were needle site bleeding and bruising. The evidence for Table 1 was from the two prospective studies discussed in the paper. Though we did not discuss the studies in great detail, the purpose of Table 1 was to summa- rize their results. Dr Rapson mentioned that, in her 11 years of practice, she did not witness any significant bleeding in patients taking anticoagulants. Her experience simply supports the fact that complications are generally rare; however, her observations are unsystematic. Our point is that anticoagulation therapy is a risk factor for bleeding but should not be interpreted as an absolute contraindi- cation to acupuncture treatment.

Acupuncture offers an effective treatment option for various health conditions with a relatively low risk. The benefits of acupuncture might outweigh its potential risks, but it is still important that acupuncture practitioners keep in mind some of these risks. Awareness of potential adverse effects will better prepare practitioners to deal with them.

Awareness is the first step in prevention.

—Ainee Chung, ND

—Luke Bui, MD

—Edward Mills, DPH

References

1. Ramnero A, Hanson U, Kihlgren M. Acupuncture treatment during labour—a randomised controlled trial. Br J Obstet Gynaecol 2002;109(6):637-44.

2. Meng CF, Wang D, Ngeow J, Lao L, Peterson M, Paget S.

Acupuncture for chronic low back pain in older patients:

a randomized, controlled trial. Rheumatology (Oxford) 2003;Jul 30.

3. Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K.

Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril 2002;77(4):721-4.

4. Zaza C, Sellick SM, Willan A, Reyno L, Browman GP.

Health care professionals’ familiarity with non-pharmaco- logical strategies for managing cancer pain. Psychooncology 1999;8:99-111.

5. White A, Hayhoe S, Hart A, Ernst E. Adverse events follow- ing acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists. BMJ 2001;323:485-6.

Dr Paul Hooker

I

am writing to let Canadian Family Physician know that Dr Paul Hooker

has passed away. My husband wrote a Reflections piece,¹ which was pub- lished in the February issue. He had chronic myeloid leukemia and had had a stem cell transplant last November in Calgary, Alta. At the time the transplant was done, he was already on the cusp of blast phase leukemia. He died of complications in May 2003. Thank you for publishing his article. It meant a lot to him and to us, his family. His son, Ross W. Hooker, is taking up the family tradition and studying to become a doctor.

—Jan Gordon-Hooker by e-mail Reference

1. Hooker WP. Lessons for us all. One doctor’s experience with a fatal illness [Reflections]. Can Fam Physician 2003;49:147-8.

Evidence sketchy on circumcision and cervical cancer link

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^{r Rivet}¹ has failed to review criticism of the article² by Castellsagué et al in the New England Journal of Medicine. The article has been criticized for its poor methodol- ogy,³ because circumcision removes specific erogenous tissue^4-6 and because male and female partners have different types of human papillomavirus (HPV).⁷

Castellsagué and colleagues admit to being “puzzled” by these findings. In addition, they emphasize that they did not recommend circumcision.⁸ These comments place Castellsagué and colleagues’ findings regarding circumcision’s protective effects against cervical cancer in the dubious category.

A vaccine for HPV has been tested and found to be effective.⁹ It is proba- ble that, by the time infants born today reach maturity, a vaccine will be available to prevent cervical cancer.

In view of the above, neonatal circumcision cannot be recommended to prevent cervical cancer. Human papillomavirus causes cervical cancer; the

foreskin does not. Safer sex, not circumcision, prevents the spread of HPV.

The recent cautionary statements by three provincial colleges of physicians and surgeons regarding non- therapeutic circumcision of male children should be of greater concern to family physicians.^10-12

—George Hill Executive Secretary, Doctors Opposing

Circumcision Seattle, Wash by e-mail References

1. Rivet C. Circumcision and cervical cancer. Is there a link?

[Critical Appraisal]. Can Fam Physician 2003;49:1096-7.

2. Castellsagué X, Bosch X, Munoz N, Meijer C, Shah K, De Sanjosé S, et al. Male circumcision, penile human papillomavirus infection, and cervical cancer in female partners.

N Engl J Med 2002;346:1105-12.

3. Travis JW. Male circumcision, penile human papillomavirus infection, and cervical cancer [letter]. N Engl J Med 2002;347(18):1452-3.

4. Bhimji A, Harrison D. Male circumcision, penile human papillomavirus infection, and cervical cancer [letter].

N Engl J Med 2002;347(18):1452-3.

5. Winkelmann RK. The erogenous zones: their nerve supply and its significance. Mayo Clin Proc 1959;34:39-47.

6. Taylor JR, Lockwood AP, Taylor AJ. The prepuce: special- ized mucosa of the penis and its loss to circumcision.

Br J Urol 1996;77:291-5.

7. Franceschi S, Castellsagué X, Dal Maso L, Smith JS, Plummer M, Ngelangel C, et al. Prevalence and determi- nants of human papillomavirus genital infection in men.

Br J Cancer 2002;86:705-11.

8. Castellsagué X, Bosch FA, Muñoz M. Author’s reply.

N Engl J Med 2002;347(18):1448.

9. Koutsky LA, Ault KA, Wheeler CM. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 2002;347:1645-51.

10. Kendel DA. Caution against routine circumcision of newborn male infants (Memorandum to physicians and surgeons of Saskatchewan). Saskatoon, Sask: College of Physicians and Surgeons of Saskatchewan; February 20, 2002.

11. College of Physicians and Surgeons of British Columbia.

Infant male circumcision. College Q 2002;Fall:2.

12. College of Physicians and Surgeons of Manitoba. Caution regarding routine circumcision of newborn male infants.

Newsletter 2002;38(Dec):4.

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r Christine Rivet¹ presents evidence suggesting that circumcision reduces risk of human papillomavirus (HPV) infection in men and cervical cancer in their female partners.

This evidence should be put in per- spective. Other studies have found no significant correlation between circumcision and either HPV or cervical cancer.^2,3 Moreover, a large and well controlled American study found that circumcised men were slightly more