Part 2
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.