Bao, Y.J., Hua, B.J., Hou, W., Lin, H.S., Zhang, X.B., & Yang, G.X. (2010). Alleviation of cancerous pain by external compress with Xiaozheng Zhitong Paste. Chinese Journal of Integrative Medicine, 16, 309–314.
To observe the clinical effectiveness of a topical application of Xiaozheng Zhitong Paste (XZP) in alleviating the cancerous pain of patients with middle/late-stage cancer
Patients were randomized into either the treatment group (64 patients) or the control group (60 patients). In addition to utilization of three-ladder (3L) analgesia therapy in both groups, topical application of XZP was given to patients in the treatment group for pain alleviation. Analgesic efficacy was recorded in terms of pain intensity, analgesia initiating time and sustaining time, and the optimal analgesic effect revealing time. Quality of life and adverse reactions that occurred in patients were also recorded.
The extent of pain, the analgesic effect initiating time and sustaining time of medication, and the optimal effect revealing time were recorded before medication and 24 hours after medication. Quality of life was estimated by Karnofsky scoring and the Brief Pain Inventory (BPI).
Intensity of pain was evaluated per standards of the World Health Organization with the numeric rating scale (NRS), expressed as digits from 0–10 (0 for no pain, 10 for extreme pain). Intensity of pain was ranked into four grades: 0 = no pain; grade I = endurable pain, normal daily life, sleep not affected, NRS 1–3; grade II = obvious pain, unendurable, patients asked for analgesia, daily life and sleep affected, NRS 4–6; grade III = severe pain, could hardly endure, analgesia necessary, sleep interfered with, impact on motion, forced posture, painful complexion, and incessant groaning, NRS 7– 10.
Effectiveness on pain treatment was classified into four grades: completely remitted (CR), partially remitted (PR), mildly remitted (MR), and no palliation (NP). Comparison of the total effective rate (sum of CR+PR+MR) between the two groups showed no significant difference (p > 0.05). Analgesic effect initiating time was decreased, and its sustaining time was elongated in both groups after medication (p < 0.01), but the initiating time was shorter in the treatment group than in the control group (p < 0.01). The mean optimal analgesia effect was shorter in the treatment group, demonstrating a significant difference (p < 0.01).
Compared by the effect of pain on patients, the effect was attenuated by both groups after medication, but the mental condition, walking capacity, social acceptability, sleep, and joy of living were all better with those in the control group, showing statistical significance (p < 0.01).
The combination of 3L analgesia and XZP compress demonstrates the similar effects in pain alleviation as compared with 3L analgesia alone.
XZP paste was prepared at the pharmaceutical department of the author’s hospital.
Chinese medicine may prove to be beneficial for patients with cancer-associated pain management issues, as well as in end-of-life and palliative care; however, these findings do not provide support for the intervention tested here. Nursing participation in these evaluations is essential.
Bao, T., Ye, X., Skinner, J., Cao, B., Fisher, J., Nesbit, S., & Grossman, S.A. (2011). The analgesic effect of magnetic acupressure in cancer patients undergoing bone marrow aspiration and biopsy: A randomized, blinded, controlled trial. Journal of Pain and Symptom Management, 41(6), 995–1002.
To compare the analgesic effect of applying magnetic acupressure to the L14 point to that of applying magnetic acupressure to a sham point
Patients were stratified by the number of prior bone marrow aspiration biopsies (BMABs) and randomized to one of two groups. In the first group, a practitioner delivered acupressure to the L14 acupoint (the dorsum of the first interosseus space of the hand). In the second group, a practitioner delivered acupressure to a sham point (the fourth interosseus space of the hand). Two HACI magnetic acupressure suction cups (HMASCs) were applied to the designated area of both the patient's hands for the duration of the BMAB procedure. The same two HMASCs were used on all study patients. All patients received standard local analgesics as ordered by the BMAB provider. The same BMAB provider and acupressure practitioner were used throughout the study. The patient, BMAB provider, and outcome evaluator were blinded to the location of the acupressure. The patient’s pain intensity was measured at baseline and after the BMAB.
Multiple phases of care
Single-center randomized single-blind clinical trial
Authors noted no significant difference in median pain scores between the patients treated at the L14 site versus the sham site (3.0 versus 3.0, p = 0.08, Mann-Whitney test). Eight patients (20%) in the sham-site group experienced severe pain. One patient (2.7%) in the L14 group experienced severe pain (p = 0.03, two-tailed Fisher’s exact test). The unadjusted risk of patients experiencing severe pain in the sham-site group was nine times higher (95% CI 1.07–75.9, p = 0.04). After accounting for age, number of prior BMABs, baseline pain scores, and the number of times the cup fell during the procedure, patients in the sham-site group were more likely to experience severe pain than were those in the L14 group (risk ratio 9.3; 95% CI 1.01–85.6; p = 0.049). The acupressure point was the only statistically significant factor associated with BMAB-related pain.
Magnetic acupressure delivered at L14 may reduce the number of patients who experience severe pain during BMAB.
The combination of magnetic acupressure at the L14 site and local anesthetics may reduce severe pain during BMAB. Acupressure is inexpensive, and it requires minimal training to deliver.
Bao, T., Goloubeva, O., Pelser, C., Porter, N., Primrose, J., Hester, L., . . . Badros, A.Z. (2014). A pilot study of acupuncture in treating bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Integrative Cancer Therapies, 13, 396–404.
To determine the effectiveness, safety, and convenience of acupuncture in decreasing bortezomib-induced peripheral neuropathy (BIPN)
Patients were treated with 10 acupuncture treatments twice a week for two weeks, then once a week for four weeks, and then every other week for four weeks. Patients remained on their prescription PN medications.
PHASE OF CARE: Active antitumor treatment
Prospective study
The Clinical Total Neuropathy Score was considered invalid because of reliability and validity issues in this setting. The FACT/GOG Neurotoxicity (Ntx) subscale and NPS scores demonstrated significant decreases in BIPN symptoms. Improvements in buttoning and walking at weeks 10 and 14 (p values < 0.0001) were observed. No differences in nerve conduction evaluations were reported from baseline to the completion of the study. No change in serum biomarkers were reported.
Acupuncture was demonstrated as a safe although inconvenient treatment for BIPN. Patients reported improvements in BIPN symptoms.
The intervention produced a decrease in some BIPN symptoms. Acupuncture needs to be administered by a licensed therapist, which may not be a realistic treatment for all patients. A large, randomized trial is indicated for future research.
Bao, T., Cai, L., Giles, J.T., Gould, J., Tarpinian, K., Betts, K., . . . Stearns, V. (2013). A dual-center randomized controlled double blind trial assessing the effect of acupuncture in reducing musculoskeletal symptoms in breast cancer patients taking aromatase inhibitors. Breast Cancer Research and Treatment, 138, 167–174.
To evaluate the effect of acupuncture on function and pain in women with aromatase inhibitor associated musculoskeletal symptoms (AIMSS) and the effect of serum hormones and proinflammatory cytokines to help clarify the molecular mechanism of action with the use of acupuncture
Patients were randomized to eight weekly real or sham acupuncture sessions evaluated by the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scare (VAS) at baseline and after intervention. Serum hormones and proinflammatory cytokines were measured pre- and post-intervention.
No significant difference was seen in HAQ-DI and VAS scores between the groups. A significant reduction of interleukin 17 was seen in both groups after eight weeks, and no significant changes were seen in other hormone/proinflammatory markers in either group. No significant difference were seen in AIMSS between the groups; however, after eight weeks of treatment, HAQ-DI and VAS scores improved for both groups.
This study does not appear to support acupuncture as a means to reduce musculoskeletal symptoms in patients with breast cancer taking aromatase inhibitors. Sham and real acupuncture seem to improve HAQ-DI and VAS scores and seem to lower baseline, as revealed by a 12-week follow-up after the study. Neither acupuncture nor sham acupuncture produced any adverse effects and seem to be safe as an option for patients with early-stage breast cancer with AIMSS.
This study does not support acupuncture over sham acupuncture for the treatment of AIMSS in women with early-stage breast cancer. That being said, acupuncture has helped to improve VAS and HAQ-DI scores, suggesting it as a positive intervention with no side effects for these patients. Education and training in acupuncture would be suggested prior to therapy, but this article suggests that sham acupuncture produces statistically similar results and improves scores.
Banzer, W., Bernhorster, M., Schmidt, K., Niederer, D., Lungwitz, A., Thiel, C., . . . Vogt, L. (2014). Changes in exercise capacity, quality of life and fatigue in cancer patients during an intervention. European Journal of Cancer Care, 23, 624–629.
To explore the interdependence of changes in oxygen uptake, quality of life (QOL), and cancer-related fatigue (CRF) during a four-month exercise intervention
Aerobic exercise capacity was determined by a physician-supervised cardiopulmonary exercise test on an electrically braked cycle ergometer. An initial watt load of 0 watts was increased by 25 watts every three minutes until exhaustion. The results were used at an initial exercise counseling session to individualize exercise plans (i.e., frequency of three to five times per week, intensity, type of exercise, opportunity to participate in a Nordic walking training session once per week). Subjects attended a second counseling session four weeks into the intervention to adjust home-based exercises to fit their conditions. An exercise counselor was available by phone, via email, or in person at any time during the intervention. Assessments were repeated at the end of 16–20 weeks. Self-reported measures of adherence to exercise plans were obtained by diaries.
Repeated measures pre- and postintervention
Subjects were active (i.e., hiking, biking, walking, bicycling) three to six times per week for 60–300 minutes at 60%–100% of individual anaerobic thresholds. At baseline, the groups differed in QOL scores but not CRF or VO2PEAK scores. Subjects with complete data sets had a significant increase in VO2PEAK and QOL scores, and their fatigue decreased significantly over the course of the intervention. No significant effect for diagnosis or time since diagnoses occurred.
A relationship between exercise capacity enhancement, QOL improvement, and fatigue symptom reduction exists during and shortly after cancer treatment.
The data in this study support the role of individualized exercise planning based on baseline exercise capacity with respect to frequency, time, and intensity as well as the importance of patient choice in the type of exercise in which to participate.
Banerjee, M., Pal, S., Bhattacharya, B., Ghosh, B., Mondal, S., & Basu, J. (2013). A comparative study of efficacy and safety of gabapentin versus amitriptyline as coanalgesics in patients receiving opioid analgesics for neuropathic pain in malignancy. Indian Journal of Pharmacology, 45, 334–338.
To determine the comparative efficacy and safety of gabapentin and amitriptyline as coanalgesics for cancer-related pain
Patients were assigned randomly to receive oral tramadol 150–200 mg and oral gabapentin titrated from 600–1,800 mg daily, or tramadol 150–200 mg and amitriptyline titrated from 25–100 mg daily. Oral morphine or fentanyl transdermal patch were used as rescue medication. At baseline, if patients were on any coanalgesic, they were entered after a washout period. Patients were followed monthly up to six months. Patients were asked to maintain a diary used for assessment of compliance. Once a patient used rescue medication, the patient was excluded from further efficacy assessment, and last pain scores were carried forward.
For patients receiving gabapentin, pain scores on the VAS reduced significantly between the first and second month (p < .001). The same timing and pattern of pain reduction were shown in the amitriptyline group (p < .001). No significant differences were seen between groups at any study time point. Six patients on gabapentin and eight patients receiving amitriptyline required rescue medication. Thirty percent of patients in the gabapentin group and 42% of patients in the amitriptyline group had adverse events. These were generally mild. More patients receiving amitriptyline experienced postural hypotension (p = .02) and dry mouth (p = .04). Sedation, dizziness, and dyspepsia were the most frequent side effects.
Findings suggest that gabapentin and amitriptyline can be effective as coanalgesics for neuropathic pain.
Findings suggest that either gabapentin or amitriptyline can be effective coanalgesics for neuropathic pain, and professional guidelines generally have suggested consideration of such medication. The side effect profiles of the two drugs studied here were slightly different, so individual patient characteristics and risks need to be considered in medication selection. In this study, patients had no significant other disorders, so if similar results would be seen among patients with comorbid conditions is not clear.
Banerjee, B., Vadiraj, H.S., Ram, A., Rao, R., Jayapal, M., Gopinath, K.S., . . . Hande, M.P. (2007). Effects of an integrated yoga program in modulating psychosocial stress and radiation-induced genotoxic stress in breast cancer patients undergoing radiotherapy. Integrative Cancer Therapies, 6, 242–250.
The yoga intervention was a 90-minute, six-week course taught by expert yoga trainers. The course included meditative practices, various postures, guided imagery of cancer cells, positive thought provocation, chanting of various sounds according to the respective patient’s religious beliefs, awareness practices, deep relaxation, and soothing sound vibrations. Control group patients were given supportive counseling and advised to take light exercise.
Three centers in India
A randomized controlled trial design was used.
There was significant decrease in anxiety levels in the yoga intervention group (repeated measures ANCOVA, p < 0.001). Yoga intervention decreased anxiety in women with breast cancer receiving radiation therapy.
Bandieri, E., Sichetti, D., Romero, M., Fanizza, C., Belfiglio, M., Buonaccorso, L., . . . Luppi, M. (2012). Impact of early access to a palliative/supportive care intervention on pain management in patients with cancer. Annals of Oncology, 23, 2016–2020.
To investigate the impact of early integration of palliative and supportive care on pain management
Patients involved in the palliative care group were seen within two to three weeks of the cancer diagnosis. Services provided by the palliative and supportive care team were individualized, but included comprehensive symptom management, psychosocial, spiritual, and emotional support to patients and families, as well as assistance with treatment choice and coping. Patients in the comparison group received standard care provided by primary specialists. Data were collected from medical records. Patients were interviewed by a pharmacist regarding perception of pain control and pain intensity on a verbal rating scale.
The study has clinical applicability for palliative care.
A descriptive, two-group comparison design was used.
Verbal rating scale (five-point)
Use of morphine and oxycodone were higher in the palliative care group (p < 0.0001). Transdermal fentanyl was used more often in the usual care group (p < 0.0001). Results from the interview showed that the percentage of patients with no pain and mild pain were significantly higher in the palliative care group (p < 0.0001). Care model and gender were the only predictive variables for pain outcomes, with male patients reporting lower pain severity (p = 0.003). Type of analgesics used was not a significant predictor of pain scoring results.
Findings suggest that provision of early palliative and supportive care is associated with lower pain severity than provision of standard care. There were significant differences in the types of analgesics used between care models, but this factor was not predictive of measured pain severity.
This study design is associated with multiple limitations and threats to validity, so results cannot be seen as conclusive. Findings do suggest that an integrated care delivery model, incorporating holistic palliative and supportive care that is initiated early in the course of cancer care, may be associated with greater control of cancer-related pain.
Bandieri, E., Romero, M., Ripamonti, C.I., Artioli, F., Sichetti, D., Fanizza, C., . . . Luppi, M. (2016). Randomized trial of low-dose morphine versus weak opioids in moderate cancer pain. Journal of Clinical Oncology, 34, 436–442.
To evaluate the efficacy and tolerability of low dose morphine in comparison to standard doses of weak opioids in the treatment of moderate cancer pain in opioid naïve patients
This multicenter, 28-day, open-label randomized controlled study for adults with moderate cancer pain assigned to receive either a weak opioid or low dose of morphine was designed to evaluate the efficacy and tolerability of low dose morphine in comparison to standard doses of weak opioids in the treatment of moderate cancer pain in opioid naïve patients. The weak opioid group received either tramadol or codeine with or without paracetamol. The morphine group received morphine after a three-day titration phase with normal release morphine up to 30 mg per day. The groups were assessed every seven days.
In patients with cancer and moderate pain (4–6 out of 10), low-dose morphine reduced pain intensity significantly compared to weak opioids (tramadol or codeine) with a similarly good tolerability and adverse effects.
This study is has very important patient and nursing implications. By not using step II, weak opioids, we could potentially have better control of our patient’s pain as well as decrease costs by not using some of the more expensive weak opioids. More research is needed to compare the most commonly used strong opioids as first-line medications for pain intensity and adverse effects. Future studies should prospectively determine the morphine equivalent daily doses. These studies may determine that step II opioids are less effective and more costly. Ending step II in the World Health Organization's (WHO) ladder could simplify pain management while giving better pain control in a more efficient manner.
Ballantyne, J.C., & Carwood, C.M. (2005). Comparative efficacy of epidural, subarachnoid, and intracerebroventricular opioids in patients with pain due to cancer. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD005178.
To compare intracerebroventricular (ICV) opioid therapy with either subarachnoid (SA) or epidural (EPI) opioid therapy
DATABASES: AgeLine (1978–1991), Bioethics (1973–1994), BIOSIS (1969–1991), Catline (through 1991), Dissertation Abstract (1966–1991), EMBASE (1974–1991), ERIC (1966–1991), FEDRIP (1966–1991), GPO (1976–1991), Health (1975–1991), NTIS (1964–1991), Psychological Abstracts (1967–1991), Religion Index (1975–2001), Sociological Abstracts (1963), Social Science Research (1972), MEDLINE (1966–2003), CINAHL (1982–2003), and CANCERLIT (1975–2002)
COMMENTS ON LITERATURE USED: Data were extracted from trials and used to compare analgesic efficacy, pharmacologic adverse effects, and catheter and system problems. No controlled trials were identified for these treatments. Data extracted looked at the best available evidence to evaluate the use of these treatments in patients with cancer.
FINAL NUMBER STUDIES INCLUDED: ICV = 13 trials (337 patients); EPI = 31 trials (1,343 patients); SA = 28 trials (722 patients)
TRIALS EVALUATED: No controlled trials were identified for these treatments.
Uncontrolled studies show that neuraxial opioid therapy often is effective for treating cancer pain that has not been controlled by systemic treatment. Long-term use of neuraxial therapy can be complicated by problems with catheters. Some of the therapies are costly. ICV therapy is more costly; however, comparative efficacy, side effects, and system longevity are unknown.
More rigorous reporting of efficacy and complications needs to be done before ICV can be recommended as a first-line therapy.