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(1) Wal ace RB, Gryzlak BM, Zimmerman MB, Nisly NL. Application of FDA adverse event report data to the surveillance of dietary botanical supplements. Ann Pharmacother 2008; 42(5):653-660.
Abstract: BACKGROUND: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) represents one of the few existing surveil ance mechanisms, but it has not been wel characterized with respect to DBS adverse effects. OBJECTIVE: To characterize data on DBSs associated with adverse event reports submitted to CAERS. METHODS: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail. RESULTS: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events. CONCLUSIONS: CAERS surveil ance of DBS adverse effects is potential y as effective as other passive surveil ance methods, but the number of reports is relatively smal , validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption (2) Keifer D, Ulbricht C, Abrams TR, Basch E, Giese N, Giles M et al. Peppermint (Mentha piperita): an evidence-based systematic review by the Natural Standard Research Col aboration. J Herb Pharmacother 2007; 7(2):91-143.
Abstract: An evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology and dosing (3) Moss M, Hewitt S, Moss L, Wesnes K. Modulation of cognitive performance and mood by aromas of peppermint and ylang-ylang. Int J Neurosci 2008; 118(1):59-77.
Abstract: This study provides further evidence for the impact of the aromas of plant essential oils on aspects of cognition and mood in healthy participants. One hundred and forty-four volunteers were randomly assigned to conditions of ylang-ylang aroma, peppermint aroma, or no aroma control. Cognitive performance was assessed using the Cognitive Drug Research computerized assessment battery, with mood scales completed before and after cognitive testing. The analysis of the data revealed significant differences between conditions on a number of the factors underpinning the tests that constitute the battery. Peppermint was found to enhance memory whereas ylang-ylang impaired it, and lengthened processing speed. In terms of subjective mood peppermint increased alertness and ylang-ylang decreased it, but significantly increased calmness. These results provide support for the contention that the aromas of essential oils can produce significant and idiosyncratic effects on both subjective and objective assessments of aspects of human behavior. They are discussed with reference to possible pharmacological and psychological modes of influence (4) Rodriguez-Fragoso L, Reyes-Esparza J, Burchiel SW, Herrera-Ruiz D, Torres E. Risks and benefits of commonly used herbal medicines in Mexico. Toxicol Appl Pharmacol 2008; 227(1):125-135.
Abstract: In Mexico, local empirical knowledge about medicinal properties of plants is the basis for their use as home remedies. It is general y accepted by many people in Mexico and elsewhere in the world that beneficial medicinal effects can be obtained by ingesting plant products. In this review, we focus on the potential pharmacologic bases for herbal plant efficacy, but we also raise concerns about the safety of these agents, which have not been ful y assessed. Although numerous randomized clinical trials of herbal medicines have been published and systematic reviews and meta-analyses of these studies are available, generalizations about the efficacy and safety of herbal medicines are clearly not possible. Recent publications have also highlighted the unintended consequences of herbal product use, including morbidity and mortality. It has been found that many phytochemicals have pharmacokinetic or pharmacodynamic interactions with drugs. The present review is limited to some herbal medicines that are native or cultivated in Mexico and that have significant use. We discuss the cultural uses, phytochemistry, pharmacological, and toxicological properties of the fol owing plant species: nopal (Opuntia ficus), peppermint (Mentha piperita), chaparral (Larrea divaricata), dandlion (Taraxacum officinale), mul ein (Verbascum densiflorum), chamomile (Matricaria recutita), nettle or stinging nettle (Urtica dioica), passionflower (Passiflora incarnata), linden flower (Tilia europea), and aloe (Aloe vera). We conclude that our knowledge of the therapeutic benefits and risks of some herbal medicines used in Mexico is stil limited and efforts to elucidate them should be intensified (5) Mel i MS, Rashidi MR, Nokhoodchi A, Tagavi S, Farzadi L, Sadaghat K et al. A randomized trial of peppermint gel, lanolin ointment, and placebo gel to prevent nipple crack in primiparous breastfeeding women. Med Sci Monit 2007; 13(9):CR406-CR411.
Abstract: BACKGROUND: Sore nipples are common during lactation and remain the major reason for failing to establish successful breastfeeding. To formulate a peppermint gel and to evaluate its effect on the prevention of nipple crack associated with breast-feeding, a randomized double-blinded clinical trial comparing the above formulation with modified lanolin and a neutral ointment was carried out. MATERIAL/METHODS: Two hundred and sixteen primiparous participants were assigned randomly to three groups. Each group applied only one of the above three preparations on both breasts for 14 days. Each group consisted of 72 primiparous mothers and was seen for a maximum of four fol ow-up visits within 14 days and a final visit at week 6. The rate of nipple and areola crack and pain was evaluated. RESULTS: The study groups were comparable in mean age and route of delivery. Nipple crack were less in mothers who received peppermint gel than in those who received lanolin ointment or placebo (chi(2)=16.8, df=6, P=0.01). Relative risk of nipple crack in the lanolin group (RR: 2.41, 95%CI: 1.20-3.01) was higher than in the peppermint group (RR: 1.85, 95%CI: 1.64-3.10). CONCLUSIONS: Prophylactic peppermint gel in breastfeeding lactating women is associated with fewer nipple cracks and is more effective than lanolin and placebo. It could be recommended for preventing of nipple crack along with teaching better breastfeeding technique at the initiation of breastfeeding (6) Akdogan M, Tamer MN, Cure E, Cure MC, Koroglu BK, Delibas N. Effect of spearmint (Mentha spicata Labiatae) teas on androgen levels in women with hirsutism. Phytother Res 2007; 21(5):444-447.
Abstract: Mentha spicata Labiatae, known as spearmint and Mentha piperita Labiatae, known as peppermint can be used for various kinds of illnesses in herbal medicine and flavoring in industry. M. spicata Labiatae grows on the Anamas plateau of Yenithornarbademli town of Isparta, located in southwest part of Turkey. In this town, clinicians thought that consumption of tea steeped with M. spicata or M. piperita caused a diminished libido. Because antiandrogenic effects of spearmint and peppermint were found previously in rats, it was decided to observe the effect of this herbal tea on the androgen levels in hirsute women.Twenty-one female hirsute patients, 12 with polycystic ovary syndrome and 9 with idiopathic hirsutism were included to the study. They were took a cup of herbal tea which was steeped with M. spicata for 5 days twice a day in the fol icular phase of their menstrual cycles. After treatment with spearmint teas, there was a significant decrease in free testosterone and increase in luteinizing hormone, fol icle-stimulating hormone and estradiol. There were no significant decreases in total testosterone or dehydroepiandrostenedione sulphate levels. Spearmint can be an alternative to antiandrogenic treatment for mild hirsutism. Further studies are needed to test the reliability of these results and the availability of spearmint as a drug for hirsutism (7) McKay DL, Blumberg JB. A review of the bioactivity and potential health benefits of peppermint tea (Mentha piperita L.). Phytother Res 2006; 20(8):619-633.
Abstract: Peppermint (Mentha piperita L.) is one of the most widely consumed single ingredient herbal teas, or tisanes. Peppermint tea, brewed from the plant leaves, and the essential oil of peppermint are used in traditional medicines. Evidence-based research regarding the bioactivity of this herb is reviewed. The phenolic constituents of the leaves include rosmarinic acid and several flavonoids, primarily eriocitrin, luteolin and hesperidin. The main volatile components of the essential oil are menthol and menthone. In vitro, peppermint has significant antimicrobial and antiviral activities, strong antioxidant and antitumor actions, and some antial ergenic potential. Animal model studies demonstrate a relaxation effect on gastrointestinal (GI) tissue, analgesic and anesthetic effects in the central and peripheral nervous system, immunomodulating actions and chemopreventive potential. Human studies on the GI, respiratory tract and analgesic effects of peppermint oil and its constituents have been reported. Several clinical trials examining the effects of peppermint oil on irritable bowel syndrome (IBS) symptoms have been conducted. However, human studies of peppermint leaf are limited and clinical trials of peppermint tea are absent. Adverse reactions to peppermint tea have not been reported, although caution has been urged for peppermint oil therapy in patients with GI reflux, hiatal hernia or kidney stones (8) Grigoleit HG, Grigoleit P. Pharmacology and preclinical pharmacokinetics of peppermint oil. Phytomedicine 2005; 12(8):612-616.
Abstract: The principal pharmacodynamic effect of peppermint oil relevant to the gastrointestinal tract is a dose-related antispasmodic effect on the smooth musculature due to the interference of menthol with the movement of calcium across the cel membrane. The choleretic and antifoaming effects of peppermint oil may play an additional role in medicinal use. Peppermint oil is relatively rapidly absorbed after oral administration and eliminated mainly via the bile. The major biliary metabolite is menthol glucuronide, which undergoes enterohepatic circulation. The urinary metabolites result from hydroxylation at the C-7 methyl group at C-8 and C-9 of the isopropyl moiety, forming a series of mono- and dihydroxymenthols and carboxylic acids, some of which are excreted in part as glucuronic acid conjugates. Studies with tritiated I-menthol in rats indicated about equal excretion in feces and urine. The main metabolite indentified was menthol-glucuronide. Additional metabolites are mono- or di-hydroxylated menthol derivatives (9) Grigoleit HG, Grigoleit P. Gastrointestinal clinical pharmacology of peppermint oil. Phytomedicine 2005; 12(8):607-611.
Abstract: In nine studies, 269 healthy subjects or patients underwent exposure to peppermint oil (PO) either by topical intraluminal (stomach or colon) or oral administration by single doses or 2 weeks treatment (n = 19). Methods used to detect effects were oro-cecal transit time by hydrogen expiration, total gastrointestinal transit time by carmine red method, gastric emptying time by radiolabel ed test meal or sonography, direct observation of colonic motility or indirect recording through pressure changes or relieve of colonic spasms during barium enema examination. The dose range covered in single dose studies is 0.1-0.24ml of PO/subject. With one exception, which show an unexplained potentiation of neostigmine stimulated colon activity, al other studies result in effects, indicating a substantial spasmolytic effect of PO of the smooth muscles of the gastrointestinal tract. Pharmacokinetic studies reveal that fractionated urinary recovery of menthol is dependent on the kind of formulation used for the application of PO. Optimal pH triggered enteric coated formulations start releasing PO in the smal intestine extending release over 10-12 h thus providing PO to the target organ in irritable bowel syndrome, i.e. the colon. The hypothesis is supported by anecdotal observations in patients with achlorhydria or ileostoma, respectively (10) Grigoleit HG, Grigoleit P. Peppermint oil in irritable bowel syndrome. Phytomedicine 2005; 12(8):601- 606.
Abstract: In a literature search 16 clinical trials investigating 180-200 mg enteric-coated peppermint oil (PO) in irritable bowel syndrome (IBS) or recurrent abdominal pain in children (1 study) with 651 patients enrol ed were identified. Nine out of 16 studies were randomized double blind cross over trials with (n = 5) or without (n = 4) run in and/or wash out periods, five had a randomized double blind paral el group design and two were open labeled studies. Placebo served in 12 and anticholinergics in three studies as comparator. Eight out of 12 placebo control ed studies show statistical y significant effects in favor of PO. Average response rates in terms of "overal success" are 58% (range 39-79%) for PO and 29% (range 10-52%) for placebo. The three studies versus smooth muscle relaxants did not show differences between treatments hinting for equivalence of treatments. Adverse events reported were general y mild and transient, but very specific. PO caused the typical GI effects like heartburn and anal/perianal burning or discomfort sensations, whereas the anticholinergics caused dry mouth and blurred vision. Anticholinergics and 5HT3/4-ant/agonists do not offer superior improvement rates, placebo responses cover the range as in PO trials. Taking into account the currently available drug treatments for IBS PO (1-2 capsules t.i.d. over 24 weeks) may be the drug of first choice in IBS patients with non-serious constipation or diarrhea to al eviate general symptoms and to improve quality of life (11) Sweet on peppermint. Nursing 2005; 35(2):76.
(12) Kumar A, Samarth RM, Yasmeen S, Sharma A, Sugahara T, Terado T et al. Anticancer and radioprotective potentials of Mentha piperita. Biofactors 2004; 22(1-4):87-91.
(13) Koretz RL, Rotblatt M. Complementary and alternative medicine in gastroenterology: the good, the bad, and the ugly. Clin Gastroenterol Hepatol 2004; 2(11):957-967.
Abstract: A large proportion of the American population avails itself of a variety of complementary and alternative medicine (CAM) interventions. Al opathic practitioners often dismiss CAM because of distrust or a belief that there is no sound scientific evidence that has established its utility. However, although not widely appreciated, there are thousands of randomized control ed trials (RCTs) that have addressed the efficacy of CAM. We reviewed the RCTs of herbal and other natural products, acupuncture, and homeopathy as examples of typical CAM modalities, focusing on conditions of interest to gastroenterologists. Peppermint (alone or in combination) has supportive evidence for use in patients with dyspepsia, irritable bowel syndrome, and as an intraluminal spasmolytic agent during barium enemas or endoscopy. Ginger appeared to be effective in relieving nausea and vomiting due to motion sickness or pregnancy. Probiotics were useful in childhood diarrhea or in diarrhea due to antibiotics; one particular formulation (VSL#3) prevented pouchitis. Acupuncture appeared to ameliorate postoperative nausea and vomiting and might be useful elsewhere. There is even a suggestion that homeopathy has efficacy in treatment of gastrointestinal problems or symptoms. The major problem in interpreting these CAM data is the general y low quality of the RCTs, although that quality might not be different compared to RCTs in the general medical literature. Gastroenterologists should become familiar with these techniques; it is likely that their patients already are (14) Tolia V, Johnston G, Stol e J, Lee C. Flavor and taste of lansoprazole strawberry-flavored delayed- release oral suspension preferred over ranitidine peppermint-flavored oral syrup: in children aged between 5-11 years. Paediatr Drugs 2004; 6(2):127-131.
Abstract: OBJECTIVE: To compare the flavor and taste preference of two acid-inhibitory therapies in healthy children aged between 5-11 years. METHODS: A single-site, single-blind, taste test trial was conducted in which 111 children participated after parental consent. One teaspoonful (5 mL) of lansoprazole delayed-release oral suspension (strawberry-flavored) and ranitidine oral syrup (peppermint-flavored) were provided to each child with a 10-minute break between samples. Children tasted the sample, swished it in their mouth for 10 seconds, and then expectorated the sample. Spring water and crackers were used to clear the palate between samples. After each sampling, children were observed for facial expressions and asked to rate their degree of liking of each sample based on a 5-point facial hedonic scale (5=like it very much, 1=dislike it very much). Likes, dislikes, and product preference were recorded. RESULTS: Of the 56 female and 54 male children who tasted both samples, 95% (105/110) preferred lansoprazole. Taste and flavor were the most often cited reasons for preferring lansoprazole (61 and 17 children, respectively) while three children preferred the flavor of ranitidine oral syrup. Lansoprazole received a higher mean liking rating compared with ranitidine (mean liking scores of 4.1 and 2.2, respectively). There was no significant difference in the preference for lansoprazole between age groups and gender with the degree of liking scores ranging between 3.5-4.4. Forty-two children disliked the texture of the lansoprazole oral suspension, citing the granules (31/110), thickness (7/110), or consistency/texture (4/110), specifical y. CONCLUSION: After sampling both products, 95% of children preferred the flavor and taste of the strawberry-flavored lansoprazole delayed-release oral suspension compared with the peppermint-flavored ranitidine oral syrup (15) Sal er R. [Peppermint (Mentha x piperita), medicinal plant of the year 2004]. Forsch Komplementarmed Klass Naturheilkd 2004; 11(1):6-7.
(16) Westfal RE. Use of anti-emetic herbs in pregnancy: women's choices, and the question of safety and efficacy. Complement Ther Nurs Midwifery 2004; 10(1):30-36.
Abstract: The majority of North American pregnant women experience some degree of nausea and vomiting, usual y in the first few months of pregnancy. Women utilize many coping strategies, including self-treatment with herbal medicine and other alternative therapies. In a qualitative study of self-care in pregnancy, birth and lactation within a non-random sample of 27 women in British Columbia, Canada, 20 women (74%) experienced pregnancy-induced nausea. Ten of these women used anti-emetic herbal remedies, which included ginger, peppermint, and Cannabis. The safety and efficacy of each of these herbal remedies is discussed here. Only ginger has been subjected to clinical trials among pregnant women, though al three herbs were clinical y effective against nausea and vomiting in other contexts, such as chemotherapy-induced nausea and post-operative nausea. While safety concerns exist in the literature for al three herbs with regards to their use by pregnant women, clinical evidence of harm is lacking (17) Barker S, Grayhem P, Koon J, Perkins J, Whalen A, Raudenbush B. Improved performance on clerical tasks associated with administration of peppermint odor. Percept Mot Skil s 2003; 97(3 Pt 1):1007-1010.
Abstract: Previous research indicates the presence of certain odors is associated with enhanced task performance. The present study investigated use of peppermint odor during typing performance, memorization, and alphabetization. Participants completed the protocol twice--once with peppermint odor present and once without. Analysis indicated significant differences in the gross speed, net speed, and accuracy on the typing task, with odor associated with improved performance. Alphabetization also improved significantly under the odor condition but not typing duration or memorization. These results suggest peppermint odor may promote a general arousal of attention, so participants stay focused on their task and increase performance (18) Wiedemann B. [Peppermint drop--irritable intestine--cardiac insufficiency. What does flatus want to tel us?]. MMW Fortschr Med 2003; 145(22):4-6.
(19) Satoh T, Sugawara Y. Effects on humans elicited by inhaling the fragrance of essential oils: sensory test, multi-channel thermometric study and forehead surface potential wave measurement on basil and peppermint. Anal Sci 2003; 19(1):139-146.
Abstract: The effects on humans inhaling the fragrance of essential oils were examined in terms of a sensory test, a multi-channel skin thermometer study and a portable forehead surface electroencephalographic (IBVA-EEG) measurement. The essential oils examined in this study were those of basil and peppermint, because our previous sensory test had indicated an opposite effect of these essential oils when mental work was undertaken; the inhalation of basil produced a more favorable impression after work than before work, whereas peppermint produced an unfavorable impression under these circumstances. For subjects administered basil or peppermint before and after mental work using an inhalator, a series of multi-channel skin thermometer studies and IBVA-EEG measurements were conducted. Using such paired odorants, our results showed that when compared between before and after mental work assigned to subjects: (1) the inhalation of basil, in which a favorable impression was predominant on the whole in terms of the sensory evaluation spectrum, was shown to be associated upward tendency in finger-tip skin temperature; (2) whereas these situations were opposite in the case of peppermint, in which the reversed (unfavorable) feature in sensory profiling was accompanied by a decrease in the magnitude of beta waves and a decrease in the finger-tip skin temperature both based on Welch's method, even at p < 0.01, implying a decreasing propensity of the aroused state and of the arousal response. The elucidation of such sensory and physiological endpoints of paired odorants would be of primary importance for human chemoreception science, because these are only rarely recorded during the same experiments, and this paradigm is highly informative about non-verbal responses to odorants (20) Aridogan BC, Baydar H, Kaya S, Demirci M, Ozbasar D, Mumcu E. Antimicrobial activity and chemical composition of some essential oils. Arch Pharm Res 2002; 25(6):860-864.
Abstract: In this study the composition and antimicrobial properties of essential oils obtained from Origanum onites, Mentha piperita, Juniperus exalsa, Chrysanthemum indicum, Lavandula hybrida, Rosa damascena, Echinophora tenuifolia, Foeniculum vulgare were examined. To evaluate the in vitro antibacterial activities of these eight aromatic extracts; their in vitro antimicrobial activities were determined by disk diffusion testing, according to the NCCLS criteria. Escherichia coli (ATTC 25922), Staphylococcus aureus (ATCC 25923) and Pseudomonas aeruginosa (ATTC 27853 were used as standard test bacterial strains. Origanum onites recorded antimicrobial activity against al test bacteria, and was strongest against Staphylococcus aureus. For Rosa damascena, Mentha piperita and Lavandula hybrida antimicrobial activity was recorded only to Staphylococcus aureus. Juniperus exalsa, and Chrysanthemum indicum exhibited antibacterial activities against both Staphylococcus aureus and Escherichia coli. We also examined the in vitro antimicrobial activities of some components of the essential oils and found some components with antimicrobial activity (21) Yeung DY, Lee T, Grant G, Ma M, Kwong E. A SPME-GC procedure for monitoring peppermint flavor in tablets. J Pharm Biomed Anal 2003; 30(5):1469-1477.
Abstract: A method was developed using solid-phase microextraction (SPME) and gas chromatography to monitor the peppermint flavor loss in a taste-masked tablet formulation. This was accomplished by headspace sampling of two major components of peppermint: menthone and menthol. It was found that the excipients from the tablet produced an important matrix effect and that standard addition analysis was necessary for improved accuracy of the determination. The method was shown to be specific and precise. Furthermore, the method produced acceptable results with adequate quantitation limits to determine peppermint flavors in taste-masked tablets. The optimized extraction procedure was successful y used to monitor the stability of peppermint flavor in an oral solid formulation. The accelerated stability studies of the tablet showed that the menthone and menthol was lost in an exponential manner and levels off after several days of heat exposure (22) Thompson CJ, Ernst E. Systematic review: herbal medicinal products for non-ulcer dyspepsia. Aliment Pharmacol Ther 2002; 16(10):1689-1699.
Abstract: BACKGROUND: Non-ulcer dyspepsia is predominantly a self-managed condition, although it accounts for a significant number of general practitioner consultations and hospital referrals. Herbal medicinal products are often used for the relief of dyspeptic symptoms. AIMS: : To critical y assess the evidence for and against herbal medicinal products for the treatment of non-ulcer dyspepsia. METHODS: Systematic searches were performed in six electronic databases and the reference lists located were checked for further relevant publications. No language restrictions were imposed. Experts in the field and manufacturers of identified herbal extracts were also contacted. Al randomized clinical trials of herbal medicinal products administered as supplements to human subjects were included. RESULTS: Seventeen randomized clinical trials were identified, nine of which involved peppermint and caraway as constituents of combination preparations. Symptoms were reduced by al treatments (60-95% of patients reported improvements in symptoms). The mechanism of any anti-dyspeptic action is difficult to define, as the causes of non-ulcer dyspepsia are unclear. There appear to be few adverse effects associated with these remedies, although, in many cases, comprehensive safety data were not available. CONCLUSIONS: There are several herbal medicinal products with anti-dyspeptic activity and encouraging safety profiles. Further research is warranted to establish their therapeutic value in the treatment of non-ulcer dyspepsia (23) Iscan G, Kirimer N, Kurkcuoglu M, Baser KH, Demirci F. Antimicrobial screening of Mentha piperita essential oils. J Agric Food Chem 2002; 50(14):3943-3946.
Abstract: Essential oils of peppermint Mentha piperita L. (Lamiaceae), which are used in flavors, fragrances, and pharmaceuticals, were investigated for their antimicrobial properties against 21 human and plant pathogenic microorganisms. The bioactivity of the oils menthol and menthone was compared using the combination of in vitro techniques such as microdilution, agar diffusion, and bioautography. It was shown that al of the peppermint oils screened strongly inhibited plant pathogenic microorganisms, whereas human pathogens were only moderately inhibited. Chemical compositions of the oils were analyzed by GC and GC/MS. Using the bioautography assay, menthol was found to be responsible for the antimicrobial activity of these oils (24) Huertas-Cebal os A, Macarthur C, Logan S. Pharmacological interventions for recurrent abdominal pain (RAP) in childhood. Cochrane Database Syst Rev 2002;(1):CD003017.
Abstract: BACKGROUND: Between 4% and 25% of school age children complain of recurrent abdominal pain (RAP) of sufficient severity to interfere with daily activities. For the majority of such children no organic cause for their pain can be found on physical examination or investigation. Although most children are likely managed by reassurance and simple measures, a large range of interventions has been recommended. OBJECTIVES: To determine the effectiveness of medication for recurrent abdominal pain in school-age children. SEARCH STRATEGY: The Cochrane Library (CENTRAL), MEDLINE, EMBASE, CINAHL, ERIC, PsycLIT, LILACS and JICST were searched using a strategy combining (Recurrent OR synonyms) AND (Abdomen OR synonyms) AND (Pain OR synonyms). Where appropriate search filters were employed. In addition, researchers working in this area were asked to identify relevant studies. SELECTION CRITERIA: Any study in which the majority of participants were school age children fulfil ing standard criteria for RAP, and who were al ocated by random or quasi-random methods to any drug treatment compared with a placebo or no treatment. DATA COLLECTION AND ANALYSIS: References identified by the searches were screened against the inclusion criteria by two independent reviewers. MAIN RESULTS: Only one trial met the inclusion criteria. This cross-over trial in 14 children who met suggested criteria for "abdominal migraine" compared pizotifen and placebo, each given for one month with no washout period. Participants reported a mean of 8.21 (95% CI 2.93, 13.48) fewer days of pain while taking the active drug. They also reported that the mean difference on an "Index of Severity" was -16.21 (95% CI -26.51, -5.90) and on an "Index of Misery" was -56.07 (95% CI -94.07, -18.07). REVIEWER'S CONCLUSIONS: There is little evidence to suggest that recommended drugs are effective in the management of RAP. At present there seems little justification for the use of these drugs other than in clinical trials. There is an urgent need for trials of al suggested pharmacologic interventions in children with RAP (25) Nair B. Final report on the safety assessment of Mentha Piperita (Peppermint) Oil, Mentha Piperita (Peppermint) Leaf Extract, Mentha Piperita (Peppermint) Leaf, and Mentha Piperita (Peppermint) Leaf Water. Int J Toxicol 2001; 20 Suppl 3:61-73.
Abstract: Mentha Piperita (Peppermint) Oil, Mentha Piperita (Peppermint) Leaf Extract, Mentha Piperita (Peppermint) Leaf, Mentha Piperita (Peppermint) Leaf Water are obtained from the Mentha piperita plant. The oil is currently used in cosmetic formulations as a fragrance component, but previously had been also described as a denaturant. The extract and leaves are described as biological additives, but only the extract is reported to be used. Peppermint Water is described as a flavoring agent or fragrance component, but is not currently in use. Peppermint Oil is used at a concentration of < or = 3% in rinse-off formulations and < or = 0.2% in leave-on formulations. Peppermint Oil is composed primarily of menthol and menthone. Other possible constituents include pulegone, menthofuran, and limone. Most of the safety test data concern Peppermint Oil. The oil is considered to present the "worst case scenario" because of its many constituents, so data on the oil were considered relevant to the entire group of ingredients. Peppermint Oil was minimal y toxic in acute oral studies. Short-term and sub-chronic oral studies reported cystlike lesions in the cerebel um in rats that were given doses of Peppermint Oil containing pulegone, pulegone alone, or large amounts (>200 mg/kg/day) of menthone. Pulegone is also a recognized hepatotoxin. Repeated intradermal dosing with Peppermint Oil produced moderate and severe reactions in rabbits, although Peppermint Oil did not appear to be phototoxic. Peppermint Oil was negative in the Ames test and a mouse lymphoma mutagenesis assay but gave equivocal results in a Chinese hamster fibroblast cel chromosome aberration assay. In a carcinogenicity study of toothpaste and its components, no apparent differences were noted between mice treated with Peppermint Oil and those treated with the toothpaste base. Isolated clinical cases of irritation and/or sensitization to Peppermint Oil and/or its constituents have been reported, but Peppermint Oil (8%) was not a sensitizer when tested using a maximization protocol. It was expected that dermal absorption of Peppermint Oil would be rapid, fol owing that of menthol, a major component, but in no case would be greater than absorption through the gastrointestinal tract. Because of the toxicity of pulegone, the safe concentration of this constituent was limited to < or = 1%. This concentration was achievable both by control ing the time of harvest and processing technique. There is evidence that menthol can enhance penetration of other agents. Formulators were cautioned that this enhanced penetration can affect the use of other ingredients whose safety assessment was based on their lack of absorption. With the limitation that the concentration of pulegone in these ingredients should not exceed 1%, it was concluded that Mentha Piperita (Peppermint) Oil, Mentha Piperita (Peppermint) Extract, Mentha Piperita (Peppermint) Leaves, Mentha Piperita (Peppermint) Water are safe as used in cosmetic formulations (26) Spirling LI, Daniels IR. Botanical perspectives on health peppermint: more than just an after-dinner mint. J R Soc Promot Health 2001; 121(1):62-63.
Abstract: Throughout history different species of mint have been used across the globe for their varying properties, both medicinal and culinary. Today, the commercial sales of mints are expanding each year--and at the end of a large meal after-dinner mints are frequently served. But why do we take them? Peppermint (Mentha piperita) is usual y taken after a meal for its ability to reduce indigestion and colonic spasms by reducing the gastrocolic reflex. It is a natural y occurring hybrid cross between water mint (M. aquatica) and spearmint (M. spicata) and is best known for its role as a popular flavouring agent. Less wel recognised is peppermint's potential role in the management of numerous other medical conditions including certain procedures, e.g. colonoscopy. With the growing popularity of herbal remedies, among both the public and medical practitioners, it would seem that now is an opportune time to consider further what peppermint has to offer the world of medicine (27) Ilmberger J, Heuberger E, Mahrhofer C, Dessovic H, Kowarik D, Buchbauer G. The influence of essential oils on human attention. I: alertness. Chem Senses 2001; 26(3):239-245.
Abstract: Scientific research on the effects of essential oils on human behavior lags behind the promises made by popular aromatherapy. Nearly al aspects of human behavior are closely linked to processes of attention, the basic level being that of alertness, which ranges from sleep to wakefulness. In our study we measured the influence of essential oils and components of essential oils [peppermint, jasmine, ylang-ylang, 1,8-cineole (in two different dosages) and menthol] on this core attentional function, which can be experimental y defined as speed of information processing. Substances were administered by inhalation; levels of alertness were assessed by measuring motor and reaction times in a reaction time paradigm. The performances of the six experimental groups receiving substances (n = 20 in four groups, n = 30 in two groups) were compared with those of corresponding control groups receiving water. Between-group analysis, i.e. comparisons between experimental groups and their respective control groups, mainly did not reach statistical significance. However, within-group analysis showed complex correlations between subjective evaluations of substances and objective performance, indicating that effects of essentials oils or their components on basic forms of attentional behavior are mainly psychological (28) Buckle J. Use of aromatherapy as a complementary treatment for chronic pain. Altern Ther Health Med 1999; 5(5):42-51.
Abstract: Chronic pain consumes approximately $70 bil ion per year and affects some 80 mil ion Americans. Increasingly, aromatherapy has been used as part of an integrated, multidisciplinary approach to pain management. This therapy is thought to enhance the parasympathetic response through the effects of touch and smel , encouraging relaxation at a deep level. Relaxation has been shown to alter perceptions of pain. Even if one ignores the possibility that essential oils have pharmacological y active ingredients--or the potential pharmacokinetic potentization of conventional drugs by essential oils--aromatherapy might possibly play a role in the management of chronic pain through relaxation. Clinical trials are in the early stages, but evidence suggests that aromatherapy might be used as a complementary therapy for managing chronic pain. As such, this article examines the potential role of clinical aromatherapy as a complementary therapy in the care of patients with chronic pain. Although the use of aromatherapy is not restricted to nursing, at least 1 state board of nursing has recognized the therapeutic value of aromatherapy and voted to accept it as part of holistic nursing care (29) Hadley SK, Petry JJ. Medicinal herbs: a primer for primary care. Hosp Pract (Minneap ) 1999; 34(6):105-12, 115.
Abstract: Used for centuries as folk remedies, herbs are enjoying a surge of public interest. Some empiric findings have been supported by formal research results. In order to advise patients about such preparations, physicians need to be aware of the indications, contraindications, drug interactions, and potential side effects. Eight popular herbs are reviewed (30) Pittler MH, Ernst E. Peppermint oil for irritable bowel syndrome: a critical review and metaanalysis. Am J Gastroenterol 1998; 93(7):1131-1135.
Abstract: OBJECTIVE: Peppermint oil is the major constituent of several over-the-counter remedies for symptoms of irritable bowel syndrome (IBS). As the etiology of IBS is not known and treatment is symptomatic, there is a ready market for such products. However, evidence to support their use is sparse. The aim of this study was to review the clinical trials of extracts of peppermint (Mentha X piperita L.) as a symptomatic treatment for IBS. METHODS: Computerized literature searches were performed to identify al randomized control ed trials of peppermint oil for IBS. Databases included Medline, Embase, Biosis, CISCOM, and the Cochrane Library. There were no restrictions on the language of publication. Data were extracted in a standardized, predefined fashion, independently by both authors. Five double blind, randomized, control ed trials were entered into a metaanalysis. RESULTS: Eight randomized, control ed trials were located. Col ectively they indicate that peppermint oil could be efficacious for symptom relief in IBS. A metaanalysis of five placebo-control ed, double blind trials seems to support this notion. In view of the methodological flaws associated with most studies, no definitive judgment about efficacy can be given. CONCLUSION: The role of peppermint oil in the symptomatic treatment of IBS has so far not been established beyond reasonable doubt. Wel designed and careful y executed studies are needed to clarify the issue (31) Haas LF. Mentha piperita (peppermint). J Neurol Neurosurg Psychiatry 1995; 59(6):607.
(32) Wilkinson SM, Beck MH. Al ergic contact dermatitis from menthol in peppermint. Contact Dermatitis 1994; 30(1):42-43.
(33) Roberts HJ. Caution regarding peppermint mints. South Med J 1983; 76(10):1331.
(34) Kligler B, Chaudhary S. Peppermint oil. Am Fam Physician 2007; 75(7):1027-1030.
Abstract: Peppermint leaf and peppermint oil have a long history of use for digestive disorders. Recent evidence suggests that enteric-coated peppermint oil may be effective in relieving some of the symptoms of irritable bowel syndrome. A combination product including peppermint oil and caraway oil seems to be moderately effective in the treatment of non-ulcer dyspepsia. Topical application of peppermint oil may be effective in the treatment of tension headache. Because of its relaxing effects on smooth muscle, peppermint oil given via enema has been modestly effective for relief of colonic spasm in patients undergoing barium enemas. Peppermint oil is wel tolerated at the commonly recommended dosage, but it may cause significant adverse effects at higher dosages



Bioorganic & Medicinal Chemistry 14 (2006) 7011–7022 Drug Guru: A computer software program for drug design using medicinal chemistry rules Kent D. Stewart,a,* Melisa Shirodaa and Craig A. Jamesb aAbbott Laboratories, Global Pharmaceuticals Research and Development, Abbott Park, IL 60064, USA bMoonview Consulting, LLC, San Diego, CA, USA Received 27 April 2006; revised 6 June 2006; accepted 8 June 2006

Comparative safety and efficacy of glibenclamide in the elderly

EML Section 18.5 – Insulin and other medicines used for diabetes Comparative Safety and Efficacy of Glibenclamide in the Elderly Should elderly patients with type 2 diabetes be treated with glibenclamide (glyburide) or different HARINDER CHAHAL For WHO Secretariat Table of Contents List of Tables