Aloe vera

 

 

Lloyd, E. C., B. C. Rodgers, M. Michener and M. S. Williams. 2012. Outpatient burns: prevention and careAm Fam Physician. 185, 1: 25-32.

Abstract: Most burn injuries can be managed on an outpatient basis by primary care physicians. Prevention efforts can significantly lower the incidence of burns, especially in children. Burns should be managed in the same manner as any other trauma, including a primary and secondary survey. Superficial burns can be treated with topical application of lotions, honey, aloe vera, or antibiotic ointment. Partial-thickness burns should be treated with a topical antimicrobial agent or an absorptive occlusive dressing to help reduce pain, promote healing, and prevent wound desiccation. Topical silver sulfadiazine is the standard treatment; however, newer occlusive dressings can provide faster healing and are often more cost-effective. Physicians must reevaluate patients frequently after a burn injury and be aware of the indications for referral to a burn specialist.

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Huseini, H. F., S. Kianbakht, R. Hajiaghaee and F. H. Dabaghian. 2011. Anti-hyperglycemic and Anti-hypercholesterolemic Effects of Aloe vera Leaf Gel in Hyperlipidemic Type 2 Diabetic Patients: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Planta Med[Epub ahead of print].

Abstract: Diabetes mellitus type 2 with dyslipidemia is a common disease. Previous studies suggest that aloe ( ALOE VERA L.) leaf gel may positively affect the blood glucose and lipid levels in dyslipidemic type 2 diabetic patients. Thus, in this randomized double-blind placebo-controlled clinical trial with hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) type 2 diabetic patients aged 40 to 60 years not using other anti-hyperlipidemic agents and resistant to daily intake of two 5 mg glyburide tablets and two 500 mg metformin tablets, the efficacy and safety of taking aloe gel (one 300 mg capsule every 12 hours for 2 months) combined with the aforementioned drugs in treatment of 30 patients were evaluated and compared with the placebo group (n = 30). The aloe gel lowered the fasting blood glucose, HbA1c, total cholesterol, and LDL levels significantly (p = 0.036, p = 0.036, p = 0.006, and p = 0.004, respectively) without any significant effects on the other blood lipid levels and liver/kidney function tests (p > 0.05) compared with the placebo at the endpoint. No adverse effects were reported. The results suggest that aloe gel may be a safe anti-hyperglycemic and anti-hypercholesterolemic agent for hyperlipidemic type 2 diabetic patients.

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Casetti, F., U. Wölfle, W. Gehring, C. M. Schempp. 2011. Dermocosmetics for Dry Skin: A New Role for Botanical Extracts. Skin Pharmacol Physiol. 24, 6: 289-293.

Abstract: Dry skin is associated with a disturbed skin barrier and reduced formation of epidermal proteins and lipids. During recent years, skin-barrier-reinforcing properties of some botanical compounds have been described. Searching the PubMed database revealed 9 botanical extracts that specifically improve skin barrier and/or promote keratinocyte differentiation in vivo after topical application. The topical application of Aloe vera (leaf gel), Betula alba (birch bark extract), Helianthus annuus (sunflower oleodistillate), Hypericum perforatum (St. John's wort extract), Lithospermum erythrorhizon (root extract), Piptadenia colubrina (angico-branco extract) and Simarouba amara(bitter wood extract) increased skin hydration, reduced the transepidermal water loss, or promoted keratinocyte differentiation in humans in vivo. The topical application of Rubia cordifolia root extract and rose oil obtained from Rosa spp. flowers stimulated keratinocyte differentiation in mouse models. The underlying mechanisms of these effects are discussed. It is concluded that some botanical compounds display skin-barrier-reinforcing properties that may be used in dermocosmetics for dry skin. However, more investigations on the mode of action and more vehicle-controlled studies are required.

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Visuthikosol, V., B. Chowchuen, Y. Sukwanarat, S. Sriurairatana and V. Boonpucknavig. 1995. Effect of aloe vera gel to healing of burn wound a clinical and histologic study. J Med Assoc Thai. 78, 8: 403-409.

Abstract: In a study of twenty-seven patients with partial thickness burn wound, they were treated with aloe vera gel compared with vaseline gauze. It revealed the aloe vera gel treated lesion healed faster than the vaseline gauze area. The average time of healing in the aloe gel area was 11.89 days and 18.19 days for the vaseline gauze treated wound. Statistical analysis by using t-test and the value of P less than 0.002 was statistically significant. In histologic study, it showed early epithelialization in the treated aloe vera gel area. Only some minor adverse effects, such as discomfort and pain were encountered in the 27 cases. This study showed the effectiveness of aloe vera gel on a partial thickness burn wound, and it might be beneficial to do further trials on burn wounds.

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Lee, T. and J. J. Dugoua. 2011. Nutritional supplements and their effect on glucose control. Curr Diab Rep. 11, 2: 142-148.

Abstract: Type 2 diabetes is a growing health concern. The use of nutritional supplements by patients with type 2 diabetes is estimated at somewhere between 8% to 49%. The objective of this review was to search the scientific literature for advances in the treatment and prevention of type 2 diabetes with nutritional supplements. Twelve databases were searched with a focus on extracting studies published in the past 3 years. The following nutritional supplements were identified as potentially beneficial for type 2 diabetes treatment or prevention: vitamins C and E, α-lipoic acid, melatonin, red mold, emodin from Aloe vera and Rheum officinale, astragalus, and cassia cinnamon. Beta-carotene was shown to be ineffective in the prevention of type 2 diabetes. Ranging from preclinical to clinical, there is evidence that nutritional supplements may be beneficial in the treatment or prevention of type 2 diabetes. Health providers should investigate drug-nutritional supplement interactions prior to treatment.

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Salazar-Sánchez N, P. López-Jornet, F. Camacho-Alonso and M. Sánchez-Siles. 2010. Efficacy of topical Aloe vera in patients with oral lichen planus: a randomized double-blind study. J Oral Pathol Med. 39, 10: 735-740.

Abstract:

BACKGROUND:   Different treatments have been used in application to symptomatic oral lichen planus (OLP), with variable results, perhaps caused by the refractory nature of the disease. The objective of this study was to evaluate the efficacy of the topical application of aloe vera (AV) in OLP compared with placebo.

METHODS: A total of 64 patients with OLP were randomized in a double-blind study to either AV (32 patients) or placebo (32 patients), at a dose of 0.4 ml (70% concentration) three times a day. A Visual Analog Scale was used for rating pain, with the application of a clinical scale for scoring the lesions, the Oral Health Impact Profile 49 (OHIP-49), and the Hospital Anxiety-Depression (HAD) scale. The patients were evaluated after 6 and 12 weeks.

RESULTS: No statistically significant differences were recorded between both groups in relation to pain after 6 and 12 weeks. In the AV group, complete pain remission was achieved in 31.2% of the cases after 6 weeks, and in 61% after 12 weeks. In the placebo group, these percentages were 17.2% and 41.6%, respectively. There were no adverse effects in any of the groups. In relation to quality of life, significant differences were observed between the two groups in the psychological disability domain and total OHIP-49 score.

CONCLUSION: The topical application of AV improves the total quality of life score in patients with OLP.

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White-Chu, E. F. and M. Reddy. 2010. Dry skin in the elderly: complexities of a common problem. Clin Dermatol. 29, 1: 37-42.

Abstract: Dry skin, or xerosis, is a common skin condition in older adults, but it is not a normal part of aging. The geriatric patient may have several incurable, but treatable, chronic diseases that affect their skin. Xerosis in older adults is multifactorial: intrinsic changes in keratinization and lipid content, use of diuretics and similar medications, and overuse of heaters or air conditioners all contribute. Xerosis causes pruritus, which then leads to excoriations and risk of skin infections. Patients can minimize the effect of xerosis by increasing the ambient humidity, modifying their bathing technique and products, and using emollients to replace the lipid components of the skin. Care should be made to avoid skin sensitizers, such as lanolin, aloe vera, and parabens, that are commonly found in emollients. These may lead to a delayed hypersensitivity reaction. This contribution reviews the intrinsic and extrinsic aging processes of skin aging and advises practical changes in environment and emollient application that can be distributed to patients.

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Cuzzolin, L., F. Francini-Pesenti, G. Verlato, M. Joppi, P. Baldelli and G. Benoni. 2010. Use of herbal products among 392 Italian pregnant women: focus on pregnancy outcome.Pharmacoepidemiol Drug Saf. 19, 11: 1151-1158.

Abstract:

PURPOSE: The present study aimed to explore the use of herbal products among a sample of Italian pregnant women and the possible influence of herbal consumption on pregnancy outcome.

METHODS: The study was conducted over a 10-month period (2 days a week, from January to October 2009) at the Maternity wards of Padua and Rovereto Hospital. Data were collected through a face-to-face interview on the basis of a prestructured questionnaire including socio-demographic characteristics of the enrolled subjects, specific questions on herbal use, information about pregnancy and newborn.

RESULTS: In total, 392 interviews were considered. One hundred and nine out of 392 women (27.8%) reported to have been taking one or more herbal products during pregnancy, in the 36.7% of cases throughout all pregnancy. The most frequently herbs taken by interviewees were chamomile, licorice, fennel, aloe, valerian, echinacea, almond oil, propolis, and cranberry. Four out of 109 women (3.7%) reported side-effects: constipation after a tisane containing a mix of herbs, rash and itching after local application of aloe or almond oil. The decision to use herbal products was mainly based on personal judgement and on the conviction that these natural substances would be safer than traditional medicines. Users were more often affected by morbidities pregnancy-related and their neonates were more frequently small for their gestational age. An higher incidence of threatening miscarriages and preterm labours was observed among regular users of chamomile and licorice.

CONCLUSIONS: This research underlines that the use of herbal products during pregnancy is common among Italian women, not always appropriate and in some cases potentially harmful.

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Morelli, V., E. Calmet and V. Jhingade. 2010. Alternative therapies for common dermatologic disorders, part 1. Primary Care: Clinics in Office Practice 37, 2: 269-283.

The exact pathophysiology and curative treatment of many common dermatologic conditions remains unclear. Often, conventional treatments are only partially effective, leading patients to look for alternative therapy. No new promising alternative treatments for aphthous stomatitis could be found in the literature. Acne may be helped by nicotinamide gel and azelaic acid. Atopic dermatitis may be helped by a trial of elimination diet, n-3 fatty acid supplementation, or Chinese 10-herb tea. Psoriasis may be helped by Aloe vera or thermal baths combined with sun exposure.

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Eshghi, F., S.J.Hosseinimehr, N.Rahmani, M. Khademloo, M.S. Norozi and O. Hojati. 2010. Effects of Aloe vera cream on posthemorrhoidectomy pain and wound healing: results of a randomized, blind, placebo-control study.  J Altern Complement Med. 16, 6: 647-650.

Abstract

OBJECTIVE: Aloe vera is an herbal medicine, which has wound healing effects in burn injury. This study assessed the effects of Aloe vera cream in reducing postoperative pain, postdefection pain, and its promotion of wound healing after open hemorrhoidectomy. DESIGN: A prospective, randomized, double-blind, placebo-controlled trial was conducted comparing the effects of a cream containingAloe vera versus a placebo cream on posthemorrhoidectomy pain. The study preparations were applied by patients to the surgical site 3 times per day for 4 weeks after hemorrhoidectomy. Pain was assessed with a visual analog scale immediately postoperatively and at hours 12, 24, and 48 after surgery and at weeks 2 and 4. Wound healing was examined and evaluated at the end of 2 and 4 weeks. The use of analgesics was recorded. RESULTS: Forty-nine (49) patients were randomly assigned to receive aloe (n = 24) or placebo (n = 25). Patients in the topical aloe cream group had significantly less postoperative pain at hours 12, 24, and 48 hours and at 2 weeks. Aloe cream reduced the pain after defecation in 24 and 48 hours postsurgery (p < 0.001). Wound healing at the end of the second postoperative week was significantly greater in the aloe group compared with the placebo group (p < 0.001). Patients required fewer additional analgesics posthemorrhoidectomy (p < 0.001). CONCLUSIONS: Application of Aloe vera cream on the surgical site is effective in reducing postoperative pain both on resting and during defecation, healing time, and analgesic requirements in the patients compared with the placebo group.

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Rodríguez, R. E.,  M. J. Darias, R. C. Díaz. 2010. .Aloe vera as a functional ingredient in foods. Crit Rev Food Sci Nutr. 50, 4: 305-326.

Abstract; The main scientific discoveries on Aloe vera published mainly in the last three decades are presented in this work. After describing Aloe from a botanical point of view, the papers related with the chemical composition of different parts of the leaf of Aloe, particularly those in which the gel is described and are presented in a synthetic manner. The chemical analyses reveal that Aloe gel contains mannose polymers with some glucose and other sugars, among which the most important is Acemannan. Besides these, other components such as glycoproteins, enzymes, amino acids, vitamins, and minerals are described. Different factors also affecting the chemical composition of the gel, such as species and variety, climatic and soil conditions, cultivation methods, processing and preservation, are enumerated and discussed. On the other hand, the main therapeutic applications have been revised and the possible damaging effects of Aloe are also commented upon. A special emphasis is placed on the biologically active compounds or groups of compounds responsible for the therapeutic applications and which are their action mechanisms. The paper concludes that more research is needed to confirm the therapeutic and beneficial effects and to definitively clarify the myth surrounding Aloe vera. A general view on the problem of the commercialization and establishment of the quality and safety of Aloe products in the food industry has been offered here. The main points and European regulations that need to be considered regarding the quality control of prepared Aloe products are presented in this paper.

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ChoonhakarnC., P. BusaracomeB. Sripanidkulchai and P. Sarakarn. 2010. A prospective, randomized clinical trial comparing topical Aloe vera with 0.1% triamcinolone acetonide in mild to moderate plaque psoriasis. J Eur Acad Dermatol Venereol. 24, 2: 168-72.

ABSTRACT

Background Topical Aloe vera (AV) has been used to treat various skin conditions, including psoriasis, with good results.

Objectives This study aims to compare the efficacy of AV and 0.1% triamcinolone acetonide (TA) in mild to moderate plaque psoriasis.

Methods A randomized, comparative, double-blind, 8-week study was designed. Eighty patients randomly received AV or 0.1% TA cream and their clinical response were evaluated using the Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI).

Results After 8 weeks of treatment, the mean PASI score decreased from 11.6 to 3.9 (–7.7) in the AV group and from 10.9 to 4.3 (–6.6) in the TA group. Between-group difference was 1.1 (95% confidence interval –2.13, –0.16, P = 0.0237). The mean DLQI score decreased from 8.6 to 2.5 (–6.1) in the AV group and from 8.1 to 2.3 (–5.8) in the TA group. Between-group difference was 0.3 (95% confidence interval –1.18, –0.64, P = 0.5497). There was no follow-up period after the 8-week treatment.

Conclusions AV cream may be more effective than 0.1% TA cream in reducing the clinical symptoms of psoriasis; however, both treatments have similar efficacy in improving the quality of life of patients with mild to moderate psoriasis.

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Nagaoka, S.-I., A. Fujii, M. Hino, M. Takemoto, M. Yasuda, M. Mishima K. Ohara et al. 2007. UV Protection and Singlet Oxygen Quenching Activity of Aloesaponarin I. J. Phys. Chem. B 111: 13116-13123.

Abstract; The UV protection and singlet oxygen quenching of aloesaponarin I have been studied by means of laser spectroscopy. The excited-state intramolecular proton transfer that provides the UV protection takes place along only one of the molecule’s two intramolecular hydrogen bonds, and this can be understood by considering the nodal pattern of the wave function. The functional groups participating in the excited-state intramolecular proton transfer also play important roles in the singlet oxygen quenching. Aloesaponarin I has a quenching rate constant larger than that of vitamin E and has a long duration of action due to its resistance to UV degradation and chemical attacks by singlet oxygen and free radicals.

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Cuttle, L., J. Pearn, J. R. McMillan and R. M. Kimble. 2009. A review of first aid treatments for burn injuries. Burns 35: 768– 775

Abstract; Throughout history there have been many different and sometimes bizarre treatments prescribed for burns. Unfortunately many of these treatments still persist today, although they often do not have sufficient evidence to support their use. This paper reviews common first aid and pre-hospital treatments for burns (water—cold or warm, ice, oils, powders and natural plant therapies), possible mechanisms whereby they might work and the literature which supports their use. From the published work to date, the current recommendations for the first aid treatment of burn injuries should be to use cold running tap water (between 2 and 15 0C) on the burn, not ice or alternative plant therapies.

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Smith, N., A. Weymann, F. A. Tausk and J. M. Gelfand. 2009. Complementary and alternative medicine for psoriasis: A qualitative review of the clinical trial literature. J AM ACAD DERMATOL 61: 841-56.

Background: Patients with psoriasis often inquire about complementary and alternative medicine in an effort to do everything possible to control the disease.

Objective: We sought to review the clinical trial literature regarding complementary and alternative medicine for the treatment of psoriasis.

Methods: We conducted qualitative systematic review of randomized, clinical trials.

Results: Although many randomized controlled trials were found, both the results and the quality of the studies varied.

Limitations: The main limitations were the relatively low quality of studies (as assessed by Jadad scores), lack of inclusion of unpublished studies, and the fact that only one author determined inclusion of studies and assignment of Jadad scores.

Conclusion: There is a large body of literature in regard to complementary and alternative medicine for the treatment of psoriasis. More work is necessary before these modalities should be recommended to our patients.

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Li, J., E. Teplicki, Q. Ma and R. Huo. 2009. P3803 Effects of Aloe vera extract on fibroblasts and keratinocytes. J AACAD DERMATOL: AB200.

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Menter, A., N. J. Korman, C. A. Elmets, S. R. Feldman, J. M. Gelfand, K. B. Gordon, A. Gottlieb, J. Y. M. Koo, M. Lebwohl, H. W. Lim, A. S. Van Voorhees, K. R. Beutner and Reva Bhushan. 2009. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 60: 643-59.

Psoriasis is a common, chronic, inflammatory, multi-system disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this third of 6 sections of the guidelines of care for psoriasis, we discuss the use of topical medications for the treatment of psoriasis. The majority of patients with psoriasis have limited disease (<5% body surface area involvement) and can be treated with topical agents, which generally provide a high efficacy-to-safety ratio. Topical agents may also be used adjunctively for patients with more extensive psoriasis undergoing therapy with either ultraviolet light, systemic or biologic medications. However, the use of topical agents as monotherapy in the setting of extensive disease or in the setting of limited, but recalcitrant, disease is not routinely recommended. Treatment should be tailored to meet individual patients’ needs. We will discuss the efficacy and safety of as well as offer recommendations for the use of topical corticosteroids, vitamin D analogues, tazarotene, tacrolimus, pimecrolimus, emollients, salicylic acid, anthralin, coal tar, as well as combination therapy.

 

 

 

 

 

 

 

 

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Cuttle ,L., M. Kempf, O. Kravchuk, N. George, P.-Y. Liu, H.-E. Chang, J. Mill, X.-Q. Wang, R. M. Kimble. 2008. The efficacy of Aloe vera, tea tree oil and saliva as first aid treatment for partial thickness burn injuries. Burns 34: 1176-1182.

Abstract; Many alternative therapies are used as first aid treatment for burns, despite limited evidencesupporting their use. In this study, Aloe vera, saliva and a tea tree oil impregnated dressing (BurnaidTM) were applied as first aid to a porcine deep dermal contact burn, compared to a control of nothing. After burn creation, the treatments were applied for 20 min and the wounds observed at weekly dressing changes for 6 weeks. Results showed that the alternative treatments did significantly decrease subdermal temperature within the skin during the treatment period. However, they did not decrease the microflora or improve re-epithelialisation, scar strength, scar depth or cosmetic appearance of the scar and cannot be recommended for the first aid treatment of partial thickness burns.

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Surjushe, A., R. Vasani and  D. G. Saple. 2008. ALOE VERA: A SHORT REVIEW. Indian J Dermatol 53, 4: 163-6.

Abstract; Aloe vera is a natural product that is now a day frequently used in the field of cosmetology. Though there are various indications for its use, controlled trials are needed to determine its real efficacy. The Aloe vera plant, its properties, mechanism of action and clinical uses are briefly reviewed in this article.

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Maenthaisong, R., N. Chaiyakunapruk, S. Niruntraporn and C. Kongkaew. 2007. The efficacy of aloe vera used for burn wound healing: A systematic review. BURNS 33: 713-718.

Abstract; Aloe vera has been traditionally used for burn healing but clinical evidence remains unclear. We conducted a systematic review to determine the efficacy of topical aloe vera for the treatment of burn wounds. We electronically searched relevant studies in MEDLINE, CINAHL, Cochrane Library, HealthSTAR, DARE, South-East Asia Database, Chinese Databases, and several Thai local Databases (1918–June 2004). Only controlled clinical trials for burn healing were included. There were no restrictions on any language of publication. Two reviewers independently extracted data on study characteristics, patient characteristics, intervention, and outcome measure. Four studies with a total of 371 patients were included in this review. Based on a metaanalysis using duration of wound healing as an outcome measure, the summary weighted mean difference in healing time of the Aloe vera group was 8.79 days shorter than those in the control group (P = 0.006). Due to the differences of products and outcome measures, there is paucity to draw a specific conclusion regarding the effect of Aloe vera for burn wound healing. However, cumulative evidence tends to support that aloe vera might be an effective interventions used in burn wound healing for first to second degree burns. Further, well-designed trials with sufficient details of the contents of aloe vera products should be carried out to determine the effectiveness of Aloe vera.

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 Kirdpon, S., W. Kirdpon, W. Airarat, A. Trevanich and S. Nanakorn. 2006. Effect of Aloe (Aloe vera Linn.) on Healthy Adult Volunteers: Changes in Urinary Composition. J Med Assoc Thai 89, 2: S9-14.

Objective: 1. To investigate the amount of citrate and tartrate in aloe gel, and in the urine of healthy normal volunteers, before and after consuming fresh aloe gel. 2. To evaluate the changes in the chemical composition of urine among subjects after taking aloe gel. 3. To determine the value of consuming aloe gel for prevention of renal stone formation.

Designs: Experimental study; before and after experiment with no control group

Material and Method: Thirty one healthy male medical students between 18 and 23 years of age were enrolled (with informed consent) in the clinical trial. Subjects ingested 100 g of fresh aloe gel twice a day for seven consecutive days. The 24-hr urine was collected one day prior to taking the gel (Day 0), Days 2 and 5 of consumption, and Day 8 (one day after completion). The authors determined the urine volume, osmolality, potassium, sodium, phosphate, calcium, magnesium, uric acid, citrate, tartrate, oxalate, Permissible Increment in calcium (PI in calcium), Permissible Increment in oxalate (PI in oxalate), Concentration product ratio of calcium phosphate (CPR of CaPO4) and the citrate per creatinine ratio.

Results: The citrate and tartrate concentration in 100 g of fresh aloe gel was 96.3 and 158.9 mg, respectively. The urinary excretion of oxalate was significantly decreased (p < 0.05). The PI in calcium was significantly increased (p < 0.05), while the citrate excretion and PI in oxalate were consistently, albeit non-significantly, increased. The mean CPR values of CaPO4 were decreased non-significantly. The other measurements were unremarkable.

Conclusion: Fresh Aloe vera gel (100 g) contains 96.3 mg of citrate and 158.9 mg of tartrate. This is mid-range for Thai fruits. Changes in chemical compositions of urine after aloe consumption shows its potential for preventing kidney stone formation among adults.

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LANGMEAD, L., R. M. FEAKINS, S. GOLDTHORPE, H. HOLT, E. TSIRONI, A. DE SILVA, D. P. JEWELL and D. S. RAMPTON. 2004. Randomized, double-blind, placebo-controlled trial of oral Aloe vera gel for active ulcerative colitis. Aliment Pharmacol Ther 19: 739–747.

SUMMARY

Background: The herbal preparation, Aloe vera, has been claimed to have anti-inflammatory effects and, despite a lack of evidence of its therapeutic efficacy, is widely used by patients with inflammatory bowel disease.

Aim: To perform a double-blind, randomized, placebocontrolled trial of the efficacy and safety of Aloe veragel for the treatment of mildly to moderately active ulcerative colitis.

Methods: Forty-four evaluable hospital out-patients were randomly given oral Aloe vera gel or placebo, 100 mL twice daily for 4 weeks, in a 2 : 1 ratio. The primary outcome measures were clinical remission (Simple Clinical Colitis Activity Index £ 2), sigmoidoscopic remission (Baron score £  1) and histological remission (Saverymuttu score £  1). Secondary outcome measures included changes in the Simple

 
 
 
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