- Email: [email protected]
Fecal incontinence treated with acupuncture - a pilot study
Autonomic Neuroscience: Basic and Clinical 145 (2009) 89–92
Contents lists available at ScienceDirect
Autonomic Neuroscience: Basic and Clinical j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / a u t n e u
Fecal incontinence treated with acupuncture - a pilot study Marco Scaglia a,⁎, GianGaetano Delaini b, Ines Destefano a, Leif Hultén c a b c
University of Turin – School of Medicine, Section of General Surgery, S. Luigi Hospital, Orbassano, Italy Department of Surgical Sciences, Section C of General Surgery, University of Verona, Italy Sahlgrenska University Hospital – Institute for Surgical Science, Goteborg, Sweden
a r t i c l e
i n f o
Article history: Received 28 April 2008 Received in revised form 28 September 2008 Accepted 13 October 2008 Keywords: Acupuncture Fecal incontinence Sacral neuromodulation Somatic afferents Anorectal manometry
a b s t r a c t Objectives: Acupuncture has been used successfully for the treatment of urinary bladder dysfunction. The aim of this study was therefore to investigate if manual acupuncture might also affect fecal incontinence favorably. Methods: The study comprises 15 female patients, median age 60 years (39 -75). Before treatment and at regular intervals after acupuncture sessions the defects of anal continence were assessed. Ano-rectal function was assessed by means of recto anal manovolumetry. Each patient was submitted to one acupuncture treatment per week for a ten-week period. Subsequently, a control session was repeated once per month up to 7 months for six patients. A final functional assessment was performed at 18 months. Result: Patients experienced a significant improvement in anal continence, the overall continence score which changed from 10 (3 -21) estimated before treatment to zero (0 - 7) (p b 0.05) at 10 weeks. Patients with irregular bowel habits and/or loose stools reported significant improvement. On the manovolumetric variables a limited increase of resting from 25 (17-35) mmHg to 36 (20-42) mmHg, (p = 0.05) and sustained squeeze anal pressure, changing from 41 (32-68) mmHg to 60 (40-100) mmHg (p b 0.05) were reported. Rectal sensory function remained unchanged. Conclusion: Acupuncture offers good opportunities for improving fecal incontinence. The mechanism of action is obscure but might be an effect of the “neuromodulation” of the recto-anal function similar to that explaining the favorable results achieved by sacral nerve stimulation. The concomitant regulation of disordered bowel habits may also contribute to the satisfactory results. © 2008 Elsevier B.V. All rights reserved.
Fecal incontinence is a distressing condition with significant medical, social and economic implications. Conservative measures including constipating drugs, behavioral therapy, anal plugs and injectable bulking agents have a low success rate. Results after dynamic graciloplasty (Baeten et al., 1988) and the artificial anal sphincter procedures (Christiansen and Lorentzen, 1989) have been disappointing and the techniques have both been abandoned in many places (Altomare et al., 2004) The currently most popular surgical technique is sacral nerve stimulation (SRS). As with most invasive surgical procedures, complications may occur with infections, wound dehiscence or displacement of stimulation electrodes (Matzel et al., 1995; Weil et al., 1998). Although promising results have been reported, the outcome is sometimes unpredictable and variable (Jarret et al., 2004). As the underlying mechanism of action of SRS remains unclear, the clinical improvement achieved is referred to as “neuromodulation” of recto anal function.
⁎ Corresponding author. The Colorectal Unit, Sahlgrenska University Hospital/ Östra Hospital, SE-416 85 Göteborg, Sweden. E-mail address: [email protected] (M. Scaglia). 1566-0702/$ – see front matter © 2008 Elsevier B.V. All rights reserved. doi:10.1016/j.autneu.2008.10.014
There is convincing evidence that the ancient Chinese method of acupuncture – apart from its pain-relieving effect and regulation of the peripheral circulation - influences favorably urinary bladder dysfunction and even gastrointestinal dysfunction (Andersson and Lundeberg, 1995). The aim of the present study has therefore been to investigate whether and, if so, to what extent acupuncture might influence fecal incontinence and the length of time it is effective after a treatment session. 1. Patients and Methods Fifteen females with fecal incontinence lasting for at least one year (median age 60 years, range 39-75), attending the outpatient clinic of the surgical department of San Luigi Hospital Orbassano (Italy), were invited to participate in the study. They had all been treated conservatively (constipating drugs, behavioral therapy ) but the attempts had failed. Details of their obstetric history and previous operations were recorded. 9 females (57%) reported a perineal tear during the delivery and 5 had had an episiotomy. 13 patients had a history of pelvic or anal surgery (hemorrhoidectomy, 3; pelvic floor repair, 3) and 7 had had a
90
M. Scaglia et al. / Autonomic Neuroscience: Basic and Clinical 145 (2009) 89–92
Table 1 Cleveland Clinic Continence score
Occasional N 1/week Daily
Flatus
Liquid stools
Solidstools
Pad
1 2 3
4 5 6
7 8 9
0 1 2
The sum of continence defects may be interpreted as follows: IC 0 = perfect continence, IC 1-7 = good continence, IC 8-14 moderate incontinence, IC 15-20 severe incontinence.
hysterectomy. Before treatment anal endosonography was available in 8 cases and 4 cases presented defects of the internal and/or external sphincter, (intact sphincters did not represent an inclusion criteria) the study of the peripheral pudendal latency was done in 6 cases and it was delayed in 4 (= or N2.5 sec.). A detailed history of patients' bowel habits was taken with specific notes being made regarding incontinence in the case of solid stool, liquid stool and flatus, together with the frequency of incontinence, the need for using a pad and the social impact of incontinence in general. For the purpose of the analysis, the Cleveland Clinic continence score was used (Table 1). The standard barostatic anorectal manovolumetry (Akervall et al., 1988) was performed in the left lateral position, before, and at intervals after treatment according to the following schedule. Each patient was submitted to one acupuncture treatment per week for a ten-week period. In occasion of the last treatment, the incontinence score was re-evaluated and manovolumetry was carried out. Subsequently, one control with a new acupuncture session was repeated once per month in six patients (an incontinence score was calculated every time) for a period of 7 months, this is called as “intermediate control”. A final functional assessment, with a new ano-rectal manovolumetry, was performed at 18 months. 1.1. The manual acupuncture procedure One and the same person (MS), well trained in the procedure, performed the acupuncture. Sterile disposable, stainless wire acupuncture needles with copper wire handle, 40 mm long and 0.3 mm in diameter were inserted, gently stimulated by rotation and then left in place for twenty minutes. The selection and the localization of these points on trial was, to a limited extent, based on traditional Chinese medicine (TCM) (Maciocia, 1994) by using the following points: 3 RM (Zhong ji), 6 RM (Qi Hai), localized respectively on the midline of the lower abdomen, 4 DM (Ming Men), 23 BL (Shen Shu) on the lumbar region, 32 BL (Ci Liao) on the the 2nd sacral foramen , 4 LI (He Gu) on the hand between the first and second metacarpal bone, 36 ST (Zu San Li) outer side of the leg below the knee, and 3 K (Tai Xi) inner side of the ankle.
when assessed at a later stage (18 months) they still scored favorably, median score 1 (0-6). When entering the acupuncture sessions the incontinence was rated less severe (flatus and/or soiling) in the remaining six patients, mean score 4 (3-5). At 10 weeks they had also improved as reflected in a median score of 0 (0-0). The improvement - clearly observed after the third acupuncture treatment - sometimes remains persistent a long time after cessation of treatment. Sporadic episodes of soiling were observed, mainly associated with irregularity in bowel movements, in patients regularly checked for a seven-month period after the completion of acupuncture. 2.2. Bowel habits As shown in Fig. 2 the majority of patients suffering irregularity in bowel habits when entering the study had improved significantly at 10 weeks and quite a few remained so even at longer follow up. At 18 months bowel habits still remained regular in eight of the 14 patients and all but two had firm stools. 2.3. Manovolumetric results At 10 weeks after acupuncture resting anal pressure had increased from 25 (17-35) mmHg to 36 (20-42) mmHg, (p= 0.05) (Table 2). While maximal sphincter squeeze pressure remained uninfluenced, the ability to sustain the squeeze pressure increased from 41 (32-68) mmHg to 60 (40-100) mmHg (pb 0.05). The first sensation of rectal filling was absent or blunted in 6 patients at start of the acupuncture sessions and the experience of the defecation urge blunt or absent in two patients. These defects in rectal sensory function remained unchanged. The average rectal volume 348 (340-402) ml also remained unchanged. At 18 months resting anal pressure was still well retained whereas the ability to sustain the anal squeeze had returned to pre-treatment levels. Rectal volume and the rectal sensory variables were unchanged. 3. Discussion Apart from the control of the anal sphincters, anal continence is dependent on the complex interplay of stool volume, fecal consistency and transit through the colon, rectal compliance, ano-rectal perception, or any combination of these factors. Moreover ano-rectal function appears also to be under supra-spinal control and is regulated by the close interaction of the autonomic and somatic nerve systems. It may
1.2. Statistical analysis Results are presented as a median and interquartile range. Statistics were made using Student Fisher t-test (p b 0.05). 2. Results 2.1. Anal incontinence The overall mean continence score in the 15 patients changed from 10 (3 -21) estimated before treatment to zero (0 - 7) (p b 0.05) at 10 weeks, reflecting a significant improvement in continence. The continence index available in 14 patients at about 18 months after start of treatment was 1 (0-8) (p b 0.05) (Fig. 1). Before acupuncture frank fecal incontinence occurred in nine of the 15 patients exhibiting a median incontinence score of 17 (9-18). After 10 weeks treatment they had improved significantly with a median score of 0 (0-3) and
Fig. 1. Individual fecal incontinence score before and at intervals after acupuncture sessions.
M. Scaglia et al. / Autonomic Neuroscience: Basic and Clinical 145 (2009) 89–92
91
Fig. 2. Bowel habits (left panel) and stool consistency (right panel) before and after acupuncture.
therefore not be surprising that results after dynamic graciloplasty (Baeten et al., 1988) and other artificial anal sphincter procedures (Christiansen and Lorentzen, 1989) have been disappointing. Fecal incontinence is a distressing condition with significant medical, social and economic implications and more sophisticated techniques have been on trial. Currently the most popular surgical technique is sacral nerve stimulation (SRS). As with most invasive surgical procedures complications may occur with infections, wound dehiscence, displacement of stimulation electrodes (Matzel et al., 1995; Weil et al., 1998). Although promising results have been reported the outcome is sometimes unpredictable and variable (Jarret et al., 2004; Kenefick and Christiansen, 2004). Moreover the underlying mechanism of action of SRS remains unclear and the clinical response achieved is referred to as an obscure “neuromodulation” of recto anal function. The results in the present study demonstrate that a significant improvement in anal incontinence can be achieved by means of acupuncture, and that the improvement sometimes remains persistent some time after the cessation of treatment. According to the results of the present study, the effects of an acupuncture session seems to last at least 3 to 6 months, which should therefore be taken to be reasonable period between treatments. The improvement in anal continence was clearly reflected both in the overall bowel habits - expressed in stool frequency, regularity and consistency - and in the faecal continence score, unfortunately, one potential weakness of this study is represented by the lack of quality of life (QOL) evaluation, mainly due to an unsatisfactory patients' compliance. On the other hand, the Cleveland Clinic incontinence score evaluates two items of QOL and an elevation of the QOL score might also reflect a successful adaptation to long-standing symptoms (Wilson, 2007). The improvement of continence was poorly reflected in the manovolumetric markers. Thus while the resting anal pressure – markedly lower than in previous controls (Akervall et al., 1988) increased insignificantly, the squeeze pressure was unaffected as were the thresholds for first sensation and defecation urge. It may be questioned whether the transitory significant increase in the sustained squeeze pressure plays a role in the improvement of the incontinence score, since the score remains good even in the long-term when the anal contraction during manometry returns to the pre-treatment levels. The rectal volume - in all patients significantly larger compared to that in historical controls – also continued to be uninfluenced after acupuncture treatment. There are, in this respect, great similarities with effects obtained through sacral nerve stimulation. Even here the results are poorly reflected in the manovolumetric markers (Table 2): it appears from a systematic review of the scientific literature (Cochrane collaboration,
2007; Jarret et al., 2004; Michelsen et al., 2005) and from larger comprehensive studies (Leroi et al., 2005; Melenhorst et al., 2006; Ganio et al., 2007) that a good clinical response is poorly reflected in manometry results with insignificant changes in sphincter tone, rectal compliance and sensory thresholds. The mechanisms of action are therefore unclear and referred to as “neuromodulation” of rectoanal function. According to the traditional acupuncture-theory “meridians” are connected to the internal organs and needles inserted in certain points influence the flow of vital energy (Qi). Therefore, diseases, due to “disturbances in the energy balance”, can be influenced. This philosophy is not evidenced by the present scientific knowledge, at least in the western society. Therefore explanations of the possible effects should be searched in the background of known biologic conditions. Former experimental studies show that there is a reflex connection between the external skin structure and the internal organ. It is also well documented the possibility of influencing internal organs by skin stimulation. Sato and coworkers made a number of researches on rats to study the reflex connection between skin and internal organ. They recorded the concomitant pressure-changes in the intestine and the activity in the vagus and splanchnic nerve. The stimulation at the abdominal wall reduced the bowel pressure and an increased activity of the sympathetic activity was noted, but on the contrary no changes in the vagus activity were seen. The section of vagus did not influence the elicited intestinal reflex, but the section of the nervi splancnici eliminated it (Sato et al., 1975a). In another study Sato and coworkers studied a skin reflex that influence the urinary bladder. It was found that a mechanical stimulation of the skin of the perineum could double the pressure in the bladder. The reflex disappeared after the section of the hypogastric nerves (Sato et al., 1975b). Table 2 Manometric results Anal pressures (mmHg) pre
post (10 weeks)
18 months
Resting press Squeeze Sustained squeeze (at 15 sec.)
25(17-35) 87(58-117) 41(32-68)
36(20-42) 87(55-132) 60(40-100)⁎
37(18-48) 65(54-118) 45(30-59)
Rectal sensibility (Distension pressure cm H2O) Threshold Urge
15(10-20) 20(20-25)
15(11-20) 20(20-25)
10(9-15) 20(14-21)
348(340-402)
334(299-369)
342(311-358)
Rectal volume (ml) Rectal volume (40 cm H2O dist press) ⁎ p b 0,05.
92
M. Scaglia et al. / Autonomic Neuroscience: Basic and Clinical 145 (2009) 89–92
The impact of somatic afferent stimulation on different effector organs has been considered the common denominator for the beneficial effects achieved by acupuncture. Activation of somatic afferents have been demonstrated to induce the release of neuropeptides important for the pain-relieving effect of acupuncture (Sjölund et al., 1977) Peripheral circulation is increased by acupuncture (Lundeberg et al., 1988; Jansen et al., 1989) due to activation of depressor afferents, reducing blood pressure by inhibition of Vasomotor Centrum, (Andersson and Lundeberg, 1995). Somatic afferent stimulation in the perineal region induces changes in bladder function and sphincter activity and acupuncture is often successful in modulation bladder instability and or incontinence (Fall et al., 1980). Considering that fecal incontinence involves disturbance in the complex interplay of stool volume, consistency and transit through the colon, rectal distensibility, anorectal perception, excretion and retention, or any combination of these factors, the result of the present study would imply that the beneficial effect of acupuncture presented in this study might well be a combined effect of “neuromodulation” both of the recto-anal function and colonic function. The study did not address the question wheter electroacupuncture might be even better than manual acupuncture. However ongoing studies on our patients are showing that the electro-acupuncture (ea) of the lower abdominal area (3 cm and 10 cm below the umbilicus) on the midline, can induce significant changes in the anal pressure recordings. Ea and traditional chinese acupuncture treatment when compared are both associated with a significant rise in plasma beta-endorphins concentrations (Ulett et al., 1998). When investigate by comparison of functional magnetic resonance they show both an activation of the limbic system , however there are some differences in the underlying neurobiologic mechanism (Napadow et al., 2005). It might be argued that spontaneous remissions and/or placebo effects may contribute to the positive results obtained. Whether or not these effects later can be shown to have such origin, the encouraging results demonstrated in the present study strongly indicate that acupuncture is still clinically useful and can be recommended for the treatment of anal incontinence. However, a randomized prospective trial comparing acupuncture and sacral neuro-modulation is needed. References Akervall, S., Nordgren, S., Fasth, S., Hultén, L., Oresland, T., 1988. Manovolumetry- a new method for investigation of anorectal function. Gut 29, 614–623. Altomare, D.F., Binda, G.A., Dodi, G., La Torre, F., Romano, G., Rinaldi, M., Melega, E., 2004. Disappointing long-term results of the artificial anal sphincter for faecal incontinence. Br J Surg 91 (10), 1352–1353.
Andersson, S., Lundeberg, T., 1995. Acupuncture-from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses Sep 45 (3), 271–281. Baeten, C., Spaans, F., Fluks, A., 1988. An implanted neuromuscular stimulator for fecal continence following previously implanted gracilis muscle. Report of a case. Dis Colon Rectum 31 (2), 134–137. Christiansen, J., Lorentzen, M., 1989. Implantation of artificial sphincter for anal incontinence. Report of five cases. Dis Colon Rectum 32, 432–436. Fall, M., Carlsson, C.A., Erlandson, B.E., 1980. Electrical stimulation in interstitial cystitis. J Urol 123, 1921–2001. Ganio, E., et al., for GINS (Italian Sacral Nerve Stimulation Group), 2007. Sacral nerve modulation for fecal incontinence. Functional results and assessment of the Quality of Life. http//www.colorep.it/RivistaCEC/sacral_nerve_modulation_for_feca.htm. Jansen, G., Lundeberg, T., Samuelson, U.E., Thomas, M., 1989. Increased survival of ischaemic musculocutaneous flaps in rats after acupuncture. Acta Physiol Scand 135 (4), 555–558. Jarret, M.E., Mowatt, G., Glazener, C.M., Fraser, C., Nicholls, R.J., Grant, A.M., Kamm, M.A., 2004. Systematic review of sacral nerve stimulation for fecal incontinence and constipation. Br J Surg Sep 29 (epub). Kenefick, N.J., Christiansen, J., 2004. A review of sacral nerve stimulation for the treatment of faecal incontinence. Colorectal Dis 6 (2), 75–80. Leroi, A.M., Parc, Y., Lehur, P.A., Mion, F., Barth, X., Rullier, E., Bresler, L., Portier, G., Michot, F., Study Group, 2005. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg 242 (5), 662–669. Lundeberg, T., Kjartansson, J., Samuelsson, U., 1988. Effect of electrical nerve stimulation on healing of ischaemic skin flaps. Lancet 24 (2(8613)), 712–714. Maciocia, G., 1994. The practice of Chinese medicine: the treatment of diseases with acupuncture and chinese herbs ed. Churchill Livingston, London. It. transl. Casa editrice ambrosiana pp. 463-477. Matzel, K.E., Stadelmaler, U., Hohenfellner, M., Gall, F.P., 1995. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet 346, 1124–1127. Melenhorst, J., Koch, S.M., Uludag, Ö., van Gemert, W.G., Baeten, C.G., 2006. Sacral neuromodulation in patients with faecal incontinence: results of the first 100 permanent implantations. Colorectal Dis 9, 725–730. Michelsen, H.B., Buntzen, S., Krogh, K., Laurberg, S.R., 2005. Rectal volume tolerability and anal pressures in patients with fecal incontinence treated with sacral nerve stimulation. Dis Colon Rectum 49, 1039–1044. Mowatt, G., Glazener, C., Jarrett, M., 2007. Sacral nerve stimulation for faecal incontinence and constipation in adults (Review). The Cochrane Collaboration. The Cochrane Library 2007. Issue 3. Napadow, V., Makris, N., Liu J Kettner, N.W., Kwong, K.K., Hui, K.K., 2005. Effects of electroacupuncture versus manual acupuncture on the human brain as measured by fMRI. Hum Brain Mapp 24 (3), 193–205. Sato, A., Sato, Y., Shimada, F., Torigata, Y., 1975a. Changes in gastric motility produced by nociceptive stimulation of the skin in rats. Brain Res 87, 151–159. Sato, A., Sato, Y., Shimada, F., Torigata, Y., 1975b. Changes in vesical function produced by cutaneous stimulation in rats. Brain Res 94, 465–474. Sjölund, B., Terenius, L., Eriksson, M., 1977. Increased cerebrospinal fluid levels of endorphins after electro-acupuncture. Acta Physiol Scand 100 (3), 382–384. Ulett, G.A., Han, S., Han, J.S., 1998. Electroacupuncture: mechanisms and clinical application. Biol Psychiatry 15 (44829), 129–138. Weil, E.H., Ruiz-Credo, J.L., Eedmans, P.H.A., Janknegt, R.A., Van Kerrebrock, P.E.V.A., 1998. Clinical results of sacral neuromodulation for chronic voiding dysfunction using unilateral sacral foramen electrodes. World J Urol 16, 313–321. Wilson, M., 2007. The impact of faecal incontinence on the quality of life. Feb 22-Mar 7; 16 (4):204-207.
Contents lists available at ScienceDirect
Autonomic Neuroscience: Basic and Clinical j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / a u t n e u
Fecal incontinence treated with acupuncture - a pilot study Marco Scaglia a,⁎, GianGaetano Delaini b, Ines Destefano a, Leif Hultén c a b c
University of Turin – School of Medicine, Section of General Surgery, S. Luigi Hospital, Orbassano, Italy Department of Surgical Sciences, Section C of General Surgery, University of Verona, Italy Sahlgrenska University Hospital – Institute for Surgical Science, Goteborg, Sweden
a r t i c l e
i n f o
Article history: Received 28 April 2008 Received in revised form 28 September 2008 Accepted 13 October 2008 Keywords: Acupuncture Fecal incontinence Sacral neuromodulation Somatic afferents Anorectal manometry
a b s t r a c t Objectives: Acupuncture has been used successfully for the treatment of urinary bladder dysfunction. The aim of this study was therefore to investigate if manual acupuncture might also affect fecal incontinence favorably. Methods: The study comprises 15 female patients, median age 60 years (39 -75). Before treatment and at regular intervals after acupuncture sessions the defects of anal continence were assessed. Ano-rectal function was assessed by means of recto anal manovolumetry. Each patient was submitted to one acupuncture treatment per week for a ten-week period. Subsequently, a control session was repeated once per month up to 7 months for six patients. A final functional assessment was performed at 18 months. Result: Patients experienced a significant improvement in anal continence, the overall continence score which changed from 10 (3 -21) estimated before treatment to zero (0 - 7) (p b 0.05) at 10 weeks. Patients with irregular bowel habits and/or loose stools reported significant improvement. On the manovolumetric variables a limited increase of resting from 25 (17-35) mmHg to 36 (20-42) mmHg, (p = 0.05) and sustained squeeze anal pressure, changing from 41 (32-68) mmHg to 60 (40-100) mmHg (p b 0.05) were reported. Rectal sensory function remained unchanged. Conclusion: Acupuncture offers good opportunities for improving fecal incontinence. The mechanism of action is obscure but might be an effect of the “neuromodulation” of the recto-anal function similar to that explaining the favorable results achieved by sacral nerve stimulation. The concomitant regulation of disordered bowel habits may also contribute to the satisfactory results. © 2008 Elsevier B.V. All rights reserved.
Fecal incontinence is a distressing condition with significant medical, social and economic implications. Conservative measures including constipating drugs, behavioral therapy, anal plugs and injectable bulking agents have a low success rate. Results after dynamic graciloplasty (Baeten et al., 1988) and the artificial anal sphincter procedures (Christiansen and Lorentzen, 1989) have been disappointing and the techniques have both been abandoned in many places (Altomare et al., 2004) The currently most popular surgical technique is sacral nerve stimulation (SRS). As with most invasive surgical procedures, complications may occur with infections, wound dehiscence or displacement of stimulation electrodes (Matzel et al., 1995; Weil et al., 1998). Although promising results have been reported, the outcome is sometimes unpredictable and variable (Jarret et al., 2004). As the underlying mechanism of action of SRS remains unclear, the clinical improvement achieved is referred to as “neuromodulation” of recto anal function.
⁎ Corresponding author. The Colorectal Unit, Sahlgrenska University Hospital/ Östra Hospital, SE-416 85 Göteborg, Sweden. E-mail address: [email protected] (M. Scaglia). 1566-0702/$ – see front matter © 2008 Elsevier B.V. All rights reserved. doi:10.1016/j.autneu.2008.10.014
There is convincing evidence that the ancient Chinese method of acupuncture – apart from its pain-relieving effect and regulation of the peripheral circulation - influences favorably urinary bladder dysfunction and even gastrointestinal dysfunction (Andersson and Lundeberg, 1995). The aim of the present study has therefore been to investigate whether and, if so, to what extent acupuncture might influence fecal incontinence and the length of time it is effective after a treatment session. 1. Patients and Methods Fifteen females with fecal incontinence lasting for at least one year (median age 60 years, range 39-75), attending the outpatient clinic of the surgical department of San Luigi Hospital Orbassano (Italy), were invited to participate in the study. They had all been treated conservatively (constipating drugs, behavioral therapy ) but the attempts had failed. Details of their obstetric history and previous operations were recorded. 9 females (57%) reported a perineal tear during the delivery and 5 had had an episiotomy. 13 patients had a history of pelvic or anal surgery (hemorrhoidectomy, 3; pelvic floor repair, 3) and 7 had had a
90
M. Scaglia et al. / Autonomic Neuroscience: Basic and Clinical 145 (2009) 89–92
Table 1 Cleveland Clinic Continence score
Occasional N 1/week Daily
Flatus
Liquid stools
Solidstools
Pad
1 2 3
4 5 6
7 8 9
0 1 2
The sum of continence defects may be interpreted as follows: IC 0 = perfect continence, IC 1-7 = good continence, IC 8-14 moderate incontinence, IC 15-20 severe incontinence.
hysterectomy. Before treatment anal endosonography was available in 8 cases and 4 cases presented defects of the internal and/or external sphincter, (intact sphincters did not represent an inclusion criteria) the study of the peripheral pudendal latency was done in 6 cases and it was delayed in 4 (= or N2.5 sec.). A detailed history of patients' bowel habits was taken with specific notes being made regarding incontinence in the case of solid stool, liquid stool and flatus, together with the frequency of incontinence, the need for using a pad and the social impact of incontinence in general. For the purpose of the analysis, the Cleveland Clinic continence score was used (Table 1). The standard barostatic anorectal manovolumetry (Akervall et al., 1988) was performed in the left lateral position, before, and at intervals after treatment according to the following schedule. Each patient was submitted to one acupuncture treatment per week for a ten-week period. In occasion of the last treatment, the incontinence score was re-evaluated and manovolumetry was carried out. Subsequently, one control with a new acupuncture session was repeated once per month in six patients (an incontinence score was calculated every time) for a period of 7 months, this is called as “intermediate control”. A final functional assessment, with a new ano-rectal manovolumetry, was performed at 18 months. 1.1. The manual acupuncture procedure One and the same person (MS), well trained in the procedure, performed the acupuncture. Sterile disposable, stainless wire acupuncture needles with copper wire handle, 40 mm long and 0.3 mm in diameter were inserted, gently stimulated by rotation and then left in place for twenty minutes. The selection and the localization of these points on trial was, to a limited extent, based on traditional Chinese medicine (TCM) (Maciocia, 1994) by using the following points: 3 RM (Zhong ji), 6 RM (Qi Hai), localized respectively on the midline of the lower abdomen, 4 DM (Ming Men), 23 BL (Shen Shu) on the lumbar region, 32 BL (Ci Liao) on the the 2nd sacral foramen , 4 LI (He Gu) on the hand between the first and second metacarpal bone, 36 ST (Zu San Li) outer side of the leg below the knee, and 3 K (Tai Xi) inner side of the ankle.
when assessed at a later stage (18 months) they still scored favorably, median score 1 (0-6). When entering the acupuncture sessions the incontinence was rated less severe (flatus and/or soiling) in the remaining six patients, mean score 4 (3-5). At 10 weeks they had also improved as reflected in a median score of 0 (0-0). The improvement - clearly observed after the third acupuncture treatment - sometimes remains persistent a long time after cessation of treatment. Sporadic episodes of soiling were observed, mainly associated with irregularity in bowel movements, in patients regularly checked for a seven-month period after the completion of acupuncture. 2.2. Bowel habits As shown in Fig. 2 the majority of patients suffering irregularity in bowel habits when entering the study had improved significantly at 10 weeks and quite a few remained so even at longer follow up. At 18 months bowel habits still remained regular in eight of the 14 patients and all but two had firm stools. 2.3. Manovolumetric results At 10 weeks after acupuncture resting anal pressure had increased from 25 (17-35) mmHg to 36 (20-42) mmHg, (p= 0.05) (Table 2). While maximal sphincter squeeze pressure remained uninfluenced, the ability to sustain the squeeze pressure increased from 41 (32-68) mmHg to 60 (40-100) mmHg (pb 0.05). The first sensation of rectal filling was absent or blunted in 6 patients at start of the acupuncture sessions and the experience of the defecation urge blunt or absent in two patients. These defects in rectal sensory function remained unchanged. The average rectal volume 348 (340-402) ml also remained unchanged. At 18 months resting anal pressure was still well retained whereas the ability to sustain the anal squeeze had returned to pre-treatment levels. Rectal volume and the rectal sensory variables were unchanged. 3. Discussion Apart from the control of the anal sphincters, anal continence is dependent on the complex interplay of stool volume, fecal consistency and transit through the colon, rectal compliance, ano-rectal perception, or any combination of these factors. Moreover ano-rectal function appears also to be under supra-spinal control and is regulated by the close interaction of the autonomic and somatic nerve systems. It may
1.2. Statistical analysis Results are presented as a median and interquartile range. Statistics were made using Student Fisher t-test (p b 0.05). 2. Results 2.1. Anal incontinence The overall mean continence score in the 15 patients changed from 10 (3 -21) estimated before treatment to zero (0 - 7) (p b 0.05) at 10 weeks, reflecting a significant improvement in continence. The continence index available in 14 patients at about 18 months after start of treatment was 1 (0-8) (p b 0.05) (Fig. 1). Before acupuncture frank fecal incontinence occurred in nine of the 15 patients exhibiting a median incontinence score of 17 (9-18). After 10 weeks treatment they had improved significantly with a median score of 0 (0-3) and
Fig. 1. Individual fecal incontinence score before and at intervals after acupuncture sessions.
M. Scaglia et al. / Autonomic Neuroscience: Basic and Clinical 145 (2009) 89–92
91
Fig. 2. Bowel habits (left panel) and stool consistency (right panel) before and after acupuncture.
therefore not be surprising that results after dynamic graciloplasty (Baeten et al., 1988) and other artificial anal sphincter procedures (Christiansen and Lorentzen, 1989) have been disappointing. Fecal incontinence is a distressing condition with significant medical, social and economic implications and more sophisticated techniques have been on trial. Currently the most popular surgical technique is sacral nerve stimulation (SRS). As with most invasive surgical procedures complications may occur with infections, wound dehiscence, displacement of stimulation electrodes (Matzel et al., 1995; Weil et al., 1998). Although promising results have been reported the outcome is sometimes unpredictable and variable (Jarret et al., 2004; Kenefick and Christiansen, 2004). Moreover the underlying mechanism of action of SRS remains unclear and the clinical response achieved is referred to as an obscure “neuromodulation” of recto anal function. The results in the present study demonstrate that a significant improvement in anal incontinence can be achieved by means of acupuncture, and that the improvement sometimes remains persistent some time after the cessation of treatment. According to the results of the present study, the effects of an acupuncture session seems to last at least 3 to 6 months, which should therefore be taken to be reasonable period between treatments. The improvement in anal continence was clearly reflected both in the overall bowel habits - expressed in stool frequency, regularity and consistency - and in the faecal continence score, unfortunately, one potential weakness of this study is represented by the lack of quality of life (QOL) evaluation, mainly due to an unsatisfactory patients' compliance. On the other hand, the Cleveland Clinic incontinence score evaluates two items of QOL and an elevation of the QOL score might also reflect a successful adaptation to long-standing symptoms (Wilson, 2007). The improvement of continence was poorly reflected in the manovolumetric markers. Thus while the resting anal pressure – markedly lower than in previous controls (Akervall et al., 1988) increased insignificantly, the squeeze pressure was unaffected as were the thresholds for first sensation and defecation urge. It may be questioned whether the transitory significant increase in the sustained squeeze pressure plays a role in the improvement of the incontinence score, since the score remains good even in the long-term when the anal contraction during manometry returns to the pre-treatment levels. The rectal volume - in all patients significantly larger compared to that in historical controls – also continued to be uninfluenced after acupuncture treatment. There are, in this respect, great similarities with effects obtained through sacral nerve stimulation. Even here the results are poorly reflected in the manovolumetric markers (Table 2): it appears from a systematic review of the scientific literature (Cochrane collaboration,
2007; Jarret et al., 2004; Michelsen et al., 2005) and from larger comprehensive studies (Leroi et al., 2005; Melenhorst et al., 2006; Ganio et al., 2007) that a good clinical response is poorly reflected in manometry results with insignificant changes in sphincter tone, rectal compliance and sensory thresholds. The mechanisms of action are therefore unclear and referred to as “neuromodulation” of rectoanal function. According to the traditional acupuncture-theory “meridians” are connected to the internal organs and needles inserted in certain points influence the flow of vital energy (Qi). Therefore, diseases, due to “disturbances in the energy balance”, can be influenced. This philosophy is not evidenced by the present scientific knowledge, at least in the western society. Therefore explanations of the possible effects should be searched in the background of known biologic conditions. Former experimental studies show that there is a reflex connection between the external skin structure and the internal organ. It is also well documented the possibility of influencing internal organs by skin stimulation. Sato and coworkers made a number of researches on rats to study the reflex connection between skin and internal organ. They recorded the concomitant pressure-changes in the intestine and the activity in the vagus and splanchnic nerve. The stimulation at the abdominal wall reduced the bowel pressure and an increased activity of the sympathetic activity was noted, but on the contrary no changes in the vagus activity were seen. The section of vagus did not influence the elicited intestinal reflex, but the section of the nervi splancnici eliminated it (Sato et al., 1975a). In another study Sato and coworkers studied a skin reflex that influence the urinary bladder. It was found that a mechanical stimulation of the skin of the perineum could double the pressure in the bladder. The reflex disappeared after the section of the hypogastric nerves (Sato et al., 1975b). Table 2 Manometric results Anal pressures (mmHg) pre
post (10 weeks)
18 months
Resting press Squeeze Sustained squeeze (at 15 sec.)
25(17-35) 87(58-117) 41(32-68)
36(20-42) 87(55-132) 60(40-100)⁎
37(18-48) 65(54-118) 45(30-59)
Rectal sensibility (Distension pressure cm H2O) Threshold Urge
15(10-20) 20(20-25)
15(11-20) 20(20-25)
10(9-15) 20(14-21)
348(340-402)
334(299-369)
342(311-358)
Rectal volume (ml) Rectal volume (40 cm H2O dist press) ⁎ p b 0,05.
92
M. Scaglia et al. / Autonomic Neuroscience: Basic and Clinical 145 (2009) 89–92
The impact of somatic afferent stimulation on different effector organs has been considered the common denominator for the beneficial effects achieved by acupuncture. Activation of somatic afferents have been demonstrated to induce the release of neuropeptides important for the pain-relieving effect of acupuncture (Sjölund et al., 1977) Peripheral circulation is increased by acupuncture (Lundeberg et al., 1988; Jansen et al., 1989) due to activation of depressor afferents, reducing blood pressure by inhibition of Vasomotor Centrum, (Andersson and Lundeberg, 1995). Somatic afferent stimulation in the perineal region induces changes in bladder function and sphincter activity and acupuncture is often successful in modulation bladder instability and or incontinence (Fall et al., 1980). Considering that fecal incontinence involves disturbance in the complex interplay of stool volume, consistency and transit through the colon, rectal distensibility, anorectal perception, excretion and retention, or any combination of these factors, the result of the present study would imply that the beneficial effect of acupuncture presented in this study might well be a combined effect of “neuromodulation” both of the recto-anal function and colonic function. The study did not address the question wheter electroacupuncture might be even better than manual acupuncture. However ongoing studies on our patients are showing that the electro-acupuncture (ea) of the lower abdominal area (3 cm and 10 cm below the umbilicus) on the midline, can induce significant changes in the anal pressure recordings. Ea and traditional chinese acupuncture treatment when compared are both associated with a significant rise in plasma beta-endorphins concentrations (Ulett et al., 1998). When investigate by comparison of functional magnetic resonance they show both an activation of the limbic system , however there are some differences in the underlying neurobiologic mechanism (Napadow et al., 2005). It might be argued that spontaneous remissions and/or placebo effects may contribute to the positive results obtained. Whether or not these effects later can be shown to have such origin, the encouraging results demonstrated in the present study strongly indicate that acupuncture is still clinically useful and can be recommended for the treatment of anal incontinence. However, a randomized prospective trial comparing acupuncture and sacral neuro-modulation is needed. References Akervall, S., Nordgren, S., Fasth, S., Hultén, L., Oresland, T., 1988. Manovolumetry- a new method for investigation of anorectal function. Gut 29, 614–623. Altomare, D.F., Binda, G.A., Dodi, G., La Torre, F., Romano, G., Rinaldi, M., Melega, E., 2004. Disappointing long-term results of the artificial anal sphincter for faecal incontinence. Br J Surg 91 (10), 1352–1353.
Andersson, S., Lundeberg, T., 1995. Acupuncture-from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses Sep 45 (3), 271–281. Baeten, C., Spaans, F., Fluks, A., 1988. An implanted neuromuscular stimulator for fecal continence following previously implanted gracilis muscle. Report of a case. Dis Colon Rectum 31 (2), 134–137. Christiansen, J., Lorentzen, M., 1989. Implantation of artificial sphincter for anal incontinence. Report of five cases. Dis Colon Rectum 32, 432–436. Fall, M., Carlsson, C.A., Erlandson, B.E., 1980. Electrical stimulation in interstitial cystitis. J Urol 123, 1921–2001. Ganio, E., et al., for GINS (Italian Sacral Nerve Stimulation Group), 2007. Sacral nerve modulation for fecal incontinence. Functional results and assessment of the Quality of Life. http//www.colorep.it/RivistaCEC/sacral_nerve_modulation_for_feca.htm. Jansen, G., Lundeberg, T., Samuelson, U.E., Thomas, M., 1989. Increased survival of ischaemic musculocutaneous flaps in rats after acupuncture. Acta Physiol Scand 135 (4), 555–558. Jarret, M.E., Mowatt, G., Glazener, C.M., Fraser, C., Nicholls, R.J., Grant, A.M., Kamm, M.A., 2004. Systematic review of sacral nerve stimulation for fecal incontinence and constipation. Br J Surg Sep 29 (epub). Kenefick, N.J., Christiansen, J., 2004. A review of sacral nerve stimulation for the treatment of faecal incontinence. Colorectal Dis 6 (2), 75–80. Leroi, A.M., Parc, Y., Lehur, P.A., Mion, F., Barth, X., Rullier, E., Bresler, L., Portier, G., Michot, F., Study Group, 2005. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg 242 (5), 662–669. Lundeberg, T., Kjartansson, J., Samuelsson, U., 1988. Effect of electrical nerve stimulation on healing of ischaemic skin flaps. Lancet 24 (2(8613)), 712–714. Maciocia, G., 1994. The practice of Chinese medicine: the treatment of diseases with acupuncture and chinese herbs ed. Churchill Livingston, London. It. transl. Casa editrice ambrosiana pp. 463-477. Matzel, K.E., Stadelmaler, U., Hohenfellner, M., Gall, F.P., 1995. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet 346, 1124–1127. Melenhorst, J., Koch, S.M., Uludag, Ö., van Gemert, W.G., Baeten, C.G., 2006. Sacral neuromodulation in patients with faecal incontinence: results of the first 100 permanent implantations. Colorectal Dis 9, 725–730. Michelsen, H.B., Buntzen, S., Krogh, K., Laurberg, S.R., 2005. Rectal volume tolerability and anal pressures in patients with fecal incontinence treated with sacral nerve stimulation. Dis Colon Rectum 49, 1039–1044. Mowatt, G., Glazener, C., Jarrett, M., 2007. Sacral nerve stimulation for faecal incontinence and constipation in adults (Review). The Cochrane Collaboration. The Cochrane Library 2007. Issue 3. Napadow, V., Makris, N., Liu J Kettner, N.W., Kwong, K.K., Hui, K.K., 2005. Effects of electroacupuncture versus manual acupuncture on the human brain as measured by fMRI. Hum Brain Mapp 24 (3), 193–205. Sato, A., Sato, Y., Shimada, F., Torigata, Y., 1975a. Changes in gastric motility produced by nociceptive stimulation of the skin in rats. Brain Res 87, 151–159. Sato, A., Sato, Y., Shimada, F., Torigata, Y., 1975b. Changes in vesical function produced by cutaneous stimulation in rats. Brain Res 94, 465–474. Sjölund, B., Terenius, L., Eriksson, M., 1977. Increased cerebrospinal fluid levels of endorphins after electro-acupuncture. Acta Physiol Scand 100 (3), 382–384. Ulett, G.A., Han, S., Han, J.S., 1998. Electroacupuncture: mechanisms and clinical application. Biol Psychiatry 15 (44829), 129–138. Weil, E.H., Ruiz-Credo, J.L., Eedmans, P.H.A., Janknegt, R.A., Van Kerrebrock, P.E.V.A., 1998. Clinical results of sacral neuromodulation for chronic voiding dysfunction using unilateral sacral foramen electrodes. World J Urol 16, 313–321. Wilson, M., 2007. The impact of faecal incontinence on the quality of life. Feb 22-Mar 7; 16 (4):204-207.