Clinical Abstracts-With Comments from Adriane Fugh-Berman, MD
Clinical Abstracts-With Comments from Adriane Fugh-Berman, MD
Vitamin E and Hot Flashes
December 1999; Volume 1: 103-104
Source: Barton DL, et al. Prospective evaluation of vitamin E for hot flashes in breast cancer survivors. J Clin Oncol 1998;16: 495-500.
Design and Setting: Randomized, placebo-controlled crossover study, conducted by the North Central Cancer Treatment Group. Daily diary questionnaires were used to assess hot flash severity and frequency as well as selected side effects (headache, nausea, and fatigue). Diaries were kept for one week prior to treatment in order to establish a baseline. Women were evaluated by oncology nurses either in person or by telephone every two weeks.
Subjects: One hundred twenty-five women over the age of 18 years with a history of breast cancer and at least 14 hot flashes per week were enrolled. Women who took more than two multivitamin tablets per day or > 60 IU of vitamin E daily were excluded; also excluded were women receiving treatment for hot flashes. Women were stratified by age, current tamoxifen use, duration of hot flashes, average frequency of hot flashes, and current multivitamin use.
Treatment/Dose/Route/Duration: Patients received four weeks of vitamin E (400 IU of vitamin E succinate bid), followed by four weeks of placebo (or vice versa).
Outcome Measures: Mean daily hot flash frequency, mean daily hot flash severity, and mean daily hot flash score (frequency times average severity) and side effects as recorded on daily diaries.
Results: One hundred twenty patients were assessable for toxicity; 104 patients finished all nine weeks. After four weeks of therapy, there were no significant differences between the two groups. The frequency of hot flashes decreased 22% with placebo and 25% with vitamin E (an average decrease of about 1.6 hot flashes per day to a level of 4.7 hot flashes daily). The hot flash score decreased by 20% with placebo and 28% with vitamin E. There was a statistically significant effect on overall intrapatient values for hot flash score and hot flash frequency (by Wilcoxon’s signed rank P values; tests for a carryover effect were negative). When asked which therapy they preferred, 32% of subjects preferred vitamin E; 29% preferred placebo; and 38% had no preference. Vitamin E did not appear to increase the incidence of headache, fatigue, or other side effects.
Funding: "In part" by multiple public health service grants from the National Cancer Institute.
Comments: Vitamin E is a popular remedy for hot flashes. This is the first controlled trial of vitamin E for this purpose that I am aware of; the only "evidence" to date has come from a few case reports from the 1940s. Although most menopausal women have the option of using estrogen for severe hot flashes, women with breast cancer often avoid estrogen because of the possibility of increased risk of recurrence. Therapies for hot flashes among breast cancer survivors are particularly important because several breast cancer treatments, including tamoxifen, increase hot flashes.
This study demonstrates that while vitamin E appears non-toxic in the short term, it does not appear to be particularly effective in reducing hot flashes among breast cancer survivors. As the authors point out, although a statistically significant advantage for vitamin E could be demonstrated, this did not appear to be clinically significant (especially as women did not express a clear preference for vitamin E). Hot flashes are very placebo-responsive, as this study demonstrates. This was a reasonably well-designed study but would have been better with a placebo run-in. It may also be argued that several doses of vitamin E should have been tested. In any case, it is clear that vitamin E does not have a dramatic effect on hot flashes.
Fish Oil and Cancer Cachexia
December 1999; Volume 1: 104
Source: Barber MD, et al. Fish-oil-enriched nutritional supplement attenuates progression of the acute-phase response in weight-losing patients with advanced pancreatic cancer. J Nutr 1999;129:1120-1125.
Subjects: Thirty-six patients with pancreatic cancer: 18 treated and 18 untreated controls. Six healthy subjects had baseline acute phase protein levels drawn for comparison purposes.
Treatment/Dose/Route/Duration: A fish oil-enriched, orally administered nutritional supplement manufactured by Ross products. Two cans daily supplied 32.2 g protein, 99.4 g carbohydrate, 13 g fat, 2.18 g eicosapentaenoic acid (EPA), and 0.92 g docosahexaenoic acid (DHA). The treatment was administered for three weeks.
Outcome Measures: Changes in albumin, transferrin, and pre-albumin, fibrinogen, haptoglobin, a-1-acid glycoprotein, a-1-antitrypsin, ceruloplasmin, and C-reactive protein one week after supplementation ended.
Results: Total positive acute phase proteins did not change significantly but there were significant differences between the groups in regards to negative acute phase proteins. At baseline, compared to healthy controls, cancer patients had lower albumin, transferrin, and pre-albumin and significantly elevated fibrinogen, haptoglobin, a-1-acid glycoprotein, a-1-antitrypsin, ceruloplasmin, and C-reactive protein. After supplementation, the only acute-phase protein that changed over the course of the study was transferrin, which increased. In the control group of cancer patients, there were further reductions in albumin, transferrin and pre-albumin, and a significant increase in C-reactive protein (CRP) concentration. The supplemented group gained a median of 1 kg over the course of the study while those receiving supportive care lost a median of 2.8 kg. The authors conclude that the progression of the acute-phase protein response may be stabilized by fish oil, a finding that may have beneficial implications or wasting.
Funding: Scotia Pharmaceuticals, Stirling, UK, and Ross Products Division, Abbott Laboratories, Columbus, OH.
Comments: This study does not actually tell us anything about the effects of fish oil, because it was incorporated into a protein-calorie supplement that was given only to the treatment group. This is not a controlled trial, and as the authors correctly point out, patients consuming the supplement consumed more protein and calories than the untreated group. Obviously, this could explain weight changes, and the effects of the supplement on acute phase proteins cannot be attributed to fish oil without comparing it to an identical, but fish oil-free, supplement. Albumin, prealbumin, and transferrin ("negative" acute phase proteins) are lower in cancer patients while fibrinogen, haptoglobin, a-1-acid glycoprotein, a-1-antitrypsin, ceruloplasmin, and C-reactive protein ("positive" acute phase proteins) are higher in cancer patients. The acute-phase protein response (APPR) is seen following trauma, infection, inflammation, or cancer (increased acute-phase proteins are associated with pro-inflammatory cytokine production). C-reactive protein is accepted as a marker for APPR, and the authors of this study state that they have found that elevated CRP is an independent and robust predictor of poor survival in pancreatic cancer.
Fish oil, which contains the omega-3 fatty acids DHA and EPA, is known to have anti-inflammatory effects. Wasting in cancer, AIDS, and advanced Parkinson’s disease is a poorly understood phenomenon, but the weakness and fatigue associated with it has a significant adverse effect on the quality of life of patients.
It is definitely worthwhile determining whether fish oil benefits wasting, but this trial has not done so. Clearly the company that sponsored this trial would like to differentiate its product, with its dollop of fish oil, from other protein-calorie supplements. However, superiority cannot be demonstrated without comparison.
December 1999; Volume 1: 103-104
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