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Self-reported Changes in Health Status in a Traditional Chinese Medicine Centre: An Observational Study | OMICS International
ISSN: 2165-7025
Journal of Novel Physiotherapies
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Self-reported Changes in Health Status in a Traditional Chinese Medicine Centre: An Observational Study

Concetta Paola Pelullo1, Amanda Valdes Abuadili1, Ottavio Iommelli2 and Francesco Attena3*
1School of Hygiene and Preventive Medicine of the Second University of Naples, via Luciano Armanni, 5, Naples, Italy
2Traditional Chinese Medicine Centre of S. Paolo Hospital, via Terracina 219, Naples, Italy
3Department of Experimental Medicine of the Second University of Naples, via Luciano Armanni, 5, Naples, Italy
Corresponding Author : Francesco Attena
Department of Experimental Medicine
Second University of Naples
Via Luciano Armanni, 5
80138 Naples, Italy
Tel: +390815666030
Received December 10, 2014; Accepted December 31, 2014; Published January 06, 2015
Citation: Pelullo CP, Abuadili AV, Iommelli O, Attena F (2015) Self-reported Changes in Health Status in a Traditional Chinese Medicine Centre: An Observational Study. J Nov Physiother 5:243. doi: 10.4172/2165-7025.1000243
Copyright: © 2015 Pelullo CP, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Background: Traditional Chinese Medicine (TCM) is a complex medical system that includes acupuncture, pharmacology, massage, gymnastics, moxibustion and cupping among its treatments.

Methods: The aim of this study was to investigate self-reported changes in health after TCM treatment that primarily involved acupuncture. An observational study of 428 patients was undertaken in a TCM centre in the city of Naples during the period 2013–2014. Six months after the first examination, we conducted telephone interviews to obtain information about the socio-demographic characteristics of patients, their clinical diagnosis and the therapy administered. The self-reported change in health status was obtained from question two of the short form-36 (SF-36) health survey questionnaire.

Results: Of the 428 interviewees, 42.5% declared that they felt “much better”, and 31.8% felt “somewhat better” compared with the period before the treatment. The main reason for consultation was osteoarticular disorders (77.1%), divided into neck pain/dysfunctional limitations (41.6%), lower back pain/dysfunctional limitations (20.1%) and other reasons (15.4%). There were no statistical differences in the change in health status among the different diagnostic categories (p>0.05). Marked improvement was higher in women.

Conclusions: Despite the well-known limitations of observational design, our study shows a satisfactory level of effectiveness of TCM and contributes to the assessment of TCM in actual clinical practice.

Acupuncture; Observational study; Health service; Traditional chinese medicine
Traditional Chinese Medicine (TCM) is classified by the World Health Organization (WHO) among the acknowledged traditional medicines [1], consisting of a complex medical system that treats many diseases. The five essential tools for diagnosis and treatment in TCM are: 1) diagnosis of energy, which is a system of examining the patient by using diagnostic points primarily located on the wrists, eyes, skin and tongue; 2) Chinese pharmacology, which uses plants, minerals and animals in different ways than Western medicine; 3) acupuncture, a technique consisting of the introduction of thin needles into specific points of the meridians where energy flows; 4) massage, which acts on the muscle-tendon system, bones and joints, meridians and acupuncture points; and 5) medical gymnastics, which consists of the patient performing exercises coordinated with proper breathing.
The other two techniques of TCM are moxibustion, which is obtained by stimulating the acupuncture points with the heat of a torch herb (usually mugwort), and cupping, a technique in which ‘cups’ are applied to the patient’s skin after the air inside them has been heated.
However, the most widespread therapeutic technique is acupuncture. In 2012, among member states of the WHO, 18 states provided health insurance coverage for acupuncture, 29 had regulations for providers and 103 acknowledged its use. The integration of complementary medicine into health service delivery is among the objectives of the WHO. This presupposes a better knowledge of the outcomes of complementary medicine’s existing treatments [1].
To this end, we conducted an observational study in a TCM centre to evaluate self-reported changes in health status 6 months after acupuncture treatment.
The study was carried out in Naples during the period 2013–14 in the TCM centre based at S. Paolo Hospital. The centre was open 5 days a week, and acupuncture treatment was administered by two different doctors, with twenty years of acupuncture practice and a collaborative relationship with Henan TCM University of China.
For each patient were planned 10 sessions twice a week. Each session of acupuncture lasted about 20 minutes, according to the Traditional Chinese Medicine. The point of insertion changed according to the Chinese diagnosis. The needles were pre-packaged, sterile, single-use and bimetallic (copper grip and steel tip), manually stimulated, their dimension of 0.25 mm×25 mm and their number for each session ranging between 5 and 20. The insertion depth varying from 3 mm. to 3 cm, while the duration of insertion were 20 minutes. Appropriate stimulation was applied in order to attain the de qi sensation.
Patients were considered eligible to participate when they had undergone a traditional medicine (TM) treatment for the first time at the centre. In some cases the patients received only acupuncture treatment. In other cases, in addition to acupuncture, they also received one or more of the other TCM treatments. Subjects excluded were those who had already consulted another acupuncturist for the same or other disorders, those who had acute symptoms and required urgent treatment without an appointment, and the very few patients who did not receive acupuncture, but only another MCT treatment.
From January to July 2013 eligible patients were asked by the office staff whether they were willing to receive one telephone call, 6 months after the first visit, to give information for statistical purposes. For those who agreed, a written informed consent has been obtained and a card was immediately filled in containing: personal details, occupation and education level. The latter was coded as low (up to lower secondary school) or high (high-school diploma or university degree). At the time of the medical examination the doctor recorded the clinical diagnosis, the Chinese diagnosis and the therapy to be administered. Of the 470 subjects approached, 452 (96.2%) agreed to participate in the study.
When more than one disease was declared, the patient was asked to indicate the most important one. Only this diagnosis was used in the analysis. All the diagnoses were then grouped into broader categories.
All patients were interviewed by telephone by a single researcher 6 months after the first treatment (±15 days). The researcher asked respondents to evaluate any changes in their health that were due to the acupuncture treatment. Question two of the short form-36 (SF- 36) health survey questionnaire [2,3] was expressed as follows: ‘How do you evaluate your health 6 months after you started acupunctural treatment?’ Respondents were also asked whether therapy had been carried out properly, i.e. if the patient had completed all acupunctural treatments prescribed by the doctor (yes/no), whether treatment was still ongoing (yes/no) and whether the patient was satisfied with the care received (yes/no). In an attempt to reduce interviewer bias, the researcher asked the interviewee to answer sincerely and correctly as the information was required only for statistical purposes and the replies would be treated anonymously. To achieve the maximum response rate, telephone calls were made throughout the day and, as a last resort, during the weekend.
Sample size
The sample size was calculated by assuming a marked/moderate improvement of 70%, and a least acceptable result of between 67% and 73% with 95% confidence. The data were analysed using SPSS 12.0.
The Ethics Committee of the Second University of Naples approved this study (reference number 41/2012).
Results and Discussion
From the total of 452 patients for whom cards were completed, telephone interviews were obtained with 428 (94.7%). The following reasons were cited for not interviewing the remaining 24 patients: the patient refused to reply, was persistently unreachable, had moved, had changed telephone numbers or had died. Table 1 shows the sociodemographic characteristics of the patients and their satisfaction with the care received. The majority of patients were female (69.9%), between 41 and70 years old (63.6%), had a high level of education (67.8%) and were satisfied with the medical care they had received (93.2%).
In Table 2 the subjective benefits of the acupunctural treatment are reported. After 6 months 74.3% of the patients declared that they felt “somewhat” or “much better” compared with the period prior to starting the treatment. “Much better” was reported with greater frequency (42.5%). When we exclude the patients who did not start or did not complete therapy, 84.8% of patients declared that they felt “somewhat” or “much better” and half of them felt “much better” (48.5%).
The main reasons given for consultation (Table 3) were osteoarticular disorders (77.1%), divided into neck pain/dysfunctional limitations (41.6%), lower back pain/dysfunctional limitations (20.1%) and other reasons (15.4%).
There are no statistical differences in the self-reported changes in health status among the different diagnostic categories (p>0.05). Marked improvement was higher among females, housewives and, as expected, those who were satisfied with the care they received (Table 4).
We did not perform a logistic regression analysis because housewives are a subgroup of females, while the other two variables (completed therapy and satisfaction) had cells with few or no records.
Although the centre is a generalist outpatient clinic, 77.1% of diagnoses reported were osteoarticular diseases. Similarly, 84.8% of patients declared that they felt “somewhat” or “much better”. Among these respondents, females/housewives reported even better outcomes [4].
In recent years, there has been a remarkable proliferation of random controlled trials (RCTs), and reviews about RCTs [5-8] to do with the efficacy of acupuncture on neck and lower back pain. Indeed, while a review published in 1999 included only 11 RCTs on these topics [9], a review published in 2010 included 105 RCTs [6]. Despite this amount of information, there is still considerable uncertainty about the effectiveness of acupuncture for these specific conditions. Some authors still note the need for further studies “to draw more definitive conclusions regarding benefits and safety of complementary and alternative medicine” [10] in neck and low-back pain.
This uncertainty has been interpreted both as a problem caused by heterogeneity among RCTs and as an indicator of the presence of potential bias [11]. Specifically, MacPherson et al. [12] have identified the following characteristics associated with different outcomes: the style of acupuncture, the point prescription, the location of needles, whether electrical stimulation and moxibustion were used, whether acupuncture-specific patient–practitioner interactions were allowed, the acupuncturist’s level of experience, the number, frequency and duration of sessions, and the number of needles used. The type of relationship [13] and the acupuncturist’s communication of optimism about treatment also seem to improve outcomes [14]. Moreover, TCM is dependent on a specific philosophical and cultural background that is essentially alien to Western culture, and this has led to problems with integration [15]. Finally, acupuncture, together with the other TCM treatments, must be considered as a weak intervention [16] that is probably more sensitive than Western therapy to contextual influences and the placebo effect. These putative causes of heterogeneity make RCTs less generalisable, and the corresponding reviews less reliable. Therefore, the main focus of future research should be to produce different levels of standardisation among RCTs to identify the variables associated with better outcomes.
In contrast, observational studies can contribute to evaluating the outcomes of TCM as a whole in single health services and to validating their activities. Moreover, they can apply to a wider sample, cover a longer period of observation and reflect actual clinical practice.
The main limitations of the study are all the usual limits of observational studies in comparison with randomised control trials. These include the subjective detection of the outcome and the lack of a separate assessment of the different treatments of TCM.



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