Some Common A: Acupuncture For Evaluative Research
Some Common A: Acupuncture For Evaluative Research
Some Common A: Acupuncture For Evaluative Research
Although there are a number of uncontrolled trials of the acupuncture treatment of asthmall""2 this review will concentrate on the controlled studies. These fall into two classes: first, those of an experimental nature where only a single or small number of sessions of acupuncture is given to asthmatic patients and the short-term effects monitored; second, treatment trials where a course of acupuncture is given and both short and longterm effects are assessed. Tashkin and colleagues compared classical acupuncture, sham acupuncture (needle insertion at incorrect sites), isoprenaline, saline and no treatment in metacholine-induced asthma.3 On a wide range of objective measures of lung function (specific airway resistance, thoracic gas volume and forced expiratory flow volume) the authors showed a significantly greater effect of real acupuncture over sham and saline, though isoprenaline was the most effective treatment. Saline and sham acupuncture were equally effective and both were more effective (but not statistically) than no treatment. Although the asthma was artificially induced the 12 patients all had chronic asthma of long duration. Similar controlled studies have been conducted by other investigators without the metacholine induction. Virsik and colleagues'3 showed a significant increase in peak flow and forced expiratory flow volume and a decrease in airway resistance after a single session of acupuncture in patients with chronic bronchial asthma. In acute asthma Takishima and colleagues'4 and Yu and colleagues'5 reported significant changes in lung
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Review article
improvements of clinical or statistical significance and only two of the children exhibited any signs of consistent improvement in hearing levels. Madell in a similar study on 40 children also failed to show any effect of acupuncture on sensorineural deafness.25 Finally, in 1982 a report was made from the Beijing Research Institute of 1000 cases of sensorineural deafness treated over a period of 20 years.26 They concluded that '... acupuncture has little effect on deaf mutism and sensorineural lesion as revealed by audiometry. It may be of some benefit in the recovery of an active and reversible cochleoneural lesion as shown in a few cases, but in the vast majority of cases acupuncture does not exert any influence on the course of the disease. Thus the earlier enthusiasm generated by reports based on subjective impressions of improvement has not been sustained when more careful studies have been carried out. Two controlled studies of the treatment of tinnitus by acupuncture have been carried out.27'28 Both compared true acupuncture with a form of sham acupuncture involving minimal penetration. Both were of crossover design and claimed to be double blind though strictly speaking they were single blind with independent assessment; that is the therapist was not blind to the treatment condition. In Hansen and colleagues' study27 subjects received six sessions of both true and sham acupuncture and change was assessed with a crude subjective rating scale and a sound balancing technique. The authors reported a significant reduction in subjective ratings of symptoms over the course of the trial for patients who had placebo acupuncture first but as there was no difference between true and placebo acupuncture for this group of patients the authors did not attribute this change to the effects of acupuncture. Subjects in Marks and colleagues' study28 received only two sessions of true and sham acupuncture. Five subjects out of 14 experienced a subjective improvement after true acupuncture, but this was not confirmed by tinnitus matching tests or visual analogue measures. No significant changes of any kind were reported for the sham group. Changes in the loudness of the tinnitus above threshold were recorded in both groups but these apparently did not reach significance. The authors of both studies commented that tinnitus matching might not reveal small subjective improvements.
While neither study revealed any significant effect of acupuncture on tinnitus, Marks and colleagues speculated that a subgroup of patients might exist who would benefit with more sustained treatment. A possible criticism of both studies, especially that of Marks and colleagues, is that too little treatment was given to assess adequately the possible contribution of acupuncture in such a refractory condition.
Christensen and colleagues conducted a similar study in which the effects of 10 twice weekly sessions of acupuncture were compared with 10 sessions of minimal sham acupuncture.'8 Seventeen patients with stable bronchial asthma were treated and changes assessed by daily self-ratings, measures of lung function and laboratory assessment of mean blood immunoglobulin E levels. The resuts of the study indicated an effect, albeit modest, of acupuncture on both subjective and objective measures of asthma as compared with baseline. There was a significant difference between true and sham acupuncture on all assessed parameters two weeks after therapy began but the differences were insignificant thereafter. At this time, for the true acupuncture group, peak flow had increased by 22% (morning) and 7% (evening) and daily medication decreased by 530/. This group remained significantly improved throughout the period of the trial (11 weeks) though with diminished gains over time. While the effects on lung function were, as the authors comment, modest there was also a substantial effect on medication intake which would be valuable even in the absence of other effects. It is unfortunate that the brief follow-up period (four weeks) did not permit any conclusions about the long-term value of acupuncture in controlling asthma with reduced medication.
important.
studies addressed the question of long-term benefits. It has proven more difficult, however, to demonstrate the efficacy of acupuncture as a therapy for asthma. In a later study Tashkin and his colleagues compared eight sessions of acupuncture with eight sessions of sham acupuncture in the management of chronic asthma.4 The treatment procedures were identical to those in the single session study. The trial was subject and evaluator blind, employing a crossover design in which all 25 subjects received both true and sham acupuncture with a three to four week interval between. They employed a range of outcome measures including daily ratings of symptoms and records of medication, objective measures of lung function, patients' self-assessment of their condition and physicians' findings preand post-acupuncture treatment and throughout the study. In contrast to Tashkin's earlier study the results failed to show a significant change from baseline for measures of symptoms, medication use or lung function with either form of acupuncture. Although the crossover design would have obscured any differential effect of true and sham acupuncture in the longterm, the absence of any short-term effects makes this less
Hypertension
Tam and Yiu gave intensive courses of daily classical acupuncture to 28 patients with hypertension.29 Each course of therapy lasted for 10 days with an interval of three to five days between courses. Patients had between one and four courses of treatment. Blood pressure was recorded pre-treatment, daily during treatment, between courses of treatment and once a week for two months after treatment. Given that there was an adequate amount of treatment and consistent and frequent blood pressure recordings including a follow-up (but no baseline) it is disappointing to find the results presented simply as single pre- and post-treatment measures, with no further information about the timing of these measures or whether they are single measures or averages. Impressive changes were nonetheless reported. The average reduction in blood pressure was of the order of 30 mmHg for systolic pressure and 10 mmHg for diastolic. In 57%o of patients blood pressure returned to 'normal' levels (criteria
Review article
acupuncture and individual sessions of equivalent time-course, maintaining 'a concerned doctor-patient relationship. There was a five-day baseline period, two weeks of true acupuncture, two weeks of supportive sessions, two weeks of sham acupuncture and a further two weeks of support. The patients were assessed by 'blind' ward staff on a standard rating scale. The authors claimed that two of the patients who had florid schizophrenic symptoms responded positively to acupuncture and negatively to sham acupuncture and that this difference in response was statistically significant. Inspection of the graphs, however, reveals no clear trends across different conditions, which casts some doubt on the statistical analysis of the small numbers of subjects. It would be interesting to see the study repeated with longer baseline and treatment periods, more clearly formulated hypotheses, higher patient numbers and more clearly presented results. The verdict for all these studies can only be that the efficacy of acupuncture in the treatment of any psychiatric disorder remains unproven. The inclusion of non-treatment and placebo control groups would be especially valuable as spontaneous fluctuations in symptomatology and high placebo responsivity are
similarly monitored in an untreated control group. Sugioka and colleagues were less enthusiastic about the results of their study of eight hypertensive patients.30 Their patients showed non-significant reductions in systolic and diastolic blood pressure after 10 treatments in a four-week period. These eight subjects were part of a larger group of 54 involved in a trial of chlorthalidone and propranolol. Although both these drugs showed significant effects for the group as a whole, chlorthalidone being the more effective, the authors stated that chlorthalidone was ineffective in reducing blood pressure in the eight subjects who went on to have acupuncture. It seems unwise to conclude as they do that acupuncture is of no benefit in the management of essential hypertension as their subjects were a highly selected sub-group who had already been shown to be resistant to conventional treatment. Although Tam and Yiu's study29 is more encouraging it too should be viewed with caution unless the results can be confirmed in a more fully reported controlled trial with a longer follow-up period.
Psychiatric disorders
It has been reported that acupuncture is used to treat a wide range of psychiatric disorders in China.31-33 Few details are available, however, of the exact diagnoses of the patients or the processes involved in their treatment, of which acupuncture is often only a component. Schizophrenia, manic-depressive psychosis and the neuroses have all been treated with acupuncture but there is little detailed information on outcome.33 More information is no doubt available in Chinese language
Smoking addiction The technique employed to aid withdrawal from smoking is difstructed to press it when a desire to smoke overtakes him or her. The actual point involved varies from study to study. Some studies have used electrical stimulation of needles in the ear but with nothing being left in place.38 Some authors have claimed impressive reductions in smoking after acupuncture treatment. Sacks,39 for example, claimed that 61% of a sample of 642 smokers were abstinent after six months, but his paper contained almost no details of how this conclusion was arrived at. Systematic controlled studies have been less encouraging. Lamontagne and colleagues4" compared self-monitoring with two types of acupuncture, one aimed specifically at smoking withdrawal and the other aimed at enhancing relaxation. Subjects in the self-monitoring group had two weekly 20-minute sessions with a therapist but only to report on their own efforts to reduce smoking with the aid of a wrist counter.4' Both types of acupuncture were significantly more effective than self-monitoring in the two weeks post-treatment but these differences disappeared at one, three and six months follow-ups. Clavel and Benhamou42 compared acupuncture, nicotine gum and a minimal intervention control in a study involving 651 smokers. Acupuncture was as effective as nicotine gum and both were significantly more effective than the control at both one and 13 months follow-up. As usual there was a high rate of relapse; at one month 19% and 22% of smokers were abstinent in the acupuncture and nicotine gum groups respectively and at 13 months 80o and 12%. Cottraux and colleagues43 found acupuncture to be superior to behaviour therapy after nine and 12 months but equal to placebo medication. They concluded that 'as in most smoking cessation studies the overall effect was small and non-specific. This is similar to the findings of Gillams and colleagues44 who concluded that 'the claims made for acupuncture are somewhat over-enthusiastic, however acupuncture does seem to be as effective as other methods of smoking withdrawal Gillams and colleagues also considered the question of the siting of the ear stud, but found no difference between the recommended 'lung' point and a nearby 'incorrect' site. Results from Fuller's technique of incorporating electrical
technique is the insertion of a stud in a particular acupuncture point in the ear. The stud is left in place and the patient is in-
week. The few studies from outside China offer little more illumination. Shauib35 reported the treatment of 40 depressed or anxious patients using an ear electroacupuncture technique. A good response was claimed for about two-thirds of the patients. But the report was vague and a particularly serious flaw was that no follow-up was reported except in two cases. Lo and Chung32 at least provided pre- and post-treatment ratings of symptoms for their series of eight anxious patients. The ratings were made by a psychiatrist not involved in the treatment and good to moderate results were claimed in six out of eight cases. The only study of acupuncture and psychiatric disorders to attempt systematic collection of data and the inclusion of baseline control conditions is that of Kane and Di Scipio.36 They treated three schizophrenic patients with acupuncture, sham
a
publications. An exception to the lack of detailed reporting of controlled studies is provided by Luo and colleagues from the Institute of Mental Health, Beijing.34 They compared electoacupuncture and amitriptyline in the treatment of depressive disorders of between one month and two years duration. Assessment interviews were carried out by two psychiatrists, using clinical rating scales; inter-rater reliability was good. Substantial reductions in depressive symptoms were achieved in both groups. There are, however, considerable problems in attributing these changes to the efficacy of either electroacupuncture or amitriptyline. Depression of comparatively short duration is likely to change substantially in a five-week period, especially when the patients have regular contact with people who are interested in their welfare and monitoring their progress. A no-treatment control group would have been a valuable addition to this study. A second problem concerns the huge number of treatment sessions given to the acupuncture group - 30 one-hour sessions in five weeks. This makes a meaningful comparison of the two groups impossible as the patients receiving drugs were only seen once
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Review article
Acupuncture seems as effective as other methods for the treatment of smoking addiction. For the other disorders reviewed here few guidelines can be given. Where benefits have been shown for the problems considered here it has not been possible to attribute them definitely to the specific effects of acupuncture. This is obviously a crucial issue for research. However, a question of possibly more immediate importance for the general practitioner is whether a patient might derive some benefit from having acupuncture treatment, whether it be from the effects of the needling or via less tangible psychological processes. Even if there are currently no clear indications for or against the use of acupuncture in a particular disorder an individual patient who finds the method and philosophy sympathetic might derive considerable benefit from it.
References
1. O'Connor J, Bensky D (eds). Acupuncture: a comprehensive text. Chicago: Eastland Press for Shanghai College of Traditional Medicine, 1921. 2. Richardson PH, Vincent CA. Acupuncture for the treatment of pain: a review of evaluative research. Pain 1986; 24: 15-40. 3. Tashkin DP, Bresler DE, Kroening RJ, et aL Comparison of real and simulated acupuncture and isoproterenol in methacholine-induced asthma. Ann Allergy 1977; 39: 379-387. 4. Tashkin DP, Kroening RJ, Bresler DE, et al. A controlled trial of real and simulated acupuncture in the management of chronic asthma. J Allergy Clin Immunol 1985; 76: 855-864. 5. Vincent CA, Richardson PH. The evaluation of therapeutic acupuncture: concepts and methods. Pain 1986; 24: 1-13. 6. Lewith GT, Machin D. On the evaluation of the clinical effects of acupuncture. Pain 1983; 16: 111-127. 7. Cardiovascular Section, Acupuncture Research Institute,
Obesity
The acupuncture technique employed to help people lose weight is similar to that used for smoking. A stud is placed in the ear to be stimulated by the patient or a small needle is stimulated electrically and then removed. The studies that purport to evaluate this technique are very poor. Sacks39 claimed a good response from 75% of 1030 subjects but few details were given. Giller45 in a study of the treatment of 120 volunteers reported that 70% of subjects treated at the 'hunger' point experienced decreased appetite compared with only 20% who had a stud in another part of the ear. Neither of these studies, however, is of sufficient quality to enable even tentative conclusions to be drawn. Bin and Jiuzhi46 treated 350 obese volunteers and reported that 66% of them reduced their weight by more than 3 kg by the end of the treatment. A course of treatment constituted seven treatment sessions; the implanted needles were replaced and adjusted every four days. It is difficult to evaluate the particular contribution of ear acupuncture to the subjects' loss of weight as they appeared to have had a variable number of courses of treatment implying a considerable number of treatment sessions extending over weeks or months. A comparison of this procedure with one in which subjects monitored their weight and received similar attention from a clinician would help clarify whether ear acupuncture has any specific contribution to make to the treatment of obesity.
Academy of Rtaditional Chinese Medicine. Acupuncture in coronary heart disease: a report of 44 cases. Chin Med J 1981; 94: 81-84. 8. Lau BHS, Wang DS, Slater JM. Effect of acupuncture on allergic rhinitis: clinical and laboratory evaluations. Am J Chin Med 1975; 3: 263-270. 9. Steinberger A. The treatment of dysmenorrhea by acupuncture. Am J Chin Med 1980; 9: 57-60. 10. Newmeyer JA, Johnson G, Klot S. Acupuncture as a detoxification modality. J Psychoactive Drugs 1984; 16:
241-261. 11. Cioppa FJ. Clinical evaluation of acupuncture in 129 patients. Dis Nervous System 1976; 37: 639-643. 12. Shao JM, Ding YD. Clinical observation of 111 cases of asthma treated by acupuncture and moxibustion. J Traditional Chin Med 1985; 5: 23-25. 13. Virsik K, Kristufek P, Bangha 0, Urban S. The effect of acupuncture on pulmonary function in bronchial asthma. Prog Respir Res 1980; 14: 271-275. 14. Takishima T, Mue S, Tamura G, et al. The bronchodilating effect of acupuncture in patients with acute asthmas. Ann Allergy 1982; 48: 44-49. 15. Yu DYC, Lee SP. Effect of acupuncture on bronchial asthma. Clin Sci Mol Med 1976; 51: 503-509. 16. Berger D, Nolte D. Acupuncture in bronchial asthma: body plethysmographic measurements of acute bronchospasmolytic effects. Comp Med East and West 1977; 5: 265-269. 17. Dias PL, Subraniam S, Lionel ND. Effects of acupuncture in bronchial asthma: a preliminary communication. J R Soc Med 1982; 75: 245-248. 18. Christensen PA, Laursen LC, Taudorf E, et aL Acupuncture and bronchial asthma. Allergy 1984; 39: 379-385. 19. Thub HA. Acupuncture and sensori-neural hearing loss: a review. J Speech Hear Disord 1975; 40: 427-433. 20. Rosen L. Acupuncture and chinese medical practices. Volta Rev 1974; 76: 340-350. 21. Kaslow AL, Lowenschuss 0. Hearing rehabilitation without needies. Am J Acupunct 1974; 2: 23-29. 22. Peng A. Acupuncture treatment for deafness. Am J Chin Med 1973; 1: 155-158.
Conclusion
The quality of the studies reviewed above has generally been poor. Even where the standard is higher studies are usually too few in number to assess definitively the efficacy of acupuncture for a particular disorder. Conclusions must therefore be largely tentative and in some areas no conclusions may be drawn at all. What are the implications for the general practitioner of this review and the previously published findings on the treatment of pain with acupuncture? Short-term and possibly long-term benefits may be expected in the treatment of back pain. The efficacy of acupuncture for headache, cervical pain and arthritis is less well supported but there are some encouraging results; at least a proportion of patients is likely to obtain significant relief.2 Modest benefits might be obtained for asthma. Treatment of sensorineural deafness by acupuncture is a waste of time.
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Review article
36. Kane J, Di Scipio WJ. Acupuncture treatment of schizophrenia: report on 3 cases. Am J Psychiatry 1979; 136: 297-302. 37. Shapiro AK, Morris LA. The placebo effect in medical and psychological therapies. In: Garfield SL, Bergin AE (eds). Handbook of psychotherapy and behaviour change (Volume 2). New York: Wiley, 1978. 38. Fuller JA. Smoking withdrawal and acupuncture. Med J Aust 1982; 69: 28-29. 39. Sacks LL. Drug addiction, alcoholism, smoking, obesity, treated by auricular staple puncture. Am J Acupunct 1975; 3: 147. 40. Lamontagne Y, Annable L, Gagnon M-A. Acupuncture for smokers: lack of long-term therapeutic effect in a controlled study. Can Med Assoc J 1980; 122: 787-790. 41. Lamontagne Y, Gagnon M-A, Gaudelle G. Thought stopping, pocket timers, and their combination, in the modification of smoking behaviour. Br J Addict 1978; 73: 220. 42. Clavel F, Benhamou S. Helping people to stop smoking: randomized comparison of groups being treated with acupuncture and nicotine gum with control group. Br Med J 1985; 291: 1538-1539. 43. Cottraux JA, Harf R, Boissel JP, et. al. Smoking cessation with behaviour therapy or acupuncture - a controlled study. Behav Res Ther 1983; 21: 417-424. 44. Gillams J, Lewith GT, Machin D. Acupuncture and group therapy in stopping smoking. Practitioner 1984; 228: 341-344. 45. Giller RM. Auricular acupuncture and weight reduction. A controlled study. Am J Acupunct 1975; 3: 151. 46. Bin X and Jiuzhi F. Clinical observation of the weight-reducing effect of ear acupuncture in 350 cases of obesity. J Trad Chin Med 1985; 5: 87-88.
Address for correspondence Dr P.H. Richardson, Academic Unit of Psychiatry, United Medical and Dental Schools of Guy's and St Thomas's Hospital, London SEI 7EH.
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