Pilot the use of sweet bee venom pharmacopuncture to assess preliminary efficacy data

Six treatments were given by one certified oriental medicine doctor to patients over a three-week period. All patients were given skin tests prior to treatment. Adverse events were recorded after each session. The bee venom used incorporated melittin, an active extract from bee venom with allergens removed. The substance was injected into acupuncture points that were chosen in relation to the patients’ symptoms based on oriental medicine theory. Study measures were obtained at baseline; after two, four, and six treatments; and three weeks after treatments were completed.

• N = 8
• MEAN AGE = 49 years
• MALES = 25%, FEMALES = 75%
• KEY DISEASE CHARACTERISTICS: Various tumor types existed. Patients had received taxanes, cisplatin, carboplatin, or oxaliplatin.
• OTHER KEY SAMPLE CHARACTERISTICS: All had diagnosed peripheral neuropathy.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Korea

PHASE OF CARE: Late effects and survivorship

Prospective trial—case series

• World Health Organization (WHO) common toxicity criteria for peripheral neuropathy
• Peripheral neuropathy questionnaire
• Functional Assessment of Cancer Therapy—General (FACT-G)
• Common Terminology Criteria for Adverse Events
• Health-related quality-of-life questionnaire
• Visual analog scale (VAS)

Three patients who initially entered dropped out of the study—two due to symptoms that may have been associated with the injections, such as swelling and pain at the injection site and fever. Other therapies used by patients included red ginseng, herbal tonics, massage, foot/hand soaks, and pressure bands. All measures showed a decline in symptoms of peripheral neuropathy, and quality-of-life scores improved. VAS measures and WHO grade of peripheral neuropathy showed significant improvement (p ≤ .01).

Findings provide minimal evidence that sweet bee venom pharmacopuncture may have some benefit for treatment of chemotherapy-induced peripheral neuropathy. Half of the patients dropped out of the study, and 30% had probably adverse events from injections.

• Small sample of < 30
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods were not well described.
• Measurement validity/reliability were questionable.
• Subject withdrawals ≥ 10%
• All study measures used are not fully described.
• Multiple other herbal and other remedies also were used.
• Timing of the intervention related to antitumor therapy is not described.
• Follow-up period is short.

This pilot study provides some evidence to suggest that pharmacoacupuncture with sweet bee venom derivative is appropriate for further research to determine its potential efficacy and safety in larger well-designed trials.

To assess the noninferiority of 1 mg granisetron injection to 3 mg granisetron injection for the treatment of acute chemotherapy-induced nausea and vomiting (CINV)

Patients were randomly assigned to two treatment arms. All patients also received dexamethasone. Researchers asked the patients directly or via phone if they experienced any emetic events within 24–36 hours following the start of administration of highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Patients recorded their symptoms, along with use of rescue antiemetics, for six days on diary cards, which were collected at each visit.

• The sample consisted of 182 participants.
• Median age was 56 years, with a range of 23–80 years.
• The sample was 96% female and 4% male.
• Participants were patients with cancer who were scheduled to undergo chemotherapy and were stratified into the high- or moderate-emetic risk groups for CINV according to the American Society for Clinical Oncology (ASCO) guidelines for antiemetic treatment.
• The most commonly reported primary cancers were breast (n = 94), gynecologic (n = 64), primary unknown (n = 16), urothelial (n = 4), and sarcoma (n = 3). 

The setting was a single site in Tokyo, Japan.

Study participants were in active treatment.

This was a single-blind, randomized parallel group trial.

• Episodes of nausea were recorded by the patients on diary cards, along with the severity of the episodes according to the following 4-point scale: 0 = none (no nausea), 1 = mild (able to take meals as usual), 2 = moderate (reduced intake of food), and 3 = severe (unable to take either food or water).
• Patients also recorded any type or doses of antiemetic agents (i.e., rescue medications).
• Adverse events were evaluated based on the Common Terminology Criteria for Adverse Events (CTAE v3.0, Japanese version).

• Complete protection was achieved in 78% of the patients in the 1-mg group and 81% of the 3-mg group.
• The one-sided test did not reveal noninferiority of either dose of granisetron to the other at the 5% significance level.
• No significant differences were found between the groups for rate of complete response.

The rate of complete protection from nausea and vomiting was similar in both the 1-mg and 3-mg granisetron groups.

Nausea was measured as ability or inability to take meals as usual, rather than the symptom of nausea.

Granisetron dosed at 1 mg is appropriate for treatment of acute CINV in patients with cancer.

All patients received initial tooth brushing with a dental brush by a dentist and scaling to teeth with an ultrasonic scaler.

Special care group:
Dentist performed oral care with irrigation and suctioning for 15 minutes three days per week for two to four weeks between 7:00 pm and 8:00 pm after dinner. 20 ml of 0.5% povidone-iodine was ejected through the e-brush, then suctioned. This was done in the mouth, sides of the teeth, tongue, and mucosal surfaces. Patients rinsed with 0.5% povidone-iodine to clean the oral cavity. A combination of physical and chemical cleaning was used.
 

Patients with newly diagnosed esophageal squamous cell carcinoma (SCC) treated with chemoradiotherapy

The study was comprised of 40 patients (20 in the regular oral care group and 20 in the e-brush group).

The mean patient age was 66.2 years (SD = +/– 7.9 years) and 58.0 years (SD = +/– 6.3 years), respectively.
 

October 2003–January 2005

RCT

Oral mucositis was diagnosed by a dentist, assessed every Monday, Wednesday, and Friday.

Japan clinical oncology group criteria-based on NCI-CTC

Bacterial analysis
 

Incidence of oral mucositis was significantly lower in the special care group (4 of 20 [20%] versus 11 of 20 [55%] [p = 0.048]).

Induced stable microflora consisting of oral streptococci
 

Small study; labor intensive intervention; unclear about costs

To assess the effect of intravenous lidocaine infusion in patients who received a subtotal gastrectomy

One group of patients received an intravenous lidocaine infusion preoperatively and throughout surgery, and the other group received normal saline.

• N = 36  
• MEAN AGE = 62.8 years (range = 57–72 years)
• MALES: 63%, FEMALES: 37%
• KEY DISEASE CHARACTERISTICS: Patients undergoing subtotal gastrectomy for early gastric cancer between May 2012 and March 2013
• OTHER KEY SAMPLE CHARACTERISTICS: Patients who weighed less than 45 kg or more than 100 kg

• SITE: Single site
• SETTING TYPE: Inpatient
• LOCATION: Chung-Ang University in Seoul, Korea

• PHASE OF CARE: Active antitumor treatment

Double-blinded, placebo-controlled, randomized study

• Visual Analog Scale (VAS) for pain
• Administration frequency of patient-controlled analgesia (PCA)
• Measured amount of consumed fentanyl, postoperative nausea and vomiting, length of hospital stay, time to return to regular diet, and patient satisfaction at discharge

The VAS pain scores (p < 0.05) and administration frequency of PCA (p < 0.05) were significantly lower in the lidocaine group until 24 hours after surgery, and fentanyl consumption (p < 0.05) was significantly lower in this group until 12 hours postoperatively compared to the placebo group. The total amount of consumed fentanyl (p = 0.007) and the total administration frequency of PCA (p = 0.003) were significantly lower in the lidocaine group than the control group.

In this study, intravenous lidocaine infusion preoperatively and throughout surgery reduced pain during the postoperative period after subtotal gastrectomy.

• Small sample (< 100)
• Findings not generalizable

Nurses should be aware of the benefits of intravenous lidocaine infusion during certain surgical procedures, including subtotal gastrectomy, so they can advocate for the use of this intervention for their patients.

To determine if the continuous IV infusion of fentanyl during radiofrequency ablation for hepatocellular carcinoma provided better analgesia than medicating via IV bolus before and after the procedure

Eighty-three patients were divided into two groups. Group 1 was given bolus doses of IV fentanyl pre- and postradiofrequency ablation, and group 2 was given a continuous infusion IV fentanyl. The doses were fairly equivocal. The patients were permitted to have IV diazepam if needed during the procedure. It was noted that not all patients used diazepam, and the median doses of diazepam differed significantly between the two groups (Group 1: 7.8 mg, SD = 5.8 mg; Group 2: 4.3 mg, SD = 5.2 mg).

• N = 86  
• AGE RANGE = 61–80 years
• MALES: 58 patients, FEMALES: 25 patients
• KEY DISEASE CHARACTERISTICS: Hepatocellular carcinoma with no metastases or vascular invasion; single tumor up to 5 cm or up to three tumors each less than 3 cm 
• OTHER KEY SAMPLE CHARACTERISTICS: Fifty-seven had hepatitis C; seven had hepatitis B; four had both hepatitis B and C; 15 had nonviral hepatitis

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Kumamoto, Japan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care  

Prospective trial

• Visual Analog Scale (VAS)

The data indicated that the median VAS score was 4 (SD = 1.8) in group 1 and 3.4 (SD = 1.9) in group 2. The findings were deemed statistically insignificant (p = 0.63). Thirteen patients experienced major toxicities from either the fentanyl or the diazepam (apnea and respiratory depression with decreased oxygen saturation).

The findings of this study indicated that there was no statistically significant difference in pain control reported between the two groups studied.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: Patients from both groups were offered valium when needed, and the doses varied significantly. Pain was assessed retrospectively three hours after the procedure. Per the terminology in the article, the first 41 patients were assigned to group 1, and the next 42 patients were assigned to group 2. No information was available regarding home medications, specifically of any short- or long-acting analgesic use, which could have had an effect on patients' VAS scores.

This study did not establish compelling evidence that a continuous infusion of fentanyl during radiofrequency ablation and embolization provided significantly better analgesia than the conventional IV boluses pre- and post procedure. I also feel the limitations of the study are significant enough to state that the study should not be used for PEP.

To complete a systematic review of the effects of aromatherapy on patients with symptoms of depression

• Databases searched were CINAHL, PubMed, MEDLINE, PsyInfo, and Cochrane Library.
• Search keywords were aromatherapy, scent, fragrance, essential oil, depression, depressive disorder, and depressive symptoms. All retrieved reports were of peer-reviewed studies, in English, published 2000–2008.
• A study was included if it referred to the clinical application of aromatherapy as the treatment of patients with some kind of clinical condition or patients suffering from symptoms of depression.
• A study was excluded if it referred to the chemistry of essential oils or if it was published as a dissertation.
   

• The total number of studies retrieved was 48.
• Two studies were of patients with depression; one, of postnatal mothers; three, of patients with cancer.
• Two studies were randomized controlled trials (RCTs), three were not RCTs, and one was quasiexperimental.
• The evaluation method consisted of a systematic review by two graduate students in a master’s degree program in occupational therapy. The graduate students extracted the data.

• The final number of studies included was six.
• The total sample size was 387. The sample range across studies was 5–288.
• Two studies evaluated the effectiveness of aromatherapy on patients with depression, three studied secondary depressive symptoms in patients with cancer, and one focused on postnatal depression. All studies discussed the effectiveness of aromatherapy massage on depressive symptoms.
   

Authors did not mention the phase of care.

Aromatherapy has an alleviation effect on the mood of patients with depressive symptoms; however, there is a notable lack of studies on the use of aromatherapy by people with depression. Almost all the studies use aromatherapy massage and not aromatherapy alone, so whether the effects are from the aroma intervention, the massage intervention, or a combination of the two remains unclear.

Of the six studies, the sample size of three included eight participants or fewer. The size of the others was 36, 42 and 288, respectively. In addition to being small, the samples did not necessarily include cancer patients. These studies were inconsistent and used various oils for the aromatherapy.

The evidence is insufficient to support recommendations for the use of aromatherapy for the treatment of depression. Aromatherapy may, however, be used as complementary and alternative therapy for depression and be considered as a treatment for depression in patients with secondary depression arising from chronic medical conditions.

To investigate the effect of a pain education program on pain intensity, satisfaction with pain treatment, and barriers to pain management

Patients were randomly assigned to a group that received the education program or to a control group. Patients in the education group received written materials and an educational slide program. They received a booklet covering the same content as the other components. Content included the definition of pain; a list of its causes; discussion of pain-related pharmacologic treatment, side effects, myths, and misconceptions (e.g., misconceptions about addiction, drug dependence, tolerance); noncompliance; and nonpharmacologic pain treatment and pain assessment. The initial session took 30–40 minutes and was provided to each patient individually, in his or her hospital room. The education session was repeated after three and seven days, as needed. Patients in the control group received standard care and answers to relevant questions but did not receive specialized education. Assessments were done at baseline and at weeks 2, 4, and 8.

• The sample was composed of 40 patients.
• Of all patients, 85% were over age 60.
• Of all patients, 55% were male and 45% were female.

• Single site
• Inpatient
• Turkey

Phase of treatment: active treatment

Randomized controlled study

• McGill Pain Questionnaire 
• Numeric rating scale
• Barriers Questionnaire, Revised

• Compared to controls at weeks 2, 4, and 8, patients in the education group had a significant decrease in mean scores regarding present pain (p < 0.001), least pain (P < 0.05), and satisfaction with pain treatment (p < 0.001).
• At the end of week 2, the barriers score decreased significantly in the education group, dropping from 2.12 to 1.29; in the control group, the barriers score decreased from 2.3 to 2.28 (p < 0.001). Compared to controls, patients who received the education had lower barrier scores, in subscales regarding use of analgesics (p = 0.023) and communication related to pain (p = 0.000).

Pain education was helpful in reducing pain intensity; education improved satisfaction with pain management and reduced barriers to pain management.

• The study had a small sample, with fewer than 100 patients.
• The study had a risk of bias due to no attentional control or blinding.
• Authors provided no information regarding analgesic use or changes in analgesics over the course of the study. Such changes could have influenced results.
• The individual education session was to have been repeated every 3–7 days as needed. However, authors did not state how many sessions were repeated.
• Whether patients were in the hospital for the duration of the study, in a controlled environment, is unclear.

Findings suggest that pain education is effective at reducing pain intensity, increasing patient satisfaction, and reducing barriers to pain management. Specifically addressing misconceptions about analgesic use and the need to communicate regarding the pain experience can be expected to help reduce barriers to effective pain management by means of analgesics. Patients' active involvement in their own pain management can improve the quality of this aspect of care.

To determine whether a nurse-led educational intervention decreased the perception of fatigue in patients diagnosed with gastrointestinal (GI) cancers who were receiving chemotherapy for the first time and to determine if improvement in fatigue resulted in improvement in quality of life (QOL).

Patients received an individual educational intervention at baseline, on the tenth day after the first cycle of chemotherapy (T1), and 10 days after the second cycle (T2) based on the results of their fatigue assessments. The education program consisted of:  one-to-one education, which consisted of training and counseling about fatigue assessment and management. It was delivered by the researcher. The intervention was designed to improve patients’ knowledge of causes of fatigue and to provide them with strategies to decrease severity, including self-monitoring of fatigue levels, advice on energy conservation, distraction, increasing mobility and activity, stress management, relaxation methods, and management of factors known to cause fatigue.

• In total, 35 patients (57% women) receiving chemotherapy for GI cancer were included.
• Mean age was 49 years (standard deviation = 10.12).
• Patients had GI cancer.
• Of the patients, 91% were married.

• Single site
• Outpatient chemotherapy unit of a large University Hospital in Izmir, Turkey

The study used a descriptive, quasiexperimental design.

• Baseline demographics
• Fatigue and QOL were assessed using the Brief Fatigue Inventory (BFI), Piper Fatigue Scale (PFS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
• Instruments were administered before the first cycle of chemotherapy, at T1, and at T2.
• Pre- and posttest analyses were conducted using t-tests.
• Relationships among variables were examined by calculating Pearson correlation coefficients with a statistical significance of p = 0.05.
• Variables included subjective reports of patients’ fatigue and QOL.

Patients’ mean fatigue scores showed a statistically significant decrease, and their EORTC QLQ-C30 scores were better at T1 and T2 compared with baseline.

Nurse-led educational interventions have the potential to reduce fatigue in patients with GI cancers receiving chemotherapy for the first time.

• The exclusion criteria limited the number of patients; the study had a small sample size.
• The sample only included patients with GI cancers in a single center in Turkey.
• No power calculation was performed.
• No control group was used.
• The findings could be culturally specific.
• These limitations prevented generalization. 

The administration of chemotherapy should be preceded by a formal fatigue assessment and the provision of individually tailored educational interventions to reduce the severity of fatigue and improve QOL.

To compare the efficacy of an aprepitant-based antiemetic regimen and a standard antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in Chinese patients with breast cancer receiving a first cycle of moderately emetogenic chemotherapy (MEC) and to compare patient-reported quality of life (QOL) among all patients

Chemotherapy naïve patients with breast cancer receiving adjuvant AC chemotherapy were assigned to either an aprepitant-based regimen (day 1: 125 mg aprepitant, 8 mg ondansetron, and 12 mg dexamethasone before chemotherapy and 8 mg ondansetron 8 hours later; days 2-3: 80 mg aprepitant four times a day) or a control arm (day 1: 8 mg ondansetron and 20 mg dexamethasone before chemotherapy and 8 mg ondansetron 8 hours later; days 2-3: 8 mg ondansetron twice daily).

• The sample consisted of 124 participants.
• Mean age (range) for the aprepitant group was 46.5 years (32–66 years) and, for the control group, 48.5 years (26–68 years).
• All of the patients were female (100%).
• Diagnoses were 94% invasive ductal carcinoma, 1.6% invasive lobular carcinoma, and 5% other.
• Cancer stages were 22% stage I, 50% stage II, 18% stage IIIa, and 9% stage IIIb.
• Patients had to be ethnic Chinese females older than 18 years with a life expectancy of four months or more and a Karnofsky score of 60 or more.
• Both groups had slight differences in history of motion sickness and vomiting during pregnancy.

The study was conducted at a single site in China.

All study participants were in active treatment.

This was a randomized, double-blind placebo-controlled study.

• Patient diaries were used to monitor the antiemetic efficacy for 120 hours following chemotherapy infusion. Vomiting episodes and the use of rescue therapy were recorded on days 1–6, and daily nausea ratings (based on a visual analogue scale [VAS]) were recorded on days 2–6.
• The Functional Living Index, an emesis questionnaire (Chinese version), was completed immediately after the patients completed the diary on day 6. It contained nine items in both the nausea and vomiting domains.
• Adverse events were collected according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTAE).
• Data on nausea, vomiting, and the use of rescue medication were collected with self-report diaries, and patient QOL assessment was self-administered.

• In the overall timeframe (0–120 hours) in cycle 1, no significant differences in symptoms were found.
• The requirement of rescue medication appeared to be less in the aprepitant group than the control group (11% versus 20%; p = 0.06).
• No significant difference was found in the median time to first vomiting and nausea domain.
• Both treatment arms were generally well tolerated.

The addition of aprepitant to ondansetron and dexamethasone for CINV did not have a definitive superiority over the existing regimen in Chinese patients with breast cancer; however the addition of aprepitant reduced the requirement of rescue medication and resulted in significantly better QOL.

• Cultural and traditional Chinese medicine influences may have influenced the study outcomes.
• No reporting was given on of how often patients needed to take the rescue therapy, metoclopramide, which may have influenced outcomes.
• Limited generalizability of study findings exists because of the homogenous sample population.
• The standard “control” regimen only included dexamethasone on day 1.

The addition of aprepitant to ondansetron and dexamethasone for CINV in Chinese patients with breast cancer receiving MEC may have some effect in improving QOL and reducing the requirement for rescue medication.

Patients were given an intravenous administration of 10 g of vitamin C twice daily with a three-day interval and an oral intake of 4 g of vitamin C daily for one week. Outcomes were assessed at baseline and at the end of the intervention.

• The sample was comprised of 39 patients with terminal cancer.
• Mean age was 53.5 years.
• The ratio of males to females was 20:19.
• Patients had varied diagnoses, the most common being stomach cancer.
• All patients were at stage IV, and 12 patients experienced a recurrence of their cancers.

Department of Family medicine, Myungji-Hospital, Kwandong University College of Medicine

Patients were undergoing the end of life phase of care.

The study was a prospective, nonrandomized trial.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

The vitamin C intervention significantly improved fatigue in patients after one week of treatment, as mean fatigue scores dropped from 52 (standard deviation [SD] = 24) to 40 (SD = 19) (p < 0.001).

• The study lacked a control group.
• When given high doses of vitamin C, patients have the risk of developing hemolysis and, therefore, should be screened for deficiency before receiving treatment.