These drugs are well-tolerated with few side effects reported. The ideal use of the OTC H2RAs is to administer the dose 1 h to 2 h before episodic and/or predictable occurrences of heartburn, such as before meals.
Alginate-based products (Gaviscon, GlaxoSmithKline, USA) are approved for heartburn relief only. Both in vitro and in vivo studies have shown that these agents produce their benefit by forming a ‘raft’ or foamy physical barrier that may prevent gastroesophageal reflux. Continue reading
In all instances when OTC medications do not provide adequate symptom relief for the patient, or symptoms occur frequently, patients should be advised to consult their family practitioner for further discussion and assessment of dyspepsia symptoms.
1. For infrequent or unpredictable episodes of dyspepsia, OTC medication can provide relief. Continue reading
Several epidemiological studies have shown that a high percentage of people with dyspepsia have tried OTC products as an initial step in management of their symptoms. OTC drugs include antacids, alginate-based products, H2RAs, bismuth products and herbal products. Published studies of these agents include few randomly assigned controlled trials and relate to a broad spectrum of patient populations, primarily functional dyspepsia or heartburn-predominant dyspepsia patient populations. Continue reading
On presentation her blood pressure was 106/70 mmHg with no postural drop. Her heart rate was 90 beats/min and she was afebrile. She weighed 46.7 kg and was 162 cm tall. She appeared ill and volume depleted. There was no lymphadenopathy or rashes. Cardiovascular examination revealed a II/VI systolic ejection murmur and jugular venous pressure was at the sternal angle. The respiratory examination was normal. Her abdominal examination showed no signs of peritonism but she had significant tenderness in the left lower quadrant and suprapubic region. Bowel sounds were present. Continue reading
The Leicester group randomly assigned 121 patients with suspected ABP to receive either conservative therapy or ERCP within 72 h of admission. Patients who were found to have choledocholithiasis then underwent ES and stone extraction. The severity of pancreatitis was graded according to a modification of the Glasgow criteria. Of the 121 patients, 59 (25 of whom had severe pancreatitis) underwent ERCP and 62 (including 28 with severe pancreatitis) received conventional treatment. Continue reading
Probiotics have the potential to improve human health, and to prevent and treat a wide variety of diseases. Results from human clinical trials and scientific studies have confirmed the preventive and therapeutic effects of selected strains of microbes in viral and bacterial intestinal infections, and in positively influencing immunological parameters. However, several of these documented results need more rigorous research to be confirmed. Furthermore, it must be remembered that not all Lactobacillus or Bifidobacterium species are equal, and not all over-the-counter products contain the bacterial species listed on the label or, indeed, any viable bacteria at all. Thus, until major improvements occur in the regulation of labelling and quality assurance procedures for probiotic compounds, it is difficult to recommend which products to purchase. In addition, more adequately designed and properly executed clinical trials are necessary to carefully explore and characterize the therapeutic applications of probiotics.
Oral administration of probiotic compounds has been demonstrated to be well tolerated and proven to be safe in 143 human clinical trials occurring between 1961 and 1999. No adverse effects or events were reported in any of the 7526 subjects participating in these trials. However, rare cases of local or systemic infections, including septicemia and endocarditis due to Lactobacillus, have been reported. These infections have occurred in immunocompromised patients with aplasia, organ transplantation and human immunodeficiency virus infection. In most of these cases, the source of the infection was the commensal Lactobacillus flora, rather than an ingested bacteria supplement, suggesting that these bacteria can act as opportunistic pathogens. With regard to Saccharomyces infections, there have been few reports of fungemia due to Saccharomyces species, again, usually in immunocompromised patients receiving high enteral doses of Ultra-Levure (Biocodex, Montrouge, France) containing S boulardii (1.5 g/day). Although rare, these reports suggest that caution and further studies are necessary to assess the safety of probiotic bacteria for immunodeficient hosts.
The probiotic approach to the treatment of gastrointestinal disease remains controversial and will remain so until the mechanisms through which probiotic bacterial strains antagonize pathogenic organisms or exert other beneficial effects in the host are fully understood through well-planned scientific study. Furthermore, there are significant differences between probiotic bacterial genera and species. It is crucial that each strain be tested on its own or in products designed for a specific function. Much research is directed toward understanding the mechanisms of action of oral probiotics. The main areas being examined are receptor competition, whereby probiotics compete with microbial pathogens for a limited number of receptors present on the surface epithelium; probiotic release of antimicrobial compounds; probiotic-induced increased levels of mucin secretion, which acts to block pathogen binding to epithelial receptors; probiotic bacterial ‘priming’ of gut-associated lymphoid tissue; and immunomodulation of gut-associated lymphoid and epithelial tissue response. Probiotics are able to enhance the activity of the intestinal immune system through the stimulation of macrophage and natural killer cells, the proliferation of lymphocytes and the increase of secretory immunoglobulin A production, although the specificity of the secretory immunoglobulin A production was unknown. Selected strains of probiotics are able to alter mucosal and systemic immune function at many levels, including stimulating mucosal production of interleukin-10 and producing systemic T helper 2 reponses. However, it remains to be proven which, if any, of these mechanisms have a clinical benefit or how they alter the pathophysiology of gastrointestinal diseases. With regard to the pathophysiology of inflammatory bowel disease, one of the most widely accepted theories is that the inflammation results from a dysregulation of the immune system to normal gut flora. Thus, common probiotic species may contribute to chronic inflammation. However, in several animal models, not all gut microflora cause the same degree of inflammation. Indeed, there are several reports demonstrating that probiotic species tend to down-regulate pro-inflammatory cytokine release rather than stimulate secretion. Thus, while it is possible that some probiotic strains may contribute to chronic inflammation, some of the strains may actively suppress inflammation.
While the above studies validate the clinical efficacy of the VSL#3 compound in maintenance therapy of some inflammatory bowel diseases, previous human trials of other probiotic compounds have produced less convincing results. For example, while Rembacken et al demonstrated that a nonpathogenic strain of Escherichia coli (serotype 06:D5:H1), two capsules twice daily (2.5×1010 viable bacteria per capsule), was as effective as mesalazine (1.4 to 2.4 g/day) in maintaining remission in patients with ulcerative colitis, this study had several flaws. The patient group was heterogeneous with regard to the severity of the illness (mild to severe), and patients were treated with several different corticosteroid formulations as well as the study medication. Also, the doses of mesalazine used were relatively low, and only a very small number of patients remained in remission at the end of the study.
Inflammatory bowel disease: Very recent reports have suggested that probiotics may be beneficial in the maintenance of remission of ulcerative colitis and pouchitis. In a preliminary study, 15 patients with ulcerative colitis who were intolerant to or allergic to 5-acetylsalicylic acid were treated with a new probiotic preparation (VSL#3 [VSL Pharmaceuticals, United States]) using a combination of three species of Bifidobacterium (B longum, Bifidobacterium breve and B infantis), four strains of Lactobacillus species (Lactobacillus casei, L plantarum, L acidophilus and Lactobacillus delbruekii subsp bulgaricus) and one strain of Streptococcus (Streptococcus salivarius subsp thermophilus) (5X1011 cells/g/day). In this study, 75% (12 of 15) of patients remained in remission after 12 months of treatment. This clinical response was associated with a significant increase in the fecal concentration of Lactobacillus species, Bifidobacterium species and S thermophilus from day 15 of treatment. This preparation has two main innovative characteristics compared with other probiotic compounds — a very high bacterial concentration and the presence of a mixture of different bacterial species that has the potential to have synergistic associations. Further to these studies, a double-blind, randomized trial was carried out to investigate the efficacy of the VSL#3 preparation in the maintenance treatment of chronic, relapsing pouchitis. Forty patients were randomly assigned to receive VSL#3 (6 g/day) or placebo for nine months. All patients had chronic pouchitis (defined as a history of the need for continuing medical suppressive therapy and recurrence within a few weeks of discontinuing suppression) and were in remission (Pouchitis Disease Activity Index [PDAI] score of zero after open induction of remission therapy with antibiotics). Relapse was defined as an increase of two or more points in the clinical portion of PDAI. Clinical assessment and stool culture were done monthly, while endoscopic and histological assessment were done every two months. At the end of the study period, 17 of the 20 patients treated with VSL#3 remained in remission compared with zero of 20 in the placebo arm. Fecal concentration of Lactobacillus, Bifidobacterium and S thermophilus increased only in the VSL#3 group and remained stable for the entire nine months of treatment. One month after stopping probiotic treatment, fecal concentrations of these bacterial species returned to baseline. Within four months of removing active therapy, 100% of the responding patients had relapsed. No toxicity or adverse effects of this treatment were observed. Whether all of these bacterial species are necessary for the VSL#3 effects is unknown and remains to be shown. Indeed, a small study examining the ability of Lactobacillus GG alone, albeit combined with FOS, to treat refractory pouchitis showed efficacy in reversing macroscopic endoscopic alterations.