Essentials of Complementary and Alternative Medicine (June 1999)


THE SAFETY OF SELECTED COMPLEMENTARY PRACTICES



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THE SAFETY OF SELECTED COMPLEMENTARY PRACTICES
This section of the book gives summary information from the published literature on adverse affects from manipulation, acupuncture, herbals, vitamins, mineral and 
other nutritional supplements, and homeopathy. The practitioner can use these chapters to review and refer to specific products and practices in CAM. One difficulty 
is that little is known about the prevalence of many of these events. The best sources of information on prevalence and adverse effect rates are from postmarketing 
surveillance studies, poison control centers, and randomized controlled trials.
Poison Control Centers
Perharic (
105
) and others have surveyed the toxicological problems resulting from traditional remedies and food supplements reported to a poison control center. Of 
the 5536 contacts, 657 (12%) had symptoms indicative of adverse effects from the ingestion. Most of these were children under 5 years of age who had ingested 
vitamins in overdose. Forty-two of these had some probability of being linked to the ingestion and two had high-probability. The rates of adverse effects calculated for 
vitamins were 343 in 4000 (8%), for food supplements 17 in 141 (12%), and for herbal products 245 in 968 (25%) (
Table 4
)(
105
). This information gives a sense of 
the rate of serious adverse events in situations of abuse but does not provide information about adverse effects rates under competent use.
Table 4. Adverse Effects from Misuse Reported to Poison Control Centers
Randomized Controlled Trials
Adverse effects reported in randomized controlled trials of alternative and complementary medicine as published in the conventional peer-reviewed literature would be 
the best type of evidence for identifying the true rate of hypothesis-driven, attributable adverse effects from the use of such interventions under normal conditions. 
This is because inflated effects would not likely be found from blinded trials that were using randomized assignment to therapy and that were specifically reporting on 
adverse effects and published in non-advocacy journals.
To access this information, we downloaded all of the citations from the National Library of Medicine (MEDLARS system) that dealt with alternative and complementary 
medicine, from double-blind, randomized control trials that specifically looked for and reported on adverse effects. Studies that involved extracted or purified plant 
toxins (e.g., podophyllotoxin) that were being used in combination with or as chemotherapeutic agents for cancer or were commonly used in conventional medicine 
(e.g., TENS therapy, direct electrical muscle stimulation, conventional chemotherapeutic agents [vincristine]) were excluded.
A total of 121 studies were found. Of these, 27 were found to meet the inclusion criteria and were evaluated for the type of therapy, the duration of the trial, the 
diagnosis and indication, the number in the trial, and the rate of adverse effects as compared with the control group (either conventional therapy or placebo). For 
alternative therapies compared to conventional therapies, we assessed whether the rate of adverse effects was lower, higher, or equal, and for the placebo trials 
whether the therapeutic efficacy of the trial was positive. Twenty-two of the studies involved plant or herbal preparations, two used megadose vitamins, two involved 
Traditional Chinese Medicine, and one involved electromagnetic pulsed fields. Mean duration of the trials was 10.3 weeks with a range of 1 to 52 weeks (sd = 11.4 
weeks). Type of condition ranged from cholesterol reduction and hay fever to nephrotic syndrome and advanced cancer. The average number of subjects enrolled in 
the trials was 89 with a range of 15 to 263 (sd = 73.1) (
Table 5
).

Table 5. Adverse Effects as Found in Hypothesis-Driven, Randomized Double-Blind Controlled Trials
The total number of adverse effects in those studies that reported on patient numbers was 17 of 565 patients, or a rate of 3%. Nine studies compared the 
complementary therapy with a conventional therapy in a direct randomized fashion. Of these, six reported decreased side effects from a complementary therapy. All 
six reported that the complementary therapy was equally efficacious as the conventional therapy for the condition. One study reported increased side effects from the 
complementary therapy. This involved patients treated with the herb  Serona repens for benign prostatic hypertrophy. The two remaining direct, comparative trials 
reported equal rates of adverse effects in both complementary and conventional therapy (
Table 5
). Two studies done in Third World countries using megadoses of 
vitamin A in healthy children are not included in this analysis. Both of these very large trials reported an increased rate of short-term (within 24 hours) vomiting, 
diarrhea, colds, rhinitis, and coughs among those receiving the megadose of vitamin A instead of placebo. Odds ratios were small, in the range of 1.02 to 1.18.
Assessing the use of complementary medical therapies under conditions that minimize indirect adverse effects and maximize an accurate estimate of attribution 
indicates an adverse effect rate of approximately 3%. It is important to note that the duration of these studies was short (mean 10.3 weeks), and the total numbers in 
each group were small (mean n = 45 per arm).
SUMMARY
Complementary medicine must deal seriously with the issue of safety and establish systems for addressing direct, indirect, and definitional issues that impact on the 
risk-benefit ratio of these practices. Purity and standardization of both the products and the training (competence) in these practices are primary. Without assurance 
of a good product and a well-trained practitioner to deliver the therapy, the risk-benefit ratio will be higher than necessary. The prevalence of adverse effects in 
homeopathy, acupuncture, manipulation, herbal products, and mind-body therapies appears to be low, probably lower than comparable therapies in conventional 
medicine. These therapies are also at low risk for acute toxicity if used for short durations in the traditional manner or in controlled trials.
Important exceptions to this general rule exist, however. Especially of concern is possible heavy metal contamination of traditional herbal products. Almost no good 
data exist on the potential long-term adverse effects that might occur from chronic use of these practices. In addition to the issues of training and competence, it 
appears that many alternative diagnostic systems have been inadequately tested and may pose a real risk of exposing individuals to unnecessary anxiety, further 
testing, unnecessary treatment, and excessive costs. Misuse and poisonings do occur with symptomatic rates of approximately 12%. True attributable adverse effect 
rates appear to be in the range of 3%, especially for herbal and vitamin products, and probably less for practices such as homeopathy, acupuncture, and mind/body 
therapies. Safety testing is needed, using appropriate, hypothesis-generated prospective randomized methods with blinded evaluators.
Finally, methods for reporting toxicity and adverse effects need improvement. Current systems used in conventional medicine must be applied with a specific 
understanding of their use and limitations for obtaining accurate information about safety. Information from poison control centers, adverse effects-reporting hotlines, 
postmarketing surveillance studies, preclinical research, and phase I and II trials all have different purposes and limitations for determining the true attributable 
incidence and severity of adverse effects from complementary medical practices. Safety, as well as efficacy, must be evaluated under the conditions of proper use. 
Ultimately, only direct randomized comparative trials can give us the relative risk-benefit ratios needed for judging optimal therapy and the extent of misapplication. In 
the meantime, assessing the risks of misuse, educating the public about proper use, clarifying indications (versus claims) and precautions, and assuring competency 
of practitioners who use and refer for complementary and alternative medicine are the best ways to maximize the safety and benefit of these practices (
106
).
C
HAPTER
 R
EFERENCES
1.
Eisenberg DM, Kessler RC, Foster E, et al. Unconventional medicine in the United States—prevalence, costs, and patterns of use. N Engl J Med 1993;328:246–252.
2.
Fisher P, Ward A. Complementary medicine in Europe. Br Med J 1994;309:107–111.
3.
World Health Organization. Guidelines for safe acupuncture treatment. Geneva: World Health Organization, 1995.
4.
MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996;347:569–573.
5.
Ernst E. Bitter pills of nature: safety issues in complementary medicine. Pain 1995;60:237–238.
6.
Ernst E. Competence in complementary medicine. Complement Therap Med 1995;6:179–186.
7.
Ernst E. The risks of acupuncture. Int J Risk & Safety in Med 1995;6:179–186.
8.
Turlings JDM, Feenstra MH. Aanbod en gebruik van voedingssupplementen. Een oriënterend onderzoek. 's-Gravenhage: Stichting Wetenschappelijk Onderzoek 
Konsumentenaangelegenheden, 1987.
9.
Philen RM, Ortiz DI, Auerbach S, Falk H. Survey of advertising for nutritional supplements in health and body building magazines. JAMA 1992;268: 1008–1011.
10.
De Smet PAGM. Gezondheidsrisico's van voedingssupplementen. In: Anema PJ, Bemelmans K, Pieters JJL, eds. Voedingssupplementen. Aktueel Gezondheidsbeleid 14. Rijswijk: Ministerie 
van Welzijn, Volksgezondheid en Cultuur, 1992:23– 34.
11.
Wieringa NF, De Meijer AHR, Schutjens MDB, Vos R. The gap between legal rules and practice on advertising non-registered pharmaceutical products. Soc Sci Med 1992;35:1497–1504.
12.
Furnham A, Smith C. Choosing alternative medicine: a comparison of the beliefs of patients visiting a general practitioner and a homoeopath. Soc Sci Med 1988;26:685–689.
13.
Sutherland LR. Alternative medicine: what are our patients telling us? Am J Gastroenterol 1988;83: 1154–1157.
14.
Dorant E, Van den Brandt PA, Hamstra AM, et al. Gebruik van voedingssupplementen in Nederland. Ned Tijdschr Geneeskd 1991;135:68–73.
15.
Moore J, Phipps K, Marcer D, Lewith G. Why do people seek treatment by alternative medicine? Br Med J 1985;290:28–29.
16.
Jensen P. Alternative therapy for atopic dermatitis and psoriasis: patient-reported motivation, information source and effect. Acta Derm Venereol (Stockh) 1990;70:425–428.
17.
Lloyd P, Lupton D, Wiesner D, Hasleton S. Choosing alternative therapy: an exploratory study of sociodemographic characteristics and motives of patients resident in Sydney. Aust J Publ 
Health 1993;17:135–144.
18.
Danielson KJ, Stewart DE, Lippert GP. Uncon- ventional cancer remedies. Can Med Assoc J 1988;138:1005–1011.
19.
Lau BWK. Why do patients go to traditional healers? J R Soc Health 1989;109:92–95.
20.
Furnham A, Bhagrath R. A comparison of health beliefs and behaviours of clients of orthodox and complementary medicine. Br J Clin Psychol 1993;32:237–246.
21.
Van der Ploeg HM, Molenaar MJ, Van Tiggelen CWM. Gebruik van alternatieve behandelwijzen door patiënten met multipele sclerose. Ned Tijdschr Geneeskd 1994;138:296–299.
22.
Van der Zouwe N, Van Dam FSAM, Aaronson NK, Hanewald GJFP. Alternatieve geneeswijzen bij kanker: omvang en achtergronden van het gebruik. Ned Tijdschr Geneeskd 1994;138:300 
–306.
23.
Visser GJ. Alternatieve geneeswijzen in de huisartspraktijk. Uitkomsten van een enquete. Huiarts Wet 1988;31:252–256.
24.
Knipschild P, Kleijnen J, Ter Riet G. Geloof in alternatieve geneeswijzen. Med Contact 1990;45: 421–412.
25.
Foets M, Visser GJ. Het voorschrijven van homeopathische middelen in de Nederlandse huisartspraktijk. Med Contact 1993;48:683–687.
26.
Taberner PV. Aphrodisiacs. The science and the myth. London: Croom Helm, 1985.
27.
Barron RL, Vanscoy GJ. Natural products and the athlete: facts and folklore. Ann Pharmacother 1993;27:607–615.
28.
Grunewald KK, Bailey RS. Commercially marketed supplements for bodybuilding athletes. Sports Med 1993;15:90–103.
29.
Short SH, Marquart LF. Sports nutrition fraud. N Y State J Med 1993;93:112–116.
30.
O'Conner BB. Healing traditions. Philadelphia: University of Pennsylvania Press, 1995.
31.
Kerr HD, Saryan LA. Arsenic content of homoeopathic medicines. Clin Toxicol 1986;24:451–459.
32.
Dossey L. Healing and the mind: is there a dark side? J Sci Explor 1994;8(1):73–90.
33.
Linde K, Ramirez G, Mulroa CD, et al. St. John's Wort for depression—an overview and meta-analysis of randomized controlled trials. Br Med J 1996;313:253–258.
34.
Baker CC. Report of the South Australian Working Party on Natural Nutritional Substances. South Australian Health Commission, 1990.
35.
Blackburn JLC. Second Report of the Expert Advisory Committee on Herbs and Botanical Preparations to the Health Branch, Health Canada, Ministry of Health, Canada, 1993.
36.
Blumenthal M, Klein ST, eds. Therapeutic monographs on medicinal plants for human use by commission E special expert committee of the German Federal Health Agency. Austin: American 

Botanicals Council, 1996.
37.
Awang DDC. The information base for safety assessment of botanicals. OAM/FDA Sponsored symposium on Botanicals: A Role in U.S. Health Care. Washington, DC, 1994.
38.
Harper P. Traditional Chinese medicine for eczema. Br Med J 1994;308:489–490.
39.
Thomas KB. Temporarily dependent patients in general practice. Br Med J 1974;1:625–626.
40.
Herbert V, Kasdan TS. Misleading nutrition claims and their gurus. Nutrition Today 1994; 29(3):28–35.
41.
Vorbach EU, Hubner WD, Arnoldt KH, et al. 1993. Nervenheilkunde 1993;12:290–296.
42.
Gibson RG, Gibson S, MacNeill AD, Watson BW. Homeopathic therapy in rheumatoid arthritis: evaluation by double-blind clinical trial. Br J Clin Pharm 1980;9:453–459.
43.
Cassir ZA. Endoscopic control trial of four regimes in the treatment of chronic duodenal ulceration. Irish Med J 1985;78:153–165.
44.
Hammerschlag R. Survey of comparative outcomes research: clinical trials comparing acupuncture to standard medical treatment. Proceedings of the Society for Acupuncture Research, 
Washington, DC, SAR, 1994.
45.
Knipschild P. Looking for gall bladder the disease in the patient's iris. Br Med J 1988;287:1578–1581.
46.
Nores JM, Remy JM, Nenna AD, Reygagne P. Malpractice by nonphysician healers. NY State J Med 1987;87:473–474.
47.
Robertson DA, Ayres RC, Smith CL, Wright R. Adverse consequences arising from misdiagnosis of food allergy. Br Med J 1988;297:719–720.
48.
Labib M, Gama R, Wright J, et al. Dietary maladvice as a cause of hypothyroidism and short stature. Br Med J 1989;298;232–233.
49.
Goodyear HM, Harper JI. Atopic eczema, hyponatraemia, and hypoalbuminaemia. Arch Dis Child 1990;65:231–232.
50.
Southwood TR, Malleson PN, Roberts-Thomson PJ, Mahy M. Unconventional remedies used for patients with juvenile arthritis. Pediatrics 1990; 85:150–153.
51.
Benmeir P, Neuman A, Weinberg A, et al. Giant melanoma of the inner thigh: a homeopathic life-threatening negligence. Ann Plast Surg 1991; 27:583–585.
52.
Tsur M. Inadvertent child health neglect by preference of homeopathy to conventional medicine. Harefuah 1992;122:137–142.
53.
Zimmer G, Miltner E, Mattern R. Lebensgefährliche Komplikationen unter Heilpraktikerbehan- dlung - Aufklärungsprobleme. Versicherungsmed- izin 1994;46:171–174.
54.
De Smet PAGM, Stricker BHCh, Nijman JJ. Indirecte risico's van alternatieve middelen - een oproep tot het rapporteren van concrete gevallen. Med Contact 1994;49:1593–1594.
55.
Urban J, Blahova E, Smejkal V, et al. Lidovy lecitel jako pricina tezkeho diabetickeho komatu (folk healing causing severe diabetic coma). Casopis Lekaru Ceskych 1992;131:342–343.
56.
Gill GV, Redmond S, Garratt F, Paisey R. Diabetes and alternative medicine: cause for concern. Diab Med 1994;11:210–213.
57.
Püschel K, Lockemann U, Saukko P, et al. Scharlatanerie mit tödlichem Ausgang. “Alternative” Fehlbehandlung juveniler Diabetiker. Münch Med Wschr 1996;138:287–290.
58.
Verrept H. Marokkaanse migranten en hun geneesmiddelen. Med Antropol 1992;4:184–198.
59.
Verrept H, Schillemans L. Ziektegedrag van Marokkaanse migranten met vakantie in Marokko. Ned Tijdschr Geneeskd 1994;138:337–339.
60.
Hoekstra DFJ. Onzorgvuldig handelen door alternatieve genezers en de wet. Med Contact 1988;43:711–714.
61.
Boström H, Rössner S. Quality of alternative medicine—complications and avoidable deaths. Quality Assurance in Health Care 1990;2:111–117.
62.
Dalvi SS, Nayak VK, Pohujani SM, et al. Effect of gugulipid on bioavailability of diltiazem and propranolol. J Assoc Physicians of India 1994;42: 454–455.
63.
Dandekar UP, Chandra RS, Dalvi SS, et al. Analysis of a clinically important interaction between phenytoin and Shankhapushpi, and Ayurvedic preparation. J Ethnopharmacol 
1992;35:285–288.
64.
Park BK, Pirmohamed M, Kitteringham NR. Idiosyncratic drug reactions: a mechanistic evaluation of risk factors. Br J Clin Pharmacol 1992;34: 377–395.
65.
Innes IR, Nickerson M. Atropine, scopolamine, and related antimuscarinic drugs. In: Goodman LS, Gilman A, Gilman AG, Koelle GB, eds. The pharmacological basis of therapeutics. 5th ed. 
New York: Macmillan Publishing Co., 1975:514–532.
66.
Anonymous. ICH guidelines finalised for 2 further aspects of ADR reporting. Inpharma 1995;18: 20–21.
67.
Anonymous. Kommission E—Aufberereitungsmonographien. Dtsch Apoth Ztg 1993;133: 2791–2794.
68.
Bateman DN, Chaplin S. Adverse reactions. I. Br Med J 1988;296:761–764.
69.
De Smet PAGM.  Teucrium chamaedrys. In: De Smet PAGM, Keller K, Hänsel R, Chandler RF, ed. Adverse effects of herbal drugs. Volume 3. Heidelberg: Springer-Verlag, 1997:137–144.
70.
De Smet PAGM.  Scutellaria species. In: De Smet PAGM, Keller K, Hänsel R, Chandler RF, eds. Adverse effects of herbal drugs. Volume 2. Heidelberg: Springer-Verlag, 1993:289–296, 317.
71.
De Smet PAGM. Health risks of herbal remedies. Drug Safety 1995;13:81–93.
72.
Gordon DW, Rosenthal G, Hart J, et al. Chaparral ingestion. The broadening spectrum of liver injury caused by herbal medications. JAMA 1995;273: 489–490.
73.
Batchelor WB, Heathcote J, Wanless IR. Chaparral-induced hepatic injury. Am J Gastroenterol 1995;90:831–833.
74.
Blumenthal M. Herb industry and FDA issue chaparral warning—experts unable to explain possible links to five cases of hepatitis. HerbalGram 1993;28:38–39,53,59,63,69.
75.
Anonymous. “Natural” medicines: a Pandora's box. WHO Drug Information 1995;9:147–149.
76.
Atawodi SE, Lamorde AG, Spiegelhalder B, Preussmann R. Nitrosation of Nigerian medicinal plant preparations under 'chemical' and 'simulated' gastric conditions. Food Chem Toxicol 1995; 
33:43–48.
77.
De Smet PAGM.  Aristolochia species. In: De Smet PAGM, Keller K, Hänsel R, Chandler RF, eds. Adverse effects of herbal drugs. Volume 1. Heidelberg: Springer-Verlag, 1992:79–89.
78.
Cosyns J-P, Jadoul M, Squifflet J-P, et al. Urothelial malignancy in nephropathy due to Chinese herbs. Lancet 1994;344:188.
79.
Vanherweghem JL, Tielemans C, Simon J, Depierreux M. Chinese herbs nephropathy and renal pelvic carcinoma. Nephrol Dial Transplant 1995; 10:270–273.
80.
De Smet PAGM. An introduction to herbal pharmacoepidemiology. J Ethnopharmacol 1993;38: 197–208.
81.
Oso BA. Mushrooms and the Yoruba people of Nigeria. Mycologia 1975;67:311–319.
82.
De Smet PAGM. Ethnopharmacological art in perspective: enema scenes in black African sculpture. Int Pharm J 1992;6:197–202,239–244.
83.
Yorston D, Foster A. Traditional eye medicines and corneal ulceration in Tanzania. J Trop Med Hyg 1994;97:211–214.
84.
Courtright P, Lewallen S, Kanjaloti S, Divala DJ. Traditional eye medicine use among patients with corneal disease in rural Malawi. Br J Ophthalmol 1994;74:810–812.
85.
Lewallen S, Courtright P. Peripheral corneal ulcers associated with use of African traditional eye medicines. Br J Ophthalmol 1995;79:343–346.
86.
Anonymous. Ostrich fern poisoning—New York and Western Canada, 1994. MMWR 1994;43: 677–684.
87.
Lai R-S, Chiang AA, Wu M-T, et al. Outbreak of bronchiolitis obliterans associated with the consumption of  Sauropus androgynus in Taiwan. Lancet 1996;348:83–85.
88.
Haynes RL. Carbon-monoxide poisoning from non-tobacco cigarettes. J Med Assoc Ga 1983; 72:553–555.
89.
King M. Nontobacco cigarettes. Can Med Assoc J 1985;133:13.
90.
Bloom JW, Kaltenborn WT, Paoletti P, et al. Respiratory effects of non-tobacco cigarettes. Br Med J 1987;295:1516–1518.
91.
Sherrill DL, Kryzanowski M, Bloom JW, Lebowitz MD. Respiratory effects of non-tobacco cigarettes: a longitudinal study in the general population. Int J Epidemiol 1991;20:132–137.
92.
Nahas G, Latour C. The human toxicity of marijuana. Med J Aust 1992;156:495–497.
93.
Polen MR, Sidney S, Tekawa IS, et al. Health care use by frequent marijuana smokers who do not smoke tobacco. Western Medical Journal 1993; 158:596–601.
94.
Jensen R, Closson W, Rothenberg R. Selenium intoxication—New York. MMWR 1984;33: 157–158.
95.
Helzlsouer K, Jacobs R, Morris S. Acute selenium intoxication in the United States. Fed Proc 1985;44:1670.
96.
Clark RF, Strukle E, Williams SR, Manoguerra AS. Selenium poisoning from a nutritional supplement. JAMA 1996;275:1087–1088.
97.
Koch-Weser J, Sellers EM, Zachest R, et al. The ambiguity of adverse drug reactions. Eur J Clin Pharmacol 1977;11:75.
98.
Reidenberg MM, Lowenthal DT. Adverse drug reactions. N Engl J Med 1968;279:678.
99.
La Haba AF, Curet JO, Pelegia A, Bangdiwala I. Thrombophlebitis among oral and non-oral contraceptive users. Obstet Gynecol 1971;38:259.
100.
De Smet PAGM. Health risks of herbal remedies. Drug Safety 1995;13(2):1995.
101.
De Gerlache, Lans JM. Modulation of experimental rat liver carcinogenesis by ultra low doses of the carcinogens. Ultra low doses. C. Doutremepuich. Washington, DC: Taylor & Francis, 
1991:17–27.
102.
Huxtable RJ. Safety of botanicals: historical perspective. OAM/FDA Sponsored Symposium on Botanicals: A Role in U.S. Health Care. Washington, DC, 1994.
103.
Peacher WC. Adverse reactions, contraindications and complications of acupuncture and moxibustion. Am J Chin Med 1975;335–346.
104.
Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Deciding whether your treatment does harm. In: Sackett DL, Haynes RB, Guyatt GH, Tugwell P, eds. Clinical epidemiology: a basic science for 
clinical medicine. Boston: Little, Brown & Co., 1993.
105.
Perharic L, Shaw D, Colbridge M, et al. Toxicological problems resulting from exposure to traditional remedies and food supplements. Drug Safety 1994;11(4):264–294.
106.
Jonas WB. Safety in complementary medicine. In: Ernst E, ed. Complementary medicine—an objective approach. Oxford: Butterworth-Heinemann, 1996:126–149.

I
NTRODUCTION:
 C
OMMON
 A
SPECTS OF
 T
RADITIONAL
 H
EALING
 S
YSTEMS
 A
CROSS
 C
ULTURES
Essentials of Complementary and Alternative Medicine
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