Managing Pain in Primary Care: Moving Beyond the Rock and the Hard Place

In April 2010 the American Society of Anesthesiologists (ASA) published updated guidelines for the management of chronic pain. The guidelines were based on a review of recent scientific evidence as well as a survey of expert opinion. As I read through the guidelines, summarizing the efficacy of various therapies for chronic pain ranging from epidural injection to medication management, some of my most challenging clinical cases involving pain management came to mind.

The assessment of pain is recognized as integral to the care of every patient to the extent that pain, similar to blood pressure, is assessed at every encounter as a “vital sign” on a scale from 1 to 10. Reports of the “under-treatment” of pain by doctors are prevalent in the literature. Yet at the same time physicians are increasingly fearful to prescribe some therapeutic options, mostly chronic narcotics, because of the regulatory and legal concerns intrinsic in prescribing these medications, and because of their addictive potential. The advent of Pain Medicine as a specialty in the past several decades has had a beneficial impact for the management of patients with chronic pain, but the reality is that most of these patients continue to be managed largely by their primary care physicians.

I remember the harrowing case of a patient in her thirties who was my patient. She had chronic abdominal pain, had been through unending diagnostic tests, referrals to pain centers and subspecialty consultation. In the end, I was left to manage her symptoms and had her on a multimodal regimen that included chronic narcotics. One weekend I received a call for the county coroner. This mother of five had been found by her husband dead from a presumed overdose. As it turned out, unbeknownst to me, she had recently visited a new pain clinic and was prescribed additional medications, which she had added to what I was already prescribing.

Another patient, a respected professional, after many years of caring for her and a good doctor-patient relationship, forged a prescription that I wrote and was caught at the pharmacy where arrest was threatened. On returning to me she was tearful and afraid that I would no longer care for her. I did, and she went on to come off of her chronic narcotics until she was diagnosed with metastatic cancer a year later, the diagnosis of which was possibly delayed given her long history of bone disease and chronic pain.

It is the impact of cases like these that cause physicians to question themselves, in a stare down with the Hippocratic Oath, “first do no harm,” and result in their reluctance to manage chronic pain. To a primary care physician the pain clinic might seem like an ideal solution. Similar to an anticoagulation clinic (for the management of patients on warfarin) the pain clinic would take over pain management, including the prescribing of medications, and provide a systematic approach, allowing primary care doctors to obviate themselves of this risky aspect of patient care. The reality is, however, that there are currently too few pain centers to handle the numbers of patients with chronic pain. Moreover, the consultative and drug monitoring aspect of pain management is not nearly as lucrative as the procedural aspect of pain management. The result is that many pain centers act as a consult services, making initial treatment recommendations, including the assessment of whether a patient is a suitable candidate for a therapeutic procedure, but send the patient back to their primary care doctor for the ongoing medication prescribing and management. It’s rare that the patient is cured after the pain clinic consultation, and so begins the back and forth, trial and error process, as the primary care doctors picks up the management and tries his or her best to advocate for the patient.

In primary care we have a lot of work to do. This is highlighted by the fact that in my 12 years of clinical practice within an 18-member group of academic general internists we had no practice-wide strategy or protocol for managing patients with chronic pain issues. Though a variety of pain contracts had been proposed for implementation during the course of my employment within this group, we could never settle on one to adopt. Some of this seemed to occur as a result of insufficient time to develop a process for a systematic practice approach to pain management. However, there was also general acceptance of the view that each physician had his or her own unique style and standard, the art of medicine. Nonetheless, I think the lack of systemization led to cross-coverage issues and increased risk for both patients and physicians related to inconsistency in practice.

What is the answer? In my view chronic pain, similar to other chronic conditions, is best managed by a patient’s primary care physician within the context of a “medical home.” There needs to be more standardization of processes and protocols within primary care practices, with clear pathways of communication back and forth with procedural specialists, opportunities for group support for patients, and linkages to physical rehabilitation and psychological support services. However, the development and management of such programs within the context of primary care will require more support from our healthcare system. Similar to other chronic health conditions, fee-for-service based reimbursement for primary care office visits at current rates is not adequate to support the care coordination necessary to deliver the highest quality and safest care to our patients.

For more information on chronic pain management I found the following site particularly informative:
Emerging Solutions in Pain

For further guidelines and resources go to:
American Pain Society
Opioid Treatment Guidelines
Institute for Clinical Systems Improvement: Assessment and Management of Chronic Pain

Snakes and Healers

On April the 7^th I saw a snake in the Temple of Asclepius at Epidaurus, Greece. It sat on top of the temple floor as I met its gaze and then slithered beneath a rock. Asclepius, the ancient Greek god of healing and medicine, son of Apollo and father to Hygieia and Panacea, among others, was worshiped as a sacred healer in antiquity. From 300 BC onward his cult became very popular. During my recent trip to the Peloponnese, I visited Epidaurus, the site of the most famous sanctuary of Asclepius. At Epidaurus I visited its ancient theater, renowned as the best preserved of Greek antiquity, looking out at the same backdrop of mountains and cypress trees that theatergoers of 2400 years prior had appreciated. However it was the ruin of the Asclepieion that most fascinated me at Epidaurus.

I learned that the rod of Asclepius, entwined with a single snake, was a symbol of his healing powers thought to derive from the snake. As described in a paper in by Susan M Kellie in Lancet:

“The Cult of Asclepius (Asklepios, Aesculapius), was one of the most enduring of classical antiquity. Hundreds of shrines dotted Italy, Greece, the eastern Mediterranean, and North Africa. The origin of the cult was thought to be at Epidaurus, from which it spread to new sites by the transport of one of the sacred serpents. The Asclepian snake is described as watchful, gentle, and endowed with perennial youth through the shedding of its skin, hence its association with healing."

The serpent, as symbol for medicine, is best recognized today in the form of a caduceus. However, the caduceus derives from the staff of the ancient messenger god, Hermes, patron god of trade. In form it is a single winged staff with two serpents entwined. The caduceus was symbolic of commerce and its initial use in medicine likely had to do with alchemy and pharmacy. Confusion of the caduceus with the staff of Asclepius likely led to its widespread application to symbolize medicine and healing.

In the healing ritual of the Cult of Asclepius the sick pilgrim would enter the Asclepieion (hospital), go through a procedure of bathing, fasting and sacrifice, and then go to sleep. While sleeping, the patient would be visited by the god, in the form of a snake, which licked or bit the patient. On waking the patient’s dream was interpreted by a priest and he or she was offered a cure.

Traveling through Greece this April I sought to understand the momentous force of Christianity, which would end Classical culture and propel European culture into the Dark Ages until the Age of Enlightenment. I visited Byzantine monasteries and churches, staring at gilded icons, Mary Theotokos, Mary Hodegetria and Mary Platytera. I lighted candles and listened to the somber music of Holy Week, church bells clanging, the austere Orthodox Easter sermon booming through my window while I lay in bed awake at midnight in Monemvasia.

But with the snake at Epidaurus I found personal meaning.

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My Take on Postmenopausal Hormone Replacement Therapy

During the past several months postmenopausal hormone replacement has resurfaced as a topic of discussion.

On April 12th The New York Times published an article written by Cynthia Goran reviewing current controversies in post-menopausal hormone replacement therapy, told from the point of view of patient-investigator.

The article, as discussed nicely by health blogger Margaret Polaneczky, tells of the so call “window hypothesis” of estrogen therapy. The premise is that reported risks of adverse effects from hormone replacement therapy (HRT) cannot be generalized from older menopausal women to younger menopausal woman. There may be some truth to this argument.

In March 2010 the North American Menopause Society (NAMS) revised its 2008 consensus statement. The 2010 evidence-based review was performed by an Advisory Panel of clinicians and researchers in the field of women’s health. The Position Statement on treatment of menopause generally looks similar to the 2008 recommendations.

Currently postmenopausal hormone replacement therapy is not advised for routine use for preventive purposes in postmenopausal women. These recommendations are in large part based on the largest randomized controlled trial (RCT) to date on hormone replacement therapy in postmenopausal women, the Women’s Health Initiative (WHI). Since the July 2002 press release from the estrogen and progesterone arm of this study reporting the negative effects of hormone replacement therapy, post-menopausal HRT use has declined substantially. This largest RCT of HRT to date of 16,000 postmenopausal women found that oral estrogen use combined with progesterone (required for women with a uterus) was associated with increased rates of carcinoma of the breast and cardiovascular risk, including increased risk of stroke. The magnitude of the breast cancer risk reported was 8 additional breast cancers per 10,000 women, or a 24% increase in breast cancer risk.

For a nice summary of the WHI findings and associated risks see Menopause Fact Sheet

In March 2004 the estrogen alone trial of the WHI was reported. This study looked at oral estrogen use (.625 mg daily) in women who did not require progesterone, as they had undergone hysterectomy. “Unopposed” estrogen (without progesterone) is a known clear risk factor for uterine cancer. This arm reported on 11,000 women who were noted to have increased stroke risk, though were not found to have increased breast cancer risk.

The dispute over the applicability of the WHI findings stems from the fact that the average age of women studied was 63 years and the average time from menopause was >10 years. More recent analysis of younger subgroups of women, closer to the time of menopause, have in fact shown decreased cardiovascular risk with HRT. Additional study has shown that younger menopausal women treated with HRT have less coronary calcium build-up (linked to cardiovascular risk) than those randomized to placebo. These data form the basis for the “window,” or timing hypothesis that HRT may be cardioprotective when initiated earlier.

Needless to say this does not negate the finding that the combination of oral conjugated estrogen (.625 mg) and oral progesterone, medroxy-progesterone (2.5-5 mg), has been found to increase breast cancer risk in postmenopausal users, regardless of timing, when used for more than 3 to 5 years. In addition, HRT, both estrogen alone and estrogen with progestin, puts women at risk for abnormal mammograms and breast procedures.

Currently, the main indication for postmenopausal HRT is for treatment of vasomotor symptoms (hot flashes and night sweats). For this purpose HRT is the most effective treatment available and is recommended for no more than 5 years of use. HRT is also effective for treatment and prevention of osteoporosis, though is not recommended for either as first line therapy given its known risks.

Other news of interest on postmenopausal hormone replacement:

• Transdermal estrogen has different biochemical effects, and therefore may have a better safety profile than oral estrogen.

• There is not evidence to support the use of progesterone based intrauterine devices (Mirena) to prevent the endometrial hyperplasia related to estrogen use.

• There is also not evidence to support the use of progesterone cream as adequate to prevent the endometrial hyperplasia related to estrogen therapy.

• An association between post-menopausal hormone replacement and improvement in depressive symptoms has not been shown.

• There is not evidence to support an association between post-menopausal hormone replacement and prevention of Alzheimer’s disease.

• The touted improved safety and better efficacy of “bio-identical” hormonal products over standard hormone replacement therapy is very suspect.

While the term “bio-identical” may refer to standard brand name and tested hormonal products, such as 17B-estradiol or micronized progesterone, the terminology more commonly refers to custom compounded products that have not been tested and are not approved. Furthermore, the dosing of such products on the basis on salivary testing has not been shown to be either reliable or accurate.

In summary, the most current expert advice is that the lowest dose of HRT required should be used to treat symptoms of menopause if needed and continued for ideally less than 5 years. The doses of HRT on the market currently are lower than those studied in the WHI and may be safer, though this still remains unproven. Transdermal therapy may be preferable over oral therapy. There is no standard procedure for the discontinuation of HRT.

The assessment of a patient's personal risk profile and preferences and clinical flexibility are key to treating postmenopausal women with HRT. We all take risks in life. Some women feel better on perpetual hormone replacement therapy and that’s ok, but I personally feel more confident prescribing formulations that are better understood.