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Helping patients taper from their antidepressant medication with NEURAPAS® balance NEURAPAS® balance is a unique herbal medicine that contains three potent psychoactive herbal extracts. Each film-coated tablet contains 60 mg of the dry extract of Hypericum perforatum, 28 mg of the dry extract of Valerian officinalis, and 32 mg of Passiflora incarnata. Each of the individual herbal extracts has well known postulated mechanisms of action.1 The extract of Hypericum perforatum exhibits monoamine oxidase inhibition (MAOI), gamma-aminobutyric acid (GABA) activity, monoamine reuptake, upregulation of 5-hydroxytryptamine1A (5-HT1A) and 5-HT2A receptors, and modulation of cytokine production. Valerian is known to have GABAergic effects and Passiflora is a partial agonist to benzodiazepine receptors. Based on these purported mechanisms of action, NEURAPAS® balance can be used to treat anxiety and/or depression. In an unpublished report (completed in 2007) of the literature pertaining to NEURAPAS® balance, I concluded that there is a sufficient body of literature showing good clinical outcomes when using these herbs individually2-13 and/or in combination.14-16 Industry-sponsored studies also support the therapeutic effectiveness of this preparation for anxiety and/or depression. A total of 10 clinical studies (2 controlled and 8 observational cohort studies) and 2 experience reports14 have shown NEURAPAS® balance to be safe and clinically effective. Over the last several years, I have been experimenting with NEURAPAS® balance in a novel manner to assist patients that want to be tapered from their antidepressant (i.e., selective serotonin reuptake inhibitor; SSRI) medi-cation. I have published a paper on this,17 and have a more substantive paper on the subject of tapering to be published in the Townsend Letter in 2013 (a draft copy can be obtained upon request via email). Generally, as my patients taper off their SSRI medication, the dose of NEURAPAS® balance is increased. I nor-mally begin with 1 tablet twice daily, and over the course of many weeks, the dose is increased to 3 tablets twice daily as their SSRI medication is eventually discontinued. Even though the elimination half-live is not known for NEURAPAS® balance, multiple daily dosing appears to yield more optimal thera-peutic outcomes than taking the preparation once daily. Helping Patients Taper from Their Antidepressant Medication . . . . 1 A 29 year-old female presented to my private clinical practice in December 2011. Sometime in 2003, she developed symptoms of anxiety that involved ru- minating excessively about being HIV-positive as well as health concerns involv-ing contamination. Her compulsive behavior involved checking and rechecking PASCOE CANADA Clinical Pearls Series: Mood Imbalances things throughout the day, which significantly impaired concerned about adverse drug interactions since this her quality of life. She was diagnosed with obsessive- specific preparation contains a very low daily dose of treatment of opiates withdrawal: a double-blind randomized controlled compulsive disorder by a psychiatrist who prescribed Hypericum (i.e. 360 mg from 6 tablets) with a corre- trial. J Clin Pharm Ther 2001;26:369-373.
25 mg/day of controlled-release Paxil (paroxetine). The spondingly low hyperforin content.
13. Miyasaka LS, Atallah AN, Soares BG. Passiflora for anxiety disorder. 1. Werneke U, Turner T, Priebe S. Complementary medicines in psychiatry. Cochrane Database Syst Rev 2007 Jan 24(1):CD004518. patient’s specific goal was to taper off the Paxil so that strating significant pharmacokinetic drug interactions 14. Pascoe NEURAPAS® CTD Documentation. Module 2:2.7 Clinical 2. Kasper S, Anghelescu IG, Szegedi A, et al. Superior efficacy of St. she could eventually become pregnant, and not worry with Hypericum extracts typically involve daily dosages Summary NEURAPAS® balance, film coated tablets. 2005;1-165.
John’s wort extract WS® 5570 compared to placebo in patients with ma- about the possible adverse effects the medication might of 900 mg or more. At the recommended daily dose of 15. Giesler M, Thum A, Haag A, et al. Effects of NEURAPAS® balance jor depression: a randomized, double-blind, placebo-controlled, multi- on sleep EEG, cognitive performance and mood: a double blind ran- have on the pregnancy. The patient’s mental status was 6 tablets, the mean amounts of hypericin and hyperfo- center trial. BMC Medicine 2006;4;14.
domised cross-over study in healthy volunteers. Z Phytother 2006;27(Is- 3. Anghelescu IG, Kohnen R, Szegedi A, et al. Comparison of Hypericum stable, and she was willing to assume the risks involved rin delivered are 0.72 mg and 1.35 mg respectively.18 extract WS® 5570 and paroxetine in ongoing treatment after recovery This small amount of hyperforin does not induce the 16. Müller D, Pfeil T, Driesch V. von den. Treating depression comorbid from an episode of moderate to severe depression: results from a ran- with anxiety – results of an open, practice-oriented study with St John’s major liver drug-metabolizing enzyme, cytochrome domized multicenter study. Pharmacopsychiatry 2006;39:213-219.
wort WS® 5572 and valerian extract in high doses. Phytomedicine 4. Davidson JR, Connor KM. St. John’s wort in generalized anxiety disor- I sent a letter to her medical doctor and suggested that P(CYP)450 3A4. Hypericum preparations containing der: three case reports. J Clin Psychopharmacol 2001;21:635-636.
our mutual patient be prescribed 20 mg/day dose of much higher amounts of hyperforin do induce this en- 17. Prousky J. When patients want to get off their psychotropic 5. Kobak KA, Taylor L, Futterer R, Warner G. St. John’s wort in general- medication(s). Integrated Healthcare Practitioners, 2012;5(1):56-59.
Prozac (fluoxetine) prior to tapering. I explained that zyme, and those are believed to be the reason for nu- ized anxiety disorder: three more case reports. J Clin Psychopharmacol 18. Pascoe NEURAPAS® CTD Documentation. Module 2:2.5 Clinical the controlled-release Paxil has a half-life less than 24 merous potential drug interactions. Overview NEURAPAS® balance, film coated tablets. 2005;1-39.
6. Taylor LH, Kobak KA. An open-label trial of St. John’s Wort (Hyperi- hours (about 15-20 hours) compared to Prozac that cum perforatum) in obsessive-compulsive disorder. J Clin Psychiatry Dr. Jonathan Prousky is the Chief Naturopathic Medical Officer and Pro- has a half-life of 4-6 days. Once the patient stabilizes Data provided by Pascoe demonstrates an excellent fessor at the Canadian College of Naturopathic Medicine. He is also the 7. Volz HP, Murck H, Kasper S, Möller HJ. St. John’s wort extract (LI 160) in on Prozac for 4 weeks, she should then be prescribed safety record and very low incidence of adverse effects editor of the Journal of Orthomolecular Medicine. He graduated from Ba- somatoform disorders: results of a placebo-controlled trial. Psychophar- a prescription for Prozac in liquid form. The liquid form from the use of NEURAPAS® balance or an equivalent, styr University with a Doctorate in Naturopathic Medicine. He has lectured extensively to medical doctors, naturopathic doctors and other healthcare of Prozac is ideal since doses can be minimally low- yet older version of the product.18 In a review of 8 open 8. Müller T, Mannel M, Murck H, Rahlfs VW. Treatment of somatoform providers on various health-related topics throughout North America. disorders with St. John's wort: a randomized, double-blind and placebo- ered while the doses of NEURAPAS® balance are in- non-controlled studies, only 22 adverse events were re- He is the author of Anxiety: Orthomolecular Diagnosis and Treatment, controlled trial. Psychosom Med 2004;66:538-547. creased. Here is the exact tapering schedule this patient corded in the 1,182 patients enrolled. The duration of Naturopathic Nutrition and Principles & Practices of Naturopathic Clinical 9. Andreatini R, Sartori VA, Seabra ML, Leite JR. Effect of valepotriates Nutrition. In addition to his supervisory role in the training of new naturo- these studies was 6-17 weeks, with one study lasting (valerian extract) in generalized anxiety disorder: a randomized placebo- pathic doctors Dr. Prousky has a private practice in Toronto focusing on controlled pilot study. Phytother Res 2002;16:650-654.
beyond 1 year. Of the 22 reported adverse events, 5 optimizing mental and neurological health with nutrition and botanical 10. Miyasaka LS, Atallah AN, Soares BG. Valerian for anxiety disorders. • Weeks 1-2: 16 mg/day Prozac and 1 tablet twice were considered to be possibly drug-related and none Cochrane Database Syst Rev 2006 Oct 18(4):CD004515. were classified as being serious. In single experience re- 11. Akhondzadeh S, Naghavi HR, Vazirian M, et al. Passionflower in the treatment of generalized anxiety: a pilot double-blind randomized con- • Weeks 3-4: 12 mg/day Prozac and 1 tablet three ports including 8,928 patients, the calculated adverse trolled trial with oxazepam. J Clin Pharm Ther 2001;26:363-367.
drug reaction rate was determined to be 0.38%. In ad- 12. Akhondzadeh S, Kashani L, Mobaseri M, et al. Passionflower in the • Weeks 5-6: 8 mg/day Prozac and 2 tablets twice dai- dition, post-marketing surveillance has shown a similar ly of NEURAPAS® balance safety record. Data from 1970 until the end of 2004 • Weeks 7-8: 4 mg/day Prozac and 3 tablets twice dai- show that the sale of these products amount to 2.8 mil-ly of NEURAPAS® balance lion packages containing 207 million tablets or 34.5 • Weeks 9+: Discontinue Prozac and remain on 3 tab- million daily doses equivalent to 94,600 patient-treat-lets of NEURAPAS® balance twice daily ment years (i.e., a patient year denotes 6 tablets daily administered to one patient for 1-year). From 1970- The patient experienced no withdrawal during the taper- 2004, only 10 suspected adverse events were reported. ing process and was stabilized on only the NEURAPAS® balance until July 2012. She then tapered from the ConclusionNEURAPAS® balance to pursue her goal of becoming pregnant via in vitro fertilization. NEURAPAS® balance is a well-studied natural health product with an extensive history of use, an impeccable safety record, and clinical studies demonstrating effi-cacy. Clinical experience has shown it to be an effec- This case highlights the safety and efficacy of tive substitute when patients are tapered from their SSRI NEURAPAS® balance when used to taper patients off medication. their SSRI medication. Clinicians should not be overly PASCOE CANADA Clinical Pearls Series: Mood Imbalances PASCOE CANADA Clinical Pearls Series: Mood Imbalances

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