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Short term reactions to acupuncture

a cross-sectional survey of patient reports
Hugh MacPherson, Kate Thomas

Hugh MacPherson senior research fellow Department of Health Sciences University of York Kate Thomas professor School of Healthcare University of Leeds Correspondence: Hugh MacPherson hm18@york.ac.uk

Abstract Objective To explore the type and frequency of short term reactions associated with a single acupuncture treatment. Methods As part of recruitment to a large-scale prospective survey of the safety of acupuncture, 9408 consecutive patients each completed one survey form soon after receiving treatment with acupuncture, and returned it directly to the research centre. On this form, patients were asked to report on a range of possible short term reactions relating to their most recent acupuncture treatment using a checklist of options. Results At least one short term reaction to acupuncture during or immediately after treatment was reported by 94.6% (CI 94.2 to 95.1) of patients, an average of 1.8 reactions per patient. The most common experiences reported were feeling relaxed (79.1%) followed by feeling energised (32.7%). A total of 24.4% of patients reported tiredness or drowsiness, with obvious implications for safety if the patient intended to drive after treatment. Negative reactions, such as pain and bruising at the site of needling, were reported by 29.7% of patients who were more likely to be female patients (OR 1.58), patients under the age of 40 (OR 1.62), patients who had consulted their GP or hospital specialist beforehand (OR 1.30), patients consulting their acupuncturist for the first time (OR 1.24), and patients treated by an acupuncturist with less than two years experience since qualification (OR 1.24). Only 13 patients were unwilling to have acupuncture again as a result of these short term reactions. Conclusion In this large cross-sectional study, extensive patient reports showed that positive reactions to acupuncture treatment were very common. Tiredness, drowsiness and a range of negative reactions were also frequently reported. Almost all patients were willing to experience these reactions again.

Introduction Recent research into the safety of acupuncture has usually been conducted via large-scale surveys where the type and frequency of adverse events associated with acupuncture have been recorded. Studies have either been retrospective or prospective, the latter providing more robust data, and have involved either acupuncturists in monitoring the effects of their treatments on patients, or patients in reporting their experience of adverse events. While these safety studies have necessarily focused on adverse events, questions have been raised as to whether all adverse reactions were necessarily experienced as negative by patients. Previous research has found that some negative short term reactions to treatment were what might be called aggravations, where, although symptoms were aggravated (became worse after treatment), a strong improvement of symptoms followed, so that the

patient was much better than prior to the treatment that caused the aggravation. In our recent practitioner survey of adverse events, 2.8% of treatments were reported as causing a worsening of symptoms, but in the majority of cases (2.4%) a subsequent improvement in symptoms was reported. 1 Acupuncturists sometimes describe this type of aggravation as a healing crisis, known in Japan as the Menken phenomenon.2 Our interest in all short term reactions to treatment, not just aggravations to symptoms, informed our first safety study,1 which we conducted with members of the British Acupuncture Council. Acupuncturists monitored more than 30 000 treatments over a one-month period in 2001, and recorded on standardised documentation 10 920 short term reactions to treatment as reported by their patients. We labelled these as mild and transient, with the most common reports being of feeling

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relaxed (reported in 11.9% of treatments) and feeling energised (6.6%). However we also received reports of tiredness or drowsiness (3.7%), as well as a range of negative reactions (6.8%). In the study we report here, we were interested in collecting data on the frequency and type of short term reactions reported by patients during or immediately after treatment. This study was part of a large safety research project, two parts of which are already reported: the profile and characteristics of the 9408 participants,3 and the adverse events reported by the same group of patients three months after baseline.4 In this paper we described patients reports of short term reactions to treatment, presenting the type and frequency of reactions and related data including reports of aggravations, that we hope adds to our understanding of how patients experience acupuncture. Methods In a large-scale national survey, patients were recruited through their acupuncturists, all of whom were UK based members of the British Acupuncture Council currently in practice. All 1955 members were invited to assist with this survey, and 638 (33%) agreed to participate. We collected information on acupuncturists who agreed to participate as well as those who declined, including their sex, years in practice, where they trained and the number of patients they were treating a week. The British Acupuncture Council, a self-regulating professional body for acupuncturists practising in the UK, requires accredited training colleges to provide a minimum of three years full-time training or equivalent. In order to maximise the involvement of practitioners, our survey did not link individual patients to specific practitioners. However, by using colour coded consent forms, we were able to determine the number of years that the patients practitioner had been in practice, categorised as less than two years, two to five years, five to 10 years, 10 to 15 years and over 15 years experience. Based on number of patients normally seen by the practitioner, we sent each one between 20 and 60 survey forms. We asked them to hand out forms as soon as possible to all consecutive patients who were over 18 years old, who were able to complete the form and who gave consent. Each patient was included once only. A total of 22 200 forms were distributed to practitioners, but we do not know the precise number of these handed out to patients. After the acupuncture session, participating patients recorded age, sex, whether they were first time acupuncture patients, and their primary reason for consulting, coded using the International Classification of Primary Care. 5 Patients also provided us with information on their pathway to care, whether they were consulting their acupuncturist for the first time, whether they had had acupuncture before and whether the National Health Service was paying for their acupuncture treatment. Patients were asked to report short term reactions, by answering the question: Thinking about the visit at which you were given this form, did you experience during or immediately after your acupuncture any of the following? We provided a checklist of possible short term reactions drawn from the results of two recently published practitioner surveys.1;6 Patients were then asked, Given this experience, would you be willing to have acupuncture treatment again? Patients then returned the form direct to the research centre using a Freepost envelope, not seen by their acupuncturist. These data provided the primary outcome for the study we report here. Ethical approval for this study was given by the Northern & Yorkshire Multi-centre Research Ethics Committee. The Statistical Package for the Social Sciences (SPSS) was used for data analysis. Confidence intervals for proportions were calculated using Confidence Interval Analysis (CIA). To control for confounding, binary logistic regression was used to estimate relative risk in the form of adjusted odds ratios for those variables that showed a statistically significant association (P<0.05) in the univariate analysis. Results A total of 9408 patients returned a completed questionnaire, an average of 15 per participating practitioner. The patients mean age was 51 years and 74% were female. Other characteristics are presented in Table 1 (these are submitted for publication elsewhere).3 Of these patients, 8904 (94.6 %) reported experiencing 15 745 short term reactions associated with their acupuncture. This corresponds to a rate of 94.7 % of patients experiencing at least one reaction (95% CI 94.2 to 95.1) with an average of 1.8 reactions per patient. The breakdown of the type

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Table 1 Characteristics of patients who participated in the survey (total responses = 9408)

Number Sex (n=9403): Male Female 2442 6961

Percentage

26 74

Average age, years (n=9315)

51

Reason for consultation most commonly reported:* Musculo-skeletal Psychological General Neurological Gynaecological/obstetric Respiratory General wellbeing** 3560 1047 852 763 713 533 446 38.1 11.2 9.1 8.2 7.6 5.7 4.8

Previously consulted their GP or hospital specialist about their main problem or symptom (n=9337)

7257

77.7

Receiving acupuncture for the first time (n=9381)

1253

13.4

Treatment paid for by NHS (n=9337)

441
5

4.7

*Coded and classified according to the International Classification of Primary Care. **Additional category

and frequency of these reactions is presented in Table 2. We classified each reaction as: a) positive, likely to be considered a good experience; b) tiredness or drowsiness (which could be interpreted as either positive or negative); and c) negative, likely to be considered an unwanted experience. Positive reactions were most common, especially a feeling of relaxation (79% of patients), followed by feeling energised (33%). In addition 24% of patients reported experiences of tiredness or drowsiness. A range of negative reactions were also reported (30%), most commonly an experience of pain at the site where a needle was inserted. A worsening of their existing condition was reported by 1.8%. Table 3 shows the results of the multivariate analysis for patients who reported positive short term reactions compared with those who did not. Similarly, we present the results for short term tiredness or drowsiness reactions in Table 4 and negative short term reactions in Table 5. From this analysis, patients were more likely to report positive short term reactions if they were

male, or had had acupuncture previously, or had consulted their acupuncturist before, or were presenting with a psychological, gynaecological or obstetric condition, or for general wellbeing; but not if they were consulting for a musculoskeletal condition or they had consulted their GP or hospital specialist beforehand. Tiredness or drowsiness was associated more with female patients, patients under the age of 40, or patients who had consulted their GP or hospital specialist beforehand. Negative reactions were more likely to be reported by female patients, patients under the age of 40, patients who had consulted their GP or hospital specialist beforehand, or patients consulting their acupuncturist for the first time. In Table 6, we present the numbers willing and unwilling to have acupuncture treatment again. These data are presented in the same three categories as discussed above: positive reactions, tiredness or drowsiness reactions, and negative reactions. The overall rate of unwillingness was only 0.14 patients per 100 consultations. Surprisingly there was no

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Table 2 Type and frequency of short term reactions associated with acupuncture (n=9408)

Type of event

Number of reported reactions

Short term reaction rate per 100 treatments

95% CI

Positive reactions Relaxed Energised Other positive Sub Total 7436 3072 166 10674 79.1 32.7 1.8 113.5 78.2, 79.8 31.7, 33.6 1.5, 2.1

Tiredness or drowsiness reactions

2295

24.4

23.5, 25.3

Negative reactions Pain where needle was inserted Bruising Pain other than at site of needling Faint / dizzy Worsening of condition Nauseous Sweating Bleeding Disorientation / anxiety / nervousness / insomnia / emotional Ache/discomfort other than at needle point Other negative Itching / pins & needles / tingling / burning sensation Irritation / ache at needle point Sub Total 1154 378 373 248 165 111 79 66 63 49 33 33 24 2776 12.3 4.0 4.0 2.6 1.8 1.2 0.8 0.7 0.7 0.5 0.4 0.4 0.3 29.7 11.6, 12.9 3.6, 4.4 3.6, 4.4 2.3, 3.0 1.5, 2.0 1.0, 1.4 0.7, 1.0 0.6, 0.9 0.5, 0.9 0.4, 0.7 0.2, 0.5 0.2, 0.5 0.2, 0.4 28.6, 30.4

Total

15745

167.5

significant difference between the three categories, providing evidence that negative short term reactions did not affect peoples willingness to have acupuncture again. In Table 7 we use a binary logistic regression model and find that only two factors were significantly (P<0.05) associated with an unwillingness to have acupuncture again: having had acupuncture recommended by an NHS practitioner (such as a GP, nurse, or physiotherapist) and having acupuncture for the first time. Discussion Our main result was that 94.6% (CI 94.2 to 95.1) of patients reported experiencing at least one short term reaction to acupuncture during or immediately after treatment, with an average of 1.8 reactions per patient. This was an unexpectedly high proportion, with the most common experiences being reported as feeling

relaxed (79.1%) followed by feeling energised (32.7%). A total of 24.4% of patients reported feeling tired or drowsy. Negative reactions, such as pain and bruising at the site of needling, were reported by 29.7% of patients; however, aggravation of symptoms was only reported by 1.8% of patients. Our post hoc classification of adverse events into three major categories has been useful in some ways, but also has limitations. With regard to the positive category for example, it may not always be positive to be energised or relaxed. Similarly, some people might experience being energised or relaxed as negative. We had difficulty in categorising tiredness or drowsiness as either positive or negative and therefore created a separate category. If one takes the view that patient safety is the key issue, then clearly excessive tiredness or drowsiness must be seen as a risk factor. In addition individual reporting

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Table 3 Adjusted odds ratios for positive short term reactions* (n=9408)

Response variable

Proportions experiencing a positive reaction*

Adjusted relative risk:** Odds Ratio (95% CI) 1.45 (1.22, 1.72) P<0.0001

Female patients vs Male patients Patients who were having acupuncture for the first time vs Patients who had had acupuncture previously Patients who were consulting their current acupuncturist for the first time vs Patients who had consulted their current acupuncturist before Patients who had not consulted for a psychological condition vs Patients who had consulted for a psychological condition Patients who had not consulted for a gynaecological or obstetric condition vs Patients who had consulted for a gynaecological or obstetric condition Patients who had consulted for a musculoskeletal condition vs Patients who had not consulted for musculoskeletal condition Patients who had not consulted for general wellbeing vs Patients who had consulted for general wellbeing Patients who had consulted their GP or specialist about their condition vs Patients who had not consulted their GP or specialist about their condition *Positive reactions are listed in Table 2.

6228/6957 (90%) vs 2247/2442 (92%) 1046/1253 (83%) vs 7417/8128 (91%) 1014/1204 (84%) vs 7360/8085 (91%) 7446/8290 (90%) vs 977/1047 (93%) 7971/8856 (90%) vs 452/ 481 (94%) 3133/3558 (88%) vs 5290/5779 (92%) 8055/8958 (90%) vs 424/ 446 (95%) 6496/7257 (90%) vs 1920/2080 (92%)

1.62 (1.32, 2.00) P<0.0001

1.41 (1.14, 1.75) P=0.002

1.48 (1.13, 1.95) P=0.004

1.70 (1.15, 2.53) P=0.008

1.24 (1.07, 1.44) P=0.005

1.60 (1.02, 2.51) P=0.041

1.27 (1.06, 1.53) P=0.011

** All variables in the left hand column were used in the logistic regression model and were shown to have an independent effect on the likelihood of patients reporting short term reactions. No associations were found for the other known variables.

Table 4 Adjusted odds ratios for short term reactions of tiredness or drowsiness (n=9408)

Response variable

Proportions experiencing tiredness or drowsiness

Adjusted relative risk:* Odds Ratio (95% CI) 1.65 (1.46, 1.85) P<0.0001

Male patients vs Female patients Patients aged 40 years and over vs Patients age under 40 years Patients who had not consulted their GP or specialist about their condition vs Patients who had consulted their GP or specialist about their condition

436/2442 (18%) vs 1859/6957 (27%) 1528/6942 (22%) vs 739/2369 (31%) 445/2080 (21%) vs 1837/7257 (25%)

1.58 (1.43, 1.76) P<0.0001

1.23 (1.10, 1.39) P=0.001

*All variables in the left hand column were used in the logistic regression model and were shown to have an independent effect on the likelihood of patients reporting short term reactions. No associations were found for the other known variables.

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Table 5 Adjusted odds ratios for negative short term reactions*(n=9408)

Response variable

Proportions experiencing a negative reaction*

Adjusted relative risk:** Odds Ratio (95% CI) 1.24 (1.05, 1.47) P=0.013

Patients who had acupuncturists who had been in practice more than two years vs Patients who had acupuncturists who had been in practice less than two years Male patients vs Female patients Patients aged 40 years and over vs Patients aged under 40 years Patients who had not consulted their GP or specialist about their condition vs Patients who had consulted their GP or specialist about their condition Patients who had consulted current acupuncturist before vs Patients who had consulted current acupuncturist for first time *Negative reactions are listed in Table 2.

3462/8787 (39%) vs 282/ 616 (46%) 779/2442 (32%) vs 2964/6957 (43%) 2544/6942 (37%) vs 1160/2369 (49%) 733/2080 (35%) vs 2990/7257 (41%) 3167/8085 (39%) vs 539/1204 (45%)

1.58 (1.43, 1.92) P<0.0001

1.62 (1.47, 1.78) P<0.0001

1.30 (1.17, 1.44) P<0.0001

1.24 (1.09, 1.41) P=0.001

** All variables in the left hand column were used in the logistic regression model and were shown to have an independent effect on the likelihood of patients reporting short term reactions. No associations were found for the other known variables.

Table 6 Patients willingness to have acupuncture treatment again

Reported experience of short term reactions

Number willing to have acupuncture again

Number unwilling to have acupuncture again

Those unwilling to have acupuncture again - rate per 100 treatments

95% CI

Positive short term reactions (n = 8428) Tiredness or drowsiness short term reactions (n=2284) Negative short term reactions (n =3726) All cases (n = 9346)

8421 2281 3719 9333

7 3 7 13

0.083 0.131 0.188 0.139

0.040, 0.172 0.045, 0.386 0.091, 0.388 0.081, 0.238

will vary, and one persons relaxation may be anothers tiredness, and this variation may be influenced by many factors such as culture, expectations, and the disease being treated. Another caveat concerning the data presented here is that the large sample size inevitably led to associations that are statistically significant but not necessarily clinically meaningful. The potential clinical relevance of these associations therefore needs to be considered and interpreted in each case, as the differences observed may be small in absolute terms. In our two previous publications we discussed the practitioners and patients responding to this

survey,3;4 concluding that the sample obtained is reasonably representative of the population it aims to describe with respect to known characteristics. However, when patients provide reports of their experiences in a questionnaire, it is possible that some biases will intrude. For example, for some patients there might be a tendency to under-report the negative reactions in order to protect their acupuncturist or acupuncture generally, due perhaps to a loyalty to their chosen approach to health care. With other patients there might be a counter tendency to over-report, because the user-friendly checklist we provided in the questionnaire encouraged the

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Table 7 Adjusted odds ratios for patients unwillingness to have acupuncture treatment again (n=9346)

Proportions unwilling to have acupuncture again Patients who did not have acupuncture recommended by an NHS practitioner (GP, nurse, physiotherapist, etc) vs Patients who had acupuncture recommended by an NHS practitioner 8/8129 (0.10%) vs 4/ 913 (0.44%)

Adjusted relative risk*: Odds Ratio (95% CI)

3.77 (1.12, 12.66) P=0.032

Patients having had acupuncture before vs Patients having acupuncture for the first time

7/8089 (0.09%) vs 6/1240 (0.48%)

5.95 (1.90, 18.61) P=0.002

* All variables in the left hand column were used in the logistic regression model and were shown to have an independent effect on the likelihood of patients reporting short term reactions. No associations were found for the other known variables.

ticking of boxes. We cannot know whether patients of non-participating practitioners, or non-participating patients of participating practitioners, would have provided the study with different data. It is possible to compare our patient reports of short term reactions with practitioner reports of their patients short term reactions from the previous survey conducted in 2001.1 While the practitioners in both studies were drawn from the same professional association, the British Acupuncture Council, the patient populations are different. Patients report short term reactions approximately five times more frequently than practitioners. For negative reactions related to pain, the difference is nearer tenfold. This raises the question as to whether practitioners are unaware of the pain they cause, or whether the dull ache usually experienced when de qi is obtained at an acupuncture point, which most acupuncturists in the British Acupuncture Council regard as a requirement for a treatment, is reported by some patients as pain. The difference overall might be related to the known tendency among healthcare practitioners to underreport adverse events.8;9 Nevertheless, it is worth noting that in both our surveys, the most common three types of reactions reported were the same, and in the same order of frequency, namely feeling relaxed, feeling energised and feeling tired or drowsy. We have also compared our results with other surveys, and found variations on a number of counts. For example, the estimates of tiredness after treatment have been wide-ranging: as high as 41%,10 but more

commonly around 3%,11 compared to 24% in this survey. Our evidence does not support a report in the literature that tiredness or drowsiness occurs more commonly after a patients first session of acupuncture.11 In terms of safety, however, tiredness and drowsiness seems likely to be the most worrying potential risk, as it could compromise a patients ability to drive home safely after acupuncture.12 One of our lines of enquiry in this study was to explore the frequency that patients reported a worsening of their symptoms as a result of acupuncture. Immediately following a single session of acupuncture, only 1.8% of our patients reported an aggravation to their condition, lower than clinical anecdotes had led us to expect. This result lies between the 2.8% reported in two other surveys,1;11 and the 1% in another.6 Our data suggest that the risk of negative short term reactions, particularly reported pain at the site of needling, is associated with patient characteristics, practitioner characteristics and consulting behaviour, including being new to acupuncture. We found no association between reported negative reactions and particular reasons for consulting, suggesting that pain at the site of needling is not linked to the presentation of painful conditions per se. In contrast, reports of positive reactions were associated with returning acupuncture patients, and with nonmusculoskeletal reasons for consulting (including psychological conditions and general wellbeing). These results are not incompatible with studies that

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have shown patient reports of relaxation following acupuncture for musculoskeletal conditions such as low back pain.13 What we have shown is that patients with these conditions are significantly less likely to report a relaxation response, compared to patients with other conditions. It is possible that short term reactions play an important role in providing some evidence for patients that acupuncture is actually doing something, providing patients with a strong motivation to continue with acupuncture long enough to be effective. Previous research has indicated that it takes on average the first six or so treatments before substantial benefits of treatment are experienced.14;15 Is it possible then that without these short term reactions, many more patients might have believed that acupuncture was ineffective, and therefore not continued with it for a sufficient number of sessions? One can also speculate that these ubiquitous and generally positive short term reactions have played a crucial role in extending acupunctures impact in the West in recent years, in some way compensating for the low level of gold standard evidence to support acupunctures reputation for effectiveness. A number of interesting questions for further research are raised by this study. Firstly, it is interesting to speculate what physiological responses might explain such marked positive short term reactions. Acupuncture needles produce a range of biophysical reactions. While our knowledge of these processes is limited, we do know that acupuncture releases endogenous opioid peptides that can generate relaxed happy feelings, as well as oxytocin, a possible mediator of anti-stress effects, and serotonin, where a deficiency is linked to depression.16-18 These effects have been demonstrated to last up to 12 hours, and have similarities with the physiological processes that result from vigorous physical exercise. 19 However acupuncture also appears to set off longer term neurophysiological processes, and it has been suggested that these are fundamentally different from short term ones,20;21 and may be responsible for longer term outcomes reported in the literature.13;22;23 Secondly, further research is indicated to explore patients and practitioners experiences. Lines of enquiry include patients perceptions of pain from needling, and the more general question of how patients value both positive and negative reactions. Given that drowsiness and tiredness are likely to be the most serious of the common risk factors, further data could be collected to give a more accurate picture of the real risk, for example by reporting on the extent that they felt compromised in their ability to drive, use machinery, cook or walk. Research could also usefully explore why so few patients were unwilling to have acupuncture again after experiencing short term reactions. From our data, only 13 patients were unwilling to have acupuncture again because of their experience of these short term reactions, a rate of 0.14% of treatments (95% CI 0.08 to 0.24). Given that not all reactions to treatment were positive, this is an exceptionally low rate, and surprisingly not related to whether the reaction was positive or negative. A qualitative study could explore in depth the reasons patients have for being willing to continue with acupuncture, hopefully helping to explain why new patients and patients who had been recommended by an NHS practitioner are less willing to continue. Finally, we could investigate the impact short term reactions may have on practitioners, how they integrate this knowledge into their treatments for example to modify their choice of points, thereby tailoring treatment more closely to the needs of the patient. Conclusion In a large-scale prospective patient survey, we found that 95% of patients reported reactions to acupuncture during or immediately after a single session, an unexpectedly high level. The most common reactions were positive, namely feeling relaxed and feeling energised, followed by feelings of tiredness or drowsiness. Despite patients also feeling a range of negative reactions, including pain at the site of needling, almost all patients were willing to have acupuncture again. Acknowledgements We acknowledge the assistance of the British Acupuncture Council who funded the study, the patients and practitioners who participated, Tony Scullion who managed much of the data collection, Bin Liu who helped with the analysis, and Richard Blackwell and Jennifer Dale who contributed to the interpretation of the results.

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Short term reactions to acupuncture a cross-sectional survey of patient reports

Hugh MacPherson and Kate Thomas Acupunct Med 2005 23: 112-120

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