Woolley Map

January 2000 Bruce H. Woolley, Pharm.D., Editor Vol. 7, No. 1
Kenneth J. Hunt, Associate Editor

Use of SAMe For Depression

Depression of some form or another afflicts more than ten percent of the U.S. population. Those seeking treatment for depression have implemented a number of alternative remedies. The most recent candidate to receive a burst in popularity is SAMe (S-adenosyl-methionine), an endogenous compound synthesized from methionine and ATP. Available by prescription in many European countries, SAMe is marketed in stores and on the Internet to promote "emotional well being".

Most of the clinical trials that have found SAMe to be effective at treating depression have concluded in three weeks or less. This is compared to trials on anti-depressant medications, which must be at least 6-8 weeks long, allowing the drug to take effect and maintain its purpose. A meta-analysis of 7 trials involving 200 patients found that oral and parenteral SAMe are about as effective as several common anti-depressant medications.1 The incidence of adverse effects with use of SAMe has been similar to those with placebo. They include flatulence, nausea, vomiting and headache. No adverse interactions between SAMe and other drugs have been reported.

There are dozens of formulations of SAMe currently marketed in stores and on the Internet. The FDA has approved none of these products in any way. This is partly due to the chemical instability of the compound. Some of the oral preparations of SAMe have been reported to contain no SAMe at all. The current products sold in the United States by nutrition stores are enteric-coated SAMe butane disulfonate manufactured by Knoll. They are similar to the Italian prescription and are claimed to be more stable than other salts. A month’s supply of the average SAMe product costs around $230 based on 800 mg b.i.d.

As with most alternative medicines, there is no persuasive evidence that SAMe is effective or safe for the treatment of depression. Most research trials on the compound are too brief and inadequate to be useful. This product also brings into question the current conundrum of alternative medicine regulation. There is no currently guarantee to the consumer of product purity or potency. Due to lenient rules in the United States, we cannot assume that supplements sold here are identical to approved medications by the same name sold in other countries, even if the same manufacturer produces them.

Bressa, GM; ACTA Neurol Scand, suppl 154:7, 1994

  1. The Medical Letter. Vol 41 p.107-8

Transmission of Helicobacter pylori

Helicobacter pylori is a bacteria that commonly infects humans as the primary cause of peptic ulcers. It has also been implicated as one cause of gastric cancer. Medical science can now treat most ulcers by eradicating the H pylori bacteria from the system. There has been, however, some question as to the mode of transmission of the bacteria from infected individuals. A study published recently in JAMA measured the possible modes of transmission of the H pylori.

Sixteen asymptomatic H pylori-infected adults were given a cathartic or emetic to measure levels of H pylori in the stool and vomitus. The bacteria was also cultured from breath and saliva of the infected patients. The researchers isolated the bacteria from each medium and confirmed the species identity.

The results of the study demonstrated that all vomitus samples from infected subjects grew H pylori, often in high quantities. Air sampled during vomiting grew H pylori from 37% of the subjects. Saliva before emesis grew low quantities of H pylori in 18.8% of subjects, while saliva after emesis contained H pylori in more than half. Only 22% of 101 induced stools grew the organism, and no normal stools produced it.

These researchers conclude that H pylori pylori can be cultivated uniformly from vomit and, occasionally, from saliva and cathartic stools. The organism is potentially transmissible during episodes of gastrointestinal tract illness, particularly those that involve vomiting. It is likely that similar studies will be performed and solid recommendation will be made to control spread of H pylori infection in the population. The authors mention that epidemiological studies within households of people with GI tract illnesses would be prudent.


Thanks to JAMA. 1999;282:2240-2245

Zoloft for Posttraumatic Stress Disorder

Until early December, there had been no drugs that were approved to treat posttraumatic stress disorder (PTSD). The FDA recently approved sertraline hydrochloride (Zoloft/Pfizer) as the first drug treatment for PTSD, a disorder that has long been recognized as an important clinical problem. Zoloft was approved in l992 for treating depression, and was subsequently approved to treat obsessive compulsive disorder and panic disorder.

The DSM-IV identifies that a diagnosis of PTSD requires exposure to a traumatic event that involved actual or threatened death or serious injury or a threat to the physical integrity of self or others. The response must involve intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include re-experiencing the event (flashbacks, dreams, and avoidance reminiscent situations). A PTSD diagnosis requires that the symptoms be present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

The effectiveness of Zoloft for treating symptoms of this disorder is based on two multi-center placebo controlled, 12-week trials in adults who were diagnosed with posttraumatic stress disorder. The overall positive outcome in these trials appeared to derive from the female patients, with little effect seen in the male subgroups. The importance of this apparent gender difference has not been suggested. Common side effects of Zoloft include dry mouth, gastrointestinal distress and sleepiness.

FDA Press Release. Dec 7, 1999. http://www.fda.gov/cder

Drug Device for Pre-cancerous Skin Lesions

Actinic Karatoses (Aks) are rough, scaly, red or brown patches that begin to form on the surface of the skin. They are mostly found among individuals with light complexions and affect more than half of elderly fair-skinned persons in hot, sunny climates. They can also be found more rarely in individuals in their teens and twenties. If they are left untreated, AKs may become malignant.

The FDA recently announced the approval of Levulan Kerastick (aminolevulinic acid HCI) to be used in conjunction with photodynamic therapy for treatment of pre-cancerous AK skin lesions of the face or scalp. It is the first combined drug and device treatment designed for targeted treatment that can be limited to just the site of the lesion. It is estimated that about half of the estimated 5 million annual cases of skin cancer began as AKs. Early detection and treatment of AKs may reduce the number of cases of skin cancer.

The Levulan Kerastick is a two-stage treatment process which involves the topical application of aminolevulinic acid by a doctor directly to the individual AK lesions, followed 14 to 18 hours later by photodynamic therapy with blue light irradiation to the affected face or scalp areas. The Levulan Kerastick dosage form was designed to treat individual AKs lesions, thereby reducing possible skin irritation of unaffected, non-lesional skin. It is not currently indicated for the treatment of AKs of the back and arms.

Other treatments for AKs include cryosurgery (freezing), curettage (scraping), electrosurgery, excision, laser surgery, and topical chemotherapy. Medical experts still recommend that the best method of combating skin cancer is prevention. Common sense measures such as wearing protective clothing, avoiding the midday sun, and wearing sunscreen with a Sun Protection Factor (SPF) of at least 15 is still the best defense against skin cancer.

DUSA Pharmaceuticals, Inc of Valhalla, NY produces Levulan Kerastick as a topical solution, 20%. It is to be marketed in combination with the light source BLU-U Blue Light Photodynamic Therapy Illuminator.


HHS News U.S. Department of Health and Human Services, Dec 6, 1999 http://www.fda.gov 

Alternative Therapies For Diabetes

With the increased promotion of alternative therapies for diabetes, it is not surprising that clinicians get questions about their use. The American Diabetes Association reports that 30% of diabetics use supplements. A thorough review of plants with hypoglycemic activity in humans has been published. (Phytomedicine 1997;4(1):73-78). More than 400 plants purported to lower glucose were reviewed. The article states the "the use of plant remedies is not supported by findings from vigorous trials." The most common supplements used by patients with diabetes include:

                    Rationale: Alters absorption of other drugs and glucose

                    Adverse eff: Contains coumarins and steroidal saponins (monitor appropriately)

                                        GI distress

                    Clinical Trials: Weeks required for effects; no long-term data

                    May cause insulin resistance by inhibiting glucose kinase

                    Decreases glucose sensing at beta cells

                    Decreases expression and translocation of GLUT 4 transporters

                    Rationale: Increases insulin secretion

                    Uses: small decrease in glucose during trials with small population

                    Adverse effects: Inhibits taste, may ingest fewer calories,

No published toxicity in humans

                    Recommendations: dose dependant effect, monitor glucose,

May increase chance of hypoglycemia

The information and opinions expressed in the Therapeutics Letter do not necessarily reflect the official policy of the sponsoring organizations