CRANIO® The Journal of Craniomandibular & Sleep Practice

ISSN: 0886-9634 (Print) 2151-0903 (Online) Journal homepage: http://www.tandfonline.com/loi/ycra20

Adverse Events of Acupuncture and Occlusal Splint Therapy in the Treatment of Craniomandibular Disorders Thomas List D.D.S., Martti Helkimo D.D.S., Odont.Dr. & Gerard L. Lapeer D.D.S. To cite this article: Thomas List D.D.S., Martti Helkimo D.D.S., Odont.Dr. & Gerard L. Lapeer D.D.S. (1992) Adverse Events of Acupuncture and Occlusal Splint Therapy in the Treatment of Craniomandibular Disorders, CRANIO®, 10:4, 318-326, DOI: 10.1080/08869634.1992.11677929 To link to this article: http://dx.doi.org/10.1080/08869634.1992.11677929

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Date: 28 March 2017, At: 05:20

• REHABILITATIVE MEDICINE

ADVERSE EVENTS OF ACUPUNCTURE AND OCCLUSAL SPLINT THERAPY IN THE TREATMENT OF CRANIOMANDIBULAR DISORDERS Thomas List, D.D.S., Martti Helkimo, D.D.S., Odont.Dr.

0886-9634/9211 0040318$03.00/0, THE JOURNAL OF CRANIOMANDIBULAR PRACTICE, Copyright © 1992 by Williams & Wilkins Manuscript received February

4, 1992; revised manuscript received May 11, 1992; accepted May 12, 1992 Address for reprint requests: Martti Helkimo, D.D.S. Department of Stomatagnathic Physiology lnst~ute for Postgraduate Dental Education Box 1030 8-551 11 JOnkOping Sweden

ABSTRACT: Occlusal splint therapy and acupuncture have been found to provide positive treatment in a number of studies. As with other therapies, adverse events may occur. In this paper, adverse event refers to any reaction to a treatment besides the intended treatment effectirrespective of any correlation between the treatment and the reaction. This reaction can be positive, as well as negative, to the patient. In the present study, 61 patients with craniomandibular dysfunction (CMD) were treated with acupuncture or occlusal splint therapy and the adverse events were carefully recorded. The results show that the profile of the adverse events differed between the two treatment modes. Acupuncture seemed to have adverse events of a more general nature, e.g., relaxed feeling, improved sleep, temporarily Dr. Thomas E.L. List received his increased pain; whereas, adverse events of occlusal splint D.D.S degree in 1981 from the Ebertherapy seemed to be more locally related to the orofacial luJrd-Karls-UniversiUJt in Tubingen, region, e.g., increased/decreased salivation and tension Germany. Since 1985, he luJs been aresearch associate at the Department of in the teeth. The majority of the patients responded posiStomatognathic Physiology at the Institively to both treatment modalities. Only in a few cases tute for Post-Graduate Dental Education in Jlinkliping, Sweden. At the presdid the patients consider the treatment uncomfortable. No ent time he is employed as a consultant serious adverse event or complication was observed in in the Department of Stomatognathic this study. Physiology in Linkliping, Sweden. Dr. List luJs studied acupuncture in Sri Lanka and the Peoples Republic of China. He is a member of the Swedish Dental Association, Swedish Society for Prosthetic Dentistry and Stomatagnathic Physiology, and the International Association for the Study of Pain.

ithin the last few years, acupuncture has become a more widely used form of pain treatment, mainly for chronic pain, in the Swedish health care system, 1 as well as in other western countries.2-4 In a literature search from January 1980 to March 1991, 74 reports of "adverse effects" after acupuncture treatment were found in Medline. As most of these reports are similar, only a few are referred to in this article. The majority of the reports describe various infections: bacterial, e.g., auricular perichondritis and endocarditis,5•6 hepatitis,1· 8 and in a few cases, the probability of HIV,9 which most likely was due to inadequate hygiene of acupuncture needles. Several mechanical penetrations have occurred: pneumothorax, 10•11 kidney, 12 spinal cord, 13 and nerves and vessels. 14 In one case, a compartment syndrome developed following acupuncture. 15 In another report, one patient died as a result of bilateral pneumothorax following acupuncture treatment 16 Most of these latter adverse events seem to be caused by inadequate knowledge of anatomy. Iso-

W

Dr. Martti I. Helkimo received his D.D.S. degree in 1966 from the University of Umed. He received his Odont. Dr. degree in 1974 from the University of GiJteborg, where he later became associate professor in the Department of Stomatognathic Physiology. He spent one year as a visiting associate professor at the University of Michigan before accepting the position of professor and cluJirman of the Department of Stomatognathic Physiology at the University of Umed. Since /979, he luJs served as head of the Depanment of Stomatagnathic Physiology at the Institute for Post-Graduate Dental Education in JlJnklJping, Sweden. A lecturer in Europe, Nonh America, and South America, he is a member of the Swedish Dental Association, the Swedish Society of Prosthetic Dentistry and Stomatognathic Physiology, and the Society for Oral Physiology.

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LIST AND HELKIMO

lated. reports of fractured needles 17 and contact allergies 18 have also been published. During electrical stimulation of needles, electromagnetic interference on pacemakers has also been observed. 19 Side effects of a more general nature, such as relaxation/drowsiness, nausea, dizziness, perspiration, increased pain, and fainting, are mentioned in the literature. 20 These symptoms are summarized in the term "hyperstimulation syndrome," which indicates that the patients respond too strongly to the treatment. 20 In a previous paper, the efficacy of acupuncture and occlusal splint therapy was compared in a group of patients with craniomandibular disorders. 21 Occlusal splint therapy has been found to provide positive treatment in a number of studies, but few reports of possible side effects of the treatment have been published. 22 •23 One important aspect in the evaluation of a treatment method besides the therapeutic effect is safety and comfort. In this paper, adverse event refers to any reaction to a treatment besides the intended treatment effectirrespective of any correlation between the treatment and the reaction. This reaction can be positive as well as negative to the patient. The aim of the present study was to: (1) compare the profile of the adverse events reported by the patients after acupuncture and occlusal splint therapy, and (2) evaluate the subjective comfort of the treatments. Materials and Methods Subjects

Sixty-one patients participated in the study. Seventeen were male, 44 were female, ranging from 19 to 69 years old, with a median age of 40 years. All the patients had been referred to the Department of Stomatognathic Physiology at the Institute for PostGraduate Dental Education in JOnkOping, Sweden, for treatment of craniomandibular dysfunction (CMD). In order to obtain a homogeneous group, all the patients were examined clinically and a comprehensive history was taken before being accepted to participate in the study. The patients involved in this investigation belong to the same group of patients with CMD described in detail in an earlier publication on the therapeutic effect of acupuncture and occlusal splint therapy. 21 Of the original 80 patients receiving active treatment, 19 were already completed when this study was initiated. Consequently, only the remaining 61 patients were evaluated concerning adverse events. Since all patients were randomly selected, there is no reason to believe that the 19 individuals not included in the analyses in any way have affected the outcome of the study. OCTOBER 1992, VOL 10, NO.4

Procedure The investigation was carried out by two operators: one (MH) who performed the screening and the evaluation at the pretreatment and post-treatment occasions; the other (TL) who completed the patient treatment. The patients were subsequently randomly assigned to acupuncture (n = 29) or occlusal splint therapy (n = 32). The active treatment period lasted between six and eight weeks. The treatment procedure has previously been described in detait.2 1 At the last treatment session, the patient was evaluated clinically and asked to answer a standardized questionnaire that also included questions concerning adverse events. Acupuncture. All the patients received at least six acupuncture treatments. In a few cases there were discrepancies in the clinical recordings and the patients' experience of the symptoms. The authors chose to extend the treatment period one to two weeks before deciding whether or not to change treatment methods. The treatments lasted for 30 minutes and were given once a week. Manual stimulation of the needles was used for the first two or three treatments. During manual stimulation, "de'qi," a subjective feeling of numbness, deep muscle pain/discomfort, paresthesia, etc. was the goal. 24 In the remaining sessions, a combination of electrical stimulation of two needles, one localized in the hand (Li 4) and the other in the leg (St 36), as well as manual stimulation, was used. The electrical stimulator (Electroform Medical 8) produced a biphasic wave current (0.2 ms pulse width) of 2 to 3 Hz, with an individually adjusted intensity of approximately 0.5 rnA, which evoked visible muscle contractions. The acupuncture points stimulated differed slightly from individual to individual. The small variation was due to the localization of the pain and tenderness on palpation. The most frequently used acupuncture points are listed in Figure 1. The localization follows the description given in "Atlas of Chinese Acupuncture Points." 25 The number of needles being applied in a single session ranged from 4 to 15 with an average of 12. The needles were made of steel alloy and of Japanese origin (Seirin nr 8a) with 30 X 0.30 mm dimensions. Occlusal Splint Therapy. The occlusal splints were full coverage, hard acrylic resin appliances constructed to fit in the maxillary arch. Only in a few patients with molar loss in the mandible was the splint applied there instead. The splint surface was adjusted so that maximum occlusion was provided after habitual closure and after passively recorded terminal hinge movement. The splint was constructed so that anterior and canine guidance was established. 26 After one week, the splints were checked and adjusted. The splints were used at night until the postTHE JOURNAL OF CRANIOMANDIBULAR PRACTICE

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LIST AND HELKIMO

ACUPUNCTURE AND SPLINT THERAPY

vomiting, increased saliva production, dry mouth. Local irritation in mucosa or adjacent tissue: pressure and/or tension in the teeth, dry lips, irritated tongue, increased or decreased snoring. Comfort of the treatment: The final question on the questionnaire asked the patient to grade the comfort of the treatment on a I- to 5-point scale (very comfortable to very uncomfortable). Statistical Methods Fischer's exact test was used for analyzing discrete data in 2 X 2 contingency tables. Two-sided testing was performed. Results Figure 1 The most frequently used acupuncture points.

treatment evaluation about seven to eight weeks later. Assessment Variables

Self-Administered Questionnaire of Side Effects. The questionnaire began with the question: "Did you observe any side effects during or after the acupuncture/occlusal splint treatment?" This question was followed by 18 symptoms with four multiple choice alternatives (never, occasionally, several times, continuously during the treatment period). If the patient had experienced an adverse event not included among the 18 symptoms, it could be reported separately in the protocol. Only adverse events that were experienced several times during the treatment period were evaluated. The symptoms were grouped as follows. Central nervous system (CNS) symptoms: dizziness, relaxation during and after the treatment, abnormal tiredness, improved or impaired sleep, and increased headache and/or facial pain. Peripheral neuromuscular symptoms: stiffness, weakness in the muscles, lingering pain in the area where the needle had been placed, paresthesia. Autonomic symptoms: nausea and/or 320

THE JOURNAL OF CRANIOMANDIBULAR PRACTICE

The results showed that the profile of the adverse events differed slightly between the two treatment modes. Acupuncture seemed to have adverse events of a more general nature compared with occlusal splints that were more related to the orofacial region. The adverse events in the acupuncture and occlusal splint group are shown in Tables 1 through 4). CNS Symptoms (Table 1) The most common adverse event reported several times and mostly following acupuncture was a relaxed feeling (69%). Abnormal tiredness was reported by 10%, and improved sleep by 24%. Increased headache and/or facial pain was reported by 21% of the patients. The increased pain was temporary in all the registered cases. A statistically significant difference between the two treatment modes was found for the relaxed-feeling symptom. In the group of patients receiving occlusal splints, the frequency of the CNS symptoms was much lower: 19% reported improved sleep while 13% reported impaired sleep in the beginning because they were unaccustomed to wearing the splint. Except for one patient, this sleep impairment was temporary. Increased headache and/or facial pain was reported among 6% of the patients receiving occlusal splints. The frequency of the other symptoms listed was low. Peripheral Neuromuscular Symptoms (Table 2) These symptoms were of a low frequency. Among the patients receiving acupuncture, lingering pain in the area OCTOBER 1992, VOL. 10, NO.4

LIST AND HELKIMO

ACUPUNCTURE AND SPLINT THERAPY

Table 1 CNS Symptoms Reported by Patients Following Acupuncture and Occlusal Splint Therapy*

Symptoms

Dizziness Relaxation Abnormal tiredness Impaired sleep Improved sleep Increased headache and/ or facial pain

18 4 17 23 20 12

*I = never; 2 = occasionally; 3 t NS = not significant.

2

3

4

~3in%

8 5 9 4 2

2 12 1 2 4 6

1 8 2 0 3 0

10% 69% 10% 7% 24% 21%

11

p Frequency

Occlusal Splint Frequency

Acupuncture Frequency

29 28 32 21 23 24

2

3

4

~3in%

1 I 0 7 3 6

1 2 0 3 4 2

1 1 0 1 2 0

6% 9% 0% 13% 19% 6%

~3

NSt p

Adverse events of acupuncture and occlusal splint therapy in the treatment of craniomandibular disorders.

Occlusal splint therapy and acupuncture have been found to provide positive treatment in a number of studies. As with other therapies, adverse events ...
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