An estimated 42% of Americans use complementary/alternative medicine (CAM) and some 50% of cancer patients routinely combine them with conventional care, despite lack of evidence on safety and efficacy. Herbal products are one of the most frequently used approaches as reflected by the 70% increase in market sales to $3.24 billion in 1997. As cancer incidence and survival time increase, the population seeking herbal therapy approaches is expected to increase also. Thus, scientific evaluation of herbals is critical. This position paper provides a rationale for such evaluations. The perspectives from manufacturers, regulatory agencies, and clinicians are presented, as well as the need for a multidisciplinary collaboration. We present guidelines for developing Investigational New Drug (IND) applications for heterogeneous botanicals and address challenges inherent in the process.
EisenbergDDavisREttnerSTrends in alternative medicine use in the United States, 1990–1997 results of a follow-up national survey. JAMA.1998;280:1569–1575.
2.
FisherPWardA. Complementary medicine in Europe. Br Med J.1994;309:107–111.
3.
MacLennanAHWilsonDHTaylorAW. Prevalence and cost of alternative medicine in Australia. Lancet.1996;347:569–573.
4.
HauserSP. Unproven methods in cancer treatment. Curr Opinion Oncol.1993;5:646–654.
5.
EisenbergDKesslerRCFosterCNorlockFECalkinsDRDelbancoTL. Unconventional medicine in the United States: Prevalance, costs, and patterns of use. New Engl J Med.1993;328:246–252.
6.
CassilethBRLuskEFStrouseTBBodenheimerBJ. Contemporary unorthodox treatments in cancer medicine: A study of patients, treatments, and practitioners. Ann Int Med.1984;101:105–112.
7.
American Cancer Society.Unproven methods of cancer management—macrobiotic diets for the treatment of cancer. CA: A Cancer J Clinicians.1989;39(4):248–251.
8.
LernerIJKennedyBJ. The prevalence of questionable methods of cancer treatments in the United States. Cancer.1992;42:181–191.
9.
RichardsonMARamirezTNanneyKSingletarySE. Alternative/complementary medicine: implications for patient-provider communication. Proceedings of ASCO.1999;18:590A.
10.
GrayREFitchMGreenbergMPerspectives of cancer survivors interested in unconventional therapies. J Psychosocial Oncology.1997, 15:149–171.
11.
BursteinHJGelberSGuadagnoliEWeeksJC. The use of complementary health strategies by women with early stage breast cancer. Presented at the American Cancer Society Meeting, 1998.
12.
CoppesMIAndersonRAEgelerRMWolffJEA. Alternative therapies for the treatment of childhood cancer. New Engl J Med.1998;339:846–847.
13.
WetzelMSEisenbergDMKaptchukTJ. Courses involving complementary and alternative medicine at US medical schools. JAMA.1998;280:784–787.
14.
AstinJA. Why patients use alternative medicine. Results of a national study. JAMA.1998;279:1548–1553.
15.
HoeyJ. The arrogance of science and the pitfalls of hope. (Editorial). Canadian Med Assoc J.1998;159: 803–804.
16.
DurantJR. Alternative medicine: an attractive nuisance. (editorial). J Clinical Oncology.1998;16:1–2.
17.
TannockIFWarrDG. Unconventional therapies for cancer: a refuge from the rules of evidence?Canadian Med Assoc J.1998;159:801–802.
18.
Office of Alternative Medicine. Washington, DC: First Investigators Meeting; 1994.
19.
CooperRAStofletSJ. Trends in the education and practice of alternative medicine clinicians. Health Aff. (Millwood).1996;15:226–238.
20.
ErnstEReschKWhiteAR. Complementary medicine: what physicians think of it—a meta-analysis. Arch Intern Med.1995;155:2405–2408.
BourgeaultI. Physicians’ attitudes toward patients’ use of alternative cancer therapies. Can Med Assoc J.1996;155(12):1679–1685.
23.
AngellMKassirerP. Alternative medicine—the risks of untested and unregulated remedies. New Engl J Med.1998;339:839–841.
24.
DiPaolaRSZhangHLambertGHClinical and biologic activity of an estrogenic herbal combination (PC-SPES) in prostate cancer. New Engl J Med.1998;339:785–791.
25.
BailarJCGornikHL. Cancer undefeated. New Engl J Med.1997;336(33): 1569–1574.
26.
BussingA. Mistletoe therapy and immunological research. Anti-Cancer Drugs (Suppl).1997;8:S65.
27.
GabiusHIAndreSKaltnerISiebertHCvon der LiethCWGabiusS. The mistletoe myth: claims, reality and provable perspectives. Zeitschrift Fur Arztliche Fortbildung.1996;90:103–110.
28.
HajtoTHostanskaKGabiusHJ. Modulatory potency of the beta-galactoside-specific lectin from mistletoe extract (Iscador) on the host defense system in vivo in rabbits and patients. Cancer Res.1989;49:4803–4808.
29.
HajtoTHostanskaKFreiKRordorfCGabiusHI. Increased secretion of tumor necrosis factor alpha, Interleukin 1, and Interleukin 6 by human mononuclear cells exposed to b-Galactoside-specific Lectin from clinically applied mistletoe extract. Cancer Res.1990;50:3322–3326.
30.
DouwesFRWolframDIMigeodF. Results of a prospective randomized study on chemotherapy vs. chemotherapy plus biological response modifier in metastasizing colorectal carcinoma. Krebsgeschehen.1986;18:155–164.
31.
DouwesFRKaldenMFrankGHolzhauerP. Treatment of advanced colorectal carcinoma. Onkologie.1988.
32.
BoieDGutschI. Helixor in cancer of colon and rectum. Schriftenreihe Krebsgeschehen.1980;23: 65–76.
33.
GutschJBergerHScholzGDenckH. Prospective study in radically operated breast cancer with poly-chemotherapy, Helixor and untreated control. Deutsche Zeitschrift Fur Onkologie.1988;21:94–101.
34.
Warner-LambertWarner-Lambert launches quanterra (TM): standardized herbal supplements clinically proven by doctors to be safe and effective—quanterra mental sharpness with ginko biloba and quanterra prostate, with saw palmetto. NewsEdge Corp./Newswire. October 14, 1998.
HoughtonPJ. Establishing identification criteria for botanicals. Drug Inf J.1998;32:461–469.
37.
LazarowychNPekosP. Use of fingerprinting and marker compounds for identification and standardization of botanical drugs: strategies for applying pharmaceutical HPLC analysis to herbal products. Drug Inf J.1998;32:497–512.
38.
EskinaziDP. Factors that shape alternative medicine. JAMA.1998;280(18):1621–1623.
