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New Botanical Medicinal Breakthroughs for the Management of Pain Presented by: Guy Chamberland, MSc, PhD, Master Herbalist.

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Presentation on theme: "New Botanical Medicinal Breakthroughs for the Management of Pain Presented by: Guy Chamberland, MSc, PhD, Master Herbalist."— Presentation transcript:

1 New Botanical Medicinal Breakthroughs for the Management of Pain Presented by: Guy Chamberland, MSc, PhD, Master Herbalist

2 PARKE DAVIS & CO

3 Objectives of This Workshop – Learn About Pharmacological mechanism of action Traditional evidence and clinical evidence supporting the use of herbs in the treatment of inflammation and pain. Dose levels and additive effects. Importance of pharmacokinetics on clinical outcome: –Duration of response –Minimal effective dose –Dose level and dosing interval

4 Guy Chamberland, M.Sc., Ph.D., Master Herbalist B.Sc. In Agricultural Chemistry, McGill University. M.Sc., Ph.D. in toxicology (Biomedical sciences), University of Montreal. Natural Health Practitioner & Bioenergetics Practitioner diploma (Oriental medicine), Alternative Medicine College of Canada. Proficiency in Herbal Prescription, Australian College of Phytotherapy. Chartered & Master Herbalist, Dominion College of Canada.

5 Guy Chamberland, M.Sc., Ph.D., Master Herbalist Over 16 years developing new drugs in pharmaceutical industry (Canada & USA). –Drug safety & Drug development. Research in herbal anxiety, sleep, pain/inflammation & wound treatments. –Since –Preclinical & clinical research: inflammation/pain; wound healing. –2 herb-based patents (pending): inflammation/pain; wound healing. –Clinical research treatment anxiety, sleep and pain/inflammation.

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7 PAIN MEDICATION Worried about addiction? Do not tolerate the pain meds? Pain meds are contraindicated? Concerned about long-term safety? Patient wants a natural treatment.

8 TRUE OR FALSE? Botanical medicines are as efficacious as prescription drugs in the management of inflammation & pain

9 Model acute pain – mice : -Evaluates inflammation – 4 hours after single dose -Results: HED based on a 154 lb (70 kg) subject -Aspirin – 68 mg/lb (150 mg/kg) (HED = 398 mg (875 mg)) -Naprosyn – 14 mg/lb (30 mg/kg) (HED = 76 mg (168 mg)) -Phenylbutazone – 14 mg/lb (30 mg/kg) (HED = 76 mg (168 mg)) -Celebrex – 4.55 mg/lb (10 mg/kg) (HED = 25 mg (56 mg)) -Devil’s claw – 114 mg/lb (250 mg/kg) (HED = 636 mg (1400 mg)) -Boswellia – 114 mg/lb (250 mg/kg) (HED = 636 mg (1400 mg)) Pain Relief: True or False? 36% 23% 18% Studies that showed equivalence to a drug active control: Osteoarthritis – knee and hip: –57 mg harpagoside/day vs 100 mg Diacerhein LBP: –60 mg harpagoside/day vs 12.5 mg Vioxx Rheumatoid arthritis: 60 mg harpagoside/day vs Phenybutazone (300mg/day D1-4; 200mg/day D5-28) © Guy-Chamberland-MasterHerbalist

10 Pain Relief: True or False? Based on animal & human data = TRUE! Caveats: A question of dose level & frequency of administration. Realistic expectations of relief! Severity of pain Living with pain Time required to reduce pain in chronic conditions Not surprising since Drugs mimic herb activities (pharmacology!!!). © Guy-Chamberland-MasterHerbalist

11 Summary – Botanical Medicines As efficacious as a drug in the treatment of pain.As efficacious as a drug in the treatment of pain. Disadvantage: bioavailability of some herbs.Disadvantage: bioavailability of some herbs. Advantages: Safety.Advantages: Safety. Good tolerance-safety.Good tolerance-safety. No negative effect on cognition or motor coordination.No negative effect on cognition or motor coordination. No addiction.No addiction. No rebound.No rebound.

12 Botanical Medicines In many cases, should be used as a First Line : When NSAID contraindicated! Night pain. Keep in mind delay to onset when treating acute pain!

13 Botanical Medicines – Treating Pain Need to set realistic expectations: Even with drugs, after many years of adjusting drug therapy, patient may still have pain. Define short-term pain relief goals for patient. 1 st target main area of pain to bring some relief to patient. Expand to other areas of body as progress is made. Focus on sleep early on. Use complementary strategies in severe cases.

14 Review of the importance of pharmacokinetics on clinical outcome.

15 Review of Key Pharmacokinetic Concepts Effective dose Absorption & Bioavailability Duration of response & Dosing Interval Accumulation Adverse Effects © Guy-Chamberland-MasterHerbalist

16 Evidence behind an effective Botanical-based treatment? Pain Sleep (Night Pain) Choice of herb √√ Dose√√ Frequency√ X

17 Review of Key Pharmacokinetic Concepts Absorption & Bioavailability –Often limited efficacy of NHP due to poor absorption/bioavailability. –Use of pharmaceutical formulation science to increase absorption of active ingredient. Protect ingredient from acid hydrolysis. –Effect of Food intake. © Guy-Chamberland-MasterHerbalist

18 Examples: Turmeric (Curcuma longa) Human trials: –Lack of quantifiable curcumin in the plasma after a dose of 3,600 mg. –Oral doses of mg of curcumin failed to establish detectable plasma levels. –Curcumin has poor bioavailability. © Guy-Chamberland-MasterHerbalist

19 Plasma concentration 24 hour period Analgesia No Analgesia Oral dosing Oral absorption: acid hydrolysis (enteric coating) Cmax Tmax intravenous X Absorption of Active Ingredient Low bioavailability of curcuminoids.

20 Absorption & Bioavailability Turmeric (Curcuma longa) Bioavailability: –Formulations developed to increase bioavailability: –BCM-95® (Biocurcumax™) curcumin vs. plain curcumin was determined in humans: The peak was: – 1600ng/g BCM-95® group & >200ng/g plain curcumin group. © Guy-Chamberland-MasterHerbalist

21 Plasma concentration 24 hour period Analgesia No Analgesia Oral dosing Cmin Cmax Pharmacokinetics: Dosing Interval Efficacy Dependent on Plasma Concentration Tmax Plasma half-life Tmax = hrs T1/2 = 5.6 hrs Duration of response: 4-6 hours

22 © Guy-Chamberland-MasterHerbalist Plasma concentration 24 hour period Analgesia No Analgesia Oral dosing Cmin Cmax Dosing Frequency/Interval Dependent on Plasma Half-life Optimize dosing interval to avoid periods of no efficacy

23 © Guy-Chamberland-MasterHerbalist Plasma concentration 24 hour period Efficacy No efficacy Oral dosing Cmin Cmax Accumulation & Side Effects Intolerable AE Half-life ranges from hours for hypericin

24 © Guy-Chamberland-MasterHerbalist ↑ Pain ↑ Plasma Concentration of active ingredient(s) Minimal effective dose Maximal effective dose 20mg Harpagosides per dose (Devil’s claw) 2 g California poppy 4 g Scullcap Minimal Effective Dose

25 Are there herbs that allow us to develop a botanical medicine that is similar in potency to a prescription drug?

26 Herbs – Anti-Inflammatory - Analgesic Many clinical trials. Main problems: Bioavailability & standardization. Not a drug development concept. Dose & frequency is critical for efficacy. Herbs used according to their pharmacology: mu1, COX-2, serotonine. Activity = ‘atypical’ eg., mu1 + 5-HT1 / 5-HT7

27 Herbs – Anti-inflammatory or Analgesic Boswellia (Boswellia sacra) Salix (Salix alba) Devil’s claw (Harpagophytum procumbens) California poppy (Eschscholzia californica) NSAID Atypical opioid Boswellia (Boswellia serrata) Salix (Salix alba) Devil’s claw (Harpagophytum procumbens) California poppy (Eschscholzia californica) Interaction with anticoagulants (heparin, coumarin derivatives) is of therapeutic importance. Use cautiously in patients taking drugs metabolized by liver cytochrome P450 enzymes. 

28 Analgesic & Hypnotic Agent

29 Should your practice consider sleep quality Pain interferes with sleep. – 50% - 88% patients treated for chronic pain (nonmalignant) reported sleep impairment. – Patients with high pain intensity had less sleep time, more delayed sleep onset, and more nighttime wakening than patients with low pain intensity. Disturbed sleep lowers pain threshold. Whether sleep disturbance precedes or follows pain onset is unclear.

30 Should your practice consider sleep quality Chronic pain: – Pain initiates and exacerbates sleep disturbance. – Disturbed sleep maintains and exacerbates chronic pain and related dysfunction. Sleep disruption, fragmentation, or restriction produces hyperalgesia (increased sensitivity to pain) and can interfere with analgesic treatments involving opiodergic and serotonergic mechanisms of action.

31 Vicious cycle! Poor sleep Increases pain sensitivity Increased pain Sleep disruption

32 Association of Sleep & Pain versus NSAID Treatment with NSAID – OA show significantly greater objective sleep disturbance. NSAID: – Inhibition of prostaglandin synthesis during nighttime hours induces change in sleep patterns due to a decrease in synthesis of prostaglandin D2. – Suppression of normal nocturnal surge in melatonin synthesis. Suppression by 75% within 75 minutes after single dose of NSAID. Melatonin surge important to induce sleep. – Aspirin and Ibuprofen (significant versus placebo); acetaminophen not significant.

33 Should your practice consider sleep quality REM sleep deprivation results in hyperalgesia during the subsequent awake period. Nonrestorative sleep occurs in 73% to 76% of fibromyalgia patients. Presence of restorative sleep in patients with fibromyalgia predicted resolution of pain at 15 months.

34 Recommended & Current Uses California poppy Night Pain: –1 or 2 capsules at night. –Analgesic & Hypnotic. –Better sleep quality. –Reduced doses of morphine at night. Co-analgesic (Adjuvant): –1 capsule bid (off-label use by physicians). –Patients intolerant to meds such as Lyrica and/or Cymbalta. Reduce doses of other pain meds. Insomnia: –1 or 2 capsules 30 minutes before bedtime. –Sedative & Hypnotic. * 1 capsule = mg extract (standardized)

35 California poppy (Eschscholzia californica) Historical Use: Relaxing nervine in anxiety and nervousness Sedative in insomnia Anodyne in pain. A more recent usage is in the treatment of heroin addiction and withdrawal. Although remedies such as Opium Poppy are of great use as an anodyne and analgesic, Felter and Lloyd considered Eschscholzia to be an “…analgesic and soporific without the dangers attending opiates, quieting pain and producing (a) calm sleep” (1893).

36 Opioid Receptors Morphine California poppy Analgesia with Sedation X X X X X X X X

37 Pharmacology - 5:1 extract of California poppy - mice Sedative activity at 90.9 mg/lb (200 mg/kg) in mice –200 mg/kg X 5:1 extract ratio = 1000 mg dried herb per kg. –Conversion to Human Equivalent Dose: 1000 mg/kg / 12.3 = 37 mg/lb (81.3 mg/kg). For a 154 lb (70 kg) subject = 5.7 grams of dried herb (1200 mg extract (5:1)). –partly antagonized by flumazenil. Equivalent to 2 capsules of a 500 mg standardized extract. © Guy-Chamberland-MasterHerbalist

38 Pharmacology - 5:1 extract of California poppy - mice Sedative activity at 90.9 mg/lb (200 mg/kg) in mice –200 mg/kg X 5:1 extract ratio = 1000 mg dried herb per kg. –Conversion to Human Equivalent Dose: 1000 mg/kg / 12.3 = 37 mg/lb (81.3 mg/kg). –For a 154 lb (70 kg) subject: 5.7 grams of dried herb (1140 mg extract (5:1)). Anxiolytic effect demonstrated at 11.4 mg/lb (25 mg/kg) (125 mg dried herb per kg). –For a 154 lb (70 kg) subject: 0.7 grams of dried herb (142 mg extract (5:1)). Use of a 500 mg 5:1 standardized PE: –1 capsule too strong to be used as a calmative! 8-fold stronger than dose tested. © Guy-Chamberland-MasterHerbalist

39 Pharmacology - 5:1 extract of California poppy - mice Antidepressant: No effect against reserpine*-induced ptosis, akinesia or hypothermia, when it was tested at 22.7, 45.5, 90.9, and mg/lb (50, 100, 200, 400, 800 mg/kg). –For a 154 lb – 90.9 mg/lb (70 kg subject mg/kg): 5.7 grams of dried herb (1140 mg extract (5:1)). –For a 154 lb – mg/lb subject (70 kg mg/kg): 22.8 grams of dried herb (4553 mg extract (5:1)). NO ANTIDEPRESSANT-LIKE EFFECT. Explains in part the good tolerability in patients versus meds! *Reserpine irreversibly blocks the vesicular monoamine transporter. This normally transports free intracellular norepinephrine, serotonin, and dopamine in the presynaptic nerve terminal into presynaptic vesicles for subsequent release into the synaptic cleft. © Guy-Chamberland-MasterHerbalist

40 Pharmacology - 5:1 extract of California poppy - mice Analgesic effect: 90.9, and mg extract/lb (200 – 800 mg extract/kg) For a 154 lb (70 kg) human subject: –5.7* – 22.8 g –1140 – 4553 mg extract (5:1 PE standardized). *A safe dose level (equivalent: 2 capsules 500 mg PE 5:1). Peripheral pain relief © Guy-Chamberland-MasterHerbalist

41 Pharmacology - 5:1 extract of California poppy - mice Dose-dependent peripheral analgesic effects were demonstrated from a dose of 90.9 mg/lb (200 mg/kg) in the writhing test: - Mild CNS effect with peripheral effect. Both peripheral & central pain relief © Guy-Chamberland-MasterHerbalist

42 California poppy (Eschscholzia californica) Pharmacological properties demonstrated: –Dose-response effect observed for analgesia. –Opioid & 5-HT1A & 5-HT7 serotonin activity. –Dose-dependent sedative & anxiolytic properties. –No antihistaminic effects. –No anticonvulsant or myorelaxant effects. –No anticholinergic effects. –No muscle relaxant and antipsychotic properties. –No antidepressant-like properties.

43 California poppy (Eschscholzia californica) Pharmacologic Class: –Opioid & 5-HT1A + 5-HT7 –Analgesic + Hypnotic/sedative Key clinical advantage: –Safety profile: No addiction/physical dependence High tolerability versus conventional narcotics. 3 key alkaloids: –At least 0.8% Isoquinoline alkaloids: Californidine Escholtzine Protopine

44 StudyPilot study; 7-day acute pain Pilot study; 28-day chronic pain Proof-of-concept; multicentre; open-label Subjects: 10 patients Patients with acute pain (VAS > 4) No drug therapy 10 patients Patients with chronic pain (VAS > 4) No drug therapy 20 patients Uncontrolled, moderate-severe, chronic pain Fibromyalgia with/without myofascial syndrome Arthritis NSLBP Neuropathic pain Herbs: California poppy (1 at night) Devil’s claw (tid) Scullcap (tid) California poppy (1 at night) Devil’s claw (tid) Scullcap (tid) Gel California poppy (1 or 2 daily) Concomitant pain meds. Short form McGill Pain Scale Sleep questionnaire Results: Improved sleep Significantly reduced pain  swelling  tenderness Improved sleep Significantly reduced pain Significant  mobility & flexibility  swelling  tenderness  stiffness Approximately 50% patient obtained a significant clinical benefit in pain relief or sleep. Delta-VAS: 2.4 (VAS <1.0 = failure) Improved sleep (night pain): 67% Improved sleep (all): 45% Significant improvement pain: 55% Reference:Chamberland G. unpublished © Guy-Chamberland-MasterHerbalist

45 Summary – California poppy Induces sleep & analgesia at correct dosage.Induces sleep & analgesia at correct dosage. Clinical evidence effective treatment night pain.Clinical evidence effective treatment night pain. No impact on cognition.No impact on cognition. No impact on motor incoordination.No impact on motor incoordination. No addiction.No addiction. No rebound.No rebound.

46 Recommended & Current Uses California poppy (Eschscholzia californica) Night Pain: –1 or 2 capsules at night. –Analgesic & Hypnotic. –Better sleep quality. –Reduced doses of morphine at night. Co-analgesic (Adjuvant): –1 capsule bid (off-label use by physicians). –Patients intolerant to meds such as Lyrica and/or Cymbalta. Reduce doses of other pain meds. Insomnia: –1 or 2 capsules 30 minutes before bedtime. –Sedative & Hypnotic. *1 capsule = mg extract (standardized)

47 Natural NSAID

48 NSAID vs Botanical Drug NSAIDs used for: –OA of knee, hip, and spine & NSLBP associated with pain, stiffness, limitation of function, and diminished quality of life. –Superior to acetaminophen in majority of trials!

49 NSAID vs BOTANICAL DRUG Treatment guidelines recommend simple analgesics as first-line drugs. –Because of superior efficacy, NSAIDs are preferred despite the lower safety-margin and the higher cost. A critical part of an effective pain management strategy.

50 NSAID vs BOTANICAL DRUG Consider alternatives to NSAID therapy: –High incidence of NSAID related adverse events. –GIT complications –Risks associated with cardiovascular systems –Especially in the elderly High costs related to adverse events: –gastrointestinal bleeding or perforation. –additional medical attendances, diagnostic procedures, treatments and admissions to hospital.

51 We need a natural NSAID! Which herb is an effective & safe choice?

52 Selection of an NSAID Herbs with Clinical Evidence for Osteoarthritis, Rheumatoid Arthritis, Low Back Pain (LBP): Boswellia Willow bark Devil’s claw LBP: Devil’s claw –Equivalence trial vs 12.5 mg rofecoxib Willow bark –Equivalence trial vs 12.5mg rofecoxib

53 Drug interactions: Assessment of EMA limited to documented interactions. Not theoretical. EMA concluded: Interaction with oral anticoagulants (heparin, coumarine derivatives) is plausible and of therapeutic importance. Clinical trials demonstrated: Willow bark significantly  AA- and ADP-induced aggregation but to a significantly lesser extent than acetylsalicylate did. Statistically significant associations between the use of willow bark and bleeding events were identified EMA recommends: The combined use of Willow bark with acetylsalicylic acid/other NSAIDS is not recommended. Willow Bark X

54 Pharmacokinetics: Poor bioavailability of boswellic acids. Food alters the pharmaco- kinetic profile. Meals high in fat increased the concentration in plasma. Mean elimination half-life: 5.97 hours. Time to Peak (Tmax): 4.5 ± 0.55 hours. Boswellia vs Devil’s claw Pharmacokinetics: Degradation of harpagosides in stomach. Food alters absorption. Mean elimination half-life: 5.6 hours. Time to Peak (Tmax): 1.3 to 2.5 hours.

55 Pharmacokinetics: Moderate-to-potent inhibitors of CYP enzymes, with equal potency for inhibiting the major drug metabolizing enzymes 1A2, 2C8, 2C9, 2C19, 2D6, and 3A4. Use cautiously in patients taking agents metabolized by the liver's cytochrome P450 enzymes. Boswellia vs Devil’s claw Pharmacokinetics: No cytochrome P450 induction or inhibition. No caution statements. X

56 Devil’s claw known safety profile Anticoagulants and antiplatelets: One case of purpura reported in a patient taking warfarin (Coumadin®) with devil's claw. Evidence is inconclusive. Could be simply due to drug. European Medical Agency (EMA) approved Devil’s claw as a medicinal herb. Detailed assessment of the safety information to issue warnings. EMA concluded: could not find any study or reported cases suggesting an interaction with oral anticoagulants, or sulfonylureas. EMA stated: no signal, even weak, has emerged from the literature to date. Conclusion: Even if evidence is weak, be cautious when using Devil’s claw on a patient taking an AC or AP. Devil’s Claw

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58 Devil’s claw (Harpagophytum procumbens) South African plant recognized for its anti-inflammatory properties. Active part of the plant is the dried secondary roots. An anti-inflammatory, antirheumatic and analgesic remedy. © Guy-Chamberland-MasterHerbalist * Doses considered safe by regulatory agencies around the world.

59 Pharmacology - extract of Devil’s claw - mice Analgesic activity in mice –Conversion to Human Equivalent Dose: mg/kg / –Corrected for a 154 lb (70 kg) subject. Writhing test – i.p. Swiss mice Devil’s Claw Harpagoside-HDE dose 154 lb or 70 kg 22.7 mg/lb (50 mg/kg) 5 mg 45.5 mg/lb (100 mg/kg) 10 mg 47% 90.9 mg/lb (200 mg/kg) 20 mg mg/lb (400 mg/kg) 40 mg 78% 30.9 mg/lb (68 mg/kg) ASA 325 mg 59% 0.52 mg/lb (1.15 mg/kg) morphine 6 mg Lanhers M.C., Fleurentin J., Mortier F., Vinche A., Younos C. Anti-inflammatory and analgesic effects of an aqueous extract of Harpagophytum procumbens. Planta Med 1992, 58: Dose dependent Peripheral pain relief % protection

60 Central Effect for Pain Relief Heat induced pain Male Swiss mice Intraperitoneally injected: –extract (90.9 and mg/lb; 200 and 400 mg/kg) or harpagoside 4.5 mg/lb (10 mg/kg). –Acetylsalicylic acid 30.9 mg/lb (68 mg/kg) and morphine sulphate 2.1 mg/lb (4.6 mg/kg) Results: - No protection: Devil’s claw, harpagoside and acetylsalicylic acid. - Protection: Morphine No central pain relief

61 Model acute pain – mice : -Evaluates inflammation – 4 hours after single dose -Results: HED expressed for 154 lb (70 kg) subject -Aspirin – 68 mg/lb (150 mg/kg) (HED = 398 mg (875 mg)) -Naprosyn – 14 mg/lb (30 mg/kg) (HED = 76 mg (168 mg)) -Phenylbutazone – 14 mg/lb (30 mg/kg) (HED = 76 mg (168 mg)) -Celebrex – 4.55 mg/lb (10 mg/kg) (HED = 25 mg (56 mg)) -Devil’s claw mg/lb (250 mg/kg) (HED = 636 mg (1400 mg)) -Boswellia – 114 mg/lb (250 mg/kg) (HED = 636 mg (1400 mg)) Pain Relief: True or False? 36% 23% 18% © Guy-Chamberland-MasterHerbalist

62 More than 23 clinical trials in patient populations of: osteoarthritis, rheumatoid arthritis, low back pain. –‘Double-blind’- RCT with placebo: 13 studies. –Studies that showed equivalence to an active control: –Osteoarthritis – knee and hip: –57 mg harpagoside/day vs 100 mg Diacerhein –LBP: –60 mg harpagoside/day vs 12.5 mg Vioxx –Rheumatoid arthritis: 60 mg harpagoside/day vs Phenybutazone (300mg/day D1-4; 200mg/day D5-28) Data shows need mg per day. Ideal is 20 mg tid. Consistent with animal data – 20 mg effective after single dose. *Gibofsky A et al. Comparing the efficacy of cyclooxygenase 2-specific inhibitors in treating osteoarthritis. Arthritis & Rheumatism 2003; 48(11): *Laudahn D et Walper A. Efficacy and tolerance of Harpagophytum extract LI 174 in patients with chronic non-radicular back pain. Phytother. Res. 2001; 15:

63 Pharmacological uses of Devil's claw: An anti-inflammatory, antirheumatic and analgesic remedy. Bioenergetic uses of Devil's claw are: Cools the exterior and dispels wind-damp-heat. (Critical treatment for many acute and chronic painful conditions: arthritis, musculoskeletal pain, and myalgia; especially of the wind- damp-heat type.) Prescribe for wind-damp-heat obstruction: - muscle and joint aches and pains, swollen red joints, stiffness. - rheumatoid, osteoarthritis, fibromyalgia, gout, low back pain, neuralgias. Devil’s claw (Harpagophytum procumbens) © Guy-Chamberland-MasterHerbalist

64 Study Design:Double-blind, RandomizedDouble-blind, Randomized, MulticentreMulticentre, Postmarketing Surveillance Subjects: 88 patients with acutely exacerbated low back pain; Rx 6 weeks. DC versus 12.5 mg/day Vioxx 122 patients suffering from osteoarthritis of the knee and hip. DC versus diacerhein 100 mg/day; 4 months treatment 75 patients with osteoarthritis of the hip or knee. 12 weeks Devil’s claw (DC): 800 mg extract (20 mg harpagoside) tid 870 mg extract (19 mg harpagoside) tid Method: 400 mg/day Tramadol rescue allowed. Arhus LBP Index & Health Assessment Questionnaire. Pain & functional disability on VAS; Severity of osteoarthritis using Lequesne's index (LI). WOMAC index VAS pain scale Results: Number of pain-free patients: DC 22%,Rofecoxib 11% NS; Percentage change Arhus component pain: DC 30%, Rofecoxib 29% (intention-to-treat analysis) Spontaneous pain: significant improvement during study; no difference in the efficacy. A progressive & significant reduction in LI & no statistical difference was found between treatments. At end of study: DC were using significantly less NSAIDs and antalgic drugs. Frequency of AE events was significantly lower in DC. Improvement in WOMAC subscale : 23.8% pain, 22.2% stiffness, 23.1% physical function. WOMAC total score  22.9%. VAS:  25.8% actual pain, 25.2% average pain, 22.6% worst pain, 24.5% total pain score. Physicians reported a continuous improvement in typical clinical findings such as 45.5% for pain on palpation, 35% for limitation of mobility and 25.4% for joint crepitus. Reference:Chrubasik S et al.. Rheumatology 2003;42: Chantre P et al. Phytomedicine.Chantre P et al. Phytomedicine Jun;7(3): Wegner et Lupke. Phytother Res Dec;17(10): Phytother Res.

65 Study Design: 8-week4-weeks, Equivalence study4-week, Randomized, Double-blind, Placebo controlled Subjects: 675 patients with painful osteoarthritis, spondylarthropathies or fibromyalgic complaints bid 197 patients, tid 65 received 200 mg tablets 66 received 400 mg tablets 66 placebo 118 patients acute low back pain (non- specific; pain for at least 6mnths). 2 tablets Tid Devil’s claw (DC): 480 mg extract 4500 and 9000 mg/day, (50 and 100 mg harpagoside per day) 4500 mg/day, (50 mg harpagoside per day) Method: CGI score Reduction in symptom severity score Use of NSAIDs or corticosteroids Pain-free without NSAIDs for 5 days at end of study. Arhus low back pain index. Use of rescue meds (Tramadol). Need to use supplementary analgesic (Tramadol) during final 3 weeks. Number of patients pain-free at end. Arhus low back pain index. Results: CGI scores rated good or very good in 82% of cases. Symptom score for painful motion decreased by 53% from 2.23 (indicating moderate pain) to 1.04 (indicating slight pain) after eight weeks. Co-medication doses were reduced or discontinued in 60% of the 464 patients taking NSAIDs and 56% of the 50 patients taking corticosteroids. Pain-free patients : 9% DC1; 15% DC2; 5% PL (p=0.027). Overall median Arhus index scores:  55% at baseline to 20% by week 4, but no statistically significant difference between both treatment groups & PL. Greater effectiveness of DC2 seen only in subgroups with more severe pain radiating to the leg, the smaller dose did not seem to have much effect on them. Non-radiating pain, DC2 was more effective. DC group tended to use fewer analgesics (p=0.44). A non-significant improvement in median Arhus low back pain index scores was seen (20% vs. 8%; p<0.059). Significantly more pain-free patients at the end of the trial (9/51 vs. 1/54; p=0.008). Percentage change Arhus component pain: DC 34%, PL 6% (p=0.016) Reference: Ribbat NaturaMed 2001;16:23-30Chrubasik et al. Eur.J Anaesthesiol. 1999;16(2): Chrubasik et al. Phytomedicine 1996;3(1):1-10.

66 Study Design: 20-week, Randomized, Placebo controlled trial 4-month, Randomized, Double-blind, Parallel-group study 8-weeks, Multicentre, Postmarketing study Subjects: 46 patients with osteoarthritis of the hip Rx DC vs PL (placebo); bid 122 patients with hip and knee osteoarthritis Rx DC vs 100 mg Diacerhein 104 patients with low back pain, 85 patients with arthritic knee pain, and 61 patients with arthritic hip pain Devil’s claw (DC): 4500 mg/day, (< 30 mg harpagoside per day DC 2610 mg (57mg of harpagoside)/day 800 mg extract (20 mg harpagoside) tid Method: Efficacy using WOMAC. Stepwise-reduced daily doses of ibuprofen: 800mg daily for the first eight weeks, 400mg daily for a further eight weeks, and none during the Spontaneous pain using VAS Lequesne Index, functional disability of movement assessed on a VAS, amount of taken rescue medication (acetaminophen-caffeine with or without diclofenac). Arhus low back pain index. WOMAC index. HAQ Unvalidated measures (total pain index, three score index, the patient's global assessment of the effectiveness of treatment. Results: WOMAC scores  both groups despite the reduced dose of ibuprofen. Stiffness, pain & dysfunction  both groups. Ibuprofen-free period,  20% or less in the pain score considered clinically relevant response rate: 71% DC vs 41% PL met criteria (p=0.04). 52% DC vs 36% PL completed without using rescue during Ibuprofen-free period % DC & 60% Diacerhein had considerable improvements in OA symptoms both groups. No significant differences for pain, functional disability, or Lequesne score. DC found to be using statistically significantly less analgesic medications (p=0.01). Adverse effects (mainly diarrhea) that were considered to be due to treatment were reported in 8.1% and 26.7% of Harpadol®and Diacerhein patients, respectively (p=0.017). Improvement tended to be more when the initial pain and disability score was more: older patients tended to improve less than younger, the hip group tended to improve convincingly more than the back group, whereas the improvement in the knee group was less readily differentiated from that in the back group. The subgroup of patients with back pain who required NSAIDs during the eight weeks used significantly more per patient than patients in the other two groups, but that requirement also declined more with time. About 10% of the patients suffered from minor adverse events that could possibly have been attributable to Doloteffin. Between 50% and 70% of the patients benefitted from Doloteffin with few adverse effects (primarily gastrointestinal). Reference: Frerick et al. Stufenschema bei Coxarthrose. Der Kassenarzt 2001;5(34):41. Chantre et al. Phytomedicine 2000;7(3): Chrubasik et al. Phytomedicine 2002;9(3):

67 Devil’s claw (Harpagophytum procumbens) According to UpToDate (www.uptodate.com): –"Devil's claw reportedly improves joint mobility and reduces pain and swelling in arthritis." –"It may be more effective for osteoarthritis as compared to rheumatoid arthritis." –"It may be more effective for chronic, rather than acute, arthritis symptoms." *UpToDate ® is an evidence-based clinical decision support system authored by physicians

68 Devil’s claw (Harpagophytum procumbens) " There is a growing body of scientific evidence suggesting that devil's claw is safe and beneficial in the short-term management of pain related to degenerative joint disease or osteoarthritis. It may be equally effective as drug therapies, such as non-steroidal anti inflammatory drugs (or may allow for dose reductions or cessation of these drugs in some patients).“ – Natural Standard database* *Natural Standard is impartial; not supported by any interest group, professional organization or product manufacturer.

69 Devil’s claw (Harpagophytum procumbens) Enteric coating required: –Studies demonstrated loss of anti-inflammatory effects by oral administration –Dose-dependent effects observed with intraperitoneal and intraduodenal administration –Enteric coating - protection of efficacy demonstrated Importance of enteric coated formulations…

70 Devil’s claw (Harpagophytum procumbens) The iridoid glycoside, harpagoside, linked to its anti- inflammatory and analgesic benefits. PD & PK - 3 studies in human volunteers*: –Relation between serum harpagoside levels and the inhibition of leukotriene biosynthesis. –Maximum levels of plasma harpagoside reached after 1.3 to 2.5 hours. –Harpagoside elimination half-life has been reported as 5.6 hours. *Clin Pharmacol Ther May;69(5):

71 Iridoids (harpagosides) interact with Arachidonic Acid metabolism pathways: Action on eicosanoids synthesis Action on cyclo-oxygenase, lipoxygenase and NO synthetase Action on TNFa liberation Action on Cys-LT synthetis Action on enzymes responsible for collagen degradation Inhibition of Cyclo Oxygenase 2Assists the extracellular matrix construction (synthesis of GAGs) Synthesis of hyaluronic acid (human chondrocytes) Devil’s claw (Harpagophytum procumbens) Explanation for absence of renal & cardiovascular toxicity: Potent cytokine release inhibitor & weak inhibitor of COX-2 mediated prostaglandin E2 biosynthesis.

72 Systematic Review - Conclusions No efficacy when less than <30 mg harpagoside per day in the treatment of knee and hip osteoarthritis. Moderate evidence when 60 mg harpagoside per day in the treatment of osteoarthritis of the spine, hip and knee. Moderate evidence (57 mg harpagoside per day) for non-inferiority to diacerhein (inhibitor of IL-1) in treatment of acute exacerbations of osteoarthritis in the hip and knee. Joel J Gagnier et al. Harpgophytum procumbens for osteoarthritis and low back pain: A systematic review. BMC Complementary and Alternative Medicine 2004, 4:13. Important to give mg harpagosides per day.

73 Systematic Review - Conclusions Moderate evidence for a daily dose of 100 mg harpagoside in the treatment of acute exacerbations of chronic non- specific low back pain. –subgroup with neurological deficits (e.g. radiation into the leg) responded well. 60 mg harpagoside being non-inferior to 12.5 mg rofecoxib (VIOXX) per day for chronic non-specific low back pain (NSLBP) in the short term. Strong evidence for 50 mg harpagoside in the treatment of acute exacerbations of chronic NSLBP. Joel J Gagnier et al. Harpgophytum procumbens for osteoarthritis and low back pain: A systematic review. BMC Complementary and Alternative Medicine 2004, 4:13. Important to give mg harpagosides per day.

74 Laudahn D and Walper A. Efficacy and Tolerance of Harpagophytum Extract LI 174 in Patients with Chronic Non-radicular Back Pain. Phytother. Res. 15, 621–624 (2001)

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76 Using Schober’s sign, a significant improvement in the evaluation of mobility of the spinal column. Laudahn D and Walper A. Efficacy and Tolerance of Harpagophytum Extract LI 174 in Patients with Chronic Non-radicular Back Pain. Phytother. Res. 15, 621–624 (2001)

77 The mobility of the spinal column increased significantly during treatment. There was a significant reduction (p 0.001) in the average finger–floor distance (FFD) from 15.1 cm initially to 10.2 cm at the end of treatment (Fig. 4). Laudahn D and Walper A. Efficacy and Tolerance of Harpagophytum Extract LI 174 in Patients with Chronic Non-radicular Back Pain. Phytother. Res. 15, 621–624 (2001)

78 Study - Conclusions The drug was slow in taking effect (about 14 days). –"Does not seem to have immediate analgesic potency. More a question of a myotonolytic effect which may be combined with an antiinflammatory effect as a result of an increased blood supply to the affected regions". Patient should be told about the slow onset of action so that treatment is not stopped prematurely. A question of dose. Consider a loading dose! Laudahn D and Walper A. Efficacy and Tolerance of Harpagophytum Extract LI 174 in Patients with Chronic Non-radicular Back Pain. Phytother. Res. 15, 621–624 (2001)

79 Study - Conclusions Treatment costs: –no need for gastric protection treatment or secondary treatment for gastrointestinal ulcers. Can be used in patients with known sensitivity to NSAIDs –high-dose Harpagophytum extract. Laudahn D and Walper A. Efficacy and Tolerance of Harpagophytum Extract LI 174 in Patients with Chronic Non-radicular Back Pain. Phytother. Res. 15, 621–624 (2001)

80 Recommended & Current Uses Devil’s claw (Harpagophytum procumbens) Chronic Pain: –1 tablet bid or tid. –Half-life 5.6 hours; 4-6 hrs prn. Fibromyalgia: –1 tablet tid. Acute Pain (sporadic): –2 tablets single dose. No contraindications: –Hypertension, cardiovascular risk, no risk of GI bleeds. * 1 tablet = 23.4 mg harpagoside (3.74 g dried secondary root)

81 Natural Antispasmodic

82 Skullcap (Scutellaria lateriflora) (also known as Virginia Skullcap) Used as a nerve tonic, sedative and nervous conditions. Used as antispasmodic medicine in the early 1900’s and the Manual of Materia Medica lists the following pain associated conditions where it was used: spasms, muscular twitching, and neuralgia. Today it is widely used for treating tension, anxiety and insomnia as well as a visceral relaxant / antispasmodic for muscular cramps.

83 Skullcap (Scutellaria lateriflora) (also known as Virginia Skullcap) Scutellarin: Shown protective effect for cerebral injury via regulating expression of NOS isoforms & angiogenic molecules (Hu XM et al) Protection against ConA-induced immunological liver injury in mice; mechanism: effect on pro-inflammatory cytokines (inhibition NF-kappaB-TNF-alpha-iNOS transduction pathway) (Tan ZH et al) Study showed neuroprotective effects on brain ischemic injury- iinhibition of the apoptosis-inducing factor pathway in rats (Zhang HF et al) Anti-inflammatory activity in microglial cell (Wang S et al)

84 Bioenergetic uses of Scullcap are: Relaxes constraint. Tonifies the Yin, clears empty heat. Relieves Heart Qi constraint (Liver-Yang rising) or Kidney/adrenal Qi constraint). Treats conditions of heart and kidney Yin deficiency: - insomnia, anxiety. Treats conditions of stomach or kidney Qi stagnation: - nervousness, stress. Treats conditions of kidney /adrenal Qi constraint: - mental/nervous tension from chronic stress or pain or mental/physical exhaustion, unrest, stress-related conditions, anxiety, panic attacks. - tension headache, neuralgia, neuritis, uterine pain, muscle spasms/cramps (e.g., lower leg, back). Should be used to treat conditions with patterns of constrained Qi arising from deficiency; empty tense conditions. Not for conditions arising from excess. Indicated for chronic and not acute stages. Recognized as a nervine tonic. Considered to have trophorestorative effect on nerves. Systemic relaxant: very effective for spasms-cramps. Skullcap (Scutellaria lateriflora)

85 Clinical trials: Insufficient evidence to determine whether skeletal muscle relaxants are effective for subacute or chronic LBP. No difference in short-term reduction of muscle spasm between cyclobenzaprine and placebo. Benzodiazepines: Used as skeletal muscle relaxants. Two trials: more effective than placebo for short-term pain intensity and overall improvement. One trial: no difference between diazepam and placebo for muscle spasm. Short term use to avoid addiction. Muscle Relaxants

86 Natural Topical Analgesic

87 Adjuvant for Chronic Pain Topical agents: Several advantages over systemic drugs: Local action Lower systemic absorption Fewer systemic effects Patient preference. Topical NSAIDs: Acute & widespread musculoskeletal pain. Chronic LBP. Peripheral neuropathic pain. Uses of essential oils: aches and pains of muscles and joints associated with backache, bursitis, lumbago, strains, bruises, sprains and arthritic or rheumatic pain, pain of tendons and ligaments. Tired, aching muscles. © Guy-Chamberland-MasterHerbalist

88 Numerous clinical trials: Peripheral & central neuropathic pain: menthol was analgesic Long-term CIPN (chemotherapy-induced peripheral neuropathy (CIPN) : Improvement in pain and function - topical menthol. Well tolerated, have minimal side effects. Works relatively quickly. Menthol, camphor, clove & eucalyptus = topical analgesic. Inhibit TRPA1: Topical analgesic. TRPA1: Transient receptor potential cation channel, subfamily A, member 1 Acute & chronic (neuropathic) pain & inflammation. Adjuvant for Chronic Pain © Guy-Chamberland-MasterHerbalist

89 Adjuvant for Chronic Pain Essential oils are often used in alternative medicine as analgesic and anti-inflammatory remedies. TRPM8 is a thermosensitive receptor that detects cool temperatures and menthol whereas TRPA1 is a sensor of noxious cold. Ideally, an effective analgesic compound would activate TRPM8 and inhibit TRPA1.’ (Takaishi et al) TRPA1 (Transient receptor potential cation channel, subfamily A, member 1) is involved in acute & chronic (neuropathic) pain & inflammation. TRPA1 antagonists are used to help reduce pain caused by inflammation. © Guy-Chamberland-MasterHerbalist

90 Adjuvant for Chronic Pain Antagonists/Inhibitors of TRPA1 include: Camphor, clove oil and menthol. They act as a topical analgesic. Study shows that Clove oil helps reduce pain via peripheral action (Alqareer et al). Eugenol, the main constituent of Clove oil, shown to provide analgesia in rat monoiodoacetate-induced osteoarthritis (Ferland et al). 1,8-cineole (Eucalyptus oil) is an antagonist of human TRPA1 that has analgesic and anti-inflammatory activity via inhibition of TRPA1. Menthol also activates heat-activated TRPV3 & TRPM8 -a cold-activated thermo TRP ion channel. Explains sensations of cold and/or heat reported after application of product. Menthol is a natural compound of plant origin that induces a cool sensation via the activation of the TRPM8 channel. Research indicates that voltage-gated Na(+) channels are critical for experiencing pain sensation. (Gaudioso) © Guy-Chamberland-MasterHerbalist

91 Can we effectively reduce moderate-severe pain with a combination of Devil’s claw, California poppy and Skullcap?

92 Pain Medications – Visual Analog Scale The clinical goal in the treatment of pain is to suppress the feeling of pain until it is tolerable (or gone) by the patient. One of the primary endpoints is the measure of the sensation of pain by the patient using a Visual Analog Scale (VAS). –An effective dose of an analgesic must lower VAS by 2.0 or more.

93 Pain Medications – Visual Analog Scale The clinical goal in the treatment of pain is to suppress the feeling of pain until it is tolerable (or gone) by the patient. One of the primary endpoints is the measure of the sensation of pain by the patient using a Visual Analog Scale (VAS). –The patient scores the level of the feeling of pain using a 0 to 10 scale. For example, a patient taking acetaminophen + ibuprofen that is in chronic severe pain has a VAS of 9. The physician will begin by adding 2 mg of hydromorphone. This can reduce the feeling of pain by 30% (VAS = 6). The physician will then increase the dosage of hydromorphone to 4 mg which is still clinically acceptable. If the VAS does not decrease to a level that is tolerable for the patient, the physician will then begin adding or analgesics and or switching to stronger narcotics.

94 INDEPENDENT CLINICAL DATA – Acute Pain Protocol Analgesic: –California poppy – single dose (2 grams Dried Herb Equivalent (DHE) per day) at night. Anti-inflammatory: –Devil’s claw – 2 tablets twice (4 grams DHE bid) a day. Anti-Spasmodic: –Scullcap – 2 tablets three times (4 grams DHE tid) a day Topical gel: –3 – 4 times a day on affected area

95 INDEPENDENT CLINICAL DATA – Chronic Pain Protocol Anti-Inflammatory: –2 capsules TID; each equivalent to 1000 mg. Daily dose = 6000 mg DHE. Analgesic-Anti-Inflammatory: –1 capsule of 2500 mg dried herb top California poppy at night mg Devil’s claw. Topical gel: –3 to 4 times a day on affected

96 StudyPilot study; 7-day acute painPilot study; 28-day chronic pain Subjects: 10 patients Patients with acute pain (VAS > 4) No drug therapy 10 patients Patients with chronic pain (VAS > 4) No drug therapy Herbs: California poppy (1 at night) Devil’s claw (tid) Scullcap (tid) California poppy (1 at night) Devil’s claw (tid) Scullcap (tid) Gel Results: Improved sleep Significantly reduced pain  swelling  tenderness Improved sleep Significantly reduced pain Significant  mobility & flexibility  swelling  tenderness  stiffness Reference:Chamberland G. unpublished © Guy-Chamberland-MasterHerbalist

97 Reassessment? Second Pharmacological intervention. Upward titration? Need co-analgesic--adjuvant meds? Initial Pharmacological intervention Examples of Analgesic-NSAID Choices acetaminophen500 mg q 4 hrs poMDD 4000 mg ibuprofen400 mg q 4-6 hrs poMDD 3200 mg Devil’s claw 20 mg harpagoside q 6 hrs po Relief obtained NSAID contraindicated © Guy-Chamberland-MasterHerbalist Devil’s claw

98 Second Pharmacological intervention - Reassessment Non-opioid analgesics (acetaminophen, NSAIDs, COX-2 Inhibitors); Tramadol; Opioids; Alpha 2 adrenergic agonists; Antidepressants (tricyclics and SNRIs); Antiepileptic drugs (gabapentin, pregabalin); Muscle relaxants; N-methyl-d-aspartate (NMDA) receptor antagonists; Topical analgesic agents Upward titration? Need co-analgesic--adjuvant meds? + © Guy-Chamberland-MasterHerbalist

99 Natural NSAID: enteric coated Devil’s claw (20 mg harpagosides). Goal: 50 – 100 mg harpagosides per day. 1 st 48 hours: loading dose to rapidly decrease inflammation. 468 mg PE 8:1 standardized 5% harpagosides (23.4 mg) Or 500 mg PE 4:1 standardized 5% harpagosides (25 mg) © Guy-Chamberland-MasterHerbalist COMPLEMENTARY ACTIVITIES – Pain Management examples Natural analgesic: California poppy (3 g DHE; 5:1 extract; standardized to 0.8% isoquinoline alkaloids). Night pain – critical part of therapy. Co-analgesic – adjuvant to natural NSAID. Antispasmodic: enteric coated Scullcap (2 g DHE). Spasms and cramps. Anxiety. Nervine tonic. Tablet of 500 mg PE 4:1 = 2 g DHE

100 Goal: 50 – 100 mg harpagosides per day. 1 st 48 hours: loading dose to rapidly decrease inflammation. 468 mg PE 8:1 standardized 5% hapragosides (23.4 mg) © Guy-Chamberland-MasterHerbalist Natural – NSAID: Enteric Coated Devil’s Claw (20 mg harpagosides) Safe daily dose: 9 g/day DHE Loading dose for 48 hrs = 2 tablets tid = 250% of dose. (Very effective speed of onset for pain reduction but consider safety – risk-to-benefit.) Therapeutic dose of 1 tablet tid = 125% of dose. Maintenance dose of 1 tablet bid = 85% of dose. (Both are safe if no contraindications. Always aim for lowest systemic exposure long-term.)

101 Goal: 50 – 100 mg harpagosides per day. 1 st 48 hours: loading dose to rapidly decrease inflammation. 500 mg PE 4:1 standardized 5% hapragosides (25 mg) © Guy-Chamberland-MasterHerbalist Natural – NSAID: Enteric Coated Devil’s Claw (20 mg harpagosides). Safe daily dose: 9 g/day DHE Loading dose for 48 hrs = 2 tablets tid = 133% of dose. (Safer than previous because of lower total herb exposure. Draw back: some efficacy associated with other ingredients that are now at lower dose than harpagoside content.) Therapeutic dose of 1 tablet tid = 67% of dose. Maintenance dose of 1 tablet bid = 44% of dose. (Both are safe if no contraindications. Always aim for lowest systemic exposure long-term.)

102 Natural Analgesic Natural analgesic: California poppy (3 g DHE; 5:1 extract); standardized to 0.8% isoquinoline alkaloids. © Guy-Chamberland-MasterHerbalist Safe daily dose: 3 g/day DHE Co-analgesic – adjuvant to natural NSAID. (200% of dose) (If no contraindications, this approach is safe. Consider dosing interval and assess effect on drowsiness.) Night pain – critical part of therapy. (100% of dose) (Safe if no contraindications.)

103 Antispasmodic Enteric coated Scullcap (2 g DHE). Spasms and cramps. Anxiety. Nervine tonic. © Guy-Chamberland-MasterHerbalist Tablet of 500 mg PE 4:1 = 2 g DHE (each tablet equivalent to 17% of dose) Safe daily dose: 12 g/day DHE 3 Tablets of 500 mg PE 4:1 given tid = 150% additive intake (Safe if no contraindications. However, consider impact on drowsiness.) 1 Tablet of 500 mg PE 4:1 given tid = 50% additive intake (Very safe if no contraindications.) 2 Tablets of 500 mg PE 4:1 given tid = 100% additive intake (Very safe if no contraindications.)

104 A Simple View of Herbs & Pain Management Combination therapy for acute or chronic pain: enteric coated Devil’s claw + California poppy + enteric coated Scullcap. Edema and/or inflammation Enteric coated Figwort Rheumatic condition Black cohosh +++ inflammation Feverfew Local pain Topical gel © Guy-Chamberland-MasterHerbalist Complementary therapeutic activity – no additive effect

105 50 year old male with history of chronic back pain due to lumbar disc hernia. Complains of low back and limb muscle spasms. Patient refuses to take narcotics because of negative impact on his ability to concentrate and opioids make him aggressive. Epidural injections of steroids and anesthetic do not provide adequate benefit and patient has severe hypertension due to steroids. Case Study – Low Back Pain Initial intervention: - 2 tablets (enteric coated) of 23.4 mg harpagoside three times a day for first 48-hours. Reduced to 1 tablet three times a day for 2 weeks (next visit). - 1 tablet (2 g DHE; enteric coated) of Scullcap three times a day for first week. Reduced to 1 tablet p.r.n. every 4-6 hours as needed for spasms. Second intervention: - Maintain 1 tablet 23.4 mg harpagoside three times a day for one month. Explained increase to 2 tablets three times a day for 24 hours when flare-up due to false movement or exertion. - 1 tablet of Scullcap p.r.n. every 4-6 hours as needed for spasms. - Night pain: 1 tablet Devil’s claw & 3 tablets Scullcap 30 minutes before bedtime.

106 50 year old male with history of chronic back pain due to lumbar disc hernia. Complains of low back and limb muscle spasms. Patient refuses to take narcotics because of negative impact on his ability to concentrate and opioids make him aggressive. Epidural injections of steroids and anesthetic do not provide adequate benefit and patient has severe hypertension due to steroids. Case Study– Low Back Pain Initial intervention: - 2 tablets of 23.4 mg harpagoside three times a day for first 48-hours. Reduced to 1 tablet three times a day for 2 weeks (next visit). - 1 tablet of Scullcap three times a day for first week. Reduced to 1 tablet p.r.n. every 4-6 hours as needed for spasms. Devil’s claw – standardized harpagoside: 1)Acute pain: use three times a day for first 48-hours. a)Do not exceed 48-hours. b)TID important based on half-life. 2) Reduce to 1 tablet three times a day for 2 weeks. 3) Reduce to 1 tablet twice a day for longer. RAPID PAIN REDUCTION: LOADING DOSE FOLLOWED BY OPTIMIZED DOSE FREQUENCY.

107 Case Study – Low Back Pain Initial intervention: - 2 tablets of 23.4 mg harpagoside three times a day for first 48-hours. Reduced to 1 tablet three times a day for 2 weeks (next visit). - 1 tablet (2 g DHE) of Scullcap three times a day for first week. Reduced to 1 tablet p.r.n. every 4-6 hours as needed for spasms. Enteric coated Scullcap: 1)Spasms-cramps: a)Depending on severity, 1 tablet every 4-6 hours as needed. b)Beware of tranquilizing effect - drowsiness. 2) Maintain lower dose during day. 3) If no sleep aid, use 2-3 tablets at bedtime. BALANCE SPASM/CRAMP REDUCTION VERSUS TRANQUILIZING EFFECT DURING DAYTIME!.

108 Case Study – Low Back Pain Second intervention: -Maintain 1 tablet 23.4 mg harpagoside three times a day for one month. Explained increase to 2 tablets three times a day for 24 hours when flare-up due to false movement or exertion. -1 tablet of (2g DHE) Scullcap p.r.n. every 4-6 hours as needed for spasms. -Night pain: 1 tablet Devil’s claw & 3 tablets Scullcap 30 minutes before bedtime. Devil’s claw : 1)Flare-ups: important to rapidly reduce sudden increase in pain. a)Do not exceed 48-hours. b)TID important based on half-life. 2) Reduce to maintenance dosing or stop if no longer taking.

109 Case Study – Low Back Pain Second intervention: -Maintain 1 tablet 23.4 mg harpagoside three times a day for one month. Explained increase to 2 tablets three times a day for 24 hours when flare-up due to false movement or exertion. -1 tablet (2 g DHE) of Scullcap p.r.n. every 4-6 hours as needed for spasms. -Night pain: 1 tablet Devil’s claw & 3 tablets Scullcap 30 minutes before bedtime. Night Pain: 1)Important to add sedative-hypnotic PLUS anti-inflammatory-analgesic. 2) Skullcap is good choice because of antispasmodic effect. Lemon balm- Passion flower can also be used for night pain in combinations with natural NSAID.


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