DRUGS AND SUPPLEMENTS

Nicosan™

March 22, 2017

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Nicosan™

Natural Standard Bottom Line Monograph, Copyright © 2013 (www.naturalstandard.com). Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified healthcare provider before making decisions about therapies and/or health conditions.

While some complementary and alternative techniques have been studied scientifically, high-quality data regarding safety, effectiveness, and mechanism of action are limited or controversial for most therapies. Whenever possible, it is recommended that practitioners be licensed by a recognized professional organization that adheres to clearly published standards. In addition, before starting a new technique or engaging a practitioner, it is recommended that patients speak with their primary healthcare provider(s). Potential benefits, risks (including financial costs), and alternatives should be carefully considered. The below monograph is designed to provide historical background and an overview of clinically-oriented research, and neither advocates for or against the use of a particular therapy.

Related Terms

  • Ashanti pepper, Benin pepper, Eugenia caryophyllum, false cubeb, Guinea cubeb, Guinea pepper, Hemoxin™, kale (Nigeria), kukauabe (Nigeria), masoro, Niprisan®, Nix-0699, Piper guineense, Pterocarpus osun, sasema (Nigeria), sorghum, Sorghum bicolor, Sorghum japonicum, soro wisa (Nigeria), uziza pepper, vanillin, West African pepper.

Background

  • Nicosan™ is an antisickling drug used for prevention of symptoms and pain management in patients with sickle cell disease (SCD). It is prepared from a mixture of four Nigerian plant materials: the seeds of Piper guineense, the stems of Pterocarpus osun, the fruits of Eugenia caryophyllum, and the leaves of Sorghum bicolor.

  • Nicosan™ was developed at the Nigerian National Institute for Pharmaceutical Research and Development (NIPRD). It had been produced by Xechem International, Inc., an American-based company that filed for bankruptcy. It is unclear when production will resume.

  • Although the evidence supporting the use of Nicosan™ for SCD is promising, it should be noted that most of these studies were carried out by the Nigerian government, which has a vested interest in the drug's success. Further large-scale, randomized, controlled studies need to be performed before conclusions may be drawn.

Scientific Evidence

Uses

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

Grade*

Sickle cell disease

According to available clinical trials, Nicosan™ appears to be safe and effective for preventing and reducing sickle cell disease (SCD) crises associated with severe pain. Future research with larger sample sizes are needed to assess the role of Nicosan™ in the management of patients with SCD.

B

*Key to grades:A: Strong scientific evidence for this use; B: Good scientific evidence for this use; C: Unclear scientific evidence for this use; D: Fair scientific evidence against this use (it may not work); F: Strong scientific evidence against this use (it likely does not work).

Tradition/Theory

The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious and should be evaluated by a qualified health care professional.

  • Antiviral, HIV/AIDS.

Dosing

The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.

Adults (18 years and older)

  • For sickle cell disease, 12 milligrams of Niprisan® per kilogram has been taken by mouth daily for six months.

Children (under 18 years old)

  • For sickle cell disease, 12 milligrams of Niprisan® per kilogram has been taken by mouth daily for six months.

Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

  • Avoid with known allergy or hypersensitivity to Piper guineense, Pterocarpus osun, Eugenia caryophyllum, or Sorghum bicolor, their constituents, or members of the Piperaceae, Leguminosae, Myrtaceae, or Poaceae families.

Side Effects and Warnings

  • Nicosan™ may cause catarrh (inflamed mucous membranes), headache, rash, and sore throat.

  • Use cautiously in patients with skin sensitivities, in patients predisposed to headaches, or in combination with antisickling drugs or acetaminophen (paracetamol, Tylenol®).

  • Avoid in pregnant and lactating women, due to a lack of safety data.

  • Avoid with known allergy or hypersensitivity to Piper guineense, Pterocarpus osun, Eugenia caryophyllum, or Sorghum bicolor, their constituents, or members of the Piperaceae, Leguminosae, Myrtaceae, or Poaceae families.

Pregnancy and Breastfeeding

  • Avoid in pregnant and lactating women, due to a lack of safety data.

Interactions

Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.

Interactions with Drugs

  • Nicosan™ may interact with acetaminophen (paracetamol, Tylenol®), antiretroviral agents (indinavir, lamivudine, nevirapine, or zidovudine), and antisickling agents.

Interactions with Herbs and Dietary Supplements

  • Nicosan™ may interact with antisickling herbs and supplements, clove, sorghum, and West Africa pepper.

Author Information

  • This information is based on a systematic review of scientific literature edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

References

Natural Standard developed the above evidence-based information based on a thorough systematic review of the available scientific articles. For comprehensive information about alternative and complementary therapies on the professional level, go to www.naturalstandard.com. Selected references are listed below.

  1. Adzu B, Garba M, Haruna A, et al. Effect of niprisan on single oral dose pharmacokinetics of paracetamol in rats. Eur J Drug Metab Pharmacokinet. 2001;26(3):201-204. View Abstract

  2. Ataga KI. Novel therapies in sickle cell disease. Hematology Am Soc Hematol Educ Program. 2009:54-61. Review. View Abstract

  3. Awodgan AO, Wambebe C, Gamaniel K, et al. Acute and short-term toxicity of NIPRISAN® in rats I: a biochemical study. J Pharm Res Dev 1996;1(1):39-45.

  4. Babalola OE, Wambebe CO. When should children and young adults with sickle cell disease be referred for eye assessment? Afr J Med Med Sci 2001;30(4):261-263. View Abstract

  5. Cordeiro NJ, Oniyangi O. Phytomedicines (medicines derived from plants) for sickle cell disease. Cochrane Database Syst Rev 2004;(3):CD004448. View Abstract

  6. Gamaniel K, Amos A, Akah PA, et al. Pharmacological Profile of NIPRD 94/002/1-0: A Novel Herbal Antisickling Agent. Journal of Pharmaceutical Research 1998;3(2):39-45.

  7. Fawibe AE. Managing acute chest syndrome of sickle cell disease in an African setting. Trans R Soc Trop Med Hyg 2008;102(6):526-531. View Abstract

  8. Iyamu EW, Turner EA, Asakura T. Niprisan (Nix-0699) improves the survival rates of transgenic sickle cell mice under acute severe hypoxic conditions. Br J Haematol 2003;122(6):1001-1008. View Abstract

  9. Iyamu EW, Turner EA, Asakura T. In vitro effects of NIPRISAN (Nix-0699): a naturally occurring, potent antisickling agent. Br J Haematol 2002;118(1):337-343. View Abstract

  10. Okpala, I. Investigational agents for sickle cell disease. Expert Opin Investig Drugs 2006;15(8):833-842. View Abstract

  11. Wambebe CO, Bamgboye EA, Badru BO, et al. Efficacy of niprisan in the prophylactic management of patients with sickle cell disease. Current Therapeutic Research, Clinical & Experimental 2001;62(1):26-34.

  12. Wambebe C, Khamofu H, Momoh JA, et al. Double-blind, placebo-controlled, randomised cross-over clinical trial of NIPRISAN in patients with Sickle Cell Disorder. Phytomedicine 2001;8(4):252-261. View Abstract

Copyright © 2013 Natural Standard (www.naturalstandard.com)

The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.

Updated:  

March 22, 2017