Palle Rosted MD Consultant Medical Acupuncturist Clinical Lecturer Sheffield University Weston Park Hospital Sheffield S10 2SJ (UK)
Summary: The author presents and discusses a survey of published papers from 1965 to 1997 on adverse effects arising from acupuncture treatments. A number of serious side effects, e.g. cardiac tamponade, pneumothorax, endocarditis, hepatitis, spinal lesions as well as minor side effects, e.g. fainting and skin reactions are described. The majority of the reported side effects are due to either lack of basic medical background or failure to apply the correct sterile techniques. In particular the education of non medical trained acupuncturists gives rise for concern. Thus it was found that serious side effects were nearly three times more frequent after treatment by non medical trained acupuncturists than treatment by medical trained acupuncturists. The need for urgent legalisation and standards of training is stressed. Despite some serious side effects, the safety of acupuncture should be judged on the results from competent practitioners who use acupuncture correctly. Acupuncture must be considered an extremely safe therapeutic procedure with rare and easily avoided complications.
Keywords: Acupuncture, adverse effects, endocarditis, cardiac tamponade, hepatitis, pneumothorax, infection, allergic dermatitis, education, legalisation INTRODUCTION Acupuncture is a technique more than 3000 thousand years old originated in China. Until the early fifties acupuncture was almost unknown in the Western World and the real introduction into the West was not until President Nixon visited China in the early 1970's. During the planning of this visit the guests and accompanying press were shown acupuncture and its potential for the use as a method of treatment in the Western World. On returning from China the newspaper and the media were full of details about this new wonder treatment. As a consequence a number of doctors and non-doctors from the Western World went to China to study the technique.
In the years following cases were reported in both the medical and public press. One could have concluded from this comment that this "new" treatment would replace a lot of diseases normally treated by orthodox medicine. Sadly, this was not the case. A number of randomised controlled studies demonstrate that in a number of cases, acupuncture was only able to demonstrate an effect similar to placebo. In other studies it was shown that acupuncture had a similar effect as conventional treatment. Yet, a few studies, acupuncture was demonstrated to be better than orthodox treatment.
The role of acupuncture today is well established and its main use is in the management of pains, in particular of musculoskeletal origin. Acupuncture is performed by medical doctors and/or laypractitioner depending of the legalisation in the individual country. I some countries, e.g. Denmark, France, Germany and Austria only doctors are allowed to perform acupuncture. However, in other countries like Sweden and Norway nurses and physiotherapists as well are allowed to perform acupuncture. Countries, such as USA the majority of acupuncturists are non-doctors but they have very strict standard for those performing acupuncture. Countries such as England have no legalisation. Anyone can put up a sign and start to practice acupuncture without any formal education.
The number of acupuncture treatment given daily World-wide is astronomic. The quality of treatment varies considerably. It is a common impression among the public that orthodox medicine is associated with varied, often serious adverse effects, e.g. suppression of the adrenal glands after steroid treatment, etc. whereas acupuncture is not associated with side effects. Unfortunately this is not the case - a number of severe side effects after acupuncture has been reported. In most countries doctors are by law, committed to report serious side effects to the Health Authorities. Unfortunately, there is no legalisation for lay-practitioners performing acupuncture nor a definitive registration of the incidence therefore the variety of acupuncture-related adverse effects is not available.
It is not possible to estimate the number of doctors world wide who uses acupuncture in their daily clinic. In England 1400 doctors are members of British Medical Acupuncture Society. In Denmark 800 doctors are member Danish Medical Society for Aacupuncture. The number of non-doctors performing acupuncture varies from one country to the other, but it is estimated the number of non medical trained practitioners using acupuncture in England is between 3000 and 5000.
Because of the lack of a reporting system of adverse effects after acupuncture it is probably only in the cases of serious side effects where patients are referred to hospitals or the treatment has a fatal outcome the incident is reported to the authorities. However, in the last twenty years a number of adverse effects has been reported in the medical literature and these are dealt with hereunder. I must stress that the adverse effects mentioned in this paper in my opinion represent only the tip of the provobial iceberg. A few ears ago I made inquiries of the different defence unions in England. Because of confidentiality they were not able to give me detailed information, but it was made clear that there has been cases in the past, of which some have been of a very serious nature. Moreover, I have personal knowledge of a number of serious side effects, among them one fatality, which was never published.
CRITERIA FOR IDENTIFICATION AND SELECTION OF RELEVANT STUDIES The study is based on a computer search of papers published between 1965 and 1997 performed by The Royal Society of Medicine, London, England and The University Library, Copenhagen, Denmark. The following databases has been used: Medline, Biological Abstracts and Excerpta Medica: The search words were: Acupuncture, adverse effects and side effects. Papers in the following language were reviewed: Danish, English, Norwegian, Swedish and German. Furthermore, a number of papers were included from the authors' long-standing collection of papers on the subject.
I was possible to identify a total of 163 papers which were listed in English, German, Danish, Norwegian, French, Spanish, Russian and Japanese. Despite great effort on my part it was not possible to get hold of 8 articles. Furthermore, 20 papers listed had to be excluded before reviewing because they were written in either Russian or Japanese.
Because of each papers anecdotal nature, non of the remaining 135 papers were rejected and were all reviewed. In the case where a paper was written in either French or Spanish the English abstract was used.
RESULTS The adverse effects can be categorised according to various criteria, for example chronological, anatomical location of the adverse effect, if acupuncture is performed by a medical trained or a non medical trained person, if the adverse effect has a fatal outcome, infectious, mechanical, etc.
In the following I will describe the individual papers according to their anatomical location where possible. Naturally, there will be side effects which logically could be grouped in more groups, e.g. neurologic symptoms caused by broken needles. In those cases the reported side effect is presented in one group only.. CARDIAC ADVERSE EFFECTS Paper (1) describe a fatal cardiac tamponade after acupuncture. A 40-year-old woman was treated for fibromyalgia by a professional acupuncturist. A needle was inserted in the sternum at the level of the 4th intercostal space. Shortly after the insertion of the needle the patient complained of chest pain and the patient was rushed to hospital.
Unfortunately, attempts at resuscitation was unsuccessful and she was pronounced dead. At the post-mortem 320 ml. blood was found in the pericardial cavity. Further examination showed a 2-3 mm perforating lesion in the anterior wall of the right ventricle. A frontal radiography of the chest revealed a sternum foramen at the level of the insertion. The distance from the skin to the posterior surface of the sternum was 13-19mm.
A case of self inserted needle in the heart is described in (2). A 40-year-old schizophrenic patient used to insert needles in different parts of the body when he was in pain. Four months prior to admission to hospital, the patient had suffered from chest pains of three days duration. Because of this pain the patient had inserted a needle in the chest in the sixth intercostal space. Unfortunately, one of the needles used by the patient broke, but the patient ignored it. By coincidence it was discovered during a visit for an other disease, that the patient had a pericardial rub and he was admitted to hospital. Examination revealed the needle traversing the anterior pericardium, right ventricular free wall and interventricular septum, with the free end lying in the left ventricular cavity. The needle was removed without any complications.
Another case of cardiac tamponade is reported in (3). A 52 years old man presented with cardiac tamponade a few years after an acupuncture needle was broken accidentally. The needle was not removed and during the intervening years it has migrated into the pulmonary artery and caused hemopericardium. The patient underwent an operation and was discharged two weeks later without any lasting damage.
Again a self-inflicted cardial tamponade is described in (4). A 82 years old woman was found dead in her bed. On examination a sewing needle projecting from the precordial area was found. An autopsy showed that the needle reaching the epicardial surface penetrating the anterior aspect of the heart with laceration of the distal branch of the anterior descending coronary artery. The pericardial cavity was filled with 250 cc blood. Further examination revealed old scars from previously self inflicted acupuncture treatments.
Endocarditis is described in a number of papers. The first paper (5) concerns a 57 old woman with an artificial mitral valve presents a 10 day history of classic signs of a flare up of a prior diagnosed rheumatic fever. The patients history revealed that 18 days previously she had received acupuncture in both ears in an attempt to stop smoking. The needle had remained in situ for one week. After replacement of the needles she complained about irritation and discharge around the needle. The diagnosis endocarditis was established by the growth of Pseudomonas aeruginosa from blood culture. Penicillin was given and the patient made a complete recovery. This patient was aware of her need for prophylactic antibiotic, e.g. before dental treatment but had not considered acupuncture to be a procedure needing antibiotic cover.
Another report of endocarditis is presented in (6). A 56-year-old woman has prothetic heart valve installed because of rheumatic valve disease. Two weeks prior to hospital admission, she had been treated with acupuncture because a head injury. The patient was treated with semi-permanent acupuncture needles in the ear and was advised to manipulate the needles several times daily. The needle were left in situ for two weeks. Endocarditis was established after blood culture and adequate antibiotic treatment was initiated and a full recovery was achieved.
Endocarditis is again described in (7). A 56-year-old woman with rheumatic valve disease received acupuncture in an attempt to stop smoking. The therapist was told that she normally received prophylactic antibiotic prior to dental treatment. The patient was treated with ear acupuncture using semi-permanent needles. Within 5 days the ear became infected and on advice from the acupuncturist the needles were removed. Her general practitioner prescribed Ampicillin but the swelling of the ear persisted and the patient was referred to an Ear Nose and Throat specialist. Despite a second course of antibiotic surgical debridement was required. Three days later the patient showed clinical signs of bacterial endocardit and Staphylococcus aureus was found in blood culture. An intravenous antibiotic treatment was initiated and a complete recovery was obtained.
Paper (8) present the last report on this subject. The paper describe four cases of bacterial endocarditis following different skin procedures. Three of the patients died among them one who had received acupuncture. A 61-years-old woman suffering from a steroid dependent rheumatoid arthritis, non-insulin dependent diabetes and hypothyroidism underwent a course of acupuncture. Two days later she was admitted to hospital and the diagnosis endocarditis was made, verified by blood culture. Despite of optimal antibiotic treatment the patient died on the 11th day.
Electro-acupuncture is another form of acupuncture stimulation and is normally considered to be a stronger form of acupuncture. The technique is often used when normal manual stimulation has failed to improve the condition. The interference of electroacupuncture on pacemakers are described in two papers. The first paper (9) shows that low frequency acupuncture has an influence on demand pacemakers. A 41-years-old woman was suffering from bradycardia and a pacemaker had been implanted. Moreover, the patient was suffering from hyperthyroidism and an operation was carried out. In an attempt to decrease the invasive procedure as much as possible low frequency electroacupuncture was used as anaesthesia. During the stimulation it was found that low frequency acupuncture interfered electromagnetically with the pacemaker. Moreover it was shown that the pacemaker was inhibited completely as the voltage of acupuncture reached a certain level. Use of electrical stimulation must therefore be considered an absolute contraindication for patients having a pacemaker.
The next paper (10) concerns a 71-years-old man who received acupuncture after complaining of pins and needles in the left leg. The patient has received this treatment for a couple of years with some benefit. In 1991 he had a pacemaker inplantet after a Stokes Adams attack. During the following nine months the patient received a number of electro-acupuncture treatments without any complication. During a treatment in the beginning of 1992, the patient suddenly became ill. His face became ashen, he was unable to move his lips and then went completely still whilst he recovered from this situation. A month later the patient again received a treatment with electroacupuncture at a frequency of 2 Hz. The patient fainted after 1 minutes and the treatment was immediately terminated.
PULMONARY ADVERSE EFFECTS Pneumothorax after acupuncture has been described in a number of papers. The first paper (11) describe a case where a 63-years-old woman received acupuncture for of back pain. During the first treatment the patient was treated with 2½ cm needles in the thorax in the region of Th 5-6. Initially the left side was treated. During the treatment the patient complained of pains in the thorax and difficulties in breathing. The condition improved over the 8-10 days where the patient was due for the next treatment. When the right side was treated the patient experienced as in the case of the previous treatment pains and dyspnea. Because of aggravation of the breathing the patient was admitted to hospital the following day. An X-ray revealed bilateral pneumothorax with a 4 cm air space on the left side and a complete collapse of the right lung. Correct medical intervention was initiated and the patient had a full recovery. The author discusses the need for reporting of such cases to the authority and expresses great concern regarding treatment given outside the normal medical environment.
The following paper (12) about pneumothorax concerns a 31-years old woman who underwent acupuncture treatment for asthma during pregnancy. Needles were inserted into the back. At the time of insertion she experienced severe pleuritic pains. Rapidly after the treatment dyspnea and tachypnea developed and she was admitted to a nearby emergency department. At that time the patient was in severe respiratory distress. A chest X-ray showed bilateral pneumothoraces. After proper treatment she rapidly improved.
The next paper too, report a case of pneumothorax 1980 (13). Because of back pain a 29-year-old woman had received mid back acupuncture. 10 minutes after completion of the treatment she experienced dyspnea and severe chest pain radiating to the anterior chest wall. An X-ray of the chest demonstrated a 30 to 40% pneumothorax. Bilateral chest tubes were inserted and the patient had a fully recovery.
Two more cases are presented in (14). A 73-year-old patient suffering from chronic bronchial asthma sought acupuncture because the conventional treatment became less effective. During one of the acupuncture sessions he felt a sharp pain in the chest and became increasingly dyspneic and was admitted to hospital. He was discharged two days later after proper treatment. The other case concerns a 68-year-old man with similar case story and symptoms. He too was discharged from hospital a few days after being treated with a chest tube. The author stresses that the danger increases when the treated subject is old or when the patient suffers from chronic obstructive pulmonary disease with hyperinflated lungs and high incidence of bullous emphysema.
Two more cases are reported in (15). In one patient a number of needle fragments were found on an X-ray of the chest. The case of a 66-year-old male treated for herpes zooster resulting in pneumothorax is presented in (16). Because of the herpes the patient received acupuncture in the chest. Unfortunately, the acupuncturist used 5 cm long needles and as a result the patient developed a pneumothorax. Again bilateral pneumothorax is described (17) after acupuncture for neck and back pain. Interesting aspect of this case was the delay in development of the shortness of breath which first developed on the journey back home.
Paper (18) describes a case concerning a 15-year-old girl who because of asthma received a treatment where needles were implanted in the chest. As a result of this implantation the patient developed a pheumothorax and subsequent a state of status asthmaticus. The authors question the implantation technique in particular and the use of acupuncture in asthmatics.
A case of delayed pneumothorax is described in (19), The author warns against use of needles more than 0.5 to 1.0 cm of length in the neck shoulder region, particularly when treating slim patients.
More cases are reported in (20, 21). Paper (22) presents a case where a patient has received six acupuncture treatments among which at least three of the treatments have caused a mild pneumothorax. It would appear that the acupuncturist who was not medically trained had ignored symptoms like chest pain and dyspnea. Moreover the acupuncturist had used 2½ inch needles in the chest. The author stresses the urgent need for the medical profession to point out to the public the dangers of untrained people inserting needles.
The following reports too, describe cases of pneumothorax ( 23-37). Paper (38) describe pneumothorax in a 73-year-old man suffering from emphysema. The needles were inserted in the anterior chest wall under the clavicle, probably in the second intercostal space. Following removal of the needle the patient began to complain about shortness of breath. Despite correct medical treatment the patient died after six days.
INFECTION A substantial number of papers have been published regarding infections, particularly the more serious infections like hepatitis and AIDS.
A number of cases of hepatitis B associated with acupuncture is reported in (39). The origin of the outbreak is believed to have been from a known HBsAg carrier. During a surgical procedure an operating room nurse had been cut by a scalpel. She later underwent a course of acupuncture and the disease was then transmitted via acupuncture needles used on the infected nurse to other patients at the same clinic. A subsequent inquiry concluded that there has been neglect in sterilising of the needles.
Another great outbreak of hepatitis is reported in (40). 35 patients developed hepatitis after treatment from a non medical trained acupuncturist. The acupuncturist held the needles before treatment in his ungloved hands and rubbed the needles with his fingers to test them for sharpness both before and immediately after treatment. Without washing his hands, he repeated this procedure for the subsequent patient. Several patients reported that he replaced used needles on the same tray from which they were taken before treatment.The authors stressed the need for correct aseptic technique and sterilisation of reusable needles. The simplest and most effective method is physical cleaning followed at 121 C for at least 15 minutes in an autoclave. Alternatively 171 C for one hour in a dry oven.
A fatal case of non-A, non-B hepatitis is described in paper (41). A 49-year-old woman developed hepatitis seven weeks after acupuncture treatment. During the cause the patient developed intra-abdominal haemorrhage and died. The high prevalence of hepatitis in China due to acupuncture (42) is discussed in (43-45). Six cases of hepatitis due to acupuncture has been reported (46). It was normal routine in the clinic to store needles overnight in a 1:759 solution of bezalkonium chloride. The author argues that benzalkonium chloride is unable to create the correct sterilisation of needles and should not have been used. He recommends either autoclaving of needles or the use of disposable needles.
A study involving 651 patients with acute viral hepatitis is presented in (47). Among the 651 reported cases in this paper, four cases were due to acupuncture performed by non medical trained acupuncturists.
A major outbreak of hepatitis is presented in (48). 36 patients who during a year attended the same acupuncture clinic all showed serologic evidence of hepatitis. The acupuncturist was not medical trained and a subsequent inspection by the senior health officer found the clinic in his words: "far from satisfactory". The author stresses the dangers and hazards to patients who in desperation turns to unqualified people for medical treatment. The paper is outlined in (49). Single cases of hepatitis are reported in (50-53). Seven cases of hepatitis are described in (54).
Four cases are presented in (55). The author stresses that patients should challenge the qualifications of the acupuncturist and discuss the methods of ensuring of proper sterilising techniques. The last paper (56) presents five cases of hepatitis among them two fatalities. AIDS is the infection giving most concern among patients. Surprisingly to date only one case has been reported (57). It concerns a 17-year-old boy who developed fever and other symptoms related to the disease after the end of acupuncture treatment. All efforts were made to eliminate any other source for the positive HIV-antibody test but without success. The author stresses the importance of proper sterilised needles.
Staphylococcus can also cause severe side effects as described in (58). A 66-year-old man was admitted to hospital because of malaise and fever. Two days before the onset of symptoms he had undergone acupuncture treatment around the knees for osteoarthritis. During the next two days he developed several septic foci in the skin together with widespread purpura. A full recovery was achieved after antibiotic treatment.
A case of osteomyelitis after acupuncture is presented in (59). One year prior to the onset of pains the patient dropped a can on her left foot and had subsequent pain and a lump ever since. She was initially treated conservatively. Because the pains persisted she received a course of acupuncture without any effect. Later the patient underwent an explorative operation and a bone biopsy showed a chronic osteomyelitis.
Two cases of fatal staphylococcal septicaemia are described in (60). Two women both in poor resistance to infection received acupuncture because of rheumatoid arthritis. Few days after the acupuncture treatment both patients developed fever and swelling of the knee joints. Despite optimal treatment both patients died. The author argue that the poor resistance to infection was due to the patients underlying disease. However, the immediate source of infection would be consistent with acupuncture. The author stresses mandatory the need for treatment by a medical physician.
Four cases of perichondritis are reported in (61-62). Patients had received acupuncture to stop smoking. In one case a semipermanent needle was embedded in the cavum conchae. The author argues that the danger in auricular acupuncture arises from penetration of the perichondrium by acupuncture needles, with inoculation of organisms into the subperichondral plane. This is further compounded by the chronic presence of a foreign body, which impairs the host's ability to eradicate infection. In addition, the repeated manipulation of indwelling needles causes further traumatic irritation and subperichondrial inoculation. The author stresses the danger of ear-acupuncture especially in the case of diabetes, the immunosuppressed and patients with chronic debilitating illness. More cases of perichondritis are described in (63-69).
NEUROLOGIC ADVERSE EFFECTS A number of neurological conditions due to acupuncture has been described. The first case (70) deals with a 20-year-old male who among other treatments has received acupuncture because of low back pain. On one occasion while the acupuncture needle was in situ he experienced a severe sciatica pain on the right side. Two months after the treatment the patient developed weakness of the right foot and difficulty in walking. During these two months period the sciatica pain increased. The patient was admitted to hospital and the initially diagnosis was a prolapsed disc between the fourth and fifth lumbar vertebrae. The diagnosis was confirmed by a lumbar radiculogram which showed a large prolaps affecting the nerve roots. The disc space between fourth and fifth lumbar vertebrae was explored and abnormal tissue was found. On suspicion on a neoplastisk disease a frozen section was examined which showed no evidence of malignancy or tuberculosis. A subsequent culture grew staphylococcus aureus. The patient was treated with antibiotic and the postoperative course was uneventful. The authors conclude that the infection was due to acupuncture and the change in the radiculogram could be due to oedema of the epidural tissue.
The following case (71) concerns a 42-year-old woman who received acupuncture because of migraine. The patient was treated with electroacupuncture on the point LI-4 located in the web between 1st and 2nd finger. The patient was treated with a 6 Hz for 20 minutes. The following day the patient reported that her right arm felt abnormal and she had a lot of pain in the forearm and paresthesia in her right tumb. During an examination a month later the pains were still present. She was treated with anti-inflammatory after which the symptoms disappeared. The author argue that the acupuncture treatment had irritated the superficial branch of the radial nerve.
Paper (72) deals with a 65-year-old woman who was admitted to a neurosurgeon with a 10 day history of headache, nausea, vomiting and painful stiff neck. The history disclosed that the patient had been treated for nervousness for several years with acupuncture. At her last session, needles had been inserted into the back. Symptoms appeared within hours of the visit. A MR-scan of the spine revealed a midthoracic epidural hematoma. All symptoms resolved within a week without specific treatment. The authors argue: "Attention is focused on the danger of worsing the imbalance of Yang and Yin, but physical harm from the techniques, aside from warning of occasional syncope during treatment, is not stressed"
A case of transverse myelopathy is described in (73). A 54-year-old man had on two occasions received acupuncture in the region extending from the posterior neck to the back. Two weeks after the second treatment he developed fever, dysarthria and urinary dysfunction, finally reaching the condition of tetraplegia. He was admitted to hospital and diagnosed as having heart failure, renal failure, liver failure and myelitis. After a month he recovered with transverse myelopathy. The author explains the case as follow: "After acupuncture, he suffered local infection of the region. Then the infection expanded to the cervical vertebrae, thus causing osteomyelitis, sepsis and finally cervical myelitis". Another case of myelopathy is reported in (74). A 43-year-old man had received a number of acupuncture treatments because of low back pain. Half an hour after the twelfth treatment, he became unconscious and paraplegic. A thoracal MRI-scan revealed a 15 cm long heterogen lesion in the middle of the thoracal region. The patient was treated with methylprednisolone after which the patient improved dramatically.
A broken needle was the cause of a gradually progressing impairment of pain and temperature sensation on the right half in a 62-year-old woman (75). The patient had five years prior to the onset of symptoms received acupuncture. A plain film revealed a 2½ cm needle between the first and second cervical vertebrae laminae. A computed axial tomography clearly demonstrated a needle embedded in the spinal cord. The needle was removed surgical and a moderate recovery was obtained. The authors suggest that the needle over a two year period had migrated deeper and eventually penetrated the spine.
BROKEN NEEDLES AND NEEDLE FRAGMENTS Subarachnoid haemorrhage and spinal root injury after acupuncture treatment is described in (76). A special technique was used where a small gold needle was inserted into the subcutaneous tissue and then cut level with the skin surface. The patient a 33-year-old woman was admitted to hospital because of headache. About 30 years previously she had been suffering from cervical sprain for which she had received acupuncture in her neck. Plain X-ray films of the cervical spine revealed a fine needle, about 1,5 cm in length, between C1 and C2 vertebral laminae. A thomograpic scan showed the needle within the spinal canal. The patient underwent a C1 laminectomy and the needle was found penetrating the dural vein and piercing the right C2 nerve root. The needle was removed without any difficulty. Deliberately breakage of needles and burial of tens or even hundreds of needles in various parts of the body to achieve prolonged effect have been used by some acupuncturists mainly in Japan without complications. Acupuncture needles may be accidentally broken because of a sudden muscular contraction. Needles of inferior quality or repeatedly used are therefore more easily broken. Electrical current used in acupuncture treatment may also hasten the failure of needles. The needles in the subcutaneous tissue probably migrate with movement over a time period causing the symptoms. The authors stressed that the removal of migrating needles must be performed as soon as possible after the occurrence of symptoms. Moreover the author argues that surgical removal of migrated needles may not be indicated in asymptomatic patients.
Four cases of spinal cord and root injury due to acupuncture is reported in (77). In all cases X-ray showed several needle fragments some of them in the spinal canal. In some cases symptoms occurred immediately after insertion of the needles, in others there was a delay of several months. More cases are presented in (78-88).
Paper (89) reports 3 cases where hundreds of needles were implanted in different parts of the body. CT images showed that multiple needles has transvered the subcutaneous tissue and penetrated the peritoneum. The ends of several needles appeared to impinge upon the anterior aspect of the stomach, left lobe of the liver and transverse colon. Two needles had migrated and were identified along the posterior gastric wall, as well as imbedded within the urinary bladder wall. More cases of migration of needles are reported in (90).
A renal complication is presented in (91). A 50-year-old male underwent an investigation because of hypertension. An intravenous urography showed a calculus in the left renal pelvis encasing a metallic foreign body. A left nephrectomy was done and a calculus was found to have grown around a piece of wire 20 mm in length. A subsequent qualitative analysis of the calculus was done and showed components of iron, silicone, manganese, copper, chromium calcium, cobalt, aluminium, nickel and magnesium.
Needle fragments have been found in many parts on the body, e.g. the bladder (92) and ureter (93). In this case a needle was found in the ureter in a patient admitted to hospital because of haematuria. A pyelogram revealed an acupuncture needle partly inside ureter, partly outside ureter. Moreover a stone was found around the tip of the needle. The patient was recommended an operation but she refused. The patient was monitored for the following 1½ year during which haematuria was noted several times. A 3,5 cm needle in length accompanying a stone was spontaneous passed without remarkable trauma. The author presents a review of eight other cases since 1936 published in Japanese . The process of the spontaneous passage of the foreign body is explained as follows. "The tip of the needle punctured through skin was brought into the ureter by natural tendency to expel foreign bodies to the outside. Then, a stone was formed to cover the tip of the needle. As the stone was brought downward with peristalsis, the other end of the needle was taking into the ureteral lumen and the needle was passed downward with the stone by peristaltic movement of the ureter". The author advocates surgical removal of the needles because complications may occur if a needle is left in the ureter. A similar case is presented in (94). The needle and stone was removed surgically without any problems. Ten years after acupuncture, a 77-year-oldwoman experienced hypoaesthesia and paraesthesia in the three middle fingers is presented in (95). An X-ray revealed a linear foreign body in the palmar sift tissue over the base of the third metacarpal. After a subsequent operation to remove the needle the patients symptoms were virtually gone.
SKIN REACTION A case of localised argyria with chrysiasis caused by implanted acupuncture needles is described in (96). A 41-year-old woman had during a two year period had 300 gold-coloured needles implanted in the skin. One year later she noticed blue-black macules on the neck and other parts of the body. X-ray examination revealed numerous needle-like shadows in the skin and a large amount of silver granules were found. A electron microscopy and X-ray microanalysis showed silver deposits extracellularly as selenide and sulphide, whereas free gold is found intracellularly.
A number of allergic dermatitis after acupuncture is described in (97-103) The reason for the allergic dermatitis were due to nickel, chromium or silver.
A case of prurigo pigmentosa is reported in (104). A 53-year-old male developed prurigo pigmentosa on his back, after undergoing acupuncture for 3 years. The eruptions were ceased on discontinuing the therapy but recurred with its resumption. A subsequent analysis of the needles revealed chromium content of 18%.
Another case of blue macles after implantation of silver needles is reported in (105). Presence of silica granuloma twenty years after implantation of gold needles is reported in (106). A case of petechiae after acupuncture is presented in (107).
Koebner phenomenon after acupuncture is presented in (108). The patient had three months prior to the onset of the condition received acupuncture with a "seven star silver needle". The location of the disease were exactly on the site of the acupuncture treatment. Finally, a case of lymphadenomatosis cutis benigna is reported in (109).
Activation of a herpes infection after acupuncture is reported in (110). A 67-year-old woman received acupuncture because of knee pain. The patient had suffered from recurrent herpes infection during the last ten years, average three attacks a year. In 11 out of 20 acupuncture treatments she developed a herpetic skin lesion in the S-1 area average 12 hours after the acupuncture treatment. The author argues that it is well known that flare up of herpes is common after e.g. a sexual intercourse and the acupuncture treatment might have activated the infection. The author argues that it has been shown in animal test that acupuncture increase the level of 5-hydroxytryptophan (5HTP) in the nervous tissue. 5-HTP does not in itself possess pharmacological activity, but is converted in the body to 5-hydroxytryptamine (5-HT) which actively stimulates a variety of sensory nerves. Therefore it is possible that such stimulation is sufficient to cause herpetic activation.
VASCULAR SIDE EFFECTS Vascular side effects are normally harmless. The most common side effect, bruising has been described in (111-112).
A case of hypotension is presented in (113). A 23-year-old male received acupuncture because of a chronic sinusitis. During the second treatment the patient complaint of giddiness and treatment was terminated. On examination he had a blood pressure 70 mm Hg and he was observed for 10 minutes and since his condition did not improve he was transferred to a ward and given 500 ml 5% dextrose intravenously twice, before his blood pressure stabilised at 100/70 mm Hg. The patient was discharged from hospital the following day. The patient continued the treatment without having acupuncture in the point GB-20 without any discomfort.
Fainting is another occasional side effect after acupuncture and is reported in (114). In this case the patient a 24-year-old woman who was forced to the treatment by the family. A similar example is reported in (115). During the treatment the patient developed a grand mal seizure during which he lost bladder control. The author stresses that the phenomenon must be a pure needle phenomenon. Moreover the author recommend that patients particularly during the first treatment should be in a supine position.
Paper (116) describes a case of recurrent fainting after acupuncture of the point GV-20. During the first treatment the patient felt nausea, vertigo, followed by vomiting and sweating. On the following two treatments the patient again felt faint. At the fourth treatment, he was closely observed for the reaction to needling of every acupuncture point and it was detected that the phenomenon was related to GV-20. The authors argues that the reaction probably is a vasovagal reflex and stress one should be cautious when treating elderly people with acupuncture, who may have compromised coronary and cerebral circulation.
Deep vein thrombophlebitis is a rare complication to acupuncture and is reported in (117). The patient, a healthy 64-year-old woman, presented with right upper calf pain 48 hours after acupuncture. A venogram showed thrombophlibitis of the deep perforating muscular vein. The author stresses that the anatomic and temporal relations strongly support a connection between needle insertion and phlebitis. Bleeding resulting from the needle penetration may have compressed the vein with resultant stasis and thrombosis, or intimal injury to the vein from direct needle penetration may have been sufficient to produce local thrombosis.
Another rare complication of causing a pseudoaneurysm by acupuncture is reported in (118). A burst of a Baker cyst after acupuncture is reported in (119). Interesting is paper (120) where increased bone metabolism was demonstrated by increased activity on bone scans after acupuncture.
Two cases of aggravation of a disease after acupuncture is reported in (121). Both cases concerns patients suffering from atopic disease involving asthma, hayfever and atopic dermatitis. The first case is a 22-year-old woman who received acupuncture because of her atopic dermatitis. The skin complaint responded well to the treatment but unfortunately she experienced a flare up in her asthma one hour after each treatment. At the fourth treatment the condition became so bad, that it was necessary to administer intravenous injection of theophyllamin and prednisolon. The treatment was terminated after this severe flare up in the asthma. The other case concerns a 46-year-old male with the same symptom but in this case the asthma was the target for the treatment. The asthma responded satisfactory to the treatment but unfortunately a flare up was noticed in the patients atopic dermatitis.
A study (122) dealing with aggravation of symptoms after acupuncture found an increase in pains in 10% and a prolonged aggravation of pains in 1% of the cases. MISCELLANEOUS A number of side effects is presented in paper (123) among which two cases of 3rd burns after moxibustion a technique where dried leaves of Artemisia vulgaris are ignited and burned down. The leaves can be placed on the top of the acupuncture needle or placed on the skin which might be protected by a slice of ginger.
A patient received acupuncture because of scar tissue in the chest and axilla after a mastectomy and subsequent radiation. Despite the patient having informed the acupuncturist that no treatment was to be given in the region, needles were inserted in the area. The patient received a total of eight treatment after which she felt much worse. When the patient again sought conventional medical treatment a moderate lymphodema was found. Moreover, typical signs of posttraumatic sympathetic dystrophy was found. The authors stress that patients with lymphoedema secondary to radical node dissection and irradiation are highly susceptible to low-grade infection in the affected extremity. In this case it is likely that the use of acupuncture needles in the patients lymphedematous arm contributed to development of a sympathetic dystrophy complicating the lymphedema already present. The same author presents a case of pneumothorax and hemothorax. The authors stress the need for legal requirements for the use of acupuncture and suggest that acupuncture should only be administered by physicians with special training in acupuncture. All treatments administered by non doctors should be under a direct supervision of a qualified physician. The authors moreover stress the need for using standard Western diagnostic procedures and proper medical treatment should be instituted before acupuncture.
A case of compartment syndrome in a patient on warfarin treatment because of prosthetic valves is reported after acupuncture in (124). Almost immediately after placement of the needles the patient noted a local right lower leg pain which progressively became more severe. A surgical decompression fasciotomy was carried out and left the patient without sequelae. The authors argue that the risk must be weighted against the potential benefit of the treatment.
DISCUSSION This paper present and discusses reported side effects after acupuncture from 1965 to 1997. A total of 135 papers were listed reporting minor and major side effects. In general it was found that the presented papers were relevant and the reported side effects were due to the acupuncture treatment. Grouping the papers gave raise to a slight problem. Several papers could easily have been grouped in two groups. E.g. needle fragments causing neurologic side effects could be grouped either under neurologic side effects or in the group of needle fragments. I have chosen to include the side effect in the group I felt was most relevant.
135 papers were listed from 1965 to 1997 but I believe it is important to emphasise that it is only the tip of the iceberg. The number of acupuncture treatments carried out in China and Japan is astronomic and a number of side effects are without any doubt published in Chinese and Japanese, languages which are not included in this review.
Furthermore, it must be expected that a substantial number of side effects have never been reported or published.
Cardiac side effects (1-10). The reported side effects seem to be a logical consequence of the acupuncture treatment. One might argue that the number of endocarditis quoted compared to the number of acupuncture treatments given world wide is surprisingly low. Only two papers discuss the adverse effects after electroacupuncture. A possible explanation could be that the incidence has been regarded as a vaso-vagal effect and not due to the electrical stimulation.
Paper (1-4) reports of cases where needles have been inserted in the heart with a fatal outcome in two cases. In two of the cases (2, 4) the needle was inserted by the patients themselves. It is well known that patients either for treatment reasons or in selfmutilating procedures insert sharp instruments in different part of the body. The two other cases (1, 3) are more serious because the treatment was performed by a registered but non medical trained acupuncturist. In the first case (1) the acupuncturist must have used at least 3 cm needle because a post mortem showed that the distance from the skin to the posterior surface of the sternum was 13-19 mm. According to acupuncture textbooks it is normally recommended to insert the needle oblique downwards 2-3 cm (125) or horizontal along the skin 0.3-0.5 inch (126). In this case a post mortem X-ray revealed a sternal foramen. Few doctors and possibly even fewer acupuncturists are aware of the sternal foramens, which is fond in 9.6% of men and 4.3% in women (127, 128). The acupuncturist had apparently inserted the needle perpendicular through the connected tissue of the foramen and continued until he reached the heart.
This story (1) clearly demonstrate several aspects. Firstly the needle had apparently not been inserted according to normal practice. Secondly too long a needle in the region had been used. If a short 15 mm needle had been used it is very unlikely that this accident would have happened. Thirdly, the acupuncturist demonstrated a complete lack of anatomical knowledge. Medical doctor knows that the distance from the skin to the sternal bone is very short, probably less than 1 cm. The acupuncturist should have been suspicious after not having reached the bone after inserting the needle to the region of 1 cm. The other story (3) is most interesting because the patient was an non medically trained acupuncturist himself. Quite a time before the accident the patient had treated himself. During a treatment one of the needles broke but he had ignored it. Two conclusions can be drawn from this incidence. Firstly that broken needles need to be removed immediately. Secondly needles can migrate and penetrate vital organs and causing serious, even fatal outcomes.
Endocarditis is described in four papers (5-8) among which one is fatal. In common for all the patients is a history of known rheumatic heart disease and artificial heart valve in three of the patients (5-7). In all three patients semipermanent acupuncture needles were used and left in situ for up to two weeks. Moreover in one case (6) the patient was informed to manipulate the needle several times daily. In the last case (8) the procedures to be used were not described in any detail. In two of the cases (5, 7) the patient was aware of the need for antibiotic treatment prior to dental treatment. It is particular worrying that the patient (7) had informed the acupuncturist prior to treatment but apparently the acupuncturist chose to ignore this. In all papers the authors advocate for prophylactic antibiotic prior to acupuncture. In my opinion this is unnecessary and supported by Burdon (129) who recommend that the skin site should be disinfected by vigorous application of 0.5% chlorhexidine in 70% ethyl alcohol for three minutes before inserting of the needles. I agree that disinfection on the acupuncture site is required, particularly prior to ear acupuncture, but vigorous application for three minutes would probably harm the skin. Personally I disinfect the skin with methylated spirit and had never caused an infections. Cheng (130) too warns against the use of antibiotic prior to treatment. He stresses that acupuncture often consists of a series of treatment which would indicate an antibiotic prophylactic during the whole treatment. Moreover he argue that the risk of an antibiotic hypersensitivity through a widespread application of antibiotic prophylactics in this popular form of treatment must be balanced against the remote possibility of ineffective endocarditis occurring among the million of patients receiving acupuncture throughout the world.
The authors of paper (5, 6) warns against the use of semipermanent needles in patients with a history of rheumatic fever or artificial heart valves. Personally, I find the use of semi-permanent needle an absolute contraindication in all risk patients. Furthermore, the often recommended manipulation of the needles several times daily should never be recommended to any patients. By inserting a semipermanent needle a small open wound has been created. It does not require a lot of imagination to understand that a patient can cause an infection by stimulating the needles.
Moreover the acupuncturists have not obeyed the normal rules for leaving semi-permanent needles in situ. It is normally recommended (131) that those needles may stay in for two days during Summer and up to a week during Winter. Finally the author of paper (6) stresses that it is illegal for non medical qualified people to perform acupuncture. The reported side effects are of a very serious nature and shows that the acupuncturists knowledge in pathology and internal medicine is insufficient - a problem I will discuss later.
Two papers (9-10) discuss the effects of electrical stimulation on the heart in patients with a pacemaker. Particularly paper (9) is interesting because the patient had received several electroacupuncture treatments before feeling ill. Both cases clearly shows that all sorts of electrical stimulation is an absolute contraindication in patients fitted with a pacemaker.
Pneumothorax (11-38) is the next big group of serious side effects including 27 papers. All diagnosis have been confirmed by X-ray and are direct consequences of acupuncture treatments. Two features are characteristic for all the reported cases. Firstly a complete lack of anatomical knowledge. The distance from the skin to the pleura is in the region of 1½ to 2 cm and the use of up to 5 cm needles are reported (11,12,14,16,20,21,22,24). The number of reported cases of pneumothorax gives great concern. It is particularly worrying that the majority of the cases were after acupuncture by a non medical trained acupuncturist. Secondly lack of basic pathophysiologic knowledge seems to be another feature (11,12,22,25). Symptoms like cough, pains in the chest, shortness of breath are typical signs of a pneumothorax which always should lead to an acute referral to hospital for X-ray and if necessary surgical procedures. Paper (11) shows concern regarding treatment by non medical qualified people and paper (33) stresses that acupuncture is a medical procedure and only qualified doctors should be allowed to perform acupuncture.
Paper (17) describe a delayed onset of the symptoms. In cases where one suspect a too deep needling the patient should be refereed to hospital for an X-ray. In two cases (15,18) the pneumothorax were caused after implantation of needles in the chest and upper back. It is known that needle fragments can migrate and the technique should never be used.
Paper (18) questions the use of acupuncture in asthma and particularly the use of acupuncture in acute attacks. In my opinion, there are no place for acupuncture in the acute phase of an asthma attack. The condition is far to serious and excellent orthodox medication are available and should be used. Regarding the use of acupuncture as prophylactic treatment the opinions are contradictory (132-135). Personally, I find acupuncture valuable in mild to moderate asthma.
The length of the needles is discussed in (19,20,21,22). The author of paper (19) suggest that the maximal needle length should be between ½ to 1 cm when doing acupuncture in the chest and the upper part of the back, a statement I fully support. The author of paper (22) urges the medical profession to clarify to the public the potential dangers which could arise from acupuncture. Finally three papers (14,25,32) warns against too long needles in patients suffering from emphysema and slim patients.
Infection is another serious side effect presented in (34-69). I seems obvious that the correct procedures in handling needles should be known among all acupuncturists and then infections should never occur. Unfortunately, the number of reported side effects clearly demonstrate that this is not always the case. A total lack of basic knowledge about aseptic procedures are described in (40,48,51,55,59,64,67). Particularly embarrassing is (51) where a medical doctor reused the same needles from one patient to the other. The qualifications of acupuncturists are discussed in (55,60,66) and the author of (60) emphasizes the need for only doctors being allowed to perform acupuncture.
Contraindication for the use of acupuncture is discussed in (60,61,63,64,65). The general opinion among the authors is that extreme care should be taken when treating patients suffering from diabetes, undergoing immunosupressive treatment and in patients suffering from chronic debilitating illnesses. Particularly, the risk when using semi-permanent needles in ear acupuncture is stressed in (64,65,68). The procedures for proper sterilisation of needles are discussed in (39,40,43,44,46,55). The author of (46) argue that immersion of needles in benzolkonium chloride solution for 20 to 27 hours is not sufficient to kill hepatites B virus. In one case (136) it was shown that plasma containing hepatitis B virus dried and stored at room temperature for one week remained infectious for chimpanzees. The author of paper (55) argues, because of the increasing number of reported cases of hepatitis due to acupuncture, that patients should be questioned as to possible previous acupuncture treatment.
Until now only one case of acupuncture has been described (57) and it is very unlikely that AIDS can be transmitted via acupuncture. AIDS virus is weakly resistant to environmental factors such as temperature and alcohol. It is known that AIDS virus is killed by 56 C for 30 minutes. The author of paper (137) category denies the possibility of transmission of AIDS by acupuncture. In this case it is important to emphasise that the author expects proper aseptic procedures like autoclaving of needles for 30 minutes at 125 C. Unfortunately, the above mentioned routine sterilising procedures is not always followed as shown in the previous papers. One might argue that the number of AIDS patients who receive acupuncture is marginal, but a survey (138) of 2059 suffering from AIDS showed that 3% gave a history of acupuncture.
Neurological side effects are presented in (64-75). Three features are characteristic for the reported side effects: Infection (70,73) which is due to lack of aseptic technique and should never have occurred. In one case (74) the cause was penetration of the spine which clearly indicate lack of basic anatomical knowledge and stresses the need for a more strict regulation to ensure that the acupuncturist has sufficient anatomical knowledge. Finally a case is reported after a broken needle (75). Needles or needle tips have a tendency to migrate and as it will be discussed later onset of symptoms often are delayed several years.
Broken needles and side effects after needle fragments are presented in (76-95). In common for the reported side effects is a technique previously used in particularly Japan where needles were inserted subcutaneously and cut in the level of the skin. The reason for this technique was to reinforce the effect of the treatment. Examples are given where several needle fragments have been shown on X-ray. To the best of my knowledge it has never been shown that this technique should be superior to normal standard technique and should be avoided. Furthermore, it is obvious that needles can migrate due to the normal muscle contraction and during a number of years penetrate vital organs. The author of paper (76) argues that it is not necessary to remove broken needles, a point on which I disagree. If one suspects a needle to be broken the correct procedure must be to establish the position of the needle by X-ray and subsequent removal. The same author warns against re-usable needles particularly when using electrical stimulation which can weaken the needles. Needles break very occasionally, and in the majority between the needle and the handle. On this point I would like to stress that it is bad practice to insert the needle up to the handle. When inserting the needle one should always leave a few mm over the skin surface. If an accident should occur and the needle breaks it will always be possible to remove the needle with a forceps. Skin reactions after acupuncture are reported in a number of papers (96-110). In general the reported side effects are of minor importance and the number of cases are probably much higher. A number of papers (97-98) present cases of eczema apparently due to nickel or chromium in the needles. Only in one case ear acupuncture was used with indwelling needles. In the other cases the patient just underwent a standard treatment of 20 to 30 minutes duration. In the case where indwelling needles were used it is understandable that eczema could occur. More difficult to understand is a short treatment e.g. twenty minutes should be sufficient to provoke an attack of eczema.
Concerning ear acupuncture it is obvious that the patient should be questioned about previous allergies to nickel or other metals. Regarding eczema or allergies arising after a normal standard treatment I will consider the problem as marginal. This opinion is supported by (139). The author stresses that stainless steel may produce free nickel in certain situations. It is possible that acupuncture needles can produce nickel dermatitis in a sentizied patient if acupuncture is applied for too long a period. At the same time the author stresses that it is normally unlikely because the needles normally are removed within half an hour at the most.
In one case (96) a number of gold needles were implanted. First implantation of needles should never occur, but in this case I find it even more questionable. Gold is a normal treatment for rheumatoid arthritis and needs carefully control of the patients white blood count. By implanting gold needles one would expect a slow release of the gold, which might be beneficial particularly for some sorts of arthritis (140-141), but as far as I know we do not have any knowledge regarding the influence on e.g. the white blood count.
Vascular side effects (111-121) are relatively common and only rarely reported. Bruisings happens quite often but is not considered a real problem. Of course it is important to observe the patient and if bruising occurs then we must squeeze the point for a minute and the damage will be minimised. More important is bruising among patients under warfarin treatment. In this case it is vital to check every point and if bleeding occur very carefully to squeeze the point for a few minutes. The reaction from the patient described in (111) must be considered as hysterical.
Vaso-vagal reactions can be seen after acupuncture but very rarely. The best way to avoid this side effect is to place the patient in a supine position. A paper describes the frequency of fainting during acupuncture treatment (142).
Among a total sample of 28,285 faintings were reported 55 times. The author conclude that the risk of fainting was higher at the first treatment (0.94%) compared to the second treatment (0.11%). In all the reported cases patients were in an upright position. The case of hypotension described in (113) is very rare and I have never seen this reaction in almost twenty years of practising acupuncture. Only once have I seen a case which had similarities to the case reported. A patient who had received acupuncture by me several times received acupuncture in the neck because of neckpains. Shortly after I have inserted the needles the patient felt faint became sweaty, felt sick and started to vomit. Immediately the needles were removed and the patient placed in a supine position. On examination the pulse was very slow, in the region of 40, and his blood pressure was 70/?. After a few minutes the patient gradually started to recover. As my primary concern was for the patient I had him admitted to hospital and a few hours later he was discharged. Paper (114-115) discusses minor side effects after patients were forced to undergo treatment by their family. It sounds unnecessary to mention this but of course one should always deny to treat a patient who doesn't want this form of treatment. I have been placed in this situation on a few occasions and I spend a few minutes talking to the patient, explaining that I am not prepared to treat them against their will. My practice is to explain the procedures to the patient and asked them to go home and consider if they want the treatment. In many cases the patient has made an appointment after reconsidering the situation.
In paper (115) the author describe the case as a Grand mal and argue that the effect is due to the needle sensation. Personally I don't believe that it is the case. I have occasionally seen patients fainting when they have had a blood test and occasionally they have showed contraction of the muscle which could be interpreted as a fit. I am not convinced that these contractions should be taken as evidence for a fit, if the patient doesn't have a history of epilepsy. Recurrent fainting after acupuncture (116) in a specific point is a rare complication and cannot be considered as a real problem.
One case of thrombophlebitis is described in (117) and occurs probably more often than it has been reported. It is a well known fact that phlebitis after intravenous infusion is a relatively common problem and one must expect that thrombophlebitis might occur after acupuncture. Previous thrombophlebitis in a leg can not be considered as an absolute contraindication but I will recommend the practitioner to be careful when giving acupuncture in that region.
The case of pseudoaneurysm after acupuncture is so rare that it must be considered as a coincidence only.
Paper (120) where an increase in the bone metabolism after acupuncture is interesting because the observed activity must have been in the skull for quite a while.
On courses it is often stressed that acupuncture might improve one disease and aggravate an other. Despite this statement, reports of aggravation of one disease after acupuncture has rarely been reported. Two cases are presented in (121) and paper (122) shows that 10% of patients demonstrate an anaggrevation of symptoms. The question is interesting because according to the Chinese theories one of the aim of the acupuncture is to create a balance in the body. This in contrast to the more modern approach to acupuncture where one will argue that acupuncture must work via the same mechanism as e.g. a drug. Also worthy of comment is a group of patients called Strong reactors (143,144) who respond extreme violent to treatment. According to Felix Mann (143) 5-10% of all patients belong to this group. Characteristic for this group of patients is that after a normal standard treatment they will feel worse for a while. Moreover, repeated treatment will aggravate their symptoms. This group of patients respond extremely well to acupuncture but need a minimal stimulation only. Insertion of a needle in a distant point without stimulation are often sufficient treatment.
Miscellaneous is discussed in (123-124). Particularly, paper (123) is interesting because the patient informed the practitioner that she should avoid direct needling in the lymphedeamtouse arm. Despite this information the acupuncturist completely ignored the patients information and thus demonstrated an insufficient training. It is well known that injection never must be give in a region with lymphoedema due to the risk of infection. But it is not only lymphedema due to cancer which might give problems. Patients suffering from edema of the crura might occasionally drip after acupuncture in the point SP-6 (situated on the inside of the leg about 5 cm proximal from the medial malleolus). This also is a risk for infection and it is recommended to avoid needling in this area in the case of crural edema. The example of compartment syndrome described in (124) must be considered as extremely rare.
The education of the acupuncturist is discussed in a number of papers (6,11,22,33,48,55,60,66,123,145,146,147, 151, 152) and many authors stress that it only should be legal for medical doctors to use acupuncture. Moreover they argue for strict legalisation for the use of acupuncture by qualified practitioners. A total number of 135 papers are presented in this article. Among the reported side effects 13 cases were done by medical doctors, 32 cases were done of non medical trained acupuncturists, 4 cases were self-inflicted by the patient and the remaining 71 cases do not give details of the qualifications of the acupuncturist. Among the 8 fatalities reported no cases were performed by medical doctors, 4 cases were performed of non medical trained acupuncturists. In one case it was self-inflicted by the patient and in the remaining 3 cases no information is given regarding the qualifications of the acupuncturist.
Despite the total number of reported side effects are relative small it clearly indicate that side effects are nearly three times more frequent if acupuncture is performed by a non medical trained acupuncturist compared to a medical trained acupuncturist. Furthermore, it is important to note that no fatalities were recorded among the medical trained acupuncturist, whereas three fatalities were reported among the non medical trained acupuncturists. The explanation to this phenomenon could be that doctors are trained to deal with adverse effects and it is more likely in the case of an adverse reaction that a medical doctor would be able to initiate the appropriate treatment at an earlier state than a non medical trained acupuncturist.
Quite a number of papers (1,3,5,6,7,11,12,14,16,19,20,21,22,24,25,32,39,40,48,51,55,60,64,67,70,72,73,74, 75,123, 145,146,147, 150,151,152) illustrate clearly that most acupuncturist did not have sufficient medical background to treat patients in a safe way. Many acupuncture schools spend the majority of its training time to introduce the student to the classical Chinese understanding of acupuncture and not sufficient time on physiology, neurophysiology, pathology, pathophysiology, pharmacology, etc. (66,123).
It is an odd situation that in many countries due to legalisation only vet's are allowed to treat animals, but yet in the case of acupuncture there are no legalisation as to who is allowed to treat humans. Actually, quite a paradox situation. To make the situation even worse many countries do not have any legalisation whatsoever on the requirements for those who want to practice acupuncture. In reality this means that anybody can decide that he/she wants to become an acupuncturist, put an advertisement in the local paper and start a clinic.
Another aspect which gives rise to concern is the lack of medical influence among teachers in acupuncture. Many acupuncture schools do not have any medical doctors as teachers. Anatomy, physiology, neurophysiology, etc. are subjects on which medical doctors spend years to learn, and understand. In some acupuncture schools these subjects are taught by people with only a very superficial knowledge of the subject and it is most surprising therefore that the number of side effects reported are so low. Acupuncture is a medical procedure (35,72,123,152) and ideally it should be performed by doctors with special training in acupuncture. If we must accept acupuncture performed by non medical trained acupuncturists, then the education must be tought qualified by consultant acupuncturists. Moreover, a proper qualification is required and doctors examine the students to ensure that the student has sufficient knowledge in medicine.
In traditional Chinese medicine the diagnosis of the patient is done by pulse diagnosis, looking at the tongue, etc. procedures which are not used today. Here too, I find it essential that the patient has been examined in a modern medical way (123,148,149) including sufficient tests, e.g. blood test, X-ray, etc. It is not ethical to treat patients based on ancient principles.
Patients are confused by the lack of standards to achieve a qualification in acupuncture. Many non medical trained acupuncturists call themself doctors and even professor in acupuncture without a medical background or a university appointment. Actually, it is possible to purchase such titles in the Far East - it is just a question of the number of dollars.
In some countries, such as Denmark it is illegal for non doctors to perform acupuncture, but yet it is legal if they are supervised by a doctor, this also gives rise for concern. Whilst correct supervision can be an excellent solution, e.g. in a hospital where a nurse has been trained in acupuncture and perform the more manual part of the treatment but only after the patient has been seen by a consultant acupuncturist before and after the treatment. Moreover, it is essential that the nurse is able to contact the doctor if side effects or unexpected reactions should occur.
Unfortunately, this practice is not the rule. In Denmark there are reports where doctors are supervising several practices located in different parts of the country. Under these circumstances the supervision is just a way to bypass the law. But at all times the patients safety is most important. CONCLUSION As revealed in this survey, the majority of adverse effects related to acupuncture are due to either lack of adequate anatomic, physiologic, pharmacologic, etc. knowledge or failure to apply the proper sterile techniques, but such deficiencies can be remedied by education and personal vigilance. It also shown that serious complications can arise only; from the improper use of acupuncture or from a gross abuse by incompetent practitioner. The safety and efficacy of the technique must be judged on its results in the hands of a competent practitioner who use it properly.
Considering the thousands of acupuncture treatments given daily throughout the world, the number of reported side effects are remarkable low. In contrast to conventional drug and surgical therapies, the available clinical data shows substantial evidence for the high degree of safety for acupuncture. It has been demonstrated that the frequency of serious side effects are nearly three times higher among non medical trained acupuncturists compared to medical trained acupuncturists. Therefore, the need for legalisation and medical control and supervision of non medical trained acupuncturists proves to be overwhelming.
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