R e s e a r c h A r t i c l e T h e U s e o f A r n i c a f o r t h e T r e a t m e n t o f S o f t - T i s s u e D a m a g e . A B S T R A C T : T h ere is g r o w in g a n e c d o ta l e v id e n c e o f th e u se o f h o m e o ­ p a th y a m o n g s p o r t s ’ p a r tic ip a n ts . A r n ic a m o n ta n a [a ls o k n o w n a s L e o p a r d ’s B a n e ] is f r e q u e n tly u s e d a s a p r o p h y la c tic a g e n t b o th b e fo re a n d a fte r lo n g d is ta n c e r u n n in g in th e b e l i e f th a t it r e d u c e s d e la y e d o n s e t m u s c le s o r e n e s s [D O M S ], T h e re is e q u iv o c a l e v id e n c e o f its effica cy. T h e la c k o f c o n v in c in g s c ie n tific p r o o f is a m a jo r re a so n f o r h o m e o p a th y n o t b e in g e m b r a c e d b y th e m e d ic a l c o m m u n ity . T h e a im o f th is r e v ie w is to d is c u s s th e p r in c ip le s o f h o m e o p a th y in g e n e r a l, f o l l o w e d b y a m o r e d e ta ile d a n a ly s is o f th e u se o f a r n ic a in th e tr e a tm e n t o f s o ft tis s u e tra u m a . C lin ic a l tr ia ls p u b lis h e d s in c e 1 9 8 2 w e re id e n tifie d u sin g th e M e d lin e d a ta b a s e . B a s e d o n th e s e d a ta it w a s c o n c lu d e d th a t th e re is n o o v e r w h e lm in g e v id e n c e th a t tr e a tm e n t w ith a h o m e o p a th ic rem edy, s p e c ific a lly A r n ic a m o n ta n a , c o n s is te n tly r e d u c e s th e s e v e r ity of, o r th e ra te of, h e a lin g o f s o ft tis s u e d a m a g e . K E Y W O R D S : H O M E O P A T H Y , A R N I C A T A B L E T S , D E L A Y E D O N S E T M U S C L E S O R E N E S S , L O N G D IS T A N C E R U N N IN G . BAUER CM, BSc Physio, BSc MED, B.A.'; WEIGHT L, PhD2; LAMBERT M l, PhD3. 1 D e p a rtm e n t o f Ph y sio th erap y , U n iv e rs ity o f C a p e Tow n. D e p a rtm e n t o f H u m a n B iology, U n iv e rs ity o f C a p e Tow n. M R C /U C T R esearch U n it fo r Exercise Science a n d Sparts M e d ic in e , D e p a rtm e n t o f H u m a n B iology, U n iversity o f C o p e Tow n , Sports Science Institute o f South A fric a . INTRODUCTION There is growing anecdotal evidence o f the use o f hom eopathy among sports’ particip an ts. F o r exam ple arnica is frequently used as a prophylactic agent both before and after long distance running in the belief that it reduces delayed onset m uscle soreness [DOMS]. A lthough hom eopaths often use arnica for the treatm ent o f soft tissue trauma, there is equivocal evidence o f its efficacy (Lokken et al 1995; Jaw ara et al 1997). This lack o f convincing scientific proof is a m ajor reason for hom eopathy in general not being accepted by th e ' medical com m unity (Lockie 1998). In co n trast the altern ativ e p ractitio n er believes that hom eopathy’s long history and continued successful use worldwide dem onstrates its efficacy. D espite the differences in approach between hom eopathy and conventional C O RRESPO N D EN C E TO: Associate Professor M ike Lam bert M RC/U CT R esearch Unit for Exercise Science and Sports Medicine, P.O. Box 115, Newlands 7925 South Africa Tel: (0 21)650-4558 Fax: (021)6 8 6 -7 5 3 0 Email: m lam bert@ sports.uct.ac.za m edicine, 40% o f general practitioners in the N etherlands practise hom eopathy and 42% o f general practitioners in B ritain refer patients to hom eopaths (Vallance 1998). In governm ent clinics in India, hom eopathy is practiced in conjunction with conventional ‘w estern’ m edicine (Vallance 1998). According to Jacobs et al (1998) the use o f hom eo­ pathy is grow ing in the U nited States o f America. The aim o f this review is to discuss the principles o f hom eopathy in general, follow ed by a more detailed analysis of the effectiveness o f arnica in the treat­ ment o f soft tissue trauma. ARNICA A rn ica m ontana, also know n as L eopard’s Bane (Allen 1978), is the most frequently studied hom eopathic rem edy in p laceb o -co n tro lled trials (Ernst 1998). It is the best known o f all hom eopathic remedies, and most often used in cases o f acute physical trauma to treat both the injury and the accom pa­ nying shock (Smith 1998) bruising and post-surgical repair (Hart et al 1997). A rnica montana is a perennial Alpine herb with a creeping underground stem and a rosette o f pale oval leaves. The flow ering, erect stem is up to 60 centim eters high, bears a single, bright yellow, daisy-like flower. The plant, which is difficult to cultivate, is native to northern and central Europe and also grows wild in Russia, Scandinavia and northern India (Lawless, 1995). PRINCIPLES OF HOMEOPATHY The word ‘hom eopathy’ is derived from two G reek words, omio m eaning ‘sam e’ and pathos m eaning ‘suffering’ (Lockie 1998). Hom eopathy is regarded as a naturopathic form o f medicine (Vallance 1998) that aims to assist the body’s healing m echanism s rather than override them (Lockie 1998). The fundam ental prem ise o f the dis­ cipline is that a hom eopathic remedy, when given to a healthy person, will produce the same symptoms as those of the ill person. The hom eopathic remedy stim ulates the b o d y ’s innate healing ability and thereby provokes the body’s system to com bat these symptoms. This is analogous to the im m unizations o f conventional m edicine that use dilutions o f allergens to control the allergies themselves. NOMENCLATURE H om eopathic treatments are prescribed as a “D ” [or “X ”], or “C H ” [centesimal H ahnem ann] preparations. “C H ” refers to the centesimal scale o f the m edicinal 3 4 SA J o u r n a l o f P h y s io t h e r a p y 2002 V o l 58 No 1 R ep ro du ce d by S ab in et G at ew ay u nd er li ce nc e gr an te d by th e P ub lis he r (d at ed 2 01 3. ) mailto:mlambert@sports.uct.ac.za preparation where the original remedy has been diluted on a scale o f one drop to 99 drops of w ater [1 part per 100 parts] and shaken by a process called succussion. In the case o f a CH 30 preparation the w hole process is repeated 30 times. The “D ” [or “X ”] prescription refers to a d ecim al scale w here each dilution involves 9 drops o f water to one drop of the original substance (Kaplan 1994). For exam ple a D6 (6X) is a 1 in 10 dilu­ tion repeated 6 times which is obtain­ able without prescription. D30, [30X] represents a medium potency [dilution 1:10 to the power o f 30, that is, succus­ sion repeated 30 times]. According to hom eopathic theory the h ig h er the p otency the g reater the effect. The most com m only used dilution are 30X preparations (Lokken et al 1995). THE BASIS OF HOMEOPATHY The two main principles o f homeopathy are the “sim illim um ” and “potentisation by succussion” (R eilly et al 1986). According to these principles, if the toxic effects o f an agent closely mimic a p a tie n t’s sym ptom s, the sim illim um argum ent applies and the physiological reaction provoked by that substance in diluted and succussed amounts may aid the patient’s recovery. Analogous to vaccination and im m unotherapy, the sim illim um principle is sometimes seen as a paradoxical drug effect. The patient is often sensitive to a homeopathic sti­ m ulus, which can aggravate symptoms initially. The principle o f “potentisation by succussion” applies when the rem edy is adm inistered after an initial process o f serial dilutions and succussion. The effect o f the remedy may be maintained and even enhanced at “apparently absurd dilutions” , [ultra-high dilutions (UHDs)] where theoretically none o f the original substance rem ains due to the dilution and succussion process (Reilly et al 1986; Vallance 1998). H om eopathic remedies are derived prim arily from plants, m inerals and metals. Substances are tested on healthy hum an volunteers to determ ine their therapeutic value. These tests are known as “provings”. A prescription is only considered to be effective if the sym p­ toms produced by the remedy during the “provings” match changes in the health o f the individual (Smith 1998). This is the basic principle o f hom eo­ pathy - similia sim ilibus curentur - like cures like. Each hom eopathic substance can be appropriately used in a range o f conditions, so there are a num ber o f remedies to chose from. Conversely, a single remedy can target a wide variety o f conditions. This explains the adm inis­ tration o f com m only used, broad-based, over-the-counter rem edies for a variety o f conditions. Hom eopathy is based on individua­ lized treatment, where ideally a single hom eopathic m edication is selected according to the signs and symptoms, temperam ent, disposition, personal and family history o f the patient (Lokken et al 1995; Smith 1998). RESEARCH IN HOMEOPATHY Homeopathy in General Research on the efficacy o f homeopathic remedies has been an ongoing process for over two hundred years (Koehler 1986). A summary o f the clinical trials published since 1982 (identified using the M edline database) is show n in Table 1. The studies have been sum m a­ rized according to the research design, the dosage and duration o f treatment, the outcom e variables and the results o f the study. Twelve o f the 14 studies included a placebo group. O f the rem aining two studies, (no placebo group), one study showed that pharm acotherapy was not more effective than hom eopathic treat­ m ent (H itzenberger et al 1982) and the other study dem onstrated no significant difference in bleeding times im m edia­ tely follow ing the adm inistration o f A rnica m ontana in a 2-period cross-over trial in healthy volunteers (Baillargeon et al 1993). Ten studies showed that the hom eopathic treatm ent had no advan­ tage over the placebo treatment. T he studies w ith an o bjective overview or m eta-analysis design are shown in Table 2. These studies are sum m arized u nder the h eadings o f ‘study selection criteria’ and ‘general conclusions’. Only one o f these studies (Reilly et al 1994] showed that treat­ ment with hom eopathy was more effec­ tive than treatm ent with placebo. Two o th er studies (K leijnen et al 1991; Barnes et al 1997) showed that hom eo­ pathic rem edies tended towards being m ore effective than placebo, but the rem aining six studies concluded that there was insufficient evidence to sup­ port any claims o f hom eopathic efficacy. Therefore, it can be concluded that there is no overw helm ing evidence that treatm ent with a hom eopathic remedy, even A rnica m ontana reduces the severity o f tissue dam age or increases the rate o f healing. Effects of arnica on delayed onset muscle sore­ ness (D 0 M S ) Tveiten et al (1991) assessed the effect o f A rnica m ontana D30 on m uscle stiff­ ness, restitution time and m uscle cell damage using a double-blind randomized trial follow ing the 1990 Oslo M arathon. Blood tests were carried out before and immediately after the finish o f the event, and again after 48 and 72 hours. There were differences in only two o f the vari­ ables m easured betw een the groups imm ediately after the finish or after 48 hours and 72 hours. The placebo group had a higher level o f plasm a creatine kinase [a physiological indication of muscle cell damage] 48 hours post-race. The placebo group also reported expe­ riencing a greater degree o f stiffness on all four occasions. The trial indicated that arnica did not reduce the time o f restitution but seemed to reduce m uscle soreness. Jaw ara et al (1997) studied the effects of arnica and rhus tox on DOM S follow ­ ing bench stepping exercise. The authors suggested that h o m eopathy w as an effective treatm ent although the data were not statistically different. Vickers et al (1997) also com pared the effect o f a hom eopathic preparation of arnica and rhus tox CH 30 and a placebo on DOMS follow ing bench stepping. Their trial also showed that there was no difference between the homeopathic groups and the placebo group in altering the perception o f m uscle soreness over the five-day period. In a further study Vickers et al (1998) conducted a random ized, double-blind, p lacebo-controlled trial to determ ine w hether treatm ent with hom eopathic arnica 30X was superior to placebo for decreasing m uscle soreness following SA J o u r n a l o f P h y s io t h e r a p y 2002 V o l 58 No 1 3 5 R ep ro du ce d by S ab in et G at ew ay u nd er li ce nc e gr an te d by th e P ub lis he r (d at ed 2 01 3. ) Table 1: REVIEW OF INDIVIDUAL TRIALS. SUBJECTS [M /F] RESEARCH DESIGN DOSAGE AND DURATION VARIABLES MEASURED RESULTS REFERENCE n=l 0 [m/f?] Randomized double blind cross-over Patients with essential hypertension treated with antihypertensive pharmacotherapy or homeopathic treatment Blood pressure No superiority of pharmacotherapy over homeopathic treatment in decreasing blood pressure Hitzenberger, [1982] n=l 18 [m/f?] Randomized double blind placebo controlled cross-over Following surgical removal of impacted wisdom teeth, under general anaesthetic Oral administration 2 x day of Group 1 Metronidazole 400ma Group 2 A r n ic a m o n ta n a 200ma Group 3 Placebo 1 tablet Pain control on VAS Trismus [limitation of mouth opening] Prevention of swelling Promotion of healing Metronidazole greater effect in pain control, preventing swelling, and more effective in promoting healing than arnica and placebo. Arnica group had greater pain [p<0.05] and more swelling than placebo [p<0.01] Kaziro, [1984] n=108 [m/f?] Randomized double blind placebo controlled Patients with active hayfever given a l week run-in, baseline placebo, for analysis. Then 1 tablet placebo or homeopathic test drug [30C potency] for 2 weeks, followed by 2weeks observation Daily VAS of over­ all symptoms and intensity of sneezing, blocked and runny nose, and watery, red and runny nose. Similar details recorded by doctor at weeks 0, 3 and 5 Subjects treated with homeopathy had a significant reduction in symptom scores assessed by patient and doctor in week five [final week] p=0.02. Initial aggravation of symptoms in homeopathic group followed by improvement Reilly et al, [1986] n=? Randomized double blind placebo controlled 3 lactose tablets sublingually 4-hourly for 2 days post partum [where tearing or suturing occurred]. Thereafter 3 times a day for 3 days. 3 groups:- Group 1 D6 arnica Grouo2 D30 arnica Group 3 Unmedicated placebo Perineal pain Breast pain Mood a] Mother b] Baby Perineal appearance More subjects using arnica D30 described themselves as 'unhappy' (p<0.05). The questionnaire responses showed a tendency towards more favourable results and with arnica D6 than placebo less favourable with D30 than placebo Hofmeyr et al, [1990] n=36 [m/f?] Randomized double blind placebo controlled Arnica C30. Five tablets twice daily for 5 days starting before 42.2km race. Blood tests before race, at finish, 48 hours and 72 hours after race. Stiffness evaluated on [VAS] after finish and for next 3 days No difference in the liver enzymes or creatine, haptoglobin or magnesium. Plasma CK increased in both groups but to a greater level in placebo group. Difference greatest on day 2 [p=0.07] A feeling of stiffness more pronounced in placebo group on all 4 tests [p=0.06 and 0.07 on day 2 and 3]. No indication that arnica decreased time of restitution Tveiten et al, [1991] n=l 01 [m=66 f =35] Randomized, double blind placebo controlled 3 groups [athletics injuries] Group 1 T ra u m e e l S ointment Group 2 T ra u m e e l Sine ointment. [Both contain 1,5g of arnica D3 in lOOg ointment] Group 3 Placebo. No arnica. Ointment base without the Medicinally active ingredients]. First medication not later than day 4 post injury. Thereafter self­ application twice daily until day 15. 6 to 10 mg each application Primary criteria - abatement of swelling and normalisation of skin temperature Secondary criteria - 1 ] maximum muscle force 2] pain index 3] time interval for resumption of training without complaints No difference between two Traumeel ointments when tested on 5th and 15th day Difference [pc.0001] between these and placebo on 15th Day 1 ] Maximum muscle force: Both Traumeel groups superior to placebo on day 15 but not day 5 2] Pain index: Both Traumeel groups superior to placebo day 5 and 15 3] Resume training: Both Traumeel groups superior to placebo Bohmer and Ambrus, [1992] Abbreviations: ► Continued on page 37. m = male, f = female, VAS = visual analogue scale, ? = data unavailable, DOMS = delayed onset muscle soreness 3 6 SA J o u r n a l o f P h y s io t h e r a p y 2002 V o l 58 No 1 R ep ro du ce d by S ab in et G at ew ay u nd er li ce nc e gr an te d by th e P ub lis he r (d at ed 2 01 3. ) Table 1: REVIEW OF INDIVIDUAL TRIALS. ► Continued from page 36. SUBJECTS [M/F] RESEARCH DESIGN DOSAGE AND DURATION VARIABLES MEASURED RESULTS REFERENCE n=? 2-period cross-over trial A r n ic a M o n ta n a in healthy volunteers Bleeding times and the impact on various blood coagulation tests immediately following administration No significant effect Baillargeon et al, [1993] n=28 [m/f?] Randomized double blind placebo controlled 4 weeks, single blind placebo. Then daily dosage for 8 weeks- Group 1 oral homeopathic immunotherapy to their principal allergen Group 2 identical placebo [no homeopathic substance] Daily VAS of overall symptom intensity Difference in favour of homeopathic immunotherapy within 1 week of treatment and persisting up to 8weeks [p=0.003] Reilly et al, [1994] See meta­ analysis table n=24 [m=4 f=20] Randomized double blind placebo controlled cross-over 3 tablets [containing 6 homeopathic drugs at D30 potency, including arnica] or placebo given 3 hours post op. for surgery on 1 side for bilateral impacted wisdom teeth and continued for 5 days. Following identical surgical procedure on opposite side 14 to 51 days later, crossover tablets administered Pain on VAS Swelling, trismus, and bleeding No positive evidence for efficacy of homeopathic treatment on pain and other inflammatory events Lokken et al, [1995] n=60 [m/f?] Randomized double blind placebo controlled First month baseline, all patients on placebo. Thereafter test group on Individualized homeopathic Prophylaxis Frequency and severity of migraine attacks No difference at baseline. No difference between placebo and homeopathic group thereafter Whitmarsh et al, [1997] n=73 [m=0 1= 7 3 ] Randomized double blind placebo controlled 2 doses arnica C30 tablets or placebo 24 hours pre-op. Then the morning after total abdominal hysterectomy, 3 doses/day for 5 days of arnica or placebo Pain and discomfort on VAS every 1 2 hours beginning 1 2 hours pre-op. Maximum 10 assessments per patient. No difference between placebo and homeopathic group on postoperative recovery Hart et al, [1997] n=50 [m/f?] Randomized double blind placebo controlled 1 tablet arnica C30 and rhus tox C30] orally 3 times a day 24 hours prior to bench stepping exercise. Continued until subject felt no muscle soreness Placebo group DOMS evaluated on VAS scale every 12 hours for 7 days No difference between placebo and homeopathic group [p>0.2] Jawara et al [1997] n=67 [m=23 f=34] Randomized, double blind placebo controlled 1 tablet 3 x/d a y orally of a complex of arnica C30, rhus tox C30 and Sarcolactic acid Placebo group Muscle soreness scored on Likert scale 5 days after 10 minute bench- stepping exercise No difference between placebo and homeopathic group Vickers et al, [1997] n=400 [m/f?] Randomized, double blind placebo controlled Arnica C30 group Placebo group Muscle soreness scored twice daily on Likert scale for the 5 days following long distance racing No difference between placebo and homeopathic group Vickers et al, [1998] Abbreviations: m = male, f = female, VAS = visual analogue scale, ? = data unavailable, DOMS = delayed onset muscle soreness S A J o u r n a l o f P h y s io t h e r a p y 2 0 0 2 V o l 5 8 No 1 3 7 R ep ro du ce d by S ab in et G at ew ay u nd er li ce nc e gr an te d by th e P ub lis he r (d at ed 2 01 3. ) Table 2: REVIEW OF META-ANALYSES (From 1990). NO. OF STUDIES STUDY SELECTION CRITERIA CONCLUSIONS REFERENCE n=40 (total of 523 subjects) 40 published randomised trials: results of the homeopathic treatment were compared to those of a standard treatment, placebo, or no treatment Results did not provide acceptable evidence that homeopathic treatments are effective Hill and Doyon, [1990] n=107 81 of 105 trials with interpretable results, were positive regardless of the quality of the trial or the variety of homeopathy used. Evidence of clinical trials is positive, but not sufficient to draw definite conclusions because most trials were of low methodological quality and unknown publication bias Kleijnen et al, [1991] n=213 Medline and Embase searches give an "impression" of the evidence Kleijnen and Knipschild, [1992] n=3 (total of 202 subjects) The effects of homeopathy were greater than placebo [p=0.0004] Reilly et al, [1994] n=6 n=776 [cases] Evidence that homeopathic remedies=/ l 2C] can reduce time to first flatus after abdominal or gynaecological surgery [p<0.05] Barnes et al, [1997] n=89 Insufficient evidence that homeopathy is effective Linde et al, [1997] n=32 (total of 1778 subjects)] Individualized homeopathy has effect over placebo. Evidence however, not convincing - methodological shortcomings and inconsistencies Linde and Melchart, [1998] n=8. The claim that homeopathic arnica is effective over placebo is not supported by rigorous clinical trials Ernst and Pittler, [1998] n=? (not described) Homeopathy perceived to be ineffective for any type of low blood pressure Ernst and Pittler, [1999] long distance running. Four hundred subjects com pleted a visual analog and Lickert scale o f m uscle soreness twice daily for the five days follow ing their race. The authors concluded from their results that arnica was not effective in reducing m uscle soreness after long distance running (Vickers et al, 1998). DISCUSSION AND CONCLUSION The aim o f this review was to describe the general principles o f homeopathy follow ed by an analysis of the research on the efficacy o f homeopathic treatment, specifically A rnica montana. It is clear from the data in Tables 1 and 2 that there is no convincing evidence that treatment with a hom eopathic remedy consistently reduces the severity of, or increases the rate o f healing of dam aged tissue. Som e hom eopathic rem edies are diluted to the point where there can be no rem aining m olecules present to explain their prop o sed b iological effects. The use o f U ltra High Dilutions [UHDs] appears to many scientists to make hom eopathy a scientific absurdity. A ccording to V allance (1998) m ost scientists reject UHD effects because of their intrinsic im plausibility in the light o f current scientific understanding. Lokken et al (1995) question whether the infinitesim ally diluted substances used in hom eopathy really exert biolo­ gical activity and Vandenbroucke (1997) argues that the ‘infinite dilutions’ o f the agents used cannot possibly produce any m easurable effect. Their scepticism is supported by the absence o f any scien­ tific p ro o f o f such activity (L ockie 1998). Yet others, such as Endler and Schulte (1994), believe that UHDs have an effect, relying on the accepted hom e­ opathic concept o f ‘horm esis’, the belief that high concentrations o f a hom eo­ pathic agent suppress, while low ones stim ulate healing. In an editorial com ­ ment, Davenas et al (1988) uses the 3 8 SA J o u r n a l o f P h y s io t h e r a p y 2002 V o l 58 No 1 R ep ro du ce d by S ab in et G at ew ay u nd er li ce nc e gr an te d by th e P ub lis he r (d at ed 2 01 3. ) argum ent that an aqueous solution o f a homeopathic substance retains its ability to elicit a biological response even at such high dilutio n s w here there is negligible chance o f a single molecule rem aining in any sample. This is based on the concept that dilutions are fol­ lowed by vigorous shaking [succussion], and the transmission o f the biological inform ation could be related to the molecular organization of water (Davenas et al 1988). The studies evaluated in table 1 and 2 were designed according to the classic scientific rationale o f an experimental group receiving the treatment, and a control group receiving a placebo. However, this goes against the basic edict o f homeopathy, where prescrip­ tions are highly individualized to meet the needs o f the patient. As Koehler (1986) points out, double-blind trials are unacceptable for establishing the efficacy o f hom eopathic rem edies because, in accordance with hom eopa­ thic principles, the individual reactivity and receptiveness o f the subject must be taken into account and the dose atten­ uated accordingly. According to Rivett (1999) double-blind, placebo-controlled clinical trials should not be regarded as the only acceptable evidence o f a treat­ ment or d rug’s therapeutic value. Smith (1998) is of the opinion that the inappro­ priateness o f the random ized clinical trial model for the individualized pre­ scription is now being overcome with the developm ent o f new double-blind protocols that are more patient orientated. In summary, scientists are taught to evaluate evidence according to a set of rules (double blind placebo type studies). H om eopathy, due to the reasons described, precludes an evaluation using a double blind placebo design. To be exam ined and judged by the scientific process, an alternative system to the conventional system must be used. Until this happens, hom eopathy w ill be viewed with scepticism by scientists. At present scientists have proved (using their rules) that homeopathy does not work. The responsibility would appear to be that o f the hom eopaths to establish a set o f rules that is acceptable to the scientific com m unity and which can be used to evaluate hom eopathic treatment. 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