A Randomized Controlled Trial of a Multifaceted
Integrated Complementary-alternative Therapy for
Chronic Herpes Zoster-related Pain

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:    Frankp@chiro.org

FROM:   Alternative Medicine Review 2012 (Mar); 17 (1): 57–68 ~ FULL TEXT

Hui F, Boyle E, Vayda E, Glazier RH.

Department of Family and Community Medicine,
University of Toronto,
Toronto, ON, Canada.

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INTRODUCTION:   Our objective was to determine whether a three-week complementary and alternative medicine (CAM) approach integrating several therapies from Traditional Chinese Medicine (TCM) along with neural therapy (injection of 1% procaine as local anesthesia) reduces the level of unresolved pain associated with herpes zoster.

METHODS:   The design was a randomized controlled clinical trial in a community-based primary care clinic in Toronto, Ontario. We studied individuals 18 years of age and older with a confirmed diagnosis of herpes zoster of at least 30 days duration and with at least moderate postherpetic neuralgia pain (=4) on a 10–point Likert scale. The CAM therapies used were acupuncture, neural therapy (1% procaine injection as a local anesthetic), cupping and bleeding, and TCM herbs. An immediate treatment group (n=32) received the CAM intervention once daily, five days per week, for three weeks. A wait-list (delayed treatment) group (n=27) was used as a control and received the same treatment starting three weeks after randomization. This three-week time period, when one group was receiving active CAM treatment and the other was not, was used as basis of comparison for treatment effects between groups. Pain, quality of life, and depression were measured at baseline, and three, six, and nine weeks post-randomization. Patients were followed for up to two years.

RESULTS:   Participants had a mean age of 69.8 years (SD=11.1) and had had herpes zoster-related pain for a median of 4.8 months (range: 1 month to 15 years). The immediate treatment and control groups had similar pain levels at baseline (treatment = 7.5; control = 7.8; p=0.5; scores based on the 10–point Likert pain scale). At three weeks post-randomization (i.e., after the immediate treatment group completed treatment) pain scores differed significantly (treatment = 2.3; control = 7.2; p<0.001). The observed reduction in pain in the immediate treatment group was maintained at nine weeks and at long-term follow-up (one to two years later). The delayed treatment (control) group also had significant reductions in pain after their integrated CAM treatment was completed.

CONCLUSION:   The described CAM protocol was associated with significantly reduced sub-acute and chronic post-herpes zoster neuralgia pain within three weeks of initiating treatment. Improvements persisted for up to two years.

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From the FULL TEXT Article

Introduction

Herpes zoster (HZ) is a painful vesicular skin disease (commonly known as shingles) that is caused by reactivation of latent varicella zoster virus infection in sensory nerve ganglia. The lifetime prevalence of HZ is between 10 and 20 percent. [1] Postherpetic neuralgia (PHN) is the most common complication of herpes zoster. PHN is characterized by neuralgia (pain that follows the path of a nerve) that persists for a period of time after the onset of herpetic skin lesions. Although there is no standardized clinical definition on the length of time required after HZ onset for a diagnosis of PHN, the presence of neuralgia one month after onset of HZ is often used as a cut-off clinically. [2, 3] As a result, we used the presence of neuralgia persisting for more than one month after the onset of skin lesions as our criteria. Incidence, severity, and complications associated with HZ tend to increase with age. This age-related increase is also observed with the incidence of PHN. Among persons with HZ, about 50 percent of those over 60 years of age and 75 percent over 70 years of age experience PHN. [3] While PHN tends to improve over time in many persons, some estimates have suggested that 23 percent of HZ patients have neuralgia that lasts for more than one year. [1] Unresolved pain in PHN can lead to a decreased quality of life, including mood changes, sleep disruption, social withdrawal, and depression, and it is associated with significant health care costs. [4,5]

Treatment for PHN generally includes one or more of antiviral medications (e.g., famciclovir and valacyclovir), tricyclic antidepressants, opioid analgesics, anticonvulsants (e.g., gabapentin and pregabalin), and topical applications (e.g., lidocaine patches or capsaicin lotion). [6–8] The use of the antiviral drugs, famciclovir and valacyclovir, is associated with reduced duration of PHN if these drugs are started within 72 hours of the appearance of herpetic lesions. [9, 10] A 2009 review listed tricyclic antidepressants, gabapentin and pregabalin, and opioids as being evidence-based interventions for pain relief. It also concluded that topical capsaicin and lidocaine 5% patch relieve pain and decrease allodynia. [11] These medications might be administered alone or combined with psychosocial support. [6–8] Although sympathetic nerve block has been reported to reduce acute herpetic pain, this procedure probably does not prevent PHN. [8] Intrathecal methylprednisolone has been reported to improve PHN. [12] Given the immediate timing required for antiviral drugs and the potential adverse effects and limited effectiveness of other established therapies, there is a need for an evidence-based CAM approach.

A multifaceted complementary and alternative medicine (CAM) approach integrating several therapies from Traditional Chinese Medicine (TCM) (acupuncture, cupping and bleeding, and Chinese herbs), meditation, and neural therapy (injection of 1% procaine used to infiltrate intradermally and subcutaneously on the affected dermatome to interrupt chronic pain and provide local anesthesia effects), along with a conventional medical approach had previously been used with success by one of the investigators (FH). Out of a series of 54 patients with PHN, 68.5 percent reported a 75–100 percent reduction in pain compared with their pre-treatment pain level using the CAM protocol. [13] The main objective of this study was to determine whether a similar CAM protocol could significantly reduce the level of pain associated with PHN in the context of a randomized controlled trial.

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Discussion

The multifaceted CAM protocol used in this trial was associated with a decrease in pain for at least nine weeks, even among those who had been experiencing moderately severe pain for over a year in duration. Along with the significant reduction in pain, there was significant improvement in physical health and a trend towards improved mental health and mood. Adverse effects were not severe and were relatively infrequent, usually involving only local discomfort associated with neural therapy injections and with the TCM cupping and bleeding therapy.

Current therapy for prolonged PHN has been of limited success [6–8, 11] except for intrathecal therapy, so the possible availability of an effective and relatively non-invasive treatment that has an effect within three weeks and appears to be free of lasting adverse effects could be a very useful treatment. Given the multiple components of treatment described in this study, it is not possible to attribute the pain reduction to a single intervention, and it is possible that a combination of therapies may have been required to produce the observed effect. Acupuncture alone for PHN has been associated with more modest effects. [25, 26] The exact mechanisms through which acupuncture, neural therapy, cupping and bleeding, and TCM herbs work are not fully established. In future research, it would be important to determine which treatment components, or combinations, are responsible for producing the therapeutic effect and to attempt to elucidate the biological mechanisms involved.

The internal validity of the study was high, given the inclusion of randomized and comparable active treatment and control (delayed treatment) groups. Although improvement in symptoms has been reported from sham acupuncture (a procedure which varies widely in format where placebo needles are used or where the needles are only partially inserted, inserted away from the acupuncture point, or inserted in a non-indicated acupuncture point), [27, 28] sham acupuncture was rejected for ethical reasons and because it was not compatible with the design of this trial. It was impossible to blind the subjects, given the nature of the treatment. However, none of the therapists providing the treatments were involved with collecting outcome data for the study.

As expected, there was dropout from both groups. The dropout rate was slightly larger in the wait-list control group. Dropouts were all included in the analyses. Differential dropout numbers from the two groups does not explain the results of this trial, since even in the worst-case scenario, where it is assumed that all of the dropouts in the immediate treatment group had pain scores of 10 and those in the wait-list control group had pain scores of 1, the groups would remain significantly different at three weeks (mean=2.8 [SD=2.5] and mean=6.3 [SD=3.1], respectively). Subjects in the immediate treatment group, who did not come back to the clinic for the six and nine-week assessments, tended to be individuals who had low pain scores (mean=2.5 [SD=2.3]) at the three-week follow-up. This may have resulted in an underestimate in the mean change scores from baseline at six and nine weeks.

The applicability of the CAM treatment used in this trial to other patients in other settings remains to be determined. Although subjects in the trial, like most PHN patients, were elderly, had multiple co-morbidities, and had lower health-related quality of life than people their age in the general population, these results might be expected to occur in other subjects with PHN.

Although one investigator (FH) has successfully taught this treatment approach to other practitioners, large-scale training in this technique has not yet been attempted and its success in the hands of other practitioners remains to be established.

The contribution of each of the five treatments is not known. Clinical experience gained in the post-trial period leads us to hypothesize that cupping and bleeding might be the most essential treatment element. The small wound produced could stimulate the various stages of wound healing, both locally and at the herpes-affected dermatome. In subsequent studies cupping and bleeding could be used alone or paired with acupuncture or TCM herbs. The neural therapy, while used strictly as a local anesthetic and so not intended as part of the actual therapy, is a necessary part of the protocol to facilitate cupping and bleeding.

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Conclusions

We conclude that this multifaceted CAM approach is effective in rapidly reducing pain and improving health-related quality of life for persons with moderately severe persistent pain from PHN. Further research is required to determine which elements of the treatment are most essential and to assess the broad applicability of these results across different practitioners and settings.

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