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A SERIES OF CASE REPORTS: CLINICAL EVALUATION OF A COMPLEX HOMEOPATHIC INJECTION THERAPY IN THE MANAGEMENT OF PAIN IN PATIENTS AFTER; P. Ruiz de Viñaspre Alvear, ; Marietta Kaszkin-Bettag, BREAST CANCER TREATMENT G. Orellana Alvarellos,
MD MD PhD
Objective • In breast cancer patients, posttreatment pain often appears after several months and strongly impairs healthrelated quality of life. Conventional methods of pain reduction are often ineffective. Injection therapy with Traumeel (Heel GmbH, Baden-Baden, Germany), a medication with analgesic properties used in homotoxicology for treatment of the pain associated with trauma as well as a mediator of inﬂammation, was proposed as an innovative approach for pain relief after breast cancer treatment. Design • Nine patients, still suffering from a high level of pain after breast cancer therapy despite use of postoperative treatment with conventional analgesics, were invited to participate. A Traumeel and procaine injection was administered once a week for three to 10 sessions. The level of pain was assessed by a pain score and physical and psychological status by a questionnaire before and directly after injection and again at follow-
up visits after 3 and 6 months. Results • After the last injection, all patients experienced a marked reduction of their level of pain on average from 7.6±1.5 to 2.4±1.4 points on a scale from 1 to 10 points. After a followup observational phase of 3 and 6 months, pain score ratings increased slightly again in some patients but remained consistently low in others. In any case, the ratings of pain levels did not reach the values assessed before the start of Traumeel injection. Similarly, health-related quality of life improved with this injection therapy. The perception of pain relief with Traumeel injection was high in 8 of 9 patients, reﬂecting an overall perceived positive outcome and tolerability of this treatment. Conclusions • This case series represents a ﬁrst encouraging approach to using this complex homeopathic injection for pain relief in breast cancer patients. (Altern Ther Health Med. 2010;16(1):54-59.)
G. Orellana Alvarellos, MD, is a board member of the Center of Obstetrics and Gynecology, Ginesia SA, Providencia, Santiago de Chile, Chile. P. Ruiz de Viñaspre Alvear, MD, is a senior member, Breast Unit, Gynecology, and Breast Surgery, at the Luis Tisne Hospital, Providencia. Marietta KaszkinBettag, PhD, is senior manager, Regulatory Affairs, at PharmaLex GmbH Mannheim, Germany. Corresponding Author: Marietta Kaszkin-Bettag, PhD Email: email@example.com
reast cancer, as a result of its high incidence, has emerged as a public health problem all over the world. One of the most troublesome consequences of breast cancer therapy, however, is the residual pain after surgery1-4 radiotherapy5,6 and/or chemotherapy (independent of the technique used).1,7-10 Chronic pain occurs in about 30% to 50% of patients with cancer who undergo active treatment for a solid tumor and 70% to 90% among those with advanced disease.11 Prospective surveys indicate that as many as 90% of patients could attain adequate relief with simple drug therapies, but this success
rate is commonly not achieved in routine practice.11-14 Patients often suffer from pain that may be derived from the scars after surgery or radiotherapy or have pain associated with lymphedema (volume increase, local edema, and sensory alteration), which is linked to arm dysfunction. These symptoms are correlated with a limitation in activity and suboptimal health-related quality of life.15 Postsurgical treatments, including tamoxifen and aromatase inhibitors (AIs), have been used increasingly in breast cancer adjuvant therapy, but the joint pain associated particularly with AIs signiﬁcantly reduces patient adherence despite the clear survival beneﬁts of this class of drugs.16,17 Moreover, anticancer therapies may induce signiﬁcant tissue damage with bleeding, inﬂammation, and exudative and degenerative processes. The ensuing devitalized matrix, together with deposition of chemicals, interferes with natural healing processes, and detoxiﬁcation and drainage are believed to eliminate these factors. According to the World Health Organization treatment strategy, conventional therapies for prevention and treatment of peripheral neuropathy and acute pain syndrome in breast cancer patients include nonsteroidal antiinﬂammatory drugs (eg, acetylsalicylic acid, paracetamol, naproxen, metamizol, diclofenac) as
ALTERNATIVE THERAPIES, jan/feb 2010, VOL. 16, NO. 1
A Homeopathic Injection Therapy for Breast Cancer Therapy–related Pain
20 In this report of a series of case reports. Compared to the assessment at the previous visit. in a palpable depression on the front of the shoulder. Thus. A maximum of 20 sites chosen from Oriental acupuncture were selected for injection. when the arm is adducted A Homeopathic Injection Therapy for Breast Cancer Therapy–related Pain ALTERNATIVE THERAPIES. in the mammary line • ST 15: in the second intercostal space.5 4 3 4 4 4 6 10 7 4 Pain score Pain score Pain score 4 (↓) 1 (↓) 2 (↓) 2 (↓) 5 (↓) 3 (↓) 3 (↓) 1 (↓) 1 (↓) 2.1±2. The injection therapy was conducted once a week. Different forms of complementary and alternative medicines (eg.2 mL) was given subcutaneously in combination with procaine 2% (5.5 The level of pain was assessed by each patient before and after the last injection therapy as well as 3 and 6 months after the last injection therapy using a pain score. (↔). a local anesthet- TABLE 1 Assessment of the Efﬁcacy of Homeopathic Injection Therapy on Pain Relief Number of Before Injection After Last Injection Therapy Injection 3-month 6-month Therapy Therapy Follow-up Follow-up (Baseline) Sessions Patient P1 P2 P3 P4 P5 P6 P7 P8 P9 Mean ± SD Pain score 8 5 10 9 8 5 8 8 8 7. Baden-Baden. effective pain management with a high compliance and acceptance rate by patients is required.the ﬁrst step and opioid analgesics (eg. no change in pain. music. Germany) and observe them for 3-month and 6-month follow-up periods. Participants Nine women with unilateral breast cancer from the Luis Tisne Hospital in Santiago de Chile were treated with Traumeel injection therapy and observed from August 2007 to April 2008. NA indicates not analyzed. could help patients who are otherwise resistant to conventional treatment cope successfully with pain syndrome in the long term. NO. hypnosis. were as follows: Breast • Liv 14: in the sixth intercostal space. who often suffer from cognitive impairment caused by the malignancy itself or by the adverse effects of chemotherapy or radiation. Medication and Disposition of Participating Patients The active ingredients of this complex homeopathic medication are listed in Table 3. (↓) indicates a reduction in pain. 16. Our intention was to treat breast cancer patients by injection therapy with Traumeel (Heel GmbH. was added to make the injections less painful.0 mL) after the skin was disinfected with denatured alcohol (95%). jan/feb 2010. beginning with the sites that appeared especially painful. when the arm is adducted • LI 16: in a depression between the lateral end of the clavicle. in the mammary line • ST 18: in the ﬁfth intercostal space.4±1. and therefore. an increase in pain. dihydrocodeine) as the second step. acupuncture. The sites of punction. In this study. This is unacceptable for many cancer patients. (↑).3±2. 2 cm lateral to the nipple. standard deviation. These patients were treated with Traumeel and procaine injection therapy and observed from August 2007 to April 2008.2 2 (↔) 2 (↔) 5 (↑) 7 (↔) 7 (↑) 5 (↔) NA NA 1 (↔) 4. antipsychotic medications such as antidepressants or antiepileptic drugs are commonly recommended. massage. we addressed the question of whether homotoxicological treatment. All patients still suffered from a high level of postoperative pain (Table 1). towards the anterior axillary line • K 23: in the fourth intercostal space. One ampoule of medication (2. METHODS The approach of individual case observations with an openactive treatment was chosen to assess pain relief and changes in health-related quality of life in order to estimate treatment effect and gain experience with this injection therapy for use in planning subsequent clinical trials. alternative and better tolerated treatments for the relief of pain are highly desirable. these medications are not always effective and may have a high incidence of side effects. scapula. VOL. tramadol. codeine. SD. Procaine. particularly in the short term.6±1. herbal supplements) are widely used and seem promising. However. The baseline characteristics and the method of breast cancer therapy for each individual patient are described in Table 2. and acromion • SI 9: about 2 cm above the axillary crease. These patients had undergone conservative or radical surgery and/or radiotherapy and/or chemotherapy and/or antiestrogen therapy and had not experienced any relief in pain symptoms after use of conventional medications.19 In addition. depending on each case. relaxation/imagery.4 2 (↓) 2 (↑) 3 (↑) 7 (↑) 6 (↑) 5 (↑) 3 (↔) 1 (↔) 1 (↔) 3. 1 55 . in the mammary line Ipsilateral shoulder • LI 14: in the inferior insertion of the deltoid muscle • LI 15: below the acromion. in the mammary line • GB 21: in the middle of a line between the seventh cervical spinous process and the acromion • PC 1: in the fourth intercostal space. we report a case series of patients from a follow-up program for breast cancer patients in which conventional medications for pain relief during the postoperative period were ineffective.18. This level of pain represents the baseline before start of the injection therapy. given as an injection therapy. ic. lateral 4 cm from the nipple towards the midline • ST 14: in the ﬁrst intercostal space.
VOL. The frequency and outcome of the use of conventional analgesics before and after the injection therapy was also assessed. One patient rated the level of her pain at 5 points.2 2.TABLE 2 Epidemiological Characteristics and Pain Management of Patients After Breast Cancer Treatment Patient P1 P2 P3 P4 P5 P6 P7 P8 P9 Age (years) 81 75 52 69 72 74 62 65 78 Surgery Conservative Conservative Conservative Conservative Conservative Radical Conservative Radical Radical Chemotherapy No No Yes Yes No No No Yes No Radiotherapy Yes Yes Yes Yes Yes Yes Yes Yes Yes Start of Posttreatment Pain Immediately Immediately After 12 months After 3 months After 5 months After 2 months Immediately After 2 months After 4 months Medication for Posttreatment Pain Paracetamol.and 6-month observational phases (Table 1). The level of pain ranged from 1 to 10. D-Potency 2 2 3 6 3 2 2 2 2 2 2 1 6 6 Quantity* (μL per 2.1 2. Immediately after the last injection. when the arm hangs in an adducted position Ipsilateral scapula • SI 11: in the center of the scapular infraspinous fossa • SI 13: in the medial end of the suprascapular fossa In addition. insomnia. Ashi points are tender points not related to the acupuncture points.1 0.2 mL. Assessment was performed by an independent member of the group who was not directly involved in the treatment.6±1. in the typical fashion of a visual analog pain scale. Outcome Criteria The patients were asked to rate the level of pain sensations before injections. or ketoprofen (Table 2).2 1. and at the followup visits after the 3. baseline).2 2. jan/feb 2010. The women were between 52 and 81 years of age (69. ketoprofen Ibuprofen Ibuprofen Paracetamol Ibuprofen. which reﬂects a high level of pain sensation. In addition.32 1. On average.2 2. 16. A non-validated questionnaire was used to identify sites.7 years average). directly after the last injection. type.55 0. paracetamol Ketoprofen No use TABLE 3 Active Ingredients of the Homeopathic Injection Solution Source of extract Arnica montana Calendula ofﬁcinalis Chamomilla recutita Symphytum ofﬁcinale Achillea millefolium Atropa belladonna Aconitum napellus Bellis perennis Hypericum perforatum Echinacea angustifolia Echinacea purpurea Hamamelis virginiana Mercurius solubilis Hahnemanni Hepar sulfuris *1 ampoule contains 2.22 1.2 2.2 mL) 2. eight of nine patients took paracetamol. RESULTS Baseline Characteristics Nine breast cancer patients were selected for the injection therapy. pregabalin. (In Chinese acupuncture. it appeared between 2 and 12 months after the mastectomy plus radiotherapy.2 pleted the 6-month follow-up phase.) The patients underwent three to a maximum of ten injection sessions until a reduction of pain was achieved (Table 1). Ashi points were also used.66 0. For pain treatment. The start of posttreatment pain was immediate in some patients. 1 A Homeopathic Injection Therapy for Breast Cancer Therapy–related Pain . Seven of the nine patients com- 56 ALTERNATIVE THERAPIES.5 points. Injection therapy was conducted once a week. the pain was rated with 7. Only one patient did not take any medication for relief of her pain symptoms. but in others. The last session with injection therapy was followed by 3-month and 6-month follow-up observational phases.55 0. eight patients rated their levels of pain between 8 and 10 points on the pain score (Table 1. The data are presented as individual pain score ratings and as mean ± standard deviation (SD). this questionnaire was used to assess the impact of pain and effect of injection therapy on health-related quality of life (physical disability.2 2. the patients were asked • SI 10: in the depression inferior to the scapular spine. pregabalin Paracetamol Ibuprofen. and psychological distress). two patients completed the 3-month follow-up phase (Table 1). Effect of Injection Therapy on Posttreatment Pain Before starting the Traumeel injection therapy. and each woman received radiotherapy (Table 2). and occurrence of pain. directly superior to the axillary crease. NO. The surgery was conservative or radical. ibuprofen.
P8. and none reported exacerbation of pain (data not shown). and there was no deterioration in any of the symptoms assessed (Table 4). In one patient (P1). VOL. Interestingly.3±2. reﬂecting an improvement in their health-related quality of life. At the last follow-up visit (for two patients after 3 months. This complex homeopathic medication has been used in the treatment of injuries in Germany since 1937. Figure 1). NO.22 A recent observational cohort study in patients with various musculoskeletal injuries has shown that it was effective and safe and judged by physicians A Homeopathic Injection Therapy for Breast Cancer Therapy–related Pain ALTERNATIVE THERAPIES. None of the patients reported a low effectiveness. In ﬁve patients. In the other ﬁve patients. Only two patients of nine reported an increase in pain symptoms (one patient from 3 to 5 points. At the end of the 6-month follow-up observational phase. all patients reported a remarkable reduction in the severity of their physical disability. However. since we assessing the validity of this therapy and were piloting this technique. the rating was between 1 and 5 points (an average of 2. This indicates a sustained reduction of pain despite a long nontreatment period after the last injection. in each case. The lack of blinding could be associated with an increased treatment effect. Seven of nine patients had severe sleep problems. the level of pain declined further from 4 to 2 points. Effect of Injection Therapy on Physical and Psychological Impairments After the breast cancer therapy and despite pretreatment with conventional pain medications. We are also not able to separate the potential beneﬁts of the injection with procaine alone from our combination injection with both the investigational medication and procaine.and 6-month followup observational phases. A deterioration back to the level before starting the injection therapy was observed in only two patients (P4 and P6). improved sleep. One patient reported good effectiveness (Figure 2). In all seven patients that continued the follow-up observational phase of 6 months. the level of pain was assessed again. In all patients. again to rate the level of their pain.1±2. and psychological distress symptoms. the physical and psychological improvement remained constant or even improved further in most of the patients. insomnia. patients were asked about their perception of the effectiveness of the injection therapy with Traumeel. the results are promising and will provide valuable information in the planning of subsequent clinical trials. however. 16. In addition. the subjects in the study were using different conventional analgesics. and although the reason they were in this study was that they were not experiencing adequate pain relief. directly after the last injection. DISCUSSION We recognize that there are limitations with this clinical study. The increase in pain. The use of validated quality of life instrument such as the SF-36 might have provided a more meaningful comparison. injection therapy for breast cancer patients resulted in a sustained reduction in pain and in improved management of daily work. some patients were contacted as many as 12 months after injection therapy. the rating remained consistent. another patient from 6 to 7 points). eight of nine patients suffered from moderate to severe physical disability in managing their home tasks or their work. the analgesics had variable dosages of different conventional pain medications. the individual ratings showed strong variations.4±1. for seven patients after 6 months). the scores were still lower than they had been before starting the treatment (Table 1. and 3 and 6 months after the last injection. and seven of nine patients suffered from moderate to severe psychological distress before starting the injection therapy (Table 4). Again. However. patients were asked to assess their level of pain using the visual pain score. did not require treatment. In summary. Eight of nine patients reported high effectiveness.P1 P6 10 8 VAS Points 6 4 2 0 Before Injection Therapy P2 P7 P3 P8 P4 P9 P5 End of Injection Therapy 3-month Follow-up 6-month Follow-up FIGURE 1 Effect of Injection Therapy on the Level of Pain Before the start of the injection therapy. Figure 1).5 points). the ratings of their pain increased to levels between 2 and 7 points. none of the patients needed any other medications for pain relief during the 3. a strong reduction in pain was reported (Table 1. the physical and psychological situation remained stable. Three months after the last injection session. a slight increase in the pain score ratings to 3. and a reduction in psychological distress. the pain remained consistently low at a level between 1 and 3 points. however.2 points was observed. After the 3-month follow-up observational phase. At the end of the injection therapy. On average. 21 Experimental studies have suggested that this complex homeopathic medication elicits analgetic and antiinﬂammatory capacities by inhibiting the release of the proinflammatory cytokines IL-1β and TNF-α and the chemokine IL-8 in vitro. The level of pain ranges from 1 to 10. the pain score ratings remained lower than they were before starting the treatment (Table 1. 1 57 . jan/feb 2010. we chose an open label method. Importantly. and P9).4 points). Importantly. Figure 1). In three patients (P7. with higher scores indicating a greater level of pain. though present. a further slight increase in the average pain score rating was observed (to 4.
to be better tolerated than conventional medicines for the treatment of acute injuries and trauma. the patients were asked to rate their perception of the injection therapy as high. an improvement in health-related quality of life. We speculate that this medication acts on pain elicited directly at nerve ﬁbers. (↑).and 6-month follow-up observational phases without further injection. insomnia. after 3 months with two patients). ++ (moderate). During the following 3.28 Many cytostatic drugs are neurotoxic. and +++ (strong) indicate the degree of symptom severity. whereby the damage does not appear immediately after application. Compared to the assessment at the previous visit. + (slight).TABLE 4 Assessment of the Efﬁcacy of Homeopathic Injection Therapy on Improving Health-related Quality of Life Before Injection Therapy After Last Injection Therapy 3-month Follow-up Physical 0 (↔) 0 (↔) ++ (↔) +++ (↔) 0 (↔) ++ (↔) NA NA 0 (↔) + (↔) 6-month Follow-up Insomnia 0 (↔) + (↔) ++ (↔) 0 (↔) + (↔) 0 (↔) NA NA 0 (↔) 0 to + (↔) Psychological 0 (↔) 0 (↔) ++ (↔) ++ (↔) + (↔) 0 (↔) NA NA 0 (↔) 0 to + (↓) Patient Physical Insomnia Psychological Physical Insomnia Psychological Physical Insomnia Psychological P1 P2 P3 P4 P5 P6 P7 P8 P9 Total ++ ++ +++ +++ 0 ++ +++ ++ +++ ++ +++ +++ +++ 0 ++ 0 +++ ++ +++ ++ +++ +++ +++ ++ ++ 0 +++ +++ 0 ++ 0 (↓) 0 (↓) + (↓) ++ (↓) 0 (↔) + (↓) + (↓) 0 (↓) 0 (↓) + (↓) 0 (↓) ++ (↓) 0 (↔) + (↓) 0 (↔) + (↓) 0 (↓) 0 (↓) + (↓) 0 (↓) ++ (↓) 0 (↓) + (↓) 0 (↔) + (↓) + (↓) 0 (↔) + (↓) 0 (↔) 0 (↔) ++ (↑) +++ 0 (↔) ++ (↑) ++ (↑) 0 (↔) 0 (↔) 0 (↓) + (↑) ++ (↔) 0 (↔) + (↔) 0 (↔) + (↔) 0 (↔) 0 (↔) 0 (↓) 0 (↔) ++ (↔) ++ (↑) + (↔) 0 (↔) ++ (↑) + (↔) 0 (↔) + (↔) 0 to + (↓) 0 to + (↓) + (↑↔) 0 to + (↔) Symptoms of physical disability. the level of pain increased again. jan/feb 2010. VOL. This is the ﬁrst time that this injection therapy has demonstrated the capacity to reduce pain sensations in a selected group of patients after breast cancer therapy. None of the patients rated her perception as low. inﬂammation. which were damaged by the methods of breast cancer treatment (ie either by surgery and/or chemotherapy and/or radiotherapy). Assessment was performed by an independent member of the group who was not directly involved in the treatment. no change of symptoms. a deterioration in health-related quality of life. such as swelling and bruising26 as well as postoperative pain. 58 ALTERNATIVE THERAPIES. and psychological distress reﬂecting the state of health-related quality of life of each patient were assessed before and after the last injection as well as 3 and 6 months after the last injection using a questionnaire. a solution from this medication was seen to be effective in vivo for chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.24 In a pilot study. observational study in patients with tendinopathies of varying etiology based on excessive tendon load showed the noninferiority of this complex homeopathic medication as an ointment compared to a 1% diclofenac gel for acute symptomatic treatment. and (↔). normal.30 This is known particularly for platinum compounds. (↓) indicates a decrease in distress symptoms. 16.31 The constituents of this complex homeopathic preparation are neuralgia-alleviating substances with reported effectiveness in homeopathy and homotoxicology. ie. n indicates number of patients. the efﬁcacy of injection therapy was assessed in nine breast cancer patients who suffered from pain induced by breast cancer therapy (posttreatment pain) with pain scores between 5 and 10 and in whom other treatment options for pain relief were unsuccessful. 0 (none). ie. 1 A Homeopathic Injection Therapy for Breast Cancer Therapy–related Pain . where sensory loss may progress for several months after cessation of treatment. This sustained reduction in pain sensation for 3 to 6 months after the last injection was unexpected. NO.25 The constituents of this medication are believed to be effective in conditions associated with pain.32-35 We can speculate that 100 n=8 80 60 40 20 n=1 0 n=0 high normal low FIGURE 2 Perception of Effectiveness of Injection Therapy Treatment At the last follow-up visit (after 6 months with seven patients. NA indicates not analyzed. and trauma. or low.29. an increase in distress symptoms. however.23 Another nonrandomized. the increase was slight and did not reach the levels seen before starting the treatment.27 These studies together with many years of experience from everyday practice in pain management provided the rationale to propose this injection therapy as an alternative treatment for the reduction of pain symptoms in patients after breast cancer treatment. In our report.
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