To compare the efficacy of pyridoxine versus placebo for the prevention of hand-foot syndrome (HFS) in patients with recurrent ovarian, metastatic breast, or endometrial cancer who received pegylated liposomal doxorubicin (PLD) chemotherapy. A secondary objective was to compare quality of life (QOL) between patients who experienced HFS during chemotherapy and those who did not.  

Patients were randomly assigned to receive pyridoxine 100 mg BID (group A) or placebo (group B). Patients also received standard HFS education and completed a QOL questionnaire. Incidence of HFS was compared between groups.

• The study reported on a sample of 34 women (18 in group A and 16 in group B).
• Mean patient age was 64 years (range 45–81).
• All patients had recurrent ovarian, breast, or endometrial cancer and were receiving PLD.
• Five patients (3 in group A and 2 in group B) were not evaluable for HFS assessment.
• The sample was 85% Caucasian.
• Five patients receiving pyridoxine and five patients receiving placebo had disease progression and died during PLD therapy.

• Single site
• Outpatient

Patients were undergoing the active treatment phase of care.

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

• Functional Assessment of Cancer Therapy (FACT) QOL analyses    
• Chi-square or Fisher exact tests
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
   

• Overall, 52% of patients developed HFS (all grades), and 35% developed grade 2 or 3 events. No grade 4 events were observed.
• Fifty-three percent of patients in group A developed HFS compared to 50% of patients in group B.
• No difference existed between groups for grade 2 or 3 events. In addition, no differences existed between groups in global or domain QOL scores after cycle 3 of PLD.
• The physical domain declined for patients with grade 2 or 3 HFS; however, the decline was not statistically significant.

Pyridoxine as administered in the current study did not prevent HFS in patients who received PLD. No difference existed in the incidence of HFS between patients who received prophylactic pyridoxine and those who received placebo. In addition, the HFS rash appeared to be tolerable in most patients because it did not disrupt patient-rated QOL in this study.

• The sample size was small (fewer than 100 patients).
• The population was all women, and most were Caucasian.
• The total sample size was reduced to 24 patients because of reactions during chemotherapy and death during PLD therapy. 
• QOL results are questionable because the line item in the tool used in the physical well-being domain relates to overall side effects of treatment and does not specifically address HFS.

Findings do not support the effectiveness of pyridoxine in the prevention of HFS. The study was likely underpowered. Additional research is needed on strategies to prevent and manage HFS.

This study evaluated the efficacy and safety of carbamazepine for the prevention of oxaliplatin-associated neuropathy in patients treated for advanced-stage colorectal cancer.

Patients were randomly assigned to receive carbamazepine 200 mg orally daily, beginning six days before the first oxaliplatin via IV, with dose increases to yield a plasma level of 4-6 mg/dl. All patients received oxaliplatin 85 mg/m² via IV every two weeks, plus folinic acid 500 mg/m² via IV followed by 5-FU 2,000 mg/m² infused over 24 hours every week. A cycle consisted of six weeks of treatment and a two week rest. Groups were compared in relation to worst neurotoxicity and neurotoxicity at each cycle.

• The study consisted of 36 total patients, with 19 assigned to the carbamazepine group and 17 to the control group.
• To be included, patients had confirmed advanced-stage colorectal cancer, were 18 years of age or older, had a World Health Organization performance status of 0 or 1, and had an anticipated life expectancy of at least three months. Laboratory criteria also needed to be met.
• Patients were excluded if they had preexisting neurologic diseases, had been treated with a drug that could interact with carbamazepine, had prior treatment with oxaliplatin, and were currently being treated with gabapentin, vitamin B, magnesium, or calcium.

The study had a randomized, controlled, multicenter phase II design.

Data were collected at baseline and following each treatment cycle using Levi’s Neurotoxicity Rating Scale (0–4), and  peripheral neuropathy score based on sensory symptoms and examination (vibrational sense, strength, and deep tendon reflexes), each scored 0–3. 

No group differences were noted in grade of neurotoxicity or in grade 3 or 4 neurotoxicity using the Levi Neurotoxicity Rating Scale for either the worst toxicity across all cycles or cycle-based comparisons. The groups did not differ in scores on the individual components of the peripheral neuropathy score or the overall peripheral neuropathy score based on worst toxicity or cycle-specific comparisons between groups. Of note, only two participants discontinued  carbamazepine for CNS side effects.

Because the current study was underpowered, no definitive conclusions can be drawn regarding efficacy and safety.

• Regarding limitations, the final sample size was not adequate enough to achieve the power needed to detect differences between groups.
• No data on reliability or validity for the Levi Neurotoxicity Rating Scale were provided.
• Reliability and validity of the two approaches used to grade or score severity of neuropathy was not discussed.
• Adherence to carbamazepine was not assessed but the plasma levels suggest that adherence was acceptable during the early phases of the study.
• The results are inconsistent with a nonrandomized pilot study conducted by the same group.

A systematic review of the English medical literature was performed. Only clinical trials were included in the first search, January 1966–May 2002. In the June 2002–May 2005 review, clinical and preclinical trials were included.

In the 2002 review, 35 studies were identified. In the 2005 review, 14 preclinical and 9 clinical studies were identified. Studies reporting on cytokines or growth factors for the amelioration of chemotherapy- and radiation-induced mucositis throughout the entire alimentary canal were included.

Based on the review, guidelines recommend palifermin at a dose of 60 mg/kg per day for three days prior to conditioning for hematologic malignancies receiving high-dose chemotherapy and total body irradiation (TBI) with autologous stem cell transplantation (SCT). Preliminary results indicated effectiveness for repifermin. Trials are in process for velafermin.

Two randomized studies of granulocyte colony-stimulating factor (G-CSF) showed reduction in mucositis incidence. Two cohort studies demonstrated reduced severity of mucositis. One study did not show any positive results for mucositis. Another showed that use of growth factors was not a significant determinant of oral mucositis. Two studies failed to demonstrate improvement with G-CSF in the radiation setting. Studies demonstrate conflicting results. No recommendation can be made at this time.

One cohort study with granulocyte macrophage colony-stimulating factor (GM-CSF) showed reduction in severity and duration of oral mucositis. Another study showed no effect on radiation-induced oral mucositis. Two studies showed some positive effects for radiation-induced mucositis. Studies demonstrated conflicting results. No recommendation can be made at this time. Two studies with GM-CSF mouthwash demonstrated no positive effects. The Multinational Association of Supportive Care in Cancer guideline has been updated to suggest that GM-CSF mouthwash not be used for the prevention of mucositis in the transplant setting.

For other agents, evidence was insufficient or toxicities too severe to recommend use.

To study the potential benefits and risks of using lipegfilgrastim to reduce neutropenia in patients receiving myelosuppressive chemotherapy for advanced non-small cell lung cancer, and to compare the outcomes of older adults (defined as patients aged older than 65 years) and adults

After receiving first-line chemotherapy (cisplatin 80 mg/m² IV on day 1 and etoposide 120 mg/m² IV on days 1–3 every three weeks) for non-small cell lung cancer, participants were randomized 2:1 to receive a single subcutaneous injection of lipegfilgrastim 6 mg or placebo, administered approximately 24 hours after the last etoposide infusion. Patients received up to four cycles of cisplatin/etoposide, with the study medication given after each cycle. Monitoring for adverse events continued until three weeks after the last intervention. Blood was drawn (for complete blood count and chemistry testing) before each cycle and on day 15 of each cycle.

• N = 375 (intention to treat [ITT] analysis), with 250 completing the study
• MEAN AGE = 62.3 years
• MALES: 87%, FEMALES: 13%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Stage IIIb–IV non-small cell lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Individuals with high risk for febrile neutropenia (FN) were excluded because of ethical concerns

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Study participants came from 72 chemotherapy centers in eight European countries (Belarus, Bosnia-Herzegovina, Bulgaria, Poland, Romania, Russia, Serbia, and Ukraine).

PHASE OF CARE: Active antitumor treatment

This study was a post hoc analysis of subgroups of patients who had enrolled in a double-blinded, randomized, controlled trial.

To determine efficacy, the authors studied the incidence of FN following the first cycle of cisplatin/etoposide chemotherapy. FN was defined as an oral temperature greater than 38.5 degrees C on two or more consecutive measurements at least 60 minutes apart, with a concurrent absolute neutrophil count (ANC) less than 0.5 x 10⁹/L, or neutropenic sepsis or potentially life-threatening neutropenic infection. The authors also compared the incidence and duration of severe neutropenia (DSN), defined as grade 4 neutropenia with an ANC less than 0.5 x 10⁹/L; the time to ANC recovery, defined as the time from any post-chemotherapy day with an ANC less than  2 x 10⁹/L to the first day with an ANC of 2 x 10⁹/L or less; and the depth of ANC nadir. For study safety, patients were not assessed for adverse events (AEs) until three weeks after the last dose of study medication.

There was no significant difference in the incidence of FN following the first chemotherapy cycle between the lipegfilgrastim and placebo groups for patients aged 65 years or younger. None of the older patients who received lipegfilgrastim developed FN during the first chemotherapy cycle, compared to 13.3% in the placebo group. The difference in incidence of severe neutropenia between the placebo and lipegfilgrastim groups was more pronounced in younger patients (56.8% versus 27.6%) than in those older than 65 years (66.7% versus 49.1%). In both age groups, the mean DSN during cycle 1 was shorter (0.6 days versus 2.1 days for patients aged 65 years or younger; 1 day versus 3 days in patients aged older than 65 years) for patients who received lipegfilgrastim compared to those who received placebo. Mean time to ANC recovery during cycle 1 was less with lipegfilgrastim than with placebo and was comparable in both age groups (6.8 days versus 13.3 days for patients aged 65 years or younger; 6.5 days versus 12.2 days in patient aged older than 65 years). Similarly, mean depth of ANC nadir during cycle 1 was also higher with lipegfilgrastim than with placebo and was comparable in both age groups (1.6 x 10⁹/L versus 0.7 x 10⁹/L for patients aged 65 years or younger; 1.5 x 10⁹/L versus 0.5 x 10⁹/L for patients aged older than 65 years). Most AEs were likely attributable to the chemotherapy, and the incidence was similar between treatment groups. The exception was the incidence of hypokalemia (6.2% versus 2.1% in patients aged 65 years or younger; 15.1% versus 3.3% in patients aged older than 65 years) and hypophosphatemia (3.6% versus 1.1% in patients aged 65 years or younger; 9.4% versus 3.3% in patients aged older than 65 years), which were higher in the lipegfilgrastim group versus the placebo group. The older adults who received lipegfilgrastim also had a higher incidence of decreased appetite (17%) than the placebo group (6.7%).

In patients aged 65 years and younger, lipegfilgrastim did not decrease the incidence of FN but limited the severity, duration, and time to recovery of neutropenia. In older adults, who have a greater risk for myelosuppression, lipegfilgrastim significantly reduced the incidence of FN in addition to the benefits realized by younger patients.

• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Findings not generalizable
• Although the overall sample size is acceptable (n = 375), only 13% were female. It has been established that growth factors generally do not benefit patients aged younger than 65 years treated with cisplatin/etoposide; therefore, the National Comprhensive Cancer Network guidelines recommend the use of growth factors only for patients aged older than 65 years for this chemotherapy regimen. The appropriate study population is the group of patients aged older than 65 years and the sample sizes in the older adult subgroups were small (n = 25 in the placebo group and n = 46 in the intervention group). In addition, those at high risk for FN were excluded from the study, leading to an artificially low incidence of FN among the study population. Last, in patients aged older than 65 years, lipegfilgrastim should have been compared to the standard of care (pegfilgrastim/filgrastim) rather than placebo to demonstrate noninferiority.

The addition of lipegfilgrastim to a cisplatin/etoposide chemotherapy regimen for non-small cell lung cancer is beneficial in reducing the incidence, severity, and duration of FN in patients aged older than 65 years. Lipegfilgrastim was generally well tolerated in both the older adult and adult populations, but those aged older than 65 years may be at risk for hypokalemia, hypophosphatemia, and decreased appetite. The sample sizes in this study were too small to be of value.

To evaluate the characteristics of oral mucositis in autologous hematopoietic stem cell transplantation (HSCT) after HD-L-PAM (high-dose [HD] methotrexate plus vincristine, HD-doxorubicin, cisplatin, and HD-melphalan) 200 mg/m² and BEAM (bis-chloroethylnitrosourea [BCNU], etoposide, cytarabine, melphalan) conditioning regimens and to analyze the impact of simple and basic clinical and laboratory factors on oral mucositis incidence

Patients who were admitted to a transplant hospital to receive BEAM or HD-L-PAM 200 mg/m² chemotherapy followed by autologous HSCT were recruited to the study. To be included, patients had to have healthy oral mucosa without symptoms of inflammation or local infection at baseline and signed informed consent. Patients were excluded from the study if they had a history of head or neck or total body radiotherapy, received keratinocyte growth factors or amifostine for oral mucositis prophylaxis, or participated in any other trial comparing any new drugs for oral mucositis prophylaxis or treatment. 

Oral cavity monitoring began on the first day of admission and continued throughout the inpatient stay. Beginning on the first day of chemotherapy administration, patients used mouthwash after main meals, before sleep, and as desired. Patients could use their mouthwash of choice, selecting from chlorhexidine, salvia officinalis, providone-iodine, normal saline, Listerine^®, benzydamine, or water. Patients were instructed to gargle for two minutes with the solution of choice. Patients were instructed to use soft toothbrushes. Cryotherapy with lollipops, ice-cold water, or crushed ice was added to the protocol in 2008.

Basic clinical and laboratory data representing individual variables, tested as oral mucositis risk factors, were recorded. Basic statistical univariate analyses were performed using statistical software with Mann-Whitney. The p values comparing the presence and absence of the characteristics and p values < 0.05 were considered indicative of statistically significant differences in relation to mucositis occurrence. 

• The study reported on 126 patients with a median age of 57 years and a range of 8–67 years.
• The sample was 57% male and 43% female.
• Patient diagnoses were chronic lymphocytic leukemia (2%), Hodgkin lymphoma (13%), non-Hodgkin lymphoma (31%), and multiple myeloma (54%).
• In all, 40% of patients were in complete remission and 60% were in partial remission.
• The median number of days since last chemotherapy administration was 72 with a range of 15–560.
• Additional patient data were as follows.
  • Diagnosed with diabetes mellitus, 7%
  • Wore removable dentures (prosthesis), 12%
  • Had a history of oral mucositis, 13%
  • Used cryotherapy of the oral cavity, 29%
• Laboratory values were as follows.
  • Absolute neutrophil count at baseline (x10 - 9/l = 2.3 [1.2–10.0])
  • Serum bilirubin level at baseline (umol/l = 11 [3–42])
  • Creatinine clearance at baseline (ml/min) = 102 (28-181)
  • Number of CD34+ cells in the graft (x10-6/kg) = 4.6 (1.4-17.9)

This was a multisite study conducted in the inpatient setting at the University Hospital in Pilsen, Czech Republic;  University Hospital in Olomouc, Czech Republic;  University Hospital in Kosice, Slovak Republic; Silesian Medical Academy in Katowice, Poland; and Pavlov Medical University in St. Petersburg, Russia.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability to end-of-life and palliative care.

This was a multicenter, prospective, observational evaluation with oral cavity care.

• The World Health Organization (WHO) 0–4 mucositis grading scale was used.
• Oral cavity monitoring was stated on the first day of the conditioning and covered the whole inpatient stay.
• Oral mucositis was assessed daily by nurses who had attended a specific training course before data collection started. Interrater reliability testing was not performed. With 7% of patients, nurses assessing oral mucositis had not attended any specific oral mucositis training courses.
• Patients evaluated the tolerability of oral cryotherapy once daily using a 1–5 visual analog scale (VAS) with 1 = tolerable without any problems and 5 = intolerable.

• Overall, 62% of patients developed oral mucositis.
• Patients experienced the following grades of oral mucositis.
  • Grade 1: 31%
  • Grade II: 13.5%
  • Grade III: 16%
  • Grade IV: 1.5%
• Oral mucositis incidence was significantly lower in the cryotherapy group (22%) compared to the noncryotherapy group (78%).
• Univariate analysis of the noncryotherapy group (n = 90) found no significant differences between patients with respect to age, gender, performance status, body mass index (BMI), neutrophil count, bilirubin levels, creatinine clearance, number of CD34+ cells in the graft, number of days since the last chemotherapy, presence of removable dentures (prosthesis), or diabetes mellitus. 
• Oral mucositis occurred more often in patients receiving the BEAM conditioning regimen (86% versus 68%, p = 0.04) and in patients with a history of oral mucositis (100% versus 73%, p = 0.0182). 
• The fact that oral cryotherapy was not provided in some patients was the most significant and independent factor for oral mucositis development.

This observational study verified the potential efficacy and feasibility of oral cryotherapy in melphalan short-infusion administration with HD-L-PAM and multidrug BEAM conditioning regimens. Much larger and more homogenous cohorts of patients are needed for future research on the oral mucositis risk factors.

The study findings are limited because of the lack of random assignment, blinding, and an appropriate control group.

Based on the results of this observational trial, the nonprovision of oral cryotherapy is a risk for the development of oral mucositis in patients after autologous HSCT with BEAM or HD-L-PAM conditioning regimens. Maximum effort should be targeted toward the education of medical and nursing teams to implement cryotherapy as a standard prophylactic approach in melphalan regimens.

The goal of the study was to define the role of anti-microbial solutions.

Two groups of patients were compared: Normal saline mw povidone-iodine mw.
Group A used NS for oral rinsing and Group B use povidone-iodine diluted 1:100 water. The solutions were blinded to patients. Study nurse started first day and covered the whole inpatient stay. It was a 2 min gargle 4x/day IN the presence of OM the mouthwashes could be more frequent according to patients' wishes. Used soft toothbrush 4 x/day. If bleeding occurred would do only MW

Mouthwash was blinded.

The study was comprised of 132 patients. Patients were treated with hi-dose BEAM or HD-LPAM followed by APSCT.

Study group A had 65 pts or group B had 67 patients, NS or povidone iodine.
 

Multicenter

Jan 2002- June 2004

Prospective, randomized

• OM assessed daily
• WHO scale
• VAS for tolerability
• Temp, oral smears
• Blood cultures with fever
   

No significant difference with oral mucositis (p = 1.0) characteristics in both groups and fever of unknown origin (p = 1.0) and other infections (p = 0.34). Povidone-iodine was less tolerable.

No healing effect with betadine.

OM occurred more significantly in females than in males (p = .0016) and was worse and of longer duration.
 

Patients disliked the taste of povidone-iodine, less use of povidone-iodine.

Note appropriate dose of povidone-iodine.

To assess the efficacy, tolerance, and impact on oral cavity microbial colonization in patients with OM post-allogeneic hematopoietic stem cell transplantation.  

Oral cavity nursing care with benzydamine, chlorhexadine, or saliva solutions was started on the first day of conditioning chemotherapy administration and covered the entire inpatient stay. Gelclair was begun for 22 consecutive patients on the day of the development of OM and continued until the OM resolved when oral cavity nursing care was resumed until the patient was discharged.

The study was comprised of 37 patients, age 19-68 years.

There were 51 males and 49 females.

KEY DISEASE CHARACTERISTICS: AML, ALL, CLL, CML, HL, NHL, MDS, MM

SITE: Single site

LOCATION: Stem Cell Transplant Center of Hokkaido University Hospital

PHASE OF CARE: Active treatment

Prospective observational study in adults with oral mucositis post-allogeneic stem cell transplant in 2008-2009.

• WHO Grading 0-4 daily    
• VAS for tolerance of oral rinses daily 1-5 scale (1 = tolerable without any problems and 5 = intolerable)  
• Pain reduction and food intake improved daily, VAS score 1-5 (1 = excellent and 5 = no effect at all).
• Oral cavity swabs weekly in the AM beginning on admission to the transplant unit and continuing through the post OM phase
   

There was no difference in the median value of tolerability of the rinses. There was also no difference in the improvement of oral intake. The duration of pain relief was significantly longer in the Gelclair group, and significantly fewer pathogens were found in the Gelclair group compared to the control group. There was significant increase in pathogen colonization after discontinuation of the Gelclair in the post OM phase.

Gelclair may be helpful in the management of OM and pain in some patients after allogeneic stem cell transplant. Use of Gelclair seemed to have helped protect the mucosa from enterococcus and candida colonization.

Small sample <30

No cost comparison performed.

Further randomized controlled studies are needed to assess the efficacy of Gelclair in the transplant population. There is also further study needed regarding the reduction in incidence of pathogen colonization with the use of Gelclair and to clarify the cost effectiveness of this treatment regimen.

To determine if using antimicrobial-coated central venous catheters (CVCs) is of benefit for patients undergoing stem cell transplantation

Patients were given multilumen polyurethane nontunneled antimicrobial chlorhexidine/silver sulfadiazine-coated CVCs. Transparent occlusive dressings were changed weekly or more frequently as needed. Blood cultures were taken from CVC lumens and peripheral blood on first occurrence of fever or at the discretion of medical staff.  Skin swabs were taken from around the CVC insertion site with dressing changes before local disinfection. Povidone-iodine was used for skin disinfection with dressing changes and before CVC insertion. CVC insertion was stated to be under strict aseptic technique. Patient outcomes were compared to those of historical controls in whom noncoated CVCs were used.

• N = 107
• MEDIAN AGE = 52 years
• AGE RANGE = 20–68 years
• MALES: 57%, FEMALES: 43%
• KEY DISEASE CHARACTERISTICS: All had hematologic malignancies; 47.7% had acute myeloid leukemia.
   

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: Czechoslovakia

• PHASE OF CARE: Active antitumor treatment

• Prospective
  • Comparison to historic controls

• Insertion site infection: positive skin swabs
• Catheter-related blood stream infection: no apparent source other than CVC and blood culture positive with the same microorganism
   

Patients experienced fewer days with fever per 1,000 catheter days with the antimicrobial CVC (p < .001). No significant differences were observed between groups in insertion site inflammation or infection. Significantly fewer patients in the coated CVC group had positive blood cultures (45% versus 36%, p < .05) and peripheral positive blood cultures (p = .005).

 This study provides minimal support that antimicrobial-coated CVCs may be of benefit for patients undergoing stem cell transplantation.

• Risk of bias (no control group) 
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Selective outcomes reporting
• Measurement/methods not well described  
• Measurement validity/reliability questionable
• Questionable protocol fidelity
• Other limitations/explanation: Whether the exact same approaches for CVC insertion were used in the prospective and historic groups is not clear. Although CVC-related infection clearly was defined, results were not reported in this way, so whether the blood and CVC culture differences were CVC-related infection, as defined, is not clear. No information is provided on whether other methods, such as prophylactic antimicrobial therapy or colony-stimulating factors, were used or differed between groups.

Results do not provide strong supportive evidence for use of chlorhexidine/silver sulfadiazine-coated CVCs because of study limitations.

To summarize all controlled clinical trials on aloe vera preparations to provide evidence for or against its clinical effectiveness.

Databases searched were MEDLINE, EMBASE, Biosis, and Cochrane Library.

Search keywords were complementary medicine, aloe vera, and review. 

Experts working in the area were contacted and asked for published and unpublished controlled clinical trials and their own papers and files. All databases were searched from their inception to May 1998.

Studies were included if they were controlled clinical trials.

Studies were excluded if they were not performed on aloe vera mono-preparation and if they were designed only on a certain pharmacologic constituent of the aloe vera plant.

Data were extracted in a predefined fashion, and the methodologic quality of the study was assessed using the Jadad scoring system.

Ten trials met the inclusion criteria and were included. Three clinical studies were excluded because of not being performed on aloe vera mono-preparation or use of only a constituent of the plant. No unpublished studies were found.

• The study included 740 participants from 10 clinical trials.
• Conditions included were arthritis, asthma, Candida, chronic fatigue syndrome, lupus erythematosus, sports injuries, ulcers, digestive disorders, and various skin conditions.
• Aloe vera was used as as a topical agent in six studies and was administered orally in four studies. Of these studies, two examined topical aloe vera for prevention or mitigation of radiodermatitis.

• In the studies regarding use for radiodermatitis, no difference was reported between the treatment group and the placebo group.
• Aloe vera might be useful in patients after dermabrasion, mild to moderate plaque-type psoriasis, and treatment of initial genital herpes episodes, with shortened time to healing.
• In postoperative gynecology surgery patients with wound complications, standard wound care was superior to aloe vera. It was concluded that evidence regarding would healing was contradictory.
• All studies had methodologic flaws and did not achieve high scores for quality of the study design. Flaws included lack of randomization, lack of blinding, small sample size, lack of intention to treat analysis, and lack of power calculations.
• Trials tended to originate from the same research groups, and independent replications were lacking. As a result, firm conclusions from the review cannot be drawn.
• Oral aloe vera may have had some effect in reducing blood glucose levels in combination with antidiabetic therapy and in influencing lower serum lipids in one study.

No firm conclusions were drawn from the review because of multiple methodologic studies. It was concluded that topical application does not seem to prevent radiation-induced skin damage. No statistical significance findings from studies were reported.

The authors only included abstracts of controlled trials but then drew no conclusions about these findings because they were only abstracts.

More and better clinical trial data are needed to define the clinical effectiveness of this remedy.

To determine the effectiveness of venlafaxine, soy, and a combination of venlafaxine and soy on hot flashes in men with prostate cancer

Participants randomly were assigned to one of four groups: daily placebo pill in the morning plus daily milk powder (20 g per day); daily venlafaxine (75 mg) in the morning plus daily milk powder (20 g per day); daily placebo pill in the morning plus daily soy powder (20 g with 160 mg isoflavones); or daily venlafaxine (75 mg) in the morning plus daily soy powder (20 g with 160 mg isoflavones). Venlafaxine was provided in extended-release capsules. Prior to enrollment, participants completed a seven-day prescreening period. The intervention was administered for 12 weeks. Patients kept a daily log of medications and were contacted via phone at week 2, 4, 8, and 12 to assess toxicities and complete study measures. Patients on venlafaxine were titrated off medication after the end of the study.

• N = 119
• MEAN AGE = 68.5 years
• AGE RANGE = 46–91 years
• MALES: 100%
• KEY DISEASE CHARACTERISTICS: Prostate cancer

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: United States

PHASE OF CARE: Late effects and survivorship

• RCT, double-blind, placebo-controlled, 2 x 2 factorial design

• Daily count of hot flashes
• Hot Flash Symptom Severity Score (HFSSS)
• Functional Assessment of Cancer Therapy-Prostate (FACT-P)
• Body mass index (BMI)

There was no significant difference in sample characteristics between the four groups including severity of disease, BMI, performance status, and type of treatment. Vasomotor symptoms decreased in all arms (p < 0.001). No differences existed between treatment arms at baseline and 4, 8, or 12 weeks. The severity of hot flashes decreased in all arms (p < 0.001). All four arms showed a decrease in the HFSSS (p < 0.001). Toxicities did not differ between groups and were mild. The study was ended by the Data Safety Monitoring Board due to a lack of effect. The placebo group had the largest decrease in HFSSS scores (55%).

In men with prostate cancer, venlafaxine, soy, and a combination of the two were no more effective than a placebo at decreasing the number and severity of hot flashes.

Venlafaxine, soy, and a combination of both are not effective at treating hot flashes in men with prostate cancer.