A Complementary Approach to Pain Management

Meenakshi Khatta, MS, CRNP

Topics in Advanced Practice Nursing eJournal. 2007;7(1) 

Pain and CAM

Complementary/alternative medicine (CAM) has been defined as, "diagnosis, treatment and/or prevention [that] complements mainstream medicine by contributing to a common whole, by satisfying a demand not met by orthodoxy or by diversifying the conceptual frameworks of medicine."^[1] The majority of patients suffering from pain due to musculoskeletal conditions will use some form of CAM.^[2]

Persistent pain may be associated with morbidity such as depression and anxiety,^[3-7] physical disability,^[6,8-13] and sleep disturbance.^[11,14,15] Despite the prevalence of pain in musculoskeletal disorders, effective treatments are not without severe side effects. Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause serious morbidity and mortality.^[16-19] Opioids, although effective, may cause constipation, altered mental status, and falls.^[20-22] When traditional treatments are ineffective or cause morbidity, patients either have to suffer in pain or seek alternative treatment.

Many different CAM modalities are used to treat pain; amongst the most popular are:

• Acupuncture;
  
  

• Mind-body therapy;
  
  

• Herbal preparations;
  
  

• Ayurvedic therapy;
  
  

• Nutritional supplements; and
  
  

• Spinal manipulation.

This article reviews the effectiveness of each of these modalities based on the best evidence available in the form of randomized clinical trials (RCTs) or systematic review of such studies.

Acupuncture

The first written account of acupuncture is believed to be the 2300-year-old Huang Di Nei Jing, or the Yellow Emperor's Classic of Internal Medicine.^[23,24] Since that time, acupuncture has undergone several evolutionary processes, both in theory and practice. Energy, or Qi (chi), flows up and down the meridians. Sometimes the energy is blocked, deficient, excessive, or unbalanced. This throws Yin (the feminine aspect of life) and Yang (the masculine counterpart) out of balance, which in turn causes illness. Acupuncture restores the balance, thereby encouraging healing.^[25]

Thus far, there is not a concrete method to prove whether or how acupuncture works. There are several theories, however, to explain the benefits of treatment, and researchers have been experimenting with nuclear medicine techniques to study acupoints and meridians.^[25] Acupuncture is believed to stimulate secretion of endorphins, serotonin, and noradrenaline in the central nervous system. Acupuncture could also work by constricting or dilating blood vessels due to release of vasodilators such as histamine. Acupuncture also may have a role in controlling pain by closing the gates of nerve fibers that result in pain perception.

Back pain and fibromyalgia.The data on effectiveness of acupuncture in the treatment of back pain are conflicting. A meta-analysis of 12 RCTs looking at acupuncture as a symptomatic treatment of back pain resulted in favorable outcomes with acupuncture.^[26] A systematic review of all RCTs of acupuncture for fibromyalgia revealed only 3 studies,^[27] each of which supported use of acupuncture for relief of fibromyalgia symptoms.

Neck pain.Even though clinical or anecdotal reports often show neck pain relief from acupuncture, a systematic review of RCTs provided mixed evidence regarding how this modality compares with placebo for neck pain^[28]:

• In 1 trial, acupuncture was superior to waiting-list controls;
  
  

• 3 trials showed acupuncture to be either equal or superior to physiotherapy; and
  
  

• Needle acupuncture was not superior to indistinguishable sham control in 4 out of 5 studies.

The bottom line was that for the 8 high-quality studies included in this review of acupuncture vs placebo for neck pain, 5 were negative.

Osteoarthritis. An RCT of 570 patients with osteoarthritis of the knee were randomized to true acupuncture or sham. At the end of 26 weeks, acupuncture seemed to provide improvements in function and pain relief as adjunctive therapy for osteoarthritis of the knee.^[29]

Because even the best-designed studies are methodologically limited, it is difficult to draw definitive conclusions that will generalize to clinical practice. Most studies are methodologically limited because of:

• Questionable intervention quality;
  
  

• Lack of an adequate control group; and/or
  
  

• Lack of adequate follow-up.

The use of a sham acupuncture group (that is, placement of needles superficially and/or in nonacupuncture points) as an experimental control is problematic. There is evidence that acupuncture needles placed in nonacupuncture points lead to pain reduction because of stimulation of endorphin release via a mechanism called diffuse noxious inhibitory control.^[30] Because of the difficulties in designing rigorous acupuncture studies, we continue to rely on our clinical experience as evidence of the effectiveness of acupuncture.

Mind-Body Therapy (MBT)

The National Institutes of Health's (NIH) National Center for Complementary and Alternative Medicine defines mind-body medicine as "behavioral, psychologic, social, and spiritual approaches to medicine not commonly used." MBTs include:

• Meditation;
  
  

• Imagery;
  
  

• Biofeedback;
  
  

• Relaxation; and
  
  

• Hypnosis.

A meta-analysis of 25 randomized trials looking at a variety of mind-body interventions as adjunctive therapy in the management of rheumatoid arthritis (RA) suggested that mind-body interventions may be effective in patients who have had RA for a short time.^[31]

The most researched MBT for arthritis has been the Arthritis Self-Management Program (ASMP).^[32] This community-based intervention consists of:

• Education;
  
  

• Cognitive restructuring;
  
  

• Physical activity to reduce pain;
  
  

• Problem solving;
  
  

• Relaxation; and
  
  

• Development of skills to communicate with healthcare professionals.

Participants in ASMP experienced reductions in pain lasting 4 years post-intervention and amounting to a savings of 4 to 5 times the cost of the program per individual.^[33]

Jon Kabat-Zinn, PhD, and colleagues from the Stress Reduction Clinic, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, have published a series of studies suggesting that mindfulness meditation may be an effective strategy for helping chronic pain patients cope more effectively with their conditions.^[34,35] Even though the studies lack adequate control groups, a 4-year follow-up showed that 60% to 72% of the 225 patients who had completed this 8-week mindfulness meditation program reported "moderate to great improvement" in pain status.^[34]

Herbal Preparations

Herbal medicines are among the most popular forms of complementary treatments. In the United States, the annual expenditure on herbal remedies exceeds 1.5 billion dollars and grows each year by approximately 25%.^[36] Between 1990 and 1997, the use of herbal remedies in the United States increased by 380%.^[37] A large proportion of these herbal remedies is used for musculoskeletal pain.^[38] Patients' reasons for trying herbal medicines are complex. Prominent motivators are the wish to leave no option untried and the desire to benefit without incurring the risk of adverse effects.

Most of the herbal medicines have an effect on the eicosanoid metabolism, inhibiting one or both of the cyclo-oxygenase and lipoxygenase pathways. The ingredients of phytomedicines may be synergistic or antagonistic. Ideal extract doses and treatment periods still have to be determined. In most cases, herbal treatments are based on traditional use, which is a notoriously unreliable indicator of effectiveness.^[39] The substances included in this report represent several of the most popular herbal analgesics for which there are some data in the literature.

Cayenne (Capsicum frutescens). In a placebo-controlled trial involving 45 fibromyalgia patients, capsaicin plasters were compared with placebo plasters. Capsaicin is the active ingredient of cayenne. Patients receiving the active therapy experienced less tenderness and significant increase in grip strength. There were no significant differences in pain scores.^[40]

A recent Cochrane review outlined 3 low-quality trials using various topical preparations of Capsicum frutescens (cayenne) and found moderately favorable results compared with placebo.^[41]

Devil's claw. In a double-blind RCT, devil's claw (Harpagophytum procumbens) taken for 3 weeks was compared with placebo in 50 subjects with osteoarthritis.^[42] The herbal preparation was reported as significantly better than placebo for pain reduction. In another study, 89 patients with osteoarthritis were treated for 2 months with devil's claw or placebo. Again, the herb produced reduction in pain and increase in mobility.^[43]

Phytodolor. The efficacy of Phytodolor (a proprietary preparation that contains Populus tremula, Fraxinus excelsior, and Solidago virgaurea [goldenrod]) for painful arthritic conditions has been demonstrated in a number of studies. In one study, 108 hospitalized patients with joint pain had greater pain relief from either Phytodolor or piroxicam (Feldene) over 4 weeks compared with placebo.^[44] A systematic review of 10 RCTs with a total sample size of 1035 patients with RA was completed.^[45] The results of this review showed positive results with this herb.

Willow bark (Salix alba). A systematic review of the literature revealed inconsistent results for proprietary willow bark extract for either osteoarthritis or chronic low back pain.^[46]

A recent Cochrane review identified 2 moderate-quality trials using willow bark in combination with rescue medication for painful syndromes; both studies demonstrated short-term improvement in pain.^[41]

Ayurvedic preparations. Boswellia (Boswellia serrata), an ayurvedic preparation, has demonstrated anti-inflammatory activity in vitro by reducing leukotriene synthesis.^[47] One study comparing a 3600-mg extract with placebo in outpatients with active rheumatoid arthritis, however, did not show positive result.^[48] Ayurvedic medicine is an ancient system of healing that originated in India over 4000 years ago. The modalities used include diet, natural therapies, and herbs, depending on body type, and place equal emphasis on body, mind, and spirit.

An ayurvedic herbal mixture of Withania somnifera (winter cherry or ashwagandha), Boswelia serrata, Zingiber officinale (ginger), and Curcurma longa (turmeric) has been tested in a double blind RCT with 182 patients suffering from chronic RA.^[49] Participants were treated for 16 weeks. Of the multiple end points, only joint swelling showed a significant intergroup difference in favor of this preparation.

Gamma-linolenic acid (GLA)-containing herbs. Blackcurrant (Ribes nigrum) seeds contain high levels of GLA, an essential fatty acid that exerts anti-inflammatory activity by interfering with prostaglandin metabolism.^[50] In an RCT comparing blackcurrant seed oil 15 capsules/day with placebo over 25 weeks, patients with RA showed objective signs of reduced disease activity, but overall clinical response, using 4 distinct measures, did not vary between groups.^[51]

Two RCTs have shown positive results using borage (Boragio officinalis), another rich source of GLA, for painful conditions compared with placebo:

1. A total of 37 RA patients suffering from active synovitis given 1.4 g/day of GLA in the form of borage seed oil showed clinical improvement on several measures compared with those who received cotton seed oil placebo^[52]; and
   
   

2. In 56 patients with active RA given GLA 2.8 g/day vs sunflower seed oil, the GLA group showed statistically significant and clinically relevant reduction in signs and symptoms of disease activity as well as at least 25% improvement in 4 measures, which was significantly better than the placebo group.^[53]

Evening primrose (Oenothera biennis) oil capsules containing 540 mg of GLA were tested in a 3-arm RCT against 240 mg of eicosapentaenoic acid (EPA) plus 540 mg of GLA, or placebo in 49 RA patients.^[54] The results showed subjective improvement in symptoms as well as a reduction in NSAID consumption in both experimental groups but no objective change in clinical measures.

Many consumers are led to believe that herbal medicines are "natural" and, therefore, safe. The truth is that all such treatments have been associated with numerous, diverse adverse effects. This is hardly surprising given that medicinal herbs contain pharmacologically active ingredients. The largely unregulated status of herbal medicines in most countries has been associated with suboptimal product quality that, in turn, may present serious safety issues.

Nutritional Supplements

Avocado-soybean unsaponifiables (ASU) were compared with placebo in a 6-month RCT in patients with osteoarthritis of the hip and knee. The ASU preparation was superior in both pain control and functional measures.^[55] A systematic review of all RCTs of ASU included 4 studies and suggested that ASU may be an effective treatment of osteoarthritis.^[56]

Two randomized, placebo-controlled trials showed that 3 years of treatment with glucosamine sulfate slowed radiologic progression of osteoarthritis.^[57,58] An NIH-sponsored multicenter, randomized, placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) revealed that glucosamine (1500 mg/day) or chondroitin (1200 mg/day) alone or in combination did not reduce pain in the overall group of patients with osteoarthritis of the knee. However, there was some benefit noted in patients with moderate to severe pain when glucosamine and chondroitin were used in combination.

Fish oil is rich in EPA and docosahexaenoic acid, both of which have anti-inflammatory activity through their effects on prostaglandin metabolism. Several RCTs have shown clinical benefit of fish oil supplementation in RA.^[59] Of note, alpha-linolenic acid (from, for example, flaxseed oil), a precursor of these omega-3 polyunsaturated fatty acids, does not seem to have the same clinical effects for RA.^[60]

A small RCT using 800 mg of SAMe for those with fibromyalgia was found to be superior to placebo in improving^[61]:

• Disease activity;
  
  

• Pain;
  
  

• Fatigue;
  
  

• Morning stiffness; and
  
  

• Mood.

The proposed effect is due to anti-inflammatory and analgesic properties.

In an open pilot study, 20 RA patients received 20 or 1000 mcg selenium orally for 4 weeks.^[62] At the end of the trial, there were positive results in both immunologic and clinical outcomes.

Spinal Manipulation

Spinal manipulation is a popular form of treatment used by chiropractors, osteopathic physicians, allopathic physicians, physiotherapists, and other healthcare professionals to treat a range of primarily musculoskeletal problems. The American Chiropractic Association defines spinal manipulation as a passive manual maneuver "during which the three joint complex may be carried beyond the normal voluntary physiological range of movement into the para-physiologic space without exceeding the boundaries of anatomic integrity."^[63] The essential characteristic is a low- or high-velocity thrust -- brief, sudden, and carefully administered at the end of the normal passive range of movement -- in an attempt to increase the joint's range of movement. This distinguishes manipulation from other forms of manual therapy. The 1-year prevalence figures of spinal manipulation in representative samples of general populations are high^[64]:

• 15% (1996, Australia);
  
  

• 10% (1988, Austria);
  
  

• 33% (1996, United Kingdom); and
  
  

• 7% (1997, United States) and 16% (1998, United States).

There are many reviews of spinal manipulation for persistent musculoskeletal pain. Most of them focus on low back pain, for which the volume of trial data is significantly more substantial than for any other condition. One systematic review located 26 RCTs comparing spinal manipulation against placebo (sham treatment) for acute and chronic back pain.^[65,66] A meta-regression analysis of these 26 RCTs reported that spinal manipulation was superior to sham therapies and therapies judged to have no evidence of a benefit but was not superior to effective conventional treatments (namely, physical therapy, massage, exercises, back schools [group education and, possibly, work simulation or occupational health at worksites], and drug treatments [analgesics, anti-inflammatories, etc.]).

Summary: CAM and Pain Management

The evidence as presented in this article indicates that some forms of CAM can be effective for relief of pain. They offer hope for patients who face adverse effects from the use of NSAIDs and opioids. However, the evidence for some of these studies is not compelling. This may be due to the unique challenge of conducting rigorous trials in CAM. For example, performing a sham acupuncture treatment could be logistically difficult.

Conducting rigorous clinical trials in CAM is also difficult due to the culture that prevails among people who choose such modalities, many of whom believe in these therapies and are unwilling to participate in being randomized. Product quality is also a challenge. Herbal preparations and nutritional supplements are regulated by the US Food and Drug Administration in a different manner from either over-the-counter or prescription drugs. Therefore, there is great variability in their quality, which may affect research.

Advanced practice nurses (APNs) face multiple challenges when patients ask for their input about CAM therapies. Patients seek advice from their providers regarding the validity of the CAM research and its application. APNs have to be cognizant of herb-drug and herb-food interaction. Since CAM is consumer driven, people believe in the modality they choose. While APNs need to be supportive of their patients' choices, they also may need to advise caution and provide education about the best ways to integrate therapies to achieve desired results.

Topics in Advanced Practice Nursing eJournal. 2007;7(1) © 2007 Medscape

Cite this: A Complementary Approach to Pain Management - Medscape - May 31, 2007.