Treatment of lymphedema of the arms and legs with 5,6-benzo-[alpha]-pyrone

BACKGROUND: Benzopyrones can reduce the volume of high-protein edema fluid by stimulating proteolysis. These compounds provide a method for removing excess protein and its consequent edema and reduce its clinical sequelae, such as chronic inflammation and secondary infections. METHODS: We conducted a randomized, double-blind, placebo-controlled, crossover trial of 5,6-benzo-[alpha]-pyrone in 31 patients with postmastectomy lymphedema of the arm and 21 patients with lymphedema of the leg of various causes (this agent, also known as 56 BaP, 1,2-benzopyrone, or coumarin, is not an anticoagulant). The patients received 400 mg of the active drug or placebo, each for six months. RESULTS: During the placebo period, lymphedema often worsened, especially in the arms. Measurements of limb volume showed that the active drug reduced the mean amount of edema fluid in the arms from 46 percent above normal to 26 percent above normal (P < 0.001) and the amount in the legs from 25 percent to 17 percent above normal (P < 0.001). The circumference of the arms was reduced from 17 percent to 13 percent above normal, and the circumference of the legs from 11 percent to 7 percent above normal (P < 0.001). The softness of the limb tissue was increased (P < 0.001), and elevated skin temperatures were reduced (P < 0.001). There were fewer attacks of secondary acute inflammation (P = 0.01). Bursting pains and feelings of hardness were decreased, as were feelings of tightness, tension, swelling, and heaviness; limb mobility also improved. The active drug was preferred to the placebo by 93 percent of the patients (P < 0.001). Side effects--mild nausea or diarrhea--occurred in seven patients taking the active drug. None withdrew from the trial, and the side effects disappeared after the first month of therapy. CONCLUSIONS: 5,6-Benzo-[alpha]-pyrone results in slow but safe reduction of lymphedema of the extremities.     

Judging words rather than authors

Coumarin is a drug which is extensively used to treat lymphedema. We report two cases of acute hepatitis probably due to coumarin. Two women, 40 year and 45 year-old, were treated with 90 mg/d of coumarin for 5 months. Clinical features included jaundice, pruritus, and diarrhea. A marked increase in serum aminotransferases was observed (ALT: 30 and 100 times the upper limit of normal, respectively). Coumarin withdrawal was rapidly followed by a favorable outcome in both cases. Rechallenge in one case induced a relapse of symptoms and liver test abnormalities. Coumarin can induce acute cytolytic hepatitis.     

The use of 5,6 benzo-[alpha]-pyrone (coumarin) and heating by microwaves in the treatment of chronic lymphedema of the legs

Sixty patients with leg lymphedema from a variety of etiologies were divided into randomized two groups, matched by Grade, duration, age, sex, and cause of lymphedema. Using a double-blind format, one group received 5,6 benzo-[alpha]-pyrone (coumarin 1,2 benzopyrone, 400 mg/day) for six months; the other received a placebo. For the next six months, both groups received a standardized regimen of heat (using microwaves) coupled with compression garments. Benzopyrone produced approximately 20% reduction in the volume (p = 10(-4)) and improvement in circumferences and tonometry (p = 10(-5) and 10(-7)). Symptoms (feelings of swelling, pain, heaviness and loss of mobility) were also significantly improved (p = 0.03 to 10(-7)). During the second six months, when microwave heat therapy was added to drug therapy, the patients who had previously received the placebo showed significant improvement (p = 0.03 to 10(-9)) in signs and symptoms of lymphedema. Some, but not all, of the group that was receiving benzopyrones were also significantly improved by heat therapy (p = 0.8 to 0.002). Taking benzopyrones for 12 months plus heat treatment for six months was significantly better, for some criteria, than the placebo plus heat therapy (p = 0.7 to 0.04). On the other hand, heat plus either placebo or benzopyrone was often significantly better than either the active or inactive drug without heat (p = 0.8 to 10(-9)).     

Liposuction combined with controlled compression therapy reduces arm lymphedema more effectively than controlled compression therapy alone

Arm lymphedema after breast cancer therapy has been treated with various forms of conservative and surgical treatment during recent years. The clinical results usually have been modest or, in some instances, even disappointing. In a previous series of patients treated with the new liposuction technique combined with controlled compression therapy, we found, however, an overall edema reduction of 106 percent after 1 year. The purpose of this study was both to investigate how much the surgical procedure contributes to the outcome and to clarify the importance of controlled compression therapy. Twenty-eight patients were, therefore, prospectively matched into two groups. One group received liposuction combined with controlled compression therapy, and one group received the therapy alone. Additionally, the therapy group was compared with our complete group of patients treated thus far with liposuction combined with therapy (n = 30). The prospective study using matched pairs (n = 14) showed that liposuction combined with controlled compression therapy is significantly more effective than the therapy alone (p < 0.0001), with a mean difference of about 1000 ml during the entire 1-year observation period. The beneficial effect of liposuction was confirmed by the comparison between the controlled compression therapy group and our complete group of patients treated with liposuction combined with the therapy, as the edema reduction figures after 1 year were 47 percent and 104 percent, respectively (p < 0.0001). In six patients who had surgery and a complete reduction of the edema, the compression garments were removed for 1 week, 1 year postoperatively. A marked increase in the arm volume was observed, which was immediately remedied by reapplying the garments. We conclude that liposuction combined with controlled compression therapy reduces arm lymphedema more efficiently than the therapy alone. Continued use of compression garments is, however, important to maintain the primary surgical outcome.     

Chronic complications of diabetes: a creative management approach

Ten women with unilateral arm lymphedema after axillary clearance (radical mastectomy) and radiotherapy for breast cancer received 16 treatment sessions with Low Level Laser Therapy (LLLT) over 10 weeks and seven patients were followed for 36 months. The effect of LLLT was monitored by arm circumference, plethysmography, tonometry, bioimpedance and a questionnaire dealing with subjective symptoms. After treatment, edema volume (both extracellular and intracellular) was decreased, the tissue (except for the upper arm) progressively softened or approached a normal texture, and the patients reported improvement in aches/pains, tightness, heaviness, cramps, pins/needles, and mobility of the arm. Skin integrity was also improved and the index for risk of infection decreased. Follow-up assessment at 1, 3, 6, and 30-36 months showed varying trends although at 30-36 months most subjective parameters and bioimpedance derived data on ECF and ICF tended to return toward pre-treatment levels. Arm circumference continued to show overall improvement, however, with a volume reduction of the affected arm reaching 29%. Tonometry also showed maintenance of near normal values for the involved forearm and anterior and posterior chest; however, the upper arm showed progressive induration. The data suggest that laser treatment, at least initially, improved most objective and subjective parameters of arm lymphedema.     

Osteoporosis: preventive strategies

We compared manual lymph drainage (MLD) with sequential pneumatic compression (SPC) for treatment of unilateral arm lymphedema in 28 women previously treated for breast cancer. After 2 weeks of therapy with a standard compression sleeve (Part I) with maintenance of a steady arm volume, each patient was randomly assigned to either one of two treatment regimens (Part II). MLD was performed according to the Vodder technique for 45 min/day and SPC was performed with a pressure of 40-60 mmHg for 2 hours/day. Both treatments were carried out for 2 weeks. Arm volume was measured by water displacement. Arm mobility, strength, and subjective assessments were also determined. Lymphedema was reduced by 49 ml (7% reduction) (p = 0.01) in the total group during Part I. During Part II, the MLD group decreased by 75 ml (15% reduction) (p < 0.001) and the SPC group by 28 ml (7% reduction) (p = 0.03). The total group reported a decrease of tension (p = 0.004) and heaviness (p = 0.01) during Part I. During Part II, only the MLD group reported a further decrease of tension (p = 0.01) and heaviness (p = 0.008). MLD and SPC each significantly decreased arm volume but no significant difference was detected between the two treatment methods.     

Genetic alterations in the development of mammary and prostate cancer in the C3(1)/Tag transgenic mouse model

PURPOSE: Finasteride therapy for benign prostatic hyperplasia (BPH) results in a marked lowering of serum prostate specific antigen (PSA) levels. However, little is known about the effect of finasteride on unbound or free serum levels of PSA. Such information would be important since percent free PSA may substantially improve the cancer specificity of PSA testing. Thus, we prospectively studied the effect of finasteride therapy on total and free serum PSA levels. MATERIALS AND METHODS: In a randomized, placebo controlled, double-blind trial 40 men with histologically confirmed BPH (age range 52 to 78 years) were treated with either 5 mg. finasteride daily (26 patients) for 9 months or placebo (14) for 6 months. Prostate volume was assessed by transrectal ultrasound. Serum levels of free and total PSA were measured from archived serum samples stored at -70C at baseline and for as long as 9 months of treatment. RESULTS: In the finasteride group mean total PSA levels declined from 3.0 ng./ml. at baseline to 1.5 ng./ml. after 6 months of treatment (50% decrease, p <0.01). In the placebo group, with similar baseline levels, no significant change was observed. PSA density declined significantly in finasteride treated men (p <0.01) but not in men receiving placebo. The mean percent free PSA (13 to 17% at baseline) was not altered significantly by finasteride or placebo. CONCLUSIONS: Total PSA serum levels decreased by an average of 50% during finasteride therapy but percent free PSA did not change significantly. This information is potentially useful in the interpretation of PSA data used for early detection of prostate cancer in men receiving finasteride. However, further studies are required to demonstrate the use of percent free PSA to detect the development of cancer.     

Liposuction reduces arm lymphedema without significantly altering the already impaired lymph transport

In a prospective study, 20 patients with arm lymphedema after breast cancer treatment underwent liposuction combined with Controlled Compression Therapy (CCT) or CCT alone. Indirect lymphoscintigraphy (ILS) was used to study lymph kinetics before and after intervention. Lymphoscintigrams from the contralateral, non-edematous arm were characterized by prompt transit of the radiotracer (99mTc-albumin nanocolloid) to the axillary nodes, whereas tracer accumulation as dermal backflow characterized tracer transport in the lymphedematous arm. Neither liposuction with CCT nor CCT alone, changed this ILS profile. Liposuction combined with CCT reduced arm edema volume by (median) 115% (range 92-179%), whereas CCT alone decreased arm edema volume by only 54% (range 7-81%) (p = 0.008). Because liposuction in conjunction with CCT was not associated with further impairment to an already restricted lymph transport, we recommend this therapy (liposuction with external compression) for chronic arm lymphedema, as it reduces edema volume safely, rapidly, and more efficiently than external compression alone. Moreover, it does not worsen an already impaired lymph transport in the lymphedematous upper extremity.     

Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial

BACKGROUND: Tamoxifen, a drug with antioestrogenic effects, is predicted to prevent the occurrence of breast cancer. We have undertaken a trial of tamoxifen in healthy women who are at increased risk of breast cancer because of family history. We report a planned interim analysis. METHODS: Between October, 1986, and April, 1996, we accrued 2494 healthy women aged between 30 and 70 with a family history of breast cancer. They have been randomised (double blind) to receive tamoxifen 20 mg per day orally or placebo for up to 8 years. Follow-up included clinical assessment, annual mammography, and assessment of toxicity and compliance. The primary endpoint was the occurrence of breast cancer, which was analysed on an intention-to-treat basis with a survival curve. FINDINGS: With a median follow-up of 70 months, 2471 women (tamoxifen 1238, placebo 1233) were suitable for analysis. The groups were evenly matched at baseline, and compliance was good. The overall frequency of breast cancer is the same for women on tamoxifen or placebo (tamoxifen 34, placebo 36, relative risk 1.06 [95% CI 0.7-1.7], p=0.8). Participants who were already on hormone-replacement therapy when they entered the study had an increased risk of breast cancer compared with non-users. Those participants who started such therapy while on trial had a significantly reduced risk. The safety profile of tamoxifen was as expected. INTERPRETATION: We have been unable to show any effect of tamoxifen on breast-cancer incidence in healthy women, contrary to the report from the NSABP-P1 study showing a 45% reduction in healthy women given tamoxifen versus placebo. Differences in the study populations for the two trials may underlie these conflicting findings: eligibility in our trial was based predominantly on a strong family history of breast cancer whereas in the NSABP trial was mostly based on non-genetic risk factors. The importance of oestrogen promotion may vary between such populations.     

Biologic activity of tamoxifen at low doses in healthy women

BACKGROUND: Results of a clinical trial recently completed in the United States indicate that administration of tamoxifen (20 mg/day) to women at risk can reduce breast cancer incidence by approximately 50% but is associated with an increased risk of developing endometrial cancer and venous thromboembolic events. Since these adverse effects may be dose related, we investigated the effect of tamoxifen on several biomarkers when the drug was given at doses lower than those currently in use. METHODS: In two sequential experiments, 127 healthy hysterectomized women aged 35-70 years were randomly assigned to one of the following four treatment arms: placebo (n = 31) or tamoxifen at 20 mg/day (n = 30) (first experiment); or tamoxifen at 10 mg/day (n = 34) or tamoxifen at 10 mg/ alternate days (n = 32) (second experiment). Baseline and 2-month measurements of the following parameters were compared: 1) total cholesterol (primary end point) and other surrogate markers of cardiovascular disease, e.g., low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and lipoprotein(a); 2) blood cell count; 3) fibrinogen; 4) antithrombin III; 5) osteocalcin; and, 6) in a subgroup of 103 women, insulin-like growth factor-I (IGF-I), a possible surrogate marker for breast cancer. RESULTS: After adjustment for the baseline values, there were reductions in circulating levels of total cholesterol and IGF-I of the same magnitude in all three tamoxifen treatment arms. A similar pattern was observed for most of the other parameters. In the placebo arm, fibrinogen level, which showed a decrease, was the only parameter exhibiting change. CONCLUSIONS: Up to a 75% reduction in the conventional dose of tamoxifen (i.e., 20 mg/day) does not affect the activity of the drug on a large number of biomarkers, most of which are surrogate markers of cardiovascular disease. This study was hypothesis generating, and larger studies are warranted to assess the efficacy of tamoxifen at low doses.     

Spectroscopic and thermodynamic evidence for a complex denaturation mechanism of bovine beta-lactoglobulin A

PURPOSE/OBJECTIVES: To investigate the patterns of functioning and psychosocial adjustment of midlife and older women following surgery for breast cancer. Differences between those who received follow-up adjuvant therapy and those who did not also were compared. DESIGN: 2 x 3 mixed design with one between-groups factor (type of treatment) and one within-subjects factor (time). SETTING: Four midwestern hospitals. SAMPLE: 46 patients with breast cancer who are age 55 or older. METHODS: Baseline data about presurgical functional status and other variables were obtained during the first week after surgery. Follow-up data were obtained at six weeks, three months, and six months postsurgery. Data were collected via telephone interviews and mailed questionnaires. MAIN RESEARCH VARIABLES: Functional status, patient symptomatology, quality of life (QOL), demands of illness, and type of treatment (surgery only versus surgery plus adjuvant therapy). FINDINGS: No differences existed between the two treatment groups at baseline, with the exception of lower functional status reported by the surgery-only group. In the surgery-only group, functional status improved significantly from six weeks to three months postsurgery. The most frequently reported symptoms of both groups included fatigue and pain. CONCLUSIONS: These results suggest that both groups did equally well, regardless of whether they received adjuvant therapy (radiation or chemotherapy). Neither QOL nor demands of illness differed between the two groups, nor did these scores change significantly over time following surgery. IMPLICATIONS FOR NURSING PRACTICE: These findings suggest that women undergoing surgery for breast cancer, whether they receive adjuvant therapy or not, may have functional and psychosocial needs that could be effectively addressed by nursing interventions pre- and postsurgery.     

Short-chain fatty acids in the treatment of radiation proctitis: a randomized, double-blind, placebo-controlled, cross-over pilot trial

PURPOSE: Treatment of chronic radiation proctitis remains unsatisfactory. Short-chain fatty acids are the preferred energy source for the colonic epithelium. We aimed to determine for the first time whether topical butyric acid enemas relieve symptoms and improve the macroscopic and microscopic findings in chronic radiation proctitis. METHODS: A randomized, double-blind, placebo-controlled, cross-over pilot trial compared patients given two weeks of butyric acid enemas (40 mmol) twice per day with those given placebo, with a one-week washout period; 15 patients were randomized and 12 completed both arms of the trial. A total symptom score combined six symptom items per week (rectal pain, episodes of rectal bleeding, amount of blood passed, days with diarrhea, number of stools, and urgency). Symptom, endoscopic, and histologic scores were obtained at the beginning of the study and again at the last week of each treatment arm. RESULTS: Total symptom score at baseline (median, 5.5) improved for those patients receiving active treatment (median, 3.5), but compared with placebo (median, 4.5), the change was not significant. Endoscopic appearances were largely unaltered by active treatment. Histology was abnormal in 82 percent of patients receiving placebo compared with 55 percent of those given butyric acid enemas (P = not significant). CONCLUSION: Butyric acid enemas do not appear to be superior to placebo in the treatment of chronic radiation proctitis.     

Structure of the multiorgan renal lymph node after blockade of its afferent lymphatics from kidney in the Wistar rats

The effect of a comprehensive lymphedema management program was assessed in 25 patients in whom moderate to severe lymphedema had developed after surgery and/or radiotherapy for carcinoma of the breast. Intensive treatment (4 weeks) involved massage, compression bandaging, and sequential pneumatic compression, with an adjunct program of education to provide skills in exercise, massage, bandage, and containment garment use. The intensive treatment phase was followed by a self-management phase based on the skills that had been acquired. A significant reduction in limb circumference and volume, with continuing improvement over 12 months of self-management, was observed. There was a decrease in need for physical assistance. Quality of life generally remained high and stable throughout the 12 months. Quality of life specific to lymphedema, however, declined during the intensive phase of treatment, but recovered and surpassed pretreatment levels during the self-management phase of treatment. Perceived comfort and strength in the lymphedematous limb improved, and perceived size decreased. The study confirmed that the combination of multimodal physical therapy and education for self-management reduces lymphedema and its adverse subjective consequences and maintains the improvement thus achieved.     

Specialty maldistribution. The next nursing crisis?

80 patients with previously untreated stage III-IV non-small cell lung cancer (NSCLC) were randomly assigned to receive chemotherapy (CT) alone (arm I: 26 patients) or the same CT combined with either interferon (IFN)-gamma (arm II: 27 patients) or with both IFN-gamma and IFN-alpha (arm III: 27 patients). The CT comprised cisplatin 60 mg/m2 intravenously (i.v.) day 1 and etoposide 100 mg/m2 i.v. days 1, 3 and 5, once every 28 days; the IFN therapy comprised either recombinant IFN-gamma 1b 0.2 mg/m2, subcutaneously, three times a week until day 25, or recombinant IFN-alpha 2c 6 x 10(6) U given according to the same schedule, and simultaneously with IFN-gamma. A maximum of six cycles were given. The treatment was discontinued if progressive disease (PD) was demonstrated. The mean numbers of cycles per patient given in the different arms were 3.6 (arm I), 3.0 (arm II) and 2.9 (arm III). The main reason for discontinuation in all arms was PD. 17 (28%) of the 61 evaluable patients achieved partial responses (35% in arm I, 29% in arm II and 35% in arm III, non-significant). No complete response was recorded. Haematological toxicity was dose-limiting in all arms: leucopenia (WHO grade 3) was observed universally, but more frequently in arm III (in 18% of cycles given). Only two episodes of grade 4 leucopenia were seen (arms II and III) and six episodes of grade 3-4 thrombocytopenia (arm III). Median survival was 6-7 months in all arms. The survival curve for arm II was slightly more favourable (non-significant) than those for other arms. The addition of IFN-gamma alone or IFN-alpha plus IFN-gamma to platinum-based CT did not improve response rates nor did it produce any significant survival benefit for patients with NSCLC. Increased haematological toxicity was observed when both IFNs were administered concomitantly with CT.     

Association of Lp(a) rather than integrally-bound apo(a) with triglyceride-rich lipoproteins of human subjects

OBJECTIVE: To assess the efficacy of unopposed estrogen, and three estrogen/progestin regimens on selected heart disease risk factors among adherent women and to contrast those results with efficacy among all women in the PEPI study. DESIGN: A 3-year, multicenter, randomized, double-blinded, placebo-controlled clinical trial. PARTICIPANTS: A total of 847 healthy postmenopausal women aged 45 to 64 years of age with no known contraindication to hormone therapy, who attended their 36 month clinical visit. INTERVENTION: Participants were randomized in equal numbers to one of the following treatments: (1) placebo; (2) conjugated equine estrogen (CEE) 0.625 mg daily; (3) CEE 0.625 daily plus medroxyprogesterone acetate (MPA) 10 mg, days 1-12; (4) CEE 0.625 daily plus MPA 2.5 mg daily; or (5) CEE 0.625 daily plus micronized progesterone (MP) 200 mg, days 1-12. ANALYSIS: Analyses are based on adherent women, where adherence is defined as taking at least 80% of pills at each 6-month visit. RESULTS: Adherence rates were high in all groups except women with a uterus assigned to unopposed CEE. The difference in HDL-C levels resulting from the CEE vs. CEE+MP was approximately three times larger than in the intent-to-treat analyses, reaching statistical significance (P < 0.05). In each active treatment, LDL-C decreased 10-15%. Triglycerides increased 15-20% in each opposed CEE arm and over 25% in the CEE only arm; this difference was not statistically significant. Fibrinogen increased by 7% among placebo adherers, but decreased or remained fairly stable among the active arm adherers. Systolic blood pressure increased 3-5% in all treatment arms. Women adherent to the CEE+MPA arms had twice the increase of 2 h glucose levels as women adherent to CEE only, or CEE+MP (8-9% vs. 3-4%). Two-hour insulin levels decreased 3-12% for all arms. The patterns of change for fibrinogen, SBP, 2 h glucose and insulin were similar to those from the intent-to-treat analyses. CONCLUSIONS: In analyses limited to adherent women, all active treatments, compared to placebo, continued to have similar and favorable effects on LDL-cholesterol and fibrinogen and no significant effects on blood pressure or insulin levels. Given the overall high adherence rates in PEPI, the results are similar to the intent-to-treat analyses, as expected. Only the trend of HDL-C to have a larger increase in the CEE only arm (in the intent-to-treat analyses) gained statistical significance in analyses restricted to adherers.     

The effect of legislative requirements on the use of breast-conserving surgery

BACKGROUND: We studied the effect of state legislation requiring the disclosure of options for the treatment of breast cancer on the use of breast-conserving surgery in clinical practice. METHODS: The National Cancer Institute's Surveillance, Epidemiology, and End Results registry provided data on women from 30 through 79 years of age who underwent breast-conserving surgery or mastectomy for local or regional breast cancer from 1983 through 1990. We examined the trend over time in use of breast-conserving surgery among patients in four sites (Connecticut, Iowa, Seattle, and Utah) where there were no state laws specifically requiring the disclosure of options for the treatment of breast cancer by physicians. For four additional sites (Detroit, Atlanta, New Mexico, and Hawaii) that had such legislation, we determined whether the rate of breast-conserving surgery after the legislation was different from the expected rate. RESULTS: An attorney rated the legislation as giving most direction to physicians in Michigan, followed by Hawaii, Georgia, and New Mexico. The rate of breast-conserving surgery was up to 8.7 percent higher than expected in Detroit for six months after the passage of the Michigan law (P<0.01). The rate was up to 13.2 percent higher than expected in Hawaii for 12 months after that state's law was passed (P<0.05) and up to 6.0 percent higher than expected in Atlanta for 3 months after the passage of the Georgia law (P<0.01). After these transient increases, the surgery rates reverted to the expected levels. No significant effect was detected in New Mexico, where only a resolution without legal force was passed. CONCLUSION: Legislation requiring physicians to disclose options for the treatment of breast cancer appeared to have only a slight and transient effect on the rate of use of breast-conserving surgery.     

Extraction of sp18 family membrane proteins on posterior head of bull sperm and the effect of anti-sp18 IgG on sperm motility and murine in vitro fertilization

BACKGROUND AND PURPOSE: We evaluated sucralfate, well-known in the treatment of gastric ulcers, in relation to its possible reduction of radiation-induced acute complications in the treatment of head and neck cancers. MATERIALS AND METHODS: One hundred two patients were randomized in a double-blind placebo-controlled prospective setting. All patients were treated to a minimum dose of 55 Gy in 5 weeks. Oral intake of sucralfate was started at the beginning of radiotherapy and continued during the whole treatment at a dose of 1 g six times a day. All patients were scored according to a scoring system developed in our department. Weight was checked once a week. RESULTS: Comparing the time course of the mean scores for subjective intolerance, mucositis, dysphagia, dermatitis and nausea, no statistically significant differences between the two treatment arms (sucralfate, n = 38; placebo, n = 45) were observed. The mean weight loss in the sucralfate arm was 1.6 +/- 3.4 kg while it was 1.3 +/- 2.0 kg in the placebo arm. Apart from gastrointestinal upset, the administration of sucralfate did not cause any side-effects. CONCLUSION: This trial produced no clinical evidence indicating that the oral intake of sucralfate reduces the acute radiation-induced side-effects. Therefore, we do not recommend the prophylactic use of sucralfate in patients with head and neck cancer treated by radiotherapy.     

Effects of estrogen replacement therapy on the lipoprotein profile in postmenopausal women with ESRD

BACKGROUND: Patients with ESRD have excessive cardiovascular morbidity and mortality. In postmenopausal women with normal renal function, estrogen replacement therapy decreases cardiovascular mortality by 50%, in part because of their beneficial effects on the lipoprotein profile. Because of similarities in the lipoprotein profile between healthy, postmenopausal women, and women with ESRD, we examined the effects of estrogen replacement on lipoproteins in 11 postmenopausal women with ESRD. METHODS: In a randomized, placebo-controlled crossover study (8 week treatment arms) using 2 mg daily of oral, micronized estradiol, 11 postmenopausal women with ESRD were treated. Neither baseline lipid nor lipoprotein abnormalities were used as entry criteria for study participation. RESULTS: Blood estradiol levels were 19 +/- 4 with placebo and 194 +/- 67 pg/ml (P = 0.024) with estradiol treatment. Total HDL cholesterol concentrations increased from 52 +/- 19 mg/dl to 61 +/- 20 mg/dl (16%), with placebo and estradiol treatments, respectively (P = 0.002). Apolipoprotein A1 increased by 24.6% (P = 0.0002) with estradiol intervention. HDL2 concentrations were 19 +/- 13 with placebo and 24 +/- 16 with estradiol treatment (P = 0.046). There were no differences in total or LDL cholesterol, other lipoprotein fractions including Lp(a), and triglycerides with 2 mg daily estradiol treatment. No significant side effects were observed. CONCLUSIONS: Therefore, using standard dosage regimens for estrogen replacement therapy in postmenopausal women with ESRD, HDL cholesterol is increased to an extent that would be expected to improve their cardiovascular risk profile. Further studies are needed to assess whether estrogen replacement therapy decreases the incidence or severity of cardiovascular disease in ESRD patients to a similar degree compared with other women.