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"Many symptoms of cancer patients, including pain, nausea, and dry mouth, are significantly different in an objective sense than in a subjective sense," says Peter Johnstone, MD, William A. Mitchell Professor and chair of Radiation Oncology at the Indiana University School of Medicine. "We have evidence now proving that a disconnect often exists between a patient's reported symptoms and objective evidence of those symptoms," says Dr. Johnstone, who is also past president of the Society for Integrative Oncology. He made his comments in response to 2 recent studies regarding the effects of acupressure/acupuncture on nausea and xerostomia (dry mouth) in patients receiving radiotherapy for cancer.
Nausea is a common problem for patients undergoing cancer therapy. Several lines of research have documented that expectation of nausea before the administration of chemotherapeutic drugs influences the development of nausea during and after treatment. A group of investigators based at the James P. Wilmot Cancer Center recently set out to determine whether acupressure bands, which previously were shown to reduce chemotherapy-related nausea, also reduce radiation-induced nausea (J Pain Symptom Manage. 2009 March 27. [Epub ahead of print]). They also tested the hypothesis that an informational manipulation designed to enhance expectations regarding the efficacy of acupressure bands would, in fact, enhance the efficacy of the bands.
This group of investigators previously conducted 2 similar studies. In the first study, patients starting chemotherapy received educational material designed to dispel common misconceptions regarding chemotherapy-induced nausea. The intervention was successful in reducing the expectation of nausea in the patients randomized to receive the educational materials, but these patients did not appear to have less nausea during treatment than the control group that did not receive the educational intervention (J Pain Symptom Manage. 2008;35:381–387).
The investigators' explanation of these results was that either the expectation of nausea is not truly related to its subsequent occurrence and perception, or that the intervention's effect on expectation was not strong enough to influence subsequent nausea. In the second study, patients who were about to start chemotherapy were randomized to receive an acupressure band or an acustimulation band, both of which stimulated the P6 point on the inner wrist, an acupuncture point that has been reported to be associated with nausea relief. A control group received no intervention. Among the patients in this study, those who used acupressure bands and who reported that they expected them to be effective were found to have significantly less nausea than people with acupressure bands who did not expect them to be effective, patients who received acustimulation bands, and patients who received no bands, suggesting that expectation was 1 factor that played a strong role in determining efficacy (J Pain Symptom Manage. 2003;26:731–742).
Patients were eligible for the current study if they had received a minimum of 2 radiation treatments and had experienced nausea/vomiting (NV) after at least 1 radiation session. Patients were asked to wear the acupressure band (Sea–Bands; Sea–Band Ltd, Hinckley, Leicestershire, UK) for 1 minute. Investigators explained that 2 things were being investigated: the efficacy of the bands and the way in which information about the bands was delivered to patients. After wearing the bands for 1 minute, patients took them off and completed a quality-of-life (QOL) measure and a questionnaire that included questions related to expected efficacy. Patients did not take the acupressure bands home, but they were given a take-home diary in which to record NV after their next 2 radiation treatments; this served as a baseline measure of NV. Study subjects were unaware of the study's primary hypothesis that expectations would influence perceptions of efficacy.
When patients returned the diary of baseline NV symptoms, they were randomized to 1 of 3 groups:
The patients in Arms 2 and 3 were instructed to wear 1 or both bands at their discretion over the next 5 days, during which time they received 5 radiation treatments. Antiemetic medications and other treatments for NV were permitted for patients in all 3 arms and were not standardized. Patients continued to record NV in a 5-day diary and completed a QOL questionnaire before going to bed after the fifth treatment.
NV were assessed with a patient report diary, in which patients reported on the severity and number of episodes of NV in the morning, afternoon, evening, and night of each radiation treatment. Investigators also assessed the amount of antiemetic medication taken by each patient. Each patient's expectation of nausea was assessed by a questionnaire. QOL was measured with the Functional Assessment of Cancer Therapy Scale–General (FACT–G), a well-characterized and validated, 28-item scale. The investigators planned to determine the change in average nausea between baseline and after treatment using analysis of variance. A total of 99 patients were randomized, and 88 (89%) provided usable data. The baseline differences in nausea between the 3 treatment arms were significant and required the use of change scores in all subsequent analyses.
Patients who used the bands (Arms 2 and 3 combined) had a 23.8% reduction in the self-reported nausea score compared with a 4.8% decrease in the control group (P = .01). However, there were no differences noted between patients using bands and those not using the bands with regard to change scores of QOL (P = .93), changes in the daily amount of antiemetic medication used (P = .78), or changes in the occurrence of vomiting (P = .17). Nonetheless, satisfaction with the bands was high, with most patients reporting that they would recommend the bands to others undergoing radiotherapy.
The investigators did not find a difference in expected band efficacy between Arms 2 and 3 (P = .56). One explanation they suggested is that information that the investigators believed was neutral was actually perceived by the patients as positive. In particular, patients may not have recognized that calling the effect of the acupressure bands "just a placebo response" was dismissive and negative. In a follow-up study, Joseph A. Roscoe, PhD, research associate professor in the Department of Radiation Oncology at the University of Rochester Medical Center and the other investigators plan to simply thank patients in Arm 2 for their participation rather than attempting to present them with neutral educational information. "We think the difference [between neutral and positive information] in this context is just too subtle," he says.
Among the 59 patients who used bands, the expected efficacy was not found to be correlated with the change in nausea (P = .61) or vomiting (P = .56). "It is possible, " the investigators wrote, "that the acupressure bands were effective in our study for reasons not related to expectancy...that the acupressure bands are indeed efficacious, as suggested by a growing body of literature showing that stimulation of acupuncture points can indeed reduce nausea. It has, after all, been a staple of Chinese medicine for centuries. While our data support this interpretation, we are reluctant to accept it at face value because of other reports in the literature, including our own, linking the efficacy of acupressure bands to expectancy/placebo effects."
"It appears that the acupressure bands are helpful in many patients, but not everyone," says Dr. Roscoe. He noted that once nausea is established in patients, as it was in this group, it is hard to remedy it. "But that's what happened here—established nausea was improved. It is preferable to prevent nausea in the first place," he added.
"Some antinausea medications are very expensive, so a low-cost intervention like acupressure bands would be great for patients who need nausea relief," Dr. Johnstone says. The only caveat, says Dr. Roscoe, is that patients with lymphedema should be careful not to use the band on the affected arm.
Xerostomia occurs as both a chronic and acute complication of radiation administered in the treatment of head and neck cancer. In addition to mouth pain and difficulty speaking resulting from xerostomia, alterations in taste and difficulty swallowing can compromise nutritional status, and changes in the oral flora can lead to dental caries and even jaw infections. Investigators at The University of Texas M. D. Anderson Cancer Center in Houston conducted a pilot study to evaluate the effect of acupuncture on radiation-induced, self-reported xerostomia and, as a secondary objective, the effect of acupuncture on salivary flow (Head Neck. 2009 April 17. [Epub ahead of print]). Xerostomia tends not to resolve spontaneously, and the currently available methods used to manage the condition, including oral pilocarpine, electrical stimulation of oral tissue, and hyperbaric oxygen therapy, have limited efficacy and limited acceptance by patients. Early studies have suggested that acupuncture might stimulate saliva production in people with xerostomia induced by radiotherapy, which led this research team in Houston to conduct their study.
Nineteen patients participated; all had completed a course of bilateral, external-beam radiotherapy (>4000 centigrays) at least 4 months before enrollment and had developed xerostomia afterward. The intervention consisted of acupuncture treatment given twice a week for 4 weeks. Five standard acupuncture sites were selected based on efficacy suggested by earlier studies with xerostomia.
Patients also completed a Xerostomia Inventory (XI) and a Patient Benefit Questionnaire (PBQ). "Both questionnaires assess symptoms related to dry mouth. They are scored differently, however, " says M. Kay Garcia, DrPH, MSN, a clinical nurse specialist and study coauthor. "For the XI, a high score indicates worse xerostomia and for the PBQ, a low score indicates worse xerostomia. We used both instruments in order to be sure we were measuring what we intended to measure and ensure validity of the assessment." Patients also completed The Functional Assessment of Cancer Therapy Scale–Head and Neck (FACT–H&N) scale. "This QOL instrument asks some questions related to dry mouth, but it also assesses symptoms related to pain, fatigue, nausea, and the impact these have on functional, emotional, and social well-being," Dr. Garcia explained.
The investigators also assessed the unstimulated whole salivary flow rate (UWSFR) and stimulated salivary flow rate (SSFR). Baseline determinations were made 1 week before the acupuncture intervention and then repeated at Weeks 1, 2, 3, 4, 5, and 8.
In these patients, the XI and PBQ scores were found to be significantly improved by acupuncture at Weeks 4 and 8 compared with baseline (XI: P = 0004 and P = .0001, respectively; and PBQ: P = .0004 and P = .0011, respectively). The FACT–H&N total scores were found to be significantly (P = .03) improved at Week 8. The authors concluded that acupuncture could improve the subjective symptoms of dry mouth and that these effects persisted for at least 1 month after acupuncture treatment. Despite these subjective improvements, the investigators found no change in the SSFR or UWSFR in these patients.
Dr. Garcia explained the difficulty in taking the salivary flow findings at face value: "Both basal and stimulated salivary flow rates vary significantly among individuals. UWSFR have been reported to range from 0.08 to 1.83 mL/minute, a difference of more than 20-fold. SSFR vary even more, from 0.2 to 5.7 mL/minute. Within this wide range of flow rates, subjective perception of dry mouth and objective signs of salivary gland dysfunction do not correlate," she says.
Given the wide range of flow rates among patients with normal oral function, the assessment of salivary gland function without individual subject baselines is difficult, Dr. Garcia says. "Subjective sensations of oral dryness are not reliable indicators of flow rate; impaired salivary gland function can exist without xerostomia, which can, conversely, exist with normal salivary gland function. A difficulty lies in the fact that there is no definitive threshold of increased saliva output that results in a clear clinical benefit. Thus, the only benefit currently recognized by the FDA [US Food and Drug Administration] for approval of xerostomia therapies is the subjective response," she adds.
"Acupuncture is a relatively low-cost intervention that is more widely available than people generally assume," says Dr. Johnstone, who echoed Dr. Garcia's observations that objective data regarding xerostomia are difficult to obtain, making the patient's subjective reports the ones that really count.
"It's how the patient feels that counts," says Dr. Johnstone. "For many symptoms of cancer treatment—pain, dry mouth, nausea, and others—management involves a richer canvas than we've seen before."
Dr. Johnstone adds that "Acupuncture and acupressure represent low-cost, but highly engaging mechanisms for potential relief of many cancer patients' symptoms. Although proper controls often are difficult in clinical trials investigating such integrative therapies, well-designed studies are ongoing in many centers.
Patients should discuss such nontraditional therapies with their oncologists prior to investigating them, but an increasing number of physicians are aware of appropriate community resources. Guidelines are available from the Society for Integrative Oncology for patients who are interested in using integrative therapies for cancer symptom control." 
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