Wednesday, August 17, 2011

Homeopathy in Pain Practice!?

Homeopathy Homeopathy, a therapeutic modality incorporating botanical agents, has been used since the 18th century. It is believed that the administration of homeopathic preparations containing very small amounts of active substances can produce different effects based on their concentration or dilution; very low doses incur beneficial effects whereas higher doses of the same agents might produce harmful ones. Homeopathy also is highly controversial and whether it could be of value in pain practice, as suggested by a review in Practical Pain Management (PPM), needs careful scrutiny.

According to Joan Lewis, MD, writing in the November/December 2010 edition of PPM, the principle whereby very low doses of a substance may produce a beneficial effect and higher doses produce a harmful effect in known as “hormesis” [Lewis 2010; access here]. “From the conventional medical perspective,” she notes, “this effect can be observed in an inoculation when the introduction of a minute amount of a substance (that in larger doses is harmful) stimulates the beneficial production of antibodies and does not overwhelm the immune system.”

Lewis — who is a graduate of UCLA and studied otolaryngology, critical care, and anesthesiology — writes, “A significant opinion from our perspective [is that] pain practitioners should acknowledge that the option of homeopathy is safe, cost-effective, and can be utilized in combination with modalities and/or medications already in place.”

Lewis asserts that research published on hormesis has underscored its validity, and an understanding and acceptance of this principle is critical for the practitioner’s understanding of the efficacy of homeopathic medicinal products in concentrations that radically differ from dosing for conventional medications. For example, some homeopathic agents show beneficial effects at concentrations in nanogram or picogram ranges.

Appropriate homeopathic preparations must be matched to a patient’s specific symptoms and constitution. Within homeopathy as integrative medicine, homotoxicology is a therapeutic approach in which a medical diagnosis is made followed by an individualized assessment of the patient’s disease severity. Treatment is then given, predominantly using homeopathic preparations, to support the inherent self-regulatory ability of the patient by means of detoxification and drainage, immunomodulation, functional organ support, and support of cellular metabolism.

“Research on combination homeopathic products has helped reveal their mechanisms of action on targeted portions of bioregulatory systems that helps to explain their efficacy,” Lewis states. Patient improvement may take longer than with conventional medications “but results can be rewarding because the underlying physiologic reactions can begin to function normally and optimally.”

Through the modulation of bioregulatory mechanisms a patient’s pain can be safely attenuated, she asserts, “…what could be safer than combination homeopathy that utilizes natural botanicals? Indeed, since the normal physiologic pathway is maintained, there are extremely rare side-effects from homeopathic products, if any, and usually consisting mainly of hypersensitivity reactions.”

In her review, Lewis focuses on injections of homeopathic agents, observing that the duration of effects can last from days to several weeks and some patients may experience permanent relief. “Although most patients report some effect, it is currently impossible to predict before injections are given what duration and magnitude of therapeutic effects will occur,” she writes. “Paradoxically, patients with long-standing pain conditions may respond rapidly with pain relief.”

Homeopathic injections may be administered intradermally, subcutaneously, intramuscularly, or intravenously. Trigger point injections, injections into tendons, and periosteal injections often are used. Lewis suggests that a small gauge needle (30g) significantly minimizes discomfort of the injection procedure and frequently makes a local anesthetic at the injection site unnecessary.

In cases where there is no relief from the pain following the injections, Lewis suggests that there may be an accumulation of stored toxins in the extracellular matrix and the resultant inflammation may prevent therapeutic effectiveness. Inflammation is more likely to be a significant factor in chronic disease states over the course of years, and the extracellular matrix is a focus of research targeting pain relief.

Lewis notes that commercial homeopathic products are labeled for different condition, such as anti-inflammatory, muscular or joint pain, or trauma. The practitioner may choose to use either combination therapy or a single product in the treatment approach. Following the injection, an oral homeopathic formulation may be provided to prolong the effect of the injection. The frequency of injection treatments can be tailored to response from the patient; weekly treatments are generally administered and injections can be continued until they are no longer needed.

Lewis concedes that many insurance plans do not cover homeopathic therapy. She says, “Patient demand may drive this inclusion, as more informed patients are beginning to demand safer and more effective alternatives for their pain. The medications are inexpensive and patients are generally willing to pay for them when they are aware of the efficacy.”

COMMENTARY: We have written about homeopathy in prior UPDATES in the CAM (Complementary and Alternative Medicine) category [see listings], and this article in PPM appeared to provide some further perspectives for pain practitioners. However, Dr. Lewis notes in full disclosure at the end of her article that since 2010 she has worked as a medical director for HeelUSA, a large producer of homeopathic products [website here]. So, one might assume that there might be commercial objectives of her article, even though it was requested from Lewis by the PPM editor as an informational offering for readers.

The review is somewhat technical in places and confusing, largely due to unfamiliar terminology and concepts that are only briefly explained. And, there are no references to clinical trials or other experimental research to substantiate claims of efficacy. At the HeelUSA website there is a link to “Clinical Research” that is only accessible to registered commercial customers, not the public (so we could not see what is there). Anyone can access their lengthy “Practitioners Handbook of Homotoxicology” [134 pp, PDF here], but this includes no supportive research evidence.

The U. S. National Center for Complementary and Alternative Medicine (NCCAM) asserts [here] that most assessments of homeopathy have concluded there is little evidence to support it as an effective treatment for any specific condition; although, some studies have reported limited positive findings. Furthermore, there is inadequate research on the safety of homeopathic treatments.

Critics have questioned the validity of homeopathy based on a lack of supportive clinical evidence or a scientific rationale for the benefits of extremely diluted solutions of ostensibly medicinal agents. Apparently, however, there can be different definitions and qualities of homeopathic formulations; those mixtures described in the article by Lewis, and in some of the research, seem to be of greater strength than usually envisioned and, thereby, may have some sort of scientific basis for their effects. Often in the literature, homeopathic and herbal remedies are considered as the same thing [Kanodia et al. 2010]. We recently discussed a research study of an herbal ginger/feverfew combination for headache [here] that was described by the authors as homeopathic but did not fit the traditional definition in terms of extensive dilution. At that, the product exhibited only small but statistically significant effects in relieving mild headache pain, compared with placebo.

So, there may be some uncertainty in the research literature, and in the marketplace, as to just what qualifies as homeopathic. And, the discussion by Lewis — which includes principles of homotoxicology and bioregulation, along with injectable preparations under the purview of pain practitioners — adds further dimension and complexity to the subject.

Overall, the relatively few Chochrane Collaboration Systematic Reviews of research on homeopathy have reported a lack of good quality studies and little or no evidence in support of homeopathic preparations for any condition. The single evidence review we found listed under homeopathy relating to pain, focusing on herbal medicines for low back pain, doubtfully involved traditional homeopathic formulations [Gagnier et al. 2009]. The quality of evidence was generally poor and there was no evidence that any of the herbal medicines were safe and effective for long-term use.

Last May 2011 we discussed in an UPDATE [here] a study of homeopathy for painful rheumatoid arthritis [Brien et al. 2011] and a limited review of homeopathy [Ernst 2002] that found homeopathic remedies were of no help for treating pain but benefits of the homeopathic consultation itself appeared to be worthwhile. In many cases, however, the quality of evidence was insufficient to reach definitive conclusions.

Via PubMed search we located a recent randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel-S in minimizing pain and analgesic consumption following orthopedic surgery [Singer et al. 2010]. Traumeel — a product produced by the company Lewis represents — was not superior to placebo in minimizing pain or analgesic consumption during the 2-week trial. There was a transient reduction in maximum postoperative pain scores on the day of surgery but this was deemed of questionable clinical importance.

Another fairly recent randomized, controlled trial assessed usual care compared with usual care plus adjunctive care by a homeopath for patients with fibromyalgia syndrome (FMS) [Relton et al. 2009]. In this small study (47 subjects total) homeopathic treatments, which were individualized to each patient’s needs, produced significant reductions in fatigue and tiredness upon waking. There was only a small-sized effect (0.21) for pain reduction but a larger effect (0.81) for improved function in the homeopath-treated group.

Some critics have dismissed homeopathy as “pseudoscience” or worse, and not even worth the possible placebo effects it might confer. Others have questioned the ethical propriety of promoting, selling, or administering any and all homeopathic products. For example, blogger/pharmacist Scott Gavura, BScPhm, MBA, RPh, seems to summarize some of the negative assessments by saying: [complete blogpost here]

“…we should stop promoting homeopathy, and the sale of homeopathic remedies. We should advocate against the allocation of limited health resources to researching, facilitating or providing homeopathy. We should avoid giving homeopathy undeserved credibility by selling it alongside actual medicine, or allowing it to be sold without clear labeling that describes its lack of ingredients and effectiveness. And when we’re asked, we have an ethical responsibility to explain why we believe homeopathy is no ‘alternative’ at all.”

In a recent article appearing in the journal Bioethics, Kevin Smith, a Scottish lecturer specializing in genetics and bioethics, examines homeopathy from pro and con perspectives [Smith 2011]. He concludes that homeopathic preparations are so diluted that they contain no significant amounts of active ingredients, and thus can have no effect on the patient's body. "Those who believe it works either do not understand the science or are simply deluded,” he writes. "Homeopathy is not ethically neutral — it is wasteful and potentially dangerous." In his opinion, “…homeopathy is ethically unacceptable and ought to be actively rejected by healthcare professionals.”

Those are strong statements from critics; meanwhile, we, ourselves, have not reviewed all of the research: for example, there are 41 records in PubMed of clinical trials relating to homeopathic treatments for pain of some type. However, the majority of research studies we have examined to date does not portray homeopathy in a favorable light in terms of efficacy — granted, there have been quality issues and other limitations in much of the research.

Despite what the critics have to say against homeopathy, we still must question how a modality such as this could have successfully withstood such a long test of time if it is consistently a complete clinical failure and waste of resources. There are a great many homeopathic products, often containing complex botanical extractions and mixtures, with each requiring careful observation and skill on the part of the practitioner for proper selection and administration. These many variable factors can confound outcomes to make controlled research difficult and have themselves been a source of criticism. Yet, homeopathy has endured.

We have not seen other discussions of the principles and approaches using injectable homeopathic agents as described by Lewis in her article. Perhaps her company’s products are exceptional and this is a valid modality for pain practice but we have not seen clinical research evidence to support this.

Before either rejecting homeopathy or recommending it for patients with pain, healthcare providers may want to learn more about this modality to thoughtfully reach their own conclusions.

ADDENDUM (8/18/11) — For further background information on this topic, readers may be interested in the Homeopathy entry in Wikipedia [here]. To the extent that such entries can be trusted — and considering that authorship and peer review processes are ongoing (see under “Discussion” tab at website) — this article appears to be well-referenced and consistent with other sources.

> Brien S, Lachance L, Prescott P, et al. Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial. Rheumatology. 2011;50(6):1070-1082 [
article here].
> Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002;54(6);577-582 [
available here].
> Gagnier JJ, van Tulder MW, Berman BM, Bombardier C. Herbal medicine for low back pain. Cochrane Database of Systematic Reviews 2006;(2)Art No:CD004504 [
> Kanodia AK, Legedza ATR, Davis RB, et al. Perceived Benefit of Complementary and Alternative Medicine (CAM) for Back Pain: A National Survey. J Am Board Fam Med. 2010;23:354-362 [
article PDF available here].
> Lewis J. Homeopathy Enters Contemporary Pain Medicine. Prac Pain Manag. 2010(Nov/Dec);10(9):11-14 [
article here].
> Relton C, Smith C, Raw J, et al. Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial. Homeopathy. 2009;98(2):77-82 [
abstract here].
> Singer SR, Amit-Kohn M, Weiss S, et al. Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial. BMC Clin Pharmacol. 2010;10:9 [
abstract here].
> Smith K. Against Homeopathy — A Utilitarian Perspective. Bioethics. 2011(Feb); online ahead of print [
abstract here].