It has been estimated that approximately one third of US

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1 THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 12, Number 4, 2006, pp Mary Ann Liebert, Inc. Open-Label Trial Regarding the Use of Acupuncture and Yin Tui Na in Parkinson s Disease Outpatients: A Pilot Study on Efficacy, Tolerability, and Quality of Life MARTY L. ENG, Pharm.D., 1 KELLY E. LYONS, Ph.D., 2 MICHAEL S. GREENE, Dipl. Ac. (A.A.C.M.A.), 3 and RAJESH PAHWA, M.D. 2 ABSTRACT Objectives: This study evaluates the effects of sequential tui na massage, acupuncture, and instrument-delivered qigong for patients with Parkinson disease (PD) over a 6-month period. Design: Patients received weekly treatments, which included tui na massage prior to acupuncture followed by instrument-delivered qigong. Each patient was assessed at baseline and at 6 months. Setting: The setting was an outpatient research/academic clinic for patients with PD and nonacademic acupuncture clinic. Subjects: Twenty-five (25) patients with idiopathic PD were the subjects. Outcome measures: Before and after treatment patients were evaluated with the Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr Staging (H&Y), Schwab and England Activities of Daily Living (S & E), Beck Depression Inventory (BDI), Parkinson s Disease Questionnaire (PDQ-39) quality of life assessment, and patient global assessments. Results: There were no significant improvements in treatment measures; however, there was a 2.4-point worsening in UPDRS motor scores (24.0 versus 26.4, p 0.018). There was a 16% improvement in the PDQ- 39 total score (23.2 versus 19.6, p 0.044) and a 29% improvement in the BDI (9.6 versus 6.8, p 0.006). Sixteen (16) patients reported moderate to marked improvement. There were no adverse effects. Conclusions: Acupuncture is safe and well tolerated in patients with PD. Most patients reported subjective improvement. The BDI and PDQ-39 total score, measuring depression and quality of life, demonstrated some improvement, but UPDRS motor scores worsened. INTRODUCTION It has been estimated that approximately one third of US adults use some form of alternative therapy. 1,2 A study regarding the use of alternative therapy in patients with Parkinson disease (PD) reported that 40% of patients used some form of alternative therapy for the treatment of PD, and 10% of these used acupuncture. 3 However, very few studies have evaluated the role of acupuncture in the treatment of PD. 4 8 The authors evaluated the safety and efficacy of acupuncture for 6 months (24 weekly treatments) on motor symptoms, quality of life, and depression in patients with PD. 1 University of Kansas Medical Center, University of Kansas, School of Pharmacy, Department of Pharmacy Practice, Kansas City, KS. 2 University of Kansas Medical Center, Department of Neurology, Parkinson s Disease and Movement Disorder Center, Kansas City, KS. 3 Westbrooke Chiropractic and Acupuncture, Lee Summit, MO. 395

2 396 MATERIALS AND METHODS Subjects Twenty-five (25) patients were recruited from the PD clinic of the University of Kansas Medical Center, Kansas City. All patients had a diagnosis of idiopathic PD and were on stable doses of antiparkinsonian medications. Patients with dementia were excluded from the study. The study protocol and informed consent were approved by the University of Kansas Medical Center Human Subjects Committee. All patients signed written informed consent forms. The first patient was entered in the study July 10, 2000 and the final patient completed on October 2, Outcome measures Patients were evaluated before initiation of acupuncture treatment and 6 months after treatment. At baseline, all patients were evaluated with the Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr staging (H & Y), Schwab and England activities of daily living scale (S&E), Beck Depression Inventory (BDI), and patient and physician clinical global impression scales in which they completed a rating of overall disability from PD categorized as none, mild, moderate, marked, or severe. In addition, all patients completed a quality of life instrument, the Parkinson s Disease Questionnaire (PDQ-39). All patients were advised not to change any of their antiparkinsonian medications during the study period and were referred to the acupuncturist (MSG) for treatment. Intervention The patients received acupuncture treatments once a week for 6 months, a total of 24 sessions. One certified acupuncturist, who has been practicing since 1975 and has over 900 hours of relevant training, performed all the acupuncture sessions. The rationale and techniques used in this study were largely based on the work of Walton-Hadlock, focusing special attention to the foot area prior to the acupuncture. 7,8 The main goal of the acupuncture sessions was aimed at restoration of qi flow in the stomach channel with adjunctive attention given to the Large Intestine Channel based on the acupuncturists impression of the patient s qi patterns. The treatment sessions began with each patient receiving a 10- minute yin tuina (Chinese energy massage) treatment to the foot corresponding to the side of the body most affected by PD. The energy massage consisted of external qi transmission via the practitioner s hands to aid in relaxing the foot muscles. Following this treatment, after the foot started to relax, mm acupuncture needles (Hua Xia; five each foot) were inserted along the entry/exit pathway from St 42 (Chongyang) to Sp 3 (Taibai) for 7 to 10 minutes to continue opening the pathways along the Stomach channel. As the energy and relaxation of the foot continued, additional mm needles were added, alternating sides of the body each treatment, one in the elbow at LI 11 (Quchi), one in the shoulder at LI 15 (Jianyu), one on the side of the nose at LI 20 (Yingxiang), one on each side of the jaw at ST 7 (Xiaguan), and one on the side of each knee at ST 36 (Tsu san li). The additional needle placement was determined and adjusted based on the individual s pattern of qi flow. Finally, a hand-held Qigong machine (manufactured by China Healthways, Inc., San Clemente, CA) was applied to each foot for a total of 10 minutes. The Qigong machine is a low-frequency electroacoustic therapeutic massager that is placed directly on the skin or clothing. It provides lowfrequency sonic stimulation in the 8 to 14 Hz range. This treatment was applied to both feet in an alternating fashion. After 6 months of acupuncture therapy baseline evaluations were repeated. Analyses Statistical analysis was performed using Wilcoxon signed rank comparisons for nonparametric data which included the UPDRS, Hoehn and Yahr, Schwab and England, and BDI and t-tests for parametric data from the PDQ-39. RESULTS Demographics Twenty-three (23) of the 25 patients completed the study. One patient withdrew because of worsening of PD symptoms and another patient was excluded from the data analyses as antiparkinsonian medication was changed during the study. There were 13 men and 10 women who received all 24 weekly treatments with a mean age of 69.3 (range, 55.3 to 78.3) and disease duration of 6.4 (range, 0.4 to 16.5). Nine patients had a disease duration 5 years and 14 5 years. Efficacy and safety ENG ET AL. Preacupuncture and postacupuncture assessment scores are shown in Table 1. Following 6 months of therapy there were no significant changes in UPDRS Mentation (Part I), UPDRS Activities of Daily Living (Part II), H & Y, or S&E. Significant changes included a 2.4-point worsening in the UPDRS Motor (Part III) (24.0 versus 26.4, p 0.018), a 16% improvement in the PDQ-39 total score (23.2 versus 19.6, p 0.044), and a 29% improvement in the BDI (9.6 versus 6.8, p 0.006). According to patient global ratings, 3 patients reported no change, 4 reported mild improvement, nine reported moderate improvement, and seven reported marked improvement. There were no significant differences between patients who reported moderate to marked improvement and patients who reported either none or mild improvement in terms of UPDRS motor scores, depression, or quality of life measures. There were no adverse effects reported from acupuncture therapy.

3 ACUPUNCTURE AND PD 397 TABLE 1. PREACUPUNCTURE AND POSTACUPUNCTURE ASSESSMENT SCORES (MEANS AND STANDARD DEVIATIONS) Baseline After acupuncture p-value UPDRS Mentation 2.3 (1.3) 2.1 (1.6) UPDRS ADL 11.5 (5.0) 10.7 (4.5) UPDRS Motor 24.0 (7.3) 26.4 (7.0) Beck Depression Inventory 9.6 (6.9) 6.8 (6.6) PDQ-Mobility 29.6 (27.8) 25.8 (24.8) PDQ-ADL 24.8 (21.2) 20.8 (17.0) PDQ-Emotional well-being 23.0 (18.6) 18.3 (16.0) PDQ-Stigma 13.9 (16.3) 12.8 (13.5) PDQ-Social support 6.5 (9.4) 5.4 (10.2) PDQ-Cognition 24.2 (15.3) 21.7 (14.7) PDQ-Communication 18.8 (15.7) 13.8 (13.2) PDQ-Bodily discomfort 30.8 (25.6) 25.4 (24.2) PDQ-Total score 23.2 (16.4) 19.6 (13.9) H & Y 2.1 (0.4) 2.1 (0.3) S & E 83.0 (8.8) 83.0 (8.2) ADL, Activities of daily living; H & Y, Hoehn and Yahr Staging; PDQ, Parkinson Disease Questionnaire; S & E, Schwab and England activities of daily living scores; UPDRS, Unified Parkinson s Disease Rating Scale. DISCUSSION The results of this pilot study suggest that acupuncture is safe and well tolerated when administered weekly for 6 months in patients with PD. However, efficacy was subjective. Subjective changes were suggested by the improvement in PDQ-39 total scores and BDI scores. The only objective measure that changed was a slight worsening in the UPDRS motor scores. The demographics of the patient population was similar to that reported in other studies of acupuncture in PD. 4 6 The mean disease duration of the authors cohort was about 1.9 years shorter than that in the Shulman et al. study and about 2 years longer than that in the Zhuang and Wang study. Chen did not report disease duration. At baseline, the authors patients had slightly higher UPDRS Mentation (2.3 versus 1.4) and UPDRS ADL scores (11.5 versus 9.5) than those seen in the Shulman et al. study. This suggests that the authors patients may have had slightly worse mental function and ADLs performance at baseline. In the present study, a 2.4-point worsening in UPDRS motor scores reached statistical significance. However, the Shulman et al. study showed a nonsignificant improvement of 1.25 points in the UPDRS motor score. Differences might be explained by differences in acupuncture methods used, duration of intervention, and potential placebo effect. However, this would need to be studied in a head-to-head controlled trial to determine if treatment differences actually exist between methods. Additionally, there were no statistically significant differences in other outcomes measured by Shulman et al. except for improvement in the Sickness Impact Profile (SIP) sleep and rest subscore. A significant limitation with both of these studies is the open-label design. Thus, patient bias and a placebo effect cannot be ruled out as factors in the improvements reported. There is a paucity of literature regarding acupuncture and the treatment of PD. Two earlier studies reported a benefit in PD with acupuncture. 5,6 Chen reported improvement in PD symptoms after three courses of treatment consisting of 10 sessions each (30 sessions total). 6 They used the Seven Acupoints of the Cranial Base acupuncture method. The Seven Acupoints were reported as GB 20 (Fengchi; bilateral), GB 12 (Wangu; bilateral), UB 10 (Tianzhu; bilateral), and Du 15 (Yamen). Adjuvant acupoints also were described. Treatment was considered effective in 65% of patients (markedly effective in 25 % and improved in 40%) and ineffective in 35%. Zhuang and Wang reported that improvement in symptoms was supported by a delay of disease progression, decrease in dosage of antiparkinsonian medications, and expectant lessening of the complications and symptoms induced by the drug side-effects. 5 They used patients receiving Western medications without acupuncture as a control group. Treatment groups and control groups were similar in demographics. Contrary to those shorter studies, the present study did not demonstrate a benefit for PD symptoms with 24 treatments given weekly for 6 months. Combined with the negative results from the Shulman et al. study, it may be suggested that treatment benefits may be early but not sustained long term. This could be assessed in a subsequent trial with more evaluation periods (1 month, 3 months, 6 months, 12 months). In the present study, prior to acupuncture, patients received a 10-minute Chinese energy massage (yin tuina) to the foot on the side of the body most affected by PD. Walton-Hadlock reported on 12 patients with PD after a nonforceful yin-type of tuina referred to as forceless spontaneous response for approximately 1 hour once a week for a minimum of 4 weeks. The basis of this treatment is that an injury to the foot is involved in the development of PD symptoms and all of their patients reported an injury to their feet. In 11 of 12, this injury was on the side in which the

4 398 PD symptoms began. All patients were reported to have an improvement in PD symptoms; however, it is not clear how improvement was measured. The technique used in the present study were similar but of much shorter duration (10 minutes versus 1 hour), and although most patients did report subjective improvement, there was no evidence of improvement in the PD rating scales. In order to determine if this type of therapy is effective for PD symptoms, a welldesigned, controlled study with objective measures of improvement is necessary. In the present study, cases with shorter disease duration ( 5 years; mean 2.2 years, range 0.4 to 5.0 years) showed similar patterns of outcomes compared to those with longer disease duration ( 5 years; mean 9.2 years, range 5.3 to 16.5 years). Those with longer disease duration were a mean of 1.9 years younger than those with shorter disease duration (68.5 versus 70.4 years). Nine (9) patients (39%) had a disease duration less than 5 years. Of these, seven (78%) showed an increase in the UPDRS motor score, which reflects worsening of motor function. Among patients in the longer disease duration group, eight (57%) showed a worsening of motor scores and an additional 14% had no change. Likewise, changes in BDI and PDQ total reflected improvements irrespective of disease duration, which suggests that disease duration may not have an influence on the treatment outcomes. One interesting observation is the potential for treatment of depression with acupuncture. In the present study, the authors reported a 2.8-point improvement in BDI that reached statistical significance (p 0.006). In the Shulman et al. study, there was a nonsignificant worsening in the BDI. 4 Other studies in non-pd patients have suggested a benefit in major depression. 9,10 In the Gallagher et al. study, 38 women were randomized in a two-phase (acute 8-week treatment and 6-month follow-up), double-blinded, controlled trial of acupuncture. 10 Women were randomized into 3 treatment groups: acupuncture specific for depression; nonspecific acupuncture not directed at depressive symptoms; and wait-list. Eventually, all women received 8 weeks of specific acupuncture treatment. Only four (24%) of the 17 patients who achieved full remission were still in full remission after 6 months of treatment with acupuncture. Roschke et al. reported in a single-blinded, placebo-controlled trial slight improvement in the depression of 70 inpatients treated with acupuncture versus placebo acupuncture and control group. 9 All patients in that study received mianserin, a tetracyclic antidepressant. Acupuncture treatment was administered three times a week over 4 weeks. In our study, only four people were taking antidepressants. Three of which experienced a decrease in BDI. The remaining 15 patients who experienced a decrease in BDI did not take antidepressants. Further, well-designed, large, randomized, controlled trials would be needed to confirm the potential benefit of acupuncture on depression in patients with PD. A significant limitation of these studies is the lack of control group with sham acupuncture such as that developed by Park et al. 11 Use of this technology as a control may help to separate out the subjective patient bias from true treatment benefits or lack thereof. Despite the lack of a control group, the present study results were similar to that of Shulman et al. 4 CONCLUSIONS After 6 months of acupuncture therapy, 70% of the patients reported moderate to marked improvement in PD symptoms. However, there were no changes in the UPDRS, H&Y, and S&E scales suggesting a lack of objective improvement in PD symptoms. In fact, there was a worsening of the UPDRS motor scores. Yet, significant improvement was seen on the BDI along with an improvement in the PDQ- 39 quality of life scale. Although subjective improvement and improvement of BDI and PDQ-39 scores were reported, one must be mindful of the potential to worsen motor symptoms. Further, controlled trials would be warranted to gain a better perspective on the risk versus benefit of treating depression with acupuncture in patients with PD versus a slight worsening in motor function. ACKNOWLEDGMENT This study was partially supported by the Parkinson s Foundation of the Heartland. REFERENCES ENG ET AL. 1. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, : Results of a follow-up national survey. JAMA 1998;280(18): Barnes P, Powell-Griner E, McFann K, Nahin R. CDC Advance Data Report #343. Complementary and alternative medicine use among adults: United States, Posted in 2004; Accessed January 12, Rajendran PR, Thompson RE, Reich SG. The use of alternative therapies by patients with Parkinson s disease. Neurology 2001;57: Shulman LM, Wen X, Weiner WJ, et al. Acupuncture therapy for the symptoms of Parkinson s disease. Mov Disord 2002;17(4): Zhuang X, Wang L. Acupuncture treatment of Parkinson s Disease a report of 29 cases. J Trad Chin Med 2000; 20(4): Chen L. Clinical observations on forty cases of paralysis agitans treated by acupuncture. J Trad Chin Med 1998;18(1): Walton-Hadlock J. Primary Parkinson s disease: The use of tuina and acupuncture in accord with an evolving hypothesis

5 ACUPUNCTURE AND PD 399 of its cause form the perspective of Chinese traditional medicine. Am J Acupunct 1998;26: Walton-Hadlock J. Primary Parkinson s disease: The use of Tuina and acupuncture in accord with an evolving hypothesis of its cause from the perspective of Chinese traditional medicine Part 2. Am J Acupunct 1999;27: Roschke J, Wolf C, Muller MJ, Wagner P, Mann K, Grozinger M, Bech S. The benefit from whole body acupuncture in major depression. J Affect Disord 2000;57(1 3): Gallagher SM, Allen JJ, Hitt SK, Schnyer RN, Manber R. Six-month depression relapse rates among women treated with acupuncture. Complement Ther Med 2001;9(4): Park J, White A, Lee H, Ernst E. Development of a new sham needle. Acupunct Med 1999;17(2): Address reprint request to: Marty L. Eng, Pharm.D. Department of Pharmacy Practice Kansas University Medical Center MS 4047, RM B Rainbow Boulevard Kansas City, KS meng@kumc.edu

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