Monday, 13 August 2018

Effectiveness of Acupuncture as Auxiliary Treatment for Chronic Headache

Journal of Acupuncture and Meridian Studies Available online 27 July 2018 open access In Press, Uncorrected ProofWhat are Uncorrected Proof articles? Journal of Acupuncture and Meridian Studies Research Article Author links open overlay panelWildeteMayrinkJoãoGarciaAlcionedos SantosJoanaNunesTárciaMendonça Federal University of Maranhão, Brazil Get rights and content Open Access funded by International Pharmacopuncture Institute Under a Creative Commons license Abstract Objectives To assess the effectiveness of acupuncture as an auxiliary analgesic treatment for chronic headaches and the influence of this treatment on the quality of life, as the effectiveness of acupuncture in chronic headache is still controversial. Methods Thirty-four patients selected from a University Hospital Clinic on Chronic Pain were divided into two groups: True acupuncture (Group 1), in which the recommended points of the Traditional Chinese Medicine were used for each type of headache and sham acupuncture (Group 2), in which the needles were inserted into a device (the stick-on moxa), at the same points as Group 1. Both groups used the prescribed preventive medication for pain. The verbal numeric scale before (VNS0) and after (VNS1) treatment, the number of crisis, and the number of analgesics used during the first and second months of treatment were used for assessment. Quality of life was also assessed before and after treatment with the Brazilian version of the Quality of Life Questionnaire: SF-6D, 2002. Results The true acupuncture group showed greater effectiveness in controlling pain in chronic headache, which was statistically significant in all domains compared to the sham acupuncture group, including quality of life. Conclusions Acupuncture can be considered an auxiliary treatment for chronic headache, reducing the intensity of pain, the number of crisis, the quantity of analgesics used, and improving the quality of life in patients with this painful condition. Keywords Acupuncture Headache Quality of life 1. Introduction Headaches are prevalent, disabling, underdiagnosed, and undertreated worldwide, with an estimated world prevalence of 46% in the adult population [1]. Studies on the epidemiology of headache in Brazil show higher prevalence rates, ranging from 43% to 93%, when compared to the estimates of prevalence around the world [2]. Chronic headaches sometimes require continuous treatment with preventive drug combinations such as beta blockers, antidepressants, and anticonvulsants, and during a crisis, with drugs such as triptans and nonsteroidal antiinflammatory drugs. Although they have good results, these drugs are not always well tolerated, and there is a need for supplementary therapies for treatment [3]. The causes for the failure of treatment of headaches were grouped into the following: diagnosis was incomplete or incorrect, important triggering factors were not minded, pharmacotherapy had been inadequate, nonpharmacological treatment had been inadequate, and other factors, including expectations and comorbidities [4]. In the scenario of difficulty in controlling chronic headache with treatment, it is necessary to increase the use of auxiliary measures in an attempt to minimize the problem. Acupuncture has a long history in the treatment of many painful conditions, including headaches. Its effectiveness has been studied mainly in primary headaches, particularly migraines and tension-type headaches (TTHs) [5]. A literature review concluded that acupuncture reduces the need for medication, provides analgesia and relaxation, promotes the release of opioids, and produces homeostatic effects and psychological harmonization of the individual. Acupuncture is highlighted as a nondrug, effective therapy for treating migraines, besides being safe, economic, and having few adverse effects [6]. Two other systematic reviews on the effectiveness of acupuncture in migraine and TTH, respectively, suggest that it is an effective and valuable treatment option [7], [8]. Although these studies suggest the therapeutic effect of acupuncture on headaches, the results are controversial. This may be explained by the limitations of the studies with regard to the sample size, different techniques used, and most importantly because the most commonly used placebo is the so-called sham acupuncture, which ranges from the use of points on the body apart from the acupuncture points to minimally invasive insertion of needles, use of masking devices, or no insertion of the needle [9], [10]. The main aim of this study was to assess the effectiveness of acupuncture as an auxiliary treatment for chronic headache, using a new placebo method, which may encourage new research and increase the use of acupuncture as a therapeutic method, to improve the patients' quality of life. 2. Materials and methods 2.1. Type of study This is a randomized, placebo-controlled, double-blinded clinical trial, with patients who were under treatment at the Federal University of Maranhão's University Hospital Clinic on Chronic Pain. 2.2. Sample under study Sample size calculation was performed considering a 5% significance level, and an 80% power to detect a difference of three in the verbal numeric scale (VNS) scores between the real and sham acupuncture groups. A total of 16 participants per group were reached. Compensating for the possible losses, the sample was amplified by 10% more to reach a total of 40 participants. Patients included in the study were females aged between 18 and 60 years, with chronic headache using medication prescribed by the pain specialist, who had never undergone acupuncture treatment. The noninclusion criteria were patients with decompensated and/or severe arterial hypertension, patients who were diagnosed with secondary headache, and patients who were under treatment with physical therapy or other nondrug auxiliary treatment. The women included in the study were divided into two groups: true acupuncture (Group 1) and sham acupuncture (Group 2). Each patient was allocated into one of the study groups by random drawing. Two patients were excluded for not adhering to the drug treatment, and four patients abandoned the research. Therefore, the sample under the study comprised of 34 patients (Group 1, n = 17; and Group 2, n = 17). All patients were informed about the experimental procedure and the methodology of the study and had signed the informed consent. 2.3. Data collection Data related to personal characteristics (age, skin color, and schooling) and pain (VNS, number of attacks, and number of analgesics used) were obtained from the records of headaches from the Clinic on Chronic Pain. Data related to the quality of life were collected using the 2002 Brazilian version of SF-6D quality of life questionnaire (QOLQ). The VNS was used to quantify the intensity of pain. The VNS numbers considered for analysis were those which were indicated by the patient as predominant during most crises in the initial consultation (before treatment) and in the last consultation (after treatment), named VNS0 and VNS1, respectively. The number of analgesics used by the participants and the number of attacks after 30 and 60 days of beginning the sessions were also evaluated. The QOLQ was used at the initial consultation and after 60 days of beginning the sessions, i.e., at the end of treatment. 2.4. Interventions True acupuncture followed the conventional treatment of the Traditional Chinese Medicine, using the local points and distance suitable for each type of headache, according to its diagnosis [11]: migraine and chronic daily headache (Shaoyang headache) and TTH (Taiyang headache). Thus, the points used were LI4 (Hegu), ST44 (Neiting), TE5 (Waiguan), GB41 (Zulinq), LR3 (Taichong), PC6 (Neiguan), HT7 (Shenmen), LU7 (Lieque), Yintang (Ex cp 3), Taiyang (Ex cp 9), GB8 (Shuaigu), GB14 (Yangbai), and GB20 (Fengchi). Additionally, in some patients with TTH, the use of acupuncture needle manipulation techniques was necessary to deactivate trigger points. The placebo method used was a device that adheres to the skin: the stick-on moxa. It was not lit in this case, was placed over the same points of true acupuncture, and served only for the insertion of needles (Figure 1, Figure 2). Figure 1 Download high-res image (268KB)Download full-size image Figure 1. Stick-on moxa. Figure 2 Download high-res image (227KB)Download full-size image Figure 2. True acupuncture. Disposable, stainless steel acupuncture needles measuring 0.25 × 30 mm of the Dongbang brand were used. Needling was performed by the manual method and the neutral method, i.e., with no manipulation. The insertion reached the proper depth for obtaining the DeQi (sense of “shock” or “stab-like sensation”). Each patient underwent two sessions per week for a total of 16 sessions. Each session lasted 25 minutes. Preventive medications prescribed by the pain specialist were topiramate, nortriptyline, and beta-blockers. During a crisis, triptans were used alone or in association with nonsteroidal antiinflammatory drugs. The research team comprised the following: - A pain specialist, blinded to which group the patient belonged to, who conducted the initial consultation, prescribed medication, headed for acupuncture, and reassessed the patients in two phases at 30 days and 60 days after beginning the sessions. - A specialist acupuncturist physician with broad experience, who performed the consultation, filled TCM-based diagnosis in the chart, and initiated the treatment. After the pain specialist's assessments, she also collected data. - A research collaborator psychologist who analyzed the results of the QOLQ. 2.5. Statistical analysis The collected data were stored and analyzed by the statistical program, STATA 12.0. The data were expressed as mean and standard deviation (mean ± SD). Comparison between the groups, to verify the effect of acupuncture on the intensity of pain in chronic headache, was performed using the Mann–Whitney test. The intragroup comparisons and the comparison of QOLQ at the beginning and end of the sessions were performed using the Wilcoxon test. In all tests, the level of significance accepted was 5%. 2.6. Ethical aspects The study was approved by the Federal University of Maranhão's Committee on Ethics in Research of the University Hospital by the assent number 721390 on 07.18.2014 and had fulfilled the ethical recommendations for research involving human beings. 3. Results The sample under study consisted of 34 patients [Group 1 (n = 17) and Group 2 (n = 17)]. The average age of patients in Group 1 was 35.5 (±11) years and from Group 2 was 40 (±10.5) years. In Group 1, 70.5% of patients had between 8 to 12 years of schooling. In Group 2, this percentage was only 47%. In both groups, the predominant skin color was brown, with 52.9% in Group 1 and 64.7% in Group 2. The most frequent headache in both groups was migraine without aura, comprising 58.82% in Group 1 and 52.94% in Group 2, followed by headache due to excessive use of medication, comprising 17.64% in Group 1 and 35.29% in Group 2. Migraine with aura occurred only in 17.64% of Group 1. A patient (5.88%) from Group 1 had isolated TTH, and two patients (11.76%) from Group 2 had dual diagnosis: migraine without aura and TTH (Table 1). Table 1. Types of headache. Variables Group 1 Group 2 N (%) N (%) Migraine without aura 10 (58.82%) 9 (52.94%) Migraine with aura 3 (17.64%) 0 EUME 3 (17.64%) 6 (35.29%) TTH 1 (5.88%) 0 TTH + migraine without aura 0 2 (11.76%) EUME, headache due to excessive use of medication; TTH, tension type headache. The average intensity of pain based on the VNS before intervention in Group 1 was 8.17 (±1.01) and in Group 2 was 7.82 (±1.07). There was no statistically significant difference (p = 0.2460). After the acupuncture sessions, average VNS of 3.76 (±1.98) in Group 1 and 5.88 (±1.11) in Group 2 was observed. This difference was statistically significant (p value = 0.0010). When compared, the intensity of pain before and after treatment in both groups had significant differences (p value = 0.0003) (Table 2). Table 2. Intensity of pain before and after treatment through the verbal numeric scale. Groups Variables p VNS0 VNS1 Intragroup intergroups G1 × G2 Group 1 8.17 (±1.01) 3.76 (±1.98) 0.0003 × 0.2450 Group 2 7.82 (±1.07) 5.88 (±1.11) 0.0003 × 0.0010* VNS0, verbal numerical scale before treatment; VNS1, verbal numerical scale after treatment; SD, standard deviation. Mean (± SD). The number of crises and amount of analgesics used in the first and second months of treatment were also analyzed. There were statistically significant decreases in the use of analgesics in both groups: in Group 1 (p value = 0.0102) and in Group 2 (p value = 0.0054). The number of analgesics used in the first month by Group 1 was 2.35 (±1.32) and by Group 2 was 3.64 (±1.53), which was a significant difference (p = 0.0185). A significant difference was also observed in the second month [Group 1: 1.47 (±0.79); Group 2: 2.47 (±1.46); p = 0.0347) (Table 3]. Table 3. Average number of analgesics used during the first and second months of treatment. Groups Variables p First month Second month Intragroup intergroups G1 × G2 Group 1 2.35 (±1.32) 1.47 (±0.79) 0.0102 × 0.0185 Group 2 3.64 (±1.53) 2.47 (±1.46) 0.0054 × 0.0347 SD, standard deviation. Mean (±SD). In Group 1, there were 17.58 (±11.13) crises during the first month, and in Group 2, there were 19.88 (±9.47) crises, with no statistically significant difference between the groups (p = 0.4077). In the second month, the number of crises in Group 1 was 2.88 (±1.61) and in Group 2 was 12.23 (±0.19), showing a statistically significant decrease in Group 1 as compared with Group 2 (p = 0.0001). When the number of crises per group in the first and second months were compared, improvements in both groups were seen (Group 1: p = 0.0003; Group 2; p = 0.0048) (Table 4). Table 4. Average number of crises during the first and second months of treatment. Groups Variables p First month Second month Intragroup intergroups G1 × G2 Group 1 17.58 (±11.13) 2.88 (±1.61) 0.0003 × 0.4077 Group 2 19.88 (±9.47) 12.23 (±0.19) 0.0048 × 0.0001* SD, standard deviation. Mean (±SD). Positive results in the SF36-SD mean scores in both groups in the domains of pain, physical limitation, and vitality, as well as in question 2, the domain which assessed health in comparison to 1 year ago, were highlighted. There was an improvement in the functional capacity (p = 0.0350), in the general state of health (p = 0.0020), and in the social aspects (p = 0.0261) domains in Group 1. There was no statistically significant difference in the mental health domain in either group. There was an improvement in the emotional limitation domain only in Group 2 (p = 0.0486) (Table 5). Table 5. SF-36 SD quality of life domains before and after treatment. Domains Group 1 Group 2 Before After p value Before After p Mean (±SD) Mean (±SD) Mean (±SD) Mean (±SD) Functional capacity 63.07 (±27.12) 74.61 (±26.09) 0.0350* 76.42 (±22.31) 77.14 (±25.39) 0.7525 Pain 33.84 (±15.27) 65.76 (±15.90) 0.0015* 35.78 (±17.29) 53.51 (±19.58) 0.0169* General state of health 38.38 (±19.85) 59 (±9.33) 0.0020* 49.92 (±19.51) 55.64 (±20.07) 0.2081 Physical limitation 23.07 (±40.13) 67.69 (±42.65) 0.0151* 21.42 (±39.04) 73.21 (±42.13) 0.0124* Vitality 33.84 (±23.37) 65 (±18.70) 0.0014* 47.85 (±23.59) 63.21 (±15.39) 0.0123* Social aspects 65.46 (±28.54) 88.46 (±17.27) 0.0261* 60.71 (±24.93) 85.70 (±31.26) 0.1105 Emotional limitation 41.02 (±49.35) 66.66 (±47.14) 0.2640 45.23 (±49.97) 85.70 (±31.26) 0.0486* Mental health 63.84 (31.15) 74.23 (±18.56) 0.1542 71.42 (±17.46) 70 (±18.87) 0.5442 Question 2 3.76 (±0.83) 1.76 (±0.60) 0.0012* 3.14 (±0.77) 2.3 (±0.93) 0.0364* SD, standard deviation. Mean (±SD). *A p value < 0.05 (considered statistically significant). Adverse effects of medication reported by participants were paresthesia and sleepiness, which did not impair the adherence to treatment. As for acupuncture, only local temporary effects were reported such as paresthesia during the session and bruising in a small number of patients in Group 1. 4. Discussion The most prevalent form of headache found in the present study was migraine, although women with headache from excessive use of medication also had the initial diagnosis of migraine. In a study conducted in six Latin American countries, migraine was the most prevalent form of headache, with Brazil in second place among the countries studied. It is observed that migraine generally affects those aged from 30 to 50 years [12], which was evident in our study also. There was a slight variation in patient ages in the groups. Few studies correlate the prognosis and natural history of migraine with age. However, this difference in the randomized groups did not affect the results of the researches [13]. When comparing the basal index of pain between the two selected groups, it was considered important that no statistical difference was present, allowing the possible conclusion that the patients started treatment with the same intensity of pain. The same instrument was used to determine the index of pain after treatment, showing the analgesic effect of acupuncture in the true acupuncture group compared with the sham acupuncture group. Furthermore, both the number of crises and the number of analgesics used during the first and second months of treatment were significantly lower in the true acupuncture group. A review from the Cochrane Institute showed that acupuncture in migraine is equally effective as or even more effective than preventive medication and has fewer adverse effects [7]. In TTH, acupuncture did not seem superior to physiotherapy, massages, or exercises; however, new studies were suggested to rectify the methodological flaws. The authors conclude that acupuncture could be a valuable nonpharmacological tool in patients with episodic TTHs or frequent chronic headache crises [8]. A prospective, randomized, controlled study with 401 patients with complaints of chronic headache (mostly migraine) in the primary care network in England and Wales compared acupuncture (12 sessions in three months) with medication and routine care. The acupuncture group had a steeper improvement in symptom scale (acupuncture 34%/control 16%), 22 fewer days of headache, used 15% less medication, and had 25% less visits to the doctor [14]. In accordance with the study mentioned above, all participants in the present research used medications recognized as standard treatment, i.e., preventive medications such as topiramate, nortriptyline, and propranolol and abortive medications such as sumatriptans and nonsteroidal antiinflammatory drugs. They, then, underwent acupuncture sessions as an auxiliary treatment, which had improvements in the evaluative variables of pain. The studies on the effects of acupuncture are frequently limited by serious methodological difficulties. To date, a universally accepted model of sham acupuncture (placebo) has not been established. By analyzing the placebo and the control model of 47 randomized controlled trials of acupuncture treatment for pain and other conditions, a group of authors observed that two studies used superficial needling of acupuncture points, four used acupuncture points that would not be suitable for the condition studied, 27 used needling out of the acupuncture points, five used placebo needles, and nine studies used pseudo-interventions, such as laser acupuncture with the equipment turned off [15]. The models that are used as placebo, such as superficial needling in acupuncture points, acupuncture points that would not be suitable for the condition studied, and needling out of the acupuncture points are not considered ideal as placebo method, as they are also methods that stimulate the peripheral nerve endings, causing analgesic effects, although in smaller proportion than true acupuncture [16]. The placebo used in this study was noninvasive masking, that is, there was no contact of the needle to the skin of patients. Therefore there was no stimulation of peripheral nerve endings. Besides, a prerequisite for reproducibility would be a uniform training of acupuncturists participating in a study [17]. This problem was overcome in the study because only one acupuncturist performed the treatment. The gold standard method for determining the effectiveness of therapies is the detection of a significant difference between a pharmacologically active agent or a procedure and an inert placebo assessed in a randomized clinical trial [16]. The present study, using both an inert placebo and a randomized design, demonstrated a statistically significant difference in the effectiveness of true acupuncture. This placebo method which involves noninvasive masking can be promising. In addition, one of the inclusion criteria used was that patients had never undergone acupuncture sessions before, which contributed to their blinding. Chronic pain has negative consequences for general health and hence to quality of life, causing physical and psychological discomforts [18], [19]. A study conducted to assess the quality of life of patients with chronic pain, including migraine, who underwent treatment with acupuncture, showed the highest score in the general state of health domain, followed by the mental health and functional capacity domains. The lowest scores were obtained in the physical limitation, pain, and emotional limitation domains [20]. Another study that assessed the effect of acupuncture on the quality of life in patients with migraine without aura compared acupuncture with flunarizine and demonstrated that although both groups had improvements in all aspects, the group that used only acupuncture had significantly superior improvements to the group that used only medication in functional capacity, physical limitations, and pain domains [21]. We can observe in the results of the present research that after treatment, there was statistically significant improvement in the true acupuncture group in almost all the domains. The exceptions were in the emotional limitation and mental health domains, since these already had good basal scores. In the Quality of Life Questionnaire, the body pain domain assesses the severity of the pain felt by the patient, limiting the usual functioning at home and at work [22]. In this domain, improvement was demonstrated in both groups because the patients in the sham acupuncture group, although receiving placebo, underwent drug treatment just as those in the true acupuncture group. These results also contributed to the significant improvement in question 2, in which health is assessed in comparison to 1 year back. Some limitations to this study should be considered including the small sample size being directed to a specific type of headache and not using the same preventive medication for pain. However, it is worth pointing out that it was conducted with the following methodological criteria which may give credibility to the results; it was randomized, the assessor (pain specialist) was blinded, one acupuncturist conducted all the sessions, and a promising placebo method was used. Another limitation of our study related to the size for comparison of the average number of analgesics used during the first and second month of treatment (Table 3). 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