A Double-Blind, Controlled Clinical Trial of Homeopathy and an Analysis of Lunar Phases and Postoperative Outcome

STUDY A Double-blind, Controlled Clinical Trial of Homeopathy and an Analysis of Lunar Phases and Postoperative Outcome

Josef Smolle, MD; Gerhard Prause, MD; Helmut Kerl, MD

Objective: To use scientific methods to evaluate 2 claims Main Outcome Measures: Reduction of area occu- made by practitioners of alternative medicine. pied by warts by at least 50% within 8 weeks; death from any cause within 30 days after surgery. Design: A placebo-controlled, double-blind study of homeopathy in children with warts, and a cohort study of Results: Nine of 30 subjects in the homeopathy the influence of lunar phases on postoperative outcome group and 7 of 30 subjects in the placebo group expe- in surgical patients. rienced at least 50% reduction in area occupied by warts (␹2 = 0.34; P = .56); the mortality rate was 1.20% Setting: Outpatients of a dermatology department (ho- in patients operated on during waxing moon and meopathy study) and inpatients evaluated at an anesthe- 1.33% in patients operated on during waning moon siology department (lunar phases). (␹2 = 0.49; P = .50).

Subjects: Sixty volunteers for the homeopathy study and Conclusions: Statements and methods of alternative 14 970 consecutive patients undergoing surgery under gen- medicine—as far as they concern observable clinical eral anesthesia for the lunar phase study. phenomena—can be tested by scientific methods. When such tests yield negative results, as in the Interventions: Treatment of children with warts with studies presented herein, the particular method individually selected homeopathic preparations (homeo- or statement should be abandoned. Otherwise one pathic study); surgical procedures including abdomi- would run the risk of supporting superstition and nal, vascular, cardiac, thoracic, plastic, and orthopedic quackery. operations and assessment of the lunar phase at the time of operation (lunar phase study). Arch Dermatol. 1998;134:1368-1370

N RECENT YEARS, methods of al- In this article we briefly summarize ternative medicine have gained and discuss 2 studies of alternative medi- increasing importance both in cine methods performed under the strin- public opinion and among phy- gent criteria of scientific evaluation. sicians. Paradoxically, the criti- These studies show that scientific criteria Ical approach to scientific medical mea- are applicable to the methods of alterna- sures often seems to be accompanied by tive medicine; scientific methods are an approach on faith to alternative meth- valuable tools for distinguishing helpful ods, even when basic data on the alterna- alternative medical methods from super- tives’ clinical effectiveness and potential stition and quackery. risks are lacking.1 The main reason many alternative HOMEOPATHY methods are rejected by representatives of IN THE TREATMENT scientific medicine is that often there are OF COMMON WARTS few or no sound studies supporting the claims of a particular alternative method. Supporters of homeopathy claim that Discussion between practitioners of sci- highly diluted preparations that are From the Departments of entific and alternative medicine is fur- chemically identical to pure water con- Dermatology (Drs Smolle and ther hampered by the view of some rep- tain properties that produce beneficial Kerl) and Anesthesiology resentatives of alternative medicine that effects in the treatment of various dis- (Dr Prause), University of clinical studies are inappropriate tools to eases. Opponents of homeopathy con- Graz, Graz, Austria. test alternative medical methods. sider all eventual clinical benefits of

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©1998 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/30/2021 homeopathic treatment to be placebo effects. In order time. During the last few years, several reports have been to evaluate the efficacy of a drug beyond the placebo published, albeit most of them negative or inconclusive, effect, randomized, double-blind, placebo-controlled concerning the moon’s influence on suicides,3,4 psychi- trials should be performed. As a drawback in homeo- atric crises,5 car crashes,6 and childbirths.7 More re- pathic trials, there is usually not a single homeopathic cently, much attention has been paid in the lay press to preparation to be tested against the placebo; rather, lunar phases, particularly the full and waxing moon, as depending on the totality of symptoms of a patient, par- potential risk factors for postoperative complications.8 ticular preparations are individually selected by the While these claims have led to serious concern among homeopathic physician. patients and to some extent also among physicians, in a We performed a double-blind, placebo-controlled pilot study9 no relationship between lunar phases and study in collaboration with the Boltzmann Institute of complications was found. Homeopathy, Graz, Austria.2 In this specially designed We examined the clinical records of 14 970 pa- study of children with common warts, the homeo- tients who underwent surgery under general anesthesia pathists prepared a list of those remedies most com- from 1990 to 1996 at the Department of Surgery, Uni- monly used in treating children with warts. They ar- versity of Graz, and who had had preoperative evalua- rived at a total of 12 different homeopathic preparations. tion at the Department of Anesthesiology.10 Surgical pro- For each preparation, an ordered sequence of bottles with cedures included abdominal, vascular, cardiac, thoracic, globuli was prepared, with the true homeopathic prepa- plastic, and orthopedic operations. Postoperative mor- ration randomly alternated with pure placebo prepara- tality was defined as death from any cause within 30 days tions. After informed written consent was obtained from after surgery. Based on scientific tables of moon phases,11 appropriate subjects and their parents, the subjects were each operation was labeled as having been done at wax- carefully examined by a homeopathic physician, and the ing, waning, or full moon. Potential relationships of lu- best homeopathic preparation—as determined by the par- nar phases and outcome were tested by ␹2 statistics. ticular physician—was selected. When 1 of the 12 pre- Of 14 970 patients, 189 (1.26%) died within 30 selected preparations was chosen, the subject entered the days after surgery. Mortality rate was 1.20% for patients study and was treated with the next bottle of the par- operated on during waxing moon and 1.33% for ticular preparation. Neither the physician nor the sub- patients operated on during waning moon (␹2 = 0.49, ject knew whether the bottle contained the homeo- P = .50). At full moon, mortality rate was 1.16% com- pathic preparation or pure placebo. When a homeopathic pared with 1.27% at other lunar phases (␹2 = 0.04; preparation was selected that was not in the predefined P= .85). These data strongly indicate that postoperative list, this patient did not enter the study. Thus, the study mortality does not depend on lunar phases. Previous design guaranteed that the subject received either opti- claims of a greater risk inherent in operations per- mal homeopathic treatment or placebo. formed during a full or waxing moon can be disre- The area occupied by the warts on the hands was garded as superstition, at least as far as lethal complica- drawn on transparent sheets and measured with a digi- tions are concerned. tizer board before and after 8 weeks of treatment. Fifty percent reduction of the area involved was chosen as the COMMENT primary outcome variable at the beginning of the study, and subjects demonstrating this 50% reduction quali- There seems to be a clear-cut difference between scien- fied as responders. tific and alternative medicine. While scientific medicine Of the 70 subjects who signed up for the study, 3 judges the truth of a given statement on observation, were rejected prior to treatment (2 because the homeo- alternative medicine often bases its judgment solely on pathic preparation required was not on the preselected a philosophical model or a certain paradigm. This does list and 1 because the subject’s symptoms did not allow not prevent scientific medicine from making errors, but for a homeopathic diagnosis). Of the remaining 67 sub- it does prevent it from creating philosophical systems jects, 7 withdrew from the study (3 from the placebo group that have no relationship to the real world. and 4 from the remedy group). The reasons for with- Supporters of alternative medical concepts often ac- drawal were exacerbation of warts in 2 cases (1 in each cuse representatives of scientific medicine of adhering group), thrombosis of a capillary hemangioma in 1 case strictly to physical facts and measurable phenomena and (placebo), and unavailability for follow-up in 4 cases (1 neglecting all other aspects of human life. Because this placebo and 3 active treatment). There were a total of 16 accusation is sometimes used to reject clinical studies like responders: 9 of 30 subjects in the homeopathic therapy those presented herein, it should be carefully evaluated. group and 7 of 30 subjects in the placebo group (␹2 = 0.34; However, we have provided 2 examples of clinical stud- P = .56). Obviously, there was no significant difference ies on aspects of alternative medicine that yielded nega- in efficacy between pure placebo and the homeopathic tive results. Both studies deal with statements of alter- remedy in the context of this study. native medicine that directly concern observable facts: homeopathists claim that children with warts will expe- RELATIONSHIP OF LUNAR rience improvement when treated with a homeopathic PHASES AND POSTOPERATIVE OUTCOME remedy compared with pure water, and physicians be- lieving in the power of lunar phases claim that the moon Potential influences of lunar phases on human behavior affects postoperative outcome. Each of these statements and incidence of disease have been discussed for a long has proven itself subject to scientific refutation.

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©1998 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/30/2021 In conclusion, methods and statements introduced of children with warts on the hands: a randomized, double-blind clinical trial. Der- by supporters of alternative medicine should be scientifi- matology. 1996;193:318-320. 3. Gutierrez Garcia JM, Tusell F. Suicides and the lunar cycle. Psychol Rep. 1997; cally tested whenever possible. If independent tests repeat- 80:243-250. edly support the alternative methods or statements, sci- 4. Martin SJ, Kelly IW, Saklofske DH. Suicide and lunar cycles: a critical review over entific medicine should gratefully accept this enrichment 28 years. Psychol Rep. 1992;71:787-795. of therapeutic modalities. When, however, as here, the find- 5. Gorvin JJ, Roberts MS. Lunar phases and psychiatric hospital admissions. Psy- ings are unambiguously negative, the alternative medicine chol Rep. 1994;75:1425-1440. 6. Kelly IW, Rotton J. Geophysical variables and behavior, XIII: comment on “lunar methods or statements should be abandoned. phase and accident injuries”: the dark side of the moon and lunar research. Per- cept Mot Skills. 1983;57:919-921. Accepted for publication April 10, 1998. 7. Kelly IW, Martens R. Geophysical variables and behavior, LXXVIII: lunar phase Corresponding author: Josef Smolle, MD, Depart- and birthrate: an update. Psychol Rep. 1994;75:507-511. 8. Paungger J, Poppe T. Vom richtigen Zeitpunkt: die Anwendung des Mondkalen- ment of Dermatology, University of Graz, Auenbrugger- ders im ta¨glichen Leben. Munich, Germany: Heinrich Hugendubel Verlag; platz 8, A-8036 Graz, Austria. 1995. 9. Smolle J, Smolle-Juettner FM, Prause G, Ratzenhofer-Kommenda B. “Vom richtigen Zeitpunkt”: Mondphasen und Operationskomplikationen. Tagliche Praxis. REFERENCES 1996;37:309-311. 10. Smolle J, Prause G, Pierer G, et al. Mondphasen und Operationskomplika- 1. Bu¨hring M. Naturheilkunde: Grundlagen, Anwendungen, Ziele. Munich, Ger- tionen: eine Analyse von mehr als 14.000 Fa¨llen. Acta Chir Aust. In press. many: Beck; 1997. 11. Meeus J. Astronomical Tables of the Sun, Moon and Planets. London, England: 2. Kainz JT, Kozel G, Haidvogl M, Smolle J. Homoeopathic versus placebo therapy Willmann-Bell; 1983.

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Critical Situations Readers are invited to submit examples of newly described disorders, the use of new diagnostic technology, dermatologic manifestations of important social disorders such as child abuse, and cases that highlight the complex nature of acute care dermatology to Anita G. Licata, MD, Division of Dermatology, UHC, 1 S Prospect St, Burlington, VT 05401-3444. When appropriate, these should be written in case presentation format with a brief discussion following. The Cutting Edge Clinicians, local and regional societies, residents, and fellows are invited to submit cases of challenges in management and therapetics to this section. Cases should follow the established pattern and be submitted double-spaced and in triplicate. Photomicrographs and illustrations must be clear and submitted as positive color transparencies (35-mm slides) or black- and-white prints. Do not submit color prints unless accompanied by original transparencies. Material should be accompanied by the required copyright transfer statement, as noted in “Instructions for Authors.” Material for this section should be submitted to George J. Hruza, MD, Cutaneous Surgery Center, 1 Barnes Hospital Plaza, Suite 16411, St Louis, MO 63110. Reprints are not available. Issues in Dermatology Issues in Dermatology solicits provocative essays relevant to all aspects of dermatology. Please submit manuscripts to the section editor, A. Bernard Ackerman, MD, 2 E 70th St, New York, NY 10021. Off-Center Fold Clinicians, local and regional societies, and residents and fellows in dermatology are invited to submit quiz cases to this section. Cases should follow the established pattern and be submitted double-spaced. Photomicrographs and illustrations must be clear and submitted as positive color transparencies. If photomicrographs are not available, the actual slide from the specimen will be acceptable. Material should be accompanied by the required copyright transfer statement, as noted in “Instructions for Authors.” Material for this section should be submitted to Lori Lowe, MD, Department of Pathology, Uni- versity of Michigan, Medical Science 1, M5242, 1301 Catherine Rd, Ann Arbor, MI 48109. Reprints are not available.

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