Critical Appraisal of the Research about Traditional Chinese Medicine and Acupuncture by Melchart - Term Paper Example

Critical appraisal of Melchart et al. (2005) This work is a critical appraisal of Melchart et al. (2005) which is a quantitative research. Aim of the research. The aim or objective of the research is to “investigate the effectiveness of acupuncture compare with minimal acupuncture and with no acupuncture in patients with tension-type headache. Appropriateness of quantitative research methodology. A quantitative research methodology is highly appropriate for the research objective. Quantitative research methodology can allow us to determine whether the quantitative differences among the effects of treatment vary across treatments. The three modes of treatment are acupuncture, minimal acupuncture, and no acupuncture. Fundamentally, the treatment is acupuncture but the research methodology/research design allows us to assess validate whether acupuncture really works by introducing a third situation: minimal acupuncture instead of only no acupuncture. On closer analysis, however, what Melchart et al. (2005) described as “minimal acupuncture” is actually zero acupuncture because the “minimal acupuncture” consisted of superficial needling at non-acupuncture points and were meant to investigate whether acupuncture have placebo effects and, if so, how of its possible effects in headache is classifiable as placebo. According to Mechart et al. (2005, p. 376), acupuncture and minimal acupuncture were administered by specialising physicians and consisted of 12 sessions for patients over eight weeks. The mobilization of “specializing physicians” raises a concern whether there is “treatment fidelity” consistent with the articulation of Rolvsjord (2005, p. 22). According to Rolvsjord (2005, p. 22), treatment fidelity is an important concern because “results of the study will only be valid if the therapy provided is true to the underlying theory and goals, and if it is provided in a comparable manner for all participants.” Meanwhile, according to Melchart et al. (2005, p. 1-3), the “no acupuncture” regimen was implemented through wait listing. Appropriateness of research design. The research design used is “three armed randomised controlled multicentre trial”. The research design factors in the possibility to investigate the possibility whether acupuncture work because of a placebo effect that acupuncture may have on patient. The “three armed randomised controlled multicentre trial” uses three groups: a no-treatment group, a treatment group, and a false treatment group to investigate whether the performance of the treatment is just as good as a placebo. In contrast, the study of Gough et al. (2008) made use of a “two-armed randomised controlled international multicentre trial” and used only two groups: a treatment and no-treatment group. According to Stanley (2007, p. 1164), “a major factor in the rapid advance of medical science in the past 50 years has been the development and refinement of the clinical research method known as the randomised controlled trial,” of which the “three-armed randomised controlled multicentre trial” is one. According to Vas et al. (2008, p. 4) pointed out that one strength of the “three-armed randomised controlled multicentre trial is that the randomisation process help ensure that the randomisation process is not affected by the participating doctor. From Rothwell (2006), several insights can be derived on conducting randomised controlled trials. Firstly, randomised controlled trials must internally valid or that the design and conduct of the study must eliminate the possibility of bias (Rothwell 2006, p. 0001). Secondly, for the randomised controlled trial to be clinically useful, the results must be relevant to a group of patients in a particular clinical setting (Rothwell 2006, p. 0001). Rothwell (2006, p. 0001) associated relevance to a particular clinical setting with external validity. Thus, Rothwell (2006, p. 0001) stressed that while the determinants of internal validity are intuitive, ensuring external validity “requires clinical rather than statistical expertise.” Rothwell (2006, p. 0001) elaborated that while the result of randomized controlled trials will never be relevant to all patients and settings, they should be designed and reported in a way that will allow the clinician to judge to whom the results can be applicable. Further, Roth well (2006, p. 0002) reminded that in controlled trials, “trials should not include centres that do not have the competence to treat patients safely, but the selection should not be so exclusive that results cannot be generalized to routine clinical practice.” Related to the Melchart et al. (2005) research, there is not assurance that the “specializing physicians” tapped for the study are adequately competent to ensure external validity. As pointed out by Rothwell (2006, p. 0001), “how centres and clinicians were selected to participate in trials is seldom reported, but cal so have important implications for external validity.” Perlmutter (2007, p. 14) clarified that “randomisation assigns patients to treatment arms by chance, avoiding any systematic imbalance between patients who will receive the experimental versus the control intervention.” In a two-arm trial, Perlmutter (2007, p. 14) pointed out that there are two groups: one experimental and one control. However, control trials involve more than two groups (Perlmutter 2007, p. 14). Hutchison and Styles (2010, p. 7) emphasized that a good random controlled trial must at least two characteristics: 1. Selection bias is eliminated and the study can generate a general a causal conclusion. 2. It avoids misleading results and has adequate controls. It follows that, fundamentally, the two aforementioned criteria must be used in the analysis of the Melchart et al. (2005) research design. Sampling. The sample consists of 270 patient with episodic or chronic tension-type headache in 28 outpatient centres in Germany. Seventy-four percent of the 270 patients are women and the mean age of the sample is 43 with a standard deviation of 13 years. The sampling procedure followed by Melchart et al. (2005) avoids a specific bias that can emerge in randomised controlled trials: according to McCann et al. (2010, p. 1), participant reasons for joining in randomised controlled trials may be conditional altruism and consideration for the self. One possible problem of the Melchart et al. (2005) study is whether the sample is adequately homogenous and whether or not they have reported objectively. According to Melchart et al. (2005, p. 376), “most of the participants were recruited through reports in local newspapers; a minority were patients who spontaneously contacted trial centres.” This manner of sample selection makes possible the recruitment of participants that can feign illness or headache. Participants can also feign recovery from an illness or headache, which is the focus of the Melchart et al. (2005) study. Further, given this manner of sample selection of the Melchart et al. (2005) study, it is worth investigating if the Melchart et al. (2005) study sample is a biased sample, given the prevailing bias against acupuncture and other non-conventional medicine or therapy. Meanwhile, a grave absence of adequate homogeneity can affect the external validity of the findings given that external validity requires “particular clinical setting” as pointed out by Rothwell (2006, p. 0001). At the same time, “strict eligibility criteria can limit the external validity” of the randomised controlled trial but “physicians should at least be able to select similar patients for treatment in routine practice” (Rothwell 2006, p. 0002). Unfortunately, the Melchart et al. (2005) study is five years ahead of the Treweek et al. (2010) study. Treweek et al. (2010, p. 2) recommended the inclusion of an evaluation of methods used for the recruitment of the sample in research reports as a possible factor that can affect the result of studies. Collection of data and address of research issue. Data on the effects of treatment were documented and analyzed: (1) from the third treatment; (2) after the treatment or twelve weeks since the start of the treatment; and (3) on a follow-up at weeks 21 to 24. In my opinion, this schedule of data collection has an underlying assumption that acupuncture works only on a long-term. A better design should consider the possibility that acupuncture works immediately after the first treatment and must gather data immediately after the first treatment. Data collection after the twelve-week period will only produce data that can suggest that acupuncture is as good as non-treating the headache because the human body can also heal itself of simple or non-serious illnesses over a fairly long time. For example, the human body can generally cure itself of colds and flu even if no medicines are administered. Thus, comparing two groups, no treatment or no medicine versus with medicine or treatment a year after a flu or cold could produce results that can tend to show that the cold or flu medicines are unnecessary. Consideration of relationship between researcher and participants. This is possibly a non-issue because of the randomisation procedure. Consideration of ethical issues. There is no indication that an informed consent of the study participants were solicited prior to the study. Thus, there is a possible violation of research ethics in the conduct of this research. Rigour of analysis. In my opinion, the study of Melchart et al. (2005) lacks rigour because acupuncture could be working as early as the first day of the treatment. If investigations are done (1) immediately after the third treatment; (2) after the treatment or 12 weeks from the start of the treatment, and on follow-up or (3) from 21-24 weeks since the start of the treatment, it is highly like that the patients would have improved their situation even without a treatment because the human body has the capability to cure itself of certain or non-serious ailments. Findings. According to Melchart et al. (2005), “the acupuncture intervention in the trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment for the treatment of tension-type headache.” In my opinion, the findings of Melchart et al. (2005) suggest that acupuncture has only placebo effects for tension-type headache. Value of research. The research is valuable but it lacks rigour for the findings to be conclusive and reliable. In my opinion, the Melchart et al (2005) research has the wrong assumptions in designing their study and has probably misled the public on the efficacy of acupuncture by the way they have designed their study. Conclusion. The Melchart et al. (2005) study while commendable for trying to put in the possibility of placebo effect of acupuncture is essentially a defective study. The Melchart et al. (2005) study assumes that therapies only have long-term effects, which is contrary to the facts or science of how many medicines and therapies work. Just like antibiotics, whose effects are real on the first session of treatment, it is possible that acupuncture have the same instantaneous effects. Of course, verifying or falsifying this assumption or hypothesis is the task of science. References Gough, M., Bodenham, A., Horrocks, M., Colam, B., Lewis, S., Rothwell, P., Banning, A., Torgerson, D., Gough, M., Dellagrammaticas, D., Leigh-Brown, A., Liapis, C., and Warlow, C., 2008. 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Rolvsjord, R., Gold, C., and Stige, B., 2005. Research rigour and therapeutic flexibility: Rationale for a therapy manual developed for randomised controlled trial. Nordic Journal of Music Therapy, 14 (1), 15-32. Rothwell, P., (2006). Factors that cam affect the external validity of randomised controlled trials. Plos Clinical Trials, May, 0001-0005. Stanley, K., 2007. Design of randomised controlled trials. Circulation (Journal of the American Heart Association), 115, 1164-1169. Treweek, S., Pitkethly, M., Cook, J., Kjelstrom, M., Taskila, T., Johansen, M., Sullivan, F., Wilson, S., Jackson, C., Jones, R., Mitchell, E., 2010. Strategies to improve recruitment to randomised controlled trials. The Cochrane Collaboration: John Wiley & Sons, Ltd. Vas, J., Rebollo, A., Perea-Milla, E., Mendez, C., Font, C., Gomez-Rio, M., Martin-Avila, M., Carbrera-Iboleon, J., Caballero, M., Olmos, M., Aguilar, I., Faus, V., and Martos, F., 2008. Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine. BMC Complementary and Alternative Medicine, 8 (12), 1-11. Read More