Herbal medicinal products or preparations for neuropathic pain

Research output: Contribution to journalReview article

2 Citations (Scopus)

Abstract

Background Neuropathic pain is a consequence of damage to the central nervous system (CNS), for example, cerebrovascular accident, multiple sclerosis or spinal cord injury, or peripheral nervous system (PNS), for example, painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN), or surgery. Evidence suggests that people suffering from neuropathic pain are likely to seek alternative modes of pain relief such as herbal medicinal products due to adverse events brought about by current pharmacological agents used to treat neuropathic pain. This review includes studies in which participants were treated with herbal medicinal products (topically or ingested) who had experienced neuropathic pain for at least three months. Objectives To assess the analgesic efficacy and effectiveness of herbal medicinal products or preparations for neuropathic pain, and the adverse events associated with their use. Search methods We searched CENTRAL and the Cochrane Database of Systematic Reviews, MEDLINE, Embase, CINAHL and AMED to March 2018.We identified additional studies from the reference lists of the retrieved papers.We also searched trials registries for ongoing trials and we contacted experts in the field for relevant data in terms of published, unpublished or ongoing studies. Selection criteria We included randomised controlled trials (including cross-over designs) of double-blind design, assessing efficacy of herbal treatments for neuropathic pain compared to placebo, no intervention or any other active comparator. Participants were 18 years and above and had been suffering from one or more neuropathic pain conditions, for three months or more. We applied no restrictions to language or gender. We excluded studies monitoring effects of isolated, single chemicals derived from the plant or synthetic chemicals based on constituents of the plant, if they were not administered at a concentration naturally present within the plant. We excluded studies monitoring the effects of traditional Asian medicine and Cannabinoids as well as studies looking at headache or migraine as these treatments and conditions are addressed in distinct reviews. Data collection and analysis We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion, assessed risk of bias, and extracted data. We calculated the risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNTB). The primary outcomes were participant-reported pain relief of 30%, or 50%, or greater, and participant-reported global impression of clinical change (PGIC). We also collected information on adverse events. We assessed evidence using GRADE and created a 'Summary of findings' table. Main results We included two studies (128 participants). Both diabetic neuropathy and non-diabetic neuropathic pain conditions were investigated across these two studies. Two herbal medicinal products, namely nutmeg (applied topically as a 125 mL spray for four weeks, containing mace oil 2%, nutmeg oil 14%, methyl salicylate 6%, menthol 6%, coconut oil and alcohol) and St John's wort (taken in capsule form containing 900 ?g total hypericin each, taken three times daily, giving a total concentration of 2700 mg for five weeks). Both studies allowed the use of concurrent analgesia. Both reported at least one pain-related outcome but we could not carry out meta-analysis of effectiveness due to heterogeneity between the primary outcomes and could not draw any conclusions of effect. Other outcomes included PGIC, adverse events and withdrawals. There were no data for participant-reported pain relief of 50% or greater or PGIC (moderate and substantial) outcomes. When looking at participant-reported pain relief of 30% or greater over baseline, we observed no evidence of a difference (P = 0.64) in response to nutmeg versus placebo (RR 1.12, 95% confidence interval (CI) 0.69 to 1.85; 48.6% vs 43.2%). We downgraded the evidence for this outcome to very low quality. We observed no change between placebo and nutmeg treatment when looking at secondary pain outcomes. Visual analogue scale (VAS) scores for pain reduction (0 to 100, where 0 = no pain reduction), were 44 for both nutmeg and placebo with standard deviations of 21.5 and 26.5 respectively. There was no evidence of a difference (P = 0.09 to 0.33) in total pain score in response to St John's wort compared to placebo, as there was only a reduction of 1 point when looking at median differences in change from baseline on a 0 to 10-point numeric rating scale. There was a total of five withdrawals out of 91 participants (5%) in the treatment groups compared to six of 91 (6.5%) in the placebo groups, whilst adverse events were the same for both the treatment and placebo groups. We judged neither study as having a low risk of bias.We attributed risk of bias to small study size and incomplete outcome data leading to attrition bias. We downgraded the evidence to very low quality for all primary and secondary outcomes reported in this review. We downgraded the quality of the evidence twice due to very serious limitations in study quality (due to small study size and attrition bias) and downgraded a further level due to indirectness as the included studies only measured outcomes at short-term time points. The results from this review should be treated with scepticism as we have very little confidence in the effect estimate.

LanguageEnglish
Article numberCD010528
JournalCochrane Database of Systematic Reviews
Volume2019
Issue number4
DOIs
Publication statusPublished - 2 Apr 2019

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Neuralgia
Myristica fragrans
Placebos
Pain
Diabetic Neuropathies
Oils
omega-Chloroacetophenone
Odds Ratio
Menthol
Postherpetic Neuralgia
Numbers Needed To Treat
Cannabinoids
Peripheral Nervous System
Phytochemicals
Traditional Medicine
Pain Measurement
Therapeutics
Migraine Disorders
Spinal Cord Injuries
MEDLINE

Cite this

@article{957f78033cb94e8fb3cdb03410964694,
title = "Herbal medicinal products or preparations for neuropathic pain",
abstract = "Background Neuropathic pain is a consequence of damage to the central nervous system (CNS), for example, cerebrovascular accident, multiple sclerosis or spinal cord injury, or peripheral nervous system (PNS), for example, painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN), or surgery. Evidence suggests that people suffering from neuropathic pain are likely to seek alternative modes of pain relief such as herbal medicinal products due to adverse events brought about by current pharmacological agents used to treat neuropathic pain. This review includes studies in which participants were treated with herbal medicinal products (topically or ingested) who had experienced neuropathic pain for at least three months. Objectives To assess the analgesic efficacy and effectiveness of herbal medicinal products or preparations for neuropathic pain, and the adverse events associated with their use. Search methods We searched CENTRAL and the Cochrane Database of Systematic Reviews, MEDLINE, Embase, CINAHL and AMED to March 2018.We identified additional studies from the reference lists of the retrieved papers.We also searched trials registries for ongoing trials and we contacted experts in the field for relevant data in terms of published, unpublished or ongoing studies. Selection criteria We included randomised controlled trials (including cross-over designs) of double-blind design, assessing efficacy of herbal treatments for neuropathic pain compared to placebo, no intervention or any other active comparator. Participants were 18 years and above and had been suffering from one or more neuropathic pain conditions, for three months or more. We applied no restrictions to language or gender. We excluded studies monitoring effects of isolated, single chemicals derived from the plant or synthetic chemicals based on constituents of the plant, if they were not administered at a concentration naturally present within the plant. We excluded studies monitoring the effects of traditional Asian medicine and Cannabinoids as well as studies looking at headache or migraine as these treatments and conditions are addressed in distinct reviews. Data collection and analysis We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion, assessed risk of bias, and extracted data. We calculated the risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNTB). The primary outcomes were participant-reported pain relief of 30{\%}, or 50{\%}, or greater, and participant-reported global impression of clinical change (PGIC). We also collected information on adverse events. We assessed evidence using GRADE and created a 'Summary of findings' table. Main results We included two studies (128 participants). Both diabetic neuropathy and non-diabetic neuropathic pain conditions were investigated across these two studies. Two herbal medicinal products, namely nutmeg (applied topically as a 125 mL spray for four weeks, containing mace oil 2{\%}, nutmeg oil 14{\%}, methyl salicylate 6{\%}, menthol 6{\%}, coconut oil and alcohol) and St John's wort (taken in capsule form containing 900 ?g total hypericin each, taken three times daily, giving a total concentration of 2700 mg for five weeks). Both studies allowed the use of concurrent analgesia. Both reported at least one pain-related outcome but we could not carry out meta-analysis of effectiveness due to heterogeneity between the primary outcomes and could not draw any conclusions of effect. Other outcomes included PGIC, adverse events and withdrawals. There were no data for participant-reported pain relief of 50{\%} or greater or PGIC (moderate and substantial) outcomes. When looking at participant-reported pain relief of 30{\%} or greater over baseline, we observed no evidence of a difference (P = 0.64) in response to nutmeg versus placebo (RR 1.12, 95{\%} confidence interval (CI) 0.69 to 1.85; 48.6{\%} vs 43.2{\%}). We downgraded the evidence for this outcome to very low quality. We observed no change between placebo and nutmeg treatment when looking at secondary pain outcomes. Visual analogue scale (VAS) scores for pain reduction (0 to 100, where 0 = no pain reduction), were 44 for both nutmeg and placebo with standard deviations of 21.5 and 26.5 respectively. There was no evidence of a difference (P = 0.09 to 0.33) in total pain score in response to St John's wort compared to placebo, as there was only a reduction of 1 point when looking at median differences in change from baseline on a 0 to 10-point numeric rating scale. There was a total of five withdrawals out of 91 participants (5{\%}) in the treatment groups compared to six of 91 (6.5{\%}) in the placebo groups, whilst adverse events were the same for both the treatment and placebo groups. We judged neither study as having a low risk of bias.We attributed risk of bias to small study size and incomplete outcome data leading to attrition bias. We downgraded the evidence to very low quality for all primary and secondary outcomes reported in this review. We downgraded the quality of the evidence twice due to very serious limitations in study quality (due to small study size and attrition bias) and downgraded a further level due to indirectness as the included studies only measured outcomes at short-term time points. The results from this review should be treated with scepticism as we have very little confidence in the effect estimate.",
author = "Adele Boyd and Chris Bleakley and Hurley, {Deirdre A.} and Chris Gill and Mary Hannon-Fletcher and Pamela Bell and Suzanne McDonough",
note = "There are four versions of this article from 2013. Checking if accepted date is required.",
year = "2019",
month = "4",
day = "2",
doi = "10.1002/14651858.CD010528.pub4",
language = "English",
volume = "2019",
journal = "Cochrane Database of Systematic Reviews",
issn = "1469-493X",
number = "4",

}

Herbal medicinal products or preparations for neuropathic pain. / Boyd, Adele; Bleakley, Chris; Hurley, Deirdre A.; Gill, Chris; Hannon-Fletcher, Mary; Bell, Pamela; McDonough, Suzanne.

In: Cochrane Database of Systematic Reviews, Vol. 2019, No. 4, CD010528, 02.04.2019.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Herbal medicinal products or preparations for neuropathic pain

AU - Boyd, Adele

AU - Bleakley, Chris

AU - Hurley, Deirdre A.

AU - Gill, Chris

AU - Hannon-Fletcher, Mary

AU - Bell, Pamela

AU - McDonough, Suzanne

N1 - There are four versions of this article from 2013. Checking if accepted date is required.

PY - 2019/4/2

Y1 - 2019/4/2

N2 - Background Neuropathic pain is a consequence of damage to the central nervous system (CNS), for example, cerebrovascular accident, multiple sclerosis or spinal cord injury, or peripheral nervous system (PNS), for example, painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN), or surgery. Evidence suggests that people suffering from neuropathic pain are likely to seek alternative modes of pain relief such as herbal medicinal products due to adverse events brought about by current pharmacological agents used to treat neuropathic pain. This review includes studies in which participants were treated with herbal medicinal products (topically or ingested) who had experienced neuropathic pain for at least three months. Objectives To assess the analgesic efficacy and effectiveness of herbal medicinal products or preparations for neuropathic pain, and the adverse events associated with their use. Search methods We searched CENTRAL and the Cochrane Database of Systematic Reviews, MEDLINE, Embase, CINAHL and AMED to March 2018.We identified additional studies from the reference lists of the retrieved papers.We also searched trials registries for ongoing trials and we contacted experts in the field for relevant data in terms of published, unpublished or ongoing studies. Selection criteria We included randomised controlled trials (including cross-over designs) of double-blind design, assessing efficacy of herbal treatments for neuropathic pain compared to placebo, no intervention or any other active comparator. Participants were 18 years and above and had been suffering from one or more neuropathic pain conditions, for three months or more. We applied no restrictions to language or gender. We excluded studies monitoring effects of isolated, single chemicals derived from the plant or synthetic chemicals based on constituents of the plant, if they were not administered at a concentration naturally present within the plant. We excluded studies monitoring the effects of traditional Asian medicine and Cannabinoids as well as studies looking at headache or migraine as these treatments and conditions are addressed in distinct reviews. Data collection and analysis We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion, assessed risk of bias, and extracted data. We calculated the risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNTB). The primary outcomes were participant-reported pain relief of 30%, or 50%, or greater, and participant-reported global impression of clinical change (PGIC). We also collected information on adverse events. We assessed evidence using GRADE and created a 'Summary of findings' table. Main results We included two studies (128 participants). Both diabetic neuropathy and non-diabetic neuropathic pain conditions were investigated across these two studies. Two herbal medicinal products, namely nutmeg (applied topically as a 125 mL spray for four weeks, containing mace oil 2%, nutmeg oil 14%, methyl salicylate 6%, menthol 6%, coconut oil and alcohol) and St John's wort (taken in capsule form containing 900 ?g total hypericin each, taken three times daily, giving a total concentration of 2700 mg for five weeks). Both studies allowed the use of concurrent analgesia. Both reported at least one pain-related outcome but we could not carry out meta-analysis of effectiveness due to heterogeneity between the primary outcomes and could not draw any conclusions of effect. Other outcomes included PGIC, adverse events and withdrawals. There were no data for participant-reported pain relief of 50% or greater or PGIC (moderate and substantial) outcomes. When looking at participant-reported pain relief of 30% or greater over baseline, we observed no evidence of a difference (P = 0.64) in response to nutmeg versus placebo (RR 1.12, 95% confidence interval (CI) 0.69 to 1.85; 48.6% vs 43.2%). We downgraded the evidence for this outcome to very low quality. We observed no change between placebo and nutmeg treatment when looking at secondary pain outcomes. Visual analogue scale (VAS) scores for pain reduction (0 to 100, where 0 = no pain reduction), were 44 for both nutmeg and placebo with standard deviations of 21.5 and 26.5 respectively. There was no evidence of a difference (P = 0.09 to 0.33) in total pain score in response to St John's wort compared to placebo, as there was only a reduction of 1 point when looking at median differences in change from baseline on a 0 to 10-point numeric rating scale. There was a total of five withdrawals out of 91 participants (5%) in the treatment groups compared to six of 91 (6.5%) in the placebo groups, whilst adverse events were the same for both the treatment and placebo groups. We judged neither study as having a low risk of bias.We attributed risk of bias to small study size and incomplete outcome data leading to attrition bias. We downgraded the evidence to very low quality for all primary and secondary outcomes reported in this review. We downgraded the quality of the evidence twice due to very serious limitations in study quality (due to small study size and attrition bias) and downgraded a further level due to indirectness as the included studies only measured outcomes at short-term time points. The results from this review should be treated with scepticism as we have very little confidence in the effect estimate.

AB - Background Neuropathic pain is a consequence of damage to the central nervous system (CNS), for example, cerebrovascular accident, multiple sclerosis or spinal cord injury, or peripheral nervous system (PNS), for example, painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN), or surgery. Evidence suggests that people suffering from neuropathic pain are likely to seek alternative modes of pain relief such as herbal medicinal products due to adverse events brought about by current pharmacological agents used to treat neuropathic pain. This review includes studies in which participants were treated with herbal medicinal products (topically or ingested) who had experienced neuropathic pain for at least three months. Objectives To assess the analgesic efficacy and effectiveness of herbal medicinal products or preparations for neuropathic pain, and the adverse events associated with their use. Search methods We searched CENTRAL and the Cochrane Database of Systematic Reviews, MEDLINE, Embase, CINAHL and AMED to March 2018.We identified additional studies from the reference lists of the retrieved papers.We also searched trials registries for ongoing trials and we contacted experts in the field for relevant data in terms of published, unpublished or ongoing studies. Selection criteria We included randomised controlled trials (including cross-over designs) of double-blind design, assessing efficacy of herbal treatments for neuropathic pain compared to placebo, no intervention or any other active comparator. Participants were 18 years and above and had been suffering from one or more neuropathic pain conditions, for three months or more. We applied no restrictions to language or gender. We excluded studies monitoring effects of isolated, single chemicals derived from the plant or synthetic chemicals based on constituents of the plant, if they were not administered at a concentration naturally present within the plant. We excluded studies monitoring the effects of traditional Asian medicine and Cannabinoids as well as studies looking at headache or migraine as these treatments and conditions are addressed in distinct reviews. Data collection and analysis We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion, assessed risk of bias, and extracted data. We calculated the risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNTB). The primary outcomes were participant-reported pain relief of 30%, or 50%, or greater, and participant-reported global impression of clinical change (PGIC). We also collected information on adverse events. We assessed evidence using GRADE and created a 'Summary of findings' table. Main results We included two studies (128 participants). Both diabetic neuropathy and non-diabetic neuropathic pain conditions were investigated across these two studies. Two herbal medicinal products, namely nutmeg (applied topically as a 125 mL spray for four weeks, containing mace oil 2%, nutmeg oil 14%, methyl salicylate 6%, menthol 6%, coconut oil and alcohol) and St John's wort (taken in capsule form containing 900 ?g total hypericin each, taken three times daily, giving a total concentration of 2700 mg for five weeks). Both studies allowed the use of concurrent analgesia. Both reported at least one pain-related outcome but we could not carry out meta-analysis of effectiveness due to heterogeneity between the primary outcomes and could not draw any conclusions of effect. Other outcomes included PGIC, adverse events and withdrawals. There were no data for participant-reported pain relief of 50% or greater or PGIC (moderate and substantial) outcomes. When looking at participant-reported pain relief of 30% or greater over baseline, we observed no evidence of a difference (P = 0.64) in response to nutmeg versus placebo (RR 1.12, 95% confidence interval (CI) 0.69 to 1.85; 48.6% vs 43.2%). We downgraded the evidence for this outcome to very low quality. We observed no change between placebo and nutmeg treatment when looking at secondary pain outcomes. Visual analogue scale (VAS) scores for pain reduction (0 to 100, where 0 = no pain reduction), were 44 for both nutmeg and placebo with standard deviations of 21.5 and 26.5 respectively. There was no evidence of a difference (P = 0.09 to 0.33) in total pain score in response to St John's wort compared to placebo, as there was only a reduction of 1 point when looking at median differences in change from baseline on a 0 to 10-point numeric rating scale. There was a total of five withdrawals out of 91 participants (5%) in the treatment groups compared to six of 91 (6.5%) in the placebo groups, whilst adverse events were the same for both the treatment and placebo groups. We judged neither study as having a low risk of bias.We attributed risk of bias to small study size and incomplete outcome data leading to attrition bias. We downgraded the evidence to very low quality for all primary and secondary outcomes reported in this review. We downgraded the quality of the evidence twice due to very serious limitations in study quality (due to small study size and attrition bias) and downgraded a further level due to indirectness as the included studies only measured outcomes at short-term time points. The results from this review should be treated with scepticism as we have very little confidence in the effect estimate.

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U2 - 10.1002/14651858.CD010528.pub4

DO - 10.1002/14651858.CD010528.pub4

M3 - Review article

VL - 2019

JO - Cochrane Database of Systematic Reviews

T2 - Cochrane Database of Systematic Reviews

JF - Cochrane Database of Systematic Reviews

SN - 1469-493X

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M1 - CD010528

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