Literature Briefs
July 1, 2000
Literature Briefs
With Analysis by Cydney E. McQueen, PharmD
CellaseneTMfor the Treatment of Cellulite
Source: Lis-Balchin M. Parallel placebo-controlled clinical study of a mixture of herbs sold as a remedy for cellulite. Phytother Res 1999;13:627-629.
Objective: To determine the effect of CellaseneTM on cellulite, weight gain, and body fat.
Design and Setting: Randomized, controlled trial conducted from the School of Applied Science in London. The study was commissioned by BBC Watchdog Healthcheck Television and results were televised.
Subjects: Twenty-three women (25-45 years old) who thought they had cellulite problems. Exclusion criteria included medications, pregnancy, epilepsy, thyroid disease, and use of anticellulite preparations within the last month. Subjects agreed to make no diet or exercise changes during the trial.
Treatment: Cellesene, containing extracts of bladderwrack, grape seed, sweet clover, gingko biloba, borage and fish oils, and soy lecithin. The herbal product ColoneaseTM (aloe vera, clary sage oil, parsley seed oil, and peppermint oil, and soy lecithin) was used as a control and considered a placebo.
Dose/Route/Duration: One capsule Cellasene or Colonease bid for eight weeks.
Outcome Measures: Weight, body fat percentage, cellulite scores, and measurements of hips, both thighs, and one knee self-assessed by subjects and independently by the author.
Results: The only significant changes between groups were an increase in body weight in the Colonease group and an increase in the independent cellulite score in the Cellasene group. Three Cellasene and two Colonease subjects felt they had a decrease in cellulite, which was not confirmed by the author’s cellulite scores. Body weight in seven of 11 Cellasene patients increased up to 3 kg at end of treatment; "most" women said they had experienced gain of up to 5 kg in the first weeks of the study. Eight of the nine Colonease patients reported bloating and weight gain, especially in the first few weeks of the study. Women reporting weight gain decreased food intake because of the gain. One Cellasene patient dropped out because of considerable weight gain, and two Colonease subjects dropped out (one bereavement, one loss to follow-up).
Level of Evidence: Level II, major limitations
Strengths: The author’s conclusion that Cellasene does not effect cellulite in most patients is in accordance with the data presented.
Limitations: One of the strongest limitations is that Colonease is a product with pharmacological effects, including at least one of the same ingredients as the active treatment, though probably in smaller amounts. Groups were not similar after randomization in regard to weight or knee measurement—apparently, changes were made after assignment because of "friendships and transport problems." Most subjects did not abide by their agreements and made diet or exercise changes during the trial because of weight gain. The treatment dose used is less than that recommended by the manufacturer and compliance was not monitored. The "cellulite score" used was not explained and is not a validated scale.
Comments: The many serious study limitations prevent a firm conclusion of complete lack of efficacy.
Clinical Impact: This study provides information on weight gain as a possible side effect of Cellasene. No decision can be made in regard to efficacy.
Vanadyl Sulfate in Non-Insulin-Dependent Diabetes Mellitus
Source: Goldfine AG, et al. Metabolic effects of vanadyl sulfate in humans with non-insulin-dependent diabetes mellitus: In vivo and in vitro studies. Metabolism 2000;29:400-410.
Objective: To determine the effects of vanadyl sulfate (VS) on glycemic control and insulin sensitivity.
Design and Setting: A comparison study at Brigham and Women’s Hospital of three doses of VS with a one-week baseline monitoring period, a one-week placebo run-in, and a two-week follow-up. Randomization or blinding status is not specified.
Subjects: Type II diabetic patients (5 female, 11 male; 38-65 years of age). Patients were "free of major active cardiovascular, pulmonary, renal, or hepatic disease," had no history of joint replacement, and normal Hgb and Hct.
Treatment: Vanadyl sulfate 75 mg (n = 3), 150 mg (n = 5), or 300 mg (n = 8) daily.
Dose/Route/Duration: 25, 50, or 100 mg capsules three times daily with meals for six weeks.
Outcome Measures: Blood glucose and HbA1c, insulin sensitivity studies, hepatic glucose production, concentrations of insulin-sensitive cellular en-zymes, oxidative vs. non-oxidative glucose disposal, and tissue oxidative stress.
Results: There was a statistically significant decrease in HbA1c at week 6 for the 150 mg and 300 mg dose groups (from 7.8% to 6.8% and 7.1% to 6.8%, respectively). The 300 mg group also had a significant decrease in mean fasting glucose. There were no significant changes in weight or caloric consumption in any group. The 300 mg group also experienced a significant decrease in cholesterol, primarily because of a decrease in HDL. Although insulin sensitivity improved in the 150 mg and 300 mg dose groups, the modest changes were not enough to produce a significant change in glucose utilization. Results of oxidative stress studies and tests of other tissue enzyme patterns revealed no differences from placebo. No patients required reduction in hypoglycemic medications during the study. Peak vanadium levels increased with no relation to side effects. All 300 mg dose subjects had some GI side effects—cramping, discomfort and/or diarrhea—requiring treatment with medication. Some patients on 150 mg experienced GI side effects, but did not require treatment. No dropouts occurred because of side effects and no hypoglycemic episodes occurred.
Level of Evidence: Level II, major limitations
Strengths: Compliance was monitored and was > 95%. Discussions of clinical relevance and the conclusion that "more potent analogs of vanadium" will be needed before it can be therapeutically useful are appropriate.
Limitations: Although compliance to treatment was monitored, no mention is made of compliance with the four-times-daily self-testing of blood glucose. No power calculation was performed, sample size was very small, and randomization and blinding status are unknown.
Comments: This study examined both clinical effects and possible mechanisms of action. Although information was obtained on pharmacological effects of VS, some inconsistencies in data leave many questions unanswered. Long-term safety is unconfirmed.
Clinical Impact: Although high doses of VS do lower HbA1c, diarrhea associated with these doses may cause further glucose control problems in diabetic patients. The low doses used in many supplement formulations for diabetics are not like to significantly affect gycemic control.
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