GlaxoSmithKline Consumer Healthcare Research Articles

Comparative Analysis of Antimicrobial Properties and Physical Properties of Mineral Trioxide Aggregate Mixed With Distilled Water, Chlorhexidine, and Sodium Hypochlorite Solutions: An In Vitro Study.

Endodontics widely uses mineral trioxide aggregate (MTA) because of its excellent sealing ability, biocompatibility, and capacity to promote healing. However, the effectiveness of MTA can vary depending on the blending solution used. Endodontics commonly employ chlorhexidine (CHX) and sodium hypochlorite (NaOCl), but their impact on MTA's properties necessitates further investigation. We blended MTA with the specified solutions and prepared it for testing according to the manufacturer's instructions. The study was divided into four groups: group 1 involved MTA blended with distilled water, group 2 consisted of MTA blended with 0.12% CHX solution (PerioGard, Colgate-Palmolive, Osasco, Brazil), group 3 included MTA blended with 0.2% CHX solution (Corsodyl, GlaxoSmithKline Consumer Healthcare, England, UK), and group 4 comprised MTA blended with 5% NaOCl(Azure Research Lab Pvt. Ltd., New Delhi, India). The antimicrobial activity of each group was assessed using the agar diffusion method againstEnterococcus faecalis,Candida albicans, andStreptococcus mutans. We measured the compressive strength at 1, 3, 7, and 21 days using an Instron universal testing machine (Hounsfield Test Equipment, Redhill, UK). Statistical significance was evaluated through one-way ANOVA and Kruskal-Wallis tests, with p values <0.05 considered significant. Group 3 (MTA blended with 0.2% CHX) exhibited the highest antimicrobial efficacy, with significantly larger inhibition zones againstEnterococcus faecalis(25.25 ± 0.21 mm vs. 13.33 ± 0.12 mm, p = 0.011),Candida albicans(29.58 ± 0.24 mm vs. 16.97 ± 0.16 mm, p = 0.004), andS. mutans(26.37 ± 0.15 mm vs. 14.55 ± 0.25 mm, p = 0.027). Group 4 (MTA blended with 5% NaOCl) showed the highest compressive strength at one and threedays (p = 0.032 and p = 0.021, respectively), but by 21 days, group 2 demonstrated the greatest compressive strength (p = 0.044). MTA mixed with 0.2% CHX provides superior antimicrobial properties, making it suitable for enhanced microbial control in endodontic treatments. Conversely, MTA mixed with 0.12% CHX offers optimal long-term compressive strength. These findings guide selecting MTA formulations to maximize performance based on clinical needs.

GI multisociety strategic plan on environmental sustainability.

GI multisociety strategic plan on environmental sustainability.

Merger and Acquisition - Income Tax Perspective

In ever-growing economies, in case of business entities, the acquisition, consolidation or merger options are impeccable to endure and, relevant in the market. Globalization coupled with faster to be developments in technology are further challenging to both, the centuries-old businesses and the new entities alike. The term Merger and Acquisition (hereinafter 'M&A') is a broader one and includes other forms also, to say, amalgamation, acquisition via business purchase, share purchase, slump sale and itemized sale, combination, capital restructure via buyback and capital reduction, reverse merger and demerger. History has recorded seven-periods as 'Merger Waves' 1 caused by the aforesaid reasons. The first six-merger wave occurred between 1897 and 2007 and seventh wave from 2011 onwards. In India's context, the first major M&A attempt was witnessed during 1983 when Sri. Swaraj Paul, a London-based industrialist's bid to take management control of two Indian entities, viz., Escorts Limited and Delhi Cloth Mills Limited followed by India Cements attempt on Raasi Cements Limited during 1998. Recent past successful attempts can be listed as Vodafone Group Plc.'s business transfer deal with Hutchinson in 2007, Emami Limited's acquisition of Zandu Pharmaceutical Works Limited in 2008, Vedanta Resources Plc.'s acquisition of the stake in Cairn India in 2011, Walmart Inc.'s acquisition of the stake in Flipkart Private Limited and Idea Cellular's merger with Vodafone India, Hindustan Unilever Limited's all-stock acquisition of Glaxosmithkline Consumer Healthcare Limited during 2018 and the latest one by Larsen and Toubro's acquisition of the stake in Mindtree Limited during March 2019. Meanwhile, sensing the hostile bidding attempts and to regulate 'M&A Regime', the Indian Government has brought in a number of legislations with suitable amendments as and when its found necessary, such as Industrial Development and Regulation Act, 1951, Monopolistic and Restrictive Trade Practice Act, 1969, Foreign Exchange Regulation Act, 1973 (now replaced with Foreign Exchange Management Act, 1999), Companies Act, 2013, SEBI (Listing Obligation & Disclosure Requirements), 2015, SEBI (Substantial Acquisition of Shares and Takeovers) Regulations, 2011, Income-tax Act, 1961, Delisting Regulations 2009, Indian Accounting Standards or Ind-AS, Competition Act, 2002, recently introduced Insolvency and Bankruptcy Code, 2016, GST Laws and proposed changes in Foreign Direct Investment to regulate e-commerce sector. The present article predominantly deals with income-tax law perspective.

Brand Horlicks in India: an epitome or an epitaph?

PurposeThis paper aims to focus on the insights from the brand journey of Horlicks in India and evolution of the health food drinks (HFD) category.Design/methodology/approachThe paper explores the key reasons for the slowdown in the HFD category and the descent of brand Horlicks in India. It follows the strategic decisions and actions that Horlicks’ parent GlaxoSmithKline Consumer Healthcare took over its journey of close to 100 years. It also highlights the cardinal mistakes that it made in distribution networks, brand extensions, etc. and how these could have possibly eroded the brand equity of Horlicks.FindingsHorlicks as a brand made many strategic errors. It frequently and needlessly fiddled with unrelated categories in contrast to its nutrition agenda. It unnecessarily spent on developing brand extensions in unhealthy categories that customers did not value or relate to. It was strategically blinded by the dominance in two geographies and continued to be under-invested in distribution networks in others. In addition, it took too long to read the writing on the wall in terms of growing consumer consciousness about the presence of sugar and fats in health foods. Even when clear signals were available of the impending slowdown the HFD category faced, despite being the market leader in the HFD segment, it showed limited urgency to foster an innovation to bolster the category.Practical implicationsCompanies need to focus on a sharp business model and not try to be everything for everyone. Companies that gain valuable insight of what its customers value and design their business model to satisfy these requirements have higher chances of surviving through the weft and warp of time.Originality/valueThe paper considers the context of the highly dynamic fast-moving consumer goods (FMCG) industry in India. It is an industry where for some of the categories like HFD, the brand equity of the mother brand may or may not have a rub-off effect on brand extensions, or dominance in a particular geography may not translate to similar dominance in another geography owing to heterogeneity factor. In such a scenario, brands such as Horlicks, which do not have a consistent and coherent strategy, find it difficult to grow their market share or the category. It provides insights into the common pitfalls in brand development strategy and how it can be avoided.

Effects of a Novel Formulation on Oral Biofilm, pH Buffering, and Gingival Health in Patients with Dry Mouth.

Goal To identify in patients with dry mouth the effects of a novel test agent (Oral Essentials Hydrating Formula Mouthwash, Beverly Hills, CA) versus a control agent (Biotène Dry Mouth Oral Rinse, GlaxoSmithKline Consumer Healthcare L.P., Moon Township, PA, USA) versus no treatment on dry mouth, plaque, salivary pH and buffering capacity, gingival health, and tooth sensitivity. Materials and Methods In this cross-over study, ten subjects with dry mouth used test and control dry mouth interventions, as well as no dry mouth intervention in randomized sequence. Plaque Index, Gingival Index, Sulcus Bleeding Index, Plaque staining, and photographs were recorded at baseline and end of each study arm. Salivary volume, pH, and buffering capacity were also recorded at these time points. Additionally, subjects completed a questionnaire for dry mouth and dentinal sensitivity at each visit. Results Reductions in plaque presence and clinical indices were similar after use of test or control products (p < 0.05). Saliva volume and pH buffering improved significantly after use of test and control products (p < 0.05). Conclusions The effects of a novel dry mouth intervention are similar to those of an existing OTC remedy and are significantly better than no intervention.

Efficacy and safety of guaifenesin for upper back, neck, and shoulder pain: a Phase II proof-of-concept, multicenter, placebo-controlled, repeat-dose, parallel-group study.

Background/objectiveGuaifenesin, an over-the-counter (OTC) expectorant, has exhibited muscle relaxant effects preclinically and clinically. This proof-of-principle study explored whether OTC doses of guaifenesin can provide relief from acute upper back, neck, or shoulder muscle spasm and pain.MethodsThis multicenter, placebo-controlled, repeat-dose, parallel study randomly assigned adults experiencing acute pain and muscle spasm in their upper back, neck, or shoulder to guaifenesin 600 or 1200 mg or matched placebo twice daily (BID) in a 2:2:1:1 ratio for 7 days. The primary end point was the change from baseline in muscle spasm relief, measured using an 11-point numeric rating scale (0=not present to 10=unbearable) recorded twice daily and averaged over the 7-day treatment period. Analyses were performed using a linear mixed model that included treatment as a fixed effect and site as a random effect.ResultsA total of 77 subjects were included in the 4 treatment groups. Least squares mean muscle spasm score over 7 days was 1.77 with guaifenesin 1200 mg, 1.42 with its matched placebo, 1.53 with guaifenesin 600 mg, and 1.74 with its matched placebo. Treatment with guaifenesin 1200 mg BID provided 25% greater reduction in mean muscle spasm over its matched placebo and 16% greater reduction than guaifenesin 600 mg BID. These differences were not statistically significant. Based on comparisons of absolute mean values, a consistent directional change in effect was observed, suggesting some benefit from placebo to lower-to-upper doses of guaifenesin with regard to muscle spasm, tension, pain, discomfort, and relaxation. No severe or serious adverse events were reported.ConclusionResults suggest the potential for OTC dose of guaifenesin 1200 mg BID to provide symptomatic relief of upper back musculoskeletal pain and spasm. Confirmation of this preliminary result in a larger, adequately powered study is needed.

Персонифицированное назначение десенситайзеров пациентам с учетом индивидуального стоматологического статуса

The purpose of the present research was studying of clinical efficiency of tоothpastes with desensitive properties. Research has been spent on a contingent of people from 48 persons at the age from 25 till 45 years with generalized catarrhal gingivitis and generalized parodontitis of the easy form with complaints on hyperesthesia teeth. The patients were selected who have at least 20 natural teeth with saved by the crown and doesn’t exposed to industrial hazards and without severe concomitant pathology. The 1st group 1 (17 persons) used the toothpaste «Sensodyne instant effect» (GlaxoSmithKline Consumer Healthcare, United Kingdom); the 2nd group (15 persons) used the toothpaste «Sensodyne F» (GlaxoSmithKline Consumer Healthcare, United Kingdom); the 3 group (16 patients) - toothpaste «Sensodyne Total Care» (GlaxoSmithKline Consumer Healthcare, UK). According to the authors’ data, all desensitive toothpastes «Sensodyne» (GlaxoSmithKline Consumer Healthcare, United Kingdom) have the effect of eliminating high sensitivity and comply with the declared parameters. However, dentists must take into account the targeted properties of hygiene and dental status of patients, all personal hygiene is necessary to select individualized, taking into account all the medical evidence and the properties of feminine hygiene products.

A clinical pharmacokinetic study comparing two azelastine hydrochloride nasal formulations in a single-dose design

Azelastine hydrochloride is a potent second-generation antihistamine, available in Europe and the USA as a nasal spray formulation for the treatment of allergic rhinitis symptoms. GlaxoSmithKline (GSK) Consumer Healthcare has developed a new nasal formulation of azelastine hydrochloride. The present study was aimed at comparing the clinical pharmacokinetic profiles and assessing the bioequivalence of the new formulation of azelastine hydrochloride with a marketed reference nasal spray product. This was a randomized, two-way crossover, two-stage, single-dose pharmacokinetic study with 2 weeks washout between the two treatment periods. A dosage of 0.28 mg of the test and reference products was administered as a single dose to healthy volunteers according to the crossover design. Twenty-three subjects (15 subjects from stage 1 and 8 subjects from stage 2) were enrolled in the study. Adjusted mean values for AUC0-t were 1,526.8 h pg/mL for the test drug and 1,441.5 h pg/mL for the reference drug; for C max the values were 61.59 pg/mL for the test drug and 58.21 pg/mL for the reference drug. The 94.12 % CI of geometric mean ratios (test/reference) were 0.99-1.13 and 0.95-1.18 for AUC0-t and C max. This met the predefined criteria for bioequivalence between test and reference drugs. Secondary pharmacokinetic parameters for azelastine and for the metabolite desmethyl azelastine, AUC(0-∞) and t max, were numerically similar between the two study treatments. Both test and reference azelastine hydrochloride formulations were well tolerated at single dose. This study demonstrated the bioequivalence between the new azelastine hydrochloride nasal spray formulation and the marketed reference Allergodil(®) after single-dose administration.

Partnering With The Industry: The Olympic Laboratory Model

David A Cowan and Campbell P Barker speak to Ryan De Vooght-Johnson at Bioanalysis in May 2012 about the partnership between industry and academia for the setup and running of the doping-control laboratory for the London 2012 Olympic Games. David A Cowan is Director of the London 2012 anti-doping laboratory as well as Director of the King's College London Drug Control Centre, the UK's only WADA-accredited anti-doping laboratory, and Head of the Department of Forensic Science and Drug Monitoring. Cowan co-founded the Drug Control Centre in 1978 and became its Director in 1990. He has published extensively in the field of pharmaceutical analysis, especially as it relates to detecting drug administration in sport, and was awarded a personal chair in pharmaceutical toxicology in 1996. Cowan became Head of the Department of Forensic Science and Drug Monitoring at King's College London in 2002. He has served on a number of national and international committees, including the Council of Europe Working Party Investigating Drug Abuse in Sport that led to the first World Anti-Doping Convention, the Laboratory Representative on the International Olympic Committee's Medical Commission, and WADA's Laboratory Accreditation Subcommittee. He is a member of the Crippen Club for Distinguished Toxicologists. In 1998 he was awarded the IOC Trophy for Sport Ethics by the BOA. He was a founding member of the World Association of Anti-Doping Scientists and became its first President serving on its Executive Board between 2001 and 2004. He was a Visiting Laboratory Director at the Salt Lake City Winter Olympic Games 2002, where the first novel erythropoiesis-stimulating protein (NESP) positive was discovered. He was also a senior advisory scientist at both the Turin Winter Olympic Games in 2006 and the Beijing Olympic Games in 2008. He was also a member of the IOC Medical Commission for the Sydney Olympic Games in 2000 and the Vancouver Winter Olympic Games in 2010. The Drug Control Centre undertook the sample analysis during the 2002 Manchester Commonwealth Games and Cowan was Co-Director of the laboratory for the Commonwealth Games in Kuala Lumpur in 1998. Cowan, who has directed the laboratory at King's College London for many years, was a member of the bid team making the presentation to the International Olympic Committee in February 2005. Campbell P Barker has been leading GlaxoSmithKline's delivery of the London 2012 laboratory services since September 2009. Prior to that time he was Director of Global Strategic Projects in GlaxoSmithKline's Consumer Healthcare business from 2006, and from 1994 to 2006 he worked in R&D for Procter & Gamble. Barker holds a PhD in chemistry from the University of Durham.

A Clinical Study to Evaluate Denture Adhesive Use in Well‐Fitting Dentures

The objective of this study was the assessment of retention and stability and functional benefits of denture adhesive applied to well-fitting and well-made dentures. This was a randomized, crossover study to compare two marketed denture adhesives (test cream, Super Poligrip® Free, and test strip, Super Poligrip® Comfort Seal Strips) and an unmarketed cream adhesive (GlaxoSmith Kline Consumer Healthcare) with no adhesive as the negative control. Thirty-six subjects completed the study. One hour after the application of denture adhesive, retention and stability were measured using the Kapur Index and maxillary incisal bite force. Two hours after application, functional tests were used to assess denture movement and peanut particle migration under the denture. Subjects also rated confidence, comfort, satisfaction with dentures, and denture wobble in conjunction with the functional tests. Denture adhesives significantly (p < 0.05) improved retention and stability of well-fitting dentures. Subjects experienced significantly (p < 0.05) fewer dislodgements while eating an apple after adhesive was applied to dentures. Significant (p < 0.05) increases in subjective ratings of confidence and comfort as well as decreases in denture wobble were associated with the use of adhesive. There was significant (p < 0.05) improvement in satisfaction ratings for cream adhesives. A single application of each denture adhesive was well tolerated. The results of this study provide evidence that use of Super Poligrip® denture adhesives can enhance aspects of performance of complete well-fitting dentures as well as provide increased comfort, confidence, and satisfaction with dentures.

Commentary on Fidler et al. (2011): Identifying quitters who are at increased risk of relapse – where to from here?

In this issue, Fidler and colleagues compare the ability of two standard measures of dependence and a measure of urges to smoke during a normal smoking day, for their ability to predict successful cessation 1. Perhaps surprisingly, the authors report that the single-item measure of urge was the strongest predictor of short-term abstinence. With this finding, Fidler and colleagues have added to the list of indicators of relapse risk; a list that includes measures of nicotine dependence 2 and responsiveness to smoking-related cues (i.e. cue–reactivity 3), among others. Such measures are potentially clinically relevant: if health-care professionals are able to identify interested quitters who are going to have difficulty maintaining abstinence then they can successfully triage the smokers whom they see, focusing their efforts on the smokers who are most likely to have the greatest difficulty quitting. In health-care systems with limited resources—and we know of no other kind—the ability to focus resources on smokers in the most need is likely to be beneficial. The obvious next question, however, remains: once identified, how do we help these particularly vulnerable smokers to maximize their chances of success? Sadly, despite years of research into cessation treatments, we have made precious little progress on this front—relapse rates for first-line treatments remain unacceptability high 4. Without substantial improvements in the available treatment options there is limited practical use in our ability to identify those smokers who are at greater risk of failure. The finding that craving intensity experienced during ad libitum smoking predicts relapse risk concurs with previous findings that craving intensity experienced during a quit attempt predicts relapse risk 5-7. It is puzzling, however—in terms of our understanding of the underlying drivers of relapse—that treatments successful at attenuating craving are not more successful at helping smokers to quit. For example, we have reported that nicotine patches suppress background craving (along with many commonly reported withdrawal symptoms) experienced during a quit attempt, but that this effect does not account for the efficacy of patches 5. This discrepancy suggests that urge itself may not be a direct measure of relapse risk. It is possible, however, that self-reported urge is a marker for more proximal factors that relate to relapse risk. Fidler et al.'s measure of craving asked smokers to summarize craving retrospectively over a 24-hour period. While, on the face of it, this would seem to refer to ‘average’ craving over that time, it is likely that such recall in fact gives much greater weight to moments of intensive or ‘peak’ craving 8. This would probably reflect smokers' response to smoking cues, or susceptibility to cue-induced cravings, which we know are important in relapse 9, 10, and are not treated adequately with current regimes 9, 11. Gaining a better understanding of the nature of craving and response to smoking cues may suggest new, and hopefully more effective, treatment strategies. In conclusion, Fidler and colleagues' work provides evidence that a simple one-item measure of urge intensity can be used to successfully predict relapse risk, and suggests the need to explore further the dynamics of craving during ad libitum smoking. The development of effective treatments is necessary so that we can better assist interested quitters who are at a high risk of failure. Through their work at Pinney Associates, Drs Ferguson and Shiffman serve as consultants to GlaxoSmithKline Consumer Healthcare on an exclusive basis on matters relating to smoking cessation. Dr Shiffman also has an interest in a venture to develop a new nicotine replacement medication. Dr Bruno has nothing to disclose.

Evidence-based guidelines for the care and maintenance of complete dentures: A publication of the American College of Prosthodontists

The current rates of edentulism have been estimated to be between 7 percent and 69 percent of the adult population internationally. In the United States, while the incidence of edentulism continues to decline, rapid population growth coupled with current economic conditions suggest that edentulism and conventional denture use will continue at current or higher numbers. Unfortunately, evidence-based guidelines for the care and maintenance of removable complete denture prostheses do not exist. In 2009, the American College of Prosthodontists (ACP) formed a task force to establish evidence-based guidelines for the care and maintenance of complete dentures. The task force comprised members of the ACP, the Academy of General Dentistry, the American Dental Association Council on Scientific Affairs, the American Dental Hygienists' Association, the National Association of Dental Laboratories and GlaxoSmithKline Consumer Healthcare. The review process included the assessment of over 300 abstracts and selection of over 100 articles meeting the inclusion criteria of this review. The task force reviewed synopses of the literature and formulated 15 evidence-based guidelines for denture care and maintenance. These guidelines were reviewed by clinical experts from the participating organizations and are being published in The Journal of the American Dental Association for widespread distribution to the dental community. These guidelines reflect the views of the task force.

Evidence‐Based Guidelines for the Care and Maintenance of Complete Dentures: A Publication of the American College of Prosthodontists

The current rates of edentulism have been estimated to be between 7% and 69% of the adult population internationally. In the United States, while the incidence of edentulism continues to decline, rapid population growth coupled with current economic conditions suggest that edentulism and conventional denture use will continue at current or higher numbers. Unfortunately, evidence-based guidelines for the care and maintenance of removable complete denture prostheses do not exist. In 2009, the American College of Prosthodontists (ACP) formed a task force to establish evidence-based guidelines for the care and maintenance of complete dentures. The task force comprised members of the ACP, the Academy of General Dentistry, American Dental Association (ADA) Council on Scientific Affairs, the American Dental Hygienists' Association, the National Association of Dental Laboratories, and representatives from GlaxoSmithKline Consumer Healthcare. The review process included the assessment of over 300 abstracts and selection of over 100 articles meeting inclusion criteria of this review. The task force reviewed synopses of the literature and formulated 15 evidence-based guidelines for denture care and maintenance. These guidelines were reviewed by clinical experts from the participating organizations and were published in February 2011 issue of The Journal of the American Dental Association for widespread distribution to the dental community. These guidelines reflect the views of the task force.

Over-the-counter weight loss with orlistat?

Orlistat first became available (as 120mg capsules [Xenical]) around 10 years ago as a prescription-only treatment for obesity.1 Earlier this year, orlistat 60mg capsules (alli – GlaxoSmithKline Consumer Healthcare) became...

Guidelines for the management of paracetamol poisoning in Australia and New Zealand — explanation and elaboration

Paracetamol is involved in a large proportion of accidental paediatric exposures and deliberate self-poisoning cases, although subsequent hepatic failure and death are both uncommon outcomes. The optimal management of most patients with paracetamol overdose is usually straightforward. However, several differing nomograms and varying recommendations regarding potential risk factors for hepatic injury introduce complexity. In order to reconcile management advice with current Australasian clinical toxicology practice, revised guidelines have been developed by a panel of clinical toxicologists consulting to the poisons information centres in Australia and New Zealand using a workshop and consultative process. This article summarises the rationale for the recommendations made in these new guidelines.

Correction of exercise‐induced sweat calcium loss in pre‐menopausal women

Exercise-induced sweat calcium losses have been reported as substantial in male athletes. The aim of this study was to determine exercise-induced calcium sweat loss and to determine the effectiveness of calcium supplements to reverse any losses in physically active women. Twenty-six pre-menopausal sportswomen completed three 9-day intervention phases in a randomized-order, crossover design. The three intervention phases were placebo + no exercise (P+NEx), placebo + exercise (P+Ex), and 400 mg Ca as Ca Carbonate (TUMS Ultra®) twice daily + Ex. The supervised exercise was 1 hr cycling at 65%VO2 heart rate reserve which was determined by a VO2 sub-max cycle ergometer test. A controlled diet of approximately 400 mg Ca/day and 24 hour pooled urine and fecal collections allowed determination of calcium balance on days 5–8 of each phase. Twenty-four hour sweat collections were made at the end of each phase using a whole body washdown procedure. Exercise significantly (P<0.05) increased calcium losses in sweat (P+Ex, 93 +/-51 vs. P+NEx 79+/-31) which was no longer significant (P=0.14)when Ca supplementation was provided (84+51 mg/d). Significantly (P<0.01) higher urinary Ca excretion during calcium supplementation is suggestive of higher Ca absorption. Exercise had no effect on urinary Ca excretion indicating lack of compensation for sweat losses. Calcium intake should be increased by more than 70 mg/d to offset sweat losses during each single hour of moderate exercise. Funded by GlaxoSmithKline Consumer Health Care.

Variation in bupropion findings is not due to differences in measurement: comment on Teneggi et al.

I read with interest the paper by Teneggi et al. (2005) on the effects of bupropion (BP) on tobacco craving and withdrawal. As the authors note, the design of their study was nearly identical to a study conducted by my group, assessing two doses of BP (Shiffman et al. 2000), but yielding different findings. Specifically, Teneggi et al. found BP effects on craving, but we did not. Teneggi et al. suggest that the absence of BP effects on craving in our study might be attributable to unreliability in our measurement of craving. However, this explanation is contradicted by data. The six-item craving scale used in our study demonstrated high reliability of 0.95 (Cronbach’s α), which compares favorably with the reliability of the brief questionnaire of smoking urges (Cox et al. 2001) used by Teneggi et al. Moreover, our study assessed craving five times per day (in contrast to the three times a day by Teneggi et al.), which would further enhance the reliability of the measurement. Finally, the craving assessment in our study was able to reliably detect significant increases in craving as deprivation time increased on the first day of abstinence—much as seen by Teneggi et al. (Figs. 2 and 3 in Teneggi et al. 2005)—validating and verifying the sensitivity of the assessment. Teneggi et al. also wondered whether our use of repeatedmeasures ANOVA to contrast smoking and nonsmoking craving ratings could have degraded reliability through its reliance on difference scores. (See Sayette et al. 2000 and Shiffman et al. 2004 for discussion of analytic approaches.) However, a reanalysis of craving data without difference scores, either using covariance analysis or contrasting 300 mg BP and placebo without adjusting for ratings during smoking, yields the same null result. Thus, it appears that both studies used reliable assessments and analyses of craving, making the explanation by Teneggi et al. of the differences as due to measurement or statistical properties highly unlikely. This is important because it suggests the need to look for other potential sources of differences. As Teneggi et al. suggest, differences in populations, assessments, and other methodological factors may influence craving responses. Particularly, as Teneggi et al. suggest these laboratory methods as models for assessing drug effects, it is important to consider a range of differences—including some in often-ignored factors—that might influence craving responses. Recent work by Sayette (Wertz and Sayette 2001; Sayette et al. 2003) and by Tiffany (Carter and Tiffany 2001) suggests that smokers’ expectations of being able to smoke may influence craving intensity. Although both experimental designs called for fixed periods of abstinence, it is possible that subtle variations in instructions or expectancies could yield differences in craving. Craving is also highly responsive to environmental cues (Carter and Tiffany 1999). It’s been suggested that craving is minimized when smokers are studied in “sterile” environments devoid of smoking cues (Hatsukami et al. 1984), which appears to characterize the study environments in both studies. However, again, subtle, unintended, and undocumented differences in the research environments could account for differences in findings. Attribution of differences in the findings of the different studies to different psychometric qualities of measures is not supported by the data and may obscure a search for other sources of variability, which might be productive in helping to develop robust paradigms for laboratory assessment of craving. The author provides consulting services regarding smoking and cessation exclusively to GlaxoSmithKline Consumer Healthcare, and has an interest in a new smoking cessation product.

P41 Tongue cleaning habits in Italians: results of a survey in a sample population

Background and objectives Mechanical cleaning of the tongue is suggested as an effective method for reducing cultivable flora of the tongue and teeth and decreasing oral malodor. The aim of this study was to evaluate the general attitude, knowledge and behaviour of a representative sample of Italian population regarding the hygienic tongue procedures.Methods The survey has been conducted in January and February 2003 through structured phone interviews using CATI (computer aided telephone interviews) methods by EuriskoOmnibus, a specialized agency, on commission by GlaxoSmithKline Consumer Healthcare S.p.A.‐Italy. The sample has been randomly chosen among urban and rural residents from age 15 onwards with a nationwide distribution in proportion to the last demoskopic feature of general Italian population. Relevant data has been processed with MSExcel and StatView software in an Apple G4 Powerbook PC.Results The sample is composed by 2000 individuals, 52% females and 48% males. Of these, 6% have an academic degree, 23% high school and 71% lower middle school Over one‐third (39%) of Italians interviewed declared to perform specifically tongue cleaning: 40% of them every time they perform oral hygiene twofold or more daily, 24% once a day and 36% less than daily; the tongue cleaning habits are more diffuse in younger people. Seventy‐one per cent of tongue cleaners perform the procedure with an ordinary toothbrush, 22% declared to clean tongue with an oral rinse and only 4% utilize specific tongue instruments. In our sample main reasons for tongue cleaning practices were reaching a better oral hygiene (60%) and fighting bad breath (25%).Conclusions In Italians tongue cleaning is more diffuse than expected but the reasons are not principally related to the reduction of halitosis.

GlaxoSmithKline Consumer Healthcare on the Path to World-Class Product Safety Surveillance

Pharmacovigilance is facing expanding challenges from both the pharmaceutical business and the regulatory agencies, which impact all global pharmaceutical organisations. In the consumer healthcare setting, world-wide sales, regulatory expectations and public awareness of product issues are all increasing. The challenge of maintaining both high-quality adverse event reporting and regulatory compliance in the face of capacity constraints and the evolving safety environment is real. In this context, the pharmacovigilance organisation of GlaxoSmithKline (GSK) Consumer Healthcare redesigned their global processes to world-class standards and implemented industry best practices in order to achieve substantial growth in productivity while maintaining regulatory and corporate compliance. In a year-long initiative, GSK Consumer Healthcare Product Safety has achieved a 70% reduction in adverse event handling process complexity and a 30% increase in productivity; global organisational and process consistency have also significantly improved. GSK Consumer Healthcare Product Safety has also implemented a managerial decision-making system that generates a wide range of rigorous key performance measures. This system allows management to stay continually informed of the global safety operation and initiate proactive, specific improvements or corrective actions based on reliable and up-to-date data. With all these initiatives, GSK Consumer Healthcare Product Safety has placed itself among the best organisations in the industry and on the clear path of continuous improvement.

GlaxoSmithKline Consumer Healthcare on the Path to World-Class Product Safety Surveillance

GlaxoSmithKline Consumer Healthcare on the Path to World-Class Product Safety Surveillance