Sun, D.Z., Jiao, J.P., Zhang, X., Xu, J.Y., Ye, M., Xiu, L.J., . . . Wei, P.K. (2014). Therapeutic effect of Jinlongshe Granule on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial. Chinese Journal of Integrative Medicine, 2014(Nov.), 1–8.
To observe functional and symptomatic changes related to quality of life in patients with advanced gastric cancer with administration of Jinlongshe granule (JLSG, a Chinese herbal medicine)
Patients were randomized into a JLSG group or a placebo group. All patients received Chinese medicinal herbs prescribed individually. The intervention arm additionally received JLSG, and the other arm received a placebo three times daily. Patients were followed biweekly in clinic visits. Study measures were obtained at enrollment and at 3, 6, 9, 12, and 15 months after treatment.
Double-blind, placebo-controlled, randomized clinical trial
There were statistically significant group-by-time effects for multiple symptoms including cognitive function, fatigue, pain, dyspnea, insomnia, appetite loss, constipation, and and general quality of life (p < .05). For some symptoms, differences were due to increased symptoms in the placebo group. No information regarding any adverse effects is reported. The direction of change in symptom scores is not always clear in this manuscript.
This study has several limitations that make it difficult to assess the potential efficacy of JLSG for symptom management.
This study provides minimal evidence in support of a specific Chinese herbal medicine in patients with advanced gastric cancer. Further well-designed studies are needed for clinically meaningful evaluation of efficacy.
Sui-Whi, J., Wilkie, D.J., Galulucci, B.B., Beaton, R.D. & Hsiu-Ying, H. (2005). Effects of massage on pain intensity, anxiety, and physiologic relaxation in Taiwanese patients with metastatic bone pain. Oncology Nursing Foundation Ninth National Conference on Cancer Nursing Research. Retrieved from http://www.ons.org/publications/journals/ONF/Volume34/Issue1/pdf/ResCon…
This intervention was a 30-minute, full-body massage delivered by the first author after completing pre-test. After the intervention, the participant was instructed to lie quietly for 30 minutes before completing the post-test.
Massage was shown to have effective, immediate, short-term (20–30 minutes; a 61% reduction in anxiety), intermediate (1–2.5 hours), and long-term benefits (16–18 hours) on present pain intensity and anxiety. The most significant reduction in anxiety occurred 15–20 minutes after the intervention. The results from ANOVA revealed a time effect of massage on anxiety visual analog score across time at a statistically significant level (F [10, 20] = 10.3, p < 0.001).
Suh, E.E. (2012). The effects of P6 acupressure and nurse-provided counseling on chemotherapy-induced nausea and vomiting in patients with breast cancer. Oncology Nursing Forum, 39(1), E1-9.
To evaluate the effects of pericardium 6 (P6) acupressure and nurse-provided counseling on chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer
Participants were randomized to one of four treatment groups. The control group received sham acupressure on SI3 point—the ulnar side of the metacarpophalangeal joint of the little finger of both hands. The three experimental groups consisted of counseling only, P6 acupressure-only, and P6 acupressure and counseling.
Counseling consisted of a one-hour cognitive behavioral session which included an introduction, cognitive preparation, symptom acceptance, the use of available resources, and question and answer session. Participants were instructed to perform the cognitive-behavioral session daily for 5 days (C2, D 1-5).
The P6 acupressure groups wore Sea-Band® bands on both wrists for 5 days.
All participants completed baseline data then received a booklet of instruments and a daily log. They were asked to check their gastrointestinal (GI) distress level nine different times the evening of the first day of cycle 2 of chemotherapy and then once in the morning and once in the evening of days 2–5. Patients were asked to keep a daily log of the antiemetic medications taken and the overall status of their GI symptoms. The research assistants called each participant once and sent two text messages during the 5-day period to increase adherence.
This study was conducted at a single outpatient setting in Seoul, South Korea.
All patients were in active treatment.
This was a randomized, controlled trial.
Synergic effects of P6 acupressure with nurse-provided counseling appeared to be effective in reducing CINV in patients with breast cancer.
The addition of P6 acupressure and nurse-provided counseling focused on cognitive awareness, affective readiness, symptom acceptance, and the use of available resources both appear to be effective as adjuncts to antiemetic medicine for the control of CINV in patients with breast cancer.
Suh, S.Y., Choi, Y.S., Oh, S.C., Kim, Y.S., Cho, K., Bae, W.K., . . . Ahn, H.Y. (2013). Caffeine as an adjuvant therapy to opioids in cancer pain: A randomized, double-blind, placebo-controlled trial. Journal of Pain and Symptom Management, 46, 474–482.
To assess the efficacy of caffeine infusion as an adjuvant analgesic for patients with advanced cancer on opioids for chronic pain
Patients were randomly assigned to either a caffeine group or a placebo group. The caffeine group was given 200 mg of caffeine intravenously over one hour daily for two days. The placebo group was given normal saline. Pain was assessed before the intervention, one hour after the infusion on day 1, before the intervention on day 2, and one hour after the intervention on day 2. Adverse events were assessed during interventions and two hours later.
A randomized, double-blind, placebo-controlled design was used.
A numeric rating scale (0–10) was used to measure pain and adverse effects.
Pain was significantly lower after the second trial, day 2, in those receiving caffeine (p = 0.038); however, the difference between groups in pain severity decline was extremely small. In those receiving caffeine, the decline in pain scores pre-post day 2 infusion was 0.83 (mean) and in those on placebo, the change was 0.81 (mean).
This study does not provide strong support for efficacy of caffeine infusion as an adjuvant analgesic compared to placebo for patients with pain associated with advanced cancer.
This study does not provide strong evidence for or against the use of caffeine infusions as adjuvant analgesia in patients with pain associated with advanced cancer.
Sugita, J., Matsushita, T., Kashiwazaki, H., Kosugi, M., Takahashi, S., Wakasa, K., … Imamura, M. (2011). Efficacy of folinic acid in preventing oral mucositis in allogeneic hematopoietic stem cell transplant patients receiving MTX as prophylaxis for GVHD. Bone Marrow Transplantation, 47, 258–264.
To assess the efficacy of folinic acid administration post-methotrexate treatment for graft-versus-host disease (GVHD) prophyllaxis on the incidence of oral mucositis and acute GVHD
A retrospective analysis of 118 consecutive patients who underwent allogeneic hematopoietic stem cell transplant (HSCT) and received methotrexate (MTX) for GVHD prophylaxis between March 2006 and December 2009. Systemic folinic acid (given at the same dose as used for methotrexate administration on additional days of treatment) and folinic acid mouthwash (13% folinic acid 4 times per day on days 1–7) were given according to physician discretion.
The study was conducted at a single site in the Stem Cell Transplant Center of Hokkaido University Hospital in Japan.
Patients were underoing the active treatment phase of care.
The study was a retrospective analysis of 118 consecutive patients between March 2006 and December 2009.
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used.
The incidence of oral mucositis (p = 0.00063) and severe oral mucositis (grade 3 or 4) was significantly lower in patients who received systemic folinic acid than in those that did not (p = 0.0005). Oral mucositis occurred in 77.1% of patients, and grade 3-4 mucositits occurred in 31.4%. No significant difference was found in the incidence of acute GVHD on day 100 post-transplant between the systemic folinic acid and non-folinic groups. Oral mucositis did not correlate with the development of severe GVHD, and no significant differences were found in the incidence of relapse between the two groups. Multivariate analysis showed that the odds of developing severe oral mucositis was significantly associated with a longer duration of severe neutropenia (> 21 days) (OR 4.78, p = 0.0019) and systemic folinic acid administration (OR 0.13, p = 0.014).
Folinic acid administration reduced the incidence of severe oral mucositis. The strongest association with the development of severe oral mucositis was longer duration of severe neutropenia.
Further randomized controlled studies are needed to assess the efficacy of systemic folinic acid plus or minus folinic acid mouthwash. Further studies are also needed to clarify the cost effectiveness of this treatment regimen. Findings suggest that prolonged severe neutropenia is an important factor in the development of severe oral mucositis.
Sugawara, Y., Akechi, T., Shima, Y., Okuyana, T., Akizuki, N., Nakano, T., . . . Uchitomi, Y. (2002). Efficacy of methylphenidate for fatigue in advanced cancer patients: a preliminary study. Palliative Medicine, 16, 261–263.
Immediate-release methylphenidate was given at a dose ranging from 5 to 30 mg per day; 11 of 16 patients were given 10 mg per day. The study was based on the hypothesis that methylphenidate may improve fatigue by counteracting the adverse effects of opiates or relieving depression.
Posttreatment assessment was conducted as soon as two days after the initiation of therapy (median of seven days after initiation of methylphenidate).
Patients were undergoing the end of life phase of care.
This was a prospective, open-label, pilot study.
A visual analog scale (VAS) was used to assess fatigue before premethylphenidate and after a median of seven days.
A statistically significant difference was found between the mean fatigue score before treatment with methylphenidate and the fatigue score after treatment. Following treatment with methylphenidate, patients reported lower fatigue scores, and six patients were classified by the investigators as having responded (defined by the investigators as a 30% improvement in fatigue severity score from pre- to posttreatment) to treatment with methylphenidate. Concomitant depression and the use of opioids did not predict methylphenidate efficacy. Two patients discontinued because of insomnia, and one reported mild palpitations but opted to continue methylphenidate. Adverse reactions reported generally were limited.
Suehiro, K., Honda, S., Kakutani, H., Morikage, N., Murakami, M., Yamashita, O., . . . Hamano, K. (2014). A novel arm sleeve for upper extremity lymphedema: A pilot study. Annals of Vascular Diseases, 7, 134–140.
To investigate the safety and efficacy of a novel arm sleeve composed of a conventional arm sleeve extending to a wider area of the body
Subjects who already used their own arm sleeves used a new conventional arm sleeve during the daytime for two weeks, followed by a novel sleeve during the daytime for two weeks. The characteristics of the arm part of the novel sleeve are the same as those of the arm part of the conventional sleeve. A large elastic body piece to cover the shoulder and the body trunk was attached to the novel sleeve. During the study, the subjects were allowed to use their own mittens or gloves.
Pre- and post-test design with repeated measures
When a new conventional arm sleeve was provided to participants, total arm volume (p < 0.05) and percentage of arm volume (p < 0.05) was reduced. When participants were given the novel sleeve, arm volume and percentage volume were reduced, but these changes were not statistically significant.
The novel arm sleeve was associated with some additional reduction in arm volume, but these changes were not significant. The conventional arm sleeve, however, did produce a significant reduction in arm volume when a new sleeve was provided to participants.
The sample for this study was extremely small, making the results difficult to generalize. Although the study showed that the novel arm sleeve provided some benefits for the management of arm lymphedema, well-designed studies with larger sample sizes are needed to replicate and examine the effectiveness of this intervention.
Suadoni, M.T. (2014). Are probiotics more efficacious than placebo at preventing radiotherapy-induced diarrhoea in adults with cancer. Journal of Radiotherapy in Practice, 13, 226–235.
DATABASES USED: MEDLINE, EMBASE
PHASE OF CARE: Active antitumor treatment
The Chitapanarux and Delia studies were most robust and the Giralt study was least robust. The Germain study could not be determined. There were no adverse events reported in the studies. The Chitapanarux and Delia studies determined that probiotics were beneficial and produced statistically significant results in the study population. The Germain study reported benefits that were statistically significant at standard dose and at high dose, which was not statistically significant. Studies revealed high clinical significance.
Evidence supporting contention that probiotics are beneficial is low quality.
More research is needed on the use of probiotics with rigorous randomized placebo controlled studies.
Su, C.K., Mehta, V., Ravikumar, L., Shah, R., Pinto, H., Halpern, J., … Quynh-Tu, L. (2004). Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms. International Journal of Radiation Oncology, Biology, Physics, 60, 171–177.
Patients were given 20 mL aloe vera solution or placebo to swish and swallow four times per day beginning on the first day of radiation therapy (RT) and continuing throughout the treatment course. The solution consisted of 94.5% aloe juice, 5.0% pear juice concentrate, 0.4% lemon-lime flavor, and 0.1% citric acid. The placebo solution was taste-matched with identical astringency, consistency, and ingredients, except that the aloe vera juice was replaced with water.
The study reported on 58 patients with stage II-IV M0 head and neck cancer who were scheduled to receive radiation of at least 50 Gy to at least one site; 28 patients were given aloe vera, and 30 were given placebo.
The study was conducted from February 1999 through March 2002.
This was a double-blind, placebo-controlled, randomized trial.
Findings were not significant.
This study did not accrue adequate patients according to statistical analysis.
Su, C.X., Wang, L.Q., Grant, S.J., & Liu, J.P. (2014). Chinese herbal medicine for cancer-related fatigue: A systematic review of randomized clinical trials. Complementary Therapies in Medicine, 22, 567–579.
PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Palliative care
CHM used alone or in combination with chemotherapy or supportive care showed significant relief in CRF compared to placebo, chemotherapy, and supportive care based on single trials. CHM plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated that CHM exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events, and no severe adverse effects were found in CHM groups.
The work suggests that CHM may be effective and safe in the treatment of CRF. However, the current evidence is insufficient to draw a confirmatory conclusion due to the poor methodological quality of included trials.
Quality of methods:
It is necessary to conduct rigorously designed trials on potential CHM.