The PAC-QOL is a brief but comprehensive assessment of the burden of constipation on patients' everyday functioning and well-being. Multinational studies demonstrate that the PAC-QOL is internally consistent, reproducible, valid, and responsive to improvements over time.

SUMMARY BackgroundHealth-related quality of life (HRQoL) has been rarely evaluated as a primary endpoint in the assessment of the effect of probiotics on the irritable bowel syndrome (IBS).

The added value for assessing the health-related quality of life (HRQOL) in chronic conditions is now well documented for evaluation of treatment eflectiveness in clinical trials and as a criterion for licensing new medications and in policy decisions. However; European standards still need to be developed for the measurement and reporting of HRQOL in clinical trials. This is one of the objectives of the European Regulatory Issues on Quality of Life Assessment (ERIQA) Working Group. This document reviews the major issues arising from the selection of an HRQOL instrument; the integration of HRQOL assessment into the research protocol (methodological design, practicalities of HRQOL administration and collection, prevention and handling of missing data); the statistical analysis plan: and the presentation and interpretation of the results. Finally, to gain wider acceptance, whether HRQOL is considered as a primary or secondary endpoint, the scientific principles of clinical trial design should apply to HRQOL.

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In patients with systolic HF, low HQoL is associated with an increased rate of cardiovascular death or hospital admission for HF. Reduction in HR with ivabradine is associated with improved HQoL. The magnitude of HR reduction is related to the extent of improvement in HQoL.

Understanding the effect of herpes zoster and zoster-related pain should inform care to improve health-related quality of life in elderly patients. A 12-month, longitudinal, prospective, multicenter observational study conducted in primary care in France enrolled patients aged ≥ 50 years with acute eruptive herpes zoster. Patient-reported zoster-related pain was assessed by validated questionnaires (Douleur Neuropathique en 4 Questions [DN4], Zoster Brief Pain Inventory [ZBPI], and Neuropathic Pain Symptom Inventory [NPSI]) on days 0 and 15, and at months 1, 3, 6, 9, and 12. Health-related quality of life was assessed by the 12-item short-form health survey (SF-12) and the Hospital Anxiety and Depression scale on day 0 and at months 3, 6, and 12. Of 1358 patients included, 1032 completed follow-up. Mean ± standard deviation age was 67.7 ± 10.7 (range, 50-95) years; 62.2% were women. Most patients (94.1%) were prescribed antiviral drugs. The prevalence of zoster-related pain on day 0 and at months 3, 6, 9, and 12 was 79.6%, 11.6%, 8.5%, 7.4%, and 6.0%, respectively. Patients with persistent pain had lower scores on the physical and mental component summaries of the SF-12 and the ZBPI interference score than those without pain. By logistic regression analysis, main predictive factors on day 0 for postherpetic neuralgia at month 3 were age, male sex, ZBPI interference score, Physical Component Summary score of the SF-12, and neuropathic quality of pain (DN4 score ≥ 4). Despite early diagnosis and treatment with antiviral agents, many patients with herpes zoster experience persistent pain and marked long-term reduction in health-related quality of life.

Diarrhoea is a relatively frequent adverse event, accounting for about 7% of all drug adverse effects. More than 700 drugs have been implicated in causing diarrhoea; those most frequently involved are antimicrobials, laxatives, magnesium-containing antacids, lactose- or sorbitol-containing products, nonsteroidal anti-inflammatory drugs, prostaglandins, colchicine, antineoplastics, antiarrhythmic drugs and cholinergic agents. Certain new drugs are likely to induce diarrhoea because of their pharmacodynamic properties; examples include anthraquinone-related agents, alpha-glucosidase inhibitors, lipase inhibitors and cholinesterase inhibitors. Antimicrobials are responsible for 25% of drug-induced diarrhoea. The disease spectrum of antimicrobial-associated diarrhoea ranges from benign diarrhoea to pseudomembranous colitis. Several pathophysiological mechanisms are involved in drug-induced diarrhoea: osmotic diarrhoea, secretory diarrhoea, shortened transit time, exudative diarrhoea and protein-losing enteropathy, and malabsorption or maldigestion of fat and carbohydrates. Often 2 or more mechanisms are present simultaneously. In clinical practice, 2 major types of diarrhoea are seen: acute diarrhoea, which usually appears during the first few days of treatment, and chronic diarrhoea, lasting more than 3 or 4 weeks and which can appear a long time after the start of drug therapy. Both can be severe and poorly tolerated. In a patient presenting with diarrhoea, the medical history is very important, especially the drug history, as it can suggest a diagnosis of drug-induced diarrhoea and thereby avoid multiple diagnostic tests. The clinical examination should cover severity criteria such as fever, rectal emission of blood and mucus, dehydration and bodyweight loss. Establishing a relationship between drug consumption and diarrhoea or colitis can be difficult when the time elapsed between the start of the drug and the onset of symptoms is long, sometimes up to several months or years.

The ability of probiotics to improve bowel habits or transit time has been shown in healthy populations. Additional data are required to support the use of specific probiotics to improve gastrointestinal (GI) well-being. The present study was designed to investigate the effect of consuming fermented milk (FM) on GI well-being, digestive symptoms and health-related quality of life (HRQoL) amongst women without diagnosed GI disorders. In this double-blind, controlled, parallel-design study, subjects were randomised to ingest daily either 2 £ 125 g FM containing Bifidobacterium lactis DN-173 010 and yoghurt strains or a control non-fermented dairy product for 4 weeks followed by a 4-week wash-out period. GI well-being and digestive symptoms were assessed weekly. HRQoL was measured every 4 weeks. Data were analysed using analysis of covariance and logistic regression, correcting for baseline values on the full analysis set population of 197 women (aged 18 -60 years). The percentage of women reporting an improvement in their GI well-being was significantly (P,0·01) higher in the FM group v. the control group (OR 1·69; 95 % CI 1·17, 2·45). A significantly (P, 0·05) more pronounced decrease in the composite score of digestive symptoms was observed in the FM group when comparing with the control group (least squares mean 2 0·57; 95 % CI 21·12, 20·02). Among HRQoL dimensions, the digestive comfort score was significantly (P, 0·05) improved in the FM group compared with the control group. The present study showed that the daily consumption of a specific FM is able to improve GI well-being and digestive symptoms in adult women without GI disorders. Probiotics: Gastrointestinal tract: Adults: Randomised controlled trialsClinical evidence of the efficacy of some probiotics in the improvement of symptoms in irritable bowel syndrome (IBS) has recently emerged (1 -3) . The variability of the effects reported has highlighted the product and strain specificity, which is supported by the high variability in their properties (anti-inflammatory activity, effect on motility or visceral sensation) (1,2) . However, due to the complexity of the pathophysiology of IBS which remains poorly understood to date, specific research is required to demonstrate these benefits in a more general population with minor digestive complaints. Only a few studies have been focused on the effects of probiotics on gastrointestinal (GI) well-being in a general population. Most of these studies have investigated the effect of probiotics on bowel habits and were conducted in small sample sizes (from thirty to eighty subjects). Improvement of stool frequency and/or volume or weight, and stool consistency has been shown (4 -8) . Unfortunately, only one study (4) has investigated the impact on a specific digestive symptom (i.e. flatulence), showing a positive effect on this parameter; therefore, the real end-benefits of such functional changes for the consumers are open to question. Studies in human subjects have been designed to investigate the effect of a fe...