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Rapid Responses: Rapid Responses published:
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Relaxation and massage often helpful
- Kevan R Wylie (12 August 2005)
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Covering title a misrepresentation
- Sharif M Elleithy (13 August 2005)
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Medicine is a human art of applying science with intention to heal.
- Konstantinos Papilas (14 August 2005)
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Hurdles to clear in the investigation of acupuncture therapy
- Takashi Seki, Koh Iwasaki , Katsutoshi Furukawa , and Hiroyuki Arai (15 August 2005)
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Another useful waste of time? Hitching a ride on the back of placebo.
- David Reilly (15 August 2005)
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Acupuncture in patients with tension-type headache: beliefs in the technique do matter
- Ulrich Ronellenfitsch (17 August 2005)
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Acupuncture, botulinum toxine, tiger balm or placebo?
- Harald G. De Cauwer (19 August 2005)
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Was it a good idea to publish the study-design before the end of the study ?
- Dieter Wettig, PhD, MD (23 August 2005)
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Re: Was it a good idea to publish the study-design before the end of the study ?
- Dieter Wettig, PhD, MD, - (4 September 2005)
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Acupuncture is no better than no treatment for headaches: misleading covering title
- Michal R. Pijak (5 September 2005)
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Were acupunctural effects recorded?
- Alexander Macdonald (15 September 2005)
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Reply from authors
- Klaus Linde, Dieter Melchart, Andrea Streng, Andrea Hoppe, Wolfgang Weidenhammer, Benno Brinkhaus, Claudia Witt, Stefan N Willich (15 September 2005)
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Re: Reply from authors
- Dieter Wettig, PhD, MD, - (18 September 2005)
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ICH-GP
- Mahmood Ahmad (19 November 2007)
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Kevan R Wylie, Consultant Porterbrook Clinic
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We studied the effects of acupuncture and massage with relaxation upon chronic headache. Sufferers were assigned to either acupuncture or massage with relaxation instead of a change to their prescribed medication. In both treatments there was a significant improvement in pain, but migraine patients treated by massage with relaxation showed significantly greater improvements compared with those patients who received acupuncture. Wylie KR et al. Does psychological testing help to predict the response to acupuncture or massage/relaxation therapy in patients presenting to a general neurology clinic with headache? Journal of Traditional Chinese Medicine 17(2): 130-9. Jun 1997 Competing interests: None declared |
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Sharif M Elleithy, Clinical Psychologist Traumatic Stress Service, London
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According to the covering title for this article on your homepage, "Acupuncture is no better than no treatment for headaches". In fact this useful study found that acupuncture was much better than no treatment for headaches. What made little difference, as I understand it, is where you stick the needles. Competing interests: None declared |
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Konstantinos Papilas, Anaesthesiologist Halkis, Haina 32 st, Greece 34100
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This is an excellent well organized study addressing the methodological problems of RCTs and placebo (incidental) effects whithin the framework of a complex intervention, such as acupunture. The study has sufficient power to detect statistically significant differences between groups, even more so for clinically significant differences. This fact speaks for itself. It is not just that the secondary null hypothesis cannot be rejected. Minimal acupunture was performed by experienced practioners. Blinding is not possible and definetely the practioners intended to treat their patients, as sessions with needling where included in both groups. The results at least imply that acupuncture is a real mode of treatment not confined to needling (either "sham" or not). What if not doctors or other health care practitioners, who have no prior knowledge of acupuncture and intention to heal, performed just superficial needling? As an anaesthesiologist, I know there is plenty of evidence on the importance of the preoperative visit and all experienced colleagues know that the quality of an anaesthetic approach goes far beyond administering particular drugs or employing certain techniques, more so in pain management. Medicine and health services do not obey only to the laws of industrial or financial management. They are not humanitarian, but humane. The time, particularly for academic medicine, to reconsider, rediscover and redefine the scientific tools that have contributed to its great progress -before they become its own chains - has come. kpapilas@hlk.forthnet.gr Competing interests: None declared |
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Takashi Seki, assistant professor Department of Geriatric and Complementary Medicine, Center for Asian Traditional Medicine Research,, Koh Iwasaki , Katsutoshi Furukawa , and Hiroyuki Arai
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EDITOR- In a recent report, Dieter Melchart and colleagues used superficial needling as a sham intervention, and they showed that the sham needling had a similar effect in the treatment of patients with tension-type headache as semistandardised acupuncture treatment.1 However, some important investigational obstacles regarding acupuncture therapy remain to be resolved. It is assumed that there are specific effects from each acupoint and that the effects obtained from a specific acupoint may vary depending on the maneuver employed.2 Therefore, great care should be taken as to the choice of acupoints and the type of maneuver performed. Acupuncturists choose acupoints and stimulus methods based on traditional medical diagnoses. However, the diagnosis, choice of acupoints, and choice of maneuver may vary. Even in textbooks of traditional Chinese medicine, the treatment acupoints vary.2 Further, different types of traditional acupuncture are performed in China, Japan and Korea. For instance, auricular acupuncture is generally accepted.3 In one school of Japanese acupuncture, a light shallow needling technique, similar to what Melchart and colleagues used as a sham acupuncture, is performed with positive clinical effects.4 Similarly, we showed that a simple needling with no de qi and with no manipulation can induce remarkable effects on the human body.5 Finally, the skills of the acupuncturist are not equal among all acupuncturist, and quantifying the skills of acupuncturist is difficult. Traditional Chinese medicine evaluates the disease and the patient from a different point of view from that of modern western medicine. Many different clinical stages may exist in patients with tension-type headache, and, if the clinical condition varies, the acupoints should also vary. Findings from the current study suggest that acupuncture shows promise for the treatment of tension-type headache. Further investigation of this treatment modality appears to be warranted. 1 Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K, Melchart D. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ, doi:10.1136/bmj. 38512.405440.8F (29 July) 2 Giovanni M. The Practice of Chinese Medicine. Edinburgh: Churchill Livingstone, 1994: 3 Avants SK, Margolin A, Holford TR, Kosten TR. A Randomized Controlled Trial of Auricular Acupuncture for Cocaine Dependence. Arch Intern Med 2000; 160(15): 2305 - 2312. 4 Birch S. Jamison RN. Controlled trial of Japanese acupuncture for chronic myofascial neck pain: assessment of specific and nonspecific effects of treatment. Clin J Pain.1998; 14(3):248-55 5 Seki T, Hayashi H, Yamada S, Iwasaki K, Toba K, Arai H, Sasaki H. Acupuncture for Dysphagia in Poststroke Patients: A Videofluoroscopic Study. J Am Geriatr Soc 2005;53: 1083-1084. Competing interests: None declared |
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David Reilly, Consultant Physician, Director of ADHOM Academic Departments The Centre for Integrative Care, Glasgow Homoeopathic Hospital, 1053 Great Western Road, Glasgow G12
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This excellent study and spark to debate (1) showed that both interventions were better than waiting for care – and clearly both interventions were useful (responders were ‘46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. ‘ May be this is another ‘double positive paradox’ where the attempt at a ‘sham’ therapy turns out to be so active in its own right, that it raises the bar for any other competing treatment (2). Sometimes those ‘non-specific effect’ of intention, touch, care, expectation, and other context impacts, will take someone’s healing so far that any other effective treatment will have difficulty achieving an additional effect - all the more perhaps when with acupuncture people are claiming effects from non-specific needling. The active intervention is a rider hitching a lift on the back of the already galloping horse of placebo. So we may be seeing the successful addition of a supplementary effect from ‘real’ acupuncture struggling to show through. However this is all the more complex because you cannot double-blind acupuncture. The additional effect may in turn be wholly, (or even more complexly, partly) due to the ‘transmitted clinicians expectation of outcome’ becoming more enlivened when they are administering what they consider a better-than-the -sham intervention. Work at the University of Glasgow showed patients with asthma reacting in very different (even opposite) ways to 2 identical placebos given by the same care team - when the context changed from single blinding to double blinding, in turn altering the researchers and clinicians expectations (3). This echoed Gracely et als finding of different analgesic effects with altered clinician expectations (4). How about a fresh post-hoc power calculation from the team: In a future study, how many patients would be needed to distinguish the effects of the two ‘active’ interventions here? David Reilly, Director, ADHOM Academic Departments, The Centre for Integrative Care, Glasgow Homoeopathic Hospital, 1053 Great Western Road, Glasgow G12 OXQ davidreilly1@compuserve.com 1. Melchart D, Streng A, Hoppe A, et al. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ 2005;331:376-382 (13 August), doi:10.1136/bmj.38512.405440.8F (published 29 July 2005 2. Reilly D. When is useful improvement a waste of time? Double positive paradox of negative trials. BMJ 2002;325:41 ( 6 July ) 3. Reilly DT, Taylor MA. Individual Patients and Their Responses. Published in - Developing Integrated Medicine. RCCM Research Fellowship in Complementary Medicine. .Complementary Therapies in Medicine 1993;1 Suppl 1: 26-28. 4. Gracely RH, Dubner R, Deeter WR, Wolksee PJ. Clinicians' expectations influence placebo analgesia. Lancet 1985;i:43 Competing interests: None declared |
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Ulrich Ronellenfitsch, PhD student University Hospital Heidelberg, Dpt. of Tropical Hygiene & Public Health, 69120 Heidelberg, Germany
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Sir, in a randomised control trial, Melchart et al. find that patients witch tension-type headache receiving either "genuine" or sham acupuncture have significantly fewer headaches than those on a waiting list.(1) By recruiting participants via newspapers, the study overcomes the limitation of numerous previous studies which included only attendants of specialised institutions such as headache clinics.(2) Nevertheless, the patients recruited here might still not be an unbiased sample of all patients with tension-type headache. The will to enrol into a clinical trial where acupuncture is among the offered treatments might depend to a large extent on one's general attitude towards this technique. Someone who a priori does not believe in this "alternative" technique might not want to participate in such a trial but opt exclusively for "standard" treatment. Consequently, patients believing in acupuncture might enrol more frequently than those who don't share this belief. In the present study, the proportion of participants expecting an improvement due to acupuncture is more than two times higher than in a study assessing attitudes towards acupuncture as a treatment for preoperative anxiety.(3) This is a clear hint towards bias in the present sample. Such a biased sample might have distorted the results considerably. Those receiving acupuncture might have experienced a much stronger effect of treatment since it is their preferred method whereas the therapeutic effect in the control group might have diminished because the patients were not given the treatment from which they expected an improvement. This would have led to a gross overestimation of the presumed effect of acupuncture. I do not doubt that acupuncture can be an effective treatment for patients with tension-type headache believing in that method but it is still to be shown that it is also an effective treatment in patients who don't believe in the wholesome effect of acupuncture. 1 Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ 2005;331:376-382 2 Melchart D, Thormaehlen J, Hager S, Liao J, Linde K, Weidenhammer W. Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial. J Intern Med. 2003;253:181-8 3 Wang SM, (2)Peloquin C, Kain ZN. Attitudes of patients undergoing surgery toward alternative medical treatment. J Altern Complement Med 2002;8:351-6. Competing interests: None declared |
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Harald G. De Cauwer, neurologist KLINA regional hospital, Augustijnslei 100, B2930 Brasschaat, Belgium
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In a recent article Melchart et al demonstrated that acupuncture was not better than ‘sham’ acupuncture at non acupuncture sites.1 Nevertheless, in both groups the amount of responders (>50% reduction in days with headache) was very high (46 and 35% respectively). This was in contrast with the controle group who were placed on a waiting list. Other studies with acupuncture also failed to demonstrate a significant better outcome compared to placebo groups (‘sham‘ acupuncture). Only laser acupuncture seemed to be better than placebo (same procedure but output power was set to zero).2 The therapy was given for 3 weeks, but the beneficial effect lasted for three months. Also other therapies failed to demonstrate any improvement compared with placebo: e.g. injection of botulinum toxine.3-5 These studies look for a difference between ‘real’ and ‘sham’ procedures. In both groups patients are hoping to get much benefit from the procedure so a placebo effect can be expected. Just taking care of patients, listen to their complaints can induce a reduction of tension. Moreover, feeling at ease because other diagnoses (e.g. cerebral tumour) were ruled out, could reduce headache complaints. On the other hand, placing patients on a waiting list could induce an adverse effect: this could negatively influence the complaints because patients experience they are not been taken care of. As far as I know just one other remedy proved to be better than placebo: tiger balm reduced headache significantly better than topical balm with menth essence and revealed to be as beneficial as acetaminophen.6 What should a clinician advise to his patients? A basic rule of medicine is not to harm patients. So I would not advise the very expensive botulinum toxine. Patients reported muscle weakness of the neck or eye lids… Also acupuncture causes some extra complaints. Tiger balm on the contrary is easy to use, on daily basis, is very cheap and side effects are not reported. References: 1. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005; 331(7513):376-82. 2. Ebneshahidi NS, Heshmatipour M, Moghaddami A, Eghtesadi-Araghi P. The effects of laser acupuncture on chronic tension headache--a randomised controlled trial. Acupunct Med. 2005 ;23(1):13-8. 3. Padberg M, de Bruijn SF, de Haan RJ, Tavy DL.Treatment of chronic tension-type headache with botulinum toxin: a double-blind, placebo- controlled clinical trial. Cephalalgia. 2004; 24(8):675-80. 4. Schulte-Mattler WJ, Krack P; BoNTTH Study Group.Pain. Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double -blind, placebo-controlled multicenter study. 2004;109(1-2):110-4. 5. Rollnik JD, Tanneberger O, Schubert M, Schneider U, Dengler R. Treatment of tension-type headache with botulinum toxin type A: a double- blind, placebo-controlled study. Headache. 2000;40(4):300-5. 6. Schattner P, Randerson D. Tiger Balm as a treatment of tension headache. A clinical trial in general practice. Aust Fam Physician. 1996; 25(2):216, 218, 220 Competing interests: None declared |
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Dieter Wettig, PhD, MD, Private Practice 65199 Wiesbaden - GERMANY
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The publication Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A, Brinkhaus B, Becker-Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Willich SN, Weidenhammer W: Acupuncture Randomized Trials (ART) in Patients with Migraine or Tension-Type Headache - Design and Protocols. Forsch Komplementärmed Klass Naturheilkd 2003;10:179- 184 (DOI: 10.1159/000073473) was published online (download) in August 2003 and was also made available through German libraries free of charge also to patients. This potentially unblinding publication made public all secret details of the study under discussion: All verum and sham acupuncture points were described in great detail. This maybe enabled patients to identify to which group (verum or placebo) they belonged, while they were still treated. In the study under discussion two evaluators had to analyse patients` headache diaries. Whenever patients made remarks in their diaries relating to the locations of their acupuncture needles, evaluators could guess to which group the patients belonged. The probability of that guess to be true was higher than mere chance when evaluators had been unblinded. Whenever a patient mentioned that the acupuncturist inserted the needles only a little bit and that this was not painful at all, unblinded evaluators could guess that this patient received sham acupuncture. A bias was introduced into the evaluation of the headache diaries. Recruitment for the headache study ended in January 2004, that means this study run fully unblinded! This practice has nothing to do with publishing the design in advance in trial registers. Devereaux et al. (2002) wrote: "When unblinded, participants may introduce bias through use of other effective interventions, differential reporting of symptoms, psychological or biological effects of receiving a placebo (although recent studies show conflicting evidence), or dropping out. .... " (Deveraux PJ, Bhandari M, Montori VM, Manns BJ, Ghall WA, Guyatt GH, Double blind, you have been voted off the island!. McMaster University, Hamilton, Ontario, Canada. Evidence-Based Mental Health. 5(2):36-7, 2002 May ) With kind regards Dieter Wettig, Ph.D., M. D.
Competing interests: None declared |
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Dieter Wettig, PhD, MD, Private Practice 65199 Wiesbaden - GERMANY, -
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In addition to my Rapid Response Was it a good idea to publish the study-design before the end of the study ? I want to illustrate the extend of the unblinding information given in the article Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A, Brinkhaus B, Becker-Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Willich SN, Weidenhammer W: Acupuncture Randomized Trials (ART) in Patients with Migraine or Tension-Type Headache - Design and Protocols. Forsch Komplementärmed Klass Naturheilkd 2003;10:179- 184 (DOI: 10.1159/000073473) This article was published online (download) in August 2003 and was also made available through German libraries free of charge also to patients. Recruitment for the study under discussion ended in January 2004, that means this study run fully unblinded! Find Details under http://www.angelfire.com/sc/naturheilverfahren/cgi-bin/points.JPG Competing interests: None declared |
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Michal R. Pijak, Consultant in Internal Medicine, Rheumatology and and Clinical Immunology 1 Department of Internal Medicine, University Hospital, Limbova 5, 83305 Bratislava, Slovakia
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I share Sharif Elleithy’s (1) critique that covering title for the Melchart et al’s (2) article on bmj homepage is misleading. According to this title "Acupuncture is no better than no treatment for headaches". This statement is in marked contrast with study results, which showed significant and clinically relevant effect of acupuncture over no treatment but not over minimal (modified) acupuncture. Moreover, the size of the effect seems to be larger than that found in trials comparing placebo interventions with no treatment.(3) Nevertheless, since the study did not include a a physiologically inert placebo group, it is impossible to exclude placebo effect. Lastly, it should be remembered that inappropriate claims of no effect or no difference should be avoided because they may suggest that further research is unnecessary. (4) 1. Elleithy SM. Covering title a misrepresentation. http://bmj.com/cgi/eletters/331/7513/376#114506, 12 Aug 2005 2. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S et al. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ 2005;331:376-82. 3. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001;344: 1594-602. 4. Alderson P. Chalmers I. Survey of claims of no effect in abstracts of Cochrane reviews. BMJ 2003; 326: 475 Competing interests: None declared |
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Alexander Macdonald, medical practitioner 19 Richmond Hill Bristol BS8 1BA
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This brave work confirms a long line of studies that Godfrey et al 1978 started in Toronto when an experienced physician, a graduate of Shanghai 2nd Medical College, was flown in to administer ‘appropriate’ acupuncture for relief of chronic dull non-inflammatory pain: the benefits he provided were compared with those achieved by Canadian practitioners who not only were ignorant of acupuncture but had been misinformed as to where the patient’s site of pain actually was. A screen separated the patient’s body from the head and neck so he or she could not spot which practitioner was which. A communicator explained in a bland voice why acupuncture required needles to be placed where they were even if they were at the other end and on the opposite side of the body. There was no significant difference between the two groups: in excess of 56% of both groups obtained relief. The fact that people in pain obtain so much relief when needled suggests this stimulus is of value wherever it is applied in relation to the site of pain. A lot goes on in the brains of those who volunteer to have a needle inserted, especially those who volunteer for a trial. Who would normally wish to lie still when someone advances upon them with a needle, especially when they might receive the ‘wrong’ treatment? A considerable degree of inhibition must be in place in the minds of those to allow this treatment to occur. Attention in the patient's mind is paid to the effects of needling, which anyone will remember if they have been subjected to a splinter or thorn. The desire for this new event not only to be painless but also relieve pain would be expected to promote changes within the CNS that are associated with pain inhibition, as molecular imaging studies by positron emission tomography have shown (Zubieta et al 2005). The existence of pathways where ascending activity arising from Aδ input excited by acupuncture can stimulate descending pain inhibitory pathways that affect all segments have been discovered (Bowsher 1998) and similar descending pain inhibitory pathways become active during the administration of morphine and induction of placebo. Unfortunately we still do not have access to the gold-standard double- blind needling system - where neither the practitioner nor the patient knows whether they have or have not been needled. Until we do, one’s desire to perform an analysis of needling locations and techniques versus placebo can not be satisfied. Park et al 1999 and Streitberger et al 1998 have both designed different types of sham needles: however neither sham needle fools the experienced practitioner. The fact we do not have access to a double-blind placebo controlled trial of acupuncture does not necessarily condemn a technique that is bound to excite complex peripheral and central changes (Sjölund 2005). If the Chinese have discovered the ‘perfect placebo’, then I say well done. However there are clues that suggest otherwise. What is so interesting is that if acupuncture did not provide a specific beneficial effect one would expect its benefit to be reduced as the treatment is repeated – but generally the reverse is true. One would not expect the treatment to be dose-related: too little needling, no effect; just right, relief is produced; but too much noxious stimulation can be followed by an increase in the patient’s complaint, a worsening that is often speedily resolved by further stimulation. It is not easy to explain why the onset of such changes occur usually after a delay of 12 to 48 hours. If these surprising effects could be documented and if we could agree these are ‘specific effects’ as compared with the so called non- specific effects usually associated with placebo then at least some advance in the credibility of this subject could be maintained. I wonder if in their more detailed unpublished records the authors documented effects that in their opinion were unlikely to be those of placebo and whether these differed in any significant way between the two groups? REFERENCES Bowsher D (1998) Mechanism of acupuncture. In: Medical Acupuncture, a Western Scientific Approach. (Eds) Filshie J, White A. Churchill Livingstone. pp69-82 Godfrey CM, Morgan P (1978) A controlled trial of the theory of acupuncture in musculoskeletal pain. Journal of Rheumatology 5 121-124 Park J, White A, Lee H, Ernst E (1999) Development of a new sham needle. Acupuncture in Medicine 17 110-112 Streitberger K, Kleinhenz J (1998) Introducing a placebo needle into acupuncture research. The Lancet 352 364-365 Sjölund B (2005) Acupuncture or acupuncture? Pain 114:311-312 Zubieta J-K, Bueller JA, Jackson LR, Scott DJ, Xu Y, Koeppe RA, Nichols TE, Stohler CS (2005) Placebo effects mediated by endogenous opioid activity on µ-opioid receptors. The Journal of Neuroscience 25(2005)7754- 7762 Competing interests: None declared |
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Klaus Linde, Epidemiologist Centre for Complementary Medicine Research, TU Munich, 80801 Munich, Germany, Dieter Melchart, Andrea Streng, Andrea Hoppe, Wolfgang Weidenhammer, Benno Brinkhaus, Claudia Witt, Stefan N Willich
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We greatly appreciate the multiple responses to our article. Indeed, as mentioned by Elleithy (12 August 2005) and Pijak (5 September 2005) the covering title on the BMJ’s website was misleading. We agree with Papilas (14 August 2005) that the fact that experienced practitioners performed minimal acupuncture might have influenced the results in an important manner. Seki et al. (15 August 2005) point to the multiple problems in acupuncture trials. There is certainly not one single correct way to do clinical trials in this area. We want to emphasize that our results cannot be extrapolated to all acupuncture but only apply to the interventions studied. As Ronellenfitsch (17 August 2005) mentions our participants had a highly positive attidute towards acupuncture and results might be less positive in “non-believers.” However, this could also apply to “standard” interventions and the enormous number of patients seeking acupuncture care in Germany is evidence that at least in this country the positive attitude towards this therapy is very widespread. De Cauwer (19 August 2005) recommends the use of tiger balm instead of acupuncture. However, tiger balm aims at treating acute headaches while acupuncture aims primarily to reduce the frequency and intensity of headache in a more preventive approach. Perhaps acupuncture and tiger balm could well be used together. Wettig (23 August and 4 September 2005) speculates that participants and diary evaluators have been unblinded by the publication of our protocol before the trial was completed. Diary evaluators and patients did not have any contact and there was not any diary on which participants made a remark on the treatment received. So unblinding of evaluators can be ruled out. Unblinding of patients recruited or observed after the protocol publication by reading details on the minimal acupuncture intervention in a specialized medical journal or in the abstract in the internet is theoretically possible but highly unlikely. Furthermore, we did an additional analysis restricted to the patients in whom data collection for the main outcome measure was completed before the protocol publication. This analysis yielded results which were almost identical to those of the analysis including all patients. We agree with the majority of the commentators that the response to both acupuncture and minimal acupuncture in our trial was clinically highly relevant. The high response to minimal acupuncture suggests that expectations, interactions, empathy and other factors associated with “good” care play a major role. Competing interests: None declared |
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Dieter Wettig, PhD, MD, Private Practice 65199 Wiesbaden - GERMANY, -
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The authors speculate that participants have not been unblinded by the publication of the detailed study protocol before the trial was completed. They maintain that "unblinding of patients recruited or observed after the protocol publication by reading details .... in a specialized medical journal or in the abstract in the internet is theoretically possible but highly unlikely." What exactly does "highly unlikely" mean statistically and how can this assumption be evidence based? Quite the opposite seems to be true, because the study plan was freely available in German libraries to all patients and the internet sources could be found easily by a simple google or pubmed search http://www.angelfire.com/sc/naturheilverfahren/cgi-bin/s1.htm http://www.angelfire.com/sc/naturheilverfahren/cgi-bin/s4.htm http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ProduktNr=224242&Ausgabe= 229609&ArtikelNr=73473&filename=73473.pdf The authors now mention an additional analysis restricted to the patients in whom data collection for the main outcome measure was completed before the protocol publication. They say that "this analysis yielded results which were almost identical to those of the analysis including all patients." Since they do not give any figures for this additional analysis its results must be disputed. The term "almost identical" is rather unscientific. The study under discussion did not observe good clinical practice rules. Competing interests: None declared |
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Mahmood Ahmad, ST3-LAT ITU Medway Maritime Hospital, Gillingham, Kent, ME7 5NY
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The ICH-GCP guidline has been the standard for conducting clinical trails that involve human subjects.[1]There are thirteen principles of ICH -GCP The EMEA as a part of the EC has published two guidelines 2001/20/EC EU Clinical Trials Directive and 2005/28/EC EU Good Clinical Practise Directive. The MHRA in the UK is reponsible for proposing legislation e.g the 2001/20/EC EU Clinical Trials became the Medicines for Human Use (Clinical Trails) Regulations 2004 and 2005/28/EC EU Good Clinical Practise became the Medicines for Human Use Clincal Trail Amendment regulations 2006. [1] Ugeskr Laeger. 2003 Apr 14;165(16):1659-62.Links [ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives]Englev E, Petersen KP. Competing interests: None declared |
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