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Venlafaxine (Effexor) No Better Than SSRI for Social Anxiety: In 434 social anxiety disorder patients in a DBPC study of venlafaxine ER 75 mg to 225 mg/day, paroxetine 20 mg to 50 mg/day, or placebo for 12 weeks, there was no difference between venlafaxine and paroxetine with response rates of 69%, 66% and 36%, respectively. Efficacy of Venlafaxine ER in patients with social anxiety disorder: a double-blind, placebo-controlled, parallel-group comparison with paroxetine. Allgulander C, Mangano R, Zhang J, Dahl AA, Lepola U, Sjodin I, Emilien G. Karolinska Institutet, Sweden. Hum Psychopharmacol. 2004 Aug;19(6):387-96. For more, see Social Anxiety.

Vitamin E Helped Arterial Flexibility: In a very small, 20-healthy adult DB PC 1-month study of 700 IU/day vitamin E, plasma vitamin E levels increased by 123%, which was associated with a 20% increase in carotid artery compliance and a 30-60% increase in baroreflex indices. All these changes regressed 1 month after cessation of vitamin E supplementation. Effect of vitamin E on carotid artery elasticity and baroreflex gain in young, healthy adults. Studinger P, Mersich B, Lenard Z, Somogyi A, Kollai M., Semmelweis University, Budapest, Hungary. Auton Neurosci. 2004 Jun 30;113(1-2):63-70

Hydrocodone Adds Only Slight Extra Pain Relief to Ibuprofen in Dental Surgery: In a DB crossover study with the patients acting as their own controls, 12 patients underwent two periodontal surgeries in different quadrants of the same dental arch at least 2 weeks apart. Patients received four doses of medication at predetermined intervals and filled out a visual analog pain scale every 2 hours for the first 12 hours after surgery. More pain was reported with ibuprofen alone, 1.81 out of a possible 10, compared to the ibuprofen with hydrocodone combination, 1.30. The difference was statistically significant (P<0.05). Efficacy of ibuprofen-hydrocodone for the treatment of postoperative pain after periodontal surgery. Betancourt JW, Kupp LI, Jasper SJ, Farooqi OA. Mayo Clinic. J Periodontol. 2004 Jun;75(6):872-6. For more, see Pain.

Supermint Oil for C-Section Pain: In a 107-woman DB PC study of pain after caesarean sections, 40 drops of supermint every 20 minutes three times just after serum disconnection significantly reduced pain at second 40 minutes (p<0/002), 60 minutes (p<0/001) and 120 minutes (p<0/001) after intervention. The effect of supermint oil on pain severity after caesarean section. Fazel N. Sabzevar Univ. Asia Pac J Clin Nutr. 2004;13(Suppl):S126

Red Vine Leaf Extract: In a 71-adult DB PC crossover study of red vine leaf extract AS 195 360 mg/d for 6 weeks on cutaneous microvascular blood flow, transcutaneous oxygen pressure (tcpO2), and leg edema in patients with chronic venous insufficiency (CVI), those on AS 195 had increased microvascular blood flow values (+242 arbitrary units [AU] versus a decrease of –41 for placebo; p < 0.0001). Oxygen increased to 1.35 mm Hg vs. -7.27 for placebo; p < 0.0001). Leg circumference was decreased (ankle level: by -0.39 vs. +0.29; p < 0.0001; calf level: by -0.54 vs. +0.14; p < 0.0001). Improvement of cutaneous microcirculation and oxygen supply in patients with chronic venous insufficiency by orally administered extract of red vine leaves AS 195: a randomised, double-blind, placebo-controlled, crossover study. Kalus U, Koscielny J, Grigorov A, Schaefer E, Peil H, Kiesewetter H. Berlin, Germany. Drugs R D. 2004;5(2):63-71

Fluoxetine (Prozac) or Olanzapine (Zyprexa) Helped Borderlines: In an 8-week DB PC study of 45 women with borderline personality disorder, fluoxetine was compared to olanzapine and both drugs. Olanzapine monotherapy and the combination were associated with a significantly greater rate of improvement than fluoxetine on both outcome measures. However, fluoxetine by itself led to a substantial reduction in impulsive aggression and severity of depression. Weight gain was greater with olanzapine. A preliminary, randomized trial of fluoxetine, olanzapine, and the olanzapine-fluoxetine combination in women with borderline personality disorder. Zanarini MC, Frankenburg FR, Parachini EA. Harvard-McLean, J Clin Psychiatry. 2004 Jul;65(7):903-7. For more, see Borderlines. 

Fish Oil Helps Lupus: In a 24-week DB PC study of 52 systemic lupus erythematosus (SLE) patients, one group received 3 g MaxEPA fish oil and 3 mg copper, another 3 g MaxEPA and placebo copper, another 3 mg copper and placebo fish oil, and the fourth group received both placebo capsules. There was a significant decline in the lupus activity SLAM-R score from 6.12 to 4.69 (p < 0.05) in those subjects taking fish oil compared to placebo. No significant effect on SLAM-R was observed in subjects taking copper. The clinical effect of dietary supplementation with omega-3 fish oils and/or copper in systemic lupus erythematosus. Duffy EM, Meenagh GK, McMillan SA, Strain JJ, Hannigan BM, Bell AL. University of Ulster, UK. J Rheumatol. 2004 Aug;31(8):1551-6. Ed: This is the third of three studies I have found with this result. For the others, see Lupus.

Raloxifene Reduces Breast Cancer But Cost Extremely High: Mammograms were routinely done in 10,575 women in DB PC trials. The 7,108 on raloxifene in 19,381 person-years had 10 cases of invasive breast cancer (0.52 per 1000 person-years). For placebo, there was 1.62 per 1000 person-years. (PDR 2004 Evista Insert). At $1000 per year cost, this is roughly $900,000 per case of invasive cancer prevented. Since breast cancer kills roughly 50% of its victims, the cost per life saved would be $1,800,000, a very high figure. The fracture-prevention benefit of raloxifene to women taking vitamin K in addition of adequate doses of vitamin D (800-1000 IU/day) and calcium (1000 mg/day) has never been determined and there may be no benefit at all. For more, see Breast Cancer.

Vitamin D Plus Calcium Helps Fracture Healing in Elderly: In a 12-week DB PC study of 30 elderly women average age 78 with humerus fractures, those receiving oral 800 IU vitamin D(3) plus 1 g calcium had a positive effect on fracture healing over the first 6 weeks. The Effect of Calcium and Vitamin D(3) Supplementation on the Healing of the Proximal Humerus Fracture: A Randomized Placebo-Controlled Study. Doetsch AM, Faber J, Lynnerup N, Watjen I, Bliddal H, Danneskiold-Samsoe B. Frederiksberg Hospital, Copenhagen, Denmark. Calcif Tissue Int. 2004 May 27. For more, see Osteoporosis.

Disulfiram (Antabuse) Helped Teen Alcoholics: In a 90-day DB PC study of 26 teen alcoholics ages 16-19, disulfiram 200 mg/day did better with 1 vs. 6 relapsing. Seven disulfiram-treated and two placebo-treated patients had been abstinent continuously (p = 0.0063). Comparison of disulfiram and placebo in treatment of alcohol dependence of adolescents. Comparison of disulfiram and placebo in treatment of alcohol dependence of adolescents. Niederhofer H, Staffen W. Drug Alcohol Rev 2003;22:295 – 297.

Cholinesterase Inhibitor Did Slow Decline in Severe Alzheimer's at a High Cost: In a 12 month study of 44 severe Alzheimer's disease patients, rivastigmine was slowly increased during the year up to an average of 11 mg/day at the end. For placebo, 45% declined by at least 4 points on the ADAS-cog. vs. 18% with rivastigmine. Patients benefited from high-dose rivastigmine treatment on all outcome measures, including the Mini-Mental State Examination, Progressive Deterioration Scale, as well as the Global Deterioration Scale (p < 0.001). By 52 weeks, rivastigmine was still favored. A 12-Month Study of the Efficacy of Rivastigmine in Patients with Advanced Moderate Alzheimer's Disease. Karaman Y, Erdogan F, Koseoglu E, Turan T, Ersoy AO. Erciyes University, Kayseri, Turkey.   Dement Geriatr Cogn Disord. 2004 Sep 21;19(1):51-56. Ed: Like many physicians, I don't think the small benefit is worth the high cost. Donepezil can be obtained from India much more cheaply and might be worth it.  Quite a number of alternative remedies appear to be of benefit at a much lower cost: fish oil, sage, lemon balm, etc. For more, see Alzheimer's.

Butterbur No Benefit for Allergic Rhinitis in Study: Butterbur (Petasites hybridus) contains the active ingredient petasin, which exhibits antileukotriene and antihistamine activity. In a DB PC study of 35 grass pollen allergy sufferers with intermittent allergic rhinitis, 50 mg twice daily of butterbut There was no significant clinical efficacy of butterbur use vs placebo use on objective and subjective outcomes in IAR. Effects of butterbur treatment in intermittent allergic rhinitis: a placebo-controlled evaluation. Gray RD, Haggart K, et al. University of Dundee, Scotland. Ann Allergy Asthma Immunol. 2004 Jul;93(1):56-60. Ed: Three other studies I have found show benefit. For more, see Butterbur.

rTMS No Benefit for Schizophrenia in Study: In a DB PC study of high-frequency left prefrontal repetitive transcranial magnetic stimulation (rTMS) for 22 chronic hospitalized schizophrenia patients, 2 weeks (10 sessions) of real vs. sham rTMS. ( 20 trains of 5-second 10-Hz stimulation at 100 percent motor threshold, 30 seconds apart) found no benefit for symptoms as measured by the PANSS, MMSE, and hormonal testing. Left prefrontal repetitive transcranial magnetic stimulation in schizophrenia. Holi MM, Eronen M, et al. Helsinki University, Finland. Schizophr Bull. 2004;30(2):429-34

Infant Formula Fermented with Yogurt Bacteria did Better: In a DB PC study of 971 infants aged 4-6 months, those given an infant formula (FF) fermented with Bifidobacterium breve C50 and Streptococcus thermophilus 065) had the same growth of the infants and acceptability of formula as the standard formula. The incidence, duration of diarrhea episodes, and number of hospital admissions did not differ significantly between groups. However, episodes were less severe in the FF (fermented formula) group. There were fewer cases of dehydration 2.5% vs. 6.1% (P = 0.01), fewer medical consultations (46% vs. 56.6%, P = 0.003), fewer ORS prescriptions 41.9% vs. 51.9% (P = 0.003) and fewer switches to other formulas (59.5% vs. 74.9%, P = 0.0001) in FF infants compared to standard. Effects of long-term consumption of a fermented infant formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on acute diarrhea in healthy infants. Thibault H, Aubert-Jacquin C, Goulet O. Paris, France. J Pediatr Gastroenterol Nutr. 2004 Aug;39(2):147-52. For more, see Yogurt.

Orlistat (Xenical) Helped Lose a Little Weight: In a 6-month DB PC study of 1,004 obese patients, orlistat 120 mg three times daily plus a mildly reduced-calorie diet produced a significantly greater weight loss than placebo and diet in type 2 diabetes (-4.2% vs. -1.4%), hypertension (-6.2% vs. -1.9%) and hypercholesterolaemia (-5.5% vs. -2.3%) groups (p < 0.0001 for all). Effects of orlistat on obesity-related diseases - a six-month randomized trial. Guy-Grand B, Drouin P, Eschwege E, Gin H, Joubert JM, Valensi P. Paris, France. Diabetes Obes Metab. 2004 Sep;6(5):375-83. Ed: These are modest 4-8 pound weight losses.

Orlistat (Xenical) and Sibutramine (Meridia) Small Benefit at High Price: Eleven orlistat weight loss studies (four of which reported a second year ) and five sibutramine studies (three weight loss and two second year) were included in a meta-analysis. Dropouts averaged 33% during the weight loss phase for orlistat and 43% for sibutramine. All received lifestyle modification. Compared to placebo, orlistat-treated patients lost 6 pound or 2.9% more weight than placebo and those on sibutramine lost 9 pound or 4.6%. The numbers achieving 10% or greater weight loss were 12% higher with orlistat and 15% higher with sibutramine. Weight loss maintenance results were similar. Orlistat caused gastrointestinal side effects and sibutramine caused small increases in blood pressure and pulse rate. Both were modestly effective, but with high dropout rates. Long-term health effects are unknown. Long-term pharmacotherapy for obesity and overweight. Padwal R, Li S, Lau D. Toronto, Ontario. Cochrane Database Syst Rev. 2004;3:CD004. Ed: The costs of these medicines are $1700 and $3000 per year. Since patients regain most of the weight shortly after stopping the medications, these medicines compare poorly with surgery. For more, see Obesity.

Highly Faulty Study Criticizes Lithium Treatment for Children: In a 2-week DB PC discontinuation study of 40 children with acute mania after 4 weeks of lithium treatment, there was only a  slightly lower exacerbation rate of those maintained on lithium (52.6%) vs. those switched to placebo (61.9%). Lithium treatment of acute mania in adolescents: a placebo-controlled discontinuation study. Kafantaris V, Coletti DJ, et al. Zucker Hillside Hospital, Glen Oaks, NY J Am Acad Child Adolesc Psychiatry. 2004 Aug;43(8):984-93. Ed: I strongly disagree with the concept of discontinuation studies.  I think that they are a bogus type of research.  Also, this small study is highly unusual in finding a 53% exacerbation of mania for individuals on lithium which occurred after more than four weeks on the medication.  It suggests that either lithium or something else (the psychiatric unit program or separation from family?) was making the children feel worse. For the authors to demean lithium treatment of children based on such a faulty study makes no sense whatsoever, but that is just what they did. For more, see Lithium.

Statin Slightly Increases HDL Good Cholesterol: In a 6-week DB PC crossover study of 151 adults with stable type 2 diabetes, both simvastatin 80 and 40 mg significantly increased total HDL-C from baseline ( 8% and 5%; p < 0.001) compared with placebo, and significantly reduced plasma concentrations of LDL-C (p < 0.001), triglycerides (p < 0.001), apolipoprotein B (p < 0.001), and hs-CRP (p < or = 0.012). Compared with simvastatin 40 mg, the 80 mg dose provided additional efficacy. Simvastatin 80 mg also significantly (p < 0.001) increased HDL(2) from baseline (14%) and placebo phases (10%). Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. Miller M, Dobs A, Yuan Z, Battisti WP, Borisute H, Palmisano J. University of Maryland. Curr Med Res Opin. 2004 Jul;20(7):1087-94

Cholesterol Lowering Statin Therapy Appears Safe for Children; Questionable Wisdom and Ethics: Children with familial hypercholesterolemia have endothelial dysfunction and increased carotid intima-media thickness (IMT), which precede the premature atherosclerotic disease they develop much later in life. In a 2-year DB PC study of 214 children with familial hypercholesterolemia, all were encouraged to follow a fat-restricted diet and to get regular physical activity. Those given pravastatin, 20 to 40 mg/d (n = 106), had a mild carotid IMT regression of -0.010 mm vs. an increase of +0.005 mm with placebo. Pravastatin significantly reduced LDL cholesterol  by 24.1% vs. an increase of +0.3% for placebo (P<.001). No differences were observed for growth, muscle or liver enzymes, endocrine function parameters, Tanner staging scores, onset of menses, or testicular volume between the 2 groups. Efficacy and safety of statin therapy in children with familial hypercholesterolemia: a randomized controlled trial. Wiegman A, Hutten BA, et al. University of Amsterdam, The Netherlands. JAMA. 2004 Jul 21;292(3):331-7. Ed: The wisdom and cost of expensive cholesterol lowering therapy to prevent heart attacks an average of 50-60 years later is highly questionable.  Diets in Amsterdam are almost as miserable as in the U.S.  I doubt that the actual diets consumed were very healthy. Policosanol is vastly less expensive and very few side-effects compared to statins.  It would have been a better choice to research.  Even if it didn't work, primary prevention with statins is extremely wasteful even for hypercholesterolemic middle-aged adults and of very minimal value. For more, see The Statins.

Unethical Industry-Funded Chinese Study Showed Evista Helped Bones: In a 1-year DB PC study of 204 postmenopausal Chinese women with osteoporosis, raloxifene (60 mg/day) increased lumbar spine BMD by 3.3% vs. 1% for placebo (P < 0.001), hip BMD by 1.4% vs. a decrease of 0.9% for placebo. There were no new vertebral fractures with raloxifene vs. 5 for placebo. Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in Chinese postmenopausal women with osteoporosis: a multi-center, randomized, placebo-controlled clinical trial. Liu JL, Zhu HM, et al. Beijing, China. Chin Med J (Engl). 2004 Jul;117(7):1029-35. Ed: This apparently industry-funded study intentionally unethically deprived the control group of vitamin D, vitamin K, calcium, and magnesium in order to make Evista look good.  If the control group had taken the supplements, it is unlikely any of them would have suffered fractures.  Anything to make money. 

Evista Giant Waste of Money for Osteoporosis: Evista (raloxifene) is $84/mo at Walgreens.com (9/27/04) or $1008 per year. In the industry sponsored raloxifene study of 7705 women with osteoporosis advertised by the company in the 2004 Physician's Desk Reference, after 3 years only 4.3% of elderly women had vertebral fractures with placebo vs. 1.9% with placebo. All received 500 mg of calcium and 400-600 IU of vitamin D. In 3 DB PC studies for prevention of osteo, That's $125,000 and taking pills 40,000 times and filling 1,333 prescriptions to prevent one vertebral fracture.  If it were your money and your time, would you do it?  Even this miniscule benefit is bogus, since taking one vitamin D 1000 IU capsule instead of a 400 IU pill, 1000 mg of calcium instead of 500 mg, and taking one vitamin K tablet daily would have considerably increased the benefits to the control group.  For more, see Osteoporosis and Cost-Effectiveness.