ARTICLE
Acupressure for Chemotherapy-Associated Nausea and Vomiting in Children Emily Jones, PA, Scott Isom, MS, Kathi J. Kemper, MD, Thomas W. McLean, MD
The objective of this study was to determine the feasibility and effectiveness of acupressure therapy in preventing chemotherapyassociated nausea in chiidren. A prospective, randomized, crossover triai was conducted among pédiatrie oncoiogy patients at Brenner Children's Hospitai (Winston-Saiem, NC). Patients were randomized to one of two treatment sequences involving acupressure wrist bands and placebo bands, separated by a standard care treatment with no bands. All patients received standard antiemetic therapy for each treatment. Expectations and outcomes of nausea and vomiting were assessed by questionnaires. Of 21 patients approached, 21 were enrolled and 18 completed all three study treatments. Patients'ages ranged from 5 to 19 years, 14 of 18 were Caucasian, and 9 were male. In general, patients expressed moderate expectations that acupressure would prevent nausea and vomiting. Following the session with an acupressure band, a third of all patiehts reported better than expected nausea prevention. There was no significant difference in nausea or vomiting between the three groups; there were no significant side effects from acupressure or placebo bands. Pédiatrie oncology patients have moderate expectations about the effectiveness of acupressure in preventing nausea and vomiting. Acupressure is feasible and well tolerated but was not more effective than placebo in this sample of patients who were also treated with standard antiemetic therapies. Key words: acupressure, cancer, chemotherapy, child, nausea, vomiting
ausea and vomiting (N/V) are significant side effects of chemotherapy and adversely affect quality of life among cancer patients. Antiemetic therapies have improved in recent years, but N/V are still common and among the most distressing side effects of chemotherapy.' Antiemetic medications are frequently used, but many patients and families are interested in using nonpharmacologic therapies. The use of acupressure, acustimulation, and acupuncture for chemotherapy-associated N/V has been studied, with mixed results. Acupressure helps prevent or reduce N/V in some adult patients receiving chemotherapy and postoperatively.'^"^ Not all studies, however, have shown benefit from acupressure.^'*'"^ One study of adult cancer patients compared acupressure and acustimulation and found gender differences, with men having less N/V with acustimulation and women having marginal benefits from
N
acupressure but not acustimulation.^ Similar results were found in women being treated for breast cancer.' Recent studies in children have shown that acupuncture may reduce antiemetic medication and episodes of vomiting in pédiatrie oncology'" and that acupressure and acupuncture are effective in reducing postoperative vomiting in children." The feasibility and effectiveness of using acupressure in children receiving chemotherapy are unknown. If helpful, acupressure could reduce symptoms of nausea and the need for antiemetic medication and improve quality of life for children receiving chemotherapy. The purpose of this pilot study was to assess the feasibility, safety, and effectiveness of acupressure therapy for preventing or reducing chemotherapy-associated N/V in children receiving chemotherapy.
Methods Emily Jones, Scott Isom, Kathi J. Kemper, and Thomas W. McLean: Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, NC. Reprint requests: Thomas W. McLean, MD, Department of Pediatrics, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157; e-mail:
[email protected].
DOI 10.2310/7200.2008.0023
This was a prospective, randomized, crossover clinical trial among the pédiatrie oncology patients at Brenner Children's Hospital (Winston-Salem, NC). Data were collected from December 2005 through January 2007. Patients aged 2 to 20 years with any type of cancer were eligible if they received emetogenic chemotherapy agents
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on the inpatient unit; chemotherapy was defined as emetogenic if it included at least one of the following: an alkylating agent (eg, cisplatin, cyclophosphamide, ifosfamide), an antitumor antibiotic (eg, doxorubicin, daunomycin, dactinomycin, mitoxantrone), or high-dose cytarabine. A course of chemotherapy ranged in length from 1 to 5 days, and each course was typically separated by a 3- to 4-week interval. Patients were excluded if they were not expected to receive at least three courses of chemotherapy, their parents did not consent, they were over 7 years old and did not assent to participate, or they were not English speaking. Patients were randomized to one of two acupressure treatment sequences (Figure 1). For each treatment session, patients received standard antiemetic therapy at the direction of the attending physician. This typically consisted of a 5-hydroxytryptamine3 receptor antagonist such as ondansetron or granisetron and sometimes also included dexamethasone, lorazepam, promethazine, or diphenhydramine; quantification of antiemetic use was not performed. In sequence 1, the patient wore acupressure wrist bands during the first course of chemotherapy, followed by a second course when no wrist bands were worn, followed by a third course when placebo acupressure wrist bands were worn. In sequence 2, the patient wore placebo wrist bands first, followed by no bands, followed by true acupressure wrist bands. Patients were not told which type of band (real or placebo) they were wearing. True acupressure was provided using Sea-Bands (manufactured and provided by Sea-Band International, Newport, RI). SeaBands are elastic wrist bands with a 1 cm protruding round plastic button that applies pressure to the P6 (Neiguan) acupressure point on the ventral surface of the wrist approximately three fingerbreadths proximal to the main wrist crease. Placebo bands (also manufactured and provided by Sea-Band International) are identical in appearance to the real bands but do not have the internal acupressure button. They were worn in the same manner as the Sea-Bands. The bands were placed on both wrists prior to the initiation of chemotherapy (ranging from minutes to hours before chemotherapy) Baseline
Treatment Acupressure
Randomize Control (plaeebo band)
Treatment 2
and were worn until the completion of chemotherapy (usually until the time of discharge). Two sizes of bands were used: adult and pédiatrie. Size determination was done by the investigators and patients based on the wrist size of each patient. Outcomes were assessed by questionnaires, based on the modified methods of Morrow.''^ Ouestionnaires were written in an age-appropriate fashion, with nausea quantified using an 11-point Likert scale (eg, 0 = none; 5 = moderate; 10 = severe). In addition to demographics and diagnoses, questionnaires measured outcomes including previous knowledge and experience with acupressure or acupuncture, expectations of nausea prevention, episodes of emesis, presence and degree of nausea at various time points, side effects, satisfaction, and perceived differences between the acupressure and placebo bands. Ouestionnaires were completed before and after each course of chemotherapy. Patients were encouraged to complete the questionnaires themselves, but parents were allowed to help if desired. Gift certificates were offered as patient incentives for enrolment; each patient could receive up to three $5 gift certificates (one for each completed course) during the study. This study was approved by the Institutional Review Board. Results Of 21 patients approached, 21 (100%) agreed to enrol; 18 of 21 (86%) completed all study treatments and questionnaires. One patient had progressive disease and died, one did not return all of the questionnaires, and one changed to a different chemotherapy regimen. The characteristics of the 18 patients who completed the study are shown in Table 1. The patients ranged in age from 5 to 19 years, 9 were male, and 14 of 18 (78%) were Caucasian. Eight patients were enrolled beginning with their first course of chemotherapy, and 10 patients were enrolled with their second or later course of chemotherapy. Four of 18 (22%) patients had heard of acupressure prior to study enrolment. No patient had ever used acupressure or acupuncture prior to study enrolment. Treatment 3
Standard care (no bands)
• Control (placebo band)
Standard care (no bands)
• Acupressure
Figure 1. Experimental design schema.
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Jones et al. Acupressure for Chemotherapy-Associated Nausea and Vomiting
the end of chemotherapy) or the number of vomiting episodes in the three groups. After a chemotherapy course in which a band was worn, patients, on average, reported that they believed the bands were moderately effective. The vast majority (89-95%) of patients reported that their expectations were met or exceeded, regardless of which band they wore (Table 3). For treatment 2, during which patients wore no bands, 61% expected more nausea without the bands, 39% expected no difference with or without the bands, and none expected less nausea without the bands. No treatment order effect between study arms was found.
Table 1. Patient Characteristics Characteristic
Total
Sequence 1
Sequence 2
Age, yr Gender Male , Female Race Caucasian African American Hispanic Other Course of chemotherapy 1 > 2 Diagnosis Acute lymphoblastic leukemia Rhabdomyosarcoma Ewing sarcoma MeduUoblastoma Osteosarcoma Other
5-19
11.7 ± 4.2
12.5 ± 3.6
9 9
3
6
5
4
14 2 1
6
8
0 1 1
0 0
1
2
8 10
4 4
4 6
3
1
2
3 2 2
2 2
2 6
0 1 2
Four of 18 (22%) patients reported that the bands (both real and placebo) felt too tight and caused discomfort. No other side effects were reported. None had bruising, bleeding, sweUing, skin irritation, or infections at the site of the band. No neurovascular compromise was reported or noted in any patient. Six (33%) patients noted a difference between the acupressure and placebo bands, whereas 12 (67%) did not notice a difference. Eight (44%) patients planned to wear acupressure bands in the future, and 12 (67%) would recommend them to others.
1 0 2 1 4
In general, patients somewhat expected the acupressure bands to prevent N/V (Table 2). There was no significant difference in the severity of the nausea (either during or at
Discussion This is the first study to assess the feasibility of acupressure for the prevention of N/V in pédiatrie oncology patients.
Table 2. Expectations and Efficacy for Each Treatment Question
Acupressure Band
Placebo Band
No Band
Scale
Expectations of nausea/ vomiting prevention by bands (pretreatment) Nausea during chemotherapy
Mean (SD): 6.9 ± 2.3 Median: 6.9
Mean (SD): 5.0 ± 3.2 Median: 5.0
Mean (SD): 3.0 ± 2.8 Median: 2.0
Mean (SD): 3.2 ± 2.6 Median: 2.5
Mean (SD): 3.2 ± 2.7 Median: 2.5
0 = none 5 = moderate 10 = severe
Vomiting episodes during therapy Nausea at end of chemotherapy
Mean (SD): 0.8 ± 1.2 Median: 0 Mean (SD): 0.1 ± 0.3 Median: 0
Mean (SD): 1.1 ± 1.2 Median: 1.0 Mean (SD): 0.3 ± 0.8 Median: 0
Mean (SD): 0.8 ± 1.3 Median: 0 Mean (SD): 0.3 ± 0.7 Median: 0
NA
Total nausea prevention (including medicines) Effectiveness of bands in preventing nausea
Mean (SD): 2.7 ± 2.9 Median: 1.5
Mean (SD): 3.4 ± 2.7 Median: 3.5
Mean (SD): 3.4 ± 3.0 Median: 3.0
Mean (SD): 5.3 ± 3.6 Median: 6.5
Mean (SD): 5.5 ± 3.4 Median: 6.0
NA = not available.
0 = none 5 = somewhat 10 = very much
0 = none 5 = moderate 10 = severe 0 = completely 5 = moderately 10 = not at all 0 = not at all 5 = moderately 10 = completely
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Table 3. Patients' Perceptions of Nausea Prevention, Reported after Completion of Each Session Perception
Better than expected Expected Worse than expected
Acupressure, n (%)
Placebo Band, n (%)
6 (33) 10 (56) 2 (11)
5(28) 12 (67) 1 (5)
Although acupuncture has shown some promising results in the prevention and treatment of N/V, it carries some risks and requires special training, and in some locations licensing, to perform. Many children are uninterested in and/or scared of any treatment involving needles. Thus, we decided to study acupressure rather than acupuncture. Other advantages of acupressure over acupuncture are that it is inexpensive and widely and easily available. We found that the concept of acupressure therapy was appealing to our patients, and this was reflected in the 100% enrolment rate. Several patients were disappointed that they were not allowed to wear the bands during treatment 2, and several patients continued to wear the bands for subsequent courses of chemotherapy after completing the study. The bands' popularity is reflected by the data: almost half planned to use acupressure in the future, and two-thirds would recommend acupressure bands to others. Although four patients reported discomfort, none of the patients dropped out of the study owing to this. We observed that the adult-size band fit comfortably on most children; thus, the smaller pédiatrie bands are probably best reserved for children with very small wrists. Evidence suggests that expectations play an important role in the effectiveness of many therapies, including acupressure.''''^ Although the numbers in our study are too small to conclude this, it is likely that prestudy biases played a role in the reported efficacy. Acupressure's safety, ease of use, and inexpensive nature make it an attractive addition to standard antiemetic therapies for the perceived (hence placebo) effect, as well as patients', parents', and providers' desire to "add" something in the face of continued nausea. Like any potential placebo effect, if the patient reports efficacy, then the treatment is working, whether the effect is real or perceived. This study is limited by its small size and diverse patients with different ages, diagnoses, and chemotherapy and antiemetic regimens. It is also limited by the lack of objective measurements, such as quantification of antiemetic use. It is important to note that all patients in this study were treated with proven, potent antiemetic
therapies during chemotherapy courses. Although the acupressure bands did not offer significant additional benefits in reducing N/V, many patients still liked them and continued using them. Despite these limitations, this study has important implications for clinical care and research. This is the first randomized, placebo-controlled trial of acupressure in children receiving chemotherapy. In general, acupressure was safe and well received, and the patients believed it to be efficacious, although objective measures did not show statistically significant improvements over usual care. To assess the efficacy of acupressure in preventing chemotherapy-associated N/V in children, larger prospective studies are required.
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