Women’s Health Update

by Tori Hudson, ND

Research Reviews and News

Probiotics Improve Exacerbations in Cystic Fibrosis

Ten patients (average age 26) with cystic fibrosis, mild to moderate lung disease with chronic infections due to Pseudomonas aeruginosa were recruited for this study. All 10 patients received two tablets per day of a probiotic mixture. One tablet contained 6 × 10⁹ CFU of Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium bifidum, and Streptococcus thermophiles. Nine of the 10 patients received their usual azithromycin before and during the study and then took the probiotic mixture at least 2 hours away from the antibiotics. Every four weeks for 6 months, patients had a history, physical exam, pulmonary function tests, body mass index (BMI) and sputum samples for cultures.

During the 6 months of probiotic treatment, none of the patients had a pulmonary exacerbations and no need for additional antibiotic treatment. Pre-probiotic treatment there were 1.3 ± 1 pulmonary exacerbations. During the probiotic treatment there were no pulmonary exacerbations and 6 months post-probiotic there were 0.6 ± 0.7 exacerbations. This was a significant reduction from the 2 years prior to the study, the 6 months of the study, and for 6 months post study. Despite this improvement, there were no changes in the pulmonary function tests or BMI during and after the study period.

Comment

: There is increasing evidence demonstrating that probiotics can play a role in treating inflammatory bowel disease, irritable bowel syndrome, and other gastrointestinal disorders with altered intestinal microflora. Intestinal inflammation has been shown to be a significant feature of cystic fibrosis as well as reducing that inflammation in cystic fibrosis patients. One other study has researched probiotics for the prevention of pulmonary exacerbations in cystic fibrosis patients (children). Lactobacillus G, 6 ×10⁹ CFU/day was given for 6 months and compared with placebo. In that study as well, there was a significant decrease in pulmonary exacerbations, and even an improvement in FEV1 and BMI. In the current study of adults, these patients have been colonized even longer with Pseudomonas than the study of children, and even under these circumstances, there was a significant reduction in pulmonary exacerbations with the probiotic combination. Even though this is only a small study of 10 individuals, the results are significantly meaningful for patients who struggle with major pulmonary challenges.

Weiss B, Bujanover Y, Yahav Y, et al. Probiotic supplementation affects pulmonary exacerbations in patients with cystic fibrosis: A pilot study. Pediatr Pulmonol. 2010;45:536–540.

Probiotic Lozenge for Reduction of Oral Mucositis in Cancer Patients

This randomized, double-blind, placebo-controlled study was conducted in patients with stage II–IVA head and neck cancer. This study evaluated the effects of Lactobacillus brevis CD2 lozenges on the incidence and severity of oral mucositis in patients receiving chemoradiotherapy to the head and neck area. Patients were randomized to receive either L. brevis CD2 lozenges or placebo lozenges. Each lozenge contained 2 billion CFU and the daily dose was 6 lozenges per day. The treatment was started the first day of chemoradiotherapy and continued until 1 week after their last treatment. Primary endpoints were the incidence of grade II and IV oral mucositis. Secondary endpoints were the incidence of grade I and II oral mucositis as quality of life assessment.

Almost 200 patients completed the study. The severity and incidence of oral mucositis was significantly better in the L. brevis lozenge group compared with the placebo group for more severe mucositis. For grade III or IV mucositis, the incidence was 52% in the probiotic group and 77% in the placebo group, while for grade I and II, the results were similar at 19% vs. 15% but the proportion remaining free of oral mucositis was 28% in the L. brevis group vs. 7% in the placebo group. In addition, more patients in the L. brevis group were able to complete their chemoradiotherapy treatment compared with placebo (92% vs. 70%). Also of meaning was that the number of patients needing analgesics to control their mucositis associated pain was 30% in the L. brevis group vs. 45% in the placebo group. Almost twice as many patients in the placebo arm required narcotic analgesics.

Comment

: Oral mucositis is a common complication of chemotherapy and radiotherapy and is a particular problem in head and neck cancers receiving conventional treatments. As many as 83% of patients with stage II or IV head and neck cancer acquire mucositis. This ends up being a rate limiting step in delivering the proper dose and regimen of their conventional treatment, and delays or breaks in the treatment are needed in 59% of those with mucositis. The epithelium of the oral mucosa is damaged due to the chemotherapy and radiation.

The current study appears to be the largest randomized controlled trial of head and neck squamous cell cancer patients undergoing chemoradiotherapy and mucositis. The L. brevis lozenge not only significantly reduced the incidence and severity of oral mucositis, especially in grade II and IV mucositis, but also fewer patients in the probiotic group discontinued their chemotherapy or radiotherapy side effects. Knowing about this safe and effective treatment is a simple solution for many individuals with not only a challenging disease of cancer, but a significant side effect of conventional treatment.

Sharma A, Rath G, Chaudhary S, et al. Lactobacillus brevis CD2 lozenges reduce radiation-and chemotherapy-induced mucositis in patients with head and neck cancer: A randomized double-blind placebo-controlled study. Eur J Cancer. 2012;875–881.

Probiotics and Antibiotic-Associated Diarrhea

A systematic review and meta-analysis was conducted using 12 electronic databases to evaluate the evidence for probiotics in the prevention and treatment of antibiotic-associated diarrhea (AAD). Studies that used one or more species of live microorganisms of Lactobacillus species, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus and/or Bacillus were included. Randomized trials were included if the probiotics were used as prevention, treatment, or concomitantly with antibiotics to enhance treatment such as is the case in Helicobacter pylori. A total of 82 randomized clinical trials met the inclusion criteria. The majority of the interventions with probiotics were primarily Lactobacillus species, either alone or in combination with other species such as Bifidobacterium, Saccharomyces boulardii, or Hansen species. Very few studies had used the Enterococcus, Streptococcus, or Bacillus strains.

According to this systematic review, using probiotics as an adjunct to antibiotic therapy reduced the risk of AAD with a relative risk of 0.58. The species predominantly used were Lactobacillus rhamnosis or Lactobacillus casei.

Comment

: These results are affirming for those clinicians who are already in the habit of recommending a probiotic for the prevention and treatment of AAD. We should remember though that AAD does not occur in the majority of patients taking antibiotics. What would be even more useful is a study that determined which patients might benefit more. Examples could include studying probiotics with those antibiotics that are more likely to cause diarrhea. Another approach would be to study those who are elderly or with a previous history of this problem. Another helpful approach would be to know which species may be indeed more effective at prevention and treatment of this particular clinical problem.

Hempel S, Newberry S, Maher A, et al. Probiotics for the prevention and treatment of antibiotic-associated diarrhea. JAMA. 2012;307(18):1959–1969.

Dr. Tori Hudson graduated from the National College of Naturopathic Medicine (NCNM) in 1984 and has served the college in many capacities over the last 25 years. She is currently a clinical professor at NCNM and Bastyr University; has been in practice for over 28 years; and is the medical director of the clinic A Woman’s Time in Portland, OR, and director of research and development for Vitanica, a supplement company for women. She is also a nationally recognized author, speaker, educator, researcher, and clinician.