Aloe Vera

Aloe Vera

PEP Topic 
Radiodermatitis
Description 

Aloe vera is a fleshy green cactus plant. A gel made from the plant is used as a complementary therapy for dry skin, cuts, and burns. Aloe vera gel may provide a protective effect on skin with increasing cumulative uses. It is described as having anti-inflammatory and antibacterial properties. It may reduce vasoconstriction and leukocyte and platelet aggregation at the site of injury. It is known to improve wound oxygenation, increase the rate of collagen formation, and decrease the amount of dead tissue at the wound site. Aloe vera preparations have been studied for radiodermatitis and mucositis.

Effectiveness Unlikely

Research Evidence Summaries

Heggie, S., Bryant, G. P., Tripcony, L., Keller, J., Rose, P., Glendenning, M., & Heath, J. (2002). A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue. Cancer Nursing, 25, 442–451.

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Study Purpose:

To see if topical aloe vera gel would be beneficial in reducing the skin side effects of radiation therapy (RT).

Intervention Characteristics/Basic Study Process:

Participants were stratified according to bra cup size, history of lymphocele drainage, and smoking. Participants were randomized to use of aloe vera or an aqueous cream for control.

Sample Characteristics:

  • The sample was comprised of 208 participants with breast cancer.
  • Median age was 57.5 years (range 28–89).
  • Patients had undergone lumpectomy or partial mastectomy.
  • Median radiation dose was 60.15 Gy.

Setting:

Mater Centre, Australia, and the Royal Brisbane Hospital Centre, Australia

Study Design:

The study was a randomized, controlled, double-blind trial.

Measurement Instruments/Methods:

  • Weekly assessment form based on Dische’s Morbidity Rating Scale was used to record skin reactions.
  • Researchers observed for erythema, itching, pain, and extent of treatment area affected by dry or moist desquamation. The areas affected by moist desquamation were identified according to site.
  • Weight, skin type, tumor stage, and previous skin cancer were also recorded.
  • Weekly assessments were performed using the Radiation Therapy Oncology Group (RTOG) scale.
  • Skin changes recorded were itching, skin texture, tanning, erythema, time to skin change, and dose at first skin change.

Results:

Aqueous cream was significantly better than aloe vera gel in reducing the incidence of dry desquamation and moderate or higher pain (p < 0.001). Participants with cup size D or more in either treatment arm experienced a significantly greater incidence of moderate or higher erythema compared with smaller-breasted women (p < 0.02). For non-chemotherapy participants, the aloe vera arm experienced a significantly reduced incidence of moderate or higher erythema (p = 0.02). The control group arm experienced a significantly reduced incidence of moderate or higher pain (p = 0.03). The most important predictors of development of skin reaction were radiation dose, breast size, patient smoking, and damage to the lymphatic system manifested by one or more lymphocele drainage. Cumulative dose was greater than 2,700 cGy, and there was a delay to onset of erythema (p = 0.013).

Conclusions:

Aqueous cream is superior to aloe vera in reducing the acute RT skin reactions of dry desquamation and pain.

Limitations:

  • The consistency and appearance of the two study preparations were quite dissimilar, so participants may have guessed the identity of their study preparation.
  • Ninety percent of the final skin assessments were conducted over the telephone, so the research nurse was not able to view the participant’s skin and had to rely on the subjective assessment.

Merchant, T. E., Bosley, C., Smith, J., Baratti, P., Pritchard, D., Davis, T., … Xiong, X. (2007). A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiation Oncology, 2, 45.

doi: 10.1186/1748-717X-2-45
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Study Purpose:

To compare an anionic polar phospholipid (APP)–based cream and an aloe vera–based gel to determine their effectiveness in preventing and treating radiodermatitis.

Intervention Characteristics/Basic Study Process:

The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by a radiation oncologist. Follow-up examinations were done four to six weeks after the completion of radiation therapy (RT).

Sample Characteristics:

  • The sample was comprised of 45 participants. 
  • Average age was 10 years (range 3–19).
  • Gender was not listed.
  • Patients had Hodgkin disease (16), central nervous system (CNS) tumor (10), pediatric sarcoma (8), and neuroblastoma (6).
  • Average total radiation dose was 34.3 Gy (range 25.2–67 Gy). 
  • Daily fractionation ranged from 1.5 to 1.8 Gy.

Setting:

St. Jude Children’s Research Hospital, Memphis, Tennessee

Study Design:

The study used a quasiexperimental design. Patients served as their own controls.

Measurement Instruments/Methods:

The primary endpoint was skin care failure, which included moderate to severe dryness, pruritus, erythema, and dry desquamation. Skin comfort assessment was completed by the patient or his/her parent and consisted of 15 items on a four-level scale. Dermatologic assessment included a questionnaire of negative items and was completed by nursing staff. The National Cancer Institute (NCI) Common Terminology Criteria (CTC) for adverse events involving the skin used a grade 1 to 5 scale.

Results:

Significant differences in specific variables favoring APP cream were noted in some patients, including:

  • Skin comfort variables: dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), and smooth (p = 0.012)
  • Dermatologic variables: dryness (p = 0.013), erythema (p = 0.002), and peely (p = 0.008).

Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream. During RT, there was a difference in CTC scores, favoring the cream (p = 0.004). 

Conclusions:

APP cream is more effective than aloe vera–based gel for the prevention and treatment of radiodermatitis.

Limitations:

  • This was a study on pediatric patients; applicability to adult patients has not been studied.
  • The study lacked a control group to enable determination of actual effectiveness of either product independently.
  • The study had a small sample size.

Olsen, D. L., Raub, W., Jr., Bradley, C., Johnson, M., Macias, J. L., Love, V., & Markoe, A. (2001). The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy. Oncology Nursing Forum, 28, 543–547.

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Study Purpose:

To determine if the use of aloe and mild soap versus mild soap (Dove) alone would decrease the incidence of skin reactions. Aloe gel included aloe vera, triethanolamine, d-α tocopherol (natural Vitamin E), carbomer, tetrasodium ethylenediaminetetraacetic acid (EDTA), methylparaben, and imdazolidinyl urea.

Intervention Characteristics/Basic Study Process:

Participants were randomized to use aloe vera gel and mild soap or mild soap alone. The skin care regimen began on the first day of treatment. Aloe was to be applied liberally after treatment each day, reapplied throughout the day, and rinsed off prior to treatment (no time frame identified). Assessments were performed on day 1 and in weekly reviews. Clinicians could order supplemental skin products as they deemed necessary.

Sample Characteristics:

  • The sample was comprised of 70 patients (34% male, 48% female).
  • Age was: 45 years (18% in each study group), 45–59 years (55% aloe/soap; 32% soap alone), and older than 59 years (27% aloe/soap; 50% soap alone).
  • Patients had cancer of the head and neck (39%), chest (58%), and extremities (3%).
  • Mean cumulative dose was 2,700 cGy (range 900–7,209 cGy) for aloe/soap and 2,838 cGy (range 1,080–5,580 cGy) for soap.

Setting:

Comprehensive Cancer Centre, University of Miami

Study Design:

The study was a prospective, randomized, blinded clinical trial.

Measurement Instruments/Methods:

  • Weekly skin scoring was performed with Radiation Therapy Oncology Group (RTOG) acute criteria. 
  • Other skin changes, such as texture, were recorded; there was no description of how these were assessed or measured.

Results:

The only significant difference found was delayed time to observation of a skin change with aloe in those with a cumulative dose greater than 2,700 cGy (p = 0.01).

Conclusions:

No clear benefit of aloe vera was demonstrated.

Limitations:

  • It was unclear if all assessments were made at the same dose intervals or only once weekly.
  • Clinicians could order supplemental skin products as needed based on scoring severity of skin reactions. It was not possible to determine if the effect was related to aloe or other products.
  • There was no documentation of skin reactions other than erythema or start to skin changes.
  • No measures were described for the only significant finding.
  • Patients were assessed weekly using RTOG, but no RTOG scores data were provided.
  • The research question was “would aloe/soap decrease the incidence of skin reactions,” but the study was designed to assess delay to erythema. Data were not provided regarding overall incidence.
  • There was a wide range of doses.
  • Study conclusions stated were not supported by any data.
  • The author stated the study was double-blind; however no control product was identified or discussed.

Williams, M. S., Burk, M., Loprinzi, C. L., Hill, M., Schomberg, P.J., Nearhood, K., … Eggleston, W. D. (1996). Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity. International Journal of Radiation Oncology, Biology, Physics, 36, 345–349.

doi: 10.1016/S0360-3016(96)00320-3
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Study Purpose:

To determine if aloe vera gel can prevent the development of radiodermatitis in patients undergoing breast radiation therapy (RT).

Intervention Characteristics/Basic Study Process:

In both studies, gels were applied twice a day starting within three days of RT initiation. Each patient received instruction on skin care. Patients were stratified by age groups:  younger than 45 years, 45 to 60 years, and older than 60 years.

Sample Characteristics:

  • Study 1 included 194 patients.  
  • Study 2 included 108 patients. 
  • Patients were younger than 45 years (21.5%), 45 to 60 years (35%), or older than 60 years (43.5%). 
  • All patients were women. 
  • Patients had breast cancer.
  • Patients were not receiving concomitant chemotherapy, and there were no scars or ulcers in the treatment field.

Study Design:

Two studies were reported:  a randomized, double-blind, controlled trial of aloe versus placebo gel and a randomized trial of aloe versus no treatment.

Measurement Instruments/Methods:

  • Patients were rated by an MD/RN on scale of 0 (normal) to 3 (moist desquamation and/or ulceration).
  • Patients self-rated on the same scale and completed questionnaires at the start and weekly until one month post RT. 
  • Kaplan-Meier curves and log rank test were used to compare treatment arms.
  • Severity scores were compared using Wilcoxon test.
  • Spearman rank correlation coefficients were calculated to compare maximum severity.

Results:

  • Study 1:  Mean severity score in aloe versus placebo gel was 1.9 and 1.9 by patient judgment. Mean severity score in aloe versus placebo gel was 1.5 versus 1.6 as judged by a healthcare provider. No significance was found.
  • Study 2: Mean severity score in aloe versus no treatment was 1.9 versus 2 by patient judgment. Mean severity score in aloe versus no treatment was 1.7 versus 1.5 as judged by a healthcare provider. No significance was found.

Conclusions:

The study does not support the hypothesis that aloe vera gel can decrease RT-induced dermatitis.

Limitations:

  • The study lacked interrater reliability.
  • The study did not use a valid or reliable scale.
  • Patients were able to use other treatments, such as hydrocortisone or domeboro if they had skin problems, so it is not clear if confounding treatments were given.
  • No skin care regimen log was used to determine adherence.

Systematic Review/Meta-Analysis

Kumar, S., Juresic, E., Barton, M., & Shafiq, J. (2010). Management of skin toxicity during radiation therapy: a review of the evidence. Journal of Medical Imaging and Radiation Oncology, 54, 264–279.

doi: 10.1111/j.1754-9485.2010.02170.x
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Purpose:

To review the evidence for skin care management and conduct a survey to assess current practices in Australia and New Zealand.

Search Strategy:

Databases searched were MEDLINE, PubMed, CINAHL, Google Scholar, and Google search. Searches were also completed by hand for the time period of 1980 to 2008.

Search keywords were radiation dermatitis, skin reaction, management, skin care, skin toxicity, moist desquamation, dry desquamation, erythema, sorbolene aqueous cream, and aloe vera.

Inclusion and exclusion criteria were not specified.

Literature Evaluated:

Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.

Sample Characteristics:

  • The final number of studies included was 31.
  • The sample size across studies was 3,174 participants (range 413–506).
  • Participants had various tumor types.
  • All participants received radiation therapy (RT).

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Results:

Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity.

Conclusions:

Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects. Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.

Limitations:

  • Analysis was limited by combining all types of interventions together, which did not allow for differentiation between those agents individually shown to be effective and not effective.
  • Methods for evaluation of the quality of the research were not well described or incorporated into the analysis. 
  • Findings regarding management were questionable because of high heterogeneity among studies included in the meta-analysis. 
  • Actual odds ratios or effect sizes from the meta-analysis were not reported. 
  • Final recommendations stated by the authors were not consistent with the rest of the conclusions stated elsewhere in the article. 
  • The basis for recommendations, concerning evaluation of the quality of the evidence, was not clear. 
  • The authors stated that they weighted studies by sample size, but this method was not described.

Nursing Implications:

Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.

Salvo, N., Barnes, E., van Draanen, J., Stacey, E., Mitera, G., Breen, D., . . . De Angelis, C. (2010). Prophylaxis and management of acute radiation-induced skin reactions: A systematic review of the literature. Current Oncology (Toronto, Ont.), 17(4), 94–112.

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Purpose:

To review the evidence for approaches to prevention and management of radiodermatitis

Search Strategy:

Databases used were MEDLINE, PubMed, and Cochrane Library. Keywords searched were skin reactions, radiation, radiation adverse effects, erythema, desquamation, and radiodermatitis. Studies were included in the review they

  • Were published reports or abstracts from January 1, 2000 to October 1, 2008.
  • Reported the method of skin grading.

Studies were excluded from the review if they were letters, comments, editorials, case reports, practice guidelines, systematic reviews, or meta-analyses.
 

Literature Evaluated:

The total references retrieved and the quality rating approach were not reported.
 

Sample Characteristics:

  • Thirty-nine trials were included in the review.
  • Patients were receiving radiation therapy.

Phase of Care and Clinical Applications:

Patients were undergoing active antitumor treatment.

Results:

Washing practice, topical corticosteroids, aloe vera, biafine, hyauronidase-based creams, sucralfate, miscellaneous creams, Amifostine, oral enzymes, pentosifylline, dressings, non-steroidal topical cream, topical colony-stimulating factors supplements, and mode of radiation delivery were reviewed. Other agents studied included beladonna 7CH and a Chinese remedy, lian bai liquid.

Conclusions:

There is lack of support for Biafine use. There is some evidence to suggest that topical corticosteroids may be beneficial. Evidence for non-steroidal topical agents is conflicting. Evidence does not support use of Aloe Vera or sucralfate cream. Some evidence to suggest that light-emitting diode, pentoxifylline, sliver-leaf dressings, washing, zinc supplements and intensity-modulated radiation therapy are beneficial.

Limitations:

  • The trials were small and had numerous design and reporting limitations.
  • Secondary trials evaluated the same agent or treatment, making comparison very difficult.

Nursing Implications:

Further research is needed in this area. Intervention goals, prevention or treatment need to be clear and further work is needed to develop and validate more sensitive assessment tools. Further work is also needed to evaluate differences in risk based on anatomical sites.

Vogler, B. K., & Ernst, E. (1999). Aloe vera: a systematic review of its clinical effectiveness. British Journal of General Practice, 49, 823–828.

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Purpose:

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

Search Strategy:

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.

Literature Evaluated:

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.

Sample Characteristics:

  • 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.

Results:

  • 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.

Conclusions:

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.

Limitations:

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

Nursing Implications:

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


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