Women's health update.
This randomized, double-blind, placebo-controlled trial investigated two doses of oral lavender essential oil in comparison with a selective serotonin reuptake inhibitor, paroxetine, in patients who have been diagnosed with generalized anxiety disorder (GAD). The primary outcome of this study was the effect of lavender essential oil in comparison with placebo, on GAD, as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score. This instrument assesses 14 symptoms of anxiety through a scale ranging from 0 (absent) to 4 (severe). The secondary outcome was the effect of lavender essential oil compared with paroxetine on GAD.
A total of 616 patients were recruited and then 536 patients randomized to treatment. These were men and women, between ages 18 and 65 year old, from 57 general and psychiatric practices in Germany, who had a diagnosis of moderate to marked severity of GAD for an average of 2.5 years. Inclusion criteria were those individuals with a HAM-A score of 18, and with scores for anxious mood and tension symptoms of 2 or greater, in addition to a score of 21 or less for psychic anxiety. An additional anxiety scale was used as well, the Clinical Anxiety Scale (CAS), and the inclusion criteria were those with a score of 9 or greater. Individuals with any additional psychiatric illnesses were excluded. Psychiatric medications other than the paroxetine were not allowed during and for 30 days prior to entering the study. A total of 128 were in the 160 mg lavender group, 135 in the 80 mg/day group, 137 in the paroxetine group, and 136 in the placebo group.
Individuals were given a lavender essential oil made from the steam-distilled fresh flowering top of lavender standardized to contain approximately 70% of two constituents, linalool and linalyl acetate. The product was given as either a 80 or 160 mg dose and then 1 placebo or 2 placebo pills daily. The paroxetine was given in capsules of 20 mg. Treatment was given for 10 weeks, and measurements of safety and efficacy were done at 2, 4, 6, 8, and 10 weeks. During a week of "down-titration" following the study, patients on the paroxetine took the treatments every other day to account for any withdrawal problems caused by paroxetine. Patients in the lavender essential oil group took placebo.
After 4 weeks of the study and at other time points, the intake of 160 mg/day of lavender essential oil resulted in a significantly greater change in the HAM-A score compared with placebo (p < 0.01). After 6 weeks and beyond, those taking the 80 mg/day of lavender essential oil had a significantly greater change in the HAM-A scores compared with placebo (p = 0.02). At week 6, the HAM-A score in those taking paroxetine approached significance (p = 0.06) but then were not significantly better than placebo after that point.
Significantly more patients in the 160 mg/d lavender group showed an improvement in the HAM-A score of 50% or more compared with the placebo group (60.3% vs. 37.8%). This was also observed in the 80 mg/d group (51.9% vs. 37.8%). The HAM-A score was <10 in significantly more of those patients taking the lavender product compared with the placebo (46.3% vs. 29.6%). According to the clinical global impression (CGI), all three treatment groups (the 80 mg/day, 160 mg/day, and paroxetine) contained a greater percentage of patients who were "much/very much improved" or had a "moderate/ marked" therapeutic effect as compared with the placebo group. The adverse events reported were 25% of those in the 160 mg/day lavender group, oddly higher in 34.8% of the 80 mg/day group, 40.9% in the paroxetine group, and 30.9% in the placebo group. These adverse events were reported as gastrointestinal disorders, infections, and nervous system problems.
Comment: Both doses of oral essential oil of lavender were effective in treating GAD and more effective than the conventional medicine, paroxetine. Adverse events in those taking lavender were similar in those taking placebo and lower than those taking paroxetine. This is another welcomed positive study in using an oral lavender essential oil standardized to linalool and linalyl acetate in the treatment of GAD. Conventional medications, whether antidepressants, anxiolytics, or barbiturates, are fraught with side effects, which makes the lavender essential oil product that much more appealing.
Chamomile and Generalized Anxiety Disorder
This randomized, double-blind, placebo-controlled trial was conducted in patients with mild to moderate generalized anxiety disorders (GAD) and compared Matricaria recutita (chamomile) extract with placebo.
Patients, all 18 years old or older, from a community health outpatient clinic were enrolled. All had a diagnosis of mild to moderate Axis I GAD and a minimum baseline total Hamilton Anxiety Rating (HAM-A) scale of 9 or more; those with comorbid minor depression were not excluded. Patients were excluded if depression was the primary disorder or if they had a current diagnosis of major depressive disorder, bipolar disorder, panic disorder, phobic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, acute stress disorder, substance-induced anxiety disorder, psychosis, dementia, or substance abuse or dependence within the preceding 3 months. Concurrent use of anxiolytics, antidepressants, mood stabilizers, sedatives, or other herbal/nutritional remedies was not permitted. A total of 57 were randomized to either chamomile extract (n = 28) or placebo (n = 29) for 8 weeks.
Patients were given either pharmaceutical-grade German chamomile extract standardized to 1.2% apigenin or 220 mg, or placebo. Patients were given 1 capsule daily for the first week and then increased to 2 capsules daily during the second week of treatment. At week 3, those patients with a 50% reduction or less in the total HAM-A score compared with baseline score were increased to 3 capsule daily during week 3 and then to 4 capsules daily during week 4. In those who continued to have a 50% reduction or less, they were increased to 5 capsules daily during weeks 5 through 8. Outcome measurements were done at baseline, and after weeks 2, 4, 6, and 8.
Sixty-one patients were originally enrolled, and 57 patients had a baseline visit and began treatment. Four were screen failures; 8 discontinued treatment before completing the trial.
There was a significantly greater reduction over time in the primary outcome with a mean total HAM-A score for chamomile versus placebo (p = 0.047). Although not statistically significant, there was a meaningful trend favorable to chamomile in the Beck Anxiety Inventory, the Psychological General Well Being index, and the Clinical Global Impression Severity rating.
Comment: Chamomile has a long, rich tradition of use for inducing relaxation and its calming effect. Its exact mechanism of action is not known, but some evidence suggests that one or more of its flavonoid constituents may have an anxiolytic effect by affecting noradrenalin, dopamine, serotonin transmission, and gamma-amino butyric acid. The apigenin constituent have been shown to bind to benzodiazepine receptors as well as reduce gamma-amino butyric acid activated activity. One might wonder if the results of this study would have been better if it had used larger doses of the chamomile extract than the maximum of 1100 mg/day. The study also did not have standard timing of the dosing, which may have altered the effectiveness. It is also possible that another species of chamomile would have produced different results. A study done on patients with just a mild to moderate disorder (rather than severe anxiety) and such a small sample size are limitations, but nonetheless the results were statistically significant and did include those with not only mild symptoms but moderate as well. The results of this study are worth exploring in terms of more clinical rigorous use and dosing of chamomile extracts for mild to moderate GAD.
Amsterdam I, Li Y, SoeIler I, et al. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. I Clin Psychopharmacol. 2009;29:378-382.
Ginger vs. Sumatriptan for Common Migraine
This double-blind, randomized, controlled clinical trial compared the efficacy of ginger with sumatriptan in the treatment of common acute migraine episodes. Assessments include the time of headache onset, severity, time interval from headache beginning to taking drug, and patient self-assessment of response for five consecutive migraine attacks.
Study subjects were 100 sufferers of common migraine headaches, from the Neurology Clinic of Zanjan Hospital in Iran. The average age of participants was 35.1 in the sumatriptan group and 33.9 in the ginger group. Women comprised 68% of the sumatriptan group vs. 74% of the ginger group. The average duration of a migraine diagnosis was similar in both groups at approximately 7 years. The average number of headache attacks in the sumatriptan groups were 5.8 and 4.9 in the ginger-treated group. Inclusion criteria for the study included a confirmed diagnosis of migraine without aura by a neurologist, age of 18 years and older, high school diploma or higher, and a frequency of 2 to 10 headaches/month.
Individuals were randomly given either 1 ginger capsule of 250 mg or 50 mg of sumatriptan upon onset of headache. Questionnaires were completed for each headache attack, recording time of headache onset; severity; timing of drug taking; and response self-assessments at 30, 60, 90, and 120 minutes and 24 hours. Any adverse effects were also recorded. The overall study duration was 1 month.
Both sumatriptan and ginger powder decreased the mean severity of common migraine attacks within 2 hours of use. No significant difference existed between the two treatments. Before taking the medication, 22% of the sumatriptan group and 20010 of the ginger group had severe headaches. The mean headache severity at 2 hours after sumatriptan or ginger use demonstrated similar effectiveness for both groups. There was 4.7 unit reduction in the headache severity in the sumatriptan group and a 4.6 reduction in the ginger group. Favorable relief was achieved in 70% of the sumatriptan-treated headache individuals and 64% of the ginger-treated patients at 2 hours following intake. Both the sumatriptan and ginger significantly provided pain relief, and no significant differences were achieved.
There were more side effects from sumatriptan use, including dizziness, sedation, vertigo, and heartburn. The only clinical adverse effect of ginger was dyspepsia.
Comment: I am quite impressed that the current study reveals that both sumatriptan at 50 mg and ginger powder at 250 mg decreased the mean severity of a common migraine attack and within 2 hours of use. Pain relief and patient satisfaction did not show any significant difference, although side effects due to ginger were far less than those with sumatriptan. This is not the only study showing benefit for ginger and acute migraine pain. In a 2005 study, a ginger-feverfew extract alleviated migraine headache completely in 48% of individuals and partially in 34% within 2 hours of taking the ginger.(1) In a double-blind, placebo-controlled study, this same ginger-feverfew medication (Gelstat) resulted in a significantly higher pain-relief rate of 65% vs. 36% at 2 hours posttreatment. (2)
In my experience, the natural-medicine strategies for reducing the frequency and severity and duration of migraines are quite effective and include basic lifestyle and nutritional plans but, more significantly, involve a multifactorial approach using riboflavin, ginger, feverfew, 5-HTP, butterbur, magnesium, CoQ10, and sometimes cyclic estrogen patches in women with menstrual migraines. I have never felt very optimistic about acute intervention for acute pain relief with these supplements or others in reducing the severity of an acute migraine. There are anecdotal reports of oral ginger for acute migraine, 500 mg at onset and repeated every 4 hours, and an open-label study of ginger with feverfew for acute mild migraine headache pain. I am encouraged, though, by this study that use of ginger capsules for acute migraines may provide pain reduction with an overall 44% palliation in all headache attacks within 2 hours.
Maghbooli M, Golipour F, Esfandabadi A, Yousefi M. Comparison between the efficacy of ginger and sumatriptan in the ablative treatment of the common migraine. Phylotherapy Res. 2014;28:412-415.
Single Safe Herbs and Challenging Issues: Anxiety and Acute Migraine
Kasper 5, Gastpar M, Muller WE, et al. Silex.an is effective in generalized anxiety disorder--a randomized, double-blind comparison to placebo and paroxetine. Int 1 Neuropsychopharmacol. Epub January 23, 2014:1-11. doi:10.101761461145714000017.
Best of Naturopathic Medicine 2015
The Townsend Letter is pleased to announce our seventh Best of Naturopathic Medicine competition. Naturopathic students, faculty, researchers, and practitioners are invited to submit research papers, reviews, and articles. Selected papers will be published in our February/March 2015 issue. The author of the winning paper will be awarded $850. Runner-up papers will be published and authors will receive an honorarium.
Papers submitted should be 1500 to 3500 words and referenced. Author guidelines are available at the Townsend Letter website: www.townsendlettercom. Papers should be submitted digitally, preferably as a Microsoft Word document. Papers authored by multiple writers are acceptable; the lead author should be an ND graduate or candidate of an accredited four-year naturopathic school. Papers submitted for the competition may not be submitted to other publications or have previously been published. All entries must be submitted by October 31, 2014.
Send papers to editorial@townsendlettercom. The subject line should read: "Paper for Best of Naturopathic Medicine 2015."
(1.) Cady R, Schreiber C, Beach M; Hart C. Gelstat migraine for acute treatment of migraine when administered during the mild pain phase. Med Sci Monk 2005;11(9):165-169.
(2.) Aurora 5, Vermaas A, Barrodale P. Gelstat is effective in relieving migraine pain in a double-blind, placebo-controlled study. American Headache Society 48th annual scientific meeting. June 22-25; Los Angeles, CA; 2006.
by Tori Hudson, ND firstname.lastname@example.org
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